Table Of Contents of the INDEX

 

Allergenic product
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(b) DEFINITIONS. - paragraph (2)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (2)
Automated Concept:

PROTEIN, allergenic product ;   Paragraph, so designated, inserting

Index of Sec 2575. ...

Analytic files
Sec 2571. -- National Medical Device Registry.
(3) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (B)
Automated Concept:

ANALYTIC files allowing for pooling and analysis of data from disparate data environments, electronic health records and other data deemed appropriate by Secretary ;   Standardizing

Index of Sec 2571. ...

Antitrust law
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) FINDINGS. - paragraph (F)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (F)
Automated Concept:

ANTITRUST law relating to settlement agreements unsettled ;   State of

Index of Sec 2573. ...

Assessment of device safety and effectiveness:
Sec 2571. -- National Medical Device Registry.
(3) - paragraph (A) - paragraph (i) - paragraph (III)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (A) (i) (III)
Automated Concept:

ASSESSMENT of device safety and effectiveness ;   Other data as Secretary deeming necessary to permit postmarket

Index of Sec 2571. ...

Biological product
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(10) NAMING.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (10)
Automated Concept:

BIOLOGICAL product licensed under subsection bearing name ;   Secretary ensuring that labeling and packaging of

Index of Sec 2575. ...
(i) REQUIRED INFORMATION. - paragraph (I)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I)
Automated Concept:

BIOLOGICAL product being biosimilar to reference product based upon data derived  ;  

Index of Sec 2575. ...
(i) REQUIRED INFORMATION. - paragraph (I) - paragraph (aa)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I) (aa)
Automated Concept:

BIOLOGICAL product being highly similar to reference product notwithstanding minor differences in clinically inactive components ;   Analytical studies demonstrating that

Index of Sec 2575. ...
(i) REQUIRED INFORMATION. - paragraph (I) - paragraph (cc)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I) (cc)
Automated Concept:

BIOLOGICAL product ;   Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for

Index of Sec 2575. ...
(i) REQUIRED INFORMATION. - paragraph (III)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (III)
Automated Concept:

BIOLOGICAL product previously approved for reference product ;   Condition or conditions of use prescribed, recommended or suggested in labeling proposed for

Index of Sec 2575. ...
(i) REQUIRED INFORMATION. - paragraph (V)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (V)
Automated Concept:

BIOLOGICAL product continuing to be safe ;   Facility in which biological product manufactured, processed, packed or holding meeting standards designed to assure that

Index of Sec 2575. ...
(iii) ADDITIONAL INFORMATION. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (iii) (II)
Automated Concept:

BIOLOGICAL product ;   Including additional information in support of application including publicly available information with respect to reference product or another

Index of Sec 2575. ...
(B) INTERCHANGEABILITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (B)
Automated Concept:

BIOLOGICAL product meeting standards described in paragraph ;   Application submitted under subsection including information demonstrating that

Index of Sec 2575. ...
(3) EVALUATION BY SECRETARY. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (3) (A)
Automated Concept:

BIOLOGICAL product ;   Secretary determining that information submitted in application being sufficient to show that

Index of Sec 2575. ...
(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (4)
Automated Concept:

BIOLOGICAL product to be interchangeable with reference product if Secretary determining that information submitted in application being sufficient to show ;   Secretary determining

Index of Sec 2575. ...
(A) ONE REFERENCE PRODUCT PER APPLICATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (A)
Automated Concept:

BIOLOGICAL product not to be evaluated against more than 1 reference product  ;  

Index of Sec 2575. ...
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D) (ii)
Automated Concept:

BIOLOGICAL product under subsection unless Secretary determining to be no increased risk to security or health of public from licensing biological product under subsection ;   Secretary not licensing

Index of Sec 2575. ...
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (A)
Automated Concept:

BIOLOGICAL product to be approved as interchangeable for reference product ;   1 year after first commercial marketing of first interchangeable biosimilar

Index of Sec 2575. ...
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (B) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (B) (i)
Automated Concept:

BIOLOGICAL product ;   Final court decision on patents in suit in action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar

Index of Sec 2575. ...
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (B) (ii)
Automated Concept:

BIOLOGICAL product ;   Dismissal withor without prejudice of action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar

Index of Sec 2575. ...
(C) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (C) (i)
Automated Concept:

BIOLOGICAL product if applicant submitting application sued under subsection and litigation being still ongoing within 42-month period ;   42 months after approval of first interchangeable biosimilar

Index of Sec 2575. ...
(C) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (C) (ii)
Automated Concept:

BIOLOGICAL product if applicant submitting application not sued under subsection ;   18 months after approval of first interchangeable biosimilar

Index of Sec 2575. ...
(C) FIRST LICENSURE. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (7) (C) (ii)
Automated Concept:

BIOLOGICAL product being reference product ;   Subsequent application filed by same sponsor or manufacturer of

Index of Sec 2575. ...
(C) FIRST LICENSURE. - paragraph (ii) - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (7) (C) (ii) (II)
Automated Concept:

BIOLOGICAL product not resulting in change in safety, purity or potency ;   Modification to structure of

Index of Sec 2575. ...
(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (D) (ii)
Automated Concept:

BIOLOGICAL product meeting standards described in paragraph ;   Criteria that Secretary using to determine whether

Index of Sec 2575. ...
(1) DEFINITIONS. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (A)
Automated Concept:

BIOLOGICAL product being subject of application under subsection ;   Biosimilar product meaning

Index of Sec 2575. ...
(b) DEFINITIONS. - paragraph (3) - paragraph (2) - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (3) Quoted: (2) (A)
Automated Concept:

BIOLOGICAL product being highly similar to reference product notwithstanding minor differences in clinically inactive components  ;  

Index of Sec 2575. ...
(b) DEFINITIONS. - paragraph (3) - paragraph (3)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (3) Quoted: (3)
Automated Concept:

BIOLOGICAL product being shown to meet standards described in subsection ;   Reference to

Index of Sec 2575. ...
(b) DEFINITIONS. - paragraph (3) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (3) Quoted: (4)
Automated Concept:

BIOLOGICAL product evaluated in application submitted under subsection ;   Term reference product meaning single biological product licensed under subsection against

Index of Sec 2575. ...
(1) REQUIREMENT TO FOLLOW SECTION 351.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (1)
Automated Concept:

BIOLOGICAL product to be submitted under section 351 of Public Health Service Act 42 USC 262 ;   Application for

Index of Sec 2575. ...
(2) EXCEPTION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (2)
Automated Concept:

BIOLOGICAL product to be submitted under section 505 of Federal Food, Drug ;   Application for

Index of Sec 2575. ...
(2) EXCEPTION. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (2) (A)
Automated Concept:

BIOLOGICAL product in product class being subject of application approved under section 505 not later than date of enactment of Act ;   Biological product in product class For which

Index of Sec 2575. ...
(3) LIMITATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (3)
Automated Concept:

BIOLOGICAL product not to be submitted under section 505 of Federal Food, Drug and Cosmetic Act 21 USC 355 ;   Application for

Index of Sec 2575. ...
(4) DEEMED APPROVED UNDER SECTION 351.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (4)
Automated Concept:

BIOLOGICAL product under section 351 on date being 10 years after date of enactment of Act ;   Approved application for biological product under section 505 of Federal Food, Drug and Cosmetic Act 21 USC 355 to be deemed to be license for

Index of Sec 2575. ...
(5) DEFINITIONS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (5)
Automated Concept:

BIOLOGICAL product having meaning given term under section 351 of Public Health Service Act 42 USC 262 ;   Term

Index of Sec 2575. ...
Sec 2577. -- Amendments To Certain Patent Provisions.
SEC 2577. -- AMENDMENTS TO CERTAIN PATENT PROVISIONS. - paragraph (a) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2577. (a) (4)
Automated Concept:

BIOLOGICAL product claimed in patent or use of which claimed in patent before expiration of patent ;   Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of

Index of Sec 2577. ...

Biological product and reference product
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (II)
Automated Concept:

BIOLOGICAL product and reference product utilizing same mechanism or mechanisms of action for condition or conditions of use prescribed, recommended or suggested in proposed labeling  ;  

Index of Sec 2575. ...
(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY. - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (4) (B)
Automated Concept:

BIOLOGICAL product and reference product being not greater than risk of using reference product without ;   Risk in terms of safety or diminished efficacy of alternating or switching between use of

Index of Sec 2575. ...

Biological product: prior
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6)
Automated Concept:

BIOLOGICAL product receiving determination of interchangeability for condition of use ;   Review of application submitted under subsection relying on same reference product For which prior

Index of Sec 2575. ...

Biological product: single
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(b) DEFINITIONS. - paragraph (3) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (3) Quoted: (4)
Automated Concept:

BIOLOGICAL product evaluated in application submitted under subsection ;   Term reference product meaning single biological product licensed under subsection against

Index of Sec 2575. ...

Biological products
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(10) NAMING.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (10)
Automated Concept:

BIOLOGICAL products licensed under subsection following evaluation against reference product ;   Reference product and other

Index of Sec 2575. ...
(C) RISK EVALUATION AND MITIGATION STRATEGIES.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (C)
Automated Concept:

BIOLOGICAL products licensed under subsection in same manner as authority applying to biological products licensed under subsection ;   Authority of Secretary with respect to risk evaluation and mitigation strategies under Federal Food, Drug and Cosmetic Act applying to

Index of Sec 2575. ...
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D)
Automated Concept:

BIOLOGICAL products containing dangerous ingredients ;   Restrictions on

Index of Sec 2575. ...
Sec 2576. -- Fees Relating To Biosimilar Biological Products.
SEC 2576. -- FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2576.
Automated Concept:

BIOLOGICAL products ;   Fees relating to BIOSIMILAR

Index of Sec 2576. ...

Biosimilar
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (I)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I)
Automated Concept:

BIOSIMILAR to reference product based upon data derived ;   Biological product being

Index of Sec 2575. ...

Biosimilar: first approved interchangeable
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (B) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (B) (i)
Automated Concept:

BIOLOGICAL product ;   Final court decision on patents in suit in action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar

Index of Sec 2575. ...
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (B) (ii)
Automated Concept:

BIOLOGICAL product ;   Dismissal withor without prejudice of action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar

Index of Sec 2575. ...

Biosimilar: first interchangeable
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (A)
Automated Concept:

BIOLOGICAL product to be approved as interchangeable for reference product ;   1 year after first commercial marketing of first interchangeable biosimilar

Index of Sec 2575. ...
(C) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (C) (i)
Automated Concept:

BIOLOGICAL product if applicant submitting application sued under subsection and litigation being still ongoing within 42-month period ;   42 months after approval of first interchangeable biosimilar

Index of Sec 2575. ...
(C) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (C) (ii)
Automated Concept:

BIOLOGICAL product if applicant submitting application not sued under subsection ;   18 months after approval of first interchangeable biosimilar

Index of Sec 2575. ...

Biosimilar product
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (A)
Automated Concept:

BIOLOGICAL product being subject of application under subsection ;   Biosimilar product meaning

Index of Sec 2575. ...
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (ii)
Automated Concept:

BIOSIMILAR product ;   Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns

Index of Sec 2575. ...
(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (D) (i)
Automated Concept:

BIOSIMILAR product and requesting Secretary not to grant final approval of application before date of expiration of noticed patent ;   Applicant not commencing marketing of

Index of Sec 2575. ...
(i) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANT AND REFERENCE PRODUCT SPONSOR.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (A) (i)
Automated Concept:

BIOSIMILAR product applicant under subsection and reference product sponsor entering into agreement described in subparagraph  ;  

Index of Sec 2575. ...
(B) SUBJECT MATTER OF AGREEMENT. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (B) (i)
Automated Concept:

BIOSIMILAR product applicant under subsection and reference product sponsor or 2 or more biosimilar product applicants under subsection regarding manufacture or sale ;   Agreement between

Index of Sec 2575. ...
(i) IN GENERAL. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (C) (i) (II)
Automated Concept:

BIOSIMILAR product being subject of application described in subparagraph ;   Biosimilar product being subject of application or

Index of Sec 2575. ...

Biosimilar product and production
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (i)
Automated Concept:

BIOSIMILAR product and production ;   Applicant providing reference product sponsor with copy of application and information concerning

Index of Sec 2575. ...

Biosimilar product: United States of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (B) (ii)
Automated Concept:

BIOSIMILAR product in method of treatment indicated in application ;   Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of

Index of Sec 2575. ...

Biosimilar product: detailed description of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (i)
Automated Concept:

BIOSIMILAR product ;   Information including detailed description of

Index of Sec 2575. ...

Biosimilar product: manufacture of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (B) (ii)
Automated Concept:

BIOSIMILAR product in method of treatment indicated in application ;   Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of

Index of Sec 2575. ...

Biosimilar product: more
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(ii) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANTS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (A) (ii)
Automated Concept:

BIOSIMILAR product applicants submitting application under subsection for biosimilar products with same reference product and entering into agreement described in subparagraph ;   2 or more

Index of Sec 2575. ...
(B) SUBJECT MATTER OF AGREEMENT. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (B) (i)
Automated Concept:

BIOSIMILAR product applicants under subsection regarding manufacture or sale ;   Agreement between biosimilar product applicant under subsection and reference product sponsor or 2 or more

Index of Sec 2575. ...

Biosimilar product: use of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (B) (ii)
Automated Concept:

BIOSIMILAR product in method of treatment indicated in application ;   Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of

Index of Sec 2575. ...

Biosimilar products
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(ii) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANTS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (A) (ii)
Automated Concept:

BIOSIMILAR products with same reference product and entering into agreement described in subparagraph ;   2 or more biosimilar product applicants submitting application under subsection for

Index of Sec 2575. ...

Biosimilar product or use of biosimilar product
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(C) IDENTIFICATION OF BASIS FOR INFRINGEMENT. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (C) (i)
Automated Concept:

BIOSIMILAR product in treatment indicated in application ;   Biosimilar product or use of

Index of Sec 2575. ...
(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS. - paragraph (ii) - paragraph (I)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (D) (ii) (I)
Automated Concept:

BIOSIMILAR product in treatment indicated in application not infringing patent ;   Biosimilar product or use of

Index of Sec 2575. ...

Caloric intake: daily
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(I) - paragraph (bb)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (I) (bb)
Automated Concept:

CALORIC intake in context of total daily diet ;   Succinct statement concerning suggested daily

Index of Sec 2572. ...
(II) - paragraph (bb)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (II) (bb)
Automated Concept:

CALORIC intake designed to enable public to understand significance of nutrition information provided on menu board ;   Succinct statement concerning suggested daily

Index of Sec 2572. ...

Calories: number of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(I) - paragraph (aa)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (I) (aa)
Automated Concept:

CALORIES contained in standard menu item as usually prepared and offered for sale ;   Number of

Index of Sec 2572. ...
(viii) VENDING MACHINES. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii) (II)
Automated Concept:

CALORIES contained in article ;   Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of

Index of Sec 2572. ...

Certification
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(d) CERTIFICATION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (c) (2) Quoted: (d)
Automated Concept:

CERTIFICATION ;   Materials filed with Federal Trade Commission and Department of Justice under section 1112 of subtitle B of title XI of Medicare Prescription Drug, Improvement and Modernization Act of 2003 with respect to agreement referenced in

Index of Sec 2573. ...

Civil action
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(iii) CERTIFICATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (C) (iii)
Automated Concept:

CERTIFICATION as following ;   Chief executive officer or company official responsible for negotiating agreement required to be filed by subparagraph including in filing under paragraph

Index of Sec 2575. ...

Clinical study or studies
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (I) - paragraph (cc)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I) (cc)
Automated Concept:

BIOLOGICAL product ;   Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for

Index of Sec 2575. ...

Commerce: interstate
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(i) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (C) (i)
Automated Concept:

COMMERCE prohibited under section 5 of Federal Trade Commission Act and enforced by Federal Trade Commission in same manner ;   Violation of subparagraph to be treated as unfair and deceptive act or practice and unfair method of competition or affecting interstate

Index of Sec 2573. ...

Commercial: first
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (A)
Automated Concept:

BIOLOGICAL product to be approved as interchangeable for reference product ;   1 year after first commercial marketing of first interchangeable biosimilar

Index of Sec 2575. ...

Commercial manufacture
Sec 2577. -- Amendments To Certain Patent Provisions.
SEC 2577. -- AMENDMENTS TO CERTAIN PATENT PROVISIONS. - paragraph (a) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2577. (a) (4)
Automated Concept:

BIOLOGICAL product claimed in patent or use of which claimed in patent before expiration of patent ;   Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of

Index of Sec 2577. ...

Compliance: order
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(ii) COMPLIANCE AND EQUITABLE RELIEF.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (E) (ii)
Automated Concept:

COMPLIANCE and granting other equitable relief as court in discretion determining necessary or appropriate ;   Order

Index of Sec 2575. ...

Consumer
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(xi) DEFINITION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (xi)
Automated Concept:

CONSUMER making order selection ;   Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which

Index of Sec 2572. ...

Contracts
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(B) SUBJECT MATTER OF AGREEMENT. - paragraph (iii) - paragraph (III)

Deceptive act or practice: unfair and
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(i) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (C) (i)
Automated Concept:

COMMERCE prohibited under section 5 of Federal Trade Commission Act and enforced by Federal Trade Commission in same manner ;   Violation of subparagraph to be treated as unfair and deceptive act or practice and unfair method of competition or affecting interstate

Index of Sec 2573. ...

Diet: daily
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(I) - paragraph (bb)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (I) (bb)
Automated Concept:

DIET ;   Succinct statement concerning suggested daily caloric intake in context of total daily

Index of Sec 2572. ...

Dietary practices: healthy
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(vi) ADDITIONAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (vi)
Automated Concept:

DIETARY practices ;   Disclosing for purpose of providing information to assist consumers in maintaining healthy

Index of Sec 2572. ...

Disclosure
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) DISCLOSURE EXEMPTION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (D)
Automated Concept:

DISCLOSURE under section 552 of title 5, United States Code and no ;   Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from

Index of Sec 2575. ...

Disclosure of nutrient
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(vi) ADDITIONAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (vi)
Automated Concept:

DISCLOSURE of nutrient in written form required under subclause ;   Secretary requiring

Index of Sec 2572. ...

Disclosure: effect nutrient content
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(d) RULE OF CONSTRUCTION. - paragraph (1)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (d) (1)
Automated Concept:

DISCLOSURES of type required under section 403(q)(5)(h) of Federal Food, Drug and Cosmetic Act and expressly preempted under section 403a(a)(4) of Act ;   Provision establishing or continuing into effect nutrient content

Index of Sec 2572. ...

Disclosure: nutrient content
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(iv) REASONABLE BASIS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (iv)
Automated Concept:

DISCLOSURES including nutrient databases ;   Restaurant or similar retail food establishment to have reasonable basis for nutrient content

Index of Sec 2572. ...

Disparate data environments
Sec 2571. -- National Medical Device Registry.
(3) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (B)
Automated Concept:

DISPARATE data environments, electronic health records and other data deemed appropriate by Secretary ;   Standardizing analytic files allowing for pooling and analysis of data from

Index of Sec 2571. ...

Drug
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(A) CONDUCT PROHIBITED. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (A) (ii)
Automated Concept:

DRUG to be manufactured under ANDA involved and subject of patent infringement claim  ;  

Index of Sec 2573. ...
(B) EXCEPTIONS. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B) (i)
Automated Concept:

DRUG to be manufactured under ANDA involved and subject of patent infringement claim ;   Right to market

Index of Sec 2573. ...
(B) EXCEPTIONS. - paragraph (i) - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B) (i) (II)
Automated Concept:

DRUG ;   Other statutory exclusivity preventing marketing of

Index of Sec 2573. ...
(B) EXCEPTIONS. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B) (ii)
Automated Concept:

DRUG ;   Waiver of patent infringement claim for damages based on prior marketing of

Index of Sec 2573. ...

Drug: court of law ANDA or
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(vi) PATENT INFRINGEMENT CLAIM.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (vi)
Automated Concept:

DRUG to be manufactured under ANDA infringing patent ;   Including in complaint filed with court of law ANDA or

Index of Sec 2573. ...

Drug: generic
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(2) PURPOSE.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (2)
Automated Concept:

DRUG manufacturers ;   Purpose of section to provide additional means to effectuate intent of 1984 Act by enhancing competition in pharmaceutical market by stopping agreements between brand name and generic

Index of Sec 2573. ...

Drug: new
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(iii) ANDA.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (iii)
Automated Concept:

DRUG under section ;   Term ANDA meaning abbreviated new drug application for approval of new

Index of Sec 2573. ...

Drug application: abbreviated new
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(iii) ANDA.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (iii)
Automated Concept:

DRUG application for approval of new drug under section ;   Term ANDA meaning abbreviated new

Index of Sec 2573. ...

Electronic exchange and use
Sec 2571. -- National Medical Device Registry.
(1) RECOMMENDATIONS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (b) (1)
Automated Concept:

ELECTRONIC exchange and use in certified electronic health records of unique device identifier for covered device ;   Hit Policy Committee established under section 3002 of Public Health Service Act 42 USC 300jj-12 recommending to head of Office of National Coordinator for Health Information Technology standards, implementation specifications and certification criteria for

Index of Sec 2571. ...
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (b) (2)
Automated Concept:

ELECTRONIC exchange and use in certified electronic health records of unique device identifier for covered device referred in paragraph ;   Secretary of Health and Human Services adopting standards, implementation specifications and certification criteria for

Index of Sec 2571. ...

Employment
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(B) SUBJECT MATTER OF AGREEMENT. - paragraph (iii) - paragraph (III)

Exclusivity: statutory
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(B) EXCEPTIONS. - paragraph (i) - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B) (i) (II)
Automated Concept:

DRUG ;   Other statutory exclusivity preventing marketing of

Index of Sec 2573. ...

Executive
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(iii) CERTIFICATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (C) (iii)
Automated Concept:

CERTIFICATION as following ;   Chief executive officer or company official responsible for negotiating agreement required to be filed by subparagraph including in filing under paragraph

Index of Sec 2575. ...

Food
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.
(iii) SELF-SERVICE FOOD AND FOOD ON DISPLAY.
(c) NATIONAL UNIFORMITY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (c)
Automated Concept:

FOOD establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ;   Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail

Index of Sec 2572. ...

Food: article of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(viii) VENDING MACHINES. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii) (II)
Automated Concept:

CALORIES contained in article ;   Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of

Index of Sec 2572. ...

Food: case of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (i)
Automated Concept:

FOOD being standard menu item offered for sale in restaurant or similar retail food establishment being part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items ;   Case of

Index of Sec 2572. ...
(iii) SELF-SERVICE FOOD AND FOOD ON DISPLAY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (iii)
Automated Concept:

FOOD on display and visible to customers ;   Case of food selling at salad bar, buffet line, cafeteria line or similar self-service facility and self-service beverages or

Index of Sec 2572. ...

Food: case of article of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(viii) VENDING MACHINES.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii)
Automated Concept:

FOOD selling from vending machine ;   Case of article of

Index of Sec 2572. ...

Food: labeling of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(d) RULE OF CONSTRUCTION. - paragraph (2)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (d) (2)
Automated Concept:

FOOD or component of food ;   Applying to State or local requirement respecting statement in labeling of food providing for warning concerning safety of

Index of Sec 2572. ...

Food: other
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(I) IN GENERAL. - paragraph (cc)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (vii) (I) (cc)
Automated Concept:

FOOD being part of cusations market test appearing on menu for less than 90 days ;   Other

Index of Sec 2572. ...

Food: self-service beverages or
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(iii) SELF-SERVICE FOOD AND FOOD ON DISPLAY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (iii)
Automated Concept:

FOOD on display and visible to customers ;   Case of food selling at salad bar, buffet line, cafeteria line or similar self-service facility and self-service beverages or

Index of Sec 2572. ...

Food service
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(II) CONTENTS. - paragraph (aa)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (x) (II) (aa)
Automated Concept:

FOOD service workers, variations in ingredients and other factors ;   Considering standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of

Index of Sec 2572. ...

General statements of policy
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(2) FTC RULEMAKING.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (2)
Automated Concept:

GENERAL statements of policy with respect to practices prohibited under paragraph ;   Rules including interpretive rules and

Index of Sec 2573. ...

Generic: potential
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) FINDINGS. - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (D)
Automated Concept:

GENERIC competitors making reverse payments ;   Intent of 1984 Act subverted by certain settlement agreements between brand companies and potential

Index of Sec 2573. ...

Generic drugs
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) FINDINGS. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (A)
Automated Concept:

GENERIC drugs when preserving incentives for innovation ;   Drug Price Competition and patenting Term Restoration Act enacted with intent of facilitating early entry of

Index of Sec 2573. ...
(1) FINDINGS. - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (C)
Automated Concept:

GENERIC drugs ;   67 percent of prescriptions dispensed in United States being

Index of Sec 2573. ...
(1) FINDINGS. - paragraph (E)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (E)
Automated Concept:

GENERIC drugs contrary to free competition and interests of consumers ;   Settlement agreements unduly delaying marketing of low-cost

Index of Sec 2573. ...
(2) PURPOSE.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (2)
Automated Concept:

GENERIC drugs ;   Limit, delay or otherwise preventing competition from

Index of Sec 2573. ...
(1) STUDY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (d) (1)
Automated Concept:

GENERIC drugs ;   Beginning 2 years after date of enactment of Act and year for period of 4 years Comptroller General conducting studying on litigation in United States courting during period beginning 5 years prior to date of enactment of Act relating to patent infringement claims involving

Index of Sec 2573. ...

Guidance
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(ii) INPUT REGARDING MOST VALUABLE GUIDANCE.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (B) (ii)
Automated Concept:

GUIDANCE ;   Secretary establishing process through public providing Secretary with input regarding priorities for issuing

Index of Sec 2575. ...
(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE.

Guidance: related
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(iv) REASONABLE BASIS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (iv)
Automated Concept:

DRUGGING Administration ;   Other reasonable means coding of Federal Regulations or related guidance of Food and

Index of Sec 2572. ...

Guidance: final
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (B) (i)
Automated Concept:

GUIDANCE ;   Secretary providing public opportunity to comment on proposed guidance issued under subparagraph before issuing final

Index of Sec 2575. ...

Guidance: issuance of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(C) NO REQUIREMENT FOR APPLICATION CONSIDERATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (C)
Automated Concept:

GUIDANCE under subparagraph not precluding review of application submitted under subsection ;   Issuance of

Index of Sec 2575. ...

Guidance: proposed
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (B) (i)
Automated Concept:

GUIDANCE issued under subparagraph before issuing final guidance ;   Secretary providing public opportunity to comment on proposed

Index of Sec 2575. ...

Guidance document
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(ii) MODIFICATION OR REVERSAL.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (E) (ii)
Automated Concept:

GUIDANCE document under clause ;   Secretary issuing subsequent guidance document under subparagraph to modify or reverse

Index of Sec 2575. ...
(iii) NO EFFECT ON ABILITY TO DENY LICENSE.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (E) (iii)
Automated Concept:

GUIDANCE document ;   Clause not to be construed to require Secretary to approve product with respect to which Secretary not indicating in

Index of Sec 2575. ...

Guidance document: subsequent
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(ii) MODIFICATION OR REVERSAL.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (E) (ii)
Automated Concept:

GUIDANCE document under clause ;   Secretary issuing subsequent guidance document under subparagraph to modify or reverse

Index of Sec 2575. ...

Health
Health: public
Sec 2571. -- National Medical Device Registry.
(A) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (A) (ii)
Automated Concept:

HEALTH ;   Requiring manufacturers of devices to submit information to registry if deemed necessary by Secretary to protect public

Index of Sec 2571. ...

Health: security or
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D) (ii)
Automated Concept:

BIOLOGICAL product under subsection ;   Secretary not licensing biological product under subsection unless Secretary determining to be no increased risk to security or health of public from licensing

Index of Sec 2575. ...

Health benefits
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCLUSIVITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (8) (A)
Automated Concept:

HEALTH benefits in population ;   Secretary determining that information relating to use of product in pediatric population producing

Index of Sec 2575. ...

Health care
Health care: intervention of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(b) DEFINITIONS. - paragraph (3) - paragraph (3)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (3) Quoted: (3)
Automated Concept:

HEALTH care provider prescribing reference product ;   Biological product to be substituted for reference product without intervention of

Index of Sec 2575. ...

Health care: national
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) FINDINGS. - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (B)
Automated Concept:

HEALTH care spending ;   Prescription drugs making up 10 percent of national

Index of Sec 2573. ...

Health care expenditures: segments of
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) FINDINGS. - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (B)
Automated Concept:

EXPENDITURES ;   Past decade being one of fastest growing segments of health care

Index of Sec 2573. ...

Health records
Health records: certified electronic
Sec 2571. -- National Medical Device Registry.
(1) RECOMMENDATIONS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (b) (1)
Automated Concept:

HEALTH records of unique device identifier for covered device ;   Hit Policy Committee established under section 3002 of Public Health Service Act 42 USC 300jj-12 recommending to head of Office of National Coordinator for Health Information Technology standards, implementation specifications and certification criteria for electronic exchange and use in certified electronic

Index of Sec 2571. ...
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (b) (2)
Automated Concept:

HEALTH records of unique device identifier for covered device referred in paragraph ;   Secretary of Health and Human Services adopting standards, implementation specifications and certification criteria for electronic exchange and use in certified electronic

Index of Sec 2571. ...

Health records: electronic
Sec 2571. -- National Medical Device Registry.
(3) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (B)
Automated Concept:

HEALTH records and other data deemed appropriate by Secretary ;   Standardizing analytic files allowing for pooling and analysis of data from disparate data environments, electronic

Index of Sec 2571. ...

Implementation
Implementation of item
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(II) REGISTRATION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ix) (II)
Automated Concept:

IMPLEMENTATION of item ;   Secretary publishing notice in Federal Register specifying terms and conditions for

Index of Sec 2572. ...

Implementation of registry
Sec 2571. -- National Medical Device Registry.
(2) EFFECTIVE DATE.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (2)
Automated Concept:

IMPLEMENTATION of registry under section 519(g) of Federal Food, Drug and Cosmetic Act as added by paragraphing without regard whether final regulations to establish and operate registry promulgated by date ;   Secretary of Health and Human Services establishing and beginning

Index of Sec 2571. ...

Implementation specifications and certification criteri
Sec 2571. -- National Medical Device Registry.
(1) RECOMMENDATIONS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (b) (1)
Automated Concept:

CERTIFICATION criteria for electronic exchange and use in certified electronic health records of unique device identifier for covered device ;   Hit Policy Committee established under section 3002 of Public Health Service Act 42 USC 300jj-12 recommending to head of Office of National Coordinator for Health Information Technology standards, implementation specifications and

Index of Sec 2571. ...
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (b) (2)
Automated Concept:

CERTIFICATION criteria for electronic exchange and use in certified electronic health records of unique device identifier for covered device referred in paragraph ;   Secretary of Health and Human Services adopting standards, implementation specifications and

Index of Sec 2571. ...

Importation: United States or
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (B) (ii)
Automated Concept:

BIOSIMILAR product in method of treatment indicated in application ;   Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of

Index of Sec 2575. ...

Information
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (B)
Automated Concept:

INFORMATION included in registry as described in subparagraph ;   Validating methods for analyzing patient safety and outcomes data from multiple sources and linking data with

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (B) (ii)
Automated Concept:

INFORMATION from public and private sources identified under paragraph  ;  

Index of Sec 2571. ...
(3) - paragraph (A) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (A) (ii)
Automated Concept:

INFORMATION in registry ;   Link data obtained under clause with

Index of Sec 2571. ...
(3) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (B)
Automated Concept:

INFORMATION respecting covered device including claims data ;   Term data refering to

Index of Sec 2571. ...
(A) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (A) (i)
Automated Concept:

INFORMATION to registry device ;   Requiring manufacturers of devices to submit

Index of Sec 2571. ...
(A) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (A) (ii)
Automated Concept:

HEALTH ;   Requiring manufacturers of devices to submit information to registry if deemed necessary by Secretary to protect public

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (E)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (E)
Automated Concept:

INFORMATION and comprehensive ;   Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (i)
Automated Concept:

INFORMATION described in subclauses ;   Restaurant or similar retail food establishment disclosing

Index of Sec 2572. ...
(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii)
Automated Concept:

FOOD establishments ;   Information required to be disclosed by restaurants and retail

Index of Sec 2572. ...
(vi) ADDITIONAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (vi)
Automated Concept:

DIETARY practices ;   Disclosing for purpose of providing information to assist consumers in maintaining healthy

Index of Sec 2572. ...
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(2) DISCLOSURE OF AGREEMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (d) (2)
Automated Concept:

INFORMATION from agreements ;   Modernization Act of 2003 21 USC 355 note or unaggregated

Index of Sec 2573. ...

Information or documentary
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i)
Automated Concept:

INFORMATION demonstrating ;   Application submitted under subsection including

Index of Sec 2575. ...
(B) INTERCHANGEABILITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (B)
Automated Concept:

BIOLOGICAL product meeting standards described in paragraph ;   Application submitted under subsection including information demonstrating that

Index of Sec 2575. ...
(3) EVALUATION BY SECRETARY. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (3) (A)
Automated Concept:

BIOLOGICAL product ;   Secretary determining that information submitted in application being sufficient to show that

Index of Sec 2575. ...
(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (4)
Automated Concept:

INFORMATION submitted in application being sufficient to show ;   Secretary determining biological product to be interchangeable with reference product if Secretary determining that

Index of Sec 2575. ...
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D)
Automated Concept:

INFORMATION in application submitted under subsection  ;  

Index of Sec 2575. ...
(A) EXCLUSIVITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (8) (A)
Automated Concept:

HEALTH benefits in population ;   Secretary determining that information relating to use of product in pediatric population producing

Index of Sec 2575. ...
(2) HANDLING OF CONFIDENTIAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (2)
Automated Concept:

INFORMATION ;   Entity receiving confidential information pursuant to subsection designating one or more individuals to receive

Index of Sec 2575. ...
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (i)
Automated Concept:

BIOSIMILAR product ;   Information including detailed description of

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (ii)
Automated Concept:

INFORMATION specified in subparagraph ;   Applicant sending to individual designated by interested third party

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (iii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (iii)
Automated Concept:

INFORMATION pursuant to clause ;   90 days of date of receiving

Index of Sec 2575. ...
(D) DISCLOSURE EXEMPTION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (D)
Automated Concept:

DISCLOSURE under section 552 of title 5, United States Code and no ;   Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from

Index of Sec 2575. ...

Information: disclosure of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) DISCLOSURE EXEMPTION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (D)
Automated Concept:

DISCLOSURE of information or documentary material to body of Congress or duly authorized committee or subcommittee of Congress ;   Nothing in subparagraph preventing

Index of Sec 2575. ...

Information: additional
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(iii) ADDITIONAL INFORMATION. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (iii) (II)
Automated Concept:

BIOLOGICAL product ;   Including additional information in support of application including publicly available information with respect to reference product or another

Index of Sec 2575. ...

Information: availability of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS. - paragraph (IV)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (IV)
Automated Concept:

INFORMATION described in item ;   Prominent, clear and conspicuous statement regarding availability of

Index of Sec 2572. ...

Information: available
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(iii) ADDITIONAL INFORMATION. - paragraph (I)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (iii) (I)
Automated Concept:

INFORMATION regarding Secretary's previous determination ;   Including publicly available

Index of Sec 2575. ...
(iii) ADDITIONAL INFORMATION. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (iii) (II)
Automated Concept:

BIOLOGICAL product ;   Including additional information in support of application including publicly available information with respect to reference product or another

Index of Sec 2575. ...

Information: caloric
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(I) - paragraph (bb)

Information: confidential
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(2) HANDLING OF CONFIDENTIAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (2)
Automated Concept:

INFORMATION pursuant to subsection designating one or more individuals to receive information ;   Entity receiving confidential

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (i)
Automated Concept:

INFORMATION from applicant ;   Identify 1 patent and designating individual executing agreement in accordance with paragraph to receive confidential

Index of Sec 2575. ...

Information: confidentiality of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(2) HANDLING OF CONFIDENTIAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (2)
Automated Concept:

CONFIDENTIALITY of information received pursuant to subsection and using information solely for purposes authorized by subsection ;   Regulations requiring individual to take reasonable steps to maintain

Index of Sec 2575. ...

Information: copy of application and
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (i)
Automated Concept:

BIOSIMILAR product and production ;   Applicant providing reference product sponsor with copy of application and information concerning

Index of Sec 2575. ...

Information: date of receipt of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (ii)
Automated Concept:

INFORMATION required to be provided under clause ;   60 days of date of receipt of

Index of Sec 2575. ...

Information: inclusion of
Sec 2571. -- National Medical Device Registry.
(1) - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (1) (C)
Automated Concept:

INFORMATION on device in registry not providing useful information on safety or effectiveness ;   Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of

Index of Sec 2571. ...

Information: linkage of
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (B) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (B) (i)
Automated Concept:

INFORMATION submitted pursuant to subparagraph with patient safety and outcomes data obtained under paragraph ;   Permitting linkage of

Index of Sec 2571. ...

Information: nutrition
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS. - paragraph (III)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (III)
Automated Concept:

INFORMATION required under clauses and subparagraph ;   Nutrition

Index of Sec 2572. ...

Information: other
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (C)
Automated Concept:

INFORMATION as necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks ;   Requiring covered device manufacturers to submit other

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (D)
Automated Concept:

INFORMATION Secretary determining appropriate ;   Establishing requirements for regular and timely reports to Secretary concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events and other

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (6)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (6)
Automated Concept:

INFORMATION in connection with safety of device under section ;   Respect to entitying that submiting or required to submit safety report or other

Index of Sec 2571. ...

Information: proprations
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (D)
Automated Concept:

INFORMATION and comprehensive ;   Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (E)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (E)
Automated Concept:

INFORMATION and comprehensive ;   Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...

Information: report or
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (6)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (6)
Automated Concept:

INFORMATION not to be construed to reflect necessarily conclusion by entity or Secretary ;   Report or

Index of Sec 2571. ...

Information: significance of nutrition
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(II) - paragraph (bb)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii) (II) (bb)
Automated Concept:

INFORMATION provided on menu board ;   Succinct statement concerning suggested daily caloric intake designed to enable public to understand significance of nutrition

Index of Sec 2572. ...

Information: useful
Sec 2571. -- National Medical Device Registry.
(1) - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (1) (C)
Automated Concept:

INFORMATION on safety or effectiveness ;   Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of information on device in registry not providing useful

Index of Sec 2571. ...

Information: visible nutrition
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(viii) VENDING MACHINES. - paragraph (I)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii) (I)
Automated Concept:

INFORMATION at point of purchase ;   Not permitting prospective purchaser to examine Nutrition Facts panelling before purchasing article or not otherwise providing visible nutrition

Index of Sec 2572. ...

Information requirements: voluntary provision of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(c) NATIONAL UNIFORMITY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (c)
Automated Concept:

INFORMATION requirements under section 403(q)(5)(h)( ix ;   Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail food establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition

Index of Sec 2572. ...

Infringement
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(v) PATENT INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (v)
Automated Concept:

INFRINGEMENT of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration, patent of addition or extension ;   Term patent infringement meaning

Index of Sec 2573. ...

Infringement: action of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (D)
Automated Concept:

INFRINGEMENT of relevant patent ;   Owns relevant patent or right to commence or participate in action for

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (iii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (iii)
Automated Concept:

INFRINGEMENT ;   Interested third party owns or respect of which interested third party having right to commence or participate in action for

Index of Sec 2575. ...
(5) ACTION FOR INFRINGEMENT INVOLVING REFERENCE PRODUCT SPONSOR.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (5)
Automated Concept:

INFRINGEMENT involving Reference product Sponsor ;   Action for

Index of Sec 2575. ...
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (ii)
Automated Concept:

BIOSIMILAR product ;   Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns

Index of Sec 2575. ...

Infringement claims
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) STUDY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (d) (1)
Automated Concept:

GENERIC drugs ;   Beginning 2 years after date of enactment of Act and year for period of 4 years Comptroller General conducting studying on litigation in United States courting during period beginning 5 years prior to date of enactment of Act relating to patent infringement claims involving

Index of Sec 2573. ...

Interchangeability: determination of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6)
Automated Concept:

INTERCHANGEABILITY for condition of use ;   Review of application submitted under subsection relying on same reference product For which prior biological product receiving determination of

Index of Sec 2575. ...

Interest
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (ii)
Automated Concept:

BIOSIMILAR product ;   Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns

Index of Sec 2575. ...
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (iii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (iii)
Automated Concept:

INTEREST in relevant patent after date on which reference product sponsor providing list required by clause to applicant ;   Reference product sponsor issued or acquiring

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (iv)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (iv)
Automated Concept:

INTEREST in relevant patent after date on which interested third party providing list required by clause ;   Issuing or acquiring

Index of Sec 2575. ...

Interpretive rules
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(2) FTC RULEMAKING.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (2)
Automated Concept:

GENERAL statements of policy with respect to practices prohibited under paragraph ;   Rules including interpretive rules and

Index of Sec 2573. ...

Licensure
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (I) - paragraph (cc)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I) (cc)
Automated Concept:

BIOLOGICAL product ;   Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for

Index of Sec 2575. ...

Nutrition labeling of food
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(c) NATIONAL UNIFORMITY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (c)
Automated Concept:

FOOD being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail food establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ;   Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of

Index of Sec 2572. ...

Patent
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(vi) PATENT INFRINGEMENT CLAIM.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (vi)
Automated Concept:

PATENT ;   Including in complaint filed with court of law ANDA or drug to be manufactured under ANDA infringing

Index of Sec 2573. ...
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (B)
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (ii)
Automated Concept:

BIOSIMILAR product ;   Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns

Index of Sec 2575. ...
(C) IDENTIFICATION OF BASIS FOR INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (C)
Automated Concept:

PATENT identified under clause or subparagraph or clause or subparagraph  ;  

Index of Sec 2575. ...
(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (D)
Automated Concept:

PATENT identified under clause or subparagraph or clause or subparagraph ;   Not later than 45 days after date on which

Index of Sec 2575. ...
(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS. - paragraph (ii) - paragraph (I)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (D) (ii) (I)
Automated Concept:

PATENT ;   Biosimilar product or use of biosimilar product in treatment indicated in application not infringing

Index of Sec 2575. ...
(5) ACTION FOR INFRINGEMENT INVOLVING REFERENCE PRODUCT SPONSOR.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (5)
Automated Concept:

PATENT infringed prior to date applicable under subsection ;   Brought within 60 days of date of receipt of statement under paragraph and court in which action commenced determining

Index of Sec 2575. ...
Sec 2577. -- Amendments To Certain Patent Provisions.
SEC 2577. -- AMENDMENTS TO CERTAIN PATENT PROVISIONS. - paragraph (a) - paragraph (1)
SEC 2577. -- AMENDMENTS TO CERTAIN PATENT PROVISIONS. - paragraph (a) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2577. (a) (4)
Automated Concept:

PATENT before expiration of patent ;   Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of biological product claimed in patent or use of which claimed in

Index of Sec 2577. ...

Patent of addition or extension
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(v) PATENT INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (v)
Automated Concept:

PATENT of addition or extension ;   Term patent infringement meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration,

Index of Sec 2573. ...

Patent: relevant
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (D)
Automated Concept:

INFRINGEMENT of relevant patent ;   Owns relevant patent or right to commence or participate in action for

Index of Sec 2575. ...

Patent or use
Sec 2577. -- Amendments To Certain Patent Provisions.
SEC 2577. -- AMENDMENTS TO CERTAIN PATENT PROVISIONS. - paragraph (a) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2577. (a) (4)
Automated Concept:

PATENT before expiration of patent ;   Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of biological product claimed in patent or use of which claimed in

Index of Sec 2577. ...

Patent: expiration of
Sec 2577. -- Amendments To Certain Patent Provisions.
SEC 2577. -- AMENDMENTS TO CERTAIN PATENT PROVISIONS. - paragraph (a) - paragraph (4)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2577. (a) (4)
Automated Concept:

PATENT ;   Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of biological product claimed in patent or use of which claimed in patent before expiration of

Index of Sec 2577. ...

Patent: identify 1
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (i)
Automated Concept:

INFORMATION from applicant ;   Identify 1 patent and designating individual executing agreement in accordance with paragraph to receive confidential

Index of Sec 2575. ...

Patent: noticed
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (D) (i)
Automated Concept:

PATENT ;   Applicant not commencing marketing of biosimilar product and requesting Secretary not to grant final approval of application before date of expiration of noticed

Index of Sec 2575. ...

Patent: relevant
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (B)
(1) DEFINITIONS. - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (D)
Automated Concept:

PATENT ;   Owns relevant patent or right to commence or participate in action for infringement of relevant

Index of Sec 2575. ...
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (iii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (iii)
Automated Concept:

PATENT after date on which reference product sponsor providing list required by clause to applicant ;   Reference product sponsor issued or acquiring interest in relevant

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (iv)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (iv)
Automated Concept:

PATENT after date on which interested third party providing list required by clause ;   Issuing or acquiring interest in relevant

Index of Sec 2575. ...
(C) IDENTIFICATION OF BASIS FOR INFRINGEMENT. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (C) (i)
Automated Concept:

PATENT to be infringed ;   Explaining in writing sponsor or interested third party believing relevant

Index of Sec 2575. ...
(5) ACTION FOR INFRINGEMENT INVOLVING REFERENCE PRODUCT SPONSOR.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (5)
Automated Concept:

PATENT identified by reference product sponsor under clause or paragraph or interested third party under clause or paragraph ;   Action for infringement concerning relevant

Index of Sec 2575. ...

Patent application: filed
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(v) PATENT INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (v)
Automated Concept:

PATENT application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration, patent of addition or extension ;   Term patent infringement meaning infringement of patenting or filed

Index of Sec 2573. ...

Patent challenges: number of
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) STUDY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (d) (1)
Automated Concept:

GENERIC drugs ;   Number of patent challenges initiated by manufacturers of

Index of Sec 2573. ...

Patent concerns
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (A) (ii)
Automated Concept:

BIOSIMILAR product ;   Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns

Index of Sec 2575. ...

Patent infringement: term
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(v) PATENT INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (v)
Automated Concept:

INFRINGEMENT meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration, patent of addition or extension ;   Term patent

Index of Sec 2573. ...

Patent infringement claim
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(A) CONDUCT PROHIBITED.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (A)
Automated Concept:

INFRINGEMENT claim ;   Unlawful for person to directly or indirectly party to agreement resolving or settling patent

Index of Sec 2573. ...

Patent infringement claim: resolution or settlement of
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(B) EXCEPTIONS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B)
Automated Concept:

INFRINGEMENT claim in which value received by ANDA filer including no more ;   Subparagraph not prohibiting resolution or settlement of patent

Index of Sec 2573. ...

Patent infringement claim: subject of
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(A) CONDUCT PROHIBITED. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (A) (ii)
Automated Concept:

INFRINGEMENT claim ;   Drug to be manufactured under ANDA involved and subject of patent

Index of Sec 2573. ...
(B) EXCEPTIONS. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B) (i)
Automated Concept:

INFRINGEMENT claim ;   Right to market drug to be manufactured under ANDA involved and subject of patent

Index of Sec 2573. ...

Patent infringement claim: term
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(vi) PATENT INFRINGEMENT CLAIM.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (vi)
Automated Concept:

INFRINGEMENT claim meaning allegation making to ANDA filer ;   Term patent

Index of Sec 2573. ...

Patent infringement claim: waiver of
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(B) EXCEPTIONS. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (B) (ii)
Automated Concept:

DRUG ;   Waiver of patent infringement claim for damages based on prior marketing of

Index of Sec 2573. ...

Patent term restoration
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(v) PATENT INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (v)
Automated Concept:

PATENT of addition or extension ;   Term patent infringement meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration,

Index of Sec 2573. ...

Payments: reverse
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(1) FINDINGS. - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (1) (D)
Automated Concept:

PAYMENTS ;   Intent of 1984 Act subverted by certain settlement agreements between brand companies and potential generic competitors making reverse

Index of Sec 2573. ...

Pediatric population
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCLUSIVITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (8) (A)
Automated Concept:

HEALTH benefits in population ;   Secretary determining that information relating to use of product in pediatric population producing

Index of Sec 2575. ...

Pharmaceutical market
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(2) PURPOSE.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (a) (2)
Automated Concept:

DRUG manufacturers ;   Purpose of section to provide additional means to effectuate intent of 1984 Act by enhancing competition in pharmaceutical market by stopping agreements between brand name and generic

Index of Sec 2573. ...

Population
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(A) EXCLUSIVITY.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (8) (A)
Automated Concept:

HEALTH benefits in population ;   Secretary determining that information relating to use of product in pediatric population producing

Index of Sec 2575. ...

Postmarket assessments of device safety and effectivene
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (C)
Automated Concept:

NOTIFICATION of device risks ;   Requiring covered device manufacturers to submit other information as necessary to facilitate postmarket assessments of device safety and effectiveness and

Index of Sec 2571. ...

Postmarket safety and outcomes data: analysis of
Sec 2571. -- National Medical Device Registry.
(1) - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (1) (A)
Automated Concept:

POSTMARKET safety and outcomes data on covered device ;   Secretary establishing national medical device registry to facilitate analysis of

Index of Sec 2571. ...

Primary
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(xi) DEFINITION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (xi)
Automated Concept:

CONSUMER making order selection ;   Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which

Index of Sec 2572. ...

Privacy: patient
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (D)
Automated Concept:

INFORMATION and comprehensive ;   Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (E)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (E)
Automated Concept:

INFORMATION and comprehensive ;   Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...

Protective
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(2) HANDLING OF CONFIDENTIAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (2)
Automated Concept:

INFORMATION agreeing to other terms or conditions regarding handling or use of confidential information ;   Court imposing protective order governing use or handling of confidential information or party providing confidential

Index of Sec 2575. ...

Protein
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(b) DEFINITIONS. - paragraph (2)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (b) (2)
Automated Concept:

PROTEIN, allergenic product ;   Paragraph, so designated, inserting

Index of Sec 2575. ...

Proximity: close
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(viii) VENDING MACHINES. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii) (II)
Automated Concept:

CALORIES contained in article ;   Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of

Index of Sec 2572. ...

Public
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (B) (ii)
Automated Concept:

INFORMATION from public and private sources identified under paragraph  ;  

Index of Sec 2571. ...
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (9) (B) (i)
Automated Concept:

GUIDANCE issued under subparagraph before issuing final guidance ;   Secretary providing public opportunity to comment on proposed

Index of Sec 2575. ...

Public access
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (D)
Automated Concept:

INFORMATION and comprehensive ;   Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (E)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (E)
Automated Concept:

INFORMATION and comprehensive ;   Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...

Purity
Purity and potency
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (I) - paragraph (cc)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I) (cc)
Automated Concept:

BIOLOGICAL product ;   Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for

Index of Sec 2575. ...

Purity or potency
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(C) FIRST LICENSURE. - paragraph (ii) - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (7) (C) (ii) (II)
Automated Concept:

PURITY or potency ;   Modification to structure of biological product not resulting in change in safety,

Index of Sec 2575. ...

Pursuant
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (B) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (B) (i)
Automated Concept:

SAFETY and outcomes data obtained under paragraph ;   Permitting linkage of information submitted pursuant to subparagraph with patient

Index of Sec 2571. ...
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(2) HANDLING OF CONFIDENTIAL INFORMATION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (2)
Automated Concept:

INFORMATION ;   Entity receiving confidential information pursuant to subsection designating one or more individuals to receive

Index of Sec 2575. ...
(B) EXCHANGES WITH INTERESTED THIRD PARTIES. - paragraph (iii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (4) (B) (iii)
Automated Concept:

INFORMATION pursuant to clause ;   90 days of date of receiving

Index of Sec 2575. ...
(D) DISCLOSURE EXEMPTION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (D)
Automated Concept:

DISCLOSURE under section 552 of title 5, United States Code and no ;   Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from

Index of Sec 2575. ...

Registry
Sec 2571. -- National Medical Device Registry.
(1) - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (1) (C)
Automated Concept:

INFORMATION on safety or effectiveness ;   Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of information on device in registry not providing useful

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (B)
Automated Concept:

REGISTRY as described in subparagraph ;   Validating methods for analyzing patient safety and outcomes data from multiple sources and linking data with information included in

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (D)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (D)
Automated Concept:

INFORMATION and comprehensive ;   Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...
(3) - paragraph (A) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (3) (A) (ii)
Automated Concept:

REGISTRY ;   Link data obtained under clause with information in

Index of Sec 2571. ...
(A) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (A) (ii)
Automated Concept:

HEALTH ;   Requiring manufacturers of devices to submit information to registry if deemed necessary by Secretary to protect public

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (E)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (E)
Automated Concept:

INFORMATION and comprehensive ;   Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations

Index of Sec 2571. ...
(2) EFFECTIVE DATE.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (2)
Automated Concept:

REGISTRY promulgated by date ;   Secretary of Health and Human Services establishing and beginning implementation of registry under section 519(g) of Federal Food, Drug and Cosmetic Act as added by paragraphing without regard whether final regulations to establish and operate

Index of Sec 2571. ...

Registry: national medical device
Sec 2571. -- National Medical Device Registry.
(1) - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (1) (A)
Automated Concept:

POSTMARKET safety and outcomes data on covered device ;   Secretary establishing national medical device registry to facilitate analysis of

Index of Sec 2571. ...

Registry device
Sec 2571. -- National Medical Device Registry.
(A) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (A) (i)
Automated Concept:

REGISTRY device ;   Requiring manufacturers of devices to submit information to

Index of Sec 2571. ...

Reissuance
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(v) PATENT INFRINGEMENT.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (b) Quoted: (w) (1) (D) (v)
Automated Concept:

PATENT of addition or extension ;   Term patent infringement meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration,

Index of Sec 2573. ...

Restaurant
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (i)
Automated Concept:

FOOD establishment being part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items ;   Case of food being standard menu item offered for sale in restaurant or similar retail

Index of Sec 2572. ...
(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii)
Automated Concept:

FOOD establishment disclosing in clear and conspicuous manner ;   Restaurant or similar retail

Index of Sec 2572. ...
(iv) REASONABLE BASIS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (iv)
Automated Concept:

DISCLOSURES including nutrient databases ;   Restaurant or similar retail food establishment to have reasonable basis for nutrient content

Index of Sec 2572. ...
(xi) DEFINITION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (xi)
Automated Concept:

CONSUMER making order selection ;   Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which

Index of Sec 2572. ...
(c) NATIONAL UNIFORMITY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (c)
Automated Concept:

FOOD establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ;   Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail

Index of Sec 2572. ...
(d) RULE OF CONSTRUCTION. - paragraph (3)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (d) (3)
Automated Concept:

FOOD establishment described in section 403(q)(5)(h)(i) of Act ;   Excepting as provided in section 403(q)(5)(h)( ix of Federal Food, Drug and Cosmetic Act to apply to restaurant or similar retail food establishment other than restaurant or similar retail

Index of Sec 2572. ...

Restaurant: official of
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(I) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ix) (I)
Automated Concept:

FOOD establishment or vending machine operator not subject to requirements of clause electing to be subject to requirements of clause as specified by Secretary by regulation ;   Authorized official of restaurant or similar retail

Index of Sec 2572. ...

Retail food establishment
Retail food establishment: similar
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (i)
Automated Concept:

FOOD establishment being part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items ;   Case of food being standard menu item offered for sale in restaurant or similar retail

Index of Sec 2572. ...
(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii)
Automated Concept:

FOOD establishment disclosing in clear and conspicuous manner ;   Restaurant or similar retail

Index of Sec 2572. ...
(iv) REASONABLE BASIS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (iv)
Automated Concept:

DISCLOSURES including nutrient databases ;   Restaurant or similar retail food establishment to have reasonable basis for nutrient content

Index of Sec 2572. ...
(I) IN GENERAL.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ix) (I)
Automated Concept:

FOOD establishment or vending machine operator not subject to requirements of clause electing to be subject to requirements of clause as specified by Secretary by regulation ;   Authorized official of restaurant or similar retail

Index of Sec 2572. ...
(xi) DEFINITION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (xi)
Automated Concept:

CONSUMER making order selection ;   Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which

Index of Sec 2572. ...
(c) NATIONAL UNIFORMITY.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (c)
Automated Concept:

FOOD establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ;   Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail

Index of Sec 2572. ...
(d) RULE OF CONSTRUCTION. - paragraph (3)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (d) (3)
Automated Concept:

FOOD establishment described in section 403(q)(5)(h)(i) of Act ;   Excepting as provided in section 403(q)(5)(h)( ix of Federal Food, Drug and Cosmetic Act to apply to restaurant or similar retail food establishment other than restaurant or similar retail

Index of Sec 2572. ...

Retail food establishments
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (ii)
Automated Concept:

FOOD establishments ;   Information required to be disclosed by restaurants and retail

Index of Sec 2572. ...

Risk
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY. - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (4) (B)
Automated Concept:

BIOLOGICAL product and reference product being not greater than risk of using reference product without ;   Risk in terms of safety or diminished efficacy of alternating or switching between use of

Index of Sec 2575. ...

Risk: no increased
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS. - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D) (ii)
Automated Concept:

BIOLOGICAL product under subsection ;   Secretary not licensing biological product under subsection unless Secretary determining to be no increased risk to security or health of public from licensing

Index of Sec 2575. ...

Safe
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (V)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (V)
Automated Concept:

SAFE ;   Facility in which biological product manufactured, processed, packed or holding meeting standards designed to assure that biological product continuing to be

Index of Sec 2575. ...

Safety
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) REQUIRED INFORMATION. - paragraph (I) - paragraph (cc)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (2) (A) (i) (I) (cc)
Automated Concept:

BIOLOGICAL product ;   Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for

Index of Sec 2575. ...
(C) FIRST LICENSURE. - paragraph (ii) - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (7) (C) (ii) (II)
Automated Concept:

PURITY or potency ;   Modification to structure of biological product not resulting in change in safety,

Index of Sec 2575. ...

Safety: patient
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (B)
Automated Concept:

INFORMATION included in registry as described in subparagraph ;   Validating methods for analyzing patient safety and outcomes data from multiple sources and linking data with

Index of Sec 2571. ...
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (4) - paragraph (B) - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (4) (B) (i)
Automated Concept:

SAFETY and outcomes data obtained under paragraph ;   Permitting linkage of information submitted pursuant to subparagraph with patient

Index of Sec 2571. ...

Safety of device
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (6)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (6)
Automated Concept:

SAFETY of device under section ;   Respect to entitying that submiting or required to submit safety report or other information in connection with

Index of Sec 2571. ...

Safety of food or component of food
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(d) RULE OF CONSTRUCTION. - paragraph (2)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (d) (2)
Automated Concept:

FOOD or component of food ;   Applying to State or local requirement respecting statement in labeling of food providing for warning concerning safety of

Index of Sec 2572. ...

Safety or effectiveness
Sec 2571. -- National Medical Device Registry.
(1) - paragraph (C)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (1) (C)
Automated Concept:

SAFETY or effectiveness ;   Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of information on device in registry not providing useful information on

Index of Sec 2571. ...

Safety: terms of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY. - paragraph (B)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (4) (B)
Automated Concept:

BIOLOGICAL product and reference product being not greater than risk of using reference product without ;   Risk in terms of safety or diminished efficacy of alternating or switching between use of

Index of Sec 2575. ...

Safety report
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (6)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (6)
Automated Concept:

INFORMATION in connection with safety of device under section ;   Respect to entitying that submiting or required to submit safety report or other

Index of Sec 2571. ...

Standardization of recipes and methods of preparation
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(II) CONTENTS. - paragraph (aa)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (x) (II) (aa)
Automated Concept:

FOOD service workers, variations in ingredients and other factors ;   Considering standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of

Index of Sec 2572. ...

Subject
Subject of application
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(1) DEFINITIONS. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (1) (A)
Automated Concept:

SUBJECT of application under subsection ;   Biosimilar product meaning biological product being

Index of Sec 2575. ...
(i) IN GENERAL. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (C) (i) (II)
Automated Concept:

SUBJECT of application described in subparagraph ;   Biosimilar product being subject of application or biosimilar product being

Index of Sec 2575. ...
(2) EXCEPTION. - paragraph (A)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (c) (2) (A)
Automated Concept:

SUBJECT of application approved under section 505 not later than date of enactment of Act ;   Biological product in product class For which biological product in product class being

Index of Sec 2575. ...

Subject of application or biosimilar product
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(i) IN GENERAL. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (C) (i) (II)
Automated Concept:

BIOSIMILAR product being subject of application described in subparagraph ;   Biosimilar product being subject of application or

Index of Sec 2575. ...

Surveillance activities: other postmarket device
Sec 2571. -- National Medical Device Registry.
(g) NATIONAL MEDICAL DEVICE REGISTRY. - paragraph (2) - paragraph (C) - paragraph (iii)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2571. (a) (1) (B) Quoted: (g) (2) (C) (iii)
Automated Concept:

SURVEILLANCE activities of Secretary authorized by chapter ;   Other postmarket device

Index of Sec 2571. ...

Title 42: section 73.3 or 73.4 of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D) (i)
Automated Concept:

TITLE 42, section 121.3 or 121.4 of title 9 or section 331.3 of title 7, Code of Federal Regulations ;   Containing selecting agent or toxin listed in section 73.3 or 73.4 of

Index of Sec 2575. ...

Title 5: section 552 of
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) DISCLOSURE EXEMPTION.
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (l) (6) (D)
Automated Concept:

TITLE 5, United States Code and no ;   Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from disclosure under section 552 of

Index of Sec 2575. ...

Title 9 or section 331.3 of title: section 121.3 or
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS. - paragraph (i)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (5) (D) (i)
Automated Concept:

TITLE 7, Code of Federal Regulations ;   Containing selecting agent or toxin listed in section 73.3 or 73.4 of title 42, section 121.3 or 121.4 of title 9 or section 331.3 of

Index of Sec 2575. ...

Title XI of Medicare Prescription: section 1112 of
Sec 2573. -- Protecting Consumer Access To Generic Drugs.
(d) CERTIFICATION.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2573. (c) (2) Quoted: (d)
Automated Concept:

CERTIFICATION ;   Materials filed with Federal Trade Commission and Department of Justice under section 1112 of subtitle B of title XI of Medicare Prescription Drug, Improvement and Modernization Act of 2003 with respect to agreement referenced in

Index of Sec 2573. ...

Vending machine
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(viii) VENDING MACHINES.
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii)
Automated Concept:

VENDING machine ;   Case of article of food selling from

Index of Sec 2572. ...
(viii) VENDING MACHINES. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii) (II)
Automated Concept:

CALORIES contained in article ;   Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of

Index of Sec 2572. ...

Vending machines: more
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(viii) VENDING MACHINES. - paragraph (II)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (viii) (II)
Automated Concept:

VENDING machines ;   Operating by person engaged in business of owning or operating 20 or more

Index of Sec 2572. ...

Withor: dismissal
Sec 2575. -- Licensure Pathway For Biosimilar Biological Products.
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT. - paragraph (B) - paragraph (ii)
DIVISION C TITLE V SUBTITLE C PART 2 SEC 2575. (a) (2) Quoted: (k) (6) (B) (ii)
Automated Concept:

BIOLOGICAL product ;   Dismissal withor without prejudice of action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar

Index of Sec 2575. ...

Worker
Workers
Sec 2572. -- Nutrition Labeling Of Standard Menu Items At Chain Restaurants And Of Articles Of Food Sold From Vending Machines.
(II) CONTENTS. - paragraph (aa)
DIVISION C TITLE V SUBTITLE C PART 1 SEC 2572. (b) Quoted: (H) (x) (II) (aa)
Automated Concept:

FOOD service workers, variations in ingredients and other factors ;   Considering standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of

Index of Sec 2572. ...


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The Index is © 2009 healthcarebillindex.com


111th CONGRESS
1st Session


    To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.


IN THE HOUSE OF REPRESENTATIVES

July 14, 2009

    Mr. Dingell (for himself, Mr. Rangel, Mr. Waxman, Mr. George Miller of California, Mr. Stark, Mr. Pallone, and Mr. Andrews) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, and the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned


A BILL

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

subtitle CFood and Drug Administration

PART 1In general

SEC. 2571. National medical device registry.

(a) Registry.—

(1) IN GENERAL.—Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended—

(A) by redesignating subsection (g) as subsection (h); and

(B) by inserting after subsection (f) the following:

“National Medical Device Registry

“(g) (1)(A) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each covered device.

“(B) In this subsection, the term ‘covered device’—

“(i) shall include each class III device; and

“(ii) may include, as the Secretary determines appropriate and specifies in regulation, a class II device that is life-supporting or life-sustaining.

“(C) Notwithstanding subparagraph (B)(i), the Secretary may by order exempt a class III device from the provisions of this subsection if the Secretary concludes that inclusion of information on the device in the registry will not provide useful information on safety or effectiveness.

“(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Agency for Healthcare Research and Quality, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for—

“(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each covered device by type, model, and serial number or other unique identifier;

“(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of—

“(i) data provided to the Secretary under other provisions of this chapter; and

“(ii) information from public and private sources identified under paragraph (3);

“(C) integrating the activities described in this subsection (so as to avoid duplication) with—

“(i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification);

“(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data);

“(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; and

“(iv) registries carried out by or for the Agency for Healthcare Research and Quality; and

“(D) providing public access to the data and analysis collected or developed through the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.

“(3)(A) To facilitate analyses of postmarket safety and patient outcomes for covered devices, the Secretary shall, in collaboration with public, academic, and private entities, develop methods to—

“(i) obtain access to disparate sources of patient safety and outcomes data, including—

“(I) Federal health-related electronic data (such as data from the Medicare program under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs);

“(II) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and

“(III) other data as the Secretary deems necessary to permit postmarket assessment of device safety and effectiveness; and

“(ii) link data obtained under clause (i) with information in the registry.

“(B) In this paragraph, the term ‘data’ refers to information respecting a covered device, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.

“(4) The Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations—

“(A)(i) in the case of covered devices that are sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; and

“(ii) in the case of covered devices that are sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;

“(B) shall establish procedures—

“(i) to permit linkage of information submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); and

“(ii) to permit analyses of linked data;

“(C) may require covered device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks;

“(D) shall establish requirements for regular and timely reports to the Secretary, which shall be included in the registry, concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; and

“(E) shall establish procedures to permit public access to the information in the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.

“(5)(A) The Secretary shall promulgate final regulations under paragraph (4) not later than 36 months after the date of the enactment of this subsection.

“(B) Before issuing the notice of proposed rulemaking preceding the final regulations described in subparagraph (A), the Secretary shall hold a public hearing before an advisory committee on the issue of which class II devices to include in the definition of covered devices.

“(C) The Secretary shall include in any regulation under this subsection an explanation demonstrating that the requirements of such regulation—

“(i) do not duplicate other Federal requirements; and

“(ii) do not impose an undue burden on device manufacturers.

“(6) With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a device under this section (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.

“(7) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 and 2012.”.

(2) EFFECTIVE DATE.—The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519(g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date.

(3) CONFORMING AMENDMENT.—Section 303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by striking “519(g)” and inserting “519(h)”.

(b) Electronic exchange and use in certified electronic health records of unique device identifiers.—

(1) RECOMMENDATIONS.—The HIT Policy Committee established under section 3002 of the Public Health Service Act (42 U.S.C. 300jj–12) shall recommend to the head of the Office of the National Coordinator for Health Information Technology standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each covered device (as defined under section 519(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).

(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA.—The Secretary of Health and Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each covered device referred to in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.

(c) Unique device identification system.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this Act.

SEC. 2572. Nutrition labeling of standard menu items at chain restaurants and of articles of food sold from vending machines.

(a) Technical amendments.—Section 403(q)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(A)) is amended—

(1) in subclause (i), by inserting “except as provided in clause (H)(ii)(III),” after “(i)” ; and

(2) in subclause (ii), by inserting “except as provided in clause (H)(ii)(III),” after “(ii)” .

(b) Labeling requirements.—Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by adding at the end the following:

“(H) Restaurants, retail food establishments, and vending machines.—

“(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.—Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii).

“(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS.—Except as provided in subclause (vii), the restaurant or similar retail food establishment shall disclose in a clear and conspicuous manner—

“(I)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and

“(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu and designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information that is provided on the menu;

“(II)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and

“(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu board, designed to enable the public to understand, in the context of a total daily diet, the significance of the nutrition information that is provided on the menu board;

“(III) in a written form, available on the premises of the restaurant or similar retail establishment and to the consumer upon request, the nutrition information required under clauses (C) and (D) of subparagraph (1); and

“(IV) on the menu or menu board, a prominent, clear, and conspicuous statement regarding the availability of the information described in item (III).

“(iii) SELF-SERVICE FOOD AND FOOD ON DISPLAY.—Except as provided in subclause (vii), in the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers, a restaurant or similar retail food establishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving.

“(iv) REASONABLE BASIS.—For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in section 101.10 of title 21, Code of Federal Regulations (or any successor regulation) or in a related guidance of the Food and Drug Administration.

“(v) MENU VARIABILITY AND COMBINATION MEALS.—The Secretary shall establish by regulation standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children's combination meals, through means determined by the Secretary, including ranges, averages, or other methods.

“(vi) ADDITIONAL INFORMATION.—If the Secretary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclosure of such nutrient in the written form required under subclause (ii)(III).

“(vii) NONAPPLICABILITY TO CERTAIN FOOD.—

“(I) IN GENERAL.—Subclauses (i) through (vi) do not apply to—

“(aa) items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use);

“(bb) daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom orders; or

“(cc) such other food that is part of a customary market test appearing on the menu for less than 90 days, under terms and conditions established by the Secretary.

“(II) WRITTEN FORMS.—Clause (C) shall apply to any regulations promulgated under subclauses (ii)(III) and (vi).

“(viii) VENDING MACHINES.—In the case of an article of food sold from a vending machine that—

“(I) does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article or does not otherwise provide visible nutrition information at the point of purchase; and

“(II) is operated by a person who is engaged in the business of owning or operating 20 or more vending machines,

the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the article.

“(ix) VOLUNTARY PROVISION OF NUTRITION INFORMATION.—

“(I) IN GENERAL.—An authorized official of any restaurant or similar retail food establishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment or vending machine operator with the Secretary, as specified by the Secretary by regulation.

“(II) REGISTRATION.—Within 120 days of the enactment of this clause, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regulations.

“(III) RULE OF CONSTRUCTION.—Nothing in this subclause shall be construed to authorize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item.

“(x) REGULATIONS.—

“(I) PROPOSED REGULATION.—Not later than 1 year after the date of the enactment of this clause, the Secretary shall promulgate proposed regulations to carry out this clause.

“(II) CONTENTS.—In promulgating regulations, the Secretary shall—

“(aa) consider standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, variations in ingredients, and other factors, as the Secretary determines; and

“(bb) specify the format and manner of the nutrient content disclosure requirements under this subclause.

“(III) REPORTING.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary's progress toward promulgating final regulations under this subparagraph.

“(xi) DEFINITION.—In this clause, the term ‘menu’ or ‘menu board’ means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.”.

(c) National uniformity.—Section 403A(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(4)) is amended by striking “except a requirement for nutrition labeling of food which is exempt under subclause (i) or (ii) of section 403(q)(5)(A)” and inserting “except that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition information requirements under section 403(q)(5)(H)(ix)”.

(d) Rule of construction.—Nothing in the amendments made by this section shall be construed—

(1) to preempt any provision of State or local law, unless such provision establishes or continues into effect nutrient content disclosures of the type required under section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)) and is expressly preempted under section 403A(a)(4) of such Act;

(2) to apply to any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food; or

(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)), to apply to any restaurant or similar retail food establishment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of such Act.

SEC. 2573. Protecting consumer access to generic drugs.

(a) Findings; purpose.—

(1) FINDINGS.—The Congress finds the following:

(A) In 1984, the Drug Price Competition and Patent Term Restoration Act (Pub. L. 98–417; in this subsection referred to as the “1984 Act”) was enacted with the intent of facilitating the early entry of generic drugs while preserving incentives for innovation.

(B) Prescription drugs make up 10 percent of national health care spending, but for the past decade have been one of the fastest growing segments of health care expenditures.

(C) Until recently, the 1984 Act was successful in facilitating generic competition to the benefit of consumers and health care payers—although 67 percent of all prescriptions dispensed in the United States are generic drugs, they account for only 20 percent of all expenditures.

(D) In recent years, the intent of the 1984 Act has been subverted by certain settlement agreements between brand companies and their potential generic competitors that make reverse payments, i.e., payments by the brand company to the generic company.

(E) These settlement agreements have unduly delayed the marketing of low-cost generic drugs contrary to free competition and the interests of consumers.

(F) The state of antitrust law relating to such settlement agreements is unsettled.

(2) PURPOSE.—The purpose of this section is to provide an additional means to effectuate the intent of the 1984 Act by enhancing competition in the pharmaceutical market by stopping agreements between brand name and generic drug manufacturers that limit, delay, or otherwise prevent competition from generic drugs.

(b) In general.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

“(w) Protecting Consumer Access to Generic Drugs.—

“(1) UNFAIR AND DECEPTIVE ACTS AND PRACTICES RELATED TO NEW DRUG APPLICATIONS.—

“(A) CONDUCT PROHIBITED.—It shall be unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which—

“(i) an ANDA filer receives anything of value; and

“(ii) the ANDA filer agrees to limit or forego research, development, manufacturing, marketing, or sales, for any period of time, of the drug that is to be manufactured under the ANDA involved and is the subject of the patent infringement claim.

“(B) EXCEPTIONS.—Notwithstanding subparagraph (A)(i), subparagraph (A) does not prohibit a resolution or settlement of a patent infringement claim in which the value received by the ANDA filer includes no more than—

“(i) the right to market the drug that is to be manufactured under the ANDA involved and is the subject of the patent infringement claim, before the expiration of—

“(I) the patent that is the basis for the patent infringement claim; or

“(II) any other statutory exclusivity that would prevent the marketing of such drug; and

“(ii) the waiver of a patent infringement claim for damages based on prior marketing of such drug.

“(C) ENFORCEMENT.—

“(i) IN GENERAL.—A violation of subparagraph (A) shall be treated as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce prohibited under section 5 of the Federal Trade Commission Act and shall be enforced by the Federal Trade Commission in the same manner, by the same means, and with the same jurisdiction as though all applicable terms and provisions of the Federal Trade Commission Act were incorporated into and made a part of this subsection.

“(ii) INAPPLICABILITY.—Subchapter A of chapter VII shall not apply with respect to this subsection.

“(D) DEFINITIONS.—In this subsection:

“(i) AGREEMENT.—The term ‘agreement’ means anything that would constitute an agreement under section 5 of the Federal Trade Commission Act.

“(ii) AGREEMENT RESOLVING OR SETTLING.—The term ‘agreement resolving or settling’, in reference to a patent infringement claim, includes any agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim.

“(iii) ANDA.—The term ‘ANDA’ means an abbreviated new drug application for the approval of a new drug under section (j).

“(iv) ANDA FILER.—The term ‘ANDA filer’ means a party that has filed an ANDA with the Food and Drug Administration.

“(v) PATENT INFRINGEMENT.—The term ‘patent infringement’ means infringement of any patent or of any filed patent application, extension, reissuance, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patent of addition, or extension thereof.

“(vi) PATENT INFRINGEMENT CLAIM.—The term ‘patent infringement claim’ means any allegation made to an ANDA filer, whether or not included in a complaint filed with a court of law, that its ANDA or drug to be manufactured under such ANDA may infringe any patent.

“(2) FTC RULEMAKING.—The Federal Trade Commission may, by rule promulgated under section 553 of title 5, United States Code, exempt certain agreements described in paragraph (1) from the requirements of this subsection if the Commission finds such agreements to be in furtherance of market competition and for the benefit of consumers. Consistent with the authority of the Commission, such rules may include interpretive rules and general statements of policy with respect to the practices prohibited under paragraph (1).”.

(c) Notice and Certification of Agreements.—

(1) NOTICE OF ALL AGREEMENTS.—Section 1112(c)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 3155 note) is amended by—

(A) striking “the Commission the” and inserting the following: “the Commission—

“(A) the”;

(B) striking the period at the end and inserting “; and”; and

(C) adding at the end the following:

“(B) any other agreement the parties enter into within 30 days of entering into an agreement covered by subsection (a) or (b).”.

(2) CERTIFICATION OF AGREEMENTS.—Section 1112 of such Act is amended by adding at the end the following:

“(d) Certification.—The chief executive officer or the company official responsible for negotiating any agreement required to be filed under subsection (a), (b), or (c) shall execute and file with the Assistant Attorney General and the Commission a certification as follows: ‘I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing.’.”.

(d) GAO Study.—

(1) STUDY.—Beginning 2 years after the date of enactment of this Act, and each year for a period of 4 years thereafter, the Comptroller General shall conduct a study on the litigation in United States courts during the period beginning 5 years prior to the date of enactment of this Act relating to patent infringement claims involving generic drugs, the number of patent challenges initiated by manufacturers of generic drugs, and the number of settlements of such litigation. The Comptroller General shall transmit to Congress a report of the findings of such a study and an analysis of the effect of the amendments made by subsections (b) and (c) on such litigation, whether such amendments have had an effect on the number and frequency of claims settled, and whether such amendments resulted in earlier or delayed entry of generic drugs to market, including whether any harm or benefit to consumers has resulted.

(2) DISCLOSURE OF AGREEMENTS.—Notwithstanding any other law, agreements filed under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note), or unaggregated information from such agreements, shall be disclosed to the Comptroller General for purposes of the study under paragraph (1) within 30 days of a request by the Comptroller General.

PART 2Biosimilars

SEC. 2575. Licensure pathway for biosimilar biological products.

(a) Licensure of Biological Products as Biosimilar or Interchangeable.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended—

(1) in subsection (a)(1)(A), by inserting “under this subsection or subsection (k)” after “biologics license”; and

(2) by adding at the end the following:

“(k) Licensure of biological products as biosimilar or interchangeable.—

“(1) IN GENERAL.—Any person may submit an application for licensure of a biological product under this subsection.

“(2) CONTENT.—

“(A) IN GENERAL.—

“(i) REQUIRED INFORMATION.—An application submitted under this subsection shall include information demonstrating that—

“(I) the biological product is biosimilar to a reference product based upon data derived from—

“(aa) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components;

“(bb) animal studies (including the assessment of toxicity); and

“(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product;

“(II) the biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product;

“(III) the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product;

“(IV) the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product; and

“(V) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent.

“(ii) DETERMINATION BY SECRETARY.—The Secretary may determine, in the Secretary's discretion, that an element described in clause (i)(I) is unnecessary in an application submitted under this subsection.

“(iii) ADDITIONAL INFORMATION.—An application submitted under this subsection—

“(I) shall include publicly available information regarding the Secretary’s previous determination that the reference product is safe, pure, and potent; and

“(II) may include any additional information in support of the application, including publicly available information with respect to the reference product or another biological product.

“(B) INTERCHANGEABILITY.—An application (or a supplement to an application) submitted under this subsection may include information demonstrating that the biological product meets the standards described in paragraph (4).

“(3) EVALUATION BY SECRETARY.—Upon review of an application (or a supplement to an application) submitted under this subsection, the Secretary shall license the biological product under this subsection if—

“(A) the Secretary determines that the information submitted in the application (or the supplement) is sufficient to show that the biological product—

“(i) is biosimilar to the reference product; or

“(ii) meets the standards described in paragraph (4), and therefore is interchangeable with the reference product; and

“(B) the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).

“(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.—Upon review of an application submitted under this subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to such application) is sufficient to show that—

“(A) the biological product—

“(i) is biosimilar to the reference product; and

“(ii) can be expected to produce the same clinical result as the reference product in any given patient; and

“(B) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

“(5) GENERAL RULES.—

“(A) ONE REFERENCE PRODUCT PER APPLICATION.—A biological product, in an application submitted under this subsection, may not be evaluated against more than 1 reference product.

“(B) REVIEW.—An application submitted under this subsection shall be reviewed by the division within the Food and Drug Administration that is responsible for the review and approval of the application under which the reference product is licensed.

“(C) RISK EVALUATION AND MITIGATION STRATEGIES.—The authority of the Secretary with respect to risk evaluation and mitigation strategies under the Federal Food, Drug, and Cosmetic Act shall apply to biological products licensed under this subsection in the same manner as such authority applies to biological products licensed under subsection (a).

“(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS.—If information in an application submitted under this subsection, in a supplement to such an application, or otherwise available to the Secretary shows that a biological product—

“(i) is, bears, or contains a select agent or toxin listed in section 73.3 or 73.4 of title 42, section 121.3 or 121.4 of title 9, or section 331.3 of title 7, Code of Federal Regulations (or any successor regulations); or

“(ii) is, bears, or contains a controlled substance in schedule I or II of section 202 of the Controlled Substances Act, as listed in part 1308 of title 21, Code of Federal Regulations (or any successor regulations);

the Secretary shall not license the biological product under this subsection unless the Secretary determines, after consultation with appropriate national security and drug enforcement agencies, that there would be no increased risk to the security or health of the public from licensing such biological product under this subsection.

“(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.—Upon review of an application submitted under this subsection relying on the same reference product for which a prior biological product has received a determination of interchangeability for any condition of use, the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use until the earlier of—

“(A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as interchangeable for that reference product;

“(B) 18 months after—

“(i) a final court decision on all patents in suit in an action instituted under subsection (l)(5) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or

“(ii) the dismissal with or without prejudice of an action instituted under subsection (l)(5) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or

“(C)(i) 42 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has been sued under subsection (l)(5) and such litigation is still ongoing within such 42-month period; or

“(ii) 18 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has not been sued under subsection (l)(5).

For purposes of this paragraph, the term ‘final court decision’ means a final decision of a court from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken.

“(7) EXCLUSIVITY FOR REFERENCE PRODUCT.—

“(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).

“(B) FILING PERIOD.—An application under this subsection may not be submitted to the Secretary until the date that is 4 years after the date on which the reference product was first licensed under subsection (a).

“(C) FIRST LICENSURE.—Subparagraphs (A) and (B) shall not apply to a license for or approval of—

“(i) a supplement for the biological product that is the reference product; or

“(ii) a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest, or other related entity) for—

“(I) a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or

“(II) a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.

“(8) PEDIATRIC STUDIES.—

“(A) EXCLUSIVITY.—If, before or after licensure of the reference product under subsection (a) of this section, the Secretary determines that information relating to the use of such product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant or holder of the approved application agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act the period referred to in paragraph (7)(A) of this subsection is deemed to be 12 years and 6 months rather than 12 years.

“(B) EXCEPTION.—The Secretary shall not extend the period referred to in subparagraph (A) of this paragraph if the determination under section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act is made later than 9 months prior to the expiration of such period.

“(C) APPLICATION OF CERTAIN PROVISIONS.—The provisions of subsections (a), (d), (e), (f), (h), (j), (k), and (l) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the extension of a period under subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act.

“(9) GUIDANCE DOCUMENTS.—

“(A) IN GENERAL.—The Secretary may, after opportunity for public comment, issue guidance in accordance, except as provided in subparagraph (B)(i), with section 701(h) of the Federal Food, Drug, and Cosmetic Act with respect to the licensure of a biological product under this subsection. Any such guidance may be general or specific.

“(B) PUBLIC COMMENT.—

“(i) IN GENERAL.—The Secretary shall provide the public an opportunity to comment on any proposed guidance issued under subparagraph (A) before issuing final guidance.

“(ii) INPUT REGARDING MOST VALUABLE GUIDANCE.—The Secretary shall establish a process through which the public may provide the Secretary with input regarding priorities for issuing guidance.

“(C) NO REQUIREMENT FOR APPLICATION CONSIDERATION.—The issuance (or non-issuance) of guidance under subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection.

“(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE.—If the Secretary issues product class-specific guidance under subparagraph (A), such guidance shall include a description of—

“(i) the criteria that the Secretary will use to determine whether a biological product is highly similar to a reference product in such product class; and

“(ii) the criteria, if available, that the Secretary will use to determine whether a biological product meets the standards described in paragraph (4).

“(E) CERTAIN PRODUCT CLASSES.—

“(i) GUIDANCE.—The Secretary may indicate in a guidance document that the science and experience, as of the date of such guidance, with respect to a product or product class (not including any recombinant protein) does not allow approval of an application for a license as provided under this subsection for such product or product class.

“(ii) MODIFICATION OR REVERSAL.—The Secretary may issue a subsequent guidance document under subparagraph (A) to modify or reverse a guidance document under clause (i).

“(iii) NO EFFECT ON ABILITY TO DENY LICENSE.—Clause (i) shall not be construed to require the Secretary to approve a product with respect to which the Secretary has not indicated in a guidance document that the science and experience, as described in clause (i), does not allow approval of such an application.

“(10) NAMING.—The Secretary shall ensure that the labeling and packaging of each biological product licensed under this subsection bears a name that uniquely identifies the biological product and distinguishes it from the reference product and any other biological products licensed under this subsection following evaluation against such reference product.

“(l) Patent notices; relationship to final approval.—

“(1) DEFINITIONS.—For the purposes of this subsection, the term—

“(A) ‘biosimilar product’ means the biological product that is the subject of the application under subsection (k);

“(B) ‘relevant patent’ means a patent that—

“(i) expires after the date specified in subsection (k)(7)(A) that applies to the reference product; and

“(ii) could reasonably be asserted against the applicant due to the unauthorized making, use, sale, or offer for sale within the United States, or the importation into the United States of the biosimilar product, or materials used in the manufacture of the biosimilar product, or due to a use of the biosimilar product in a method of treatment that is indicated in the application;

“(C) ‘reference product sponsor’ means the holder of an approved application or license for the reference product; and

“(D) ‘interested third party’ means a person other than the reference product sponsor that owns a relevant patent, or has the right to commence or participate in an action for infringement of a relevant patent.

“(2) HANDLING OF CONFIDENTIAL INFORMATION.—Any entity receiving confidential information pursuant to this subsection shall designate one or more individuals to receive such information. Each individual so designated shall execute an agreement in accordance with regulations promulgated by the Secretary. The regulations shall require each such individual to take reasonable steps to maintain the confidentiality of information received pursuant to this subsection and use the information solely for purposes authorized by this subsection. The obligations imposed on an individual who has received confidential information pursuant to this subsection shall continue until the individual returns or destroys the confidential information, a court imposes a protective order that governs the use or handling of the confidential information, or the party providing the confidential information agrees to other terms or conditions regarding the handling or use of the confidential information.

“(3) PUBLIC NOTICE BY SECRETARY.—Within 30 days of acceptance by the Secretary of an application filed under subsection (k), the Secretary shall publish a notice identifying—

“(A) the reference product identified in the application; and

“(B) the name and address of an agent designated by the applicant to receive notices pursuant to paragraph (4)(B).

“(4) EXCHANGES CONCERNING PATENTS.—

“(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR.—

“(i) Within 30 days of the date of acceptance of the application by the Secretary, the applicant shall provide the reference product sponsor with a copy of the application and information concerning the biosimilar product and its production. This information shall include a detailed description of the biosimilar product, its method of manufacture, and the materials used in the manufacture of the product.

“(ii) Within 60 days of the date of receipt of the information required to be provided under clause (i), the reference product sponsor shall provide to the applicant a list of relevant patents owned by the reference product sponsor, or in respect of which the reference product sponsor has the right to commence an action of infringement or otherwise has an interest in the patent as such patent concerns the biosimilar product.

“(iii) If the reference product sponsor is issued or acquires an interest in a relevant patent after the date on which the reference product sponsor provides the list required by clause (ii) to the applicant, the reference product sponsor shall identify that patent to the applicant within 30 days of the date of issue of the patent, or the date of acquisition of the interest in the patent, as applicable.

“(B) EXCHANGES WITH INTERESTED THIRD PARTIES.—

“(i) At any time after the date on which the Secretary publishes a notice for an application under paragraph (3), any interested third party may provide notice to the designated agent of the applicant that the interested third party owns or has rights under 1 or more patents that may be relevant patents. The notice shall identify at least 1 patent and shall designate an individual who has executed an agreement in accordance with paragraph (2) to receive confidential information from the applicant.

“(ii) Within 30 days of the date of receiving notice pursuant to clause (i), the applicant shall send to the individual designated by the interested third party the information specified in subparagraph (A)(i), unless the applicant and interested third party otherwise agree.

“(iii) Within 90 days of the date of receiving information pursuant to clause (ii), the interested third party shall provide to the applicant a list of relevant patents which the interested third party owns, or in respect of which the interested third party has the right to commence or participate in an action for infringement.

“(iv) If the interested third party is issued or acquires an interest in a relevant patent after the date on which the interested third party provides the list required by clause (iii), the interested third party shall identify that patent within 30 days of the date of issue of the patent, or the date of acquisition of the interest in the patent, as applicable.

“(C) IDENTIFICATION OF BASIS FOR INFRINGEMENT.—For any patent identified under clause (ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph (B), the reference product sponsor or the interested third party, as applicable—

“(i) shall explain in writing why the sponsor or the interested third party believes the relevant patent would be infringed by the making, use, sale, or offer for sale within the United States, or importation into the United States, of the biosimilar product or by a use of the biosimilar product in treatment that is indicated in the application;

“(ii) may specify whether the relevant patent is available for licensing; and

“(iii) shall specify the number and date of expiration of the relevant patent.

“(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS.—Not later than 45 days after the date on which a patent is identified under clause (ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph (B), the applicant shall send a written statement regarding each identified patent to the party that identified the patent. Such statement shall either—

“(i) state that the applicant will not commence marketing of the biosimilar product and has requested the Secretary to not grant final approval of the application before the date of expiration of the noticed patent; or

“(ii) provide a detailed written explanation setting forth the reasons why the applicant believes—

“(I) the making, use, sale, or offer for sale within the United States, or the importation into the United States, of the biosimilar product, or the use of the biosimilar product in a treatment indicated in the application, would not infringe the patent; or

“(II) the patent is invalid or unenforceable.

“(5) ACTION FOR INFRINGEMENT INVOLVING REFERENCE PRODUCT SPONSOR.—If an action for infringement concerning a relevant patent identified by the reference product sponsor under clause (ii) or (iii) of paragraph (4)(A), or by an interested third party under clause (iii) or (iv) of paragraph (4)(B), is brought within 60 days of the date of receipt of a statement under paragraph (4)(D)(ii), and the court in which such action has been commenced determines the patent is infringed prior to the date applicable under subsection (k)(7)(A) or (k)(8), the Secretary shall make approval of the application effective on the day after the date of expiration of the patent that has been found to be infringed. If more than one such patent is found to be infringed by the court, the approval of the application shall be made effective on the day after the date that the last such patent expires.

“(6) NOTIFICATION OF AGREEMENTS.—

“(A) REQUIREMENTS.—

“(i) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANT AND REFERENCE PRODUCT SPONSOR.—If a biosimilar product applicant under subsection (k) and the reference product sponsor enter into an agreement described in subparagraph (B), the applicant and sponsor shall each file the agreement in accordance with subparagraph (C).

“(ii) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANTS.—If 2 or more biosimilar product applicants submit an application under subsection (k) for biosimilar products with the same reference product and enter into an agreement described in subparagraph (B), the applicants shall each file the agreement in accordance with subparagraph (C).

“(B) SUBJECT MATTER OF AGREEMENT.—An agreement described in this subparagraph—

“(i) is an agreement between the biosimilar product applicant under subsection (k) and the reference product sponsor or between 2 or more biosimilar product applicants under subsection (k) regarding the manufacture, marketing, or sale of—

“(I) the biosimilar product (or biosimilar products) for which an application was submitted; or

“(II) the reference product;

“(ii) includes any agreement between the biosimilar product applicant under subsection (k) and the reference product sponsor or between 2 or more biosimilar product applicants under subsection (k) that is contingent upon, provides a contingent condition for, or otherwise relates to an agreement described in clause (i); and

“(iii) excludes any agreement that solely concerns—

“(I) purchase orders for raw material supplies;

“(II) equipment and facility contracts;

“(III) employment or consulting contracts; or

“(IV) packaging and labeling contracts.

“(C) FILING.—

“(i) IN GENERAL.—The text of an agreement required to be filed by subparagraph (A) shall be filed with the Assistant Attorney General and the Federal Trade Commission not later than—

“(I) 10 business days after the date on which the agreement is executed; and

“(II) prior to the date of the first commercial marketing of, for agreements described in subparagraph (A)(i), the biosimilar product that is the subject of the application or, for agreements described in subparagraph (A)(ii), any biosimilar product that is the subject of an application described in such subparagraph.

“(ii) IF AGREEMENT NOT REDUCED TO TEXT.—If an agreement required to be filed by subparagraph (A) has not been reduced to text, the persons required to file the agreement shall each file written descriptions of the agreement that are sufficient to disclose all the terms and conditions of the agreement.

“(iii) CERTIFICATION.—The chief executive officer or the company official responsible for negotiating any agreement required to be filed by subparagraph (A) shall include in any filing under this paragraph a certification as follows: ‘I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 351(l)(6) of the Public Health Service Act, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to such section and have not been reduced to writing.’.

“(D) DISCLOSURE EXEMPTION.—Any information or documentary material filed with the Assistant Attorney General or the Federal Trade Commission pursuant to this paragraph shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this subparagraph prevents disclosure of information or documentary material to either body of the Congress or to any duly authorized committee or subcommittee of the Congress.

“(E) ENFORCEMENT.—

“(i) CIVIL PENALTY.—Any person that violates a provision of this paragraph shall be liable for a civil penalty of not more than $11,000 for each day on which the violation occurs. Such penalty may be recovered in a civil action—

“(I) brought by the United States; or

“(II) brought by the Federal Trade Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act.

“(ii) COMPLIANCE AND EQUITABLE RELIEF.—If any person violates any provision of this paragraph, the United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Federal Trade Commission.

“(F) RULEMAKING.—The Federal Trade Commission, with the concurrence of the Assistant Attorney General and by rule in accordance with section 553 of title 5, United States Code, consistent with the purposes of this paragraph—

“(i) may define the terms used in this paragraph;

“(ii) may exempt classes of persons or agreements from the requirements of this paragraph; and

“(iii) may prescribe such other rules as may be necessary and appropriate to carry out the purposes of this paragraph.

“(G) SAVINGS CLAUSE.—Any action taken by the Assistant Attorney General or the Federal Trade Commission, or any failure of the Assistant Attorney General or the Commission to take action, under this paragraph shall not at any time bar any proceeding or any action with respect to any agreement between a biosimilar product applicant under subsection (k) and the reference product sponsor, or any agreement between biosimilar product applicants under subsection (k), under any other provision of law, nor shall any filing under this paragraph constitute or create a presumption of any violation of any competition laws.”.

(b) Definitions.—Section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) is amended—

(1) by striking “In this section, the term ‘biological product’ means” and inserting the following: “In this section:

“(1) The term ‘biological product’ means”;

(2) in paragraph (1), as so designated, by inserting “protein (except any chemically synthesized polypeptide),” after “allergenic product,”; and

(3) by adding at the end the following:

“(2) The term ‘biosimilar’ or ‘biosimilarity’, in reference to a biological product that is the subject of an application under subsection (k), means—

“(A) that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and

“(B) there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

“(3) The term ‘interchangeable’ or ‘interchangeability’, in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

“(4) The term ‘reference product’ means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under subsection (k).”.

(c) Products Previously Approved Under Section 505.—

(1) REQUIREMENT TO FOLLOW SECTION 351.—Except as provided in paragraph (2), an application for a biological product shall be submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).

(2) EXCEPTION.—An application for a biological product may be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if—

(A) such biological product is in a product class for which a biological product in such product class is the subject of an application approved under such section 505 not later than the date of enactment of this Act; and

(B) such application—

(i) has been submitted to the Secretary of Health and Human Services (referred to in this Act as the “Secretary”) before the date of enactment of this Act; or

(ii) is submitted to the Secretary not later than the date that is 10 years after the date of enactment of this Act.

(3) LIMITATION.—Notwithstanding paragraph (2), an application for a biological product may not be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if there is another biological product approved under subsection (a) of section 351 of the Public Health Service Act that could be a reference product with respect to such application (within the meaning of such section 351) if such application were submitted under subsection (k) of such section 351.

(4) DEEMED APPROVED UNDER SECTION 351.—An approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be deemed to be a license for the biological product under such section 351 on the date that is 10 years after the date of enactment of this Act.

(5) DEFINITIONS.—For purposes of this subsection, the term “biological product” has the meaning given such term under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).

SEC. 2576. Fees relating to biosimilar biological products.

Subparagraph (B) of section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by inserting “, including licensure of a biological product under section 351(k) of such Act” before the period at the end.

SEC. 2577. Amendments to certain patent provisions.

(a) Section 271(e)(2) of title 35, United States Code is amended—

(1) in subparagraph (A), by striking “or” after “patent,”;

(2) in subparagraph (B), by adding “or” after the comma at the end;

(3) by inserting the following after subparagraph (B):

“(C) a statement under section 351(l)(4)(D)(ii) of the Public Health Service Act,”; and

(4) in the matter following subparagraph (C) (as added by paragraph (3)), by inserting before the period the following: “, or if the statement described in subparagraph (C) is provided in connection with an application to obtain a license to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent”.

(b) Section 271(e)(4) of title 35, United States Code, is amended by striking “in paragraph (2)” in both places it appears and inserting “in paragraph (2)(A) or (2)(B)”.


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