199 
Service Act (42 U.S.C. 262(a)) with re-
spect to a biological product; 
(B) a person owning or controlling enforce-
ment of the patent on— 
(i) the list published under section 
505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)) in con-
nection with the application described in 
subparagraph (A)(i); or 
(ii) any list published under section 
351 of the Public Health Service Act (42 
U.S.C. 262) comprised of patents associ-
ated with biologics license applications filed 
under section 351(a) of such Act (42 
U.S.C. 262(a)); or 
(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any en-
tity described in subparagraph (A) or (B) (such 
control to be presumed by direct or indirect 
share ownership of 50 percent or greater), as 
well as the licensees, licensors, successors, and 
assigns of each of the entities. 
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(6) PATENT.—The term ‘‘patent’’ means a pat-
ent issued by the United States Patent and Trade-
mark Office. 
(7) 
STATUTORY
EXCLUSIVITY.—The 
term 
‘‘statutory exclusivity’’ means those prohibitions on 
the submission or approval of drug applications 
under 
clauses 
(ii) 
through 
(iv) 
of 
section 
505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) 
through (iv) of section 505(j)(5)(F) (5-year and 3- 
year exclusivity), section 505(j)(5)(B)(iv) (180-day 
exclusivity), section 527 (orphan drug exclusivity), 
section 505A (pediatric exclusivity), or section 505E 
(qualified infectious disease product exclusivity) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 
360cc, 355a, 355f), or prohibitions on the submis-
sion or licensing of biologics license applications 
under section 351(k)(6) (interchangeable biological 
product exclusivity) or section 351(k)(7) (biological 
product reference product exclusivity) of the Public 
Health Service Act (42 U.S.C. 262(k)(6), (7)). 
(8) SUBSEQUENT
FILER.—The term ‘‘subse-
quent filer’’ means— 
(A) in the case of a drug, a party that 
owns or controls an abbreviated new drug appli-
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cation submitted pursuant to section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) or a new drug application sub-
mitted pursuant to section 505(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(2)) and filed under section 
505(b)(1) of such Act (21 U.S.C. 355(b)(1)) or 
has the exclusive rights to distribute the cov-
ered product that is the subject of such applica-
tion; or 
(B) in the case of a biological product, a 
party that owns or controls an application filed 
with the Food and Drug Administration under 
section 351(k) of the Public Health Service Act 
(42 U.S.C. 262(k)) or has the exclusive rights 
to distribute the biological product that is the 
subject of such application. 
(h) EFFECTIVE DATE.—This section applies with re-
spect to agreements described in subsection (a) entered 
into on or after the date of the enactment of this Act. 
SEC. 312. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 
of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (21 U.S.C. 355 note) is 
amended by inserting ‘‘or the owner of a patent for which 
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a claim of infringement could reasonably be asserted 
against any person for making, using, offering to sell, sell-
ing, or importing into the United States a biological prod-
uct that is the subject of a biosimilar biological product 
application’’ before the period at the end. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act (21 U.S.C. 355 note) is amended by adding 
at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official responsible for negotiating any 
agreement under subsection (a) or (b) that is required to 
be filed under subsection (c) shall, within 30 days of such 
filing, execute and file with the Assistant Attorney General 
and the Commission a certification as follows: ‘I declare 
that the following is true, correct, and complete to the best 
of my knowledge: The materials filed with the Federal 
Trade Commission and the Department of Justice under 
section 1112 of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003, with respect to the 
agreement referenced in this certification— 
‘‘ ‘(1) represent the complete, final, and exclu-
sive agreement between the parties; 
‘‘ ‘(2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for, 
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were entered into within 30 days of, or are otherwise 
related to, the referenced agreement; and 
‘‘ ‘(3) include written descriptions of any oral 
agreements, representations, commitments, or prom-
ises between the parties that are responsive to sub-
section (a) or (b) of such section 1112 and have not 
been reduced to writing.’.’’. 
SEC. 313. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
Section 505(j)(5)(D)(i)(V) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 
is amended by inserting ‘‘section 311 of the Lower Costs, 
More Cures Act of 2019 or’’ after ‘‘that the agreement 
has violated’’. 
SEC. 314. COMMISSION LITIGATION AUTHORITY. 
Section 16(a)(2) of the Federal Trade Commission 
Act (15 U.S.C. 56(a)(2)) is amended— 
(1) in subparagraph (D), by striking ‘‘or’’ after 
the semicolon; 
(2) in subparagraph (E), by inserting ‘‘or’’ 
after the semicolon; and 
(3) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) under section 311(d)(3)(A) of the 
Lower Costs, More Cures Act of 2019;’’. 
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SEC. 315. STATUTE OF LIMITATIONS. 
(a) IN GENERAL.—Except as provided in subsection 
(b), the Commission shall commence any administrative 
proceeding or civil action to enforce section 311 of this 
Act not later than 6 years after the date on which the 
parties to the agreement file the Notice of Agreement as 
provided by section 1112(c)(2) and (d) of the Medicare 
Prescription Drug, Improvement, and Modernization Act 
of 2003 (21 U.S.C. 355 note). 
(b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND 
DESIST ORDER.—If the Commission has issued a cease 
and desist order under section 5 of the Federal Trade 
Commission Act (15 U.S.C. 45) for violation of section 
311 of this Act and the proceeding for the issuance of 
such order was commenced within the period required by 
subsection (a) of this section, such subsection does not 
prohibit the commencement, after such period, of a civil 
action under section 311(d)(3)(A) against a party to such 
order or a civil action under subsection (l) of such section 
5 for violation of such order. 
Subtitle C—BLOCKING Act 
SEC. 321. CHANGE CONDITIONS OF FIRST GENERIC EXCLU-
SIVITY TO SPUR ACCESS AND COMPETITION. 
(a) IN GENERAL.—Section 505(j)(5)(B)(iv) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)(B)(iv)) is amended— 
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(1) in subclause (I), by striking ‘‘180 days 
after’’ and all that follows through the period at the 
end and inserting the following: ‘‘180 days after the 
earlier of— 
‘‘(aa) the date of the first com-
mercial marketing of the drug (includ-
ing the commercial marketing of the 
listed drug) by any first applicant; or 
‘‘(bb) the applicable date speci-
fied in subclause (III).’’; and 
(2) by adding at the end the following new sub-
clause: 
‘‘(III) APPLICABLE DATE.—The appli-
cable date specified in this subclause, with 
respect to an application for a drug de-
scribed in subclause (I), is the date on 
which each of the following conditions is 
first met: 
‘‘(aa) The approval of such an 
application could be made effective, 
but for the eligibility of a first appli-
cant for 180-day exclusivity under 
this clause. 
‘‘(bb) At least 30 months have 
passed since the date of submission of 
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an application for the drug by at least 
one first applicant. 
‘‘(cc) Approval of an application 
for the drug submitted by at least one 
first applicant is not precluded under 
clause (iii). 
‘‘(dd) No application for the drug 
submitted by any first applicant is ap-
proved at the time the conditions 
under items (aa), (bb), and (cc) are 
all met, regardless of whether such an 
application 
is 
subsequently 
ap-
proved.’’. 
(b) INFORMATION.—The Secretary of Health and 
Human Services shall— 
(1) not later than 120 days after the date of 
enactment of this Act, publish, as appropriate and 
available, information sufficient to allow applicants 
to assess whether the conditions described in section 
505(j)(5)(B)(iv)(III) of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (a)) are satis-
fied for all applications where the exclusivity period 
under clause (iv)(I) of section 505(j)(5)(B) of the 
Federal Food, Drug, and Cosmetic Act (as amended 
by such subsection) has not expired; and 
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(2) publish updates to such information to re-
flect the most recent information available to the 
Secretary. 
Subtitle D—Purple Book 
SEC. 331. PUBLIC LISTING. 
Section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)) is amended by adding at the end the fol-
lowing: 
‘‘(9) PUBLIC LISTING.— 
‘‘(A) IN GENERAL.— 
‘‘(i) INITIAL PUBLICATION.—Not later 
than 180 days after the date of enactment 
of the Lower Costs, More Cures Act of 
2019, the Secretary shall publish and 
make available to the public in a search-
able, electronic format— 
‘‘(I) a list in alphabetical order of 
the nonproprietary or proper name of 
each biological product for which a 
biologics license under subsection (a) 
or this subsection is in effect, or that 
has been deemed to be licensed under 
this 
section 
pursuant 
to 
section 
7002(e)(4) of the Biologics Price 
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Competition and Innovation Act of 
2009, as of such date of enactment; 
‘‘(II) the date of approval of the 
marketing application and the applica-
tion number; and 
‘‘(III) the marketing or licensure 
status of the biological product for 
which a biologics license under sub-
section (a) or this subsection is in ef-
fect or that has been deemed to be li-
censed under this section pursuant to 
section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act 
of 2009. 
‘‘(ii) 
REVISIONS.—Every 
days 
after the publication of the first list under 
clause (i), the Secretary shall revise the list 
to include each biological product which 
has been licensed under subsection (a) or 
this subsection during the 30-day period. 
‘‘(iii) PATENT
INFORMATION.—Not 
later than 30 days after a list of patents 
under subsection (l)(3)(A), or a supple-
ment to such list under subsection (l)(7), 
has been provided by the reference product 
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sponsor to the subsection (k) applicant re-
specting a biological product included on 
the list published under this subparagraph, 
the reference product sponsor shall provide 
such list of patents (or supplement there-
to) and their corresponding expiry dates to 
the Secretary, and the Secretary shall, in 
revisions made under clause (ii), include 
such information for such biological prod-
uct. Within 30 days of providing any sub-
sequent or supplemental list of patents to 
any subsequent subsection (k) applicant 
under subsection (l)(3)(A) or (l)(7), the 
reference product sponsor shall update the 
information provided to the Secretary 
under this clause with any additional pat-
ents from such subsequent or supplemental 
list and their corresponding expiry dates. 
‘‘(iv) LISTING
OF
EXCLUSIVITIES.— 
For each biological product included on the 
list published under this subparagraph, the 
Secretary shall specify each exclusivity pe-
riod that is applicable and has not con-
cluded under paragraph (6) or paragraph 
(7). 
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‘‘(B) WITHDRAWAL OR SUSPENSION OF LI-
CENSURE.—If the licensing of a biological prod-
uct was withdrawn or suspended for safety, pu-
rity, or potency reasons, it may not be pub-
lished in the list under subparagraph (A). If the 
withdrawal or suspension occurred after its 
publication in such list, the reference product 
sponsor shall notify the Secretary that— 
‘‘(i) the biological product shall be im-
mediately removed from such list— 
‘‘(I) for the same period as the 
withdrawal or suspension; or 
‘‘(II) if the biological product has 
been withdrawn from sale, for the pe-
riod of withdrawal from sale or, if ear-
lier, the period ending on the date the 
Secretary determines that the with-
drawal from sale is not for safety, pu-
rity, or potency reasons; and 
‘‘(ii) a notice of the removal shall be 
published in the Federal Register.’’. 
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SEC. 332. REVIEW AND REPORT ON TYPES OF INFORMA-
TION TO BE LISTED. 
Not later than 3 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall— 
(1) solicit public comment regarding the type of 
information, if any, that should be added to or re-
moved from the list required by paragraph (9) of 
section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), as added by section 331; and 
(2) transmit to Congress an evaluation of such 
comments, including any recommendations about the 
types of information that should be added to or re-
moved from the list. 
Subtitle E—Orange Book 
SEC. 341. ORANGE BOOK. 
(a) SUBMISSION
OF PATENT INFORMATION
FOR 
BRAND NAME DRUGS.—Paragraph (1) of section 505(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) is amended to read as follows: 
‘‘(b)(1) Any person may file with the Secretary an 
application with respect to any drug subject to the provi-
sions of subsection (a). Such persons shall submit to the 
Secretary as part of the application— 
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‘‘(A) full reports of investigations which have 
been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; 
‘‘(B) a full list of the articles used as compo-
nents of such drug; 
‘‘(C) a full statement of the composition of such 
drug; 
‘‘(D) a full description of the methods used in, 
and the facilities and controls used for, the manufac-
ture, processing, and packing of such drug; 
‘‘(E) such samples of such drug and of the arti-
cles used as components thereof as the Secretary 
may require; 
‘‘(F) specimens of the labeling proposed to be 
used for such drug; 
‘‘(G) any assessments required under section 
505B; and 
‘‘(H) patent information, with respect to each 
patent for which a claim of patent infringement 
could reasonably be asserted if a person not licensed 
by the owner engaged in the manufacture, use, or 
sale of the drug, and consistent with the following 
requirements: 
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‘‘(i) The applicant shall file with the appli-
cation the patent number and the expiration 
date of— 
‘‘(I) any patent which claims the drug 
for which the applicant submitted the ap-
plication and is a drug substance (includ-
ing active ingredient) patent or a drug 
product (including formulation and com-
position) patent; and 
‘‘(II) any patent which claims the 
method of using such drug. 
‘‘(ii) If an application is filed under this 
subsection for a drug and a patent of the type 
described in clause (i) which claims such drug 
or a method of using such drug is issued after 
the filing date but before approval of the appli-
cation, the applicant shall amend the applica-
tion to include such patent information. 
Upon approval of the application, the Secretary shall pub-
lish the information submitted under subparagraph (H). 
The Secretary shall, in consultation with the Director of 
the National Institutes of Health and with representatives 
of the drug manufacturing industry, review and develop 
guidance, as appropriate, on the inclusion of women and 
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214 
minorities in clinical trials required by subparagraph 
(A).’’. 
(b) CONFORMING CHANGES TO REQUIREMENTS FOR 
SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 
Section 505(c)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(7)) is amended— 
(1) by inserting after ‘‘the patent number and 
the expiration date of any patent which’’ the fol-
lowing: ‘‘fulfills the criteria in subsection (b) and’’; 
(2) by inserting after the first sentence the fol-
lowing: ‘‘Patent information that is not the type of 
patent information required by subsection (b) shall 
not be submitted.’’; and 
(3) by inserting after ‘‘could not file patent in-
formation under subsection (b) because no patent’’ 
the following: ‘‘of the type required to be submitted 
in subsection (b)’’. 
(c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) 
of section 505(j)(7) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(7)) is amended by adding at 
the end the following: 
‘‘(iv) For each drug included on the list, the Sec-
retary shall specify each exclusivity period that is applica-
ble and has not concluded under— 
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‘‘(I) clause (ii), (iii), or (iv) of subsection 
(c)(3)(E) of this section; 
‘‘(II) clause (iv) or (v) of paragraph (5)(B) of 
this subsection; 
‘‘(III) clause (ii), (iii), or (iv) of paragraph 
(5)(F) of this subsection; 
‘‘(IV) section 505A; 
‘‘(V) section 505E; or 
‘‘(VI) section 527(a).’’. 
(d) REMOVAL OF INVALID PATENTS.— 
(1) IN
GENERAL.—Section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)) is amended by adding at the end the fol-
lowing: 
‘‘(D)(i) The holder of an application approved under 
subsection (c) for a drug on the list shall notify within 
14 days the Secretary in writing if either of the following 
occurs: 
‘‘(I) The Patent Trial and Appeals Board issues 
a decision from which no appeal has been or can be 
taken that a patent for such drug is invalid. 
‘‘(II) A court issues a decision from which no 
appeal has been or can be taken that a patent for 
such drug is invalid. 
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‘‘(ii) The holder of an approved application shall in-
clude in any notification under clause (i) a copy of the 
decision described in subclause (I) or (II) of clause (i). 
‘‘(iii) The Secretary shall remove from the list any 
patent that is determined to be invalid in a decision de-
scribed in subclause (I) or (II) of clause (i)— 
‘‘(I) promptly; but 
‘‘(II) not before the expiration of any 180-day 
exclusivity period under paragraph (5)(B)(iv) that 
relies on a certification described in paragraph 
(2)(A)(vii)(IV) that such patent was invalid.’’. 
(2) APPLICABILITY.—Subparagraph (D) of sec-
tion 505(j)(7) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(7)), as added by para-
graph (1), applies only with respect to a decision de-
scribed in such subparagraph that is issued on or 
after the date of enactment of this Act. 
(e) REVIEW AND REPORT.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall— 
(1) solicit public comment regarding the types 
of patent information that should be included on the 
list under section 507(j)(7) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)); and 
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217 
(2) transmit to the Congress an evaluation of 
such comments, including any recommendations 
about the types of patent information that should be 
included on or removed from such list. 
SEC. 342. GAO REPORT TO CONGRESS. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Comptroller General 
of the United States (referred to in this section as the 
‘‘Comptroller General’’) shall submit to the Committee on 
Energy and Commerce of the House of Representatives 
a report on the patents included in the list published under 
section 505(j)(7) of the Federal Food, Drug and Cosmetic 
Act (21 U.S.C. 355(j)(7)), including an analysis and eval-
uation of the types of patents included in such list and 
the claims such patents make about the products they 
claim. 
(b) CONTENTS.—The Comptroller General shall in-
clude in the report under subsection (a)— 
(1) data on the number of— 
(A) patents included in the list published 
under paragraph (7) of section 505(j) of the 
Federal Food, Drug and Cosmetic Act (21 
U.S.C. 355(j)), that claim the active ingredient 
or formulation of a drug in combination with a 
device that is used for delivery of the drug, to-
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gether comprising the finished dosage form of 
the drug; and 
(B) claims in each patent that claim a de-
vice that is used for the delivery of the drug, 
but do not claim such device in combination 
with an active ingredient or formulation of a 
drug; 
(2) data on the date of inclusion in the list 
under paragraph (7) of such section 505(j) for all 
patents under such list, as compared to patents that 
claim a method of using the drug in combination 
with a device; 
(3) an analysis regarding the impact of includ-
ing on the list under paragraph (7) of such section 
505(j) certain types of patent information for drug 
product applicants and approved application holders, 
including an analysis of whether— 
(A) the listing of the patents described in 
paragraph (1)(A) delayed the market entry of 
one or more drugs approved under such section 
505(j); and 
(B) not listing the patents described in 
paragraph (1)(A) would delay the market entry 
of one or more such drugs; and 
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219 
(4) recommendations about which kinds of pat-
ents relating to devices described in paragraph 
(1)(A) should be submitted to the Secretary of 
Health and Human Services for inclusion on the list 
under paragraph (7) of such section 505(j) and 
which patents should not be required to be so sub-
mitted. 
Subtitle F—Advancing Education 
on Biosimilars 
SEC. 351. EDUCATION ON BIOLOGICAL PRODUCTS. 
(a) WEBSITE; CONTINUING EDUCATION.—Subpart 1 
of part F of title III of the Public Health Service Act (42 
U.S.C. 262 et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 
‘‘(a) INTERNET WEBSITE.— 
‘‘(1) IN GENERAL.—The Secretary shall main-
tain and operate an internet website to provide edu-
cational materials for health care providers, patients, 
and caregivers, regarding the meaning of the terms, 
and the standards for review and licensing of, bio-
logical products, including biosimilar biological prod-
ucts and interchangeable biosimilar biological prod-
ucts. 
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‘‘(2) CONTENT.—Educational materials pro-
vided under paragraph (1) may include— 
‘‘(A) explanations of key statutory and 
regulatory terms, including ‘biosimilar’ and 
‘interchangeable’, and clarification regarding 
the use of interchangeable biosimilar biological 
products; 
‘‘(B) information related to development 
programs for biological products, including bio-
similar biological products and interchangeable 
biosimilar biological products and relevant clin-
ical considerations for prescribers, which may 
include, as appropriate and applicable, informa-
tion related to the comparability of such biologi-
cal products; 
‘‘(C) an explanation of the process for re-
porting adverse events for biological products, 
including biosimilar biological products and 
interchangeable biosimilar biological products; 
and 
‘‘(D) an explanation of the relationship be-
tween biosimilar biological products and inter-
changeable biosimilar biological products li-
censed under section 351(k) and reference 
products (as defined in section 351(i)), includ-
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ing the standards for review and licensing of 
each such type of biological product. 
‘‘(3) FORMAT.—The educational materials pro-
vided under paragraph (1) may be— 
‘‘(A) in formats such as webinars, con-
tinuing medical education modules, videos, fact 
sheets, infographics, stakeholder toolkits, or 
other formats as appropriate and applicable; 
and 
‘‘(B) tailored for the unique needs of 
health care providers, patients, caregivers, and 
other audiences, as the Secretary determines 
appropriate. 
‘‘(4) OTHER INFORMATION.—In addition to the 
information described in paragraph (2), the Sec-
retary shall continue to publish the following infor-
mation: 
‘‘(A) The action package of each biological 
product licensed under subsection (a) or (k). 
‘‘(B) The summary review of each biologi-
cal product licensed under subsection (a) or (k). 
‘‘(5) CONFIDENTIAL AND TRADE SECRET IN-
FORMATION.—This subsection does not authorize 
the disclosure of any trade secret, confidential com-
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mercial or financial information, or other matter de-
scribed in section 552(b) of title 5. 
‘‘(b) CONTINUING EDUCATION.—The Secretary shall 
advance education and awareness among health care pro-
viders regarding biological products, including biosimilar 
biological products and interchangeable biosimilar biologi-
cal products, as appropriate, including by developing or 
improving continuing education programs that advance 
the education of such providers on the prescribing of, and 
relevant clinical considerations with respect to, biological 
products, including biosimilar biological products and 
interchangeable biosimilar biological products.’’. 
(b) APPLICATION UNDER THE MEDICARE MERIT- 
BASED
INCENTIVE
PAYMENT
SYSTEM.—Section 
1848(q)(5)(C) of the Social Security Act (42 U.S.C. 
1395w–4(q)(5)(C)) is amended by adding at the end the 
following new clause: 
‘‘(iv) CLINICAL MEDICAL EDUCATION 
PROGRAM
ON
BIOSIMILAR
BIOLOGICAL 
PRODUCTS.—Completion of a clinical med-
ical education program developed or im-
proved under section 352A(b) of the Public 
Health Service Act by a MIPS eligible pro-
fessional during a performance period shall 
earn such eligible professional one-half of 
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the highest potential score for the perform-
ance category described in paragraph 
(2)(A)(iii) for such performance period. A 
MIPS eligible professional may only count 
the completion of such a program for pur-
poses of such category one time during the 
eligible professional’s lifetime.’’. 
Subtitle G—Streamlining 
Transition of Biological Products 
SEC. 361. STREAMLINING THE TRANSITION OF BIOLOGICAL 
PRODUCTS. 
Section 7002(e)(4) of the Biologics Price Competition 
and Innovation Act of 2009 (Public Law 111–148) is 
amended— 
(1) by striking ‘‘An approved application’’ and 
inserting the following: 
‘‘(A) IN GENERAL.—An approved applica-
tion’’; 
(2) by adding at the end the following: 
‘‘(B) TREATMENT OF CERTAIN APPLICA-
TIONS.— 
‘‘(i) IN GENERAL.—With respect to an 
application for a biological product sub-
mitted under subsection (b) or (j) of sec-
tion 505 of the Federal Food, Drug, and 
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Cosmetic Act (21 U.S.C. 355) that is filed 
not later than March 23, 2019, the Sec-
retary shall continue to review such appli-
cation under such section 505, even if such 
review continues after March 23, 2020. 
‘‘(ii) EFFECT
ON
LISTED
DRUGS.— 
Only for purposes of carrying out clause 
(i), with respect to any applicable listed 
drug with respect to such application, the 
following shall apply: 
‘‘(I) Any drug that is a biological 
product that has been deemed licensed 
under section 351 of the Public 
Health Service Act (42 U.S.C. 262) 
pursuant to subparagraph (A) and 
that is referenced in an application 
described in clause (i), shall continue 
to be identified as a listed drug on the 
list published pursuant to section 
505(j)(7) of the Federal Food, Drug, 
and Cosmetic Act, and the informa-
tion for such drug on such list shall 
not be revised after March 20, 2020, 
until— 
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‘‘(aa) such drug is removed 
from such list in accordance with 
subclause (III) or subparagraph 
(C) of such section 505(j)(7); or 
‘‘(bb) this subparagraph no 
longer has force or effect. 
‘‘(II) Any drug that is a biologi-
cal product that has been deemed li-
censed under section 351 of the Pub-
lic Health Service Act (42 U.S.C. 
262) pursuant to subparagraph (A) 
and that is referenced in an applica-
tion described in clause (i) shall be 
subject only to requirements applica-
ble to biological products licensed 
under such section. 
‘‘(III) Upon approval under sub-
section (c) or (j) of section 505 of the 
Federal Food, Drug, and Cosmetic 
Act of an application described in 
clause (i), the Secretary shall remove 
from the list published pursuant to 
section 505(j)(7) of the Federal Food, 
Drug, and Cosmetic Act any listed 
drug that is a biological product that 
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has been deemed licensed under sec-
tion 351 of the Public Health Service 
Act pursuant to subparagraph (A) 
and that is referenced in such ap-
proved application, unless such listed 
drug is referenced in one or more ad-
ditional 
applications 
described 
in 
clause (i). 
‘‘(iii) 
DEEMED
LICENSURE.—Upon 
approval of an application described in 
clause (i), such approved application shall 
be deemed to be a license for the biological 
product under section 351 of the Public 
Health Service Act, pursuant to subpara-
graph (A), and any period of exclusivity, as 
applicable, shall be determined in accord-
ance with such section. 
‘‘(iv) RULE OF CONSTRUCTION.— 
‘‘(I) APPLICATION
OF
CERTAIN 
PROVISIONS.— 
‘‘(aa) 
PATENT
CERTIFI-
CATION OR STATEMENT.—An ap-
plication described in clause (i) 
shall contain a patent certifi-
cation or statement described in, 
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as applicable, section 505(b)(2) 
of the Federal Food, Drug, and 
Cosmetic Act or clauses (vii) and 
(viii) of section 505(j)(2)(A) of 
such Act and, with respect to any 
listed drug referenced in such ap-
plication, comply with related re-
quirements concerning any timely 
filed patent information listed 
pursuant to section 505(j)(7). 
‘‘(bb) 
DATE
OF
AP-
PROVAL.—The earliest possible 
date on which any pending appli-
cation described in clause (i) may 
be approved shall be determined 
based on— 
‘‘(AA) the last expira-
tion date of any applicable 
period of exclusivity that 
would prevent such approval 
and that is described in sec-
tion 
505(c)(3)(E), 
505(j)(5)(B)(iv), 
505(j)(5)(F), 505A, 505E, 
or 527 of the Federal Food, 
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Drug, and Cosmetic Act; 
and 
‘‘(BB) if the application 
was submitted under section 
505(b)(2) of the Federal 
Food, Drug, and Cosmetic 
Act and references any list-
ed drug, the last applicable 
date determined under sub-
paragraph (A), (B), or (C) 
of section 505(c)(3) of such 
Act, or, if the application 
was submitted under section 
505(j) of such Act, the last 
applicable date determined 
under clause (i), (ii), or (iii) 
of section 505(j)(5)(B). 
‘‘(II) RULE
OF
CONSTRUCTION 
WITH
RESPECT
TO
EXCLUSIVITY.— 
Nothing in this subparagraph shall be 
construed 
to 
affect 
section 
351(k)(7)(D) of the Public Health 
Service Act. 
‘‘(v) AUTHORIZED DISCLOSURE.—The 
Secretary may continue to review an appli-
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cation after March 23, 2020, pursuant to 
clause (i), and continue to identify any ap-
plicable listed drug pursuant to clause (ii) 
on the list published pursuant to section 
505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act, even if such review or listing 
may reveal the existence of such applica-
tion and the identity of any listed drug for 
which the investigations described in sec-
tion 505(b)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act are relied upon by 
the applicant for approval of the pending 
application. Nothing in this subparagraph 
shall be construed as authorizing the Sec-
retary to disclose any other information 
that is a trade secret or confidential infor-
mation described in section 552(b)(4) of 
title 5, United States Code. 
‘‘(vi) SUNSET.—Beginning on October 
1, 2022, this subparagraph shall have no 
force or effect and any applications de-
scribed in clause (i) that have not been ap-
proved shall be deemed withdrawn.’’. 
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Subtitle 
H—Over-the-Counter 
Monograph Safety, Innovation, 
and Reform 
SEC. 370. SHORT TITLE; REFERENCES IN SUBTITLE. 
(a) SHORT TITLE.—This subtitle may be cited as the 
‘‘Over-the-Counter Monograph Safety, Innovation, and 
Reform Act of 2019’’. 
(b) REFERENCES.—Except as otherwise specified, 
any reference to ‘‘this Act’’ contained in this subtitle shall 
be treated as referring only to the provisions of this sub-
title. 
PART 1—OTC DRUG REVIEW 
SEC. 371. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505F of such Act (21 U.S.C. 355g) the following: 
‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH-
OUT
AN
APPROVED
APPLICATION.—Nonprescription 
drugs marketed without an approved drug application 
under section 505, as of the date of the enactment of this 
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section, shall be treated in accordance with this sub-
section. 
‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 
CATEGORY
I
DRUGS
SUBJECT
TO
A
TENTATIVE 
FINAL MONOGRAPH.—A drug is deemed to be gen-
erally recognized as safe and effective under section 
201(p)(1), not a new drug under section 201(p), and 
not subject to section 503(b)(1), if— 
‘‘(A) the drug is— 
‘‘(i) in conformity with the require-
ments for nonprescription use of a final 
monograph issued under part 330 of title 
21, Code of Federal Regulations (except as 
provided in paragraph (2)), the general re-
quirements for nonprescription drugs, and 
conditions or requirements under sub-
sections (b), (c), and (k); and 
‘‘(ii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
formity with an order issued under sub-
section (c), in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
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extent and for a material time under sec-
tion 201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a tentative final 
monograph that is the most recently appli-
cable proposal or determination issued 
under part 330 of title 21, Code of Federal 
Regulations; 
‘‘(ii) in conformity with the proposed 
requirements for nonprescription use of 
such tentative final monograph, any appli-
cable subsequent determination by the Sec-
retary, the general requirements for non-
prescription drugs, and conditions or re-
quirements under subsections (b), (c), and 
(k); and 
‘‘(iii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
formity with an order issued under sub-
section (c), in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
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extent and for a material time under sec-
tion 201(p)(2). 
‘‘(2) TREATMENT
OF
SUNSCREEN
DRUGS.— 
With respect to sunscreen drugs subject to this sec-
tion, the applicable requirements in terms of con-
formity with a final monograph, for purposes of 
paragraph (1)(A)(i), shall be the requirements speci-
fied in part 352 of title 21, Code of Federal Regula-
tions, as published on May 21, 1999, beginning on 
page 27687 of volume 64 of the Federal Register, 
except that the applicable requirements governing ef-
fectiveness and labeling shall be those specified in 
section 201.327 of title 21, Code of Federal Regula-
tions. 
‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN-
TATIVE
FINAL
MONOGRAPH; CATEGORY
I
DRUGS 
SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE 
NOTICE OF PROPOSED RULEMAKING.—A drug that 
is not described in paragraph (1), (2), or (4) is not 
required to be the subject of an application approved 
under section 505, and is not subject to section 
503(b)(1), if— 
‘‘(A) the drug is— 
‘‘(i) classified in category III for safe-
ty or effectiveness in the preamble of a 
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proposed rule establishing a tentative final 
monograph that is the most recently appli-
cable proposal or determination for such 
drug issued under part 330 of title 21, 
Code of Federal Regulations; 
‘‘(ii) in conformity with— 
‘‘(I) the conditions of use, includ-
ing indication and dosage strength, if 
any, described for such category III 
drug in such preamble or in an appli-
cable subsequent proposed rule; 
‘‘(II) the proposed requirements 
for drugs classified in such tentative 
final monograph in category I in the 
most recently proposed rule estab-
lishing requirements related to such 
tentative final monograph and in any 
final rule establishing requirements 
that are applicable to the drug; and 
‘‘(III) the general requirements 
for nonprescription drugs and condi-
tions or requirements under sub-
section (b) or (k); and 
‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment 
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of this section, had been used to a material 
extent and for a material time under sec-
tion 201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a proposed mono-
graph or advance notice of proposed rule-
making that is the most recently applicable 
proposal or determination for such drug 
issued under part 330 of title 21, Code of 
Federal Regulations; 
‘‘(ii) in conformity with the require-
ments for nonprescription use of such pro-
posed monograph or advance notice of pro-
posed rulemaking, any applicable subse-
quent determination by the Secretary, the 
general requirements for nonprescription 
drugs, and conditions or requirements 
under subsection (b) or (k); and 
‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
extent and for a material time under sec-
tion 201(p)(2). 
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‘‘(4) CATEGORY
II
DRUGS
DEEMED
NEW 
DRUGS.—A drug that is classified in category II for 
safety or effectiveness under a tentative final mono-
graph or that is subject to a determination to be not 
generally recognized as safe and effective in a pro-
posed rule that is the most recently applicable pro-
posal issued under part 330 of title 21, Code of Fed-
eral Regulations, shall be deemed to be a new drug 
under section 201(p), misbranded under section 
502(ee), and subject to the requirement for an ap-
proved new drug application under section 505 be-
ginning on the day that is 180 calendar days after 
the date of the enactment of this section, unless, be-
fore such day, the Secretary determines that it is in 
the interest of public health to extend the period 
during which the drug may be marketed without 
such an approved new drug application. 
‘‘(5) 
DRUGS
NOT
GRASE
DEEMED
NEW 
DRUGS.—A drug that the Secretary has determined 
not to be generally recognized as safe and effective 
under section 201(p)(1) under a final determination 
issued under part 330 of title 21, Code of Federal 
Regulations, shall be deemed to be a new drug under 
section 201(p), misbranded under section 502(ee), 
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and subject to the requirement for an approved new 
drug application under section 505. 
‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 
Except as provided in subsection (m), a drug is 
deemed to be a new drug under section 201(p) and 
misbranded under section 502(ee) if the drug— 
‘‘(A) is not subject to section 503(b)(1); 
and 
‘‘(B) is not described in paragraph (1), 
(2), (3), (4), or (5), or subsection (b)(1)(B). 
‘‘(b) ADMINISTRATIVE ORDERS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) 
DETERMINATION.—The 
Secretary 
may, on the initiative of the Secretary or at the 
request of one or more requestors, issue an ad-
ministrative order determining whether there 
are conditions under which a specific drug, a 
class of drugs, or a combination of drugs, is de-
termined to be— 
‘‘(i) not subject to section 503(b)(1); 
and 
‘‘(ii) generally recognized as safe and 
effective under section 201(p)(1). 
‘‘(B) EFFECT.—A drug or combination of 
drugs shall be deemed to not require approval 
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under section 505 if such drug or combination 
of drugs— 
‘‘(i) is determined by the Secretary to 
meet the conditions specified in clauses (i) 
and (ii) of subparagraph (A); 
‘‘(ii) is marketed in conformity with 
an administrative order under this sub-
section; 
‘‘(iii) meets the general requirements 
for nonprescription drugs; and 
‘‘(iv) meets the requirements under 
subsections (c) and (k). 
‘‘(C) STANDARD.—The Secretary shall find 
that a drug is not generally recognized as safe 
and effective under section 201(p)(1) if— 
‘‘(i) the evidence shows that the drug 
is not generally recognized as safe and ef-
fective under section 201(p)(1); or 
‘‘(ii) the evidence is inadequate to 
show that the drug is generally recognized 
as 
safe 
and 
effective 
under 
section 
201(p)(1). 
‘‘(2) ADMINISTRATIVE
ORDERS
INITIATED
BY 
THE SECRETARY.— 
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‘‘(A) IN GENERAL.—In issuing an adminis-
trative order under paragraph (1) upon the 
Secretary’s initiative, the Secretary shall— 
‘‘(i) make reasonable efforts to notify 
informally, not later than 2 business days 
before the issuance of the proposed order, 
the sponsors of drugs who have a listing in 
effect under section 510(j) for the drugs or 
combination of drugs that will be subject 
to the administrative order; 
‘‘(ii) after any such reasonable efforts 
of notification— 
‘‘(I) issue a proposed administra-
tive order by publishing it on the 
website of the Food and Drug Admin-
istration and include in such order the 
reasons for the issuance of such order; 
and 
‘‘(II) publish a notice of avail-
ability of such proposed order in the 
Federal Register; 
‘‘(iii) except as provided in subpara-
graph (B), provide for a public comment 
period with respect to such proposed order 
of not less than 45 calendar days; and 
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‘‘(iv) if, after completion of the pro-
ceedings specified in clauses (i) through 
(iii), the Secretary determines that it is ap-
propriate to issue a final administrative 
order— 
‘‘(I) issue the final administrative 
order, together with a detailed state-
ment of reasons, which order shall not 
take effect until the time for request-
ing judicial review under paragraph 
(3)(D)(ii) has expired; 
‘‘(II) publish a notice of such 
final administrative order in the Fed-
eral Register; 
‘‘(III) afford requestors of drugs 
that will be subject to such order the 
opportunity for formal dispute resolu-
tion up to the level of the Director of 
the Center for Drug Evaluation and 
Research, which initially must be re-
quested within 45 calendar days of 
the issuance of the order, and, for 
subsequent levels of appeal, within 30 
calendar days of the prior decision; 
and 
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‘‘(IV) except with respect to 
drugs described in paragraph (3)(B), 
upon completion of the formal dispute 
resolution procedure, inform the per-
sons which sought such dispute reso-
lution of their right to request a hear-
ing. 
‘‘(B) EXCEPTIONS.—When issuing an ad-
ministrative order under paragraph (1) on the 
Secretary’s initiative proposing to determine 
that a drug described in subsection (a)(3) is not 
generally recognized as safe and effective under 
section 201(p)(1), the Secretary shall follow the 
procedures in subparagraph (A), except that— 
‘‘(i) the proposed order shall include 
notice of— 
‘‘(I) the general categories of 
data the Secretary has determined 
necessary to establish that the drug is 
generally recognized as safe and effec-
tive under section 201(p)(1); and 
‘‘(II) the format for submissions 
by interested persons; 
‘‘(ii) the Secretary shall provide for a 
public comment period of no less than 180 
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calendar days with respect to such pro-
posed order, except when the Secretary de-
termines, for good cause, that a shorter pe-
riod is in the interest of public health; and 
‘‘(iii) any person who submits data in 
such comment period shall include a cer-
tification that the person has submitted all 
evidence created, obtained, or received by 
that person that is both within the cat-
egories of data identified in the proposed 
order and relevant to a determination as to 
whether the drug is generally recognized as 
safe and effective under section 201(p)(1). 
‘‘(3) HEARINGS; JUDICIAL REVIEW.— 
‘‘(A) IN
GENERAL.—Only a person who 
participated in each stage of formal dispute res-
olution under subclause (III) of paragraph 
(2)(A)(iv) of an administrative order with re-
spect to a drug may request a hearing con-
cerning a final administrative order issued 
under such paragraph with respect to such 
drug. If a hearing is sought, such person must 
submit a request for a hearing, which shall be 
based solely on information in the administra-
tive record, to the Secretary not later than 30 
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calendar days after receiving notice of the final 
decision of the formal dispute resolution proce-
dure. 
‘‘(B) NO
HEARING
REQUIRED
WITH
RE-
SPECT
TO
ORDERS
RELATING
TO
CERTAIN 
DRUGS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall not be required to provide notice and 
an opportunity for a hearing pursuant to 
paragraph (2)(A)(iv) if the final adminis-
trative order involved relates to a drug— 
‘‘(I) that is described in sub-
section (a)(3)(A); and 
‘‘(II) with respect to which no 
human or non-human data studies rel-
evant to the safety or effectiveness of 
such drug have been submitted to the 
administrative 
record 
since 
the 
issuance of the most recent tentative 
final monograph relating to such 
drug. 
‘‘(ii) HUMAN
DATA
STUDIES
AND 
NON-HUMAN DATA DEFINED.—In this sub-
paragraph: 
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‘‘(I) The term ‘human data stud-
ies’ means clinical trials of safety or 
effectiveness (including actual use 
studies), pharmacokinetics studies, or 
bioavailability studies. 
‘‘(II) The term ‘non-human data’ 
means data from testing other than 
with human subjects which provides 
information concerning safety or ef-
fectiveness. 
‘‘(C) HEARING PROCEDURES.— 
‘‘(i) DENIAL OF REQUEST FOR HEAR-
ING.—If the Secretary determines that in-
formation submitted in a request for a 
hearing under subparagraph (A) with re-
spect to a final administrative order issued 
under paragraph (2)(A)(iv) does not iden-
tify the existence of a genuine and sub-
stantial question of material fact, the Sec-
retary may deny such request. In making 
such a determination, the Secretary may 
consider only information and data that 
are based on relevant and reliable scientific 
principles and methodologies. 
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‘‘(ii) SINGLE HEARING FOR MULTIPLE 
RELATED
REQUESTS.—If more than one 
request for a hearing is submitted with re-
spect to the same administrative order 
under subparagraph (A), the Secretary 
may direct that a single hearing be con-
ducted in which all persons whose hearing 
requests were granted may participate. 
‘‘(iii) PRESIDING OFFICER.—The pre-
siding officer of a hearing requested under 
subparagraph (A) shall— 
‘‘(I) be designated by the Sec-
retary; 
‘‘(II) not be an employee of the 
Center for Drug Evaluation and Re-
search; and 
‘‘(III) not have been previously 
involved in the development of the ad-
ministrative order involved or pro-
ceedings relating to that administra-
tive order. 
‘‘(iv) RIGHTS OF PARTIES TO HEAR-
ING.—The parties to a hearing requested 
under subparagraph (A) shall have the 
right to present testimony, including testi-
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mony of expert witnesses, and to cross-ex-
amine witnesses presented by other parties. 
Where appropriate, the presiding officer 
may require that cross-examination by par-
ties representing substantially the same in-
terests be consolidated to promote effi-
ciency and avoid duplication. 
‘‘(v) FINAL DECISION.— 
‘‘(I) At the conclusion of a hear-
ing requested under subparagraph 
(A), the presiding officer of the hear-
ing shall issue a decision containing 
findings of fact and conclusions of 
law. The decision of the presiding offi-
cer shall be final. 
‘‘(II) The final decision may not 
take effect until the period under sub-
paragraph (D)(ii) for submitting a re-
quest for judicial review of such deci-
sion expires. 
‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN-
ISTRATIVE ORDER.— 
‘‘(i) IN
GENERAL.—The procedures 
described in section 505(h) shall apply 
with respect to judicial review of final ad-
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ministrative orders issued under this sub-
section in the same manner and to the 
same extent as such section applies to an 
order described in such section except that 
the judicial review shall be taken by filing 
in an appropriate district court of the 
United States in lieu of the appellate 
courts specified in such section. 
‘‘(ii) PERIOD TO SUBMIT A REQUEST 
FOR JUDICIAL REVIEW.—A person eligible 
to request a hearing under this paragraph 
and seeking judicial review of a final ad-
ministrative order issued under this sub-
section shall file such request for judicial 
review not later than 60 calendar days 
after the latest of— 
‘‘(I) the date on which notice of 
such order is published; 
‘‘(II) the date on which a hearing 
with respect to such order is denied 
under subparagraph (B) or (C)(i); 
‘‘(III) the date on which a final 
decision is made following a hearing 
under subparagraph (C)(v); or 
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‘‘(IV) if no hearing is requested, 
the date on which the time for re-
questing a hearing expires. 
‘‘(4) EXPEDITED PROCEDURE WITH RESPECT 
TO
ADMINISTRATIVE
ORDERS
INITIATED
BY
THE 
SECRETARY.— 
‘‘(A) IMMINENT HAZARD TO THE PUBLIC 
HEALTH.— 
‘‘(i) IN GENERAL.—In the case of a 
determination by the Secretary that a 
drug, class of drugs, or combination of 
drugs subject to this section poses an im-
minent hazard to the public health, the 
Secretary, after first making reasonable ef-
forts to notify, not later than 48 hours be-
fore issuance of such order under this sub-
paragraph, sponsors who have a listing in 
effect under section 510(j) for such drug 
or combination of drugs— 
‘‘(I) may issue an interim final 
administrative order for such drug, 
class of drugs, or combination of 
drugs under paragraph (1), together 
with a detailed statement of the rea-
sons for such order; 
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‘‘(II) shall publish in the Federal 
Register a notice of availability of any 
such order; and 
‘‘(III) shall provide for a public 
comment period of at least 45 cal-
endar days with respect to such in-
terim final order. 
‘‘(ii) 
NONDELEGATION.—The 
Sec-
retary may not delegate the authority to 
issue an interim final administrative order 
under this subparagraph. 
‘‘(B) SAFETY LABELING CHANGES.— 
‘‘(i) IN GENERAL.—In the case of a 
determination by the Secretary that a 
change in the labeling of a drug, class of 
drugs, or combination of drugs subject to 
this section is reasonably expected to miti-
gate a significant or unreasonable risk of 
a serious adverse event associated with use 
of the drug, the Secretary may— 
‘‘(I) make reasonable efforts to 
notify informally, not later than 48 
hours before the issuance of the in-
terim final order, the sponsors of 
drugs who have a listing in effect 
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250 
under section 510(j) for such drug or 
combination of drugs; 
‘‘(II) after reasonable efforts of 
notification, issue an interim final ad-
ministrative order in accordance with 
paragraph (1) to require such change, 
together with a detailed statement of 
the reasons for such order; 
‘‘(III) publish in the Federal 
Register a notice of availability of 
such order; and 
‘‘(IV) provide for a public com-
ment period of at least 45 calendar 
days with respect to such interim final 
order. 
‘‘(ii) CONTENT
OF
ORDER.—An in-
terim final order issued under this sub-
paragraph with respect to the labeling of a 
drug may provide for new warnings and 
other information required for safe use of 
the drug. 
‘‘(C) EFFECTIVE DATE.—An order under 
subparagraph (A) or (B) shall take effect on a 
date specified by the Secretary. 
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‘‘(D) FINAL ORDER.—After the completion 
of the proceedings in subparagraph (A) or (B), 
the Secretary shall— 
‘‘(i) issue a final order in accordance 
with paragraph (1); 
‘‘(ii) publish a notice of availability of 
such final administrative order in the Fed-
eral Register; and 
‘‘(iii) afford sponsors of such drugs 
that will be subject to such an order the 
opportunity for formal dispute resolution 
up to the level of the Director of the Cen-
ter for Drug Evaluation and Research, 
which must initially be within 45 calendar 
days of the issuance of the order, and for 
subsequent levels of appeal, within 30 cal-
endar days of the prior decision. 
‘‘(E) HEARINGS.—A sponsor of a drug 
subject to a final order issued under subpara-
graph (D) and that participated in each stage 
of formal dispute resolution under clause (iii) of 
such subparagraph may request a hearing on 
such order. The provisions of subparagraphs 
(A), (B), and (C) of paragraph (3), other than 
paragraph (3)(C)(v)(II), shall apply with re-
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spect to a hearing on such order in the same 
manner and to the same extent as such provi-
sions apply with respect to a hearing on an ad-
ministrative order issued under paragraph 
(2)(A)(iv). 
‘‘(F) TIMING.— 
‘‘(i) FINAL ORDER AND HEARING.— 
The Secretary shall— 
‘‘(I) not later than 6 months 
after the date on which the comment 
period closes under subparagraph (A) 
or (B), issue a final order in accord-
ance with paragraph (1); and 
‘‘(II) not later than 12 months 
after the date on which such final 
order is issued, complete any hearing 
under subparagraph (E). 
‘‘(ii) 
DISPUTE
RESOLUTION
RE-
QUEST.—The Secretary shall specify in an 
interim final order issued under subpara-
graph (A) or (B) such shorter periods for 
requesting dispute resolution under sub-
paragraph (D)(iii) as are necessary to 
meet the requirements of this subpara-
graph. 
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253 
‘‘(G) JUDICIAL
REVIEW.—A final order 
issued pursuant to subparagraph (F) shall be 
subject to judicial review in accordance with 
paragraph (3)(D). 
‘‘(5) ADMINISTRATIVE
ORDER
INITIATED
AT 
THE REQUEST OF A REQUESTOR.— 
‘‘(A) IN GENERAL.—In issuing an adminis-
trative order under paragraph (1) at the re-
quest of a requestor with respect to certain 
drugs, classes of drugs, or combinations of 
drugs— 
‘‘(i) the Secretary shall, after receiv-
ing a request under this subparagraph, de-
termine whether the request is sufficiently 
complete and formatted to permit a sub-
stantive review; 
‘‘(ii) if the Secretary determines that 
the request is sufficiently complete and for-
matted to permit a substantive review, the 
Secretary shall— 
‘‘(I) file the request; and 
‘‘(II) initiate proceedings with re-
spect to issuing an administrative 
order in accordance with paragraphs 
(2) and (3); and 
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‘‘(iii) except as provided in paragraph 
(6), if the Secretary determines that a re-
quest does not meet the requirements for 
filing or is not sufficiently complete and 
formatted to permit a substantive review, 
the requestor may demand that the request 
be filed over protest, and the Secretary 
shall initiate proceedings to review the re-
quest in accordance with paragraph (2)(A). 
‘‘(B) 
REQUEST
TO
INITIATE
PRO-
CEEDINGS.— 
‘‘(i) IN GENERAL.—A requestor seek-
ing an administrative order under para-
graph (1) with respect to certain drugs, 
classes of drugs, or combinations of drugs, 
shall submit to the Secretary a request to 
initiate proceedings for such order in the 
form and manner as specified by the Sec-
retary. Such requestor may submit a re-
quest under this subparagraph for the 
issuance of an administrative order— 
‘‘(I) determining whether a drug 
is generally recognized as safe and ef-
fective under section 201(p)(1), ex-
empt from section 503(b)(1), and not 
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255 
required to be the subject of an ap-
proved application under section 505; 
or 
‘‘(II) 
determining 
whether 
a 
change to a condition of use of a drug 
is generally recognized as safe and ef-
fective under section 201(p)(1), ex-
empt from section 503(b)(1), and not 
required to be the subject of an ap-
proved application under section 505, 
if, absent such a changed condition of 
use, such drug is— 
‘‘(aa) generally recognized 
as safe and effective under sec-
tion 201(p)(1) in accordance with 
subsection (a)(1), (a)(2), or an 
order under this subsection; or 
‘‘(bb) subject to subsection 
(a)(3), but only if such requestor 
initiates such request in conjunc-
tion with a request for the Sec-
retary to determine whether such 
drug is generally recognized as 
safe and effective under section 
201(p)(1), which is filed by the 
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256 
Secretary under subparagraph 
(A)(ii). 
‘‘(ii) EXCEPTION.—The Secretary is 
not required to complete review of a re-
quest for a change described in clause 
(i)(II) if the Secretary determines that 
there is an inadequate basis to find the 
drug is generally recognized as safe and ef-
fective under section 201(p)(1) under para-
graph (1) and issues a final order an-
nouncing that determination. 
‘‘(iii) WITHDRAWAL.—The requestor 
may withdraw a request under this para-
graph, according to the procedures set 
forth pursuant to subsection (d)(2)(B). 
Notwithstanding any other provision of 
this section, if such request is withdrawn, 
the Secretary may cease proceedings under 
this subparagraph. 
‘‘(C) EXCLUSIVITY.— 
‘‘(i) IN GENERAL.—A final adminis-
trative order issued in response to a re-
quest under this section shall have the ef-
fect of authorizing solely the order re-
questor (or the licensees, assignees, or suc-
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257 
cessors in interest of such requestor with 
respect to the subject of such order), for a 
period of 18 months following the effective 
date of such final order and beginning on 
the date the requestor may lawfully market 
such drugs pursuant to the order, to mar-
ket drugs— 
‘‘(I) incorporating changes de-
scribed in clause (ii); and 
‘‘(II) subject to the limitations 
under clause (iv). 
‘‘(ii) 
CHANGES
DESCRIBED.—A 
change described in this clause is a change 
subject to an order specified in clause (i), 
which— 
‘‘(I) provides for a drug to con-
tain an active ingredient (including 
any ester or salt of the active ingre-
dient) not previously incorporated in a 
drug described in clause (iii); or 
‘‘(II) provides for a change in the 
conditions of use of a drug, for which 
new human data studies conducted or 
sponsored by the requestor (or for 
which the requestor has an exclusive 
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258 
right of reference) were essential to 
the issuance of such order. 
‘‘(iii) DRUGS DESCRIBED.—The drugs 
described in this clause are drugs— 
‘‘(I) 
specified 
in 
subsection 
(a)(1), (a)(2), or (a)(3); 
‘‘(II) subject to a final order 
issued under this section; 
‘‘(III) subject to a final sun-
screen order (as defined in section 
586(2)(A)); or 
‘‘(IV) described in subsection 
(m)(1), other than drugs subject to an 
active enforcement action under chap-
ter III of this Act. 
‘‘(iv) 
LIMITATIONS
ON
EXCLU-
SIVITY.— 
‘‘(I) IN GENERAL.—Only one 18- 
month period under this subpara-
graph shall be granted, under each 
order described in clause (i), with re-
spect to changes (to the drug subject 
to such order) which are either— 
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‘‘(aa) changes described in 
clause (ii)(I), relating to active 
ingredients; or 
‘‘(bb) changes described in 
clause (ii)(II), relating to condi-
tions of use. 
‘‘(II) 
NO
EXCLUSIVITY
AL-
LOWED.—No exclusivity shall apply to 
changes to a drug which are— 
‘‘(aa) the subject of a Tier 2 
OTC monograph order request 
(as defined in section 744L); 
‘‘(bb) safety-related changes, 
as defined by the Secretary, or 
any other changes the Secretary 
considers necessary to assure 
safe use; or 
‘‘(cc) changes related to 
methods of testing safety or effi-
cacy. 
‘‘(v) NEW HUMAN DATA STUDIES DE-
FINED.—In this subparagraph, the term 
‘new human data studies’ means clinical 
trials of safety or effectiveness (including 
actual use studies), pharmacokinetics stud-
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260 
ies, or bioavailability studies, the results of 
which— 
‘‘(I) have not been relied on by 
the Secretary to support— 
‘‘(aa) a proposed or final de-
termination that a drug described 
in subclause (I), (II), or (III) of 
clause (iii) is generally recognized 
as safe and effective under sec-
tion 201(p)(1); or 
‘‘(bb) approval of a drug 
that was approved under section 
505; and 
‘‘(II) do not duplicate the results 
of another study that was relied on by 
the Secretary to support— 
‘‘(aa) a proposed or final de-
termination that a drug described 
in subclause (I), (II), or (III) of 
clause (iii) is generally recognized 
as safe and effective under sec-
tion 201(p)(1); or 
‘‘(bb) approval of a drug 
that was approved under section 
505. 
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‘‘(6) INFORMATION
REGARDING
SAFE
NON-
PRESCRIPTION MARKETING AND USE AS CONDITION 
FOR FILING A GENERALLY RECOGNIZED AS SAFE 
AND EFFECTIVE REQUEST.— 
‘‘(A) IN GENERAL.—In response to a re-
quest under this section that a drug described 
in subparagraph (B) be generally recognized as 
safe and effective, the Secretary— 
‘‘(i) may file such request, if the re-
quest includes information specified under 
subparagraph (C) with respect to safe non-
prescription marketing and use of such 
drug; or 
‘‘(ii) if the request fails to include in-
formation specified under subparagraph 
(C), shall refuse to file such request and 
require that nonprescription marketing of 
the drug be pursuant to a new drug appli-
cation as described in subparagraph (D). 
‘‘(B) DRUG
DESCRIBED.—A drug de-
scribed in this subparagraph is a nonprescrip-
tion drug which contains an active ingredient 
not previously incorporated in a drug— 
‘‘(i) specified in subsection (a)(1), 
(a)(2), or (a)(3); 
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262 
‘‘(ii) subject to a final order under 
this section; or 
‘‘(iii) subject to a final sunscreen 
order (as defined in section 586(2)(A)). 
‘‘(C) 
INFORMATION
DEMONSTRATING 
PRIMA
FACIE
SAFE
NONPRESCRIPTION
MAR-
KETING
AND
USE.—Information specified in 
this subparagraph, with respect to a request de-
scribed in subparagraph (A)(i), is— 
‘‘(i) information sufficient for a prima 
facie demonstration that the drug subject 
to such request has a verifiable history of 
being marketed and safely used by con-
sumers in the United States as a non-
prescription drug under comparable condi-
tions of use; 
‘‘(ii) if the drug has not been pre-
viously marketed in the United States as a 
nonprescription drug, information suffi-
cient for a prima facie demonstration that 
the drug was marketed and safely used 
under comparable conditions of marketing 
and use in a country listed in section 
802(b)(1)(A) or designated by the Sec-
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263 
retary 
in 
accordance 
with 
section 
802(b)(1)(B)— 
‘‘(I) for such period as needed to 
provide reasonable assurances con-
cerning the safe nonprescription use 
of the drug; and 
‘‘(II) during such time was sub-
ject to sufficient monitoring by a reg-
ulatory body considered acceptable by 
the Secretary for such monitoring 
purposes, including for adverse events 
associated with nonprescription use of 
the drug; or 
‘‘(iii) if the Secretary determines that 
information described in clause (i) or (ii) is 
not needed to provide a prima facie dem-
onstration that the drug can be safely mar-
keted and used as a nonprescription drug, 
such other information the Secretary deter-
mines is sufficient for such purposes. 
‘‘(D) MARKETING
PURSUANT
TO
NEW 
DRUG APPLICATION.—In the case of a request 
described in subparagraph (A)(ii), the drug 
subject to such request may be resubmitted for 
filing only if— 
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264 
‘‘(i) the drug is marketed as a non-
prescription drug, under conditions of use 
comparable to the conditions specified in 
the request, for such period as the Sec-
retary determines appropriate (not to ex-
ceed 5 consecutive years) pursuant to an 
application approved under section 505; 
and 
‘‘(ii) during such period, 1,000,000 
retail packages of the drug, or an equiva-
lent quantity as determined by the Sec-
retary, were distributed for retail sale, as 
determined in such manner as the Sec-
retary finds appropriate. 
‘‘(E) RULE OF APPLICATION.—Except in 
the case of a request involving a drug described 
in section 586(9), as in effect on January 1, 
2017, if the Secretary refuses to file a request 
under this paragraph, the requestor may not 
file such request over protest under paragraph 
(5)(A)(iii). 
‘‘(7) PACKAGING.—An administrative order 
issued under paragraph (2), (4)(A), or (5) may in-
clude requirements for the packaging of a drug to 
encourage use in accordance with labeling. Such re-
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quirements may include unit dose packaging, re-
quirements for products intended for use by pedi-
atric populations, requirements to reduce risk of 
harm from unsupervised ingestion, and other appro-
priate requirements. This paragraph does not au-
thorize the Food and Drug Administration to re-
quire standards or testing procedures as described in 
part 1700 of title 16, Code of Federal Regulations. 
‘‘(8) FINAL
AND
TENTATIVE
FINAL
MONO-
GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL 
ADMINISTRATIVE ORDERS.— 
‘‘(A) IN GENERAL.—A final monograph or 
tentative final monograph described in subpara-
graph (B) shall be deemed to be a final admin-
istrative order under this subsection and may 
be amended, revoked, or otherwise modified in 
accordance with the procedures of this sub-
section. 
‘‘(B) MONOGRAPHS DESCRIBED.—For pur-
poses of subparagraph (A), a final monograph 
or tentative final monograph is described in this 
subparagraph if it— 
‘‘(i) establishes conditions of use for a 
drug described in paragraph (1) or (2) of 
subsection (a); and 
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‘‘(ii) represents the most recently pro-
mulgated version of such conditions, in-
cluding as modified, in whole or in part, by 
any proposed or final rule. 
‘‘(C) DEEMED ORDERS INCLUDE HARMO-
NIZING
TECHNICAL
AMENDMENTS.—The 
deemed establishment of a final administrative 
order under subparagraph (A) shall be con-
strued to include any technical amendments to 
such order as the Secretary determines nec-
essary to ensure that such order is appro-
priately harmonized, in terms of terminology or 
cross-references, with the applicable provisions 
of this Act (and regulations thereunder) and 
any other orders issued under this section. 
‘‘(c) PROCEDURE FOR MINOR CHANGES.— 
‘‘(1) IN GENERAL.—Minor changes in the dos-
age form of a drug that is described in paragraph 
(1) or (2) of subsection (a) or the subject of an 
order issued under subsection (b) may be made by 
a requestor without the issuance of an order under 
subsection (b) if— 
‘‘(A) the requestor maintains such infor-
mation as is necessary to demonstrate that the 
change— 
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‘‘(i) will not affect the safety or effec-
tiveness of the drug; and 
‘‘(ii) will not materially affect the ex-
tent of absorption or other exposure to the 
active ingredient in comparison to a suit-
able reference product; and 
‘‘(B) the change is in conformity with the 
requirements of an applicable administrative 
order issued by the Secretary under paragraph 
(3). 
‘‘(2) ADDITIONAL INFORMATION.— 
‘‘(A) ACCESS
TO
RECORDS.—A sponsor 
shall submit records requested by the Secretary 
relating to such a minor change under section 
704(a)(4), within 15 business days of receiving 
such a request, or such longer period as the 
Secretary may provide. 
‘‘(B) INSUFFICIENT INFORMATION.—If the 
Secretary determines that the information con-
tained in such records is not sufficient to dem-
onstrate that the change does not affect the 
safety or effectiveness of the drug or materially 
affect the extent of absorption or other expo-
sure to the active ingredient, the Secretary— 
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268 
‘‘(i) may so inform the sponsor of the 
drug in writing; and 
‘‘(ii) if the Secretary so informs the 
sponsor, shall provide the sponsor of the 
drug with a reasonable opportunity to pro-
vide additional information. 
‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN-
FORMATION.—If the sponsor fails to provide 
such additional information within a time pre-
scribed by the Secretary, or if the Secretary de-
termines that such additional information does 
not demonstrate that the change does not— 
‘‘(i) affect the safety or effectiveness 
of the drug; or 
‘‘(ii) materially affect the extent of 
absorption or other exposure to the active 
ingredient in comparison to a suitable ref-
erence product, 
the drug as modified is a new drug under sec-
tion 201(p) and shall be deemed to be mis-
branded under section 502(ee). 
‘‘(3) DETERMINING WHETHER A CHANGE WILL 
AFFECT SAFETY OR EFFECTIVENESS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
issue one or more administrative orders speci-
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269 
fying requirements for determining whether a 
minor change made by a sponsor pursuant to 
this subsection will affect the safety or effective-
ness of a drug or materially affect the extent of 
absorption or other exposure to an active ingre-
dient in the drug in comparison to a suitable 
reference product, together with guidance for 
applying those orders to specific dosage forms. 
‘‘(B) STANDARD PRACTICES.—The orders 
and guidance issued by the Secretary under 
subparagraph (A) shall take into account rel-
evant public standards and standard practices 
for evaluating the quality of drugs, and may 
take into account the special needs of popu-
lations, including children. 
‘‘(d) CONFIDENTIALITY
OF
INFORMATION
SUB-
MITTED TO THE SECRETARY.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
any information, including reports of testing con-
ducted on the drug or drugs involved, that is sub-
mitted by a requestor in connection with proceedings 
on an order under this section (including any minor 
change under subsection (c)) and is a trade secret 
or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 
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1905 of title 18, United States Code, shall not be 
disclosed to the public unless the requestor consents 
to that disclosure. 
‘‘(2) PUBLIC AVAILABILITY.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Secretary shall— 
‘‘(i) make any information submitted 
by a requestor in support of a request 
under subsection (b)(5)(A) available to the 
public not later than the date on which the 
proposed order is issued; and 
‘‘(ii) make any information submitted 
by any other person with respect to an 
order requested (or initiated by the Sec-
retary) under subsection (b), available to 
the public upon such submission. 
‘‘(B) LIMITATIONS
ON
PUBLIC
AVAIL-
ABILITY.—Information described in subpara-
graph (A) shall not be made public if— 
‘‘(i) the information pertains to phar-
maceutical quality information, unless such 
information is necessary to establish stand-
ards under which a drug is generally rec-
ognized as safe and effective under section 
201(p)(1); 
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‘‘(ii) the information is submitted in a 
requestor-initiated request, but the re-
questor withdraws such request, in accord-
ance with withdrawal procedures estab-
lished by the Secretary, before the Sec-
retary issues the proposed order; 
‘‘(iii) the Secretary requests and ob-
tains the information under subsection (c) 
and such information is not submitted in 
relation to an order under subsection (b); 
or 
‘‘(iv) the information is of the type 
contained in raw datasets. 
‘‘(e) UPDATES TO DRUG LISTING INFORMATION.— 
A sponsor who makes a change to a drug subject to this 
section shall submit updated drug listing information for 
the drug in accordance with section 510(j) within 30 cal-
endar days of the date when the drug is first commercially 
marketed, except that a sponsor who was the order re-
questor with respect to an order subject to subsection 
(b)(5)(C) (or a licensee, assignee, or successor in interest 
of such requestor) shall submit updated drug listing infor-
mation on or before the date when the drug is first com-
mercially marketed. 
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272 
‘‘(f) APPROVALS UNDER SECTION 505.—The provi-
sions of this section shall not be construed to preclude a 
person from seeking or maintaining the approval of an ap-
plication for a drug under sections 505(b)(1), 505(b)(2), 
and 505(j). A determination under this section that a drug 
is not subject to section 503(b)(1), is generally recognized 
as safe and effective under section 201(p)(1), and is not 
a new drug under section 201(p) shall constitute a finding 
that the drug is safe and effective that may be relied upon 
for purposes of an application under section 505(b)(2), so 
that the applicant shall be required to submit for purposes 
of such application only information needed to support any 
modification of the drug that is not covered by such deter-
mination under this section. 
‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR-
DERS.—The Secretary shall establish, maintain, update 
(as determined necessary by the Secretary but no less fre-
quently than annually), and make publicly available, with 
respect to orders issued under this section— 
‘‘(1) a repository of each final order and in-
terim final order in effect, including the complete 
text of the order; and 
‘‘(2) a listing of all orders proposed and under 
development under subsection (b)(2), including— 
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273 
‘‘(A) a brief description of each such order; 
and 
‘‘(B) the Secretary’s expectations, if re-
sources permit, for issuance of proposed orders 
over a 3-year period. 
‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures 
under which sponsors or requestors may meet with appro-
priate officials of the Food and Drug Administration to 
obtain advice on the studies and other information nec-
essary to support submissions under this section and other 
matters relevant to the regulation of nonprescription 
drugs and the development of new nonprescription drugs 
under this section. 
‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures to 
facilitate efficient participation by multiple sponsors or re-
questors in proceedings under this section, including provi-
sion for joint meetings with multiple sponsors or reques-
tors or with organizations nominated by sponsors or re-
questors to represent their interests in a proceeding. 
‘‘(j) ELECTRONIC FORMAT.—All submissions under 
this section shall be in electronic format. 
‘‘(k) EFFECT
ON EXISTING REGULATIONS GOV-
ERNING NONPRESCRIPTION DRUGS.— 
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274 
‘‘(1) REGULATIONS
OF
GENERAL
APPLICA-
BILITY
TO
NONPRESCRIPTION
DRUGS.—Except as 
provided in this subsection, nothing in this section 
supersedes regulations establishing general require-
ments for nonprescription drugs, including regula-
tions of general applicability contained in parts 201, 
250, and 330 of title 21, Code of Federal Regula-
tions, or any successor regulations. The Secretary 
shall establish or modify such regulations by means 
of rulemaking in accordance with section 553 of title 
5, United States Code. 
‘‘(2) REGULATIONS
ESTABLISHING
REQUIRE-
MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 
‘‘(A) The provisions of section 310.545 of 
title 21, Code of Federal Regulations, as in ef-
fect on the day before the date of the enact-
ment of this section, shall be deemed to be a 
final order under subsection (b). 
‘‘(B) Regulations in effect on the day be-
fore the date of the enactment of this section, 
establishing requirements for specific non-
prescription drugs marketed pursuant to this 
section (including such requirements in parts 
201 and 250 of title 21, Code of Federal Regu-
lations), shall be deemed to be final orders 
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under subsection (b), only as they apply to 
drugs— 
‘‘(i) subject to paragraph (1), (2), (3), 
or (4) of subsection (a); or 
‘‘(ii) otherwise subject to an order 
under this section. 
‘‘(3) WITHDRAWAL
OF
REGULATIONS.—The 
Secretary shall withdraw regulations establishing 
final monographs and the procedures governing the 
over-the-counter drug review under part 330 and 
other relevant parts of title 21, Code of Federal 
Regulations (as in effect on the day before the date 
of the enactment of this section), or make technical 
changes to such regulations to ensure conformity 
with appropriate terminology and cross references. 
Notwithstanding subchapter II of chapter 5 of title 
5, United States Code, any such withdrawal or tech-
nical changes shall be made without public notice 
and comment and shall be effective upon publication 
through notice in the Federal Register (or upon such 
date as specified in such notice). 
‘‘(l) GUIDANCE.—The Secretary shall issue guidance 
that specifies— 
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276 
‘‘(1) the procedures and principles for formal 
meetings between the Secretary and sponsors or re-
questors for drugs subject to this section; 
‘‘(2) the format and content of data submis-
sions to the Secretary under this section; 
‘‘(3) the format of electronic submissions to the 
Secretary under this section; 
‘‘(4) consolidated proceedings for appeal and 
the procedures for such proceedings where appro-
priate; and 
‘‘(5) for minor changes in drugs, recommenda-
tions on how to comply with the requirements in or-
ders issued under subsection (c)(3). 
‘‘(m) RULE OF CONSTRUCTION.— 
‘‘(1) IN GENERAL.—This section shall not af-
fect the treatment or status of a nonprescription 
drug— 
‘‘(A) that is marketed without an applica-
tion approved under section 505 as of the date 
of the enactment of this section; 
‘‘(B) that is not subject to an order issued 
under this section; and 
‘‘(C) to which paragraphs (1), (2), (3), (4), 
or (5) of subsection (a) do not apply. 
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277 
‘‘(2) TREATMENT
OF
PRODUCTS
PREVIOUSLY 
FOUND TO BE SUBJECT TO TIME AND EXTENT RE-
QUIREMENTS.— 
‘‘(A) Notwithstanding subsection (a), a 
drug described in subparagraph (B) may only 
be lawfully marketed, without an application 
approved under section 505, pursuant to an 
order issued under this section. 
‘‘(B) A drug described in this subpara-
graph is a drug which, prior to the date of the 
enactment of this section, the Secretary deter-
mined in a proposed or final rule to be ineligible 
for review under the OTC drug review (as such 
phrase ‘OTC drug review’ was used in section 
330.14 of title 21, Code of Federal Regulations, 
as in effect on the day before the date of the 
enactment of this section). 
‘‘(3) PRESERVATION OF AUTHORITY.— 
‘‘(A) Nothing in paragraph (1) shall be 
construed to preclude or limit the applicability 
of any provision of this Act other than this sec-
tion. 
‘‘(B) Nothing in subsection (a) shall be 
construed to prohibit the Secretary from issuing 
an order under this section finding a drug to be 
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278 
not generally recognized as safe and effective 
under section 201(p)(1), as the Secretary deter-
mines appropriate. 
‘‘(n) INVESTIGATIONAL NEW DRUGS.—A drug is not 
subject to this section if an exemption for investigational 
use under section 505(i) is in effect for such drug. 
‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION 
ACT.—Chapter 35 of title 44, United States Code, shall 
not apply to collections of information made under this 
section. 
‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT 
RULEMAKING
AND OTHER REQUIREMENTS.—The re-
quirements of subsection (b) shall apply with respect to 
orders issued under this section instead of the require-
ments of subchapter II of chapter 5 of title 5, United 
States Code. 
‘‘(q) DEFINITIONS.—In this section: 
‘‘(1) The term ‘nonprescription drug’ refers to 
a drug not subject to the requirements of section 
503(b)(1). 
‘‘(2) The term ‘sponsor’ refers to any person 
marketing, manufacturing, or processing a drug 
that— 
‘‘(A) is listed pursuant to section 510(j); 
and 
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279 
‘‘(B) is or will be subject to an administra-
tive order under this section of the Food and 
Drug Administration. 
‘‘(3) The term ‘requestor’ refers to any person 
or group of persons marketing, manufacturing, proc-
essing, or developing a drug.’’. 
(b) GAO STUDY.—Not later than 4 years after the 
date of enactment of this Act, the Comptroller General 
of the United States shall submit a study to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate addressing the effec-
tiveness and overall impact of exclusivity under section 
505G of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a), and section 586C of such Act 
(21 U.S.C. 360fff–3), including the impact of such exclu-
sivity on consumer access. Such study shall include— 
(1) an analysis of the impact of exclusivity 
under such section 505G for nonprescription drug 
products, including— 
(A) the number of nonprescription drug 
products that were granted exclusivity and the 
indication for which the nonprescription drug 
products were determined to be generally recog-
nized as safe and effective; 
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(B) whether the exclusivity for such drug 
products was granted for— 
(i) a new active ingredient (including 
any ester or salt of the active ingredient); 
or 
(ii) changes in the conditions of use of 
a drug, for which new human data studies 
conducted or sponsored by the requestor 
were essential; 
(C) whether, and to what extent, the exclu-
sivity impacted the requestor’s or sponsor’s de-
cision to develop the drug product; 
(D) an analysis of the implementation of 
the exclusivity provision in such section 505G, 
including— 
(i) the resources used by the Food 
and Drug Administration; 
(ii) the impact of such provision on 
innovation, as well as research and devel-
opment in the nonprescription drug mar-
ket; 
(iii) the impact of such provision on 
competition in the nonprescription drug 
market; 
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281 
(iv) the impact of such provision on 
consumer access to nonprescription drug 
products; 
(v) the impact of such provision on 
the prices of nonprescription drug prod-
ucts; and 
(vi) whether the administrative orders 
initiated by requestors under such section 
505G have been sufficient to encourage the 
development of nonprescription drug prod-
ucts that would likely not be otherwise de-
veloped, or developed in as timely a man-
ner; and 
(E) whether the administrative orders ini-
tiated by requestors under such section 505G 
have been sufficient incentive to encourage in-
novation in the nonprescription drug market; 
and 
(2) an analysis of the impact of exclusivity 
under such section 586C for sunscreen ingredients, 
including— 
(A) the number of sunscreen ingredients 
that were granted exclusivity and the specific 
ingredient that was determined to be generally 
recognized as safe and effective; 
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282 
(B) whether, and to what extent, the exclu-
sivity impacted the requestor’s or sponsor’s de-
cision to develop the sunscreen ingredient; 
(C) whether, and to what extent, the sun-
screen ingredient granted exclusivity had pre-
viously been available outside of the United 
States; 
(D) an analysis of the implementation of 
the exclusivity provision in such section 586C, 
including— 
(i) the resources used by the Food 
and Drug Administration; 
(ii) the impact of such provision on 
innovation, as well as research and devel-
opment in the sunscreen market; 
(iii) the impact of such provision on 
competition in the sunscreen market; 
(iv) the impact of such provision on 
consumer access to sunscreen products; 
(v) the impact of such provision on 
the prices of sunscreen products; and 
(vi) whether the administrative orders 
initiated by requestors under such section 
505G have been utilized by sunscreen in-
gredient sponsors and whether such proc-
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283 
ess has been sufficient to encourage the 
development of sunscreen ingredients that 
would likely not be otherwise developed, or 
developed in as timely a manner; and 
(E) whether the administrative orders ini-
tiated by requestors under such section 586C 
have been sufficient incentive to encourage in-
novation in the sunscreen market. 
(c) CONFORMING AMENDMENT.—Section 751(d)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379r(d)(1)) is amended— 
(1) in the matter preceding subparagraph (A)— 
(A) by striking ‘‘final regulation promul-
gated’’ and inserting ‘‘final order under section 
505G’’; and 
(B) by striking ‘‘and not misbranded’’; and 
(2) in subparagraph (A), by striking ‘‘regula-
tion in effect’’ and inserting ‘‘regulation or order in 
effect’’. 
SEC. 372. MISBRANDING. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the 
following: 
‘‘(ee) If it is a nonprescription drug that is subject 
to section 505G, is not the subject of an application ap-
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284 
proved under section 505, and does not comply with the 
requirements under section 505G. 
‘‘(ff) If it is a drug and it was manufactured, pre-
pared, propagated, compounded, or processed in a facility 
for which fees have not been paid as required by section 
744M.’’. 
SEC. 
373. 
DRUGS 
EXCLUDED 
FROM 
THE 
OVER-THE- 
COUNTER DRUG REVIEW. 
(a) IN GENERAL.—Nothing in this Act (or the 
amendments made by this Act) shall apply to any non-
prescription drug (as defined in section 505G(q) of the 
Federal Food, Drug, and Cosmetic Act, as added by sec-
tion 1001 of this Act) which was excluded by the Food 
and Drug Administration from the Over-the-Counter 
Drug Review in accordance with the paragraph numbered 
25 on page 9466 of volume 37 of the Federal Register, 
published on May 11, 1972. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to preclude or limit the applica-
bility of any other provision of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.). 
SEC. 374. TREATMENT OF SUNSCREEN INNOVATION ACT. 
(a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC-
TIVE INGREDIENTS.— 
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285 
(1) APPLICABILITY
OF
SECTION
505G
FOR 
PENDING SUBMISSIONS.— 
(A) IN GENERAL.—A sponsor of a non-
prescription sunscreen active ingredient or com-
bination of nonprescription sunscreen active in-
gredients that, as of the date of enactment of 
this Act, is subject to a proposed sunscreen 
order under section 586C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360fff–3) 
may elect, by means of giving written notifica-
tion to the Secretary of Health and Human 
Services within 180 calendar days of the enact-
ment of this Act, to transition into the review 
of such ingredient or combination of ingredients 
pursuant to the process set out in section 505G 
of the Federal Food, Drug, and Cosmetic Act, 
as added by section 1001 of this Act. 
(B) ELECTION EXERCISED.—Upon receipt 
by the Secretary of Health and Human Services 
of a timely notification under subparagraph 
(A)— 
(i) the proposed sunscreen order in-
volved is deemed to be a request for an 
order under subsection (b) of section 505G 
of the Federal Food, Drug, and Cosmetic 
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Act, as added by section 1001 of this Act; 
and 
(ii) such order is deemed to have been 
accepted 
for 
filing 
under 
subsection 
(b)(6)(A)(i) of such section 505G. 
(C) ELECTION NOT EXERCISED.—If a noti-
fication under subparagraph (A) is not received 
by the Secretary of Health and Human Services 
within 180 calendar days of the date of enact-
ment of this Act, the review of the proposed 
sunscreen order described in subparagraph 
(A)— 
(i) shall continue under section 586C 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360fff–3); and 
(ii) shall not be eligible for review 
under section 505G, added by section 1001 
of this Act. 
(2) DEFINITIONS.—In this subsection, the 
terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac-
tive ingredient’’, and ‘‘proposed sunscreen order’’ 
have the meanings given to those terms in section 
586 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff). 
(b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 
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(1) FINAL
SUNSCREEN
ORDERS.—Paragraph 
(3) of section 586C(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend-
ed to read as follows: 
‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC-
TION 505G.—A final sunscreen order shall be deemed 
to be a final order under section 505G.’’. 
(2) MEETINGS.—Paragraph (7) of section 
586C(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360fff–3(b)) is amended— 
(A) by striking ‘‘A sponsor may request’’ 
and inserting the following: 
‘‘(A) IN
GENERAL.—A sponsor may re-
quest’’; and 
(B) by adding at the end the following: 
‘‘(B) CONFIDENTIAL MEETINGS.—A spon-
sor may request one or more confidential meet-
ings with respect to a proposed sunscreen order, 
including a letter deemed to be a proposed sun-
screen order under paragraph (3), to discuss 
matters relating to data requirements to sup-
port a general recognition of safety and effec-
tiveness involving confidential information and 
public information related to such proposed 
sunscreen order, as appropriate. The Secretary 
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shall convene a confidential meeting with such 
sponsor in a reasonable time period. If a spon-
sor requests more than one confidential meeting 
for the same proposed sunscreen order, the Sec-
retary may refuse to grant an additional con-
fidential meeting request if the Secretary deter-
mines that such additional confidential meeting 
is not reasonably necessary for the sponsor to 
advance its proposed sunscreen order, or if the 
request for a confidential meeting fails to in-
clude sufficient information upon which to base 
a substantive discussion. The Secretary shall 
publish a post-meeting summary of each con-
fidential meeting under this subparagraph that 
does not disclose confidential commercial infor-
mation or trade secrets. This subparagraph 
does not authorize the disclosure of confidential 
commercial information or trade secrets subject 
to 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.’’. 
(3) EXCLUSIVITY.—Section 586C of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360fff–3) is amended by adding at the end the fol-
lowing: 
‘‘(f) EXCLUSIVITY.— 
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‘‘(1) IN
GENERAL.—A final sunscreen order 
shall have the effect of authorizing solely the order 
requestor (or the licensees, assignees, or successors 
in interest of such requestor with respect to the sub-
ject of such request and listed under paragraph (5)) 
for a period of 18 months, to market a sunscreen in-
gredient under this section incorporating changes 
described in paragraph (2) subject to the limitations 
under paragraph (4), beginning on the date the re-
questor (or any licensees, assignees, or successors in 
interest of such requestor with respect to the subject 
of such request and listed under paragraph (5)) may 
lawfully market such sunscreen ingredient pursuant 
to the order. 
‘‘(2) CHANGES
DESCRIBED.—A change de-
scribed in this paragraph is a change subject to an 
order specified in paragraph (1) that permits a sun-
screen to contain an active sunscreen ingredient not 
previously incorporated in a marketed sunscreen list-
ed in paragraph (3). 
‘‘(3) MARKETED
SUNSCREEN.—The marketed 
sunscreen ingredients described in this paragraph 
are sunscreen ingredients— 
‘‘(A) marketed in accordance with a final 
monograph for sunscreen drug products set 
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forth at part 352 of title 21, Code of Federal 
Regulations (as published at 64 Fed. Reg. 
27687); or 
‘‘(B) marketed in accordance with a final 
order issued under this section. 
‘‘(4) LIMITATIONS ON EXCLUSIVITY.—Only one 
18-month period may be granted per ingredient 
under paragraph (1). 
‘‘(5) LISTING OF LICENSEES, ASSIGNEES, OR 
SUCCESSORS IN INTEREST.—Requestors shall submit 
to the Secretary at the time when a drug subject to 
such request is introduced or delivered for introduc-
tion into interstate commerce, a list of licensees, as-
signees, or successors in interest under paragraph 
(1).’’. 
(4) SUNSET PROVISION.—Subchapter I of chap-
ter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 586H. SUNSET. 
‘‘This subchapter shall cease to be effective at the end 
of fiscal year 2022.’’. 
(5) 
TREATMENT
OF
FINAL
SUNSCREEN 
ORDER.—The Federal Food, Drug, and Cosmetic 
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Act is amended by striking section 586E of such Act 
(21 U.S.C. 360fff–5). 
(c) TREATMENT OF AUTHORITY REGARDING FINAL-
IZATION OF SUNSCREEN MONOGRAPH.— 
(1) IN GENERAL.— 
(A) REVISION
OF
FINAL
SUNSCREEN 
ORDER.—Not later than November 26, 2019, 
the Secretary of Health and Human Services 
(referred to in this subsection as the ‘‘Sec-
retary’’) shall amend and revise the final ad-
ministrative order concerning nonprescription 
sunscreen (referred to in this subsection as the 
‘‘sunscreen order’’) for which the content, prior 
to the date of enactment of this Act, was rep-
resented by the final monograph for sunscreen 
drug products set forth in part 352 of title 21, 
Code of Federal Regulations (as in effect on 
May 21, 1999). 
(B) ISSUANCE
OF
REVISED
SUNSCREEN 
ORDER; EFFECTIVE DATE.—A revised sunscreen 
order described in subparagraph (A) shall be— 
(i) issued in accordance with the pro-
cedures described in section 505G(c)(2) of 
the Federal Food, Drug, and Cosmetic 
Act; 
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(ii) issued in proposed form not later 
than May 28, 2019; 
(iii) effective not later than November 
26, 2020; and 
(iv) issued by the Secretary at least 1 
year prior to the effective date of the re-
vised order. 
(2) REPORTS.—If a revised sunscreen order 
issued under paragraph (1) does not include provi-
sions related to the effectiveness of various sun pro-
tection factor levels, and does not address all dosage 
forms known to the Secretary to be used in sun-
screens marketed in the United States without a 
new drug application approved under section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), the Secretary shall submit a report to 
the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate on the rationale for omission of such provisions 
from such order, and a plan and timeline to compile 
any information necessary to address such provisions 
through such order. 
(d) TREATMENT OF NON-SUNSCREEN TIME AND EX-
TENT APPLICATIONS.— 
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(1) IN GENERAL.—Any application described in 
section 586F of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360fff–6) that was submitted 
to the Secretary pursuant to section 330.14 of title 
21, Code of Federal Regulations, as such provisions 
were in effect immediately prior to the date of enact-
ment date of this Act, shall be extinguished as of 
such date of enactment, subject to paragraph (2). 
(2) ORDER REQUEST.—Nothing in paragraph 
(1) precludes the submission of an order request 
under section 505G(b) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 1001 of this 
Act, with respect to a drug that was the subject of 
an application extinguished under paragraph (1). 
SEC. 375. ANNUAL UPDATE TO CONGRESS ON APPRO-
PRIATE PEDIATRIC INDICATION FOR CER-
TAIN OTC COUGH AND COLD DRUGS. 
(a) IN GENERAL.—Subject to subsection (c), the Sec-
retary of Health and Human Services shall, beginning not 
later than 1 year after the date of enactment of this Act, 
annually submit to the Committee on Energy and Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate 
a letter describing the progress of the Food and Drug Ad-
ministration— 
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(1) in evaluating the cough and cold monograph 
described in subsection (b) with respect to children 
under age 6; and 
(2) as appropriate, revising such cough and cold 
monograph to address such children through the 
order process under section 505G(b) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
1001 of this Act. 
(b) COUGH AND COLD MONOGRAPH DESCRIBED.— 
The cough and cold monograph described in this sub-
section consists of the conditions under which nonprescrip-
tion drugs containing antitussive, expectorant, nasal de-
congestant, or antihistamine active ingredients (or com-
binations thereof) are generally recognized as safe and ef-
fective, as specified in part 341 of title 21, Code of Federal 
Regulations (as in effect immediately prior to the date of 
enactment of this Act), and included in an order deemed 
to be established under section 505G(b) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 1001 
of this Act. 
(c) DURATION
OF AUTHORITY.—The requirement 
under subsection (a) shall terminate as of the date of a 
letter submitted by the Secretary of Health and Human 
Services pursuant to such subsection in which the Sec-
retary indicates that the Food and Drug Administration 
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has completed its evaluation and revised, in a final order, 
as applicable, the cough and cold monograph as described 
in subsection (a)(2). 
SEC. 376. TECHNICAL CORRECTIONS. 
(a) 
IMPORTS
AND
EXPORTS.—Section 
801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by striking 
‘‘subparagraph’’ each place such term appears and insert-
ing ‘‘paragraph’’. 
(b) FDA REAUTHORIZATION ACT OF 2017.— 
(1) IN
GENERAL.—Section 905(b)(4) of the 
FDA Reauthorization Act of 2017 (Public Law 115– 
52) is amended by striking ‘‘Section 744H(e)(2)(B)’’ 
and inserting ‘‘Section 744H(f)(2)(B)’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall take effect as of the enact-
ment of the FDA Reauthorization Act of 2017 
(Public Law 115–52). 
PART 2—USER FEES 
SEC. 381. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This part may be cited as the 
‘‘Over-the-Counter Monograph User Fee Act of 2019’’. 
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this part will be dedi-
cated to OTC monograph drug activities, as set forth in 
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the goals identified for purposes of part 10 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
SEC. 382. FEES RELATING TO OVER-THE-COUNTER DRUGS. 
Subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 
amended by inserting after part 9 the following: 
‘‘PART 10—FEES RELATING TO OVER-THE- 
COUNTER DRUGS 
‘‘SEC. 744L. DEFINITIONS. 
‘‘In this part: 
‘‘(1) The term ‘affiliate’ means a business enti-
ty that has a relationship with a second business en-
tity if, directly or indirectly— 
‘‘(A) one business entity controls, or has 
the power to control, the other business entity; 
or 
‘‘(B) a third party controls, or has power 
to control, both of the business entities. 
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‘‘(2) The term ‘contract manufacturing organi-
zation facility’ means an OTC monograph drug facil-
ity where neither the owner of such manufacturing 
facility nor any affiliate of such owner or facility 
sells the OTC monograph drug produced at such fa-
cility directly to wholesalers, retailers, or consumers 
in the United States. 
‘‘(3) The term ‘costs of resources allocated for 
OTC monograph drug activities’ means the expenses 
in connection with OTC monograph drug activities 
for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees and costs related to 
contracts with such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
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‘‘(D) collecting fees under section 744M 
and accounting for resources allocated for OTC 
monograph drug activities. 
‘‘(4) The term ‘FDA establishment identifier’ is 
the unique number automatically generated by Food 
and Drug Administration’s Field Accomplishments 
and Compliance Tracking System (FACTS) (or any 
successor system). 
‘‘(5) The term ‘OTC monograph drug’ means a 
nonprescription drug without an approved new drug 
application which is governed by the provisions of 
section 505G. 
‘‘(6) The term ‘OTC monograph drug activities’ 
means activities of the Secretary associated with 
OTC monograph drugs and inspection of facilities 
associated with such products, including the fol-
lowing activities: 
‘‘(A) The activities necessary for review 
and evaluation of OTC monographs and OTC 
monograph order requests, including— 
‘‘(i) orders proposing or finalizing ap-
plicable conditions of use for OTC mono-
graph drugs; 
‘‘(ii) orders affecting status regarding 
general recognition of safety and effective-
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ness of an OTC monograph ingredient or 
combination of ingredients under specified 
conditions of use; 
‘‘(iii) all OTC monograph drug devel-
opment and review activities, including 
intra-agency collaboration; 
‘‘(iv) regulation and policy develop-
ment activities related to OTC monograph 
drugs; 
‘‘(v) development of product standards 
for products subject to review and evalua-
tion; 
‘‘(vi) meetings referred to in section 
505G(i); 
‘‘(vii) review of labeling prior to 
issuance of orders related to OTC mono-
graph drugs or conditions of use; and 
‘‘(viii) regulatory science activities re-
lated to OTC monograph drugs. 
‘‘(B) Inspections related to OTC mono-
graph drugs. 
‘‘(C) Monitoring of clinical and other re-
search conducted in connection with OTC 
monograph drugs. 
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‘‘(D) Safety activities with respect to OTC 
monograph drugs, including— 
‘‘(i) collecting, developing, and review-
ing safety information on OTC monograph 
drugs, including adverse event reports; 
‘‘(ii) developing and using improved 
adverse event data-collection systems, in-
cluding information technology systems; 
and 
‘‘(iii) developing and using improved 
analytical tools to assess potential safety 
risks, including access to external data-
bases. 
‘‘(E) Other activities necessary for imple-
mentation of section 505G. 
‘‘(7) The term ‘OTC monograph order request’ 
means a request for an order submitted under sec-
tion 505G(b)(5). 
‘‘(8) The term ‘Tier 1 OTC monograph order 
request’ means any OTC monograph order request 
not determined to be a Tier 2 OTC monograph 
order request. 
‘‘(9)(A) The term ‘Tier 2 OTC monograph 
order request’ means, subject to subparagraph (B), 
an OTC monograph order request for— 
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‘‘(i) the reordering of existing information 
in the drug facts label of an OTC monograph 
drug; 
‘‘(ii) the addition of information to the 
other information section of the drug facts label 
of an OTC monograph drug, as limited by sec-
tion 201.66(c)(7) of title 21, Code of Federal 
Regulations (or any successor regulations); 
‘‘(iii) modification to the directions for use 
section of the drug facts label of an OTC mono-
graph drug, if such changes conform to changes 
made pursuant to section 505G(c)(3)(A); 
‘‘(iv) the standardization of the concentra-
tion or dose of a specific finalized ingredient 
within a particular finalized monograph; 
‘‘(v) a change to ingredient nomenclature 
to align with nomenclature of a standards-set-
ting organization; or 
‘‘(vi) addition of an interchangeable term 
in accordance with section 330.1 of title 21, 
Code of Federal Regulations (or any successor 
regulations). 
‘‘(B) The Secretary may, based on program im-
plementation experience or other factors found ap-
propriate by the Secretary, characterize any OTC 
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monograph order request as a Tier 2 OTC mono-
graph order request (including recharacterizing a re-
quest from Tier 1 to Tier 2) and publish such deter-
mination in a proposed order issued pursuant to sec-
tion 505G. 
‘‘(10)(A) The term ‘OTC monograph drug facil-
ity’ means a foreign or domestic business or other 
entity that— 
‘‘(i) is— 
‘‘(I) under one management, either di-
rect or indirect; and 
‘‘(II) at one geographic location or ad-
dress engaged in manufacturing or proc-
essing the finished dosage form of an OTC 
monograph drug; 
‘‘(ii) includes a finished dosage form man-
ufacturer facility in a contractual relationship 
with the sponsor of one or more OTC mono-
graph drugs to manufacture or process such 
drugs; and 
‘‘(iii) does not include a business or other 
entity whose only manufacturing or processing 
activities are one or more of the following: pro-
duction of clinical research supplies, testing, or 
placement of outer packaging on packages con-
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taining multiple products, for such purposes as 
creating multipacks, when each monograph 
drug product contained within the overpack-
aging is already in a final packaged form prior 
to placement in the outer overpackaging. 
‘‘(B) For purposes of subparagraph (A)(i)(II), 
separate buildings or locations within close proximity 
are considered to be at one geographic location or 
address if the activities conducted in such buildings 
or locations are— 
‘‘(i) closely related to the same business 
enterprise; 
‘‘(ii) under the supervision of the same 
local management; and 
‘‘(iii) under a single FDA establishment 
identifier and capable of being inspected by the 
Food and Drug Administration during a single 
inspection. 
‘‘(C) If a business or other entity would meet 
criteria specified in subparagraph (A), but for being 
under multiple management, the business or other 
entity is deemed to constitute multiple facilities, one 
per management entity, for purposes of this para-
graph. 
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‘‘(11) The term ‘OTC monograph drug meet-
ing’ means any meeting regarding the content of a 
proposed OTC monograph order request. 
‘‘(12) The term ‘person’ includes an affiliate of 
a person. 
‘‘(13) The terms ‘requestor’ and ‘sponsor’ have 
the meanings given such terms in section 505G. 
‘‘SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONO-
GRAPH FEES. 
‘‘(a) TYPES OF FEES.—Beginning with fiscal year 
2019, the Secretary shall assess and collect fees in accord-
ance with this section as follows: 
‘‘(1) FACILITY FEE.— 
‘‘(A) IN
GENERAL.—Each person that 
owns a facility identified as an OTC monograph 
drug facility on December 31 of the fiscal year 
or at any time during the preceding 12-month 
period shall be assessed an annual fee for each 
such facility as determined under subsection 
(c). 
‘‘(B) EXCEPTIONS.— 
‘‘(i) A fee shall not be assessed under 
subparagraph (A) if the identified OTC 
monograph drug facility— 
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‘‘(I) has ceased all activities re-
lated to OTC monograph drugs prior 
to January 31, 2019, for the first pro-
gram year, and December 31 of the 
fiscal year for subsequent fiscal years; 
and 
‘‘(II) has updated its registration 
to reflect such change under the re-
quirements for drug establishment 
registration set forth in section 510. 
‘‘(ii) The amount of the fee for a con-
tract manufacturing organization facility 
shall be equal to two-thirds of the amount 
of the fee for an OTC monograph drug fa-
cility that is not a contract manufacturing 
organization facility. 
‘‘(C) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (c). 
‘‘(D) DUE DATE.— 
‘‘(i) FOR FIRST PROGRAM YEAR.—For 
fiscal year 2019, the facility fees required 
under subparagraph (A) shall be due 45 
calendar days after publication of the Fed-
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eral Register notice provided for under 
subsection (c)(4)(A). 
‘‘(ii) SUBSEQUENT
FISCAL
YEARS.— 
For each fiscal year after fiscal year 2019, 
the facility fees required under subpara-
graph (A) shall be due on the later of— 
‘‘(I) the first business day of 
June of such year; or 
‘‘(II) the first business day after 
the enactment of an appropriations 
Act providing for the collection and 
obligation of fees under this section 
for such year. 
‘‘(2) 
OTC 
MONOGRAPH
ORDER
REQUEST 
FEE.— 
‘‘(A) IN GENERAL.—Each person that sub-
mits an OTC monograph order request shall be 
subject to a fee for an OTC monograph order 
request. The amount of such fee shall be— 
‘‘(i) for a Tier 1 OTC monograph 
order request, $500,000, adjusted for in-
flation for the fiscal year (as determined 
under subsection (c)(1)(B)); and 
‘‘(ii) for a Tier 2 OTC monograph 
order request, $100,000 adjusted for infla-
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tion for the fiscal year (as determined 
under subsection (c)(1)(B)). 
‘‘(B) DUE
DATE.—The OTC monograph 
order request fees required under subparagraph 
(A) shall be due on the date of submission of 
the OTC monograph order request. 
‘‘(C) EXCEPTION
FOR
CERTAIN
SAFETY 
CHANGES.—A person who is named as the re-
questor in an OTC monograph order shall not 
be subject to a fee under subparagraph (A) if 
the Secretary finds that the OTC monograph 
order request seeks to change the drug facts la-
beling of an OTC monograph drug in a way 
that would add to or strengthen— 
‘‘(i) a contraindication, warning, or 
precaution; 
‘‘(ii) a statement about risk associated 
with misuse or abuse; or 
‘‘(iii) an instruction about dosage and 
administration that is intended to increase 
the safe use of the OTC monograph drug. 
‘‘(D) REFUND OF FEE IF ORDER REQUEST 
IS RECATEGORIZED AS A TIER 2 OTC MONO-
GRAPH ORDER REQUEST.—If the Secretary de-
termines that an OTC monograph request ini-
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tially characterized as Tier 1 shall be re-charac-
terized as a Tier 2 OTC monograph order re-
quest, and the requestor has paid a Tier 1 fee 
in accordance with subparagraph (A)(i), the 
Secretary shall refund the requestor the dif-
ference between the Tier 1 and Tier 2 fees de-
termined under subparagraphs (A)(i) and 
(A)(ii), respectively. 
‘‘(E) REFUND OF FEE IF ORDER REQUEST 
REFUSED FOR FILING OR WITHDRAWN BEFORE 
FILING.—The Secretary shall refund 75 percent 
of the fee paid under subparagraph (B) for any 
order request which is refused for filing or was 
withdrawn before being accepted or refused for 
filing. 
‘‘(F) FEES
FOR
ORDER
REQUESTS
PRE-
VIOUSLY REFUSED FOR FILING OR WITHDRAWN 
BEFORE
FILING.—An OTC monograph order 
request that was submitted but was refused for 
filing, or was withdrawn before being accepted 
or refused for filing, shall be subject to the full 
fee under subparagraph (A) upon being resub-
mitted or filed over protest. 
‘‘(G) REFUND OF FEE IF ORDER REQUEST 
WITHDRAWN.—If an order request is withdrawn 
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after the order request was filed, the Secretary 
may refund the fee or a portion of the fee if no 
substantial work was performed on the order 
request after the application was filed. The Sec-
retary shall have the sole discretion to refund a 
fee or a portion of the fee under this subpara-
graph. A determination by the Secretary con-
cerning a refund under this subparagraph shall 
not be reviewable. 
‘‘(3) REFUNDS.— 
‘‘(A) IN
GENERAL.—Other than refunds 
provided pursuant to any of subparagraphs (D) 
through (G) of paragraph (2), the Secretary 
shall not refund any fee paid under paragraph 
(1) except as provided in subparagraph (B). 
‘‘(B) DISPUTES
CONCERNING
FEES.—To 
qualify for the return of a fee claimed to have 
been paid in error under paragraph (1) or (2), 
a person shall submit to the Secretary a written 
request justifying such return within 180 cal-
endar days after such fee was paid. 
‘‘(4) NOTICE.—Within the timeframe specified 
in subsection (c), the Secretary shall publish in the 
Federal Register the amount of the fees under para-
graph (1) for such fiscal year. 
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‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) FISCAL YEAR 2019.—For fiscal year 2019, 
fees under subsection (a)(1) shall be established to 
generate a total facility fee revenue amount equal to 
the sum of— 
‘‘(A) the annual base revenue for fiscal 
year 2019 (as determined under paragraph 
(3)); 
‘‘(B) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(2)); and 
‘‘(C) additional direct cost adjustments (as 
determined under subsection (c)(3)). 
‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 
the fiscal years 2020 through 2023, fees under sub-
section (a)(1) shall be established to generate a total 
facility fee revenue amount equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
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applicable (as determined under subsection 
(c)(2)); 
‘‘(D) additional direct cost adjustments (as 
determined under subsection (c)(3)); and 
‘‘(E) additional dollar amounts for each 
fiscal year as follows: 
‘‘(i) $7,000,000 for fiscal year 2020. 
‘‘(ii) $6,000,000 for fiscal year 2021. 
‘‘(iii) $7,000,000 for fiscal year 2022. 
‘‘(iv) $3,000,000 for fiscal year 2023. 
‘‘(3) ANNUAL BASE REVENUE.—For purposes 
of paragraphs (1)(A) and (2)(A), the dollar amount 
of the annual base revenue for a fiscal year shall 
be— 
‘‘(A) for fiscal year 2019, $8,000,000; and 
‘‘(B) for fiscal years 2020 through 2023, 
the dollar amount of the total revenue amount 
established under this subsection for the pre-
vious fiscal year, not including any adjustments 
made under subsection (c)(2) or (c)(3). 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of sub-
section (b)(2)(B), the dollar amount of the in-
flation adjustment to the annual base revenue 
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for fiscal year 2020 and each subsequent fiscal 
year shall be equal to the product of— 
‘‘(i) such annual base revenue for the 
fiscal year under subsection (b)(2); and 
‘‘(ii) the inflation adjustment percent-
age under subparagraph (C). 
‘‘(B) OTC MONOGRAPH ORDER REQUEST 
FEES.—For purposes of subsection (a)(2), the 
dollar amount of the inflation adjustment to the 
fee for OTC monograph order requests for fis-
cal year 2020 and each subsequent fiscal year 
shall be equal to the product of— 
‘‘(i) the applicable fee under sub-
section (a)(2) for the preceding fiscal year; 
and 
‘‘(ii) the inflation adjustment percent-
age under subparagraph (C). 
‘‘(C) INFLATION
ADJUSTMENT
PERCENT-
AGE.—The inflation adjustment percentage 
under this subparagraph for a fiscal year is 
equal to— 
‘‘(i) for each of fiscal years 2020 and 
2021, the average annual percent change 
that occurred in the Consumer Price Index 
for urban consumers (Washington-Balti-
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more, DC–MD–VA–WV; Not Seasonally 
Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 4 years of 
available data; and 
‘‘(ii) for each of fiscal years 2022 and 
2023, the sum of— 
‘‘(I) the average annual percent 
change in the cost, per full-time equiv-
alent position of the Food and Drug 
Administration, of all personnel com-
pensation and benefits paid with re-
spect to such positions for the first 3 
years of the preceding 4 fiscal years, 
multiplied by the proportion of per-
sonnel 
compensation 
and 
benefits 
costs to total costs of OTC mono-
graph drug activities for the first 3 
years of the preceding 4 fiscal years; 
and 
‘‘(II) the average annual percent 
change that occurred in the Consumer 
Price Index for urban consumers 
(Washington-Baltimore, DC–MD–VA– 
WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 
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years of the preceding 4 years of 
available data multiplied by the pro-
portion of all costs other than per-
sonnel 
compensation 
and 
benefits 
costs to total costs of OTC mono-
graph drug activities for the first 3 
years of the preceding 4 fiscal years. 
‘‘(2) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2019 
and subsequent fiscal years, for purposes of 
subsections (b)(1)(B) and (b)(2)(C), the Sec-
retary may, in addition to adjustments under 
paragraph (1), further increase the fee revenue 
and fees if such an adjustment is necessary to 
provide operating reserves of carryover user 
fees for OTC monograph drug activities for not 
more than the number of weeks specified in 
subparagraph (B). 
‘‘(B) NUMBER OF WEEKS.—The number of 
weeks specified in this subparagraph is— 
‘‘(i) 3 weeks for fiscal year 2019; 
‘‘(ii) 7 weeks for fiscal year 2020; 
‘‘(iii) 10 weeks for fiscal year 2021; 
‘‘(iv) 10 weeks for fiscal year 2022; 
and 
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‘‘(v) 10 weeks for fiscal year 2023. 
‘‘(C) DECREASE.—If the Secretary has 
carryover balances for such process in excess of 
10 weeks of the operating reserves referred to 
in subparagraph (A), the Secretary shall de-
crease the fee revenue and fees referred to in 
such subparagraph to provide for not more than 
10 weeks of such operating reserves. 
‘‘(D) RATIONALE
FOR
ADJUSTMENT.—If 
an adjustment under this paragraph is made, 
the rationale for the amount of the increase or 
decrease (as applicable) in fee revenue and fees 
shall be contained in the annual Federal Reg-
ister notice under paragraph (4) establishing 
fee revenue and fees for the fiscal year involved. 
‘‘(3) 
ADDITIONAL
DIRECT
COST
ADJUST-
MENT.—The Secretary shall, in addition to adjust-
ments under paragraphs (1) and (2), further in-
crease the fee revenue and fees for purposes of sub-
section (b)(2)(D) by an amount equal to— 
‘‘(A) $14,000,000 for fiscal year 2019; 
‘‘(B) $7,000,000 for fiscal year 2020; 
‘‘(C) $4,000,000 for fiscal year 2021; 
‘‘(D) $3,000,000 for fiscal year 2022; and 
‘‘(E) $3,000,000 for fiscal year 2023. 
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‘‘(II) OTC monograph order re-
quest fees under subsection (a)(2); 
and 
‘‘(ii) 
publish 
such 
fee 
revenue 
amounts, facility fees, and OTC mono-
graph order request fees in the Federal 
Register. 
‘‘(d) IDENTIFICATION OF FACILITIES.—Each person 
that owns an OTC monograph drug facility shall submit 
to the Secretary the information required under this sub-
section each year. Such information shall, for each fiscal 
year— 
‘‘(1) be submitted as part of the requirements 
for drug establishment registration set forth in sec-
tion 510; and 
‘‘(2) include for each such facility, at a min-
imum, identification of the facility’s business oper-
ation as that of an OTC monograph drug facility. 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) OTC MONOGRAPH DRUG FACILITY FEE.— 
‘‘(A) IN GENERAL.—Failure to pay the fee 
under subsection (a)(1) within 20 calendar days 
of the due date as specified in subparagraph 
(D) of such subsection shall result in the fol-
lowing: 
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‘‘(i) The Secretary shall place the fa-
cility on a publicly available arrears list. 
‘‘(ii) All OTC monograph drugs man-
ufactured in such a facility or containing 
an ingredient manufactured in such a facil-
ity shall be deemed misbranded under sec-
tion 502(ff). 
‘‘(B) APPLICATION
OF
PENALTIES.—The 
penalties under this paragraph shall apply until 
the fee established by subsection (a)(1) is paid. 
‘‘(2) ORDER REQUESTS.—An OTC monograph 
order request submitted by a person subject to fees 
under subsection (a) shall be considered incomplete 
and shall not be accepted for filing by the Secretary 
until all fees owed by such person under this section 
have been paid. 
‘‘(3) MEETINGS.—A person subject to fees 
under this section shall be considered ineligible for 
OTC monograph drug meetings until all such fees 
owed by such person have been paid. 
‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
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thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for OTC 
monograph drug activities. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C), the fees authorized by this section 
shall be collected and available in each fiscal 
year in an amount not to exceed the amount 
specified in appropriation Acts, or otherwise 
made available for obligation, for such fiscal 
year. 
‘‘(B) USE
OF
FEES
AND
LIMITATION.— 
The fees authorized by this section shall be 
available to defray increases in the costs of the 
resources allocated for OTC monograph drug 
activities (including increases in such costs for 
an additional number of full-time equivalent po-
sitions in the Department of Health and 
Human Services to be engaged in such activi-
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ties), only if the Secretary allocates for such 
purpose an amount for such fiscal year (exclud-
ing amounts from fees collected under this sec-
tion) no less than $12,000,000, multiplied by 
the adjustment factor applicable to the fiscal 
year involved under subsection (c)(1). 
‘‘(C) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
subparagraph (B) in any fiscal year if the costs 
funded by appropriations and allocated for OTC 
monograph drug activities are not more than 15 
percent below the level specified in such sub-
paragraph. 
‘‘(D) PROVISION FOR EARLY PAYMENTS IN 
SUBSEQUENT YEARS.—Payment of fees author-
ized under this section for a fiscal year (after 
fiscal year 2019), prior to the due date for such 
fees, may be accepted by the Secretary in ac-
cordance with authority provided in advance in 
a prior year appropriations Act. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2019 through 2023, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total amount of 
fees assessed for such fiscal year under this section. 
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‘‘(g) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 calendar days after 
it is due, such fee shall be treated as a claim of the United 
States Government subject to subchapter II of chapter 37 
of title 31, United States Code. 
‘‘(h) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in OTC monograph drug activities, be reduced 
to offset the number of officers, employees, and advisory 
committees so engaged. 
‘‘SEC. 744N. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2019, and not later than 120 calendar days after the 
end of each fiscal year thereafter for which fees are col-
lected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
concerning the progress of the Food and Drug Adminis-
tration in achieving the goals identified in the letters de-
scribed in section 2001(b) of the Over-the-Counter Mono-
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graph Safety, Innovation, and Reform Act of 2019 during 
such fiscal year and the future plans of the Food and 
Drug Administration for meeting such goals. 
‘‘(b) FISCAL REPORT.—Not later than 120 calendar 
days after the end of fiscal year 2019 and each subsequent 
fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the implementation 
of the authority for such fees during such fiscal year and 
the use, by the Food and Drug Administration, of the fees 
collected for such fiscal year. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 
make the reports required under subsections (a) and (b) 
available to the public on the internet website of the Food 
and Drug Administration. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals described in subsection (a), and 
plans for meeting the goals, for OTC monograph 
drug activities for the first 5 fiscal years after fiscal 
year 2023, and for the reauthorization of this part 
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for such fiscal years, the Secretary shall consult 
with— 
‘‘(A) the Committee on Energy and Com-
merce of the House of Representatives; 
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
‘‘(C) provide for a period of 30 calendar 
days for the public to provide written comments 
on such recommendations; 
‘‘(D) hold a meeting at which the public 
may present its views on such recommenda-
tions; and 
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‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary. 
‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2023, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (2), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions in response to such views and comments.’’. 
Subtitle I—Other Provisions 
SEC. 391. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS. 
Section 351(k)(7) of the Public Health Service Act 
(42 U.S.C. 262(k)(7)) is amended by adding at the end 
the following: 
‘‘(D) DEEMED LICENSES.— 
‘‘(i) NO
ADDITIONAL
EXCLUSIVITY 
THROUGH DEEMING.—An approved appli-
cation that is deemed to be a license for a 
biological product under this section pursu-
ant to section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act of 
2009 shall not be treated as having been 
first licensed under subsection (a) for pur-
poses of subparagraphs (A) and (B). 
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‘‘(ii) APPLICATION
OF
LIMITATIONS 
ON EXCLUSIVITY.—Subparagraph (C) shall 
apply with respect to a reference product 
referred to in such subparagraph that was 
the subject of an approved application that 
was deemed to be a license pursuant to 
section 7002(e)(4) of the Biologics Price 
Competition and Innovation Act of 2009. 
‘‘(iii) 
APPLICABILITY.—The 
exclu-
sivity periods described in section 527, sec-
tion 
505A(b)(1)(A)(ii), 
and 
section 
505A(c)(1)(A)(ii) of the Federal Food, 
Drug, and Cosmetic Act shall continue to 
apply to a biological product after an ap-
proved application for the biological prod-
uct is deemed to be a license for the bio-
logical product under subsection (a) pursu-
ant to section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act of 
2009.’’. 
SEC. 392. ORPHAN DRUG CLARIFICATION. 
Section 527(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360cc(c)) is amended by adding at 
the end the following: 
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‘‘(3) APPLICABILITY.—This subsection applies 
to any drug designated under section 526 for which 
an application was approved under section 505 of 
this Act or licensed under section 351 of the Public 
Health Service Act after the date of enactment of 
the FDA Reauthorization Act of 2017, regardless of 
the date on which such drug was designated under 
section 526.’’. 
SEC. 393. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
Section 351(k)(2)(A)(iii) of the Public Health Service 
Act (42 U.S.C. 262(k)(2)(A)(iii)) is amended— 
(1) in subclause (I), by striking ‘‘; and’’ and in-
serting a semicolon; 
(2) in subclause (II), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(III) may include information to 
show that the conditions of use pre-
scribed, recommended, or suggested in 
the labeling proposed for the biological 
product have been previously approved 
for the reference product.’’. 
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327 
SEC. 394. CLARIFYING THE MEANING OF NEW CHEMICAL 
ENTITY. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended— 
(1) in section 505 (21 U.S.C. 355)— 
(A) in subsection (c)(3)(E)— 
(i) in clause (ii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tions))’’; and 
(ii) in clause (iii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tions))’’; 
(B) in subsection (j)(5)(F)— 
(i) in clause (ii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
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