[Congressional Record Volume 165, Number 197 (Tuesday, December 10, 2019)]
[Senate]
[Pages S6921-S6930]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
LEGISLATIVE SESSION
______
OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM ACT OF 2019
The PRESIDING OFFICER. Under the previous order, the Senate will
proceed to legislative session and the consideration of S. 2740, which
the clerk will report.
The senior assistant legislative clerk read as follows:
A bill (S. 2740) to amend the Federal Food, Drug, and
Cosmetic Act to clarify the regulatory framework with respect
to certain nonprescription drugs that are marketed without an
approved new drug application, and for other purposes.
The PRESIDING OFFICER. The Senator from Pennsylvania.
Mr. CASEY. Madam President, the Senate is about to vote on the Over-
the-Counter Monograph Safety, Innovation, and Reform Act of 2019.
I want to thank my friend and colleague Senator Isakson for his good
work on this for many years, Chairman Alexander, and Ranking Member
Patty Murray.
The current OTC monograph system is broken, and what we are talking
about, in simple form, is literally what is on your pill bottle, that
kind of information.
It is a broken system. The FDA doesn't have the authority to move
swiftly when there is a threat to public health; it doesn't have the
opportunity to update existing monographs; and there is no incentive
for innovation.
This legislation is decades overdue. I am grateful for the good work
of so many who made it possible. It is a commonsense bill, consumer
group supported, industry stakeholder supported, and of course the FDA
not only supports it but needs it.
I will now yield to my friend and colleague, Senator Johnny Isakson.
Mr. ISAKSON. Madam President, I thank the Senator from Pennsylvania.
If you want to go home on time, if you want to take something home to
give to the American people that they want and they need, then you will
vote with me and the other Members who have spoken on the Over-the-
Counter Monograph bill today.
There are sunscreens on the market in Europe that are 12 years short
of being on the market in America all because of an antiquated approval
system to make sure they are safe but to get them to the market in
time. It is about time we ended melanoma, and it is about time we got
American consumers what they want. It is about time we settle the
problem. It has been a problem for a long time.
So I ask you--in fact, I plead with you--to vote for this bill, and
you will make everybody happy, nobody mad, and you will save a life.
There is nothing better than that.
I yield the floor.
The PRESIDING OFFICER. The Senator from North Carolina.
Mr. BURR. Madam President, I ask unanimous consent to speak for 1
minute in opposition.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
Mr. BURR. Madam President, I reluctantly rise in opposition to this
legislation, and I have worked with Senator Isakson over the years on
FDA legislation.
I want to be perfectly clear that I agree with all of the reforms
that are in this piece of legislation within the over-the-counter
division at FDA. I simply disagree with the way in which this
legislation provides the resources to achieve these reforms because I
don't believe it will result in what the expectations are of the
authors.
When the drug industry first agreed to user fees in 1993, the fee to
file a new drug application was $100,000. Today that fee is $2.1
million. To that end, the FDA has struggled to uphold its end of the
bargain, falling behind in its commitment to hire the number of
employees the agency needs to actually review the applications that
cost millions of dollars to file.
The FDA continues to increase the amount of user fee dollars it
requires to review applications, eroding the balance of congressional
oversight provided by the appropriation of taxpayer dollars.
I encourage my colleagues that what Johnny is trying to do is the
right thing to do, but it is the wrong way to pay for it.
I yield the floor.
The bill was ordered to be engrossed for a third reading and was read
the third time.
The PRESIDING OFFICER. The bill having been read the third time, the
question is, Shall the bill pass?
Mr. CARDIN. Madam President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be a sufficient second.
The clerk will call the roll.
The legislative clerk called the roll.
Mr. DURBIN. I announce that the Senator from Colorado (Mr. Bennet),
the Senator from New Jersey (Mr. Booker), the Senator from California
(Ms. Harris), the Senator from Minnesota (Ms. Klobuchar), the Senator
from Vermont (Mr. Sanders), the Senator from Virginia (Mr. Warner), and
the Senator from Massachusetts (Ms. Warren) are necessarily absent.
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
The result was announced--yeas 91, nays 2, as follows:
[Rollcall Vote No. 389 Leg.]
YEAS--91
Alexander
Baldwin
Barrasso
Blackburn
Blumenthal
Blunt
Boozman
Braun
Brown
Cantwell
Capito
Cardin
Carper
Casey
Cassidy
Collins
Coons
Cornyn
Cortez Masto
Cotton
Cramer
Crapo
Cruz
Daines
Duckworth
Durbin
Enzi
Ernst
Feinstein
Fischer
Gardner
Gillibrand
Graham
Grassley
Hassan
Hawley
Heinrich
Hirono
Hoeven
Hyde-Smith
Inhofe
Isakson
Johnson
Jones
Kaine
Kennedy
King
Lankford
Leahy
Lee
Manchin
Markey
McConnell
McSally
Menendez
Merkley
Moran
Murkowski
Murphy
Murray
Paul
Perdue
Peters
Portman
Reed
Risch
Roberts
Romney
Rosen
Rounds
Rubio
Sasse
Schatz
Schumer
Scott (SC)
Shaheen
Shelby
Sinema
Smith
Stabenow
Sullivan
Tester
Thune
Tillis
Toomey
Udall
Van Hollen
Whitehouse
Wicker
Wyden
Young
NAYS--2
Burr
Scott (FL)
NOT VOTING--7
Bennet
Booker
Harris
Klobuchar
Sanders
Warner
Warren
The bill (S. 2740) was passed, as follows:
S. 2740
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Over-the-
Counter Monograph Safety, Innovation, and Reform Act of
2019''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--OTC DRUG REVIEW
Sec. 101. Regulation of certain nonprescription drugs that are marketed
without an approved drug application.
Sec. 102. Misbranding.
Sec. 103. Drugs excluded from the over-the-counter drug review.
Sec. 104. Treatment of Sunscreen Innovation Act.
Sec. 105. Annual update to Congress on appropriate pediatric indication
for certain OTC cough and cold drugs.
Sec. 106. Technical corrections.
TITLE II--USER FEES
Sec. 201. Short title; finding.
Sec. 202. Fees relating to over-the-counter drugs.
TITLE I--OTC DRUG REVIEW
SEC. 101. 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 section 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 Without an Approved
Application.--Nonprescription drugs marketed without an
approved drug application under section 505, as of the date
of the enactment of this section, shall be treated in
accordance with this subsection.
``(1) Drugs subject to a final monograph; category i drugs
subject to a tentative final monograph.--A drug is deemed to
be
[[Page S6922]]
generally 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 requirements 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 requirements for
nonprescription drugs, and conditions or requirements under
subsections (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 conformity with an order issued under subsection (c), in a
dosage form that, immediately prior to the date of the
enactment of this section, has been used to a material extent
and for a material time under section 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
applicable 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
applicable subsequent determination by the Secretary, the
general requirements for nonprescription drugs, and
conditions or requirements 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 conformity with an order issued under subsection (c), in a
dosage form that, immediately prior to the date of the
enactment of this section, has been used to a material extent
and for a material time under section 201(p)(2).
``(2) Treatment of sunscreen drugs.--With respect to
sunscreen drugs subject to this section, the applicable
requirements in terms of conformity with a final monograph,
for purposes of paragraph (1)(A)(i), shall be the
requirements specified in part 352 of title 21, Code of
Federal Regulations, as published on May 21, 1999, beginning
on page 27687 of volume 64 of the Federal Register, except
that the applicable requirements governing effectiveness and
labeling shall be those specified in section 201.327 of title
21, Code of Federal Regulations.
``(3) Category iii drugs subject to a tentative 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 safety or
effectiveness in the preamble of a proposed rule establishing
a tentative final monograph 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--
``(I) the conditions of use, including indication and
dosage strength, if any, described for such category III drug
in such preamble or in an applicable subsequent proposed
rule;
``(II) the proposed requirements for drugs classified in
such tentative final monograph in category I in the most
recently proposed rule establishing 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 conditions or requirements under subsection (b) or (k);
and
``(iii) in a dosage form that, immediately prior to the
date of the enactment of this section, had been used to a
material extent and for a material time under section
201(p)(2); or
``(B) the drug is--
``(i) classified in category I for safety and effectiveness
under a proposed monograph or advance notice of proposed
rulemaking 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 requirements for
nonprescription use of such proposed monograph or advance
notice of proposed rulemaking, any applicable subsequent
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, immediately prior to the
date of the enactment of this section, has been used to a
material extent and for a material time under section
201(p)(2).
``(4) Category ii drugs deemed new drugs.--A drug that is
classified in category II for safety or effectiveness under a
tentative final monograph or that is subject to a
determination to be not generally recognized as safe and
effective in a proposed rule that is the most recently
applicable proposal 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), and
subject to the requirement for an approved new drug
application under section 505 beginning on the day that is
180 calendar days after the date of the enactment of this
section, unless, before 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), 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 administrative order determining whether there are
conditions under which a specific drug, a class of drugs, or
a combination of drugs, is determined 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 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 subsection;
``(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 effective 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.--
``(A) In general.--In issuing an administrative 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 administrative order by publishing
it on the website of the Food and Drug Administration and
include in such order the reasons for the issuance of such
order; and
``(II) publish a notice of availability of such proposed
order in the Federal Register;
``(iii) except as provided in subparagraph (B), provide for
a public comment period with respect to such proposed order
of not less than 45 calendar days; and
``(iv) if, after completion of the proceedings specified in
clauses (i) through (iii), the Secretary determines that it
is appropriate to issue a final administrative order--
``(I) issue the final administrative order, together with a
detailed statement of reasons, which order shall not take
effect until the time for requesting judicial review under
paragraph (3)(D)(ii) has expired;
``(II) publish a notice of such final administrative order
in the Federal Register;
``(III) afford requestors of drugs that will be subject to
such order the opportunity for formal dispute resolution up
to the level of the Director of the Center for Drug
Evaluation and Research, which initially must be requested
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
``(IV) except with respect to drugs described in paragraph
(3)(B), upon completion of the formal dispute resolution
procedure, inform the persons which sought such dispute
resolution of their right to request a hearing.
``(B) Exceptions.--When issuing an administrative 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 effective 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 calendar days with respect to such
proposed order, except when the Secretary determines, for
good cause, that a shorter period is in the interest of
public health; and
``(iii) any person who submits data in such comment period
shall include a certification that the person has submitted
all evidence created, obtained, or received by that person
that is both within the categories of data identified in the
proposed order and relevant
[[Page S6923]]
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 resolution under subclause (III) of
paragraph (2)(A)(iv) of an administrative order with respect
to a drug may request a hearing concerning 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 administrative record, to the Secretary
not later than 30 calendar days after receiving notice of the
final decision of the formal dispute resolution procedure.
``(B) No hearing required with respect 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 administrative order
involved relates to a drug--
``(I) that is described in subsection (a)(3)(A); and
``(II) with respect to which no human or non-human data
studies relevant 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 subparagraph:
``(I) The term `human data studies' 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 effectiveness.
``(C) Hearing procedures.--
``(i) Denial of request for hearing.--If the Secretary
determines that information submitted in a request for a
hearing under subparagraph (A) with respect to a final
administrative order issued under paragraph (2)(A)(iv) does
not identify the existence of a genuine and substantial
question of material fact, the Secretary 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.
``(ii) Single hearing for multiple related requests.--If
more than one request for a hearing is submitted with respect
to the same administrative order under subparagraph (A), the
Secretary may direct that a single hearing be conducted in
which all persons whose hearing requests were granted may
participate.
``(iii) Presiding officer.--The presiding officer of a
hearing requested under subparagraph (A) shall--
``(I) be designated by the Secretary;
``(II) not be an employee of the Center for Drug Evaluation
and Research; and
``(III) not have been previously involved in the
development of the administrative order involved or
proceedings relating to that administrative order.
``(iv) Rights of parties to hearing.--The parties to a
hearing requested under subparagraph (A) shall have the right
to present testimony, including testimony of expert
witnesses, and to cross-examine witnesses presented by other
parties. Where appropriate, the presiding officer may require
that cross-examination by parties representing substantially
the same interests be consolidated to promote efficiency and
avoid duplication.
``(v) Final decision.--
``(I) At the conclusion of a hearing requested under
subparagraph (A), the presiding officer of the hearing shall
issue a decision containing findings of fact and conclusions
of law. The decision of the presiding officer shall be final.
``(II) The final decision may not take effect until the
period under subparagraph (D)(ii) for submitting a request
for judicial review of such decision expires.
``(D) Judicial review of final administrative order.--
``(i) In general.--The procedures described in section
505(h) shall apply with respect to judicial review of final
administrative orders issued under this subsection 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 administrative order
issued under this subsection 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
``(IV) if no hearing is requested, the date on which the
time for requesting 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 imminent hazard to the
public health, the Secretary, after first making reasonable
efforts to notify, not later than 48 hours before issuance of
such order under this subparagraph, 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
reasons for such order;
``(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 calendar days with respect to such interim final
order.
``(ii) Nondelegation.--The Secretary 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 mitigate 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 interim final
order, the sponsors of drugs who have a listing in effect
under section 510(j) for such drug or combination of drugs;
``(II) after reasonable efforts of notification, issue an
interim final administrative 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 comment period of at least 45
calendar days with respect to such interim final order.
``(ii) Content of order.--An interim final order issued
under this subparagraph 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.
``(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 Federal 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 Center 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 calendar days of the
prior decision.
``(E) Hearings.--A sponsor of a drug subject to a final
order issued under subparagraph (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
respect to a hearing on such order in the same manner and to
the same extent as such provisions apply with respect to a
hearing on an administrative 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 accordance 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 request.--The Secretary shall
specify in an interim final order issued under subparagraph
(A) or (B) such shorter periods for requesting dispute
resolution under subparagraph (D)(iii) as are necessary to
meet the requirements of this subparagraph.
``(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 administrative order under
paragraph (1) at the request of a requestor with respect to
certain drugs, classes of drugs, or combinations of drugs--
``(i) the Secretary shall, after receiving a request under
this subparagraph, determine whether the request is
sufficiently complete and formatted to permit a substantive
review;
``(ii) if the Secretary determines that the request is
sufficiently complete and formatted to permit a substantive
review, the Secretary shall--
``(I) file the request; and
``(II) initiate proceedings with respect to issuing an
administrative order in accordance with paragraphs (2) and
(3); and
``(iii) except as provided in paragraph (6), if the
Secretary determines that a request does not meet the
requirements for filing or is not
[[Page S6924]]
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 request in accordance with paragraph (2)(A).
``(B) Request to initiate proceedings.--
``(i) In general.--A requestor seeking an administrative
order under paragraph (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 Secretary.
Such requestor may submit a request under this subparagraph
for the issuance of an administrative order--
``(I) determining whether a drug is generally recognized as
safe and effective under section 201(p)(1), exempt from
section 503(b)(1), and not required to be the subject of an
approved application under section 505; or
``(II) determining whether a change to a condition of use
of a drug is generally recognized as safe and effective under
section 201(p)(1), exempt from section 503(b)(1), and not
required to be the subject of an approved application under
section 505, if, absent such a changed condition of use, such
drug is--
``(aa) generally recognized as safe and effective under
section 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 conjunction with a
request for the Secretary to determine whether such drug is
generally recognized as safe and effective under section
201(p)(1), which is filed by the Secretary under subparagraph
(A)(ii).
``(ii) Exception.--The Secretary is not required to
complete review of a request 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 effective under section 201(p)(1) under paragraph
(1) and issues a final order announcing that determination.
``(iii) Withdrawal.--The requestor may withdraw a request
under this paragraph, 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 administrative order issued in
response to a request under this section 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 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 market
drugs--
``(I) incorporating changes described 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 contain an active ingredient
(including any ester or salt of the active ingredient) 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
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 sunscreen 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 chapter III of
this Act.
``(iv) Limitations on exclusivity.--
``(I) In general.--Only one 18-month period under this
subparagraph shall be granted, under each order described in
clause (i), with respect to changes (to the drug subject to
such order) which are either--
``(aa) changes described in clause (ii)(I), relating to
active ingredients; or
``(bb) changes described in clause (ii)(II), relating to
conditions of use.
``(II) No exclusivity allowed.--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
efficacy.
``(v) New human data studies defined.--In this
subparagraph, the term `new human data studies' means
clinical trials of safety or effectiveness (including actual
use studies), pharmacokinetics studies, or bioavailability
studies, the results of which--
``(I) have not been relied on by the Secretary to support--
``(aa) a proposed or final determination that a drug
described in subclause (I), (II), or (III) of clause (iii) is
generally recognized as safe and effective under section
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 determination that a drug
described in subclause (I), (II), or (III) of clause (iii) is
generally recognized as safe and effective under section
201(p)(1); or
``(bb) approval of a drug that was approved under section
505.
``(vi) Notification of drug not available for sale.--A
requestor that is granted exclusivity with respect to a drug
under this subparagraph shall notify the Secretary in writing
within 1 year of the issuance of the final administrative
order if the drug that is the subject of such order will not
be available for sale within 1 year of the date of issuance
of such order. The requestor shall include with such notice
the--
``(I) identity of the drug by established name and by
proprietary name, if any;
``(II) strength of the drug;
``(III) date on which the drug will be available for sale,
if known; and
``(IV) reason for not marketing the drug after issuance of
the order.
``(6) Information regarding safe nonprescription marketing
and use as condition for filing a generally recognized as
safe and effective request.--
``(A) In general.--In response to a request 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 request includes
information specified under subparagraph (C) with respect to
safe nonprescription marketing and use of such drug; or
``(ii) if the request fails to include information
specified under subparagraph (C), shall refuse to file such
request and require that nonprescription marketing of the
drug be pursuant to a new drug application as described in
subparagraph (D).
``(B) Drug described.--A drug described in this
subparagraph is a nonprescription drug which contains an
active ingredient not previously incorporated in a drug--
``(i) specified in subsection (a)(1), (a)(2), or (a)(3);
``(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 marketing and use.--Information specified in
this subparagraph, with respect to a request described 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
consumers in the United States as a nonprescription drug
under comparable conditions of use;
``(ii) if the drug has not been previously marketed in the
United States as a nonprescription drug, information
sufficient 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 Secretary in accordance with section
802(b)(1)(B)--
``(I) for such period as needed to provide reasonable
assurances concerning the safe nonprescription use of the
drug; and
``(II) during such time was subject to sufficient
monitoring by a regulatory 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 demonstration that the drug can be safely
marketed and used as a nonprescription drug, such other
information the Secretary determines 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--
``(i) the drug is marketed as a nonprescription drug, under
conditions of use comparable to the conditions specified in
the request, for such period as the Secretary determines
appropriate (not to exceed 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 equivalent quantity as determined by the
Secretary, were distributed for retail sale, as determined in
such manner as the Secretary 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 include requirements for
the packaging of a drug to encourage use in accordance with
labeling. Such requirements may include unit dose packaging,
requirements for products intended for use by pediatric
populations, requirements to reduce risk of harm from
unsupervised ingestion, and other appropriate requirements.
This paragraph does not authorize the Food and Drug
Administration to require standards or testing procedures as
described in part 1700 of title 16, Code of Federal
Regulations.
[[Page S6925]]
``(8) Final and tentative final monographs for category i
drugs deemed final administrative orders.--
``(A) In general.--A final monograph or tentative final
monograph described in subparagraph (B) shall be deemed to be
a final administrative order under this subsection and may be
amended, revoked, or otherwise modified in accordance with
the procedures of this subsection.
``(B) Monographs described.--For purposes 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
``(ii) represents the most recently promulgated version of
such conditions, including as modified, in whole or in part,
by any proposed or final rule.
``(C) Deemed orders include harmonizing technical
amendments.--The deemed establishment of a final
administrative order under subparagraph (A) shall be
construed to include any technical amendments to such order
as the Secretary determines necessary to ensure that such
order is appropriately 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 dosage 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 information as is
necessary to demonstrate that the change--
``(i) will not affect the safety or effectiveness of the
drug; and
``(ii) will not materially affect the extent of absorption
or other exposure to the active ingredient in comparison to a
suitable 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 contained in such records is
not sufficient to demonstrate that the change does not affect
the safety or effectiveness of the drug or materially affect
the extent of absorption or other exposure to the active
ingredient, the Secretary--
``(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 provide additional information.
``(C) Failure to submit sufficient information.--If the
sponsor fails to provide such additional information within a
time prescribed by the Secretary, or if the Secretary
determines 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
reference product,
the drug as modified is a new drug under section 201(p) and
shall be deemed to be misbranded 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 specifying requirements for determining
whether a minor change made by a sponsor pursuant to this
subsection will affect the safety or effectiveness of a drug
or materially affect the extent of absorption or other
exposure to an active ingredient 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 relevant public standards and standard practices for
evaluating the quality of drugs, and may take into account
the special needs of populations, including children.
``(d) Confidentiality of Information Submitted to the
Secretary.--
``(1) In general.--Subject to paragraph (2), any
information, including reports of testing conducted on the
drug or drugs involved, that is submitted 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 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
Secretary) under subsection (b), available to the public upon
such submission.
``(B) Limitations on public availability.--Information
described in subparagraph (A) shall not be made public if--
``(i) the information pertains to pharmaceutical quality
information, unless such information is necessary to
establish standards under which a drug is generally
recognized as safe and effective under section 201(p)(1);
``(ii) the information is submitted in a requestor-
initiated request, but the requestor withdraws such request,
in accordance with withdrawal procedures established by the
Secretary, before the Secretary issues the proposed order;
``(iii) the Secretary requests and obtains 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 calendar days of the date when
the drug is first commercially marketed, except that a
sponsor who was the order requestor 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 information on or before the date when the drug
is first commercially marketed.
``(f) Approvals Under Section 505.--The provisions of this
section shall not be construed to preclude a person from
seeking or maintaining the approval of an application 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 determination under this
section.
``(g) Public Availability of Administrative Orders.--The
Secretary shall establish, maintain, update (as determined
necessary by the Secretary but no less frequently than
annually), and make publicly available, with respect to
orders issued under this section--
``(1) a repository of each final order and interim 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--
``(A) a brief description of each such order; and
``(B) the Secretary's expectations, if resources permit,
for issuance of proposed orders over a 3-year period.
``(h) Development Advice to Sponsors or Requestors.--The
Secretary shall establish procedures under which sponsors or
requestors may meet with appropriate officials of the Food
and Drug Administration to obtain advice on the studies and
other information necessary 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 Requestors.--
The Secretary shall establish procedures to facilitate
efficient participation by multiple sponsors or requestors in
proceedings under this section, including provision for joint
meetings with multiple sponsors or requestors or with
organizations nominated by sponsors or requestors 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 Governing
Nonprescription Drugs.--
``(1) Regulations of general applicability to
nonprescription drugs.--Except as provided in this
subsection, nothing in this section supersedes regulations
establishing general requirements for nonprescription drugs,
including regulations of general applicability contained in
parts 201, 250, and 330 of title 21, Code of Federal
Regulations, 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 requirements for specific
nonprescription drugs.--
``(A) The provisions of section 310.545 of title 21, Code
of Federal Regulations, as in effect on the day before the
date of the enactment of this section, shall be deemed to be
a final order under subsection (b).
``(B) Regulations in effect on the day before the date of
the enactment of this section, establishing requirements for
specific nonprescription drugs marketed pursuant to this
section (including such requirements in parts 201 and 250 of
title 21, Code of Federal Regulations), shall be deemed to be
final orders under subsection (b), only as they apply to
drugs--
``(i) subject to paragraph (1), (2), (3), or (4) of
subsection (a); or
[[Page S6926]]
``(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 technical 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--
``(1) the procedures and principles for formal meetings
between the Secretary and sponsors or requestors for drugs
subject to this section;
``(2) the format and content of data submissions 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 appropriate; and
``(5) for minor changes in drugs, recommendations on how to
comply with the requirements in orders issued under
subsection (c)(3).
``(m) Rule of Construction.--
``(1) In general.--This section shall not affect the
treatment or status of a nonprescription drug--
``(A) that is marketed without an application 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 paragraph (1), (2), (3), (4), or (5) of
subsection (a) do not apply.
``(2) Treatment of products previously found to be subject
to time and extent requirements.--
``(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 subparagraph is a drug
which, prior to the date of the enactment of this section,
the Secretary determined 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 section.
``(B) Nothing in subsection (a) shall be construed to
prohibit the Secretary from issuing an order under this
section finding a drug to be not generally recognized as safe
and effective under section 201(p)(1), as the Secretary
determines 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 requirements of subsection (b) shall
apply with respect to orders issued under this section
instead of the requirements 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
``(B) is or will be subject to an administrative order
under this section of the Food and Drug Administration.
``(3) The term `requestor' refers to any person or group of
persons marketing, manufacturing, processing, 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 Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate
addressing the effectiveness 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
exclusivity 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
recognized as safe and effective;
(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 exclusivity impacted
the requestor's or sponsor's decision 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 development in the nonprescription drug market;
(iii) the impact of such provision on competition in the
nonprescription drug market;
(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 products; and
(vi) whether the administrative orders initiated by
requestors under such section 505G have been sufficient to
encourage the development of nonprescription drug products
that would likely not be otherwise developed, or developed in
as timely a manner; and
(E) whether the administrative orders initiated by
requestors under such section 505G have been sufficient
incentive to encourage innovation 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;
(B) whether, and to what extent, the exclusivity impacted
the requestor's or sponsor's decision to develop the
sunscreen ingredient;
(C) whether, and to what extent, the sunscreen ingredient
granted exclusivity had previously 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 development 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 ingredient sponsors and whether such process 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 initiated by
requestors under such section 586C have been sufficient
incentive to encourage innovation 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 promulgated'' and
inserting ``final order under section 505G''; and
(B) by striking ``and not misbranded''; and
(2) in subparagraph (A), by striking ``regulation in
effect'' and inserting ``regulation or order in effect''.
SEC. 102. 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 approved
under section 505, and does not comply with the requirements
under section 505G.
``(ff) If it is a drug and it was manufactured, prepared,
propagated, compounded, or processed in a facility for which
fees have not been paid as required by section 744M.''.
SEC. 103. 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 nonprescription drug (as
defined in section 505G(q) of the Federal Food, Drug, and
Cosmetic Act, as added by section 101 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 section shall be
construed to preclude or limit the applicability of any other
provision of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT.
(a) Review of Nonprescription Sunscreen Active
Ingredients.--
(1) Applicability of section 505g for pending
submissions.--
(A) In general.--A sponsor of a nonprescription sunscreen
active ingredient or combination of nonprescription sunscreen
active ingredients 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
[[Page S6927]]
written notification to the Secretary of Health and Human
Services within 180 calendar days of the enactment 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 101 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 involved is deemed to be a
request for an order under subsection (b) of section 505G of
the Federal Food, Drug, and Cosmetic Act, as added by section
101 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 notification under
subparagraph (A) is not received by the Secretary of Health
and Human Services within 180 calendar days of the date of
enactment 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 101 of this Act.
(2) Definitions.--In this subsection, the terms
``sponsor'', ``nonprescription'', ``sunscreen active
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.--
(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 amended to read as follows:
``(3) Relationship to orders under section 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 request''; and
(B) by adding at the end the following:
``(B) Confidential meetings.--A sponsor may request one or
more confidential meetings with respect to a proposed
sunscreen order, including a letter deemed to be a proposed
sunscreen order under paragraph (3), to discuss matters
relating to data requirements to support a general
recognition of safety and effectiveness involving
confidential information and public information related to
such proposed sunscreen order, as appropriate. The Secretary
shall convene a confidential meeting with such sponsor in a
reasonable time period. If a sponsor requests more than one
confidential meeting for the same proposed sunscreen order,
the Secretary may refuse to grant an additional confidential
meeting request if the Secretary determines 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 include
sufficient information upon which to base a substantive
discussion. The Secretary shall publish a post-meeting
summary of each confidential meeting under this subparagraph
that does not disclose confidential commercial information 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 Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at
the end the following:
``(f) Exclusivity.--
``(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 subject of such request and
listed under paragraph (5)) for a period of 18 months, to
market a sunscreen ingredient under this section
incorporating changes described in paragraph (2) subject to
the limitations under paragraph (4), beginning on the date
the requestor (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 described in this
paragraph is a change subject to an order specified in
paragraph (1) that permits a sunscreen to contain an active
sunscreen ingredient not previously incorporated in a
marketed sunscreen listed 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 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 introduction into interstate commerce, a list
of licensees, assignees, or successors in interest under
paragraph (1).''.
(4) Sunset provision.--Subchapter I of chapter 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 Act is amended by striking section 586E of
such Act (21 U.S.C. 360fff-5).
(c) Treatment of Authority Regarding Finalization of
Sunscreen Monograph.--
(1) In general.--
(A) Revision of final sunscreen order.--The Secretary of
Health and Human Services (referred to in this subsection as
the ``Secretary'') shall amend and revise the final
administrative 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 represented 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 procedures described in
section 505G(b)(2) of the Federal Food, Drug, and Cosmetic
Act;
(ii) issued in proposed form not later than 18 months after
the date of enactment of this Act; and
(iii) issued by the Secretary at least 1 year prior to the
effective date of the revised order.
(2) Reports.--If a revised sunscreen order issued under
paragraph (1) does not include provisions related to the
effectiveness of various sun protection factor levels, and
does not address all dosage forms known to the Secretary to
be used in sunscreens 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
Senate 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 Extent
Applications.--
(1) In general.--Any application described in section 586F
of the Federal Food, Drug, and Cosmetic 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 enactment 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 101
of this Act, with respect to a drug that was the subject of
an application extinguished under paragraph (1).
SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC
INDICATION FOR CERTAIN OTC COUGH AND COLD
DRUGS.
(a) In General.--Subject to subsection (c), the Secretary
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 Commerce 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 Administration--
(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 101 of this Act.
(b) Cough and Cold Monograph Described.--The cough and cold
monograph described in this subsection consists of the
conditions under which nonprescription drugs containing
antitussive, expectorant, nasal decongestant, or
antihistamine active ingredients (or combinations thereof)
are generally recognized as safe and effective, 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 101 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 Secretary indicates
that the Food and Drug Administration has completed its
evaluation and revised, in a final order, as applicable, the
cough and cold monograph as described in subsection (a)(2).
[[Page S6928]]
SEC. 106. 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 inserting ``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 enactment of the FDA
Reauthorization Act of 2017 (Public Law 115-52).
TITLE II--USER FEES
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Over-
the-Counter Monograph User Fee Act of 2019''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to OTC
monograph drug activities, as set forth in 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 Congressional Record.
SEC. 202. 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 entity that has
a relationship with a second business entity 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.
``(2) The term `contract manufacturing organization
facility' means an OTC monograph drug facility where neither
the owner of such manufacturing facility nor any affiliate of
such owner or facility sells the OTC monograph drug produced
at such facility 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 committees, and costs related to
such officers, employees, and committees and costs related to
contracts with such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer 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
``(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 following activities:
``(A) The activities necessary for review and evaluation of
OTC monographs and OTC monograph order requests, including--
``(i) orders proposing or finalizing applicable conditions
of use for OTC monograph drugs;
``(ii) orders affecting status regarding general
recognition of safety and effectiveness of an OTC monograph
ingredient or combination of ingredients under specified
conditions of use;
``(iii) all OTC monograph drug development and review
activities, including intra-agency collaboration;
``(iv) regulation and policy development activities related
to OTC monograph drugs;
``(v) development of product standards for products subject
to review and evaluation;
``(vi) meetings referred to in section 505G(i);
``(vii) review of labeling prior to issuance of orders
related to OTC monograph drugs or conditions of use; and
``(viii) regulatory science activities related to OTC
monograph drugs.
``(B) Inspections related to OTC monograph drugs.
``(C) Monitoring of clinical and other research conducted
in connection with OTC monograph drugs.
``(D) Safety activities with respect to OTC monograph
drugs, including--
``(i) collecting, developing, and reviewing safety
information on OTC monograph drugs, including adverse event
reports;
``(ii) developing and using improved adverse event data-
collection systems, including information technology systems;
and
``(iii) developing and using improved analytical tools to
assess potential safety risks, including access to external
databases.
``(E) Other activities necessary for implementation of
section 505G.
``(7) The term `OTC monograph order request' means a
request for an order submitted under section 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--
``(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 section 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 monograph drug, if such
changes conform to changes made pursuant to section
505G(c)(3)(A);
``(iv) the standardization of the concentration 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-setting 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 implementation
experience or other factors found appropriate by the
Secretary, characterize any OTC monograph order request as a
Tier 2 OTC monograph order request (including
recharacterizing a request from Tier 1 to Tier 2) and publish
such determination in a proposed order issued pursuant to
section 505G.
``(10)(A) The term `OTC monograph drug facility' means a
foreign or domestic business or other entity that--
``(i) is--
``(I) under one management, either direct or indirect; and
``(II) at one geographic location or address engaged in
manufacturing or processing the finished dosage form of an
OTC monograph drug;
``(ii) includes a finished dosage form manufacturer
facility in a contractual relationship with the sponsor of
one or more OTC monograph 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: production of clinical research supplies,
testing, or placement of outer packaging on packages
containing multiple products, for such purposes as creating
multipacks, when each monograph drug product contained within
the overpackaging 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 paragraph.
``(11) The term `OTC monograph drug meeting' 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 MONOGRAPH FEES.
``(a) Types of Fees.--Beginning with fiscal year 2021, the
Secretary shall assess and collect fees in accordance 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) Facilities that cease activities.--A fee shall not be
assessed under subparagraph (A) if the identified OTC
monograph drug facility--
``(I) has ceased all activities related to OTC monograph
drugs prior to December 31
[[Page S6929]]
of the year immediately preceding the applicable fiscal year;
and
``(II) has updated its registration to reflect such change
under the requirements for drug establishment registration
set forth in section 510.
``(ii) Contract manufacturing organizations.--The amount of
the fee for a contract manufacturing organization facility
shall be equal to two-thirds of the amount of the fee for an
OTC monograph drug facility that is not a contract
manufacturing organization facility.
``(C) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection (c).
``(D) Due date.--
``(i) For first program year.--For fiscal year 2021, the
facility fees required under subparagraph (A) shall be due on
the later of--
``(I) the first business day of June of 2020; or
``(II) 45 calendar days after publication of the Federal
Register notice provided for under subsection (c)(4)(A).
``(ii) Subsequent fiscal years.--For each fiscal year after
fiscal year 2021, the facility fees required under
subparagraph (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 submits 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 inflation 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 inflation 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 requestor 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 labeling 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 monograph order request.--If the Secretary
determines that an OTC monograph request initially
characterized as Tier 1 shall be re-characterized as a Tier 2
OTC monograph order request, and the requestor has paid a
Tier 1 fee in accordance with subparagraph (A)(i), the
Secretary shall refund the requestor the difference between
the Tier 1 and Tier 2 fees determined 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 previously 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
resubmitted or filed over protest.
``(G) Refund of fee if order request withdrawn.--If an
order request is withdrawn 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 Secretary shall have the sole
discretion to refund a fee or a portion of the fee under this
subparagraph. A determination by the Secretary concerning 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 calendar 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 paragraph (1) for such fiscal year.
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2021.--For fiscal year 2021, 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 2021 (as
determined under paragraph (3));
``(B) the dollar amount equal to the operating 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 2022 through 2025, 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 the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if 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 2022.
``(ii) $6,000,000 for fiscal year 2023.
``(iii) $7,000,000 for fiscal year 2024.
``(iv) $3,000,000 for fiscal year 2025.
``(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 2021, $8,000,000; and
``(B) for fiscal years 2022 through 2025, the dollar amount
of the total revenue amount established under this subsection
for the previous 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 subsection (b)(2)(B),
the dollar amount of the inflation adjustment to the annual
base revenue for fiscal year 2022 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 percentage 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
fiscal year 2022 and each subsequent fiscal year shall be
equal to the product of--
``(i) the applicable fee under subsection (a)(2) for the
preceding fiscal year; and
``(ii) the inflation adjustment percentage under
subparagraph (C).
``(C) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a fiscal
year is equal to--
``(i) for each of fiscal years 2022 and 2023, 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 years of the preceding 4 years of available data; and
``(ii) for each of fiscal years 2024 and 2025, the sum of--
``(I) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by the proportion of
personnel compensation and benefits costs to total costs of
OTC monograph 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 years of the preceding 4 years
of available data multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of OTC monograph drug activities for the first 3 years
of the preceding 4 fiscal years.
``(2) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2021 and subsequent
fiscal years, for purposes of subsections (b)(1)(B) and
(b)(2)(C), the Secretary 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 2021;
``(ii) 7 weeks for fiscal year 2022;
``(iii) 10 weeks for fiscal year 2023;
``(iv) 10 weeks for fiscal year 2024; and
``(v) 10 weeks for fiscal year 2025.
``(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
decrease 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 Register notice
under paragraph (4) establishing fee revenue and fees for the
fiscal year involved.
``(3) Additional direct cost adjustment.--The Secretary
shall, in addition to adjustments under paragraphs (1) and
(2),
[[Page S6930]]
further increase the fee revenue and fees for purposes of
subsection (b)(2)(D) by an amount equal to--
``(A) $14,000,000 for fiscal year 2021;
``(B) $7,000,000 for fiscal year 2022;
``(C) $4,000,000 for fiscal year 2023;
``(D) $3,000,000 for fiscal year 2024; and
``(E) $3,000,000 for fiscal year 2025.
``(4) Annual fee setting.--
``(A) Fiscal year 2021.--The Secretary shall, not later
than the second Monday in March of 2020--
``(i) establish OTC monograph drug facility fees for fiscal
year 2021 under subsection (a), based on the revenue amount
for such year under subsection (b) and the adjustments
provided under this subsection; and
``(ii) publish fee revenue, facility fees, and OTC
monograph order requests in the Federal Register.
``(B) Subsequent fiscal years.--The Secretary shall, for
each fiscal year that begins after September 30, 2021, not
later than the second Monday in March that precedes such
fiscal year--
``(i) establish for such fiscal year, based on the revenue
amounts under subsection (b) and the adjustments provided
under this subsection--
``(I) OTC monograph drug facility fees under subsection
(a)(1); and
``(II) OTC monograph order request fees under subsection
(a)(2); and
``(ii) publish such fee revenue amounts, facility fees, and
OTC monograph 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 subsection each year.
Such information shall, for each fiscal year--
``(1) be submitted as part of the requirements for drug
establishment registration set forth in section 510; and
``(2) include for each such facility, at a minimum,
identification of the facility's business operation 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
following:
``(i) The Secretary shall place the facility on a publicly
available arrears list.
``(ii) All OTC monograph drugs manufactured in such a
facility or containing an ingredient manufactured in such a
facility shall be deemed misbranded under section 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 subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year
limitation 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 subparagraph (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 positions in the
Department of Health and Human Services to be engaged in such
activities), only if the Secretary allocates for such purpose
an amount for such fiscal year (excluding amounts from fees
collected under this section) 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 subparagraph.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2021), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2021 through 2025, 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.
``(g) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed 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 construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, 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 REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2021,
and not later than 120 calendar days after the end of each
fiscal year thereafter 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 concerning the
progress of the Food and Drug Administration in achieving the
goals identified in the letters described in section 201(b)
of the Over-the-Counter Monograph 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 2021 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 recommendations to
present to the Congress with respect 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 2025, and for the reauthorization of this part
for such fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce 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 consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed 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 recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2025, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (2), a
summary of the views and comments received under such
paragraph, and any changes made to the recommendations in
response to such views and comments.''.
____________________