Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019
This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.
The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.
The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.
The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.
The FDA must establish a user fee program for OTC drugs.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2740 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 30, 2019
Mr. Isakson (for himself and Mr. Casey) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
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.
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
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
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 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.
``(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
``(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 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).
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 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),
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.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.
Passed/agreed to in Senate: Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389.(consideration: CR S6921-6930; text: CR S6921-6930)
Roll Call #389 (Senate)Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
Roll Call #389 (Senate)Message on Senate action sent to the House.
Received in the House.
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Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.