Over-the-Counter Drug Safety, Innovation, and Reform Act
This bill amends the Federal Food, Drug, and Cosmetic Act to substantially revise how over-the-counter (OTC) drugs are approved.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2315 Introduced in Senate (IS)]
<DOC>
115th CONGRESS
2d Session
S. 2315
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
January 17, 2018
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
Drug Safety, Innovation, and Reform Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--REGULATION OF NONPRESCRIPTION DRUGS
Sec. 101. Regulation of certain nonprescription drugs that are marketed
without an approved new drug application.
Sec. 102. Misbranding.
Sec. 103. Conforming amendments to the Sunscreen Innovation Act.
Sec. 104. Drugs excluded from over-the-counter review.
Sec. 105. Conforming amendment.
Sec. 106. Annual update to Congress on appropriate pediatric indication
for certain cough and cold monograph drugs.
TITLE II--FEES RELATING TO MONOGRAPH DRUGS
Sec. 201. Short title; findings.
Sec. 202. Authority to access and use fees.
TITLE I--REGULATION OF NONPRESCRIPTION DRUGS
SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED
WITHOUT AN APPROVED NEW DRUG APPLICATION.
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 505F (21 U.S.C. 355g) the following:
``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE
MARKETED WITHOUT AN APPROVED NEW DRUG APPLICATION.
``(a) Definitions.--In this section:
``(1) Nonprescription drug.--The term `nonprescription
drug' means a drug, an active ingredient, or a combination of
active ingredients that is not subject to section 503(b)(1).
``(2) Requestor.--The term `requestor' means a person or
group of persons marketing, manufacturing, processing, or
developing a drug.
``(3) Sponsor.--The term `sponsor' means a person or group
of persons marketing, manufacturing, or processing a drug and
who has a listing in effect under section 510(j) for such drug.
``(b) Monograph Drugs.--
``(1) In general.--With respect to a nonprescription drug
that, on or after the date of enactment of the Over-the-Counter
Drug Safety, Innovation, and Reform Act, is introduced or
delivered for introduction in interstate commerce for which an
approved application under section 505 is not required, the
following shall apply:
``(A) A nonprescription drug is deemed to be
generally recognized as safe and effective within the
meaning of section 201(p)(1) and not a new drug under
section 201(p) if--
``(i)(I) such drug is--
``(aa)(AA) subject to a
final monograph issued under
part 330 of title 21, Code of
Federal Regulations, as of the
date of enactment of the Over-
the-Counter Drug Safety,
Innovation, and Reform Act;
``(BB) in conformity with
the conditions for
nonprescription use of such
monograph and the general
requirements specified for
nonprescription drugs,
including any modifications to
those conditions made under
subsections (c), (d), and (j);
and
``(CC) except as permitted
by an administrative order
issued under subsection (c) or
a minor change in the drug in
conformity with subsection (d),
is in a dosage form that has
been used to a material extent
and for a material time within
the meaning of section
201(p)(2); or
``(bb)(AA) the subject of a
tentative final monograph that
is the most recently applicable
proposal or determination
issued under part 330 of title
21, Code of Federal
Regulations, as of the date of
enactment of the Over-the-
Counter Drug Safety,
Innovation, and Reform Act;
``(BB) classified in
category I for safety and
effectiveness under such
tentative final monograph;
``(CC) in conformity with
the conditions for
nonprescription use of such
tentative final monograph, any
subsequent determination by the
Secretary, and the general
conditions for nonprescription
drugs, including any
modifications of those
conditions under subsections
(c), (d), and (j); and
``(DD) except as permitted
by an administrative order
issued under subsection (c) or
a minor change in the drug in
conformity with subsection (d),
is in a dosage form that has
been used to a material extent
and for a material time within
the meaning of section
201(p)(2); or
``(II) the active ingredient in such drug
is in conformity with--
``(aa) the requirements of a final
administrative order issued under
subsection (c) determining that such
drug under the specific conditions of
use is generally recognized as safe and
effective within the meaning of section
201(p)(1); and
``(bb) the general requirements for
nonprescription drugs, including any
modifications of the requirements under
subsections (c), (d), and (j); and
``(ii) such drug is--
``(I) not classified in Category II
for safety or effectiveness under a
tentative final monograph; or
``(II) determined by the Secretary
to be not safe and effective, in a
final monograph or preamble to a rule
that is the most recently applicable
proposal or determination issued under
part 330 of title 21, Code of Federal
Regulations.
``(B) A nonprescription drug may be introduced into
interstate commerce if such drug is--
``(i)(I) not classified in Category II for
safety or effectiveness under a tentative final
monograph; or
``(II) determined by the Secretary to be
not safe and effective, in a final monograph or
preamble to a rule that is the most recently
applicable proposal or determination issued
under part 330 of title 21, Code of Federal
Regulations; and
``(ii)(I)(aa) the subject of a tentative
final monograph that is the most recently
applicable proposal or determination issued
under part 330 of title 21, Code of Federal
Regulations;
``(bb) classified in category III for
safety or effectiveness in the preamble of a
proposed rule establishing such tentative final
monograph;
``(cc) in conformity with the most recently
proposed or final rule establishing or
proposing conditions of nonprescription use
published in the Federal Register related to
such tentative final monograph and the general
requirements for nonprescription drugs,
including any modifications of those
requirements under subsections (c) and (j); and
``(dd) in a dosage form that has been used
to a material extent and for a material time
within the meaning of section 201(p)(2); or
``(II)(aa) the subject of a proposed
monograph or advance notice of proposed
rulemaking that is the most recently applicable
proposal or determination issued under part 330
of title 21, Code of Federal Regulations;
``(bb) classified in category I for safety
and effectiveness under such proposed monograph
or advance notice of proposed rulemaking;
``(cc) in conformity with the most recently
proposed or final rule establishing or
proposing conditions of nonprescription use
published in the Federal Register related to
such proposed monograph or advance notice of
proposed rulemaking and the general
requirements for nonprescription drugs,
including any modifications of those
requirements under subsections (c) and (j); and
``(dd) in a dosage form that has been used
to a material extent and for a material time
within the meaning of section 201(p)(2).
``(C) A nonprescription drug may be introduced into
interstate commerce if--
``(i) such drug is classified in category
II for safety or effectiveness under a
tentative final monograph, or the Secretary has
determined such drug not to be safe and
effective in a final monograph or preamble to a
rule that is the most recently applicable
proposal or determination issued under part 330
of title 21, Code of Federal Regulations; and
``(ii) the Secretary determines within 6
months of the date of enactment of the Over-
the-Counter Drug Safety, Innovation, and Reform
Act, that it is in the interest of public
health to extend the period during which the
drug may be marketed without an approved new
drug application under section 505.
``(D) A drug that is subject to the final monograph
for sunscreen drug products set forth at part 352 of
title 21, Code of Federal Regulations (as published at
volume 64 page 27687 of the Federal Register), shall
comply with the requirements of that monograph, except
that the testing requirements for effectiveness and the
provisions governing labeling shall be in accordance
with section 201.327 of title 21, Code of Federal
Regulations (as in effect on the date of enactment of
the Over-the-Counter Drug Safety, Innovation, and
Reform Act), or such changes to those requirements as
may be made under subsections (c), (d), and (j).
``(2) New drugs.--A nonprescription drug is a new drug
within the meaning of section 201(p) and subject to the
requirements of section 505 if the drug is--
``(A) not described in subparagraph (A), (B), or
(D) of paragraph (1) and not in conformity with
subsection (d);
``(B) not subject to an administrative final order
pursuant to subsection (c); or
``(C) not a nonprescription sunscreen active
ingredient or combination of ingredients subject to a
final sunscreen order, as defined in section 586(2).
``(3) Monograph drug.--A nonprescription drug that is in
compliance with paragraph (1) shall be referred to in this
section as a `monograph drug'.
``(4) Rules of construction.--
``(A) In general.--This section shall not affect
the treatment or status of a nonprescription drug
subject to section 505--
``(i) that, on the date of enactment of the
Over-the-Counter Drug Safety, Innovation, and
Reform Act, is marketed without an application
approved under section 505; and
``(ii) to which subparagraphs (A), (B),
(C), and (D) of paragraph (1) do not apply.
``(B) Applicability of other provisions.--Nothing
in this paragraph shall be construed to preclude or
limit the applicability of any other provision of this
Act.
``(C) No effect on other authorities.--Nothing in
this subsection 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.
``(c) Administrative Orders.--
``(1) In general.--
``(A) Generally recognized as safe and effective.--
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
requirements under which a specific drug, class of such
drugs, or combination of such drugs is determined to
be, after substantive review of evidence--
``(i) not subject to section 503(b)(1);
``(ii) generally recognized as safe and
effective within the meaning of section
201(p)(1); and
``(iii) not required to be approved under
section 505.
``(B) Not generally recognized as safe and
effective.--The Secretary shall issue an order
determining that a drug is not generally recognized as
safe and effective within the meaning of section
201(p)(1) for the specified requirements if, after
substantive review of evidence, the Secretary
determines that--
``(i) the evidence shows that the drug is
not generally recognized as safe and effective
within the meaning of section 201(p)(1); or
``(ii) the evidence is inadequate to show
that the drug is generally recognized as safe
and effective within the meaning of section
201(p)(1).
``(2) Nonapplication of certain requirements.--The
requirements of subchapter II of chapter 5 of title 5, United
States Code, shall not apply with respect to administrative
orders issued under this section.
``(3) Administrative orders initiated by the secretary;
citizen petitions.--
``(A) In general.--Except as provided in paragraph
(5), in issuing an administrative order under paragraph
(1) on the initiative of the Secretary, the Secretary
shall--
``(i) not later than 2 business days before
issuance of the proposed order, informally
communicate the pending issuance of the order
to sponsors of drugs that will be subject to
such order;
``(ii) after making any such informal
communication--
``(I) issue such a proposed
administrative order by publishing it
on the internet website of the Food and
Drug Administration and include in such
order the reasons for the issuance of
such order; and
``(II) publish 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 satisfying the
requirements of 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, but such
order shall not take effect until the
time for requesting judicial review
under paragraph (4)(D)(ii) has expired;
``(II) publish a notice of
availability of such final
administrative order in the Federal
Register;
``(III) afford requestors of
products 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 shall 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 (4)(B), upon
completion of the formal dispute
resolution procedure, inform the person
or persons which sought such dispute
resolution of their right to request a
hearing.
``(B) Special requirements with respect to certain
monograph drugs.--When issuing an administrative order
under paragraph (1) on the initiative of the Secretary
(except as provided under paragraph (5)) proposing to
determine that a monograph drug described in subsection
(b)(1)(B) is not generally recognized as safe and
effective within the meaning of 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 within the meaning of section
201(p)(1); and
``(II) the format for submissions
by interested persons;
``(ii) the Secretary shall provide for a
public comment period of not 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
within the meaning of section 201(p)(1).
``(C) Citizen petitions.--
``(i) In general.--The Secretary may issue
an administrative order under paragraph (1) in
response to a citizen petition submitted under
section 10.30 of title 21, Code of Federal
Regulations (or any successor regulation),
subject to clause (ii).
``(ii) Effect of petition.--Nothing in
clause (i) shall be construed to provide an
alternative to, or otherwise supplant or
supersede--
``(I) the processes through which a
requestor may seek an administrative
order pursuant to paragraph (6); or
``(II) the fee structure under
section 744L-1(a)(2).
``(4) Hearings; judicial review.--
``(A) In general.--A person who participated in
each level of formal dispute resolution under paragraph
(3)(A)(iv)(III) of an administrative order with respect
to a drug may request a hearing concerning a final
administrative order issued under paragraph (3)(A)(iv)
with respect to such drug. Such person may submit a
request for a hearing, which shall be based solely on
the 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.--The Secretary is not
required to provide notice and an opportunity for a
hearing pursuant to paragraph (3)(A)(iv) if the final
administrative order involved relates to a drug--
``(i) that is described in subclause (I) or
(II) of subsection (b)(1)(B)(i); and
``(ii) with respect to which no data
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
(or, as applicable, since the deeming of such
tentative final monograph as a final
administrative order under paragraph (7)).
``(C) Hearing procedures.--
``(i) Denial of request for hearing.--If
the Secretary determines that a request for a
hearing under subparagraph (A) with respect to
a final administrative order issued under
paragraph (3)(A)(iv), does not establish 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 Secretary
shall appoint a presiding officer of a hearing
requested under subparagraph (A) who--
``(I) is not an employee of the
Center for Drug Evaluation and
Research; and
``(II) has not previously been
involved in the development of the
applicable administrative order or in
the 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.--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. 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) Time 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 a
request for such 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 any
hearing with respect to such order is
denied under subparagraph (C)(i);
``(III) the date on which a final
decision is made following any hearing
with respect to such order under
subparagraph (C)(v); or
``(IV) if no hearing is requested,
the date on which the time for
requesting a hearing expires.
``(5) 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 monograph
drug poses an imminent hazard to the public
health, the Secretary may, after informally
communicating with any sponsor that will be the
subject of such determination, not later than
48 hours before issuance of an order under this
subparagraph--
``(I) issue an interim final
administrative order for such drug or
combination of drugs under paragraph
(1), together with a detailed statement
of the reasons for such order;
``(II) publish in the Federal
Register a notice of availability of
such order; and
``(III) provide for a public
comment period of at least 45 calendar
days after issuance of 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, after informally communicating with any
sponsor that will be the subject of such
determination, not later than 48 hours before
issuance of an order under this subparagraph--
``(I) 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;
``(II) publish in the Federal
Register a notice of availability of
such order; and
``(III) provide for a public
comment period of at least 45 calendar
days after issuance of 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, which date, in the case of an order under
subparagraph (B) that includes changes to the packaging
of the drug, shall not be earlier than the day after
the date on which the comment period described in
subparagraph (B)(i)(III) ends.
``(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 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 initially shall 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.--
``(i) In general.--A sponsor of a drug
subject to a final order issued under
subparagraph (D) who participated in each level
of formal dispute resolution under subparagraph
(D)(iii) may request a hearing on such order.
The provisions of subparagraphs (A), (B), and
(C) of paragraph (4) 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 (3)(A)(iv).
``(ii) References.--For purposes of a
hearing under this subparagraph, the references
in subparagraphs (A), (B), and (C) of paragraph
(4)--
``(I) to `each level of dispute
resolution under paragraph
(3)(A)(iv)(III)' shall be deemed to
mean `each level of formal dispute
resolution under subparagraph
(D)(iii)'; and
``(II) to `final administrative
order issued under paragraph
(3)(A)(iv)' shall be deemed to mean
`final order under subparagraph
(D)(i)'.
``(F) Final order.--Not later than 1 year after the
date on which an interim final order is issued under
subparagraph (A) or (B), the Secretary shall issue a
final order in accordance with paragraph (1) and
complete any required hearing.
``(G) Judicial review.--A final order issued
pursuant to subparagraph (F) shall be subject to
judicial review in accordance with paragraph (4)(D).
``(H) Clarification.--Paragraph (3) shall not apply
to the orders issued under this paragraph.
``(6) Administrative order initiated by request.--
``(A) In general.--In issuing an administrative
order under paragraph (1) at the request of a requestor
or a group of requestors 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) subject to subparagraph (D), 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 (3)
and (4); and
``(iii) except as provided in subparagraph
(D)(v), if the Secretary determines that a
request does not meet the requirements for
filing or is not sufficiently complete or
formatted to permit a substantive review, the
requestor may elect that the Secretary file the
request over protest, and the Secretary shall
initiate proceedings to review the request in
accordance with paragraph (3)(A).
``(B) Request to initiate proceedings.--
``(i) In general.--A requestor seeking an
administrative order 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 within the meaning of 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 or a new
condition of use of a drug is generally
recognized as safe and effective within
the meaning of 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 such drug is--
``(aa) described in
subsection (b)(1)(A); or
``(bb) described in
subsection (b)(1)(B), 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 within the meaning of
section 201(p)(1), which is
filed by the Secretary under
subparagraph (A)(ii)(I).
The Secretary is not required to complete
review of the request for a change described in
subclause (II) if the Secretary determines, in
accordance with subparagraph (D), that there is
an inadequate basis to find the drug is
generally recognized as safe and effective
under paragraph (1) and issues a final order
announcing that determination.
``(ii) Withdrawal of request.--The
requestor may withdraw a request under this
paragraph, according to the procedures
established by the Secretary. Notwithstanding
any other provision of this section, if such
request is withdrawn, the Secretary shall cease
proceedings under this subparagraph.
``(C) Product differentiation.--
``(i) In general.--A final administrative
order issued in response to a request under
this paragraph shall have the effect of
providing the order requestor (or the
licensees, assignees, or successors in interest
of such requestor with respect to the subject
of such order and listed under clause (v)) the
exclusive right, for a period of 2 years, to
market drugs under this section incorporating
changes described in clause (ii), subject to
the limitations under clause (iv), and
beginning on the date the requestor (or any
such licensees, assignees, or successors in
interest of such requestor) may lawfully market
such drugs pursuant to the order.
``(ii) Changes described.--A change
described in this clause is a change subject to
an order specified in clause (i), which--
``(I) permits a drug to contain an
active ingredient not previously
incorporated in a marketed drug listed
in clause (iii); or
``(II) permits a change in the
conditions of use of a drug, for which
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) Marketed drugs.--The marketed drugs
listed in this clause are drugs--
``(I) marketed in accordance with a
final monograph issued under part 330
of title 21, Code of Federal
Regulations (including conditions of
use thereunder), as in effect on the
day before the date of enactment of
this section;
``(II) marketed as category I or
III in accordance with a tentative
final monograph issued under such part
330 (including conditions of use and
any applicable subsequent
determinations thereunder), as so in
effect;
``(III) marketed as category I in
accordance with an advance notice of
proposed rulemaking issued under such
part 330 (including conditions of use
and any applicable subsequent
determinations thereunder), as so in
effect;
``(IV) marketed in accordance with
a final order issued under this
section; or
``(V) described in subsection
(b)(1)(C), other than drugs subject to
an active enforcement action under
section 303.
``(iv) Limitations on product
differentiation.--
``(I) Only one period.--Only one 2-
year period may be granted per drug
under clause (i) with respect to any
change described in clause (ii).
``(II) Exclusions.--No period of
product differentiation under this
subparagraph shall apply to changes to
a drug that are--
``(aa) `Tier 2' changes
described in section
744L(14)(A);
``(bb) safety-related
changes described in section
744L-1(a)(2)(C), required under
paragraph (5), or any other
change the Secretary determines
necessary to ensure safe use;
or
``(cc) changes related to
methods of testing safety or
efficacy.
``(v) Listing of licensees, assignees, or
successors in interest.--The requestors of an
order described in clause (i) shall, as
applicable, submit to the Secretary, at a time
when a finished dosage form subject to such
order is introduced or delivered for
introduction into interstate commerce, a list
of licensees, assignees, or successors in
interest that have the exclusive right
described in such clause.
``(vi) Human data defined.--For purposes of
this subparagraph, the term `human data' means
data from clinical trials of safety or
effectiveness, or pharmacokinetics or
bioavailability studies.
``(D) Information regarding safe nonprescription
marketing and use as a condition for filing a grase
request.--
``(i) In general.--In response to a request
under this paragraph that a drug described in
clause (ii) be generally recognized as safe and
effective, the Secretary--
``(I) may file such request, if the
request includes information specified
under clause (iii) with respect to safe
nonprescription marketing and use of
such drug; or
``(II) if the request fails to
include information specified under
clause (iii), shall refuse to file such
request and may require that
nonprescription marketing of the drug
be pursuant to a new drug application
as described in clause (iv).
``(ii) Drug described.--A drug described in
this clause is a monograph drug that contains
an active ingredient not previously
incorporated in a drug--
``(I) marketed in accordance with a
final monograph issued under part 330
of title 21, Code of Federal
Regulations (including conditions of
use under such part), as in effect on
the day before the date of enactment of
this section;
``(II) marketed as category I in
accordance with a tentative final
monograph issued under part 330 of
title 21, Code of Federal Regulations
(including conditions of use and any
applicable subsequent determinations
under such part), as in effect on the
day before the date of enactment of
this section; or
``(III) marketed in accordance with
a final order issued under this
section.
``(iii) Sufficient information for a
threshold demonstration of nonprescription
marketing and use.--Information specified in
this subparagraph, with respect to a request
described in clause (i)(I), is--
``(I) information sufficient for a
threshold 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 threshold
demonstration that the drug was
marketed and safely used in a foreign
country under conditions of marketing
and use--
``(aa) for such period of
time as needed to provide
reasonable assurances
concerning the safe
nonprescription use of the
drug; and
``(bb) during such period
of time, was subject to
sufficient monitoring by a
regulatory body of any country
listed in section 802(b)(1)(A)
or any country designated by
the Secretary in accordance
with section 802(b)(1)(B); or
``(III) if the Secretary determines
that information described in subclause
(I) or (II) is not needed to provide a
threshold demonstration that the drug
can be safely marketed and used as a
nonprescription drug, other information
the Secretary determines sufficient for
such purposes.
``(iv) Marketing pursuant to new drug
application.--In the case of a request
described in clause (i)(II), the drug subject
to such request may be re-submitted for filing
only if--
``(I) the drug is marketed as a
nonprescription drug, under conditions
of use comparable to the requirements
specified in the request, for such
period of the time as the Secretary
determines appropriate (not to exceed 5
consecutive years) pursuant to an
application approved under section 505;
and
``(II) during such period of time,
1,000,000 retail packages of the drug,
or an equivalent quantity of the active
ingredient or ingredients of such drug
as determined by the Secretary, were
distributed for retail sale, as
determined in such manner as the
Secretary may require.
``(v) Rule of application.--If the
Secretary refuses to file a request under this
subparagraph, the requestor may not file over
protest under subparagraph (A)(iii) unless the
request involves a drug described in section
586(9) as in effect on January 1, 2017.
``(7) Treatment of final and tentative final monographs.--A
final monograph or tentative final monograph establishing
requirements of use for a drug described in subsection (b)(1)
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.
``(8) Packaging.--
``(A) In general.--An administrative order issued
under paragraph (3), (5)(A), or (6) may include
requirements for the packaging of a drug, such as to
promote use in accordance with labeling, unit dose
packaging, or requirements to prevent accidental
overdose or ingestion, misuse, or abuse, including by
pediatric populations. The Secretary shall consider, as
appropriate, any such nonprescription drugs currently
available, and the impact of the removal of such drugs
without such packaging and the changing of such
packaging on patients and manufacturers when
establishing such requirements.
``(B) Effective date.--Requirements for packaging
in an administrative order under paragraph (5)(B) shall
not take effect earlier than the day after the date on
which the comment period under paragraph (5)(B)(i)(III)
ends.
``(C) Clarification.--This paragraph does not
authorize the Secretary to require special packaging or
child-resistant packaging under the Poison Prevention
Packaging Act of 1970.
``(d) Procedure for Minor Changes.--
``(1) In general.--Minor changes in the dosage form of a
drug that is described in clause (i)(I)(aa)(CC) or (ii) of
subsection (b)(1)(A) may be made by a requestor without the
issuance of an administrative order under subsection (c) if--
``(A) the requestor maintains information 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;
``(B) the requestor submits updated drug listing
information for the drug in accordance with the
requirements of section 510(j) within 30 calendar days
of the date on which the drug is first introduced into
interstate commerce with the change; and
``(C) 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.--The requestor shall
submit to the Secretary, under section 704(a)(4),
records requested by the Secretary related to a minor
change within 15 business days of receiving such
request, or such longer period as the Secretary may
provide. Such request shall be specific to a company
and limited to the product and the minor change that
prompted such request. Such request shall be specific
to a company and limited to the product and the minor
change that prompted such request.
``(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 requestor of the
drug in writing; and
``(ii) provide the requestor of the drug
with a reasonable opportunity to provide
additional information.
``(C) Failure to submit sufficient information.--If
the requestor fails to provide such additional
information within the prescribed time, or if the
Secretary determines that such additional information
does not 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 drug as modified is a new
drug within the meaning of section 201(p) and shall be
deemed to be misbranded under section 502(ee).
``(3) Determining whether change will affect safety or
effectiveness.--
``(A) In general.--The Secretary shall issue one or
more administrative orders under subsection (c)
specifying requirements for determining whether a minor
change made by a requestor 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 and special needs of
populations.--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 drug products
and may take into account special needs of populations,
including children.
``(e) Information Submitted by Requestors.--
``(1) Confidential information.--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 administrative order under this section (or any minor
change under subsection (d)) 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 limitations.--The Secretary shall
make available to the public any information (other than
information contained in subject-level data sets, such as those
derived from individual case report forms) submitted by a
requestor in support of a request under subsection (c)(6)(A) as
of the date on which the proposed order is issued unless--
``(A) the information pertains to pharmaceutical
quality, unless such information is necessary to
establish standards under which a drug is generally
recognized as safe and effective within the meaning of
section 201(p)(1);
``(B) the information is submitted in a requestor-
initiated request, but the requestor withdraws such
request before the Secretary issues the proposed order
in accordance with withdrawal procedures established by
the Secretary; or
``(C) the Secretary otherwise obtains the
information under subsection (d).
``(f) Public Availability of Administrative Orders.--The Secretary
shall establish, maintain, update (as the Secretary determines
necessary, but not less frequently than annually), and make available
on the internet website of the Food and Drug Administration--
``(1) a repository of each final administrative order and
interim final order issued under subsection (c) that is in
effect, including the complete text of the administrative
order; and
``(2) a listing of all administrative orders proposed and
under development on the initiative of the Secretary under this
section, including--
``(A) a brief description of the administrative
order; and
``(B) the expectations of the Secretary, for
issuance of proposed administrative orders over a 3-
year period.
``(g) Updates to Drug Listing Information.--A sponsor who makes a
change to a drug other than a change in dosage form, which is in
conformity with the requirements under subparagraph (A) or (B) of
subsection (b)(1), shall not be subject to the requirements of
subsection (c) or (d) with respect to such change, and shall submit
updated drug listing information for the drug in accordance with the
requirements of section 510(j) within 30 calendar days of the date on
which the drug, with the change, is first introduced or delivered for
introduction into interstate commerce.
``(h) Approvals Under Section 505.--This section shall not be
construed to preclude a sponsor of a drug or requestor from seeking or
maintaining the approval of an application for such drug under
subsection (b)(1), (b)(2), or (j) of section 505. A determination under
this section that a drug is not subject to section 503(b)(1), is
generally recognized as safe and effective within the meaning of
section 201(p)(1), and is not a new drug under section 201(p), shall
constitute a finding of safety and effectiveness for purposes of
section 505(b)(2) so that the applicant shall be required to submit
only that information needed to support the modification of the drug
that is subject to the determination under this section.
``(i) Development Advice to Requestors or Sponsors.--
``(1) In general.--The Secretary shall establish procedures
under which requestors may meet with appropriate officials of
the Food and Drug Administration to obtain advice on the
studies and other information necessary to support requests
under this section and other matters relevant to the regulation
of monograph drugs and the development of new monograph drugs
under this section.
``(2) Participation of multiple sponsors.--The Secretary
shall establish procedures to facilitate efficient
participation by multiple requestors in proceedings under this
section, including provision for joint meetings with multiple
requestors or with organizations nominated by requestors to
represent their interests in a proceeding.
``(3) Private meetings with requestors.--The procedures
established under this subsection shall include appropriate
provision for confidential meetings with requestors with
respect to discussion of matters involving confidential
commercial information or trade secrets.
``(j) 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) In general.--Section 310.545 of title 21,
Code of Federal Regulations, as in effect on the date
of enactment of this section, shall be deemed to be
final administrative order under subsection (c).
``(B) Other regulations.--Regulations establishing
requirements for specific nonprescription drugs
marketed pursuant to this section that are in effect on
the day before the date of enactment of this section
(including such requirements in parts 201, 250, and 330
of title 21, Code of Federal Regulations), shall be
deemed to be final administrative orders under
subsection (c) only as such requirements apply to
monograph drugs.
``(C) Effective date period.--Unless withdrawn or
revised by the Secretary, the regulations under title
21 of the Code of Federal Regulations that are
described in subparagraph (B) shall remain in effect
with respect to drugs not subject to subparagraph (A),
(B), (C), or (D) of subsection (b)(1).
``(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
enactment of this Act), or make technical changes to such
regulations to ensure conformity with appropriate terminology
and cross references, to the extent needed to effectuate or
harmonize the provisions of this section. Notwithstanding
subchapter II of chapter 5 of title 5, United States Code, any
such withdrawal or technical amendments shall be made without
public notice and comment and be effective upon publication
through notice in the Federal Register (or upon such date as
specified in such notice).
``(k) Guidance.--
``(1) Issuance.--The Secretary shall issue guidance that
provides--
``(A) the procedures and principles for formal
meetings between the Secretary and sponsors or
requestors for drugs subject to this section;
``(B) the format and content of data submissions to
the Secretary under this section;
``(C) the format of electronic submissions to the
Secretary under this section;
``(D) consolidated proceedings and the procedures
for such proceedings where appropriate; and
``(E) for minor changes in drugs, recommendations
on how to comply with the requirements in
administrative orders issued under subsection (c)(3).
``(l) Electronic Format.--All submissions under this section shall
be in an electronic format specified by the Secretary after providing a
period for public comment.
``(m) Inapplicability of Paperwork Reduction Act.--Chapter 35 of
title 44, United States Code, shall not apply to collections of
information made under this section.''.
SEC. 102. MISBRANDING.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended by inserting after subsection (dd) the following:
``(ee) If it is a nonprescription drug that 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 for which fees under section 744L-1 have
been assessed but have not been paid.''.
SEC. 103. CONFORMING AMENDMENTS TO THE SUNSCREEN INNOVATION ACT.
(a) Review of Nonprescription Ingredients Subject to Sunscreen
Innovation Act.--
(1) Pending sunscreen ingredients.--Nonprescription
sunscreen active ingredients or combinations of sunscreen
active ingredients subject, on the date of enactment of this
Act, to a proposed sunscreen order, as defined in section
586(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff(7)), shall--
(A) continue to be reviewed in accordance with
section 586C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360fff-3); or
(B) be reviewed under section 505G of such Act upon
notification of the Secretary by the sponsor that such
sponsor elects to have such ingredient or combination
of ingredients reviewed under such section 505G, and
such proposed sunscreen order under such section 586C
shall be considered a proposed administrative order
under section 505G(c)(3)(A)(ii) of such Act.
(2) Pending nonsunscreen ingredients.--The sponsor of 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 of Health and Human Services (referred to in
this section as the ``Secretary'') pursuant to section 330.14
of title 21, Code of Federal Regulations (as in effect on the
day before the date of enactment of this Act), shall--
(A) notify the Secretary that the sponsor elects to
withdraw such application; or
(B) notify the Secretary that the sponsor elects
for such ingredient to be considered under section 505G
of the Federal Food, Drug, and Cosmetic Act, and any
proposed order under such section 586F shall be
considered a proposed administrative order under
section 505G(c)(3)(A)(ii) of that Act.
(3) Ingredients submitted after the date of enactment of
section 506g.--Any ingredient that is eligible for review under
section 506G of the Federal Food, Drug, and Cosmetic Act and is
submitted after the date of enactment of this Act shall be
considered under that section.
(b) Meetings Regarding Sunscreen Ingredients.--Section 586C(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is
amended by adding at the end the following:
``(11) Meetings with sponsors.--A sponsor may request an
individual, confidential meeting to discuss the data
requirements to support a general recognition of safety and
effectiveness with respect to the subject of a pending
sunscreen ingredient. The Secretary shall respond within 14
calendar days of the request and schedule such meeting within
45 calendar days, or within such timeline as specified in the
letters described in section 201 of the Over-the-Counter Drug
Safety, Innovation, and Reform Act. If a sponsor requests more
than one confidential meeting for the same request, the
Secretary may refuse to grant an additional confidential
meeting request if the Secretary determines such additional
confidential meeting is not reasonably necessary for the
sponsor to advance its request. The Secretary shall publish a
post-meeting summary on the internet website of the Food and
Drug Administration of any confidential meeting that does not
disclose confidential business information. Such meetings shall
not be required to comply with guidance issued by the Secretary
addressing formal meetings for sponsors of human drug
applications, as defined in section 735.''.
(c) Product Differentiation.--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) Product Differentiation.--
``(1) In general.--A final sunscreen order shall have the
effect of providing 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)) the exclusive right, for a period of 2 years, 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--
``(A) permits a sunscreen to contain an active
ingredient not previously incorporated in a marketed
sunscreen listed in paragraph (3); or
``(B) permits a change in the conditions of use of
a sunscreen ingredient, for which 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.
``(3) Marketed sunscreen.--The marketed sunscreen
ingredients described this paragraph are sunscreen
ingredients--
``(A) marketed in accordance with a final monograph
issued under part 330 of title 21, Code of Federal
Regulations (including conditions of use thereunder),
as in effect on the day before the date of enactment of
this section;
``(B) marketed as category I or III in accordance
with a tentative final monograph issued under such part
330 (including conditions of use and any applicable
subsequent determinations thereunder), as so in effect;
``(C) marketed as category I in accordance with an
advance notice of proposed rulemaking issued under such
part 330 (including conditions of use and any
applicable subsequent determinations thereunder), as so
in effect; or
``(D) marketed in accordance with a final order
issued under this section.
``(4) Limitations on product differentiation.--
``(A) Only one period.--Only one 2-year period may
be granted per ingredient under paragraph (1).
``(B) Exclusions.--No period of product
differentiation under this subparagraph shall apply to
changes to a sunscreen that are--
``(i) `Tier 2' changes described in section
744L(14)(A);
``(ii) safety-related changes described in
section 744L-1(a)(2)(C), required under section
505G(c)(5), or any other change the Secretary
determines necessary to ensure safe use; or
``(iii) changes related to methods of
testing safety or efficacy.
``(5) Listing of licensees, assignees, or successors in
interest.--Requestors shall submit to the Secretary at the time
when a final dosage form subject to such request is introduced
or delivered for introduction into interstate commerce, a list
of licensees, assignees, or successors in interest that have
the exclusive right described in paragraph (1).
``(6) Human data defined.--For purposes of this subsection,
the term `human data' means data from clinical trials of safety
or effectiveness (including actual use studies),
pharmacokinetics, or bioavailability.''.
(d) Sunscreen Innovation Act Amendments.--Section 586C(e) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(e)) is amended
by striking paragraph (3) and inserting the following:
``(3) Relationship to orders under section 505g.--A final
sunscreen order shall be deemed to be a final administrative
order under section 505G and subject to the applicable
provisions under such section 505G, including with respect to
amendment of such order.''.
(e) Preclusion of New Sunscreen Submissions; Option To Transfer
Submissions to OTC Monograph Order Process.--
(1) Sunset.--Beginning on the date of enactment of this
Act, section 586A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360fff-1) shall have no force or effect.
(2) Option to transfer submissions to otc monograph order
process.--
(A) In general.--Any person who submitted a request
described in subparagraph (B) may, at any time prior to
the sunset of subchapter I of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.)
under section 586H of such Act, withdraw such request
from the process under such subchapter and resubmit
such request as an order request under section 505G of
such Act.
(B) Requests.--A request described in this
subparagraph is--
(i) a request under section 586A of the
Federal Food, Drug, and Cosmetic Act submitted
before the date of enactment of this Act; or
(ii) a pending request described in section
586(6).
(f) Treatment of Authority Regarding Finalization of Sunscreen
Monograph.--Section 586E of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360fff-5) is amended to read as follows:
``SEC. 586E. SUNSCREEN ORDER.
``(a) In General.--
``(1) Revision of final sunscreen order.--Not later than
November 26, 2019, the Secretary shall amend and revise the
final administrative order concerning nonprescription sunscreen
(referred to in this section as the `sunscreen order') for
which the substance, prior to the date of enactment of the
Over-the-Counter Drug Safety, Innovation, and Reform Act, was
represented by stayed regulations under part 352 of title 21,
Code of Federal Regulations.
``(2) Issuance of revised sunscreen order; effective
date.--A revised sunscreen order described in paragraph (1)
shall be--
``(A) effective not later than November 26, 2019;
and
``(B) issued by the Secretary at least 30 calendar
days prior to such date.
``(b) Reports.--If a revised sunscreen order issued under
subsection (a) 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, the Secretary shall submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives 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.''.
(g) Sunset of Process Under Sunscreen Innovation Act.--Subchapter I
of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff et seq.), as amended by subsection (f), is further amended by
inserting at the end the following new section:
``SEC. 586H. SUNSET.
``This subchapter shall no longer be effective upon the later of--
``(1) a final determination by the Secretary under this
subchapter with respect to every request described in section
586A(b)(2) (other than any withdrawn requests and requests
resubmitted as order requests under section 505G); or
``(2) the effective date of the revised sunscreen order
described in section 586E(a)(2).''.
SEC. 104. DRUGS EXCLUDED FROM OVER-THE-COUNTER REVIEW.
(a) In General.--Nothing in this Act (or the amendments made by
this Act) shall apply to any nonprescription drug which was excluded by
the Food and Drug Administration from the Over-the-Counter Drug Review
in accordance with the statement set out at 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 provision of
the Federal Food, Drug, and Cosmetic Act.
SEC. 105. 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'' and inserting
``final order''; 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. 106. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC INDICATION
FOR CERTAIN COUGH AND COLD MONOGRAPH DRUGS.
(a) In General.--Not later than one year after the date of
enactment of this Act and annually thereafter, the Secretary of Health
and Human Services (referred to in this section as the ``Secretary'')
shall submit to the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives a 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 administrative order
process under section 505G(b) of the Federal Food, Drug, and
Cosmetic Act, as added by section 101.
(b) Cough and Cold Monograph Described.--The cough and cold
monograph described in this subsection consists of the conditions under
which nonprescription drug products 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 on the day before the date of enactment of
this Act), and included in an administrative order deemed established
under such section 505G(b) of the Federal Food, Drug, and Cosmetic Act.
(c) Duration of Authority.--Subsection (a) shall have no force or
effect beginning on the date on which the Secretary submits a letter
under subsection (a) in which the Secretary indicates that the Food and
Drug Administration has completed its evaluation and revised, in a
final administrative order, as applicable, the cough and cold monograph
in accordance with this section.
TITLE II--FEES RELATING TO MONOGRAPH DRUGS
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This title may be cited as the ``Over-the-Counter
Monograph User Fee Act of 2018''.
(b) Findings.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward the regulation
of monograph drugs under section 505G of the Federal, Food, Drug, and
Cosmetic Act, as set forth in the goals identified for purposes of such
section, 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. AUTHORITY TO ACCESS AND USE FEES.
Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379f et seq.) is amended by adding at the end the
following:
``PART 10--FEES RELATING TO MONOGRAPH DRUGS
``SEC. 744L. DEFINITIONS.
``For purposes of 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 a monograph drug facility where neither the
owner of such manufacturing facility nor any affiliate of such
owner or facility sells such monograph drug produced at such
facility directly to wholesalers, retailers, or consumers in
the United States.
``(3) The term `costs of resources allocated for monograph
drug activities' means the expenses in connection with
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 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 744L-1 and
accounting for resources allocated for monograph drug
activities.
``(4) The term `firm establishment identifier' is the
unique number automatically generated by the Field
Accomplishments and Compliance Tracking System of the Food and
Drug Administration.
``(5) The term `monograph drug' shall have the meaning
given the term under section 505G.
``(6) The term `monograph drug activities' means activities
of the Secretary associated with monograph drug products and
inspection of facilities associated with such products,
including--
``(A) the activities necessary for review and
evaluation of monograph drugs and monograph drug order
requests, including--
``(i) orders proposing or finalizing
applicable requirements of use for monograph
drugs products;
``(ii) orders affecting status regarding
general recognition of safety and effectiveness
of a monograph drug ingredient or combination
of ingredients under specified requirements of
use;
``(iii) all monograph drug development and
review activities, including intra-agency
collaboration;
``(iv) regulation and policy development
activities related to monograph drugs;
``(v) development of product standards for
products subject to review and evaluation;
``(vi) meetings regarding monograph drug
activities;
``(vii) review of labeling prior to
issuance of orders related to monograph drugs
or conditions of use; and
``(viii) regulatory science activities
related to monograph drugs;
``(B) inspections related to monograph drugs;
``(C) monitoring of clinical and other research
conducted in connection with monograph drugs;
``(D) safety activities with respect to monograph
drugs, including--
``(i) collecting, developing, and reviewing
safety information on 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;
and
``(E) other activities necessary for implementation
of section 505G.
``(7)(A) The term `monograph drug facility' means a foreign
or domestic business or other entity--
``(i) that is under one management, either direct
or indirect;
``(ii) at one geographic location or address
engaged in manufacturing or processing a monograph drug
in finished dosage form;
``(iii) includes a finished dosage form
manufacturer facility or an affiliate thereof in a
contractual relationship with a monograph drug
requestor or requestors to manufacture or process
monograph drugs; and
``(iv) does not include a business or other entity
whose only manufacturing or processing activities
relate to--
``(I) production of clinical research
supplies;
``(II) testing; or
``(III) packaging of packaged final dosages
in a manner that does not affect the drug.
``(B) For purposes of subparagraph (A), separate buildings
or locations within close proximity are considered to be at 1
geographic location or address if the activities conducted in
them are--
``(i) closely related to the same business
enterprise;
``(ii) under the supervision of the same local
management; and
``(iii) under a single firm 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 the
definition of a facility under this paragraph 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.
``(8) The term `monograph drug meeting' means any meeting
regarding the content of a proposed monograph drug order
request.
``(9) The term `monograph drug product' means a monograph
drug product that is marketed without an approved new drug
application in accordance with section 505G.
``(10) The term `monograph drug order request' means a
request for an order under section 505G for the issuance of an
administrative order for a change to the monograph drug
product.
``(11) The term `monograph drug requestor' means an entity
submitting a monograph drug order request or a monograph drug
meeting request or any other inquiry relating to a request for
an order or development of a monograph drug order request.
``(12) The term `person' includes an affiliate thereof.
``(13) The term `Tier 1 monograph drug order request' means
any monograph drug order request not determined to be a Tier 2
monograph drug order request.
``(14)(A) The term `Tier 2 monograph drug order request'
means subject to subparagraph (B), a monograph drug order
request for--
``(i) the reordering of existing information in the
drug facts label of a monograph drug product;
``(ii) the addition of information to the other
information section of the drug facts label of a
nonprescription drug product, as limited by part
201.66(c)(7) of title 21, Code of Federal Regulations;
``(iii) modification to the directions for use
section of the drug facts label of a nonprescription
drug product, if such changes conform to changes made
pursuant to section 505G(d);
``(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 part 330.1 of title 21, Code of Federal
Regulations.
``(B) The Secretary may, based on program implementation
experience or other factors found appropriate by the Secretary,
characterize any monograph drug order request as a Tier 2
monograph drug order request (including recategorizing a
request from Tier 1 to Tier 2) and publish such determination
in a proposed order issued pursuant to section 505G(c).
``SEC. 744L-1. AUTHORITY TO ASSESS AND USE MONOGRAPH DRUG FEES.
``(a) Types of Fees.--Beginning with fiscal year 2018, the
Secretary shall assess and collect fees in accordance with this section
as follows:
``(1) Facility fee.--
``(A) In general.--Except as provided in
subparagraph (B), each person that owns a facility
identified as a 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) Exception.--
``(i) In general.--A fee shall not be
assessed under subparagraph (A) if the
identified monograph drug facility has ceased
all activities related to monograph drug
products prior to the publication of the Notice
under subparagraph C and has updated its
registration to reflect such change under the
requirements for drug establishment
registration set forth in section 510.
``(ii) Fee amount.--The amount of the fee
for a contract manufacturing organization
facility shall be equal to two-thirds the
amount of the fee for a monograph drug facility
that is not a contract manufacturing
organization facility.
``(C) Due date.--For each fiscal year, the facility
fees required under subparagraph (A) shall be due on
the later of--
``(i) the first business day of April of
such year; and
``(ii) the first business day after the
date of enactment of an appropriations Act
providing for the collection and obligation of
fees under this section for such year.
``(2) Monograph drug order request fee.--
``(A) In general.--Each person that submits a
monograph drug order request shall be subject to a fee
for a monograph drug order request. The monograph drug
order request fee under paragraph (2) shall be--
``(i) for a Tier 1 monograph drug order
request, $500,000, adjusted for inflation for
the fiscal year (as determined under subsection
(c)(1)); and
``(ii) for a Tier 2 monograph drug order
request other than a Tier 1 request, $100,000
adjusted for inflation for the fiscal year (as
determined under subsection (c)(1)).
``(B) Due date.--The monograph drug order request
fees required under subparagraph (A) shall be due on
the date of submission of the monograph drug order
request.
``(C) Exception for certain safety changes.--A
person who is named as the requestor in a monograph
drug order shall not be subject to a fee under
subparagraph (A) if the Secretary finds that the
monograph drug order request seeks to change the Drug
Facts labeling of a monograph drug product 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 monograph drug product.
``(D) Refund of fee if order request is
recategorized as a tier 2 monograph drug order
request.--If the Secretary determines that a monograph
drug request initially characterized as Tier 1 should
be re-characterized as a Tier 2 monograph drug 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 that is refused for filing.
``(F) Fees for order requests previously refused
for filing or withdrawn before filing.--A monograph
drug 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 paragraph shall not be reviewable.
``(3) Refunds.--
``(A) In general.--Other than refunds under
subparagraphs (D) through (G) of paragraph (2), the
Secretary shall not refund any fee paid under this
subsection, 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 this paragraph, a person shall submit to the
Secretary a written request justifying such return
within 180 calendar days after such fee was paid.
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2018.--For fiscal year 2018, 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 2018
(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 2019 through 2022, 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 2019.
``(ii) $6,000,000 for fiscal year 2020.
``(iii) $7,000,000 for fiscal year 2021.
``(iv) $3,000,000 for fiscal year 2022.
``(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 2018, $8,000,000; and
``(B) for fiscal years 2019 through 2022, 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
2019 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 (B).
``(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this subparagraph
for a fiscal year is equal to--
``(i) for each of fiscal years 2019 through
2020, 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 2021 and
2022, 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 monograph drug
activities (as defined in subsection
(a)) 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
monograph drug activities for the first
3 years of the preceding 4 fiscal
years.
``(2) Operating reserve adjustment.--
``(A) For fiscal year 2018 and subsequent fiscal
years, the Secretary may, in addition to adjustments
under paragraphs (1) and (2), further increase the fee
revenue and fees if such an adjustment is necessary to
provide operating reserves of carryover user fees for
monograph drug activities for the number of weeks
specified in subparagraph (B).
``(B) For each fiscal year the number of weeks of
operating reserves shall be no more than--
``(i) 3 weeks for fiscal year 2018;
``(ii) 7 weeks for fiscal year 2019;
``(iii) 10 weeks for fiscal year 2020;
``(iv) 10 weeks for fiscal year 2021; and
``(v) 10 weeks for fiscal year 2022.
``(C) If, for fiscal years 2019 through 2022, the
Secretary has carryover balances for monograph drug
activities in excess of the number of weeks of such
operating reserves specified in subparagraph B, the
Secretary shall reduce such fee revenue and fees to
provide for not more than the number of weeks of such
operating reserves specified in subparagraph (B)(v).
``(D) 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 (5) 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 by an amount equal to--
``(A) 14,000,000 for fiscal year 2018;
``(B) 7,000,000 for fiscal year 2019;
``(C) 4,000,000 for fiscal year 2020;
``(D) 3,000,000 for fiscal year 2021; and
``(E) 3,000,000 for fiscal year 2022.
``(4) Annual fee setting.--
``(A) Fiscal year 2018.--The Secretary shall, not
later than January 31, 2018--
``(i) establish monograph drug facility
fees for fiscal year 2018 under subsection
(a)(1), based on the revenue amount for such
year under subsection (b) and the adjustments
provided under this subsection; and
``(ii) publish such fee revenue and
facility fees in the Federal Register.
``(B) Subsequent fiscal years.--The Secretary
shall, not later than January 31 of each fiscal year
that begins after September 30, 2018, establish for
each such fiscal year, based on the revenue amounts
under subsection (b) and the adjustments provided under
this subsection--
``(i) monograph drug facility fees under
subsection (a)(1);
``(ii) monograph drug order request fees
under subsection (a)(2); and
``(iii) publish such fee revenue, facility
fees, and monograph drug order request fees in
the Federal Register.
``(d) Identification of Facilities.--Each person that owns a
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
a monograph drug facility.
``(e) Effect of Failure To Pay Fees.--
``(1) In general.--A monograph drug 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 have been
paid.
``(2) Effect on eligibility for meetings.--If a monograph
drug requestor fails to pay a fee assessed under subsection
(a), the requestor shall be considered ineligible for monograph
drug meetings.
``(f) Monograph Drug Facility Fee.--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 Secretary
placing the facility on a publicly available arrears list until such
fee has been paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2)(D), 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 monograph drug
activities.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraphs (C) and
(D), 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
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 collecting
under this section) no less than $12,000,000,
multiplied by the adjustment factor applicable to the
fiscal year involved.
``(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 the monograph drug
activities are not more than 15 percent below the level
specified in such subparagraph.
``(D) Fee collection during first program year.--
Until the date of enactment of an Act making
appropriations and providing for the collection and
obligation of fees under this section through September
30, 2018, for the salaries and expenses account of the
Food and Drug Administration, fees authorized by this
section for fiscal year 2018 may be collected and shall
be credited to such account and remain available until
expended.
``(E) Provision for early payments in subsequent
years.--Payment of fees authorized under this section
for a fiscal year (after fiscal year 2018), 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 2018 through 2022, 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.
``(h) 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.
``(i) 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 monograph drug activities, be reduced to
offset the number of officers, employees, and advisory committees so
engaged.
``SEC. 744L-2. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2018, 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 the Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report concerning the
progress of the Food and Drug Administration in achieving the goals
identified in the letters described in section 201 of the 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 2018 and each subsequent fiscal year for which fees
are collected under this part, the Secretary shall prepare and submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a 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 Congress with respect to the goals described in
subsection (a), and plans for meeting the goals, for monograph
drug activities for the first 5 fiscal years after fiscal year
2022, and for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
``(A) the Committee on Health, Education, Labor,
and Pensions of the Senate;
``(B) the Committee on Energy and Commerce of the
House of Representatives;
``(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, 2022, the Secretary shall transmit to 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 with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 413.
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