‘‘(B) Regulations in effect on the day before 
the date of the enactment of this section, estab-
lishing requirements for specific nonprescription 
drugs marketed pursuant to this section (includ-
ing 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 Sec-
retary shall withdraw regulations establishing final 
monographs and the procedures governing the over- 
the-counter drug review under part 330 and other rel-
evant parts of title 21, Code of Federal Regulations 
(as in effect on the day before the date of the enact-
ment of this section), or make technical changes to 
such regulations to ensure conformity with appro-
priate terminology and cross references. Notwith-
standing subchapter II of chapter 5 of title 5, United 
States Code, any such withdrawal or technical 
changes shall be made without public notice and com-
ment and shall be effective upon publication through 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00050
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
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 re-
questors 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 and the procedures 
for such proceedings where appropriate; and 
‘‘(5) for minor changes in drugs, recommenda-
tions on how to comply with the requirements in or-
ders issued under subsection (c)(3). 
‘‘(m) RULE OF CONSTRUCTION.— 
‘‘(1) IN GENERAL.—This section shall not affect 
the treatment or status of a nonprescription drug— 
‘‘(A) that is marketed without an applica-
tion approved under section 505 as of the date 
of the enactment of this section; 
‘‘(B) that is not subject to an order issued 
under this section; and 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(C) to which paragraphs (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 RE-
QUIREMENTS.— 
‘‘(A) Notwithstanding subsection (a), a drug 
described in subparagraph (B) may only be law-
fully 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 enact-
ment of this section, the Secretary had deter-
mined in a proposed or final rule to be ineligible 
for review under the OTC drug review (as such 
phrase ‘OTC drug review’ was used in section 
330.14 of title 21, Code of Federal Regulations, 
as in effect on the day before the date of the en-
actment of this section). 
‘‘(3) PRESERVATION OF AUTHORITY.— 
‘‘(A) Nothing in paragraph (1) shall be con-
strued to preclude or limit the applicability of 
any other provision of this Act. 
‘‘(B) Nothing in subsection (a) shall be con-
strued to prohibit the Secretary from issuing an 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
order under this section finding a drug to be not 
generally recognized as safe and effective within 
the meaning of section 201(p)(1), as the Sec-
retary 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 require-
ments of subsection (b) shall apply with respect to orders 
issued under this section instead of the requirements of sub-
chapter 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 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(B) is or will be subject to an administra-
tive order of the Food and Drug Administration. 
‘‘(3) The term ‘requestor’ refers to any person or 
group of persons marketing, manufacturing, proc-
essing, or developing a drug.’’. 
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 require-
ments under section 505G. 
‘‘(ff) If it is a drug and it was manufactured, pre-
pared, propagated, compounded, or processed in a facility 
for which fees have not been paid as required by section 
744O.’’. 
SEC. 
103. 
DRUGS 
EXCLUDED 
FROM 
THE 
OVER-THE- 
COUNTER DRUG REVIEW. 
(a) IN GENERAL.—Nothing in this Act (or the amend-
ments made by this Act) shall apply to any nonprescription 
drug which was excluded by the Food and Drug Adminis-
tration from the Over-the-Counter Drug Review in accord-
ance with the statement set out at page 9466 of volume 37 
of the Federal Register, published on May 11, 1972. 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
(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 Cos-
metic Act (21 U.S.C. 301 et seq.). 
SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT. 
(a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC-
TIVE INGREDIENTS.— 
(1) APPLICABILITY OF SECTION 505G FOR PEND-
ING SUBMISSIONS.— 
(A) IN
GENERAL.—A sponsor of a non-
prescription sunscreen active ingredient or com-
bination of nonprescription sunscreen active in-
gredients that, as of the date of enactment of this 
Act, is subject to a proposed sunscreen order 
under section 586C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360fff–3) may elect, 
by means of giving written 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 sec-
tion 101 of this Act. 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
(B) ELECTION EXERCISED.—Upon receipt 
by the Secretary of Health and Human Services 
of a timely notification under subparagraph 
(A)— 
(i) the proposed sunscreen order in-
volved is deemed to be a request for an order 
under subsection (b) of section 505G of the 
Federal Food, Drug, and Cosmetic 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.—A sponsor 
of a nonprescription sunscreen active ingredient 
or combination of nonprescription sunscreen ac-
tive ingredients described in subparagraph (A) 
that does not elect for such ingredient or com-
bination of ingredients to be reviewed under sec-
tion 505G of the Federal Food, Drug, and Cos-
metic Act, as added by section 101 of this Act, 
shall continue to have such ingredient or com-
bination of ingredients reviewed in accordance 
with section 586C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360fff–3) and may 
not subsequently elect to transition into the re-
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
view of such ingredient or combination of ingre-
dients pursuant to the process set out in section 
505G of such Act, as added by section 101 of this 
Act. 
(2) DEFINITIONS.—In this subsection, the terms 
‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen active in-
gredient’’, 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 re-
quest’’; and 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
(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, in-
cluding a letter deemed to be a proposed sun-
screen order under paragraph (3), to discuss 
matters involving confidential commercial infor-
mation or trade secrets. The Secretary shall con-
vene 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 meet-
ing 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 confiden-
tial meeting fails to include sufficient informa-
tion upon which to base a substantive discussion. 
The Secretary shall publish a post-meeting sum-
mary of each confidential meeting under this 
subparagraph that does not disclose confidential 
commercial information or trade secrets.’’. 
(3) SUNSET PROVISION.—Subchapter I of chap-
ter V of the Federal Food, Drug, and Cosmetic Act 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
(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.’’. 
(4) TREATMENT OF FINAL SUNSCREEN ORDER.— 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by striking section 586E of such Act (21 U.S.C. 
360fff–5). 
(c) TREATMENT OF NON-SUNSCREEN TIME AND EX-
TENT 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 of Health and Human Services pursuant to 
section 330.14 of title 21, Code of Federal Regula-
tions, 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 Cos-
metic Act, as added by section 101 of this Act, with 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
respect to a drug that was the subject of an applica-
tion 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 Sec-
retary of Health and Human Services shall, beginning not 
later than one year after the date of enactment of this Act, 
annually submit to the Committee on Energy and Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate 
a letter describing the progress of the Food and Drug Ad-
ministration— 
(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 con-
sists of the conditions under which nonprescription drugs 
containing antitussive, expectorant, nasal decongestant, or 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
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 Cos-
metic 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 indi-
cates 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). 
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 2018’’. 
(b) FINDING.—The Congress finds that the fees author-
ized 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 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00061
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
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. 744N. 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 organiza-
tion facility’ means an OTC monograph drug facility 
where neither the owner of such manufacturing facil-
ity nor any affiliate of such owner or facility sells the 
OTC monograph drug produced at such facility di-
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00062
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
rectly 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 com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific equip-
ment, and other necessary materials and sup-
plies; and 
‘‘(D) collecting fees under section 744O and 
accounting for resources allocated for OTC mono-
graph drug activities. 
‘‘(4) The term ‘FDA establishment identifier’ is 
the unique number automatically generated by Food 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00063
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
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 associ-
ated with such products, including the following ac-
tivities: 
‘‘(A) The activities necessary for review and 
evaluation of OTC monographs and OTC mono-
graph order requests, including— 
‘‘(i) orders proposing or finalizing ap-
plicable conditions of use for OTC mono-
graph drugs; 
‘‘(ii) orders affecting status regarding 
general recognition of safety and effective-
ness of an OTC monograph ingredient or 
combination of ingredients under specified 
conditions of use; 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00064
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(iii) all OTC monograph drug devel-
opment and review activities, including 
intraagency collaboration; 
‘‘(iv) regulation and policy develop-
ment activities related to OTC monograph 
drugs; 
‘‘(v) development of product standards 
for products subject to review and evalua-
tion; 
‘‘(vi) meetings referred to in section 
505G(i); 
‘‘(vii) review of labeling prior to 
issuance of orders related to OTC mono-
graph drugs or conditions of use; and 
‘‘(viii) regulatory science activities re-
lated to OTC monograph drugs. 
‘‘(B) Inspections related to OTC monograph 
drugs. 
‘‘(C) Monitoring of clinical and other re-
search conducted in connection with OTC mono-
graph drugs. 
‘‘(D) Safety activities with respect to OTC 
monograph drugs, including— 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00065
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(i) collecting, developing, and review-
ing safety information on OTC monograph 
drugs, including adverse event reports; 
‘‘(ii) developing and using improved 
adverse event data-collection systems, in-
cluding information technology systems; 
and 
‘‘(iii) developing and using improved 
analytical tools to assess potential safety 
risks, including access to external databases. 
‘‘(E) Other activities necessary for imple-
mentation of section 505G. 
‘‘(7) The term ‘OTC monograph order request’ 
means a request for an order submitted under section 
505G(b)(5). 
‘‘(8) The term ‘Tier 1 OTC monograph order re-
quest’ means any OTC monograph order request not 
determined to be a Tier 2 OTC monograph order re-
quest. 
‘‘(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; 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00066
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
tion in a proposed order issued pursuant to section 
505G. 
‘‘(10)(A) The term ‘OTC monograph drug facil-
ity’ means a foreign or domestic business or other en-
tity that— 
‘‘(i) is— 
‘‘(I) under one management, either di-
rect or indirect; and 
‘‘(II) at one geographic location or ad-
dress engaged in manufacturing or proc-
essing the finished dosage form of an OTC 
monograph drug; 
‘‘(ii) includes a finished dosage form manu-
facturer 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: pro-
duction of clinical research supplies, or testing. 
‘‘(B) For purposes of subparagraph (A)(i)(II), 
separate buildings or locations within close proximity 
are considered to be at one geographic location or ad-
dress if the activities conducted in such buildings or 
locations are— 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00068
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(i) closely related to the same business en-
terprise; 
‘‘(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 cri-
teria specified in subparagraph (A), but for being 
under multiple management, the business or other en-
tity 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 pro-
posed 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. 744O. AUTHORITY TO ASSESS AND USE OTC MONO-
GRAPH FEES. 
‘‘(a) TYPES OF FEES.—Beginning with fiscal year 
2019, the Secretary shall assess and collect fees in accord-
ance with this section as follows: 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00069
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(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 fa-
cility as determined under subsection (c). 
‘‘(B) EXCEPTIONS.— 
‘‘(i) A fee shall not be assessed under 
subparagraph (A) if the identified OTC 
monograph drug facility has ceased all ac-
tivities related to OTC monograph drugs 
prior to the date specified in subparagraph 
(D)(ii) and has updated its registration to 
reflect such change under the requirements 
for drug establishment registration set forth 
in section 510. 
‘‘(ii) The amount of the fee for a con-
tract manufacturing organization facility 
shall be equal to 2⁄3 the amount of the fee for 
an OTC monograph drug facility that is 
not a contract manufacturing organization 
facility. 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00070
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(C) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (c). 
‘‘(D) DUE DATE.— 
‘‘(i) FOR FIRST PROGRAM YEAR.—For 
fiscal year 2019, the facility fees required 
under subparagraph (A) shall be due 45 cal-
endar days after publication of the Federal 
Register notice provided for under sub-
section (c)(4)(A). 
‘‘(ii) SUBSEQUENT
FISCAL
YEARS.— 
For each fiscal year after fiscal year 2019, 
the facility fees required under subpara-
graph (A) shall be due on the later of— 
‘‘(I) the first business day of June 
of such year; or 
‘‘(II) the first business day after 
the enactment of an appropriations 
Act providing for the collection and ob-
ligation of fees under this section for 
such year. 
‘‘(2) OTC MONOGRAPH ORDER REQUEST FEE.— 
‘‘(A) IN GENERAL.—Each person that sub-
mits an OTC monograph order request shall be 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00071
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
subject to a fee for an OTC monograph order re-
quest. The amount of such fee shall be— 
‘‘(i) for a Tier 1 OTC monograph 
order request, $500,000, adjusted for infla-
tion for the fiscal year (as determined under 
subsection (c)(1)(B)); and 
‘‘(ii) for a Tier 2 OTC monograph 
order request, $100,000 adjusted for infla-
tion for the fiscal year (as determined under 
subsection (c)(1)(B)). 
‘‘(B) DUE
DATE.—The OTC monograph 
order request fees required under subparagraph 
(A) shall be due on the date of submission of the 
OTC monograph order request. 
‘‘(C) EXCEPTION
FOR
CERTAIN
SAFETY 
CHANGES.—A person who is named as the re-
questor in an OTC monograph order shall not be 
subject to a fee under subparagraph (A) if the 
Secretary finds that the OTC monograph order 
request seeks to change the drug facts labeling of 
an OTC monograph drug in a way that would 
add to or strengthen— 
‘‘(i) a contraindication, warning, or 
precaution; 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00072
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(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
OTC
MONO-
GRAPH ORDER REQUEST.—If the Secretary deter-
mines 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 re-
fund the requestor the difference between the Tier 
1 and Tier 2 fees determined under subpara-
graphs (A)(i) and (A)(ii), respectively. 
‘‘(E) REFUND OF FEE IF ORDER REQUEST 
REFUSED FOR FILING OR WITHDRAWN BEFORE 
FILING.—The Secretary shall refund 75 percent 
of the fee paid under subparagraph (B) for any 
order request which is refused for filing or was 
withdrawn before being accepted or refused for 
filing. 
‘‘(F) FEES
FOR
ORDER
REQUESTS
PRE-
VIOUSLY REFUSED FOR FILING OR WITHDRAWN 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00073
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
been paid in error under paragraph (1) or (2), 
a person shall submit to the Secretary a written 
request justifying such return within 180 cal-
endar days after such fee was paid. 
‘‘(4) NOTICE.—Within the timeframe specified in 
subsection (c), the Secretary shall publish in the Fed-
eral Register the amount of the fees under paragraph 
(1) for such fiscal year. 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) FISCAL YEAR 2019.—For fiscal year 2019, 
fees under subsection (a)(1) shall be established to 
generate a total facility fee revenue amount equal to 
the sum of— 
‘‘(A) the annual base revenue for fiscal year 
2019 (as determined under paragraph (3); 
‘‘(B) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(2)); and 
‘‘(C) additional direct cost adjustments (as 
determined under subsection (c)(3)). 
‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 
the fiscal years 2020 through 2023, fees under sub-
section (a)(1) shall be established to generate a total 
facility fee revenue amount equal to the sum of— 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00075
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
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 fis-
cal year as follows: 
‘‘(i) $7,000,000 for fiscal year 2020. 
‘‘(ii) $6,000,000 for fiscal year 2021. 
‘‘(iii) $7,000,000 for fiscal year 2022. 
‘‘(iv) $3,000,000 for fiscal year 2023. 
‘‘(3) ANNUAL BASE REVENUE.—For purposes of 
paragraphs (1)(A) and (2)(A), the dollar amount of 
the annual base revenue for a fiscal year shall be— 
‘‘(A) for fiscal year 2019, $8,000,000; and 
‘‘(B) for fiscal years 2020 through 2023, the 
dollar amount of the total revenue amount estab-
lished under this subsection for the previous fis-
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00076
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
under this subparagraph for a fiscal year is 
equal to— 
‘‘(i) for each of fiscal years 2020 and 
2021, the average annual percent change 
that occurred in the Consumer Price Index 
for urban consumers (Washington-Balti-
more, DC–MD–VA–WV; Not Seasonally Ad-
justed; All items; Annual Index) for the first 
3 years of the preceding 4 years of available 
data; and 
‘‘(ii) for each of fiscal years 2022 and 
2023, the sum of— 
‘‘(I) the average annual percent 
change in the cost, per full-time equiv-
alent position of the Food and Drug 
Administration, of all personnel com-
pensation and benefits paid with re-
spect to such positions for the first 3 
years of the preceding 4 fiscal years, 
multiplied by the proportion of per-
sonnel compensation and benefits costs 
to total costs of OTC monograph drug 
activities for the first 3 years of the 
preceding 4 fiscal years; and 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00078
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(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 avail-
able data multiplied by the proportion 
of all costs other than personnel com-
pensation and benefits costs to total 
costs of OTC monograph drug activi-
ties for the first 3 years of the pre-
ceding 4 fiscal years. 
‘‘(2) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2019 
and subsequent fiscal years, for purposes of sub-
sections (b)(1)(B) and (b)(2)(C), the Secretary 
may, in addition to adjustments under para-
graph (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— 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00079
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(i) 3 weeks for fiscal year 2019; 
‘‘(ii) 7 weeks for fiscal year 2020; 
‘‘(iii) 10 weeks for fiscal year 2021; 
‘‘(iv) 10 weeks for fiscal year 2022; 
and 
‘‘(v) 10 weeks for fiscal year 2023. 
‘‘(C) DECREASE.—If the Secretary has car-
ryover balances for such process in excess of 10 
weeks of the operating reserves referred to in sub-
paragraph (A), the Secretary shall decrease the 
fee revenue and fees referred to in such subpara-
graph 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 de-
crease (as applicable) in fee revenue and fees 
shall be contained in the annual Federal Reg-
ister notice under paragraph (4) establishing fee 
revenue and fees for the fiscal year involved. 
‘‘(3) ADDITIONAL DIRECT COST ADJUSTMENT.— 
The Secretary shall, in addition to adjustments under 
paragraphs (1) and (2), further increase the fee rev-
enue and fees for purposes of subsection (b)(2)(D) by 
an amount equal to— 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00080
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(A) $14,000,000 for fiscal year 2019; 
‘‘(B) $7,000,000 for fiscal year 2020; 
‘‘(C) $4,000,000 for fiscal year 2021; 
‘‘(D) $3,000,000 for fiscal year 2022; and 
‘‘(E) $3,000,000 for fiscal year 2023. 
‘‘(4) ANNUAL FEE SETTING.— 
‘‘(A) FISCAL
YEAR
2019.—The Secretary 
shall, not later than January 31, 2019— 
‘‘(i) establish OTC monograph drug fa-
cility fees for fiscal year 2019 under sub-
section (a), based on the revenue amount for 
such year under subsection (b) and the ad-
justments 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, not later than January 31 of 
each fiscal year that begins after September 30, 
2019, establish for each 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); 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00081
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(ii) OTC monograph order request 
fees under subsection (a)(2); and 
‘‘(iii) 
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 sub-
section each year. Such information shall, for each fiscal 
year— 
‘‘(1) be submitted as part of the requirements for 
drug establishment registration set forth in section 
510; and 
‘‘(2) include for each such facility, at a min-
imum, identification of the facility’s business oper-
ation as that of an OTC monograph drug facility. 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) OTC MONOGRAPH DRUG FACILITY FEE.— 
‘‘(A) IN GENERAL.—Failure to pay the fee 
under subsection (a)(1) within 20 calendar days 
of the due date as specified in subparagraph (D) 
of such subsection shall result in the following: 
‘‘(i) The Secretary shall place the facil-
ity on a publicly available arrears list. 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00082
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(ii) All OTC monograph drugs manu-
factured in such a facility or containing an 
ingredient manufactured in such a facility 
shall be deemed misbranded under section 
502(a). 
‘‘(B) APPLICATION
OF
PENALTIES.—The 
penalties under this paragraph shall apply until 
the fee established by subsection (a)(1) is paid. 
‘‘(2) ORDER REQUESTS.—An OTC monograph 
order request submitted by a person subject to fees 
under subsection (a) shall be considered incomplete 
and shall not be accepted for filing by the Secretary 
until all fees owed by such person under this section 
have been paid. 
‘‘(3) MEETINGS.—A person subject to fees under 
this section shall be considered ineligible for OTC 
monograph drug meetings until all such fees owed by 
such person have been paid. 
‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00083
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries and 
expenses with such fiscal year limitation. The sums 
transferred shall be available solely for OTC mono-
graph drug activities. 
‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C), the fees authorized by this section 
shall be collected and available in each fiscal 
year in an amount not to exceed the amount 
specified in appropriation Acts, or otherwise 
made available for obligation, for such fiscal 
year. 
‘‘(B) USE OF FEES AND LIMITATION.—The 
fees authorized by this section shall be available 
to defray increases in the costs of the resources 
allocated for OTC monograph drug activities 
(including increases in such costs for an addi-
tional number of full-time equivalent positions 
in the Department of Health and Human Serv-
ices 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 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00084
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
$12,000,000, multiplied by the adjustment factor 
applicable to the fiscal year involved under sub-
section (c)(1). 
‘‘(C) COMPLIANCE.—The Secretary shall be 
considered to have met the requirements of sub-
paragraph (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 subpara-
graph. 
‘‘(D) PROVISION FOR EARLY PAYMENTS IN 
SUBSEQUENT YEARS.—Payment of fees author-
ized under this section for a fiscal year (after fis-
cal year 2019), prior to the due date for such 
fees, may be accepted by the Secretary in accord-
ance with authority provided in advance in a 
prior year appropriations Act. 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 
each of the fiscal years 2019 through 2023, there is 
authorized to be appropriated for fees under this sec-
tion an amount equal to the total amount of fees as-
sessed 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 as-
sessed under subsection (a) within 30 calendar days after 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00085
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
it is due, such fee shall be treated as a claim of the United 
States Government subject to subchapter II of chapter 37 
of title 31, United States Code. 
‘‘(h) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in OTC monograph drug activities, be reduced to 
offset the number of officers, employees, and advisory com-
mittees so engaged. 
‘‘SEC. 744P. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2019, and not later than 120 calendar days after the 
end of each fiscal year thereafter for which fees are 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 2018 during such fiscal year and the future 
plans of the Food and Drug Administration for meeting 
such goals. 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00086
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(b) FISCAL REPORT.—Not later than 120 calendar 
days after the end of fiscal year 2019 and each subsequent 
fiscal year for which fees are collected under this part, the 
Secretary shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pensions 
of the Senate a report on the implementation of the author-
ity for such fees during such fiscal year and the use, by 
the Food and Drug Administration, of the fees collected for 
such fiscal year. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make 
the reports required under subsections (a) and (b) available 
to the public on the Internet website of the Food and Drug 
Administration. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with 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 2023, and 
for the reauthorization of this part for such fiscal 
years, the Secretary shall consult with— 
‘‘(A) the Committee on Energy and Com-
merce of the House of Representatives; 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00087
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— 
After negotiations with the regulated industry, the 
Secretary shall— 
‘‘(A) present the recommendations developed 
under paragraph (1) to the congressional com-
mittees 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 recommenda-
tions as necessary. 
VerDate Sep 11 2014 
22:29 Jul 16, 2018
Jkt 079200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6203
E:\BILLS\H5333.RH
H5333
tkelley on DSKBCP9HB2PROD with BILLS