‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC-
TION 505G.—A final sunscreen order shall be deemed 
to be a final order under section 505G.’’. 
(2) MEETINGS.—Paragraph (7) of section 
586C(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360fff–3(b)) is amended— 
(A) by striking ‘‘A sponsor may request’’ 
and inserting the following: 
‘‘(A) IN
GENERAL.—A sponsor may re-
quest’’; and 
(B) by adding at the end the following: 
‘‘(B) CONFIDENTIAL MEETINGS.—A spon-
sor may request one or more confidential meet-
ings with respect to a proposed sunscreen order, 
including a letter deemed to be a proposed sun-
screen order under paragraph (3), to discuss 
matters involving confidential commercial infor-
mation or trade secrets. The Secretary shall 
convene a confidential meeting with such spon-
sor in a reasonable time period. If a sponsor re-
quests more than one confidential meeting for 
the same proposed sunscreen order, the Sec-
retary may refuse to grant an additional con-
fidential meeting request if the Secretary deter-
mines that such additional confidential meeting
is not reasonably necessary for the sponsor to 
advance its proposed sunscreen order, or if the 
request for a confidential meeting fails to in-
clude sufficient information upon which to base 
a substantive discussion. The Secretary shall 
publish a post-meeting summary of each con-
fidential meeting under this subparagraph that 
does not disclose confidential commercial infor-
mation or trade secrets.’’. 
(3) SUNSET PROVISION.—Subchapter I of chap-
ter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 586H. SUNSET. 
‘‘This subchapter shall cease to be effective at the end 
of fiscal year 2022.’’. 
(4) 
TREATMENT
OF
FINAL
SUNSCREEN 
ORDER.—The Federal Food, Drug, and Cosmetic 
Act is amended by striking section 586E of such Act 
(21 U.S.C. 360fff–5). 
(c) TREATMENT OF NON-SUNSCREEN TIME AND EX-
TENT APPLICATIONS.— 
(1) IN GENERAL.—Any application described in 
section 586F of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360fff–6) that was submitted
to the Secretary of Health and Human Services pur-
suant to section 330.14 of title 21, Code of Federal 
Regulations, as such provisions were in effect imme-
diately prior to the date of enactment date of this 
Act, shall be extinguished as of such date of enact-
ment, subject to paragraph (2). 
(2) ORDER REQUEST.—Nothing in paragraph 
(1) precludes the submission of an order request 
under section 505G(b) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 101 of this 
Act, with respect to a drug that was the subject of 
an application extinguished under paragraph (1). 
SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPRO-
PRIATE PEDIATRIC INDICATION FOR CER-
TAIN OTC COUGH AND COLD DRUGS. 
(a) IN GENERAL.—Subject to subsection (c), the Sec-
retary of Health and Human Services shall, beginning not 
later than 1 year after the date of enactment of this Act, 
annually submit to the Committee on Energy and Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate 
a letter describing the progress of the Food and Drug Ad-
ministration—
(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 sub-
section consists of the conditions under which nonprescrip-
tion drugs containing antitussive, expectorant, nasal de-
congestant, or antihistamine active ingredients (or com-
binations thereof) are generally recognized as safe and ef-
fective, as specified in part 341 of title 21, Code of Federal 
Regulations (as in effect immediately prior to the date of 
enactment of this Act), and included in an order deemed 
to be established under section 505G(b) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 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 Sec-
retary indicates that the Food and Drug Administration
has completed its evaluation and revised, in a final order, 
as applicable, the cough and cold monograph as described 
in subsection (a)(2). 
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 au-
thorized by the amendments made in this title will be dedi-
cated to OTC monograph drug activities, as set forth in 
the goals identified for purposes of part 10 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional 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 enti-
ty that has a relationship with a second business en-
tity if, directly or indirectly— 
‘‘(A) one business entity controls, or has 
the power to control, the other business entity; 
or 
‘‘(B) a third party controls, or has power 
to control, both of the business entities. 
‘‘(2) The term ‘contract manufacturing organi-
zation facility’ means an OTC monograph drug facil-
ity where neither the owner of such manufacturing 
facility nor any affiliate of such owner or facility 
sells the OTC monograph drug produced at such fa-
cility directly to wholesalers, retailers, or consumers 
in the United States. 
‘‘(3) The term ‘costs of resources allocated for 
OTC monograph drug activities’ means the expenses 
in connection with OTC monograph drug activities 
for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees and costs related to 
contracts with such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(D) collecting fees under section 744O 
and accounting for resources allocated for OTC 
monograph drug activities. 
‘‘(4) The term ‘FDA establishment identifier’ is 
the unique number automatically generated by Food 
and Drug Administration’s Field Accomplishments 
and Compliance Tracking System (FACTS) (or any 
successor system). 
‘‘(5) The term ‘OTC monograph drug’ means a 
nonprescription drug without an approved new drug 
application which is governed by the provisions of 
section 505G. 
‘‘(6) The term ‘OTC monograph drug activities’ 
means activities of the Secretary associated with
OTC monograph drugs and inspection of facilities 
associated with such products, including the fol-
lowing activities: 
‘‘(A) The activities necessary for review 
and evaluation of OTC monographs and OTC 
monograph order requests, including— 
‘‘(i) orders proposing or finalizing ap-
plicable conditions of use for OTC mono-
graph drugs; 
‘‘(ii) orders affecting status regarding 
general recognition of safety and effective-
ness of an OTC monograph ingredient or 
combination of ingredients under specified 
conditions of use; 
‘‘(iii) all OTC monograph drug devel-
opment and review activities, including 
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 mono-
graph drugs. 
‘‘(C) Monitoring of clinical and other re-
search conducted in connection with OTC 
monograph drugs. 
‘‘(D) Safety activities with respect to OTC 
monograph drugs, including— 
‘‘(i) collecting, developing, and review-
ing safety information on OTC monograph 
drugs, including adverse event reports; 
‘‘(ii) developing and using improved 
adverse event data-collection systems, in-
cluding information technology systems; 
and 
‘‘(iii) developing and using improved 
analytical tools to assess potential safety 
risks, including access to external data-
bases. 
‘‘(E) Other activities necessary for imple-
mentation of section 505G.
‘‘(7) The term ‘OTC monograph order request’ 
means a request for an order submitted under sec-
tion 505G(b)(5). 
‘‘(8) The term ‘Tier 1 OTC monograph order 
request’ means any OTC monograph order request 
not determined to be a Tier 2 OTC monograph 
order request. 
‘‘(9)(A) The term ‘Tier 2 OTC monograph 
order request’ means, subject to subparagraph (B), 
an OTC monograph order request for— 
‘‘(i) the reordering of existing information 
in the drug facts label of an OTC monograph 
drug; 
‘‘(ii) the addition of information to the 
other information section of the drug facts label 
of an OTC monograph drug, as limited by sec-
tion 201.66(c)(7) of title 21, Code of Federal 
Regulations (or any successor regulations); 
‘‘(iii) modification to the directions for use 
section of the drug facts label of an OTC mono-
graph drug, if such changes conform to changes 
made pursuant to section 505G(c)(3)(A); 
‘‘(iv) the standardization of the concentra-
tion or dose of a specific finalized ingredient 
within a particular finalized monograph;
‘‘(v) a change to ingredient nomenclature 
to align with nomenclature of a standards-set-
ting organization; or 
‘‘(vi) addition of an interchangeable term 
in accordance with section 330.1 of title 21, 
Code of Federal Regulations (or any successor 
regulations). 
‘‘(B) The Secretary may, based on program im-
plementation experience or other factors found ap-
propriate by the Secretary, characterize any OTC 
monograph order request as a Tier 2 OTC mono-
graph order request (including recharacterizing a re-
quest from Tier 1 to Tier 2) and publish such deter-
mination in a proposed order issued pursuant to sec-
tion 505G. 
‘‘(10)(A) The term ‘OTC monograph drug facil-
ity’ means a foreign or domestic business or other 
entity that— 
‘‘(i) is— 
‘‘(I) under one management, either di-
rect or indirect; and 
‘‘(II) at one geographic location or ad-
dress engaged in manufacturing or proc-
essing the finished dosage form of an OTC 
monograph drug;
‘‘(ii) includes a finished dosage form man-
ufacturer facility in a contractual relationship 
with the sponsor of one or more OTC mono-
graph drugs to manufacture or process such 
drugs; and 
‘‘(iii) does not include a business or other 
entity whose only manufacturing or processing 
activities are one or more of the following: pro-
duction of clinical research supplies, 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 
address if the activities conducted in such buildings 
or locations are— 
‘‘(i) closely related to the same business 
enterprise; 
‘‘(ii) under the supervision of the same 
local management; and 
‘‘(iii) under a single FDA establishment 
identifier and capable of being inspected by the 
Food and Drug Administration during a single 
inspection. 
‘‘(C) If a business or other entity would meet 
criteria specified in subparagraph (A), but for being 
under multiple management, the business or other
entity is deemed to constitute multiple facilities, one 
per management entity, for purposes of this para-
graph. 
‘‘(11) The term ‘OTC monograph drug meet-
ing’ means any meeting regarding the content of a 
proposed OTC monograph order request. 
‘‘(12) The term ‘person’ includes an affiliate of 
a person. 
‘‘(13) The terms ‘requestor’ and ‘sponsor’ have 
the meanings given such terms in section 505G. 
‘‘SEC. 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: 
‘‘(1) FACILITY FEE.— 
‘‘(A) IN
GENERAL.—Each person that 
owns a facility identified as an OTC monograph 
drug facility on December 31 of the fiscal year 
or at any time during the preceding 12-month 
period shall be assessed an annual fee for each 
such facility as determined under subsection 
(c). 
‘‘(B) EXCEPTIONS.—
‘‘(i) A fee shall not be assessed under 
subparagraph (A) if the identified OTC 
monograph drug facility 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 organiza-
tion facility. 
‘‘(C) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (c). 
‘‘(D) DUE DATE.— 
‘‘(i) FOR FIRST PROGRAM YEAR.—For 
fiscal year 2019, the facility fees required 
under subparagraph (A) shall be due 45 
calendar days after publication of the Fed-
eral Register notice provided for under 
subsection (c)(4)(A).
‘‘(ii) SUBSEQUENT
FISCAL
YEARS.— 
For each fiscal year after fiscal year 2019, 
the facility fees required under subpara-
graph (A) shall be due on the later of— 
‘‘(I) the first business day of 
June of such year; or 
‘‘(II) the first business day after 
the enactment of an appropriations 
Act providing for the collection and 
obligation of fees under this section 
for such year. 
‘‘(2) 
OTC 
MONOGRAPH
ORDER
REQUEST 
FEE.— 
‘‘(A) IN GENERAL.—Each person that sub-
mits an OTC monograph order request shall be 
subject to a fee for an OTC monograph order 
request. The amount of such fee shall be— 
‘‘(i) for a Tier 1 OTC monograph 
order request, $500,000, adjusted for in-
flation for the fiscal year (as determined 
under subsection (c)(1)(B)); and 
‘‘(ii) for a Tier 2 OTC monograph 
order request, $100,000 adjusted for infla-
tion for the fiscal year (as determined 
under subsection (c)(1)(B)).
‘‘(B) DUE
DATE.—The OTC monograph 
order request fees required under subparagraph 
(A) shall be due on the date of submission of 
the OTC monograph order request. 
‘‘(C) EXCEPTION
FOR
CERTAIN
SAFETY 
CHANGES.—A person who is named as the re-
questor in an OTC monograph order shall not 
be subject to a fee under subparagraph (A) if 
the Secretary finds that the OTC monograph 
order request seeks to change the drug facts la-
beling of an OTC monograph drug in a way 
that would add to or strengthen— 
‘‘(i) a contraindication, warning, or 
precaution; 
‘‘(ii) a statement about risk associated 
with misuse or abuse; or 
‘‘(iii) an instruction about dosage and 
administration that is intended to increase 
the safe use of the OTC monograph drug. 
‘‘(D) REFUND OF FEE IF ORDER REQUEST 
IS RECATEGORIZED AS A TIER 2 OTC MONO-
GRAPH ORDER REQUEST.—If the Secretary de-
termines that an OTC monograph request ini-
tially characterized as Tier 1 shall be re-charac-
terized as a Tier 2 OTC monograph order re-
quest, and the requestor has paid a Tier 1 fee 
in accordance with subparagraph (A)(i), the 
Secretary shall refund the requestor the dif-
ference between the Tier 1 and Tier 2 fees de-
termined under subparagraphs (A)(i) and 
(A)(ii), respectively. 
‘‘(E) REFUND OF FEE IF ORDER REQUEST 
REFUSED FOR FILING OR WITHDRAWN BEFORE 
FILING.—The Secretary shall refund 75 percent 
of the fee paid under subparagraph (B) for any 
order request which is refused for filing or was 
withdrawn before being accepted or refused for 
filing. 
‘‘(F) FEES
FOR
ORDER
REQUESTS
PRE-
VIOUSLY REFUSED FOR FILING OR WITHDRAWN 
BEFORE
FILING.—An OTC monograph order 
request that was submitted but was refused for 
filing, or was withdrawn before being accepted 
or refused for filing, shall be subject to the full 
fee under subparagraph (A) upon being resub-
mitted or filed over protest. 
‘‘(G) REFUND OF FEE IF ORDER REQUEST 
WITHDRAWN.—If an order request is withdrawn 
after the order request was filed, the Secretary 
may refund the fee or a portion of the fee if no
substantial work was performed on the order 
request after the application was filed. The Sec-
retary shall have the sole discretion to refund a 
fee or a portion of the fee under this subpara-
graph. A determination by the Secretary con-
cerning a refund under this subparagraph shall 
not be reviewable. 
‘‘(3) REFUNDS.— 
‘‘(A) IN
GENERAL.—Other than refunds 
provided in subparagraphs (D) through (G) of 
paragraph (2), the Secretary shall not refund 
any fee paid under paragraph (1) except as pro-
vided in subparagraph (B). 
‘‘(B) DISPUTES
CONCERNING
FEES.—To 
qualify for the return of a fee claimed to have 
been paid in error under paragraph (1) or (2), 
a person shall submit to the Secretary a written 
request justifying such return within 180 cal-
endar days after such fee was paid. 
‘‘(4) NOTICE.—Within the timeframe specified 
in subsection (c), the Secretary shall publish in the 
Federal Register the amount of the fees under para-
graph (1) for such fiscal year. 
‘‘(b) FEE REVENUE AMOUNTS.—
‘‘(1) FISCAL YEAR 2019.—For fiscal year 2019, 
fees under subsection (a)(1) shall be established to 
generate a total facility fee revenue amount equal to 
the sum of— 
‘‘(A) the annual base revenue for fiscal 
year 2019 (as determined under paragraph (3); 
‘‘(B) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(2)); and 
‘‘(C) additional direct cost adjustments (as 
determined under subsection (c)(3)). 
‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 
the fiscal years 2020 through 2023, fees under sub-
section (a)(1) shall be established to generate a total 
facility fee revenue amount equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
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 million for fiscal year 2020. 
‘‘(ii) $6 million for fiscal year 2021. 
‘‘(iii) $7 million for fiscal year 2022. 
‘‘(iv) $3 million 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 million; and 
‘‘(B) for fiscal years 2020 through 2023, 
the dollar amount of the total revenue amount 
established under this subsection for the pre-
vious fiscal year, not including any adjustments 
made under subsection (c)(2) or (c)(3). 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of sub-
section (b)(2)(B), the dollar amount of the in-
flation adjustment to the annual base revenue 
for fiscal year 2020 and each subsequent fiscal 
year shall be equal to the product of—
‘‘(i) such annual base revenue for the 
fiscal year under subsection (b)(2); and 
‘‘(ii) the inflation adjustment percent-
age under subparagraph (C). 
‘‘(B) OTC MONOGRAPH ORDER REQUEST 
FEES.—For purposes of subsection (a)(2), the 
dollar amount of the inflation adjustment to the 
fee for OTC monograph order requests for fis-
cal year 2020 and each subsequent fiscal year 
shall be equal to the product of— 
‘‘(i) the applicable fee under sub-
section (a)(2) for the preceding fiscal year; 
and 
‘‘(ii) the inflation adjustment percent-
age under subparagraph (C). 
‘‘(C) INFLATION
ADJUSTMENT
PERCENT-
AGE.—The inflation adjustment percentage 
under this subparagraph for a fiscal year is 
equal to— 
‘‘(i) for each of fiscal years 2020 and 
2021, the average annual percent change 
that occurred in the Consumer Price Index 
for urban consumers (Washington-Balti-
more, DC–MD–VA–WV; Not Seasonally 
Adjusted; All items; Annual Index) for the
first 3 years of the preceding 4 years of 
available data; and 
‘‘(ii) for each of fiscal years 2022 and 
2023, the sum of— 
‘‘(I) the average annual percent 
change in the cost, per full-time equiv-
alent position of the Food and Drug 
Administration, of all personnel com-
pensation and benefits paid with re-
spect to such positions for the first 3 
years of the preceding 4 fiscal years, 
multiplied by the proportion of per-
sonnel 
compensation 
and 
benefits 
costs to total costs of OTC mono-
graph drug activities for the first 3 
years of the preceding 4 fiscal years; 
and 
‘‘(II) the average annual percent 
change that occurred in the Consumer 
Price Index for urban consumers 
(Washington-Baltimore, DC–MD–VA– 
WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 
years of the preceding 4 years of 
available data multiplied by the pro-
portion of all costs other than per-
sonnel 
compensation 
and 
benefits 
costs to total costs of OTC mono-
graph drug activities for the first 3 
years of the preceding 4 fiscal years. 
‘‘(2) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2019 
and subsequent fiscal years, for purposes of 
subsections (b)(1)(B) and (b)(2)(C), the Sec-
retary may, in addition to adjustments under 
paragraph (1), further increase the fee revenue 
and fees if such an adjustment is necessary to 
provide operating reserves of carryover user 
fees for OTC monograph drug activities for not 
more than the number of weeks specified in 
subparagraph (B). 
‘‘(B) NUMBER OF WEEKS.—The number of 
weeks specified in this subparagraph is— 
‘‘(i) 3 weeks for fiscal year 2019; 
‘‘(ii) 7 weeks for fiscal year 2020; 
‘‘(iii) 10 weeks for fiscal year 2021; 
‘‘(iv) 10 weeks for fiscal year 2022; 
and 
‘‘(v) 10 weeks for fiscal year 2023.
‘‘(C) DECREASE.—If the Secretary has 
carryover balances for such process in excess of 
10 weeks of the operating reserves referred to 
in subparagraph (A), the Secretary shall de-
crease the fee revenue and fees referred to in 
such subparagraph to provide for not more than 
10 weeks of such operating reserves. 
‘‘(D) RATIONALE
FOR
ADJUSTMENT.—If 
an adjustment under this paragraph is made, 
the rationale for the amount of the increase or 
decrease (as applicable) in fee revenue and fees 
shall be contained in the annual Federal Reg-
ister notice under paragraph (4) establishing 
fee revenue and fees for the fiscal year involved. 
‘‘(3) 
ADDITIONAL
DIRECT
COST
ADJUST-
MENT.—The Secretary shall, in addition to adjust-
ments under paragraphs (1) and (2), further in-
crease the fee revenue and fees for purposes of sub-
section (b)(2)(D) by an amount equal to— 
‘‘(A) $14 million for fiscal year 2019; 
‘‘(B) $7 million for fiscal year 2020; 
‘‘(C) $4 million for fiscal year 2021; 
‘‘(D) $3 million for fiscal year 2022; and 
‘‘(E) $3 million 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 
facility fees for fiscal year 2019 under sub-
section (a), based on the revenue amount 
for such year under subsection (b) and the 
adjustments provided under this sub-
section; 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 sub-
section— 
‘‘(i) OTC monograph drug facility fees 
under subsection (a)(1); 
‘‘(ii) OTC monograph order request 
fees under subsection (a)(2); and 
‘‘(iii) 
publish 
such 
fee 
revenue 
amounts, facility fees, and OTC mono-
graph order request fees in the Federal 
Register. 
‘‘(d) IDENTIFICATION OF FACILITIES.—Each person 
that owns an OTC monograph drug facility shall submit 
to the Secretary the information required under this sub-
section each year. Such information shall, for each fiscal 
year— 
‘‘(1) be submitted as part of the requirements 
for drug establishment registration set forth in sec-
tion 510; and 
‘‘(2) include for each such facility, at a min-
imum, identification of the facility’s business oper-
ation as that of an OTC monograph drug facility. 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) OTC MONOGRAPH DRUG FACILITY FEE.— 
‘‘(A) IN GENERAL.—Failure to pay the fee 
under subsection (a)(1) within 20 calendar days 
of the due date as specified in subparagraph 
(D) of such subsection shall result in the fol-
lowing: 
‘‘(i) The Secretary shall place the fa-
cility on a publicly available arrears list. 
‘‘(ii) All OTC monograph drugs man-
ufactured in such a facility or containing 
an ingredient manufactured in such a facil-
ity shall be deemed misbranded under sec-
tion 502(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 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for OTC 
monograph drug activities. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C), the fees authorized by this section 
shall be collected and available in each fiscal 
year in an amount not to exceed the amount 
specified in appropriation Acts, or otherwise 
made available for obligation, for such fiscal 
year. 
‘‘(B) USE
OF
FEES
AND
LIMITATION.— 
The fees authorized by this section shall be 
available to defray increases in the costs of the 
resources allocated for OTC monograph drug 
activities (including increases in such costs for 
an additional number of full-time equivalent po-
sitions in the Department of Health and 
Human Services to be engaged in such activi-
ties), only if the Secretary allocates for such 
purpose an amount for such fiscal year (exclud-
ing amounts from fees collected under this sec-
tion) no less than $12 million, multiplied by the
adjustment factor applicable to the fiscal year 
involved under subsection (c)(1). 
‘‘(C) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
subparagraph (B) in any fiscal year if the costs 
funded by appropriations and allocated for OTC 
monograph drug activities are not more than 15 
percent below the level specified in such sub-
paragraph. 
‘‘(D) PROVISION FOR EARLY PAYMENTS IN 
SUBSEQUENT YEARS.—Payment of fees author-
ized under this section for a fiscal year (after 
fiscal year 2019), prior to the due date for such 
fees, may be accepted by the Secretary in ac-
cordance with authority provided in advance in 
a prior year appropriations Act. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2019 through 2023, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total amount of 
fees assessed for such fiscal year under this section. 
‘‘(g) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 calendar days after 
it is due, such fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37 
of title 31, United States Code. 
‘‘(h) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in OTC monograph drug activities, be reduced 
to offset the number of officers, employees, and advisory 
committees so engaged. 
‘‘SEC. 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 col-
lected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
concerning the progress of the Food and Drug Adminis-
tration in achieving the goals identified in the letters de-
scribed in section 201(b) of the Over-the-Counter Mono-
graph 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.
‘‘(b) FISCAL REPORT.—Not later than 120 calendar 
days after the end of fiscal year 2019 and each subsequent 
fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the implementation 
of the authority for such fees during such fiscal year and 
the use, by the Food and Drug Administration, of the fees 
collected for such fiscal year. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 
make the reports required under subsections (a) and (b) 
available to the public on the Internet website of the Food 
and Drug Administration. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals described in subsection (a), and 
plans for meeting the goals, for OTC monograph 
drug activities for the first 5 fiscal years after fiscal 
year 2023, and for the reauthorization of this part 
for such fiscal years, the Secretary shall consult 
with— 
‘‘(A) the Committee on Energy and Com-
merce of the House of Representatives;
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
‘‘(C) provide for a period of 30 calendar 
days for the public to provide written comments 
on such recommendations; 
‘‘(D) hold a meeting at which the public 
may present its views on such recommenda-
tions; and 
‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary.
‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2023, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (2), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions in response to such views and comments.’’. 
Passed the House of Representatives July 16, 2018. 
Attest: 
Clerk.
115TH CONGRESS 
2D SESSION 
H. R. 5333 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act to clarify the regulatory framework with re-
spect to certain nonprescription drugs that are 
marketed without an approved new drug applica-
tion, and for other purposes.