‘‘(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). 
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‘‘(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.—Subject to paragraph 
(2)(D), fees authorized under subsection (a) shall be 
collected and available for obligation only to the ex-
tent and in the amount provided in advance in ap-
propriations Acts. Such fees are authorized to re-
main available until expended. Such sums as may be 
necessary may be transferred from the Food and 
Drug Administration salaries and expenses appro-
priation account without fiscal year limitation to 
such appropriation account for salaries and expenses 
with such fiscal year limitation. The sums trans-
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ferred shall be available solely for OTC monograph 
drug activities. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graphs (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 oth-
erwise 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 $12,000,000, multiplied by 
the adjustment factor applicable to the fiscal 
year involved under subsection (c)(1). 
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‘‘(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) FEE
COLLECTION
DURING
FIRST 
PROGRAM YEAR.—Until the date of the enact-
ment of an Act making appropriations and pro-
viding for the collection and obligation of fees 
under this section through September 30, 2019, 
for the salaries and expenses account of the 
Food and Drug Administration, fees authorized 
by this section for fiscal year 2019 may be col-
lected and shall be credited to such account and 
remain available until expended. 
‘‘(E) 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. 
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‘‘(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 
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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-
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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; 
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‘‘(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.’’. 
Æ 
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