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-
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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). 
‘‘(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. 
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‘‘(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. 744N. 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 2001(b) of the Over-the-Counter Mono-
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graph Safety, Innovation, and Reform Act of 2019 during 
such fiscal year and the future plans of the Food and 
Drug Administration for meeting such goals. 
‘‘(b) FISCAL REPORT.—Not later than 120 calendar 
days after the end of fiscal year 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 
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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 
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