datamatters24/research-document-archive huggingface dataset:
178 
such section 520(gg). Such study shall include an analysis 
of the following: 
(1) The types of information communicated be-
tween such manufacturers and payors. 
(2) The manner of communication between 
such manufacturers and payors. 
(3)(A) Whether such manufacturers file a sub-
mission for approval, marketing authorization, clear-
ance, or licensing of a new drug or device or the new 
use of a drug or device that is the subject of commu-
nication between such manufacturers and payors 
under section 502(gg) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a). 
(B) How frequently the Food and Drug Admin-
istration approves, grants marketing authorization, 
clears, or licenses the new drug or device or new use. 
(C) The timeframe between the initial commu-
nications permitted under section 502(gg) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), regarding an investigational drug or 
device or investigational use, and the initial mar-
keting of such drug or device. 
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(3) by striking ‘‘Such term does not include 
whole blood’’ and inserting the following: 
‘‘(B) Such term does not include whole blood’’; 
(4) by striking ‘‘an allergenic extract product,’’ 
and inserting ‘‘an allergenic extract product licensed 
before October 1, 2022, a standardized allergenic ex-
tract product submitted pursuant to a notification to 
the applicant from the Secretary regarding the exist-
ence of a potency test that measures the allergenic 
activity of an allergenic extract product licensed by 
the applicant before October 1, 2022,’’ ; and 
(5) by adding at the end the following: 
‘‘(C)(i) If a written request to place a 
product in the discontinued section of either of 
the lists referenced in subparagraph (A)(iii) is 
submitted to the Secretary on behalf of an ap-
plicant, and the request identifies the date the 
product is withdrawn from sale, then for pur-
poses of assessing the prescription drug pro-
gram fee under section 736(a)(2), the Secretary 
shall consider such product to have been in-
cluded in the discontinued section on the later 
of— 
‘‘(I) the date such request was re-
ceived; or
(B) in subparagraph (C), by striking 
‘‘paragraph (5)’’ and inserting ‘‘paragraph 
(6)’’. 
(5) ADDITIONAL DIRECT COST ADJUSTMENT.— 
Paragraph (5), as redesignated, of section 736(c) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(c)) is amended to read as follows: 
‘‘(5) 
ADDITIONAL
DIRECT
COST
ADJUST-
MENT.— 
‘‘(A) INCREASE.—The Secretary shall, in 
addition to adjustments under paragraphs (1), 
(2), (3), and (4), further increase the fee rev-
enue and fees— 
‘‘(i) 
for 
fiscal 
year 
2023, 
by 
$44,386,150; and 
‘‘(ii) for each of fiscal years 2024 
through 2027, by the amount set forth in 
clauses (i) through (iv) of subparagraph 
(B), as applicable, multiplied by the Con-
sumer Price Index for urban consumers 
(Washington-Arlington-Alexandria, 
DC– 
VA–MD–WV; Not Seasonally Adjusted; All 
Items; Annual Index) for the most recent 
year of available data, divided by such 
Index for 2021.
‘‘(iii) For fiscal year 2026, $35,799, 
314. 
‘‘(iv) 
For 
fiscal 
year 
2027, 
$35,799,314.’’. 
(6) ANNUAL FEE SETTING.—Paragraph (6), as 
redesignated, of section 736(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is 
amended by striking ‘‘September 30, 2017’’ and in-
serting ‘‘September 30, 2022’’. 
(d) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 736(g)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379h(g)(3)) is amended by striking ‘‘fiscal 
years 2018 through 2022’’ and inserting ‘‘fiscal years 
2023 through 2027’’. 
(e) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, EXEMPTIONS, AND RETURNS; DISPUTES CON-
CERNING FEES.—Section 736(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended 
to read as follows: 
‘‘(i) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, EXEMPTIONS, AND RETURNS; DISPUTES CON-
CERNING FEES.—To qualify for consideration for a waiver 
or reduction under subsection (d), an exemption under 
subsection (k), or the return of any fee paid under this 
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SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.—Section 738(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 
amended— 
(1) in paragraph (1), by striking ‘‘fiscal year 
2018’’ and inserting ‘‘fiscal year 2023’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘October 1, 2017’’ and insert-
ing ‘‘October 1, 2022’’; 
(ii) in clause (iii), by striking ‘‘75 per-
cent’’ and inserting ‘‘80 percent’’; and 
(iii) in clause (viii), by striking ‘‘3.4 
percent’’ and inserting ‘‘4.5 percent’’; 
(B) in subparagraph (B)(iii), by striking 
‘‘or premarket notification submission’’ and in-
serting ‘‘premarket notification submission, or 
de novo classification request’’; and 
(C) in subparagraph (C), by striking ‘‘or 
periodic reporting concerning a class III device’’ 
and inserting ‘‘periodic reporting concerning a 
class III device, or de novo classification re-
quest’’. 
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(b) FEE AMOUNTS.—Section 738(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is 
amended— 
(1) in paragraph (1), by striking ‘‘2018 
through 2022’’ and inserting ‘‘2023 through 2027’’; 
(2) by amending paragraph (2) to read as fol-
lows: 
‘‘(2) BASE
FEE
AMOUNTS
SPECIFIED.—For 
purposes of paragraph (1), the base fee amounts 
specified in this paragraph are as follows: 
‘‘Fee Type 
Fiscal 
Year 
2023 
Fiscal 
Year 
2024 
Fiscal 
Year 
2025 
Fiscal 
Year 
2026 
Fiscal 
Year 
2027 
Premarket Application ........................
$425,000 
$435,000 
$445,000 
$455,000 
$470,000 
Establishment Registration ................
$6,250 
$6,875 
$7,100 
$7,575 
$8,465’’; 
and 
(3) by amending paragraph (3) to read as fol-
lows: 
‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— 
For purposes of paragraph (1), the total revenue 
amounts specified in this paragraph are as follows: 
‘‘(A) $312,606,000 for fiscal year 2023. 
‘‘(B) $335,750,000 for fiscal year 2024. 
‘‘(C) $350,746,400 for fiscal year 2025. 
‘‘(D) $366,486,300 for fiscal year 2026. 
‘‘(E) $418,343,000 for fiscal year 2027.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 
738(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j(c)) is amended— 
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171 
(d) MISBRANDING.—Section 502(t) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is 
amended— 
(1) by striking ‘‘or (3)’’ and inserting ‘‘(3)’’; 
and 
(2) by inserting before the period at the end the 
following: ‘‘, or (4) to furnish a software bill of ma-
terials as required under section 524C (relating to 
ensuring device cybersecurity)’’. 
SEC. 808. PUBLIC DOCKET ON PROPOSED MODIFICATIONS 
TO APPROVED STRATEGIES. 
(a) IN GENERAL.—Not later than 90 days after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall open a public docket for the 
submission of public comments regarding factors related 
to patient access to a drug that is subject to a risk evalua-
tion and mitigation strategy and the administration or 
prescribing of such drug by health care providers that 
should be taken into consideration when a proposed modi-
fication to such strategy is reviewed under section 505– 
1(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 255–1(h)). The Secretary may close such public 
docket not earlier than 90 days after such docket is 
opened. 
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HR 7667 RDS
ing ‘‘premarket notification submissions, or de 
novo classification requests’’; and 
(2) in paragraph (11), by striking ‘‘2016’’ and 
inserting ‘‘2021’’. 
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.—Section 738(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 
amended— 
(1) in paragraph (1), by striking ‘‘fiscal year 
2018’’ and inserting ‘‘fiscal year 2023’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘October 1, 2017’’ and insert-
ing ‘‘October 1, 2022’’; 
(ii) in clause (iii), by striking ‘‘75 per-
cent’’ and inserting ‘‘80 percent’’; and 
(iii) in clause (viii), by striking ‘‘3.4 
percent’’ and inserting ‘‘4.5 percent’’; 
(B) in subparagraph (B)(iii), by striking 
‘‘or premarket notification submission’’ and in-
serting ‘‘premarket notification submission, or 
de novo classification request’’; and 
(C) in subparagraph (C), by striking ‘‘or 
periodic reporting concerning a class III device’’ 
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I 
118TH CONGRESS 
2D SESSION H. R. 10062 
To amend title 29, District of Columbia Official Code, to treat meetings 
held with officials of the Federal Government which are held in the 
District of Columbia as activities not constituting doing business in 
the District of Columbia for purposes of determining whether organiza-
tions are required to register with the District of Columbia. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 29, 2024 
Mr. BIGGS (for himself, Mr. OGLES, Mr. CRANE, Mr. BURLISON, and Mr. 
GOSAR) introduced the following bill; which was referred to the Com-
mittee on Oversight and Accountability 
A BILL 
To amend title 29, District of Columbia Official Code, to 
treat meetings held with officials of the Federal Govern-
ment which are held in the District of Columbia as 
activities not constituting doing business in the District 
of Columbia for purposes of determining whether organi-
zations are required to register with the District of Co-
lumbia. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Amend-
ments of 2022’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—FEES RELATING TO DRUGS 
Sec. 101. Short title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Reauthorization; reporting requirements. 
Sec. 105. Sunset dates. 
Sec. 106. Effective date. 
Sec. 107. Savings clause. 
TITLE II—FEES RELATING TO DEVICES 
Sec. 201. Short title; finding. 
Sec. 202. Definitions. 
Sec. 203. Authority to assess and use device fees. 
Sec. 204. Reauthorization; reporting requirements. 
Sec. 205. Conformity assessment pilot program. 
Sec. 206. Reauthorization of third-party review program. 
Sec. 207. Sunset dates. 
Sec. 208. Effective date. 
Sec. 209. Savings clause. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 301. Short title; finding. 
Sec. 302. Authority to assess and use human generic drug fees. 
Sec. 303. Reauthorization; reporting requirements. 
Sec. 304. Sunset dates. 
Sec. 305. Effective date. 
Sec. 306. Savings clause. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 
Sec. 401. Short title; finding. 
Sec. 402. Definitions. 
Sec. 403. Authority to assess and use biosimilar fees. 
Sec. 404. Reauthorization; reporting requirements. 
Sec. 405. Sunset dates. 
Sec. 406. Effective date. 
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(2) STRATEGIC HIRING AND RETENTION ADJUST-
MENT.—Section 736(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(c)) is amended— 
(A) 
by 
redesignating 
paragraphs 
(2) 
through (6) as paragraphs (3) through (7), re-
spectively; and 
(B) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) STRATEGIC
HIRING
AND
RETENTION
AD-
JUSTMENT.—For each fiscal year, after the annual 
base revenue established in subsection (b)(1)(A) is ad-
justed for inflation in accordance with paragraph (1), 
the Secretary shall further increase the fee revenue 
and fees by the following amounts: 
‘‘(A) For fiscal year 2023, $9,000,000. 
‘‘(B) For each of fiscal years 2024 through 
2027, $4,000,000.’’. 
(3) CAPACITY
PLANNING
ADJUSTMENT.—Para-
graph (3), as redesignated, of section 736(c) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(c)) is amended to read as follows: 
‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For each fiscal year, 
after the annual base revenue established in sub-
section (b)(1)(A) is adjusted in accordance with 
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117TH CONGRESS 
2D SESSION 
H. R. 8226 
AN ACT 
To designate the facility of the United States Postal Service 
located at 236 Concord Exchange North in South Saint 
Paul, Minnesota, as the ‘‘Officer Leo Pavlak Post Office 
Building’’. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
related programs may be utilized by Ukraine for the pro-
curement of defense articles, defense services, or design 
and construction services that are not sold by the United 
States Government under the Arms Export Control Act 
(22 U.S.C. 2751 et seq.): Provided, That such procure-
ments shall be subject to the applicable notification re-
quirements of section 38 of the Arms Export Control Act 
(22 U.S.C. 2778). 
SEC. 505. (a) Funds appropriated by this title under 
the headings ‘‘Diplomatic Programs’’, ‘‘Capital Invest-
ment Fund’’, ‘‘Embassy Security, Construction, and 
Maintenance’’, and ‘‘Operating Expenses’’ may be trans-
ferred to, and merged with, funds available under such 
headings and with funds available under the heading 
‘‘Educational and Cultural Exchange Programs’’ to re-
spond to the situation in Ukraine and countries impacted 
by the situation in Ukraine. 
(b) Funds appropriated by this title under the head-
ings ‘‘International Disaster Assistance’’ and ‘‘Migration 
and Refugee Assistance’’ may be transferred to, and 
merged with, funds appropriated by this title under such 
headings. 
(c) Funds appropriated by this title under the head-
ing ‘‘Economic Support Fund’’ may be transferred to, and 
merged with, funds available under the heading ‘‘Assist-
IB 
Union Calendar No. 299 
117TH CONGRESS 
2D SESSION 
H. R. 8238 
[Report No. 117–391] 
Making appropriations for military construction, the Department of Veterans 
Affairs, and related agencies for the fiscal year ending September 30, 
2023, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 27, 2022 
Ms. WASSERMAN SCHULTZ, from the Committee on Appropriations, reported 
the following bill; which was committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
A BILL 
Making appropriations for military construction, the Depart-
ment of Veterans Affairs, and related agencies for the 
fiscal year ending September 30, 2023, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
That the following sums are appropriated, out of any 
money in the Treasury not otherwise appropriated, for 
military construction, the Department of Veterans Affairs, 
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I 
117TH CONGRESS 
2D SESSION 
H. R. 7670 
To amend the Small Business Act to require a report on small business 
concerns owned and controlled by women, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 6, 2022 
Ms. HOULAHAN (for herself and Ms. TENNEY) introduced the following bill; 
which was referred to the Committee on Small Business 
A BILL 
To amend the Small Business Act to require a report on 
small business concerns owned and controlled by women, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Women-Owned Small 
Business Program Transparency Act’’ or the ‘‘WOSB 
Program Transparency Act’’. 
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ance for Europe, Eurasia and Central Asia’’ for assistance 
and related programs for Ukraine and other countries 
identified in section 3 of the FREEDOM Support Act (22 
U.S.C. 5801) and section 3(c) of the Support for East 
European Democracy (SEED) Act of 1989 (22 U.S.C. 
5402(c)) and under the headings ‘‘Transition Initiatives’’ 
and ‘‘Complex Crises Fund’’ to respond to the situation 
in Ukraine and in countries impacted by the situation in 
Ukraine. 
(d) Funds appropriated by this title under the head-
ings ‘‘International Narcotics Control and Law Enforce-
ment’’, ‘‘Nonproliferation, Anti-terrorism, Demining and 
Related Programs’’, and ‘‘Foreign Military Financing 
Program’’ may be transferred to, and merged with, funds 
appropriated by this title under such headings to respond 
to the situation in Ukraine and in countries impacted by 
the situation in Ukraine. 
(e) The transfer authorities provided by this title are 
in addition to any other transfer authority provided by 
law. 
(f) The exercise of the transfer authorities provided 
by this title shall be subject to prior consultation with, 
and the regular notification procedures of, the Committees 
on Appropriations.
‘‘(ii) The result obtained under this subpara-
graph for an institution shall be referred to in this 
Act as the ‘adjusted cohort default rate’.’’. 
(c) PUBLICATION OF ADJUSTED COHORT DEFAULT 
RATE.—Section 435(m) of the Higher Education Act of 
1965 (20 U.S.C. 1085(m)) is further amended by adding 
at the end the following: 
‘‘(5) Beginning on the date on which the final 
adjusted cohort default rates for fiscal year 2021 are 
made available for publication by the Secretary, 
paragraph (4) shall be applied by substituting ‘ad-
justed cohort default’ for ‘cohort default’ each place 
it appears.’’. 
SEC. 7. ADJUSTED COHORT DEFAULT RATE. 
Section 487(a)(14) of the Higher Education Act of 
1965 is amended by adding at the end the following: 
‘‘(D) Beginning on the date on which the 
final adjusted cohort default rates are published 
by the Secretary for fiscal year 2021 under sec-
tion 435(m), subparagraph (C) shall be applied 
by substituting ‘adjusted cohort default rate in 
excess of 5 percent’ for ‘cohort default rate in 
excess of 10 percent’ each place it appears.’’. 
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(b) TECHNICAL AMENDMENT.—Section 8(m)(2)(C) 
of the Small Business Act is amended by striking ‘‘para-
graph (3)’’ and inserting ‘‘paragraph (4)’’. 
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01:55 May 18, 2022
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Union Calendar No. 249 
117TH CONGRESS 
2D SESSION 
H. R. 7670 
[Report No. 117–331] 
A BILL 
To amend the Small Business Act to require a re-
port on small business concerns owned and con-
trolled by women, and for other purposes. 
MAY 17, 2022 
Committed to the Committee of the Whole House on the 
State of the Union and ordered to be printed 
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I 
117TH CONGRESS 
2D SESSION 
H. R. 7674 
To provide Members of Congress access to United States Postal Service 
facilities, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 6, 2022 
Mr. CONNOLLY (for himself, Mrs. CAROLYN B. MALONEY of New York, and 
Ms. WASSERMAN SCHULTZ) introduced the following bill; which was re-
ferred to the Committee on Oversight and Reform 
A BILL 
To provide Members of Congress access to United States 
Postal Service facilities, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ensuring Oversight 
Access at the Postal Service Act’’. 
SEC. 2. PROVIDING ACCESS TO USPS FACILITIES TO MEM-
BERS OF CONGRESS. 
The United States Postal Service may not prevent or 
otherwise inhibit any Member of Congress (as that term 
is defined in section 2106 of title 5, United States Code) 
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from accessing or visiting any Postal Service facility for 
official purposes, including accessing or visiting such a fa-
cility on or around the date of an election for Federal of-
fice. 
Æ 
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the 1967 Protocol Relating to the 
Status of Refugees, or the Convention 
against Torture and Other Cruel, In-
human or Degrading Treatment or 
Punishment.’’. 
Æ 
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culture and food system supply chain, including 
recommendations that address challenges iden-
tified under paragraph (1) and that also ad-
dress— 
‘‘(i) long-term strategies; 
‘‘(ii) industry best practices; 
‘‘(iii) risk-mitigation actions to pre-
vent future bottlenecks and vulnerabilities 
at all levels of the agriculture and food sys-
tem supply chain; and 
‘‘(iv) legislative and regulatory actions 
that would positively impact the security 
and resilience of the agriculture and food 
system supply chain.’’. 
(b) TECHNICAL AMENDMENT.—Section 296(b) of the 
Department of Agriculture Reorganization Act of 1994 (7 
U.S.C. 7014(b)) is amended by adding at the end the fol-
lowing: 
‘‘(11) The authority of the Secretary to estab-
lish in the Department the Agricultural and Food 
System Supply Chain Resilience and Crisis Response 
Task Force in accordance with section 229.’’. 
Æ 
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