H. R. 2471—740 
SEC. 203. RURAL HEALTHCARE WORKERS. 
Subclauses 220(c) of the Immigration and Nationality Technical 
Corrections Act of 1994 (8 U.S.C. 1182 note) shall be applied by 
substituting ‘‘September 30, 2022’’ for ‘‘September 30, 2015’’. 
SEC. 204. H–2B SUPPLEMENTAL VISAS EXEMPTION. 
Notwithstanding the numerical limitation set forth in section 
214(g)(1)(B) of the Immigration and Nationality Act (8 U.S.C. 
1184(g)(1)(B)), the Secretary of Homeland Security, after consulta-
tion with the Secretary of Labor, and upon the determination that 
the needs of American businesses cannot be satisfied in fiscal year 
2022 with United States workers who are willing, qualified, and 
able to perform temporary nonagricultural labor, may increase the 
total number of aliens who may receive a visa under section 
101(a)(15)(H)(ii)(b) of such Act (8 U.S.C. 1101(a)(15)(H)(ii)(b)) in 
such fiscal year above such limitation by not more than the highest 
number of H–2B nonimmigrants who participated in the H–2B 
returning worker program in any fiscal year in which returning 
workers were exempt from such numerical limitation. 
TITLE III—LIVESTOCK REPORTING 
EXTENSION 
SEC. 301. LIVESTOCK MANDATORY REPORTING EXTENSION. 
(a) IN GENERAL.—Section 260 of the Agricultural Marketing 
Act of 1946 (7 U.S.C. 1636i) is amended by striking ‘‘2020’’ and 
inserting ‘‘2022’’. 
(b) CONFORMING AMENDMENT.—Section 942 of the Livestock 
Mandatory Reporting Act of 1999 (7 U.S.C. 1635 note; Public Law 
106–78) is amended by striking ‘‘2020’’ and inserting ‘‘2022’’. 
TITLE IV—TVPA EXTENSION 
SEC. 401. EXTENSION OF ADDITIONAL SPECIAL ASSESSMENT. 
Section 3014(a) of title 18, United States Code, is amended 
by striking ‘‘March 11, 2022’’ and inserting ‘‘September 11, 2022’’. 
TITLE V—BUDGETARY EFFECTS 
SEC. 501. BUDGETARY EFFECTS. 
(a) STATUTORY PAYGO SCORECARDS.—The budgetary effects of 
this division and each succeeding division shall not be entered 
on either PAYGO scorecard maintained pursuant to section 4(d) 
of the Statutory Pay-As-You-Go Act of 2010. 
(b) SENATE PAYGO SCORECARDS.—The budgetary effects of this 
division and each succeeding division shall not be entered on any 
PAYGO scorecard maintained for purposes of section 4106 of H. 
Con. Res. 71 (115th Congress). 
(c) CLASSIFICATION OF BUDGETARY EFFECTS.—Notwithstanding 
Rule 3 of the Budget Scorekeeping Guidelines set forth in the 
joint explanatory statement of the committee of conference accom-
panying Conference Report 105–217 and section 250(c)(8) of the 
Balanced Budget and Emergency Deficit Control Act of 1985, the
H. R. 2471—741 
budgetary effects of this division and each succeeding division shall 
not be estimated— 
(1) for purposes of section 251 of such Act; 
(2) for purposes of an allocation to the Committee on Appro-
priations pursuant to section 302(a) of the Congressional 
Budget Act of 1974; and 
(3) for purposes of paragraph (4)(C) of section 3 of the 
Statutory Pay-As-You-Go Act of 2010 as being included in an 
appropriation Act. 
DIVISION P—HEALTH PROVISIONS 
TITLE I—PUBLIC HEALTH 
Subtitle A—National Disaster Medical 
System 
SEC. 101. EXTENSION OF AUTHORITY TO MAKE CERTAIN APPOINT-
MENTS FOR NATIONAL DISASTER MEDICAL SYSTEM. 
Section 2812(c)(4)(B) of the Public Health Service Act (42 U.S.C. 
300hh–11(c)(4)(B)) is amended by striking ‘‘March 11, 2022’’ and 
inserting ‘‘September 30, 2023’’. 
Subtitle B—Synthetic Nicotine 
SEC. 111. FDA AUTHORITY OVER PRODUCTS CONTAINING NICOTINE. 
(a) TOBACCO PRODUCT DEFINED.—Section 201(rr) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)) is amended— 
(1) in subparagraph (1), by inserting ‘‘, or containing nico-
tine from any source,’’ after ‘‘from tobacco’’; and 
(2) by adding at the end the following: 
‘‘(5) The term ‘tobacco product’ does not mean an article that 
is a food under paragraph (f), if such article contains no nicotine, 
or no more than trace amounts of naturally occurring nicotine.’’. 
(b) APPLICABILITY TO CERTAIN PRODUCTS.—Section 901(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) 
is amended by adding at the end the following: ‘‘This chapter 
shall also apply to any tobacco product containing nicotine that 
is not made or derived from tobacco.’’. 
(c) EFFECTIVE DATE.—The amendments made by subsections 
(a) and (b) shall take effect 30 days after the date of enactment 
of this Act. 
(d) SUBMISSION OF APPLICATIONS FOR PREVIOUSLY MARKETED 
PRODUCTS.— 
(1) TRANSITION PERIOD FOR ALL PRODUCTS.—With respect 
to a tobacco product that contains nicotine from any source 
other than tobacco and that was being marketed in the United 
States within 30 days after the date of enactment of this 
Act, such product shall not be considered to be in violation 
of section 910 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387j) (relating to applications for review of certain 
tobacco products) during the 60-day period following the date 
of enactment of this Act. 
(2) SUBMISSION OF APPLICATIONS.—
H. R. 2471—742 
(A) IN
GENERAL.—As a condition for continuing to 
market a product described in paragraph (1) after the 
60-day period specified in such paragraph, during the 30- 
day period beginning on the effective date specified in 
subsection (c), the manufacturer shall submit a new tobacco 
product application under section 910(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)) with 
respect to such product. 
(B) TRANSITION
PERIOD.—Except as provided in 
subparagraph (C), with respect to a tobacco product for 
which an application is submitted as described in subpara-
graph (A), the manufacturer of such product may continue 
to market such product during the 90-day period beginning 
on the effective date specified in subsection (c). 
(C) EXCEPTION.—If the Secretary of Health and Human 
Services previously denied an application under section 
910(c)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387j(c)(2)), refused to file an application under 
section 910(b) of such Act, or withdrew an order under 
section 910(d) of such Act for a previous version of a tobacco 
product that used nicotine made or derived from tobacco, 
such product is not eligible for continued marketing under 
subparagraph (B). 
(3) END OF TRANSITION PERIOD.—Beginning on the date 
that is 90 days after the effective date specified in subsection 
(c), a tobacco product described in paragraph (1) (including 
such a tobacco product that is the subject of a pending applica-
tion under section 910 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387j)) is in violation of such section 910 if 
such tobacco product does not have an order in effect under 
subsection (c)(1)(A)(i) of such section. 
(e) APPLICABILITY OF EXISTING REQUIREMENTS FOR TOBACCO 
PRODUCTS.—Effective 30 days after the date of enactment of this 
Act, with respect to any regulation promulgated or related guidance 
issued, in whole or part, under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) before the date that is 30 days 
after such date of enactment, the term ‘‘tobacco product’’ shall 
have the meaning of, and shall be deemed amended to reflect 
the meaning of, such term as defined in section 201(rr) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)), as 
amended by subsection (a). Products that are tobacco products 
under such section 201(rr), as so amended, shall be subject to 
all requirements of regulations for tobacco products. The Secretary 
of Health and Human Services shall publish a notice in the Federal 
Register to update the Code of Federal Regulations to reflect such 
deemed amendment to existing regulations and guidance. 
(f) TECHNICAL ACHIEVABILITY.—Section 907(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387g(b)(1)) is amended 
by inserting before the period at the end the following: ‘‘, including 
with regard to any differences related to the technical achievability 
of compliance with such standard for products in the same class 
containing nicotine not made or derived from tobacco and products 
containing nicotine made or derived from tobacco’’. 
SEC. 112. REPORTING ON TOBACCO REGULATION ACTIVITIES. 
(a) IN GENERAL.—For fiscal year 2022 and each subsequent 
fiscal year for which fees are collected under section 919 of the
H. R. 2471—743 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s), the Sec-
retary of Health and Human Services shall, not later than 180 
days after the end of the fiscal year, prepare and submit to the 
Committee on Energy and Commerce and the Committee on Appro-
priations of the House of Representatives, and the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate, an annual report that contains the 
information required under subsection (b). 
(b) REQUIRED INFORMATION.—Each report submitted under sub-
section (a) shall contain the following information for the previous 
fiscal year: 
(1) Total annual user fee collections. 
(2) Total amount of fees obligated. 
(3) The amount of unobligated carryover balance from fees 
collected. 
(4) The amount obligated by the Center for Tobacco Prod-
ucts for each of the following activities: 
(A) Compliance and enforcement. 
(B) Public education campaigns. 
(C) Scientific research and research infrastructure. 
(D) Communications. 
(E) Leadership, management oversight, and adminis-
trative services. 
(F) Related overhead activities. 
(5) The numbers of applications, categorized by class of 
tobacco product and review pathway under sections 905, 910, 
and 911 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387e; 387j; 387k), that were— 
(A) submitted; 
(B) pending; 
(C) accepted; 
(D) refused to file; 
(E) withdrawn; 
(F) denied; 
(G) authorized for marketing under an order; 
(H) issued a deficiency letter or environmental informa-
tion request letter; or 
(I) referred to the Tobacco Products Scientific Advisory 
Committee. 
(6) The number and titles of draft and final guidance 
documents and proposed and final regulations issued on topics 
related to the process for the review of tobacco product applica-
tions, whether such regulations and guidance documents were 
issued as required by statute or by other legal or regulatory 
requirements, and whether the issuance met the deadlines 
set forth by the applicable statute or other requirements. 
(7) The number and titles of public meetings related to 
the review of tobacco product applications by the Center for 
Tobacco Products or other offices or centers within the Food 
and Drug Administration. 
(8) The number of pre-submission meetings relating to 
applications under section 910 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387j), including the number of meeting 
requests received, the number of meetings held, and the median 
amount of time between when such meeting requests were 
made and when the requests were granted or denied.