H. R. 6833—53 
shall submit to the Secretary a written request justifying such 
waiver or return and, except as otherwise specified in this section, 
such written request shall be submitted to the Secretary not later 
than 180 days after such fee is due. A request submitted under 
this paragraph shall include any legal authorities under which 
the request is made.’’. 
SEC. 4004. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744I of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–53) is amended— 
(1) in subsection (a)(1), by striking ‘‘Beginning with fiscal 
year 2018, not’’ and inserting ‘‘Not’’; 
(2) by striking ‘‘Biosimilar User Fee Amendments of 2017’’ 
each place it appears and inserting ‘‘Biosimilar User Fee 
Amendments of 2022’’; 
(3) in subsection (a)(2), by striking ‘‘Beginning with fiscal 
year 2018, the’’ and inserting ‘‘The’’; 
(4) in subsection (a)(3)(A), by striking ‘‘Not later than 30 
calendar days after the end of the second quarter of fiscal 
year 2018, and not later than 30 calendar days after the end 
of each quarter of each fiscal year thereafter’’ and inserting 
‘‘Not later than 30 calendar days after the end of each quarter 
of each fiscal year for which fees are collected under this 
part’’; 
(5) in subsection (b), by striking ‘‘Not later than 120 days 
after the end of fiscal year 2018 and each subsequent fiscal 
year for which fees are collected under this part’’ and inserting 
‘‘Not later than 120 days after the end of each fiscal year 
for which fees are collected under this part’’; 
(6) in subsection (c), by striking ‘‘Beginning with fiscal 
year 2018, and for’’ and inserting ‘‘For’’; and 
(7) in subsection (f)— 
(A) in paragraph (1), in the matter preceding subpara-
graph (A), by striking ‘‘fiscal year 2022’’ and inserting 
‘‘fiscal year 2027’’; and 
(B) in paragraph (3), by striking ‘‘January 15, 2022’’ 
and inserting ‘‘January 15, 2027’’. 
SEC. 4005. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51, 379j–52) shall 
cease to be effective October 1, 2027. 
(b) REPORTING REQUIREMENTS.—Section 744I of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) shall cease to 
be effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2022, 
subsections (a) and (b) of section 405 of the FDA Reauthorization 
Act of 2017 (Public Law 115–52) are repealed. 
SEC. 4006. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2022, or the date of the enactment of this Act, whichever is 
later, except that fees under part 8 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
51 et seq.) shall be assessed for all biosimilar biological product 
applications received on or after October 1, 2022, regardless of 
the date of the enactment of this Act.
H. R. 6833—54 
SEC. 4007. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 8 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in effect on the day 
before the date of the enactment of this title, shall continue to 
be in effect with respect to biosimilar biological product applications 
and supplements (as defined in such part as of such day) that 
were accepted by the Food and Drug Administration for filing 
on or after October 1, 2017, but before October 1, 2022, with 
respect to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2023. 
TITLE V—REAUTHORIZATION OF 
OTHER PROVISIONS 
SEC. 5001. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR 
CHILDREN PROGRAM. 
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 
284m(d)(1)) is amended by striking ‘‘$25,000,000 for each of fiscal 
years 2018 through 2022’’ and inserting ‘‘$5,273,973 for the period 
beginning on October 1, 2022 and ending on December 16, 2022’’. 
SEC. 5002. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMP-
TION INCENTIVE. 
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 
‘‘October 1’’ and inserting ‘‘December 17’’. 
SEC. 5003. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA 
PROGRAM. 
Section 305(e) of the Food and Drug Administration Amend-
ments Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note) is 
amended by striking ‘‘$5,250,000 for each of fiscal years 2018 
through 2022’’ and inserting ‘‘$1,107,534 for the period beginning 
on October 1, 2022, and ending on December 16, 2022’’. 
SEC. 5004. REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS 
CONTAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(u)(4)) is amended by striking ‘‘October 1’’ and 
inserting ‘‘December 17’’. 
SEC. 5005. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRI-
VATE PARTNERSHIP. 
Section 566(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–5(f)) is amended by striking ‘‘$6,000,000 for 
each of fiscal years 2018 through 2022’’ and inserting ‘‘$1,265,753 
for the period beginning on October 1, 2022 and ending on December 
16, 2022’’. 
SEC. 5006. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is 
amended by striking ‘‘$30,000,000 for each of fiscal years 2018 
through 2022’’ and inserting ‘‘$6,328,767 for the period beginning 
on October 1, 2022, and ending on December 16, 2022’’.
H. R. 6833—55 
SEC. 5007. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS. 
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘October 1’’ and 
inserting ‘‘December 17’’. 
SEC. 
5008. 
REAUTHORIZATION 
OF 
REPORTING 
REQUIREMENTS 
RELATED TO PENDING GENERIC DRUG APPLICATIONS 
AND PRIORITY REVIEW APPLICATIONS. 
Section 807 of the FDA Reauthorization Act of 2017 (Public 
Law 115–52) is amended, in the matter preceding paragraph (1), 
by striking ‘‘October 1’’ and inserting ‘‘December 16’’. 
DIVISION G—HERMIT’S PEAK/CALF 
CANYON FIRE ASSISTANCE ACT 
SEC. 101. SHORT TITLE. 
This division may be cited as the ‘‘Hermit’s Peak/Calf Canyon 
Fire Assistance Act’’. 
SEC. 102. FINDINGS AND PURPOSES. 
(a) FINDINGS.—Congress finds that— 
(1) on April 6, 2022, the Forest Service initiated the Las 
Dispensas-Gallinas prescribed burn on Federal land in the 
Santa Fe National Forest in San Miguel County, New Mexico, 
when erratic winds were prevalent in the area that was also 
suffering from severe drought after many years of insufficient 
precipitation; 
(2) on April 6, 2022, the prescribed burn, which became 
known as the ‘‘Hermit’s Peak Fire’’, exceeded the containment 
capabilities of the Forest Service, was declared a wildfire, and 
spread to other Federal and non-Federal land; 
(3) on April 19, 2022, the Calf Canyon Fire, also in San 
Miguel County, New Mexico, began burning on Federal land 
and was later identified as the result of a pile burn in January 
2022 that remained dormant under the surface before re-
emerging; 
(4) on April 27, 2022, the Hermit’s Peak Fire and the 
Calf Canyon Fire merged, and both fires were reported as 
the Hermit’s Peak Fire or the Hermit’s Peak/Calf Canyon Fire, 
which shall be referred to hereafter as the Hermit’s Peak/ 
Calf Canyon Fire; 
(5) by May 2, 2022, the fire had grown in size and caused 
evacuations in multiple villages and communities in San Miguel 
County and Mora County, including in the San Miguel county 
jail, the State’s psychiatric hospital, the United World College, 
and New Mexico Highlands University; 
(6) on May 4, 2022, the President issued a major disaster 
declaration for the counties of Colfax, Mora, and San Miguel, 
New Mexico; 
(7) on May 20, 2022, U.S. Forest Service Chief Randy 
Moore ordered a 90-day review of prescribed burn policies to 
reduce the risk of wildfires and ensure the safety of the commu-
nities involved; 
(8) the U.S. Forest Service has assumed responsibility for 
the Hermit’s Peak/Calf Canyon Fire;