H. R. 2617—1370 
drugs in the same context of use for which the designation 
was granted. 
‘‘(e) IMPLEMENTATION AND EVALUATION OF ADVANCED MANU-
FACTURING TECHNOLOGIES PROGRAM.— 
‘‘(1) PUBLIC MEETING.—The Secretary shall publish in the 
Federal Register a notice of a public meeting, to be held not 
later than 180 days after the date of enactment of this section, 
to discuss, and obtain input and recommendations from relevant 
stakeholders regarding— 
‘‘(A) the goals and scope of the program under this 
section, and the framework, procedures, and requirements 
suitable for such program; and 
‘‘(B) ways in which the Food and Drug Administration 
will support the use of advanced manufacturing tech-
nologies and other innovative manufacturing approaches 
for drugs. 
‘‘(2) PROGRAM GUIDANCE.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) not later than 180 days after the public meeting 
under paragraph (1), issue draft guidance regarding 
the goals and implementation of the program under 
this section; and 
‘‘(ii) not later than 2 years after the date of enact-
ment of this section, issue final guidance regarding 
the implementation of such program. 
‘‘(B) CONTENT.—The guidance described in subpara-
graph (A) shall address— 
‘‘(i) the process by which a person may request 
a designation under subsection (b); 
‘‘(ii) the data and information that a person 
requesting such a designation is required to submit 
under subsection (c), and how the Secretary intends 
to evaluate such submissions; 
‘‘(iii) the process to expedite the development and 
review of applications under subsection (d); and 
‘‘(iv) the criteria described in subsection (b) for 
eligibility for such a designation. 
‘‘(3) REPORT.—Not later than 3 years after the date of 
enactment of this section and annually thereafter, the Secretary 
shall publish on the website of the Food and Drug Administra-
tion and submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives a report con-
taining a description and evaluation of the program being con-
ducted under this section, including the types of innovative 
manufacturing approaches supported under the program. Such 
report shall include the following: 
‘‘(A) The number of persons that have requested des-
ignations and that have been granted designations. 
‘‘(B) The number of methods of manufacturing that 
have been the subject of designation requests and that 
have been granted designations. 
‘‘(C) The average number of calendar days for comple-
tion of evaluations under subsection (c)(2). 
‘‘(D) An analysis of the factors in data submissions 
that result in determinations to designate and not to des-
ignate after evaluation under subsection (c)(2).
H. R. 2617—1371 
‘‘(E) The number of applications received under section 
505 of this Act or section 351 of the Public Health Service 
Act, including supplemental applications, that have 
included an advanced manufacturing technology designated 
under this section, and the number of such applications 
approved. 
‘‘(f) SUNSET.—The Secretary— 
‘‘(1) may not consider any requests for designation sub-
mitted under subsection (c) after October 1, 2032; and 
‘‘(2) may continue all activities under this section with 
respect to advanced manufacturing technologies that were des-
ignated pursuant to subsection (b) prior to such date, if the 
Secretary determines such activities are in the interest of the 
public health.’’. 
CHAPTER 2—TRANSPARENCY, PROGRAM INTEGRITY, 
AND REGULATORY IMPROVEMENTS 
SEC. 3221. SAFER DISPOSAL OF OPIOIDS. 
Section 505–1(e)(4)(B) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355–1(e)(4)(B)) is amended by striking ‘‘for purposes 
of rendering drugs nonretrievable (as defined in section 1300.05 
of title 21, Code of Federal Regulations (or any successor regula-
tion))’’. 
SEC. 3222. THERAPEUTIC EQUIVALENCE EVALUATIONS. 
Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(7)(A)) is amended by adding at the end the 
following: 
‘‘(v)(I) With respect to an application submitted pursuant to 
subsection (b)(2) for a drug that is subject to section 503(b) for 
which the sole difference from a listed drug relied upon in the 
application is a difference in inactive ingredients not permitted 
under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code 
of Federal Regulations (or any successor regulations), the Secretary 
shall make an evaluation with respect to whether such drug is 
a therapeutic equivalent (as defined in section 314.3 of title 21, 
Code of Federal Regulations (or any successor regulations)) to 
another approved drug product in the prescription drug product 
section of the list under this paragraph as follows: 
‘‘(aa) With respect to such an application submitted after 
the date of enactment of the Food and Drug Omnibus Reform 
Act of 2022, the evaluation shall be made with respect to 
a listed drug relied upon in the application pursuant to sub-
section (b)(2) that is a pharmaceutical equivalent (as defined 
in section 314.3 of title 21, Code of Federal Regulations (or 
any successor regulations)) to the drug in the application pursu-
ant to subsection (b)(2) at the time of approval of such applica-
tion or not later than 180 days after the date of such approval, 
provided that the request for such an evaluation is made in 
the original application (or in a resubmission to a complete 
response letter), and all necessary data and information are 
submitted in the original application (or in a resubmission 
in response to a complete response letter) for the therapeutic 
equivalence evaluation, including information to demonstrate 
bioequivalence, in a form and manner prescribed by the Sec-
retary.
H. R. 2617—1372 
‘‘(bb) With respect to such an application approved prior 
to or on the date of enactment of the Food and Drug Omnibus 
Reform Act of 2022, the evaluation shall be made not later 
than 180 days after receipt of a request for a therapeutic 
equivalence evaluation submitted as part of a supplement to 
such application; or with respect to an application that was 
submitted prior to the date of enactment of the Food and 
Drug Omnibus Reform Act of 2022 but not approved as of 
the date of enactment of such Act, the evaluation shall be 
made not later than 180 days after the date of approval of 
such application if a request for such evaluation is submitted 
as an amendment to the application, provided that— 
‘‘(AA) such request for a therapeutic equivalence 
evaluation is being sought with respect to a listed drug 
relied upon in the application, and the relied upon listed 
drug is in the prescription drug product section of the 
list under this paragraph and is a pharmaceutical equiva-
lent (as defined in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations)) to the drug 
for which a therapeutic equivalence evaluation is sought; 
and 
‘‘(BB) the amendment or supplement, as applicable, 
containing such request, or the relevant application, 
includes all necessary data and information for the thera-
peutic equivalence evaluation, including information to 
demonstrate bioequivalence, in a form and manner pre-
scribed by the Secretary. 
‘‘(II) When the Secretary makes an evaluation under subclause 
(I), the Secretary shall, in revisions made to the list pursuant 
to clause (ii), include such information for such drug.’’. 
SEC. 3223. PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY 
VENDORS. 
(a) IN GENERAL.— 
(1) OPENING PUBLIC DOCKET.—Not later than 90 days after 
the date of enactment of this Act, the Secretary shall open 
a single public docket to solicit comments on factors that gen-
erally should be considered by the Secretary when reviewing 
requests from sponsors of drugs subject to risk evaluation and 
mitigation strategies to change third-party vendors engaged 
by sponsors to aid in implementation and management of the 
strategies. 
(2) FACTORS.—Such factors include the potential effects 
of changes in third-party vendors on— 
(A) patient access; and 
(B) prescribing and administration of the drugs by 
health care providers. 
(3) CLOSING PUBLIC DOCKET.—The Secretary may close such 
public docket not earlier than 90 days after such docket is 
opened. 
(4) NO DELAY.—Nothing in this section shall delay agency 
action on any modification to a risk evaluation and mitigation 
strategy. 
(b) GAO REPORT.—Not later than December 31, 2026, the 
Comptroller General of the United States shall submit to the Com-
mittee on Energy and Commerce of the House of Representatives
H. R. 2617—1373 
and the Committee on Health, Education, Labor, and Pensions 
of the Senate a report on— 
(1) the number of changes in third-party vendors (engaged 
by sponsors to aid implementation and management of risk 
evaluation and mitigation strategies) for an approved risk 
evaluation and mitigation strategy the Secretary has approved 
under section 505–1(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355–1(h)); 
(2) any issues affecting patient access to the drug that 
is subject to the strategy or considerations with respect to 
the administration or prescribing of such drug by health care 
providers that arose as a result of such changes; and 
(3) how such issues were resolved, as applicable. 
SEC. 3224. ENHANCING ACCESS TO AFFORDABLE MEDICINES. 
Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) 
through (iii) and inserting the following: 
‘‘(i) a revision to the labeling of the listed drug has been 
approved by the Secretary within 90 days of when the applica-
tion is otherwise eligible for approval under this subsection; 
‘‘(ii) the sponsor of the application agrees to submit revised 
labeling for the drug that is the subject of the application 
not later than 60 days after approval under this subsection 
of the application; 
‘‘(iii) the labeling revision described under clause (i) does 
not include a change to the ‘Warnings’ section of the labeling; 
and’’. 
Subtitle C—Medical Devices 
SEC. 3301. DUAL SUBMISSION FOR CERTAIN DEVICES. 
Section 513 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c) is amended by adding at the end the following: 
‘‘(k) For a device authorized for emergency use under section 
564 for which, in accordance with section 564(m), the Secretary 
has deemed a laboratory examination or procedure associated with 
such device to be in the category of examinations and procedures 
described in section 353(d)(3) of the Public Health Service Act, 
the sponsor of such device may, when submitting a request for 
classification under section 513(f)(2), submit a single submission 
containing— 
‘‘(1) the information needed for such a request; and 
‘‘(2) sufficient information to enable the Secretary to deter-
mine whether such laboratory examination or procedure satis-
fies the criteria to be categorized under section 353(d)(3) of 
the Public Health Service Act.’’. 
SEC. 3302. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS. 
(a) IN GENERAL.—The Secretary shall convene one or more 
panels of the Medical Devices Advisory Committee not less than 
once per year for the purpose of providing advice to the Secretary 
on topics related to medical devices used in pandemic preparedness 
and response, including topics related to in vitro diagnostics. 
(b) REQUIRED PANEL MEMBER.—A panel convened under sub-
section (a) shall include at least 1 population health-specific rep-
resentative.