H. R. 2617—1378 
‘‘(2) PREDETERMINED
CHANGE
CONTROL
PLAN.—The Sec-
retary may clear a predetermined change control plan sub-
mitted in a notification submitted under section 510(k) that 
describes planned changes that may be made to the device 
(and that would otherwise require a new notification), if— 
‘‘(A) the device remains safe and effective without any 
such change; and 
‘‘(B) the device would remain substantially equivalent 
to the predicate. 
‘‘(3) SCOPE.—The Secretary may require that a change 
control plan include labeling required for safe and effective 
use of the device as such device changes pursuant to such 
plan, notification requirements if the device does not function 
as intended pursuant to such plan, and performance require-
ments for changes made under the plan. 
‘‘(c) PREDICATE
DEVICES.—In making a determination of 
substantial equivalence pursuant to section 513(i), the Secretary 
shall not compare a device to changed versions of a device imple-
mented in accordance with an established predetermined change 
control plan as a predicate device. Only the version of the device 
cleared or approved, prior to changes made under the predetermined 
change control plan, may be used by a sponsor as a predicate 
device.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) CLEARED
DEVICES.—Section 510(l)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)(1)) is amended, 
in the first sentence, by inserting ‘‘, or with respect to a change 
that is consistent with a predetermined change control plan 
cleared under section 515C’’ before the period at the end. 
(2) APPROVED DEVICES.—Section 515(d)(5)(A)(i) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(i)) 
is amended by striking ‘‘A supplemental’’ and inserting ‘‘Unless 
the change is consistent with a predetermined change control 
plan approved under section 515C, a supplemental’’. 
(3) DOCUMENTATION
OF
RATIONALE
FOR
SIGNIFICANT 
DECISIONS.—Section 517A(a)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is amended to read as 
follows: 
‘‘(1) IN
GENERAL.—The Secretary shall provide a sub-
stantive summary of the scientific and regulatory rationale 
for any significant decision of the Center for Devices and Radio-
logical Health regarding submission or review of a report under 
section 510(k), a petition for classification under section 513(f), 
an application under section 515, or an application for an 
exemption under section 520(g), including documentation of 
significant controversies or differences of opinion and the reso-
lution of such controversies or differences of opinion.’’. 
SEC. 3309. SMALL BUSINESS FEE WAIVER. 
(a) IN GENERAL.—Section 738(a)(3)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— 
(1) by striking ‘‘No fee’’ and inserting the following: 
‘‘(i) IN GENERAL.—No fee’’; and 
(2) by adding at the end the following: 
‘‘(ii) SMALL BUSINESSES FEE WAIVER.— 
‘‘(I) DEFINITION OF SMALL BUSINESS.—For pur-
poses of this clause, the term ‘small business’
H. R. 2617—1379 
means an entity that reported $1,000,000 or less 
of gross receipts or sales in its most recent Federal 
income tax return for a taxable year, including 
such returns of all of its affiliates. 
‘‘(II) WAIVER.—The Secretary may grant a 
waiver of the fee required under subparagraph 
(A) for the annual registration (excluding the ini-
tial registration) of an establishment for a year, 
beginning on October 1, 2024, if the Secretary 
finds that the establishment is a small business 
and paying the fee for such year represents a 
financial hardship to the establishment as deter-
mined by the Secretary. 
‘‘(III) FIRMS SUBMITTING TAX RETURNS TO THE 
UNITED STATES INTERNAL REVENUE SERVICE.—The 
establishment shall support its claim that it meets 
the definition under subclause (I) by submission 
of a copy of its most recent Federal income tax 
return for a taxable year, and a copy of such 
returns of its affiliates, which show an amount 
of gross sales or receipts that is less than the 
maximum established in subclause (I). The 
establishment, and each of such affiliates, shall 
certify that the information provided is a true and 
accurate copy of the actual tax forms they sub-
mitted to the Internal Revenue Service. If no tax 
forms are submitted for any affiliate, the establish-
ment shall certify that the establishment has no 
affiliates. 
‘‘(IV) FIRMS NOT SUBMITTING TAX RETURNS TO 
THE UNITED STATES INTERNAL REVENUE SERVICE.— 
In the case of an establishment that has not pre-
viously submitted a Federal income tax return, 
the establishment and each of its affiliates shall 
demonstrate that it meets the definition under 
subclause (I) by submission of a signed certifi-
cation, in such form as the Secretary may direct 
through a notice published in the Federal Register, 
that the establishment or affiliate meets the cri-
teria for a small business and a certification, in 
English, from the national taxing authority, if 
extant, of the country in which the establishment 
or, if applicable, affiliate is headquartered. The 
certification from such taxing authority shall bear 
the official seal of such taxing authority and shall 
provide the establishment’s or affiliate’s gross 
receipts or sales for the most recent year in both 
the local currency of such country and in United 
States dollars, the exchange rate used in con-
verting such local currency to dollars, and the 
dates during which these receipts or sales were 
collected. The establishment shall also submit a 
statement signed by the head of the establish-
ment’s firm or by its chief financial officer that 
the establishment has submitted certifications for 
all of its affiliates, or that the establishment has 
no affiliates.
H. R. 2617—1380 
‘‘(V) REQUEST FOR WAIVER.—An establishment 
seeking a fee waiver for a year under this clause 
shall submit supporting information to the Sec-
retary at least 60 days before the fee is required 
pursuant to subparagraph (C). The decision of the 
Secretary regarding whether an entity may receive 
the waiver for such year is not reviewable.’’. 
(b) TAXING AUTHORITY.—Section 738(d)(2)(B)(iii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)(2)(B)(iii)) is 
amended by inserting ‘‘, if extant,’’ after ‘‘national taxing authority’’. 
Subtitle D—Infant Formula 
SEC. 3401. PROTECTING INFANTS AND IMPROVING FORMULA SUPPLY. 
(a) DEFINITIONS.— 
(1) IN GENERAL.—In this section, the term ‘‘infant formula’’ 
has the meaning given such term in section 201(z) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)). 
(2) CRITICAL FOOD.—Section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321) is amended by adding at 
the end the following: 
‘‘(ss) The term ‘critical food’ means a food that is— 
‘‘(1) an infant formula; or 
‘‘(2) a medical food, as defined in section 5(b)(3) of the 
Orphan Drug Act.’’. 
(b) OFFICE OF CRITICAL FOODS.— 
(1) IN GENERAL.—The Secretary shall establish within the 
Center for Food Safety and Applied Nutrition an office to be 
known as the Office of Critical Foods. The Secretary shall 
appoint a Director to lead such Office. 
(2) DUTIES.—The Office of Critical Foods shall be respon-
sible for oversight, coordination, and facilitation of activities 
related to critical foods, as defined in section 201(ss) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection 
(a)(2). 
(c) PREMARKET SUBMISSIONS OF INFANT FORMULA TO ADDRESS 
SHORTAGES.—Section 412 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a) is amended by adding at the end the following: 
‘‘(j) PREMARKET SUBMISSIONS TO ADDRESS SHORTAGES.— 
‘‘(1) IN GENERAL.—The Secretary shall waive the 90-day 
premarket submission requirement under subsection (c) and 
apply a 30-day premarket submission requirement for any per-
son who intends to introduce or deliver for introduction into 
interstate commerce any new infant formula. 
‘‘(2) EFFECTIVE PERIOD.—The waiver authority under this 
subsection shall remain in effect— 
‘‘(A) for 90 days beginning on the date that the Sec-
retary distributes information under section 424(a)(2) with 
respect to a shortage of infant formula; or 
‘‘(B) such longer period as the Secretary determines 
appropriate, to prevent or mitigate a shortage of infant 
formula.’’. 
(d) REPORT.—Not later than one year after the date of enact-
ment of this Act, the Secretary shall submit a report to the Com-
mittee on Health, Education, Labor, and Pensions of the Senate
H. R. 2617—1381 
and the Committee on Energy and Commerce of the House of 
Representatives that includes— 
(1) the number of premarket submissions for new infant 
formula the Secretary has received under section 412(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) 
each year since 2012; 
(2) how many of such submissions received requests from 
the Secretary for additional information; 
(3) how long after receiving such submissions the Secretary 
sent such requests for additional information; 
(4) what additional information the Secretary requested 
of the persons submitting such submissions; and 
(5) the date each new infant formula described in subpara-
graph (A) was first marketed, if available. 
(e) INFANT FORMULA FLEXIBILITIES.—The Secretary shall pub-
lish a list on the website of the Department of Health and Human 
Services providing information on how to identify appropriate sub-
stitutes for infant formula products in shortage that are relied 
upon by infants and other individuals with inborn errors of metabo-
lism or other serious health conditions. 
(f) INTERNATIONAL
HARMONIZATION
OF
INFANT
FORMULA 
REQUIREMENTS.— 
(1) IN GENERAL.—The Secretary— 
(A) shall participate in meetings with representatives 
from other countries to discuss methods and approaches 
to harmonizing regulatory requirements for infant formula, 
including with respect to inspections, labeling, and nutri-
tional requirements; and 
(B) may enter into arrangements or agreements 
regarding such requirements with other countries, as 
appropriate, including arrangements or agreements with 
a foreign government or agency of a foreign government 
to recognize the inspection of foreign establishments that 
manufacture infant formula for export to the United States. 
(2) STUDY ON INFANT FORMULA.— 
(A) IN GENERAL.—Not later than 60 days after the 
date of enactment of this Act, the Secretary shall seek 
to enter into an agreement with the National Academies 
of Sciences, Engineering, and Medicine (referred to in this 
paragraph as the ‘‘National Academies’’) to examine and 
report on challenges in supply, market competition, and 
regulation of infant formula in the United States. 
(B) CONTENTS OF THE REPORT.—The report developed 
pursuant to the agreement under subparagraph (A) shall— 
(i) assess and evaluate— 
(I) infant formula marketed in the United 
States; 
(II) any challenges in supply, or market com-
petition with respect to such infant formula; and 
(III) any differences between infant formula 
marketed in the United States and infant formula 
marketed in the European Union, including with 
respect to nutritional content and applicable 
labeling and other regulatory requirements; and 
(ii) include recommendations, including for infant 
formula manufacturers, on measures to address supply 
and market competition in the United States.
H. R. 2617—1382 
(C) FINAL
REPORT.—The agreement under subpara-
graph (A) shall specify that the National Academies shall, 
not later than 1 year after the date of enactment of this 
Act, complete such study and submit a report on the results 
of such study to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives. 
(g) TRANSPARENCY AND ACCOUNTABILITY TO SUPPORT INFANT 
FORMULA INNOVATION.— 
(1) CONGRESSIONAL NOTIFICATION OF RECALL.—Section 412 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), 
as amended by subsection (c), is further amended by adding 
at the end the following: 
‘‘(k) CONGRESSIONAL NOTIFICATION OF RECALL.— 
‘‘(1) IN GENERAL.—Not later than 24 hours after the initi-
ation of a recall of infant formula as described in subsection 
(e), the Secretary shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Representa-
tives a notification of such recall. 
‘‘(2) CONTENTS.—A notification under paragraph (1) shall 
include the following: 
‘‘(A) If the recall is required by the Food and Drug 
Administration, a summary of the information supporting 
a determination that the adulterated or misbranded infant 
formula presents a risk to human health. 
‘‘(B) If the recall is voluntarily initiated by the manu-
facturer, a summary of the information provided to the 
Food and Drug Administration by the manufacturer 
regarding infant formula that has left the control of the 
manufacturer that may be adulterated or misbranded. 
‘‘(C) Specification of when the Food and Drug Adminis-
tration was first made aware of the instance or cir-
cumstances surrounding the recall. 
‘‘(D) An initial estimate of the disruption in domestic 
production that may result from the recall.’’. 
(2) ANNUAL REPORT TO CONGRESS.—Section 412 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended 
by paragraph (1), is further amended by adding at the end 
the following: 
‘‘(l) ANNUAL REPORT TO CONGRESS.— 
‘‘(1) IN GENERAL.—Not later than March 30 of each year, 
the Secretary shall submit a report to Congress containing, 
with respect to the preceding calendar year, the following 
information: 
‘‘(A) The number of submissions received by the Sec-
retary under subsection (d). 
‘‘(B) The number of such submissions that included 
any new ingredients that were not included in any infant 
formula already on the market. 
‘‘(C) The number of inspections conducted by the Food 
and Drug Administration or any agent thereof to evaluate 
compliance with the requirements for infant formulas 
under subsection (b). 
‘‘(D) The time between any inspection referred to in 
subparagraph (C) and any necessary reinspection to
H. R. 2617—1383 
evaluate compliance with the requirements for infant for-
mulas under subsection (b). 
‘‘(E) A breakdown of the information described in sub-
paragraphs (A) through (D) between foreign and domestic 
manufacturers and facilities. 
‘‘(2) CONFIDENTIALITY.—The Secretary shall ensure that 
the reports under paragraph (1) do not include any information 
that is a trade secret or confidential information subject to 
section 552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code.’’. 
(3) NEW INFANT FORMULA SUBMISSIONS.—Section 412(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) 
is amended by adding at the end the following: 
‘‘(4) The Secretary shall provide a response to a submission 
under this subsection not later than 45 days after receiving such 
submission.’’. 
(4) LIST OF NUTRIENTS.—Section 412(i)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) is amended 
by striking ‘‘or, if revised by the Secretary under paragraph 
(2), as so revised’’ and inserting the following: ‘‘, which shall 
be reviewed by the Secretary every 4 years as appropriate. 
In reviewing such table, the Secretary shall consider any new 
scientific data or information related to infant formula nutri-
ents, including international infant formula standards. The Sec-
retary may revise the list of nutrients and the required level 
for any nutrient required by the table’’. 
(5) GUIDANCE.—Not later than 1 year after the date of 
enactment of this Act, the Secretary shall issue guidance 
regarding information sponsors may consider including in 
submissions required under section 412(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350a(d)), including consider-
ations for meeting each of the requirements of paragraphs 
(1), (2), and (3) of subsection (d). 
(6) TECHNICAL
CORRECTION.—Section 412(c)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(B)) 
is amended by striking ‘‘subsection (c)(1)’’ and inserting ‘‘sub-
section (d)(1)’’. 
(h) RESPONSE TO RECALL.— 
(1) MANUFACTURER SUBMISSION.— 
(A) IN GENERAL.—Promptly after the initiation of a 
recall of infant formula, the manufacturer of the recalled 
infant formula shall submit information to the Secretary 
regarding such recall. 
(B) CONTENTS.—A submission under subparagraph (A) 
shall include the following: 
(i) A plan (including an estimated timeline, as 
applicable) of actions the manufacturer will take, 
suited to the individual circumstances of the particular 
recall, including— 
(I) to identify and address any cause of, and 
contributing 
factor 
in, 
known 
or 
suspected 
adulteration or known or suspected misbranding; 
and 
(II) if appropriate, to restore operation of the 
impacted facilities. 
(ii) In the case that a recall of the manufacturer’s 
infant formula products, and subsequent actions to
H. R. 2617—1384 
respond to such recall, impacts over 10 percent of 
the production of the infant formula intended for sale 
in the United States, a plan to backfill the supply 
of the manufacturer’s infant formula supply if the cur-
rent domestic supply of such infant formula has fallen, 
or is expected to fall, below the expected demand for 
the formula. 
(2) REPORT TO CONGRESS.— 
(A) IN GENERAL.—Promptly after a submission under 
paragraph (1) is received, the Secretary shall provide such 
submission, together with the information specified in 
subparagraph (B), in a report to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Rep-
resentatives. 
(B) CONTENTS.—A report under subparagraph (A) shall 
include the following: 
(i) Information concerning the current domestic 
supply of infant formula, including— 
(I) a breakdown of the specific types of formula 
involved; and 
(II) an estimate of how long current supplies 
will last. 
(ii) If a submission or submissions under para-
graph (1) show that the recall and subsequent actions 
to respond to the recall impact over 10 percent of 
the domestic production of infant formula intended 
for sale in the United States— 
(I) actions to work with the impacted manufac-
turer or other manufacturers to increase produc-
tion; and 
(II) specification of— 
(aa) any additional authorities needed 
regarding production or importation to fill a 
supply gap; and 
(bb) any supplemental funding necessary 
to address the shortage. 
(3) SUNSET.—This subsection shall cease to have force or 
effect on September 30, 2026. 
(i) COORDINATION WITH MANUFACTURER.— 
(1) IN GENERAL.— 
(A) COMMUNICATION
FOLLOWING
INSPECTION.—Upon 
completing an inspection of an infant formula manufac-
turing facility impacted by a recall, the Secretary, acting 
through the Commissioner of Food and Drugs, shall provide 
the manufacturer involved a list of any actions necessary 
to— 
(i) address deficiencies contributing to the potential 
adulteration or misbranding of product at the facility; 
and 
(ii) safely restart production at the facility. 
(B) RESPONSE TO MANUFACTURER.—Not later than 7 
days after receiving a written communication from a manu-
facturer of infant formula containing corrective actions to 
address manufacturing deficiencies identified during an 
inspection of a facility engaged in the manufacturing of 
an infant formula impacted by a recall, the Secretary,
H. R. 2617—1385 
acting through the Commissioner of Food and Drugs, shall 
provide a substantive response to such communication con-
cerning the sufficiency of the proposed corrective actions. 
(2) INSPECTIONS.—The Secretary shall ensure timely 
communication with a manufacturer of infant formula following 
an inspection of a facility engaged in the manufacturing of 
infant formula for consumption in the United States. If a 
reinspection of a manufacturer of an infant formula is required 
to ensure that such manufacturer completed any remediation 
actions or addressed any deficiencies, the Secretary shall 
reinspect such facility in a timely manner. The Secretary shall 
prioritize and expedite an inspection or reinspection of an 
establishment that could help mitigate or prevent a shortage 
of an infant formula. 
(3) ANNUAL INSPECTIONS.—Not later than 6 months after 
the date of enactment of this Act, and not less than once 
per calendar year thereafter, the Secretary shall conduct inspec-
tions, including unannounced inspections, of the facilities 
(including foreign facilities) of each manufacturer of an infant 
formula required to be registered under section 412(c)(1)(A) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(c)(1)(A)), in accordance with a risk-based approach and 
ensure timely and effective internal coordination and alignment 
among the Office of Regulatory Affairs and the Center for 
Food Safety and Applied Nutrition. In meeting the inspection 
requirements under this subsection, the Secretary may rely 
on inspections conducted by foreign regulatory authorities, 
under arrangements or agreements, and conducted by State 
agencies under contract, memoranda of understanding, or any 
other obligation. 
(j) NATIONAL STRATEGY ON INFANT FORMULA.— 
(1) IN GENERAL.—The Secretary, in consultation with the 
Secretary of Agriculture and other heads of relevant depart-
ments and agencies, shall develop and issue, not later than 
90 days after the date of enactment of this Act, a national 
strategy on infant formula to increase the resiliency of the 
infant formula supply chain, protect against future contamina-
tion and other potential causes of supply disruptions and short-
ages, and ensure parents and caregivers have access to infant 
formula and information they need. 
(2) IMMEDIATE NATIONAL STRATEGY.—The national strategy 
under paragraph (1) shall include efforts— 
(A) to increase the resiliency of the infant formula 
supply chain in the short-term by— 
(i) assessing causes of any supply disruption or 
shortage of infant formula in existence as of the date 
of enactment of this Act and potential causes of future 
supply disruptions and shortages; 
(ii) assessing and addressing immediate infant for-
mula needs associated with the shortage; and 
(iii) developing a plan to increase infant formula 
supply, including through increased competition; and 
(B) to ensure the development and updating of edu-
cation and communication materials for parents and care-
givers that cover— 
(i) where and how to find infant formula; 
(ii) comparable infant formulas on the market;
H. R. 2617—1386 
(iii) what to do if a specialty infant formula is 
unavailable; 
(iv) safe practices for handling infant formula; and 
(v) other topics, as appropriate. 
(3) LONG-TERM STRATEGY.—Not later than 90 days after 
the submission of the report described in subsection (f)(2), the 
Secretary shall update the national strategy under paragraph 
(1) to include efforts to improve preparedness against infant 
formula shortages in the long-term by— 
(A) outlining methods to improve information-sharing 
between the Federal Government and State and local 
governments, and other entities as appropriate, regarding 
shortages; 
(B) recommending measures for protecting the integrity 
of the infant formula supply and preventing contamination; 
(C) outlining methods to incentivize new infant formula 
manufacturers to increase supply and mitigate future 
shortages; and 
(D) recommending other necessary authorities to gain 
insight into the supply chain and risk for shortages, and 
to incentivize new infant formula manufacturers. 
(k) MEANINGFUL DISRUPTION IN THE PRODUCTION OF CRITICAL 
FOOD.—Chapter IV of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 341 et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 424. REQUIREMENTS FOR CRITICAL FOOD. 
‘‘(a) NOTIFICATION OF MEANINGFUL DISRUPTION FOR CRITICAL 
FOOD.— 
‘‘(1) IN GENERAL.—A manufacturer of a critical food (as 
defined in section 201(ss)) shall notify the Secretary of a perma-
nent discontinuance in the manufacture or an interruption 
of the manufacture of such food that is likely to lead to a 
meaningful disruption in the supply of such food in the United 
States, and the reasons for such discontinuance or interruption, 
as soon as practicable, but not later than 5 business days 
after such discontinuance or such interruption. 
‘‘(2) DISTRIBUTION OF INFORMATION.—Not later than 5 cal-
endar days after receiving a notification under paragraph (1), 
if the Secretary has determined that such discontinuance or 
interruption has resulted, or is likely to result, in a shortage 
of such critical food, the Secretary shall distribute, to the Sec-
retary of Agriculture and to the maximum extent practicable 
to the appropriate entities, as determined by the Secretary 
through such means as the Secretary determines appropriate, 
information on such shortage. 
‘‘(3) CONFIDENTIALITY.—Nothing in this subsection author-
izes the Secretary to disclose any information that is a trade 
secret or confidential information subject to section 552(b)(4) 
of title 5, United States Code, or section 1905 of title 18, 
United States Code. 
‘‘(4) MEANINGFUL DISRUPTION.—In this subsection, the term 
‘meaningful disruption’— 
‘‘(A) means a change in production that is reasonably 
likely to lead to a significant reduction in the supply of 
a critical food by a manufacturer that affects the ability