Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements

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Published

October 14, 2026

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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<title>Federal Register, Volume 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Notices]
[Pages 65225-65228]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20980]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-7131]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Infant Formula
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by November 13, 2026.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0256. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5733,
<a href="/cdn-cgi/l/email-protection#4b1b190a183f2a2d2d0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="3e6e6c7f6d4a5f58587e585a5f1056564d10595148">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

[[Page 65226]]

Infant Formula Requirements--21 CFR parts 106 and 107

OMB Control Number 0910-0256--Revision

Statutory requirements for infant formula under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) are intended to protect the health of
infants and include a number of reporting and recordkeeping
requirements. Among other things, section 412 of the FD&C Act (21
U.S.C. 350a) requires manufacturers of infant formula to establish and
adhere to quality control procedures, notify us when infant formula
that has left the manufacturers' control may be adulterated or
misbranded, and keep records of infant formula distribution. We have
issued regulations to implement the FD&C Act's requirements for infant
formula in parts 106 and 107 (21 CFR parts 106 and 107). We also
regulate the labeling of infant formula under the authority of section
403 of the FD&C Act (21 U.S.C. 343). Under our labeling regulations for
infant formula in part 107, the label of an infant formula must include
nutrient information and directions for use. Failure to comply with any
of the applicable labeling regulations will render an infant formula
misbranded under section 403 of the FD&C Act. The purpose of these
labeling requirements is to ensure that consumers have the information
they need to prepare and use infant formula appropriately.
While the infant formula regulations help ensure the consistent
production of safe and nutritionally adequate infant formulas for
healthy term infants, they apply with one narrow exception. Section
412(h)(1) of the FD&C Act exempts an infant formula represented and
labeled for use by an infant with an inborn error of metabolism, low
birth weight, or who otherwise has an unusual medical or dietary
problem from the requirements of subsections 412(a), (b), and (c) of
the FD&C Act. These formulas are customarily referred to as ``exempt
infant formulas.'' Section 412(h)(2) of the FD&C Act authorizes us to
establish terms and conditions for the exemption of an infant formula
from the requirements of subsections 412(a), (b), and (c) of the FD&C
Act.
In support of exempt infant formulas, we have issued the Agency
guidance document titled ``Exempt Infant Formula Production: Current
Good Manufacturing Practices (CGMPs), Quality Control Procedures,
Conduct of Audits, and Records and Reports'' (April 2016). The guidance
document includes our recommendation that manufacturers of exempt
infant formulas follow, to the extent practicable, subparts A, B, C, D,
and F of 21 CFR part 106, and is available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production</a>.
We have also developed electronic Form FDA 3978 (Infant Formula
Tracking System (IFTRACK)) so that infant formula manufacturers may
electronically submit reports and notifications in a standardized
format to FDA. However, manufacturers that prefer to submit paper
submissions in a format of their own choosing will still have the
option to do so. Form FDA 3978 prompts a respondent to include reports
and notifications in a standard electronic format and helps the
respondent organize their submission to include only the information
needed for our review. Screenshots of Form FDA 3978 and instructions
are available at <a href="http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm">http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm</a>.
FDA has requested voluntary notifications pertaining to product
samples found to be positive for Cronobacter spp. or Salmonella, even
if the affected lot(s) have not been distributed. Associated
recordkeeping requirements are found in 21 CFR 106.55(e). FDA has
requested this information to help prevent future Cronobacter spp.
illnesses associated with powdered infant formula. As part of a
constituent update, available at <a href="https://www.fda.gov/food/cfsan-constituent-updates/fda-calls-enhanced-safety-measures-letter-powdered-infant-formula-industry">https://www.fda.gov/food/cfsan-constituent-updates/fda-calls-enhanced-safety-measures-letter-powdered-infant-formula-industry</a>, we issued a letter on March 8, 2023, to share
current information to assist industry in improving the microbiological
safety of powdered infant formula. As communicated in the letter, we
shared the information with the expectation that infant formula
manufacturers, packers, distributors, exporters, importers, and
retailers will act to mitigate potential food safety risks in powdered
infant formula in accordance with FDA regulations while further
striving to improve operations, especially given the critical nature of
these products.
Regulations in 21 CFR part 107, subpart E--Recalls (21 CFR 107.200
through 107.280) pertain to infant formula recalls. Specifically, Sec.
107.230 requires manufacturing firms conducting infant formula recalls
to:
(1) evaluate the hazard to human health;
(2) devise a written recall strategy;
(3) promptly notify each affected direct-account (customer) about
the recall; and
(4) furnish the appropriate FDA district office with copies of
these documents.
If the recalled formula presents a risk to human health, the
recalling firm must also request that each establishment that sells the
recalled formula post (at point of purchase) a notice of the recall and
provide FDA with a copy of the notice.
Similarly, regulations in Sec. 107.240 require recalling firms to:
(1) notify the appropriate FDA district office of the recall by
telephone within 24 hours;
(2) submit a written report to that office within 14 days; and
(3) submit a written status report at least every 14 days until the
recall is terminated.
Before terminating a recall, recalling firms are required to submit
a recommendation for termination of the recall to the appropriate FDA
district office and wait for written FDA concurrence. Where the recall
strategy or implementation is determined to be deficient, FDA may
require the firm to change the extent of the recall, carry out
additional effectiveness checks, and issue additional notifications.
Finally, to facilitate identifying the location of the product being
recalled, the recalling firm is required to maintain distribution
records for at least 1 year after the expiration of the shelf life of
the infant formula.
We use the information collection to determine industry compliance
with Agency regulations which implement public health protection
provisions of the FD&C Act applicable to infants and all infant
formula. Respondent disclosures are used by consumers when purchasing,
storing, and preparing infant formula to help ensure its safe use.
Section 424(a)(1) of the FD&C Act (21 U.S.C. 350m) requires a
manufacturer of a critical food to notify FDA of a permanent
discontinuance or an interruption of the manufacture of a critical food
that is likely to lead to a meaningful disruption in the supply of the
food in the United States. Section 201(ss) of the FD&C Act (21 U.S.C.
321(ss)) defines a ``critical food'' as 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. A manufacturer of a critical food is required to
notify FDA of a permanent 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

[[Page 65227]]

discontinuance or such interruption. To help facilitate the process,
FDA accepts notifications via email (<a href="/cdn-cgi/l/email-protection#f5b6879c819c969499b39a9a91a69d9a8781949290b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="084b7a617c616b69644e67676c5b60677a7c696f6d486e6c692660607b266f677e">[email&#160;protected]</span></a>).
The draft guidance titled ``Notifying FDA of a Permanent
Discontinuance in the Manufacture or an Interruption of the Manufacture
of an Infant Formula'' (December 2024), when finalized, will provide
FDA's interpretation regarding the circumstances under which infant
formula manufacturers should notify FDA. The draft guidance, available
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-notifying-fda-permanent-discontinuance-manufacture-or-interruption">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-notifying-fda-permanent-discontinuance-manufacture-or-interruption</a>, provides recommendations
for notifications to include certain information and how respondents
should notify FDA of a permanent discontinuance or interruption of
supply of infant formula.
Section 424(b) of the FD&C Act requires a manufacturer of a
critical food to develop, maintain, and implement a redundancy risk
management plan that identifies and evaluates risks to the supply of
the food for each establishment in which a critical food is
manufactured. A risk management plan may identify and evaluate risks to
the supply of more than one critical food manufactured at the same
establishment. A risk management plan may also identify mechanisms by
which the manufacturer would mitigate the impacts of a supply
disruption through alternative production sites, alternative suppliers,
stockpiling of inventory, or other means. Records of a risk management
plan are subject to FDA inspection and copying.
Description of Respondents: Respondents to this information
collection are manufacturers of infant formula and include
manufacturers of critical foods in the limited instance of a meaningful
disruption in the supply of the food in the United States.
In the Federal Register of July 17, 2026 (91 FR 44859), we
published a 60-day notice requesting public comment on the proposed
collections of information. Two comments were received. Both comments
supported FDA's need for the information collections established by the
regulatory requirements and recommended in associated guidance, as well
as the Agency's use of IFTRACK and other electronic mechanisms utilized
for collection. The comments also encouraged the continued development
of automated collection techniques that would enhance our ability to
efficiently receive and evaluate information. We appreciate all
comments and will continue to explore enhanced collection methods and
upgrade respective IT systems as our limited resources permit. Finally,
while both comments discussed specific considerations and criteria FDA
should apply in evaluating the safety of infant formula products and in
assessing effort necessary to complete the required recordkeeping
tasks, they suggested no change to the burden estimates proffered in
our 60-day notice. We therefore retain those figures, which are as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Activity; 21 CFR section Number of responses per annual Average burden per Total
respondents respondent responses response hours
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Reports; Section 412(d) of 5 13 65 10........................ 650
the FD&C Act.
Notifications; Sec. 1 1 1 4......................... 4
106.120(b).
Reports for exempt infant 3 2 6 4......................... 24
formula; Sec.
107.50(b)(3) and (4).
Notifications for exempt 1 1 1 4......................... 4
infant formula; Sec.
107.50(e)(2).
Requirements for quality 4 9 36 20........................ 720
factors--growth monitoring
study exemption; Sec.
106.96(c).
Requirements for quality 1 34 34 12........................ 408
factors--PER exemption;
Sec. 106.96(g).
New infant formula 4 9 36 0.50 (30 minutes)......... 18
registration; Sec.
106.110.
New infant formula 4 9 36 10........................ 360
submission; Sec. 106.120.
Elements of infant formula 2 1 2 4,450..................... 8,900
recall; Sec. 107.230.
Notification requirements; 2 1 2 1,482..................... 2,964
Sec. 107.240.
Termination of infant 2 1 2 120....................... 240
formula recall; Sec.
107.250.
Revision of an infant 1 1 1 625....................... 625
formula recall; Sec.
107.260.
Notification of a permanent 8 1 8 2......................... 16
discontinuance or an
interruption of the
manufacture of a critical
food; draft guidance for
Notifying FDA of a
Permanent Discontinuance in
the Manufacture or an
Interruption of the
Manufacture of an Infant
Formula.
Notify FDA of test results 20 1 20 0.25 (15 minutes)......... 5
as discussed in constituent
letter of March 8, 2023.
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Total................... ............ ................ .......... .......................... 14,938
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The estimates in table 1 are based on our experience with similar
notification programs. Regarding activities found in the draft
guidance, we estimate that each year 5 manufacturers of infant formula
will submit notifications in compliance with section 424(a)(1) of the
FD&C Act and following recommendations found in the draft guidance. We
also estimate that each year 3 manufacturers of medical foods will
submit notifications in compliance with section 424(a)(1) of the FD&C
Act, for a total of 8 manufacturers of a critical food. We estimate
that each manufacturer will submit 1 notification for 8 total annual
notifications (8 manufacturers x 1 notification). Each submission will
take an estimated 2 hours to complete for an annual reporting burden of
16 hours (8 notifications x 2 hours).

[[Page 65228]]

Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of Total Average
Activity; FD&C Act or 21 CFR part Number of records per annual burden per Total
recordkeepers recordkeeper records record hours
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SUBPART B: CGMP Requirements; Part 106..... 5 429.8 2,149 4.4 9,414
SUBPARTS C-G: Quality control; audits; 5 726.8 3,634 6 21,818
quality factors; records and reports; Part
106.......................................
SUBPART C; Exempt infant formulas; Part 107 3 10 30 300 9,000
Exempt infant formula production; GMP; 3 634 1,902 45 85,590
audits, recordkeeping, & reports..........
Risk management plan; draft guidance for 11 1 11 60 660
Notifying FDA of a Permanent
Discontinuance in the Manufacture or an
Interruption of the Manufacture of an
Infant Formula............................
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Total \2\.............................. ............. ................ .......... .......... 126,482
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Figures have been rounded.

Regarding recordkeeping found in the draft guidance, we estimate
that each year 11 manufacturers of critical foods will create and
maintain a risk management plan in compliance with section 424(b) of
the FD&C Act. We estimate that each risk management plan will take an
estimated 60 hours to create and maintain for an annual recordkeeping
burden of 660 hours (11 records x 60 hours).

Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total LI>burden Total
Activity; 21 CFR section respondents disclosures per annual per hours
respondent disclosures disclosure
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Nutrient labeling; Sec. Sec. 107.10(a) 5 13 65 8 520
and 107.20................................
Elements of infant formula recall; Sec. 2 1 2 50 100
107.230...................................
Revision of an infant formula recall; Sec. 1 1 1 25 25
107.260..................................
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Total.................................. ............ ................ ........... .......... 645
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Based on a review of the information collection since our last
request for OMB approval, we are revising the information collection to
include activities recommended in the draft guidance titled ``Notifying
FDA of a Permanent Discontinuance in the Manufacture or an Interruption
of the Manufacture of an Infant Formula.'' We are also removing burden
associated with the guidance titled ``Infant Formula Transition Plan
for Exercise of Enforcement Discretion'' (September 2022) as we are no
longer experiencing disruptions in the supply of infant formula in the
United States and therefore did not extend the guidance's in-effect end
date. Lastly, we are correcting an inadvertent omission of 22 responses
from the previous approval.
The draft guidance added 676 hours and 19 responses to the
information collection. We also are adding 22 responses to correct an
inadvertent omission. However, removal of the enforcement discretion
guidance will reduce the burden estimate by 3,805 hours and 137
responses. Calculating hours and responses for the addition of the
draft guidance and the correction along with the subtraction of the
enforcement discretion guidance results in a net reduction of 3,129
hours (3,805 hours reduced for enforcement discretion guidance-676
hours added for draft guidance) and 96 responses (137 responses reduced
for enforcement discretion guidance-19 responses added for draft
guidance-22 responses added for the correction).

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20980 Filed 10-13-26; 8:45 am]
BILLING CODE 4164-01-P

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