[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18146-18148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0814]


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 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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by April 26, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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, 301-796-5733, 
[email protected].

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 18147]]

Infant Formula Requirements Under the Federal Food, Drug, and Cosmetic 
Act--21 CFR Parts 106 and 107

OMB Control Number 0910-0256--Revision

    This information collection supports FDA regulations, and 
associated Agency forms and guidance, pertaining to infant formula 
requirements. Statutory provisions for infant formula under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) were enacted to protect the 
health of infants and include specific current good manufacturing 
practice (CGMP), labeling (disclosure), and a number of reporting and 
recordkeeping requirements. Section 412 of the FD&C Act (21 U.S.C. 
350a) requires manufacturers of infant formula to establish and 
document the adherence to quality control procedures, notify FDA when a 
batch of infant formula that has left the manufacturers' control may be 
adulterated or misbranded, and keep records of infant formula 
distribution. Notification requirements are also included in the 
regulations regarding the quantitative formulation of the infant 
formula; a description of any reformulation or change in processing; 
assurances that the formula will not be marketed until regulatory 
requirements are met as demonstrated by specific testing; and 
assurances that manufacturing processes comply with the regulations. 
The regulations are found in 21 CFR part 106: Infant Formula 
Requirements Pertaining to Current Good Manufacturing Practice, Quality 
Control Procedures, Quality Factors, Records and Reports, and 
Notifications; and 21 CFR part 107: Infant Formula.
    We have revised the information collection as part of the Federal 
Government's response to address ongoing disruptions in the infant 
formula supply. We communicated our initial efforts to address the 
infant formula shortage in the May 2022 guidance entitled ``Infant 
Formula Enforcement Discretion Policy: Guidance for Industry'' (May 
2022 guidance; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy). To clarify whether products 
currently subject to enforcement discretion would be able to remain on 
the market, we issued the September 2022 guidance entitled ``Infant 
Formula Transition Plan for Exercise of Enforcement Discretion: 
Guidance for Industry'' (September 2022 guidance; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion). The September 2022 guidance sets out a pathway for 
manufacturers of infant formula that began marketing infant formula 
products in the United States after receiving a letter of enforcement 
discretion based on information provided in response to the May 2022 
guidance to seek to continue marketing such products under enforcement 
discretion while they work to bring their infant formula products fully 
into compliance with applicable requirements.
    In the Federal Register of October 6, 2022 (87 FR 60689), FDA 
announced that we had requested, and OMB had approved, emergency 
processing of the proposed collection of information under section 
3507(j) of the PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13) and invited 
public comment, instructing comments be submitted to OMB. No comments 
have been received. On our own initiative, however, we are also 
revising the collection to account for 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. 
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 https://www.fda.gov/food/cfsan-constituent-updates/fda-calls-enhanced-safety-measures-letter-powdered-infant-formula-industry, 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.
    FDA estimates the burden of this collection of information as 
follows:

                             Table 1--Estimated One-Time Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Submit information in                      115               1             115  24..............           2,760
 accordance with timing and
 content schedule discussed in
 guidance document for both
 exempt and non-exempt infant
 formulas.
Letter of Intent..............              11               1              11  5...............              55
Plan to Meet Applicable Infant              11               1              11  90..............             990
 Formula Requirements.
Voluntary Submission of sample              20               1              20  0.25 (15                       5
 results as described in                                                         minutes).
 constituent update of March
 8, 2023.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           3,810
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate is based on submissions received in response to the 
May 2022 guidance, for which we account for 115 respondents, each of 
whom submitted 1 request. We assume it requires an average of 24 hours 
to prepare each submission, and therefore calculate a total of 2,760 
burden hours (115 requests x 24 hours). Although originally we assumed 
15 respondents would initiate requesting enforcement discretion, out of 
those 115 respondents,

[[Page 18148]]

we have issued letters of enforcement discretion to 12 of them. We 
received letters from 11 of these respondents indicating their intent 
to bring their products fully into compliance with applicable 
regulatory requirements and requesting that we continue to exercise 
enforcement discretion in the interim, and have therefore adjusted the 
number of respondents associated with the corresponding activities 
accordingly. We assume each request requires an average of 5 hours to 
prepare, for a total of 55 burden hours (11 letters x 5 hours). We 
estimate these same respondents will then submit a compliance plan and 
assume each plan will require an average of 90 hours to prepare, for a 
total of 990 burden hours (11 plans x 90 hours).
    We estimate the burden associated with the voluntary notification 
of positive sampling results as discussed in our March 8, 2023, letter 
to be 20 responses and 5 hours annually, assuming 15 minutes is 
necessary for the completion of this activity. We also assume 
respondents will utilize established notification methods found on our 
website or by contacting the FDA district office in which the positive 
sampling results have occurred.

    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06249 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P