Notice2023-06249
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 58 (Monday, March 27, 2023)</title>
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[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18146-18148]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#bbebe9fae8cfdaddddfbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de">[email 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 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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy</a>). 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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion</a>). 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 <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.
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.
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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
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