[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67303-67304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21432]


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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 
Recalls

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the 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 October 30, 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, 
<a href="/cdn-cgi/l/email-protection#faaaa8bba98e9b9c9cba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="67373526341306010127010306490f0f1449000811">[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.

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, 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 part 107 (21 CFR part 107): Infant Formula.
    In the Federal Register of October 6, 2022 (87 FR 60689), we 
provided notice communicating updates to the information collection and 
invited public comment on the proposed

[[Page 67304]]

collections of information. No comments were received. On our own 
initiative, for efficiency of Agency operations, we are again revising 
the information collection to include related activities applicable to 
regulations in part 107, subpart E (21 CFR 107.200 through 107.280) 
pertaining to infant formula recalls. These information collections are 
currently approved in OMB control number 0910-0188. Specifically, 21 
CFR 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, Agency regulations in 21 CFR 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 (21 CFR 107.250). 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 (21 CFR 107.260). 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 (Sec.  107.280 (21 CFR 107.280)).
    We estimate the burden of the collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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107.230; Elements of infant                    2               1               2           4,450           8,900
 formula recall.................
107.240; Notification                          2               1               2           1,482           2,964
 requirements...................
107.250; Termination of infant                 2               1               2             120             240
 formula recall.................
107.260; Revision of an infant                 1               1               1             625             625
 formula recall.................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          12,729
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The reporting and third-party disclosure burden estimates are based 
on current available data showing eight manufacturers of infant formula 
and that there have been, on average, two infant formula recalls per 
year for the past 3 years. Under 5 CFR 1320.3(b)(2), the time, effort, 
and financial resources necessary to comply with a collection of 
information are excluded from the burden estimate if the reporting, 
recordkeeping, or disclosure activities needed to comply are usual and 
customary because they would occur in the normal course of activities. 
Accordingly, because we believe that associated records are maintained 
as a usual and customary part of normal business activities, we include 
no separate burden estimate for recordkeeping requirements found in 
Sec.  107.280.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
    21 CFR section; activity         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2              50             100
 formula recall.................
107.260; Revision of an infant                 1               1               1              25              25
 formula recall.................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             125
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Although we have increased the number of respondents to the 
information collection since our last request for OMB approval, we have 
made no adjustments to the burden we estimate for the time necessary to 
complete activities associated with infant formula recalls.

    Dated: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21432 Filed 9-28-23; 8:45 am]
BILLING CODE 4164-01-P


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