Notice2023-21432
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recalls
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
September 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 188 (Friday, September 29, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67303-67304]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21432]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <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#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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 29, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.