Document ID: FDA-2014-N-1027-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Infant Formula Recall Regulations
Posted Date: 2020-08-12T04:00Z

[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Pages 48705-48706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17542]

[[Page 48705]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1027]

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

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 September 11, 2020.

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 0910-0188. 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, 
PRAStaff@fda.hhs.gov.

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 Recall Regulations--21 CFR 107.230, 107.240, 107.250, 
107.260, and 107.280

OMB Control Number 0910-0188--Extension

    Section 412(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a(e)) (FD&C Act) provides that if the manufacturer of an 
infant formula has knowledge that reasonably supports the conclusion 
that an infant formula processed by that manufacturer has left its 
control and may not provide the nutrients required in section 412(i) of 
the FD&C Act or is otherwise adulterated or misbranded, the 
manufacturer must promptly notify the Secretary of Health and Human 
Services (the Secretary). If the Secretary determines that the infant 
formula presents a risk to human health, the manufacturer must 
immediately take all actions necessary to recall shipments of such 
infant formula from all wholesale and retail establishments, consistent 
with recall regulations and guidelines issued by the Secretary. Section 
412(f)(2) of the FD&C Act states that the Secretary shall by regulation 
prescribe the scope and extent of recalls of infant formula necessary 
and appropriate for the degree of risk to human health presented by the 
formula subject to recall. FDA's infant formula recall regulations in 
part 107 (21 CFR part 107) implement these statutory provisions.
    Section 107.230 (21 CFR 107.230) requires each recalling firm to 
conduct an infant formula recall with the following elements: (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. Section 107.240 (21 CFR 107.240) requires the recalling firm to 
conduct an infant formula recall with the following elements: (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, the 
recalling firm is required to submit a recommendation for termination 
of the recall to the appropriate FDA district office and wait for FDA's 
written concurrence (Sec.  107.250 (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 
(Sec.  107.260 (21 CFR 107.260)). In addition, to facilitate 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)).
    The reporting and recordkeeping requirements described previously 
are designed to enable FDA to monitor the effectiveness of infant 
formula recalls in order to protect babies from infant formula that may 
be unsafe because of contamination, nutritional inadequacy, or is 
otherwise adulterated or misbranded. FDA uses the information collected 
under these regulations to help ensure that such products are quickly 
and efficiently removed from the market.
    Description of Respondents: Respondents to this collection of 
information are manufacturers of infant formula who are for-profit 
businesses in the private sector.
    In the Federal Register of April 27, 2020 (85 FR 23367), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection 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.................
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[[Page 48706]]

 
    Total \2\...................  ..............  ..............  ..............  ..............          12,729
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ No burden has been estimated for the recordkeeping requirement in Sec.   107.280 because these records are
  maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula
  distribution records for the prescribed period as a matter of routine business practice.

    The reporting and third-party disclosure burden estimates are based 
on Agency data, which shows that there are six manufacturers of infant 
formula and that there have been, on average, two infant formula 
recalls per year for the past 3 years. Based on this information, we 
estimate that there are, on average, approximately two infant formula 
recalls per year.
    Thus, we estimate that two respondents conduct recalls annually 
pursuant to Sec. Sec.  107.230, 107.240, and 107.250. The estimated 
number of respondents for Sec.  107.260 is minimal because we seldom 
use this section; therefore, we estimate that there are one or fewer 
respondents annually for Sec.  107.260. The estimated number of hours 
per response is an average based on our experience and information from 
firms that have conducted recalls. We estimate that two respondents 
will conduct infant formula recalls under Sec.  107.230 and that it 
takes 4,450 hours to comply with the requirements of that section, for 
a total of 8,900 hours. We estimate that two respondents conduct infant 
formula recalls under Sec.  107.240 and that it takes a respondent 
1,482 hours to comply with the requirements of that section, for a 
total of 2,964 hours. We estimate that two respondents submit 
recommendations for termination of infant formula recalls under Sec.  
107.250 and that it takes a respondent 120 hours to comply with the 
requirements of that section, for a total of 240 hours. Finally, we 
estimate that one respondent needs to carry out additional 
effectiveness checks and issue additional notifications, for a total of 
625 hours. Therefore, the total annual burden hours for reporting is 
12,729 hours (8,900 + 2,964 + 240 + 625).
    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. No burden has been estimated 
for the recordkeeping requirement in Sec.  107.280 because these 
records are maintained as a usual and customary part of normal business 
activities. Manufacturers keep infant formula distribution records for 
the prescribed period as a matter of routine business practice.

                           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.

    Table 2 reports FDA's third-party disclosure burden estimates for 
Sec. Sec.  107.230 and 107.260. The estimated burden hours per 
disclosure is an average based on our experience with the information 
collection. The third-party disclosure burden in Sec.  107.230 is the 
requirement to promptly notify each affected direct account (customer) 
about the recall, and 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 a notice of the recall at the 
point of purchase. We estimate that two respondents conduct infant 
formula recalls under Sec.  107.230 and that it takes a respondent 50 
hours to comply with the third-party disclosure requirements of that 
section, for a total of 100 hours. The third-party disclosure burden in 
Sec.  107.260 is the requirement to issue additional notifications 
where the recall strategy or implementation is determined to be 
deficient. We estimate that one respondent issues additional 
notifications under Sec.  107.260 and that it takes a respondent 25 
hours to comply with the third-party disclosure requirements of that 
section, for a total of 25 hours. The total annual third-party 
disclosure burden is 125 hours (100 + 25).
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: August 6, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17542 Filed 8-11-20; 8:45 am]
BILLING CODE 4164-01-P