[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52055-52056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24410]


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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, 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.

DATES: Fax written comments on the collection of information by 
December 11, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0188. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

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 (the 
FD&C Act) (21 U.S.C. 350a(e)) 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 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 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). 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). 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).
    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.
    In the Federal Register of June 15, 2017 (82 FR 27509), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment that was unrelated 
to the information collection.
    FDA estimates the burden of this 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 an 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 an                     2               1               2             120             240
 infant formula recall..........
107.260; Revision of an infant                 1               1               1             625             625
 formula recall \2\.............
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[[Page 52056]]

 
    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 FDA's records, which show 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, FDA 
estimates that there will be, on average, approximately two infant 
formula recalls per year over the next 3 years.
    Thus, FDA estimates that two respondents will conduct recalls 
annually under Sec. Sec.  107.230, 107.240, and 107.250. The estimated 
number of respondents for Sec.  107.260 is minimal because FDA seldom 
uses this section; therefore, FDA estimates that there will be one or 
fewer respondents annually for Sec.  107.260. The estimated number of 
hours per response is an average based on FDA's experience and 
information from firms that have conducted recalls. FDA estimates that 
two respondents will conduct infant formula recalls under Sec.  107.230 
and that it will take a respondent 4,450 hours to comply with the 
requirements of that section, for a total of 8,900 hours. FDA estimates 
that two respondents will conduct infant formula recalls under Sec.  
107.240 and that it will take a respondent 1,482 hours to comply with 
the requirements of that section, for a total of 2,964 hours. FDA 
estimates that two respondents will submit recommendations for 
termination of infant formula recalls under Sec.  107.250 and that it 
will take a respondent 120 hours to comply with the requirements of 
that section, for a total of 240 hours. Finally, FDA estimates that one 
respondent will need to carry out additional effectiveness checks and 
issue additional notifications, for a total of 625 hours.
    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     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
107.230; Elements of an infant                 2               1               2              50             100
 formula recall.................
107.260; Revision of an infant                 1               1               1              25              25
 formula recall.................
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    Total \2\...................  ..............  ..............  ..............  ..............             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 FDA's experience. 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. FDA 
estimates that two respondents will conduct infant formula recalls 
under Sec.  107.230 and that it will take 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. FDA 
estimates that one respondent will issue additional notifications under 
Sec.  107.260 and that it will take a respondent 25 hours to comply 
with the third-party disclosure requirements of that section, for a 
total of 25 hours.

    Dated: November 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24410 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P


