
[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63127-63128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25105]


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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) 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 
November 21, 2014.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 (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.'' Our 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 us 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 our written concurrence (Sec.  107.250). Where the recall 
strategy or implementation is determined to be deficient, we 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 us to monitor the effectiveness of infant 
formula recalls in order to protect babies from infant formula that may 
be unsafe because of contamination or nutritional inadequacy or 
otherwise adulterated or misbranded. We use 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 August 7, 2014 (79 FR 46270), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the annual 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 infant formula recall....................                 2                 1                 2             4,450             8,900
107.240; notification requirements............................                 2                 1                 2             1,482             2,964
107.250; termination of infant formula recall.................                 2                 1                 2               120               240
107.260; revision of an infant formula recall \2\.............                 1                 1                 1               625               625
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................            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.


[[Page 63128]]

    The reporting and third-party disclosure burden estimates are based 
on our records, which show that there are 5 manufacturers of infant 
formula and that there have been, on average, 2 infant formula recalls 
per year for the past 3 years. Based on this information, we estimate 
that there will be, on average, approximately 2 infant formula recalls 
per year over the next 3 years.
    Thus, we estimate that 2 respondents will 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 will be 1 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 2 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. We estimate that 2 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. We estimate that 2 
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, we estimate that 1 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      disclosures per    Total annual     Average burden      Total hours
                                                                   respondents       respondent        disclosures     per disclosure
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107.230; elements of infant formula recall....................                 2                 1                 2                50               100
107.260; revision of an infant formula recall.................                 1                 1                 1                25                25
                                                               -----------------------------------------------------------------------------------------
    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 our 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. 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 requirement 
that 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 2 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. We 
estimate that 1 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: October 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25105 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P


