
[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51371-51373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0425]


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 
September 19, 2011.

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 e-mailed 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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

[[Page 51372]]

for termination of the recall to the appropriate FDA district office 
and wait for written FDA 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 or nutritional inadequacy or 
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 7, 2011 (76 FR 32976), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA has added a new table 2 to this document to comply with the new 
requirement to report third-party disclosure burden hours in a separate 
table. The third-party disclosure burden hours were previously reported 
in the 60-day notice under the reporting burden table (table 1). In 
compliance with the new requirement, we have broken out the third-party 
disclosure burden hours in a new third-party disclosure burden table 
(table 2). FDA has moved 50 hours per recall from line 1 of table 1 to 
line 1 of table 2, and 25 hours per recall from line 4 of table 1 to 
line 2 of table 2. This is being done to show the third-party 
disclosure burden previously disclosed in table 1. The total estimated 
burden of this collection remains unchanged at 12,864 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Number of                        Average burden
                        21 CFR Section                              Number of       responses per     Total annual    per response (in     Total hours
                                                                   respondents       respondent         responses          hours)
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107.230.......................................................                 2                 1                 2             4,450             8,900
107.240.......................................................                 2                 1                 2             1,482             2,964
107.250.......................................................                 2                 1                 2               120               240
107.260 \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.

    The reporting and third-party disclosure burden estimates are based 
on Agency records, which show that there are five 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 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 this section 
is seldom used by FDA; therefore, the Agency estimates that there will 
be one or fewer respondents annually for Sec.  107.260.
    The estimated number of reporting burden hours per response is an 
average based on the Agency's 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 will 
take a respondent 4,450 hours to comply with the requirements of that 
section, for a total of 8,900 hours. In the 60-day notice, we estimated 
that it will take a respondent 4,500 hours per recall to comply with 
Sec.  107.230 for a total of 9,000 hours. As noted, we have added a new 
table 2 to report third-party disclosure burden hours. The new lower 
figure of 4,450 hours per recall reflects that 50 hours are being 
reported in new table 2. We estimate 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. We estimate 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, we estimate that one respondent will need to carry out 
additional effectiveness checks and issue additional notifications 
under Sec.  107.260, for a total of 625 hours. In the 60-day notice, we 
estimated that it will take a respondent 650 hours per recall to comply 
with Sec.  107.260 for a total of 650 hours. As noted, we have added a 
new table 2 to report third-party disclosure burden hours. The new 
lower figure of 625 hours per recall reflects that 25 hours are being 
reported in new table 2.
    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.

[[Page 51373]]



                                               Table 2--Estimated Annual Third-Party Disclosure Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of                        Average burden
                        21 CFR Section                              Number of      disclosures per    Total annual     per disclosure      Total hours
                                                                   respondents       respondent        disclosures       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.230.......................................................                 2                 1                 2                50               100
107.260.......................................................                 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.

    New table 2 reports the Agency'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 the Agency'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 
requirement that the recalling firm must also request that each 
establishment that sells the recalled formula post (at the point of 
purchase) a notice of the recall. We estimate 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. We estimate 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: August 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21040 Filed 8-17-11; 8:45 am]
BILLING CODE 4160-01-P


