
[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Notices]
[Pages 32976-32977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements related to the 
recall of infant formula.

DATES: Submit either electronic or written comments on the collection 
of information by August 8, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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

[[Page 32977]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                      No. of          No. of       Total annual     burden per
       21 CFR Section \2\           respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
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107.230.........................               2               1               2           4,500           9,000
107.240.........................               2               1               2           1,482           2,964
107.250.........................               2               1               2             120             240
107.260.........................               1               1               1             650             650
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    Total.......................  ..............  ..............  ..............  ..............          12,854
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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 burden estimate is 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 pursuant to 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 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 4,500 
hours to comply with the requirements of that section, for a total of 
9,000 hours. 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 650 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.

    Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13941 Filed 6-6-11; 8:45 am]
BILLING CODE 4160-01-P


