[Federal Register Volume 67, Number 109 (Thursday, June 6, 2002)]
[Notices]
[Pages 39011-39012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0055]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Infant Formula Recall Regulations

AGENCY: Food and Drug Administration, HHS.

[[Page 39012]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below 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 on the collection of information by July 
8, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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 
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 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 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 (part 107, subpart E (21 CFR 
part 107, subpart E)) implement these statutory provisions.
    Section 107.230 requires each recalling firm to: (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 an FDA approved notice of recall. 
Section 107.240 requires the recalling firm to: (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 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. If manufacturers were not 
required to provide this information to FDA, FDA's ability to ensure 
that recalls are conducted properly would be greatly impaired.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                             Annual Frequency per    Total Annual     Hours per
   21 CFR Section      No. of Respondents          Response            Responses      Response      Total Hours
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107.230                        3                      1                   3          4,500         13,500
107.240                        3                      1                   3          1,482          4,446
107.250                        3                      1                   3            120            360
107.260                        3                      1                   3            650            650
Total                                                                                              18,956
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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. The 
reporting burden estimate is based on agency records, which show that 
there are five manufacturers of infant formula and that there have been 
three recalls in the last 3 years, or one recall annually.

    Dated: May 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-14169 Filed 6-5-02; 8:45 am]
BILLING CODE 4160-01-S