[Federal Register Volume 61, Number 156 (Monday, August 12, 1996)]
[Notices]
[Pages 41792-41793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0226]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Reinstatement

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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed reinstatement 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 written comments on the collection of information by 
October 11, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 
reinstatement 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 listed below.
    With respect to the following collection of information, FDA 
invites comments on: (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, 107.280 (OMB Control Number 0910-0188-Reinstatement)

    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) 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 evaluate the hazard 
to human health, devise a written recall strategy, promptly notify each 
affected direct account (customer) about the recall, and 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 notify the appropriate FDA district office of the recall by 
telephone within 24 hours, to submit a written report to that office 
within 14 days, and to 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 above 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:

[[Page 41793]]



                                        ESTIMATED ANNUAL REPORTING BURDEN                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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107.230                                  .5             1                .5         4,500           2,250       
107.240                                  .5             1                .5         1,482             741       
107.250                                  .5             1                .5           120              60       
107.260                                  .5             1                .5           650             325       
Total                                                                               6,752           3,376       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    -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. 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.
    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 6 years, or 0.5 recalls annually. -

    Dated: August 3, 1996.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 96-20439 Filed 8-9-96; 8:45 am]
BILLING CODE 4160-01-F