[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Notices]
[Pages 59445-59446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29945]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0416]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 
December 23, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the

[[Page 59446]]

Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC, Attn: Desk Officer 
for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Wolff, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (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, 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:

                                        Estimated Annual Reporting Burden                                       
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
107.230                                 0.5             1               0.5         4,500           2,250       
107.240                                 0.5             1               0.5         1,482             741       
107.250                                 0.5             1               0.5           120              60       
107.260                                 0.5             1               0.5           650             325       
Total                                                                               6,752           3,376       
----------------------------------------------------------------------------------------------------------------
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: November 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-29945 Filed 11-21-96; 8:45 am]
BILLING CODE 4160-01-F