[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Page 22885-22886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0029]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Infant Formula Recall 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 June 2, 

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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, 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 (21 CFR part 107), 
subpart E) 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 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 February 1, 2005 (70 FR 5188), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of the collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR section      Respondents        per Response        Responses           Response         Total Hours
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
Total                                                                                                     12,854
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

[[Page 22886]]

    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, on average, two infant formula recalls per year for the past 
3 years.

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8766 Filed 5-2-05; 8:45 am]