[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Pages 26765-26766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12283]



Food and Drug Administration
[Docket No. 99N-0192]

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

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 (the PRA). In addition, this 
notice is correcting the title of the information collection. In the 
Federal Register of February 23, 1999 (64 FR 8832 at 8833), the title 
of the information collection was incorrectly listed as a 
``Reinstatement;'' it should have been listed as an ``Extension.'' This 
document corrects that error.

DATES: Submit written comments on the collection of information by June 
16, 1999.

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: 
Desk Officer for FDA.

Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(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, 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 a copy of the notice. 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

[[Page 26766]]

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.
    In the Federal Register of February 23, 1999 (64 FR 8832), the 
agency requested comments on the proposed collections of information. 
No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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               1             650             650
Total                                                                                             18,956\2\
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Due to clerical error, the reporting burden hours for Secs.  107.230, 107.240, 107.250, and the total burden
  hours that appeared in a notice issued in the Federal Register of February 23, 1999 (64 FR 8832), were
  incorrect. Table 1 of this document contains the correct estimates.

    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 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12283 Filed 5-14-99; 8:45 am]