[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Notices]
[Pages 26765-26766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12283]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-0192]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Infant Formula Recall Regulations and
Correction
AGENCY: Food and Drug Administration, HHS.
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 (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.
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 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
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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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 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\
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\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]
BILLING CODE 4160-01-F