[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
