[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Pages 30525-30526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-1392]
Agency Information Collection Activities: Proposed Collection;
Comment Request; State Enforcement Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements
contained in existing FDA regulations governing State enforcement
notifications.
DATES: Submit written comments on the collection of information by
August 9, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: Under 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 extension 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 set forth in this document.
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.
State Enforcement Notification--21 CFR 100.2(d) (OMB Control Number
0910-0275--Extension)
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections
of the act in their own names, but provides that States must notify FDA
before doing so. Section 100.2(d) (21 CFR 100.2(d)) sets forth the
information that a State must provide to FDA in a letter of
notification when it intends to take enforcement action under the act
against a particular food located in the State. The information
required under Sec. 100.2(d) will enable FDA to identify the food
against which the State intends to take action and advise the State
whether Federal action has been taken against it. With certain narrow
exceptions, Federal enforcement action precludes State action under the
act.
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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100.2(d) 1 1 1 10 10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 30526]]
The reporting burden for Sec. 100.2(d) is insignificant because
enforcement notifications are seldom submitted by States requesting the
agency take enforcement action under the act against a particular food.
Over the last 3 years, FDA has not received any enforcement
notifications. Since the enactment of section 403A(b) of the act (21
U.S.C. 343-1(b)) as part of the Nutrition Labeling and Education Act of
1990, FDA has received only a few enforcement notifications.
Although FDA believes that the burden will be insignificant, it
believes these information collection provisions should be extended to
provide for the potential future need of a State or local government to
petition for an exemption from preemption under the provisions of
section 310(b) of the act.
Dated: May 28, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-14458 Filed 6-7-99; 8:45 am]
BILLING CODE 4160-01-F