[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41360-41361]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy08-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0397]
Agency Information Collection Activities; Proposed Collection;
Comment Request; State Enforcement Notifications
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 or electronic comments on the collection of
information by September 16, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
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 these topics: (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 Notifications--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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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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.
The estimated reporting burden for Sec. 100.2(d) is minimal
because enforcement notifications are seldom used by States. During the
last 3 years, FDA has not received any new enforcement notifications;
therefore, the agency estimates that one or fewer notifications will be
submitted annually. Although FDA has not received any new enforcement
notifications in the last 3 years, it believes these information
collection provisions should be extended to provide for the potential
future need of a State government to submit enforcement notifications
informing FDA when it intends to take enforcement action under the act
against a particular food located in the State.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
[[Page 41361]]
Dated: July 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16447 Filed 7-17-08; 8:45 am]
BILLING CODE 4160-01-S