
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34082-34083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0402]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; State Petitions for Exemption From Preemption

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 petitions for 
exemption from preemption.

DATES: Submit either electronic or written comments on the collection 
of information by August 9, 2011.

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, Room 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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

[[Page 34083]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

State Petitions for Exemption From Preemption--21 CFR 100.1(d) (OMB 
Control Number 0910-0277)--Extension

    Under Section 403A(b) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for 
exemption from Federal preemption of State food labeling and standard 
of identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth 
the information a State is required to submit in such a petition. The 
information required under section 100.1(d) enables FDA to determine 
whether the State food labeling or standard of identity requirement 
satisfies the criteria of section 403A(b) of the FD&C Act for granting 
exemption from Federal preemption.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                  Number of
                      21 CFR Section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
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100.1(d).................................................                 1                  1                  1                 40                 40
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec.  100.1(d) is minimal because 
petitions for exemption from preemption are seldom submitted by States. 
In the last 3 years, FDA has not received any new petitions for 
exemption from preemption; therefore, the Agency estimates that one or 
fewer petitions will be submitted annually. Although FDA has not 
received any new petitions for exemption from preemption in the last 3 
years, 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 403(A) of the FD&C Act.

    Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14412 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P


