[Federal Register Volume 73, Number 43 (Tuesday, March 4, 2008)]
[Notices]
[Pages 11648-11649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0132]


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 written or electronic comments on the collection of 
information by May 5, 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, 301-827-4659.

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 Petitions for Exemption From Preemption--21 CFR 100.1(d) (OMB 
Control No. 0910-0277) --Extension

    Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act 
(the 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 Sec.  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 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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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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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

[[Page 11649]]

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 act.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: February 26, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4066 Filed 3-3-08; 8:45 am]
BILLING CODE 4160-01-S