[Federal Register Volume 67, Number 104 (Thursday, May 30, 2002)]
[Notices]
[Pages 37838-37839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0053]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Medical Devices; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
1, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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 [sect] 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

[[Page 37839]]

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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                                          Annual Frequency per    Total Annual     Hours per
   21 CFR Section    No. of Respondents         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 [sect] 100.1(d) is insignificant because 
petitions for exemption from preemption are seldom submitted by States. 
In the last 3 years, FDA has not received any new petitions; therefore, 
the agency estimates that one or fewer petitions will be submitted 
annually. Because [sect] 100.1(d) implements a statutory information 
collection requirement, only the additional burden attributable to the 
regulation has been included in the estimate. 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 403(A) of the act.

    Dated: May 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-13588 Filed 5-29-02; 8:45 am]
BILLING CODE 4160-01-S