[Federal Register: May 30, 2002 (Volume 67, Number 104)]
[Notices]
[Page 37838-37839]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my02-105]
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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