[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Notices]
[Pages 27059-27060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12952]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0151]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
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 (the PRA).
DATES: Submit written comments on the collection of information by June
16, 1997.
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:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1479.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Application for Exemption From Federal Preemption of State and
Local Medical Device Requirements--21 CFR Part 808--(OMB Control
No. 0910-0129--Reinstatement)
Section 521(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360k(a)) provides that no State or local government may
establish, or continue in effect, any requirement with respect to a
medical device that is different from, or in addition to, any Federal
requirement applicable to the device under the act. Under section
521(b) of the act, following receipt of a written application from the
State or local government involved, FDA may exempt from preemption a
requirement that is more stringent than the Federal requirement, or
that is necessitated by compelling local conditions and compliance with
the requirement would not cause the device to be in violation of any
portion of any requirement under the act. Exemptions are granted by
regulation issued after notice and opportunity for an oral hearing.
The regulations in 21 CFR 808.20 require a State or local
government that is seeking an exemption from preemption to submit an
application to FDA. The application must include a copy of the State or
local requirement, as well as information about its interpretation and
application, and a statement as to why the applicant believes that the
requirement qualifies for exemption from preemption under the act. FDA
will use the information in the application to determine whether the
requirement meets the criteria for exemption in the act and whether
granting an exemption would be in the interest of the public health.
In addition, 21 CFR 808.25 provides that an interested person may
request a hearing on an application by submitting a letter to FDA
following the publication by FDA of a proposed response to the
application.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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808.20 3 1 3 100 300
808.25 3 1 3 10 30
Total 6 2 6 110 330
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There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based its estimates of the number of submissions expected on
the number of submissions submitted in the last 3 years and on the
number of inquiries received indicating that applications would be
submitted in the next year. FDA based its estimates of the time
required to prepare submissions on discussions with those who have
prepared submissions in the last 3 years.
[[Page 27060]]
Dated: April 25, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12952 Filed 5-15-97; 8:45 am]
BILLING CODE 4160-01-F
