[Federal Register Volume 65, Number 72 (Thursday, April 13, 2000)]
[Notices]
[Pages 19915-19916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0002]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Application for Exemption From Federal 
Preemption of State and Local Medical Device Requirements

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 May 
15, 2000.

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: 
Wendy Taylor, 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.

Application for Exemption From Federal Preemption of State and 
Local Medical Device Requirements--21 CFR Part 808 (OMB Control No. 
0910-0129)--Extension

    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 that 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.
    In the Federal Register of January 18, 2000 (65 FR 2631), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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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                                                                                                330
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\1\ 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 in 
the future contained in table 1 of this document 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 19916]]


    Dated: April 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-9132 Filed 4-12-00; 8:45 am]
BILLING CODE 4160-01-F