[Federal Register: January 23, 2003 (Volume 68, Number 15)]
[Notices]
[Page 3260-3261]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja03-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0009]
Agency Information Collection Activities; Proposed Collection;
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 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 FDA's requirements for State
and local governments' applications for exemption from preemption for
medical device requirements.
DATES: Submit written or electronic comments on the collection of
information by March 24, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: Peggy Robbins, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1223.
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
[[Page 3261]]
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: (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.
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 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:
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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808.20 3 1 3 100 300
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808.25 3 1 3 10 30
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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.
Dated: January 14, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1435 Filed 1-22-03; 8:45 am]
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