[Federal Register Volume 68, Number 15 (Thursday, January 23, 2003)]
[Notices]
[Pages 3260-3261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1435]


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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]
BILLING CODE 4160-01-S