[Federal Register Volume 61, Number 238 (Tuesday, December 10, 1996)]
[Notices]
[Pages 65068-65069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31321]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0445]
Agency Information Collection Activities: Proposed Collection;
Reinstatement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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,
Federal agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed reinstatement 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 comments on the collection of information by
February 10, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: Under the Paperwork Reduction Act of 1995
(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 provide information to a third party. FDA submitted a
copy of this notice to OMB for its review of this information
collection and requested emergency processing. OMB approved the
information collection through March 31, 1997, and assigned OMB Control
No. 0910-0129. Section 3506(c)(2)(A) of the Paperwork Reduction Act of
1995 (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 reinstatement 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 listed below.
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--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:
[[Page 65069]]
Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
808.20 3 1 3 100 300
808.25 3 1 3 10 30
Total Burden Hours 6 2 6 110 330
----------------------------------------------------------------------------------------------------------------
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 the above table 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. Persons are not required to respond to a collection of
information unless it displays a valid control number.
Dated: November 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31321 Filed 12-9-96; 8:45 am]
BILLING CODE 4160-01-F
