[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]


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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.

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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, 
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                                       
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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 Burden Hours                      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 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