Agency Information Collection Activities: Proposed Collection; Comment Request; Extension

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N-0298]

Agency Information Collection Activities: Proposed Collection;

Comment Request; Extension

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 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 the voluntary collection of information for the

Medical Devices Standards Activities Report, a comprehensive listing of

current national and international standards for medical devices.

DATES: Submit written comments on the collection of information by

January 3, 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: Charity B. Smith, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,

301-827-1686.

SUPPLEMENTARY INFORMATION: 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

extension of an existing collection of information. ``Collection of

information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). 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.

[[Page 56686]]

Medical Devices Standards Activities Report (OMB Control Number

0910-0219--Extension)

FDA is collecting information necessary to update a comprehensive

listing of current national and international standards activities in

the field of medical devices. The collection of this information is

authorized by section 514(a)(4)(B) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360d(a)(4)(B)), which requires FDA to consult

with other nationally or internationally recognized standard-setting

entities, including other Federal agencies concerned with standard-

setting, in carrying out its responsibility to establish special

controls for medical devices. This report is used by approximately 39

standards-developing organizations to coordinate their standards

activities. This coordination prevents duplication of effort and

insures efficient and expeditious management of standards development.

Over 700 copies of this report are used by government, hospitals,

libraries, industry, private citizens, and State and local government

agencies, including FDA, to keep abreast of standards development

activities and current technology concerning the safety of medical

devices. Without the report, there would be duplication of standards

efforts by voluntary standards organizations since there is no other

publication that can be easily referenced to ascertain if a certain

medical device standard is being or has been developed.

FDA estimates the burden of this collection of information as

follows:

Estimated Annual Reporting Burden

----------------------------------------------------------------------------------------------------------------

Annual Frequency per Total Annual

No. of Respondents Response Responses Hours per Response Total Hours

----------------------------------------------------------------------------------------------------------------

39................... .5 19.5 3 58.5

----------------------------------------------------------------------------------------------------------------

There are no capital costs or operating and maintenance costs associated with this collection of information.

This collection occurs biennially and is voluntary. There are 39

national and international organizations with one report each reporting

---------------------------------------------------------------------------

period.

Dated: October 29, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-28209 Filed 11-1-96; 8:45 am]

BILLING CODE 4160-01-F