Agency Information Collection Activities; Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0025]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the

proposed collection of information listed below has been submitted to

the Office of Management and Budget (OMB) for review and clearance

under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by

March 24, 1997.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:

Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of

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

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

301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the

Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the

following proposed collection of information to OMB for review and

clearance:

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 because 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

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Annual

No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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39............. 0.5 19.5 3 58.5

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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: February 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-4227 Filed 2-20-97; 8:45 am]

BILLING CODE 4160-01-F