8024 Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Notices

document should be sent by mail or

facsimile to: Nancy Tips, NCEH/CDC,

Mailstop F42, 4770 Buford Highway,

N.E., Atlanta, GA, 30341–3724,

facsimile (770) 488–7335.

SUPPLEMENTARY INFORMATION: Childhood

lead poisoning is a major preventable

environmental health problem in the

United States. Since 1975, when CDC

issued its first comprehensive

guidelines for preventing lead poisoning

in children, ‘‘Increased Lead Absorption

and Lead Poisoning in Young

Children,’’ CDC has worked with public

health agencies, child health-care

providers, and various concerned

groups to prevent lead poisoning in

young children. Other editions of the

guidelines have been published in 1975,

1978, 1985, and 1991. Each revision has

incorporated new scientific and

practical information on how best to

reduce the adverse effects of lead on the

health of young children. This draft

guidance is narrower in scope than the

1991 edition of ‘‘Preventing Lead

Poisoning in Young Children.’’ It does

not modify CDC’s position on adverse

health effects caused by lead. Instead, it

makes recommendations to improve the

use of screening to prevent lead

poisoning among young children. These

recommendations are needed because

data indicate that many children,

especially those living in older housing,

continue to be heavily exposed to lead,

whereas the average exposure of

children in the United States has

substantially declined. To address this

situation, the recommendations in this

guidance are intended to increase the

screening and follow-up care of children

who most need these services and to

ensure that prevention approaches are

appropriate to local conditions. The

audience for this guidance includes

State and local public health officials,

who will make screening

recommendations for their jurisdictions,

and pediatricians and other child

health-care providers, public health

agencies, and health care organizations,

including managed care organizations.

Dated: February 14, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–4281 Filed 2–20–97; 8:45 am]

BILLING CODE 4163–18–P

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.

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 standardsetting entities, including other Federal

agencies concerned with standardsetting, 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

No. of Respondents Annual Frequency per

Response Total Annual Responses Hours per Response Total Hours

39 0.5 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: 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

[Docket No. 95D–0283]

Deciding When to Submit a 510(k) for

a Change to an Existing Device;

Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.