Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices 10571

Headquarters, 200 Independence Avenue,

SW, Room 5–35E, Washington, DC 20201

Centers for Disease Control and Prevention

CDC Employee Assistance Program

Administrator, Personnel Management

Office, 1600 Clifton Road, NE, Mail Stop

K17, Atlanta, GA 30333

Southwest Complex

Employee Assistance Program Administrator,

Program Support Center, 330 C Street, SW,

Room 1036 Washington, DC 20201

Health Care Financing Administration

HCFA Employee Assistance Program

Administrator, 7500 Security Boulevard,

C2–15–05, Baltimore, MD 21244

National Institutes of Health

NIH Employee Assistance Program

Administrator, Building 31, Room 1C02,

9000 Rockville Pike, Bethesda, MD 20892

Parklawn/Hyattsville Complex

Employee Assistance Program Team Leader,

Office of the Secretary, ASMB, HHS EAP

Headquarters, 200 Independence Avenue,

SW, Room–35E, Washington, DC 20201

[FR Doc. 97–5571 Filed 3–6–97; 8:45 am]

BILLING CODE 4150–04–M

Centers for Disease Control and

Prevention

Advisory Committee for Injury

Prevention and Control: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting.

Name: Advisory Committee for Injury

Prevention and Control (ACIPC).

Times and Dates: 2 p.m.–4 p.m., March 24,

1997. 8:30 a.m.–3:30 p.m., March 25, 1997.

Place: The Ritz-Carlton, Atlanta

(Downtown), 181 Peachtree Street, NE,

Atlanta, Georgia 30303.

Status: Closed: 2 p.m.–3 p.m., March 24,

1997, and 8:30–9 a.m., March 25, 1997;

Open: 3 p.m.–4 p.m., March 24, 1997, and 9

a.m.–3:30 p.m., March 25, 1997.

Purpose: This committee makes

recommendations regarding policies,

strategies, objectives, and priorities, and

reviews progress toward injury prevention

and control. The Committee provides advice

on the appropriate balance and mix of

intramural and extramural research,

including laboratory research, and provides

guidance on intramural and extramural

scientific program matters, both present and

future, particularly from a long-range

viewpoint. The Committee provides secondlevel scientific and programmatic review for

applications for research grants, cooperative

agreements, and training grants related to

injury control and violence prevention, and

recommends approval of projects that merit

further consideration for funding support.

The Committee recommends areas of

research to be supported by contracts and

provides concept review of program

proposals and announcements.

Matters to be Discussed: The meeting will

convene in closed session from 2 p.m. to 3

p.m. on March 24, 1997. The purpose of this

closed session is for the Science and Program

Review Work Group to consider Injury

Control Research Center grant applications

recommended for further consideration by

the CDC Injury Research Grant Review

Committee. On March 25, 1997, from 8:30

a.m. to 9 a.m., the meeting will convene in

closed session in order for the full Committee

to vote on a funding recommendation. These

portions of the meeting will be closed to the

public in accordance with provisions set

forth in section 552(c)(4) and (6) title 5

U.S.C., and the Determination of the

Associate Director for Management and

Operations, CDC, pursuant to Public Law 92–

463. Following the closed session there will

be discussions on future grant program

announcements, ad hoc committee reports,

and updates on further progress on standing

Work Group issues. The Committee will also

discuss (1) an update from the Director,

National Center for Injury Prevention and

Control (NCIPC); (2) Safe America:

Advancing the Initiative; and (3) a report

from the Science and Program Review Work

Group which will include reports on the

motor vehicle programmatic review and

poison control centers.

Agenda items are subject to change as

priorities dictate.

Contace Person for More Information: Mr.

Thomas A. Blakeney, Acting Executive

Secretary, ACIPC, NCIPC, CDC, 4770 Buford

Highway, NE, M/S K61, Atlanta, Georgia

30341–3724, telephone 770/488–1481.

Dated: March 4, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–5818 Filed 3–6–97; 8:45 am]

BILLING CODE 4163–18–P

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Detailed Case Data Component

(DCDC) of the National Child Abuse and

Neglect Data System.

OMB No.: 0980–0256.

Description: The Detailed Case Data

Component of the National Child Abuse

and Neglect Data System compiles

automated case-level data on child

maltreatment investigated by State child

protective services agencies. Data are

collected on reports of abuse and

neglect, characteristics of victims, risk

factors associated with victims and their

families, and the development of polices

and programs relating the child abuse

and neglect at the National, State and

local levels.

Respondents: State, Local or Tribal

Govt.

Annual Burden Estimates

Instrument Number of

respondents

Number of

responses per respondent

Average burden

hours per response Total burden hours

DCDC ............................................................................... 56 1 110 6,160

Estimated Total Annual Burden Hours: 6,160.

In compliance with the requirements

of Section 3506(c)(2)(A) of the Paper

work Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to
10572 Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices

comments and suggestions submitted

within 60 days of this publication.

Dated: March 3, 1997.

Bob Sargis,

Acting Reports Clearance Officer

[FR Doc. 97–5570 Filed 3–6–97; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 97N–0022]

Agency Information Collection

Activities: Proposed Collection;

Reinstatements

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 (the

PRA), Federal agencies are required to

publish a notice in the Federal Register

concerning each 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

reporting and recordkeeping

requirements relating to the

manufacture and distribution of hearing

aid devices, reporting requirements for

firms that provide electronic product

samples to FDA for research and testing

purposes, reporting requirements for

firms that intend to export certain

unapproved medical devices, and

reporting and recordkeeping

requirements relating to shipment of

nonsterile devices that are to be

sterilized elsewhere or are shipped to

other establishments for further process

labeling or repacking.

DATES: Submit written comments on the

collection of information requirements

by May 6, 1997.

ADDRESSES: Submit written comments

on the collection of information

requirements 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

PRA (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.

Section 3506(c)(2)(A) of the PRA (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 collections of

information listed below.

With respect to the following

collections of information, FDA invites

comments on: (1) Whether the proposed

collections of information are necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of the agency’s

estimates of the burdens of the proposed

collections of information, including the

validity of the methodologies and

assumptions used; (3) ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4)

ways to minimize the burdens of the

collections of information on

respondents, including through the use

of appropriate automated collection

techniques, when appropriate, and other

forms of information technology.

1. Hearing Aid Devices: Professional

and Patient Package Labeling and

Conditions for Sale—21 CFR 801.420

and 801.421 (OMB Control No. 0910–

0171—Reinstatement)

Under section 520(e) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(e)), the Secretary of the

Department of Health and Human

Services (the Secretary) may, under

certain conditions, require by regulation

that a device be restricted to sale,

distribution, or use only upon

authorization of a licensed practitioner

or upon other prescribed conditions.

Sections 801.420 and 801.421 (21 CFR

801.420 and 801.421) implement this

authority for hearing aids, which are

restricted devices. The regulations

require that the manufacturer or

distributor provide to the user data

useful in selecting, fitting, and checking

the performance of a hearing aid

through distribution of a User

Instructional Brochure. The User

Instructional Brochure must also

contain technical data about the device,

instructions for its use, maintenance,

and care, a warning statement, a notice

about the medical evaluation

requirement, and a statement if the aid

is rebuilt or used.

Hearing aid dispensers are required to

provide the prospective user, before the

sale of a hearing aid, with a copy of the

User Instructional Brochure for the

hearing aid model that has been, or may

be, selected for the prospective user and

to review the contents of the brochure

with the buyer. In addition, upon

request by an individual who is

considering the purchase of a hearing

aid, the dispenser is required to provide

a copy of the User Instructional

Brochure for that model hearing aid or

the name and address or telephone

number of the manufacturer or

distributor from whom a User

Instructional Brochure for the hearing

aid may be obtained. Under conditions

of sale of hearing aid devices,

manufacturers or distributors shall

provide sufficient copies of the User

Instructional Brochure to sellers for

distribution to users and prospective

users and provide a copy of the User

Instructional Brochure to any health

care professional, user, or prospective

users who requests a copy in writing.

The regulations also require that the

patient provide a written statement that

he or she has undergone a medical

evaluation within the previous 6

months before the hearing aid is

dispensed, although informed adults

may waive the medical evaluation

requirement by signing a written

statement. Finally, the regulation

requires that the dispenser retain for 3

years copies of all physician statements

or any waivers of medical evaluations.

The information obtained through this

collection of information is used by

FDA to ensure that hearing aids are sold

and used in a way consistent with the

public health.

The information contained in the User

Instructional Brochure is intended not

only for the hearing aid user but also for

the physician, audiologist, and

dispenser. The data is used by these

health care professionals to evaluate the

suitability of a hearing aid, to permit

proper fitting of it, and to facilitate

repairs. The data also permits the

comparison of the performance

characteristics of various hearing aids.

Noncompliance could result in a

substantial risk to the hearing impaired

because the physician, audiologist, or

dispenser would not have sufficient

data to match the aid to the needs of the

user.