Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Notices 48291

for Infectious Diseases, CDC, M/S P02/MLR,

P.O. Box 2087 (Foothills Campus), Fort

Collins, Colorado 80522, telephone 970/221–

6415.

Dated: September 8, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–24335 Filed 9–12–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Child Care Quarterly Case

Record Report; Republication, In

Federal Register Document 97–23469

(Volume 62, Number 171), Page 46743

the word ‘‘Disaggregate’’ replaces the

word ‘‘Desegregate’’ and ‘‘Respondents:

States and Territories’’ replaces

‘‘Respondents: State, Local or Tribal

Govt.’’ For the convenience of the

reader, the document is being

republished in its entirety.

OMB No.: New Request.

Description: This legislativelymandated report collects program and

participants data on children receiving

direct CCDF funds. Disaggregate data

will be collected and will be used to

determine the participants and program

characteristics, as well as cost and level

of child care services. The data will be

used to provide a report to Congress.

Respondents: States and Territories.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

ACF–801 ........................................................................................................................... 56 4 20 4,360

Estimated Total Annual Burden

Hours: 4,360.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, S.W.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Laura Oliven.

Dated: September 9, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–24280 Filed 9–12–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0022]

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 (the PRA).

DATES: Submit written comments on the

collection of information by October 15,

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, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Judith V. Bigelow, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1479.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

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