17850 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

application. On December 20, 1995,

CDRH approved the application by a

letter to the applicant from the Director

of the Office of Device Evaluation,

CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before May 12, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: March 17, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–9432 Filed 4–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposals for the

collection of information. Interested

persons are invited to send comments

regarding this burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

1. Type of Request: Extension of a

currently approved collection; Title of

Information Collection: Medicaid,

EPSDT, Maternal and Child Health;

Form No.: HCFA–416; Use: States are

required to submit annual EPSDT

program reports to HCFA pursuant to

Section 1902(a) (43) of the Social

Security Act. These reports provide

HCFA with data necessary to assess the

effectiveness of State EPSDT programs,

to develop trend patterns and

projections nationally, and respond to

inquiries. Respondents are State

Medicaid agencies; Frequency:

Annually; Affected Public: State, local

or tribal government; Number of

Respondents: 56; Total Annual

Responses: 56; Total Annual Hours:

1,568.

To request copies of the proposed

paperwork collection referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: Linda

Mansfield, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 2, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–9356 Filed 4–10–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Special Project Grants; Traumatic

Brain Injury Demonstration Grants

AGENCY: Health Resources and Services

Administration (HRSA).

ACTION: Notice; correction.

SUMMARY: The Health Resources and

Services Administration published a

document in the Federal Register of

March 27, 1997, concerning Special

Project Grants; Traumatic Brain Injury

Demonstration Grants. The document

contained an incorrect phone number

for the Division of Maternal, Infant,

Child and Adolescent Health

(DMICAH).

Correction

In the Federal Register issue of

Thursday, March 27, 1997 (62 FR

14684), in FR Doc. 97–7727, on page

14685 in the second column, correct the

FOR FURTHER INFORMATION CONTACT

caption to read:

FOR FURTHER INFORMATION CONTACT:

Requests for technical or programmatic

information from MCHB should be

directed to the Division of Maternal,

Infant, Child and Adolescent Health

(DMICAH), Maternal and Child Health

Bureau, Health Resources and Services

Administration, Room 18A–39,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857. The

DMICAH telephone number for TBI

inquiries is 301–443–5599.

The rest of the notice remains the

same.

Dated: April 7, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–9337 Filed 4–10–97; 8:45 am]

BILLING CODE 4160–15–P