18638 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices

instrument to assess the extent to which

such individuals and families believe

they have opportunities to exercise

meaningful choice and selfdetermination and to carry out personal

responsibilities in life; and

(6) Develop a prototypical public

opinion survey instrument which can be

reliably and cost effectively

administered to a representative

national sample of the general public at

least once every five years.

(Federal Catalog of Domestic Assistance

Number 93.631—Developmental

Disabilities—Projects of National

Significance)

Dated: April 10, 1997.

Bob Williams,

Commissioner, Administration on

Developmental Disabilities.

[FR Doc. 97–9801 Filed 4–15–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0139]

Genzyme Corp.; Premarket Approval of

SeprafilmTM Bioresorbable Membrane

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Genzyme

Corp., Cambridge, MA, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of

SeprafilmTM Bioresorbable Membrane.

After reviewing the recommendation of

the General and Plastic Surgery Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of August 12, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by May 16, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Stephen P. Rhodes, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–3090.

SUPPLEMENTARY INFORMATION: On

October 27, 1995, Genzyme Corp.,

Cambridge, MA 02139–1562, submitted

to CDRH an application for premarket

approval of SeprafilmTM Bioresorbable

Membrane. The device is an absorbable

adhesion barrier and is indicated for use

in patients undergoing abdominal or

pelvic laparotomy as an adjunct

intended to reduce the incidence,

extent, and severity of postoperative

adhesions between the abdominal wall

and the underlying viscera such as

omentum, small bowel, bladder, and

stomach, and between the uterus and

surrounding structures such as tubes

and ovaries, large bowel and bladder.

On March 25, 1996, the General and

Plastic Surgery Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On August 12, 1996, 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 15, 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. 97–9726 Filed 4–15–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2552, HCFA–R–88]

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, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the 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 Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Hospital and

Hospital Health Care Complex Cost

Report, 42 CFR 413.20 and 413.24; Form

No.: HCFA–2552–96; Use: This form is
Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices 18639

required by statute and regulation for

participation in the Medicare program.

The information is used to determine

final payment for Medicare. Hospitals

and related complexes are the main

users. Frequency: Annually; Affected

Public: Business or other for-profit, Notfor profit institutions, and State, Local

or Tribal government; Number of

Respondents: 7,000; Total Annual

Responses: 7,000; Total Annual Hours

Requested: 4,599,000.

2. Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Information

Collection Requirements in HCFA Pub

14–3 Section 2120.1–2125 and Section

4115 of the Carriers Manual (HCFA–R–

88); Use: Verification of ambulance

compliance with State and Local

requirements is necessary to determine

whether the ambulance qualifies for

reimbursement under Medicare. Carriers

require ambulances providing service to

Medicare beneficiaries to submit

documentation showing that they have

the required equipment. Frequency: On

occasion; Affected Public: Business or

other for-profit; Number of

Respondents: 100; Total Annual Hours:

25.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

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: Louis Blank,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: April 7, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–9721 Filed 4–15–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1514]

Agency Information Collection

Activities: Submission for OMB

Review; 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 proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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.

Type of Information Collection

Request: Extension of currently

approved collection; Title of

Information Collection: Hospital

Request for Certification in the

Medicare/Medicaid Programs; Form

No.: HCFA–1514; Use: Section 1861 of

the Social Security Act and 42 CFR part

482 requires hospitals to be certified to

participate in the Medicare/Medicaid

programs. As part of the certification

process, providers must complete form

HCFA–1514. This certification form is a

facility identification and screening

form used to initiate the certification

process and to determine if the provider

has sufficient personnel to participate in

the Medicare/Medicaid programs.

Frequency: Annually; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 2,500; Total

Annual Responses: 2,500; Total Annual

Hours: 625.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC. 20503

Dated: April 8, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–9708 Filed 4–15–97; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Availability of Funds for the National

Health Service Corps Loan Repayment

Program

AGENCY: Health Resources and Services

Administration, PHS, HHS.

ACTION: Extension of deadline date.

SUMMARY: The Health Resources and

Services Administration (HRSA)

published a document in the Federal

Register of March 28, 1997, concerning

availability of funds for the National

Health Service Corps (NHSC) Loan

Repayment Program (LRP). The

deadline date needs to be extended.

In the Federal Register issue of

Friday, March 28, 1997, in FR Doc. 97–

7838, on page 14925, in the second

column, correct the ‘‘Dates’’ caption to

read:

DATES: The deadline for applications is

August 31, 1997, or until all

appropriated funds have been obligated,

whichever occurs first. Due to limited

funding, it is anticipated that all

appropriated funds will be obligated

prior to August 31, 1997. The volume of

applications is historically three times

greater than the number of contracts that

can be awarded. Therefore, to receive

consideration for funding, health

professionals must submit an

application and proof of a job offer at an

approved NHSC LRP Service Site.

Dated: April 9, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–9725 Filed 4–15–97; 8:45 am]

BILLING CODE 4160–15–P