16592 Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Advisory Committees; Notice

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: The purpose of this notice is

to solicit nominations for membership

on the National Committee on Vital and

Health Statistics (NCVHS). The NCVHS,

which consists of 18 members, is the

statutory public advisory body to the

Department of Health and Human

Services in the area of health statistics,

health data standards, health

information privacy and health

information policy generally. In this

capacity, the NCVHS provides advice

and assistance to the Department on a

variety of health data policy and privacy

issues. Public Law 104–191, the Health

Insurance Portability and

Accountability Act of 1996, has

assigned new responsibilities to the

Committee in health data standards and

health information privacy.

Several vacancies are expected to

occur on the Committee during 1997.

New members will be appointed to

terms of up to four years by the

Secretary from among persons who have

distinguished themselves in the fields of

health statistics, electronic interchange

of health care information, privacy and

security of electronic information,

population-based public health,

purchasing or financing of health care

services, integrated computerized health

information systems, health services

research, consumer interests in health

information, health data standards,

epidemiology, and the provision of

health services.

In appointing members to the

Committee, the Department will give

close attention to equitable geographic

distribution and to minority and female

representation. Appointments will be

made without discrimination on the

basis of age, race, gender, sexual

orientation, HIV status, cultural,

religious or socioeconomic status.

DATES: Nominations for new members

should include a letter describing the

qualifications of the nominee and the

nominee’s current resume or vitae. The

closing date for nominations is May 7,

1997. Nominations previously

submitted for vacancies occurring in

1995 and 1996 automatically will be

considered in this solicitation and need

not be resubmitted.

Nominations should be sent to the

person named below: James Scanlon,

Executive Secretary, HHS Data Council,

U.S. Department of Health and Human

Services, Room 440–D, 200

Independence Avenue S.W.,

Washington, D.C. 20201, (202) 690–

7100.

FOR FURTHER INFORMATION CONTACT:

James Scanlon (202) 690–7100

Additional information about the

NCVHS, including the charter and

current roster of members, is available

on the NCVHS home page of the HHS

website: http://aspe.os.dhhs.gov/ncvhs/

index/htm.

Dated: March 30, 1997.

David Garrison

Dated: March 29, 1997.

Bruce Vladeck,

Cochairpersons HHS Data Council.

[FR Doc. 97–8805 Filed 4–4–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

RIN 0905–ZA99

Office of Public Health and Science;

Announcement of Availability of

Grants for Adolescent Family Life

Demonstration Projects

AGENCY: Office of Adolescent Pregnancy

Programs, Office of Population Affairs,

OPHS, HHS.

ACTION: Correction to notice.

SUPPLEMENTARY INFORMATION: In notice

document 97–6307, on March 13, 1997,

Part VI, Federal Register, Vol. 62, No.

49, Page 12031, Column 3, under (2)

Review Under Executive Order 12372,

the date for State comments to be

received by the Office of Population

Affairs was incorrect. The date should

be corrected to June 30, 1997.

Dated: March 25, 1997.

Diane J. Osterhus,

Director, Grants Management Office, Office

of Population Affairs.

[FR Doc. 97–8803 Filed 4–4–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

RIN 0905–ZBOO

Office of Public Health and Science;

Announcement of Availability of

Grants for Adolescent Family Life

Demonstration Projects

AGENCY: Office of Adolescent Pregnancy

Programs, Office of Population Affairs,

OPHS, HHS.

ACTION: Correction to notice.

SUPPLEMENTARY INFORMATION: In notice

document 97–6308, on March 13, 1997,

Part V, Federal Register, Vol. 62, No. 49,

Page 12027, Column 3, under (2) Review

Under Executive Order 12372, the date

for State comments to be received by the

Office of Population Affairs was

incorrect. The date should be corrected

to June 13, 1997.

Dated: March 25, 1997.

Diane J. Osterhus,

Director, Grants Management Office, Office

of Population Affairs.

[FR Doc. 97–8804 Filed 4–4–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. 93612–973]

Administration for Native Americans:

Availability of Financial Assistance;

Correction

In notice document 93612–973

beginning on page 14276 in the issue of

Tuesday, March 25, 1997, make the

following corrections:

1. On page 14276 the sentence DATES:

The closing date for receipt of

applications is May 27, 1997’’ should

read, DATES: The closing date for

submission of applications is May 27,

1997.’’

2. On page 14278 in part II, in section

D titled ‘‘Eligible Applicants’’, in the

first column, second line from the

bottom, the following sentence, ‘‘An

organization can conclusively establish

that it meets this requirement through a

signed statement or resolution stating

that its duly elected or appointed board

of directors are either Native Americans

or Native Alaskans or a copy of the

organizational charter or by-laws that

clearly states that the organization has a

board drawn from members of these

groups’’ should read, ‘‘To establish

compliance with the requirement in the

regulations for a Board representative of

the community applicants should

provide information establishing that at

least ninety (90) percent of the

individuals serving on a non-profit

applicant’s board fall into one or more

of the following categories: (1) a current

or past member of the community to be

served; (2) a prospective participant or

beneficiary of the project to be funded;

or (3) have a cultural relationship with

the community to be served.’’
Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices 16593

Dated: March 26, 1997.

Gary N. Kimble,

Commissioner, Administration for Native

Americans.

[FR Doc. 97–8729 Filed 4–4–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. 93612–971]

Administration for Native Americans:

Availability of Financial Assistance

ACTION: Announcement of availability of

competitive financial assistance for

projects in competitive areas

administered by the Administration for

Native Americans for American Indians,

Native Hawaiian, Alaska Natives and

Native American Pacific Islanders;

Correction

In notice document 93612–971

beginning on page 44122 in the issue of

Tuesday, August 27, 1996, make the

following corrections:

1. On pages 44124, 44129, 44127, and

44132 in section D titled Eligible

Applicants, the following sentence

repeated on each of those pages, ‘‘An

organization can conclusively establish

that it meets this requirement through a

signed statement or resolution stating

that its duly elected or appointed board

of directors are either Native Americans

or Native Alaskans or a copy of the

organizational charter or by-laws that

clearly states that the organization has a

board drawn from members of these

groups’’ should read, ‘‘To establish

compliance with the requirement in the

regulations for a Board representative of

the community applicants should

provide information establishing that at

least ninety (90) percent of the

individuals serving on a non-profit

applicant’s board fall into one or more

of the following categories: (1) A current

or past member of the community to be

served; (2) a prospective participant or

beneficiary of the project to be funded;

or (3) have a cultural relationship with

the community to be served.’’

Dated: March 26, 1997.

Gary N. Kimble,

Commissioner, Administration for Native

Americans.

[FR Doc. 97–8733 Filed 4–4–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0124]

COOK OB/GYN; Humanitarian Device

Exemption Approval of Harrison Fetal

Bladder Stent Set (Lowery

Modification)

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the humanitarian device

exemption (HDE) application by COOK

OB/GYN, Spencer, IN, under the

Federal Food, Drug, and Cosmetic Act

(the act) of the Harrison Fetal Bladder

Stent Set (Lowery Modification).

DATES: Petitions for administrative

review by May 7, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and probable

benefit and petitions for administrative

review should be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Donna-Bea Tillman, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION: On

November 13, 1996, COOK OB/GYN,

Spencer, IN 47460, submitted to CDRH

an application for an HDE for the

Harrison Fetal Bladder Stent Set

(Lowery Modification). The device is a

fetal bladder stent and is indicated for

fetal urinary tract decompression

following the diagnosis of fetal

postvesicular obstructive uropathy in

fetuses 18 to 32 weeks gestational age.

In accordance with 21 CFR

814.116(a), this HDE was not referred to

the Obstetrics and Gynecology Devices

Panel, an FDA advisory committee, for

review and recommendation because

the information in the HDE substantially

duplicates information previously

reviewed by this panel.

On February 14, 1997, 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 probable

benefit upon which CDRH based its

approval is on file in the Dockets

Management Branch (address above)

and is available from the 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(s) to be

reviewed, the form of 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 7, 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 petitioners may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under section

520(h) of the act (21 U.S.C. 360j(h)), 21

CFR 814.116(b), 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: February 20, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8707 Filed 4–4–97; 8:45 am]

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