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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