8744 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices

and develop new and innovative

approaches to reduce welfare

dependency, as well as the Tribal

Temporary Assistance for Needy

Families (TANF) and Job Opportunities

and Basic Skills Training (JOBS)

programs.

2. KG.10 Organization. Delete this

section in its entirety and replace it with

the following:

KG.10 Organization. The Office of

Community Services is headed by a

Director who reports directly to the

Assistant Secretary for Children and

Families and consists of:

Office of the Director (KGA)

Division of State Assistance (KGB)

Division of Community Discretionary

Programs (KGC)

Division of Community Demonstration

Programs (KGD)

Division of Energy Assistance (KGE)

Division of Tribal Services (KGF)

3. KG.20 Functions. Add the

following Paragraph F:

F. Division of Tribal Services is

responsible for assisting in

implementation and coordination of

ongoing consultation with tribal

governments and, where appropriate,

state and federal agencies regarding

issues relating to the Personal

Responsibility and Work Opportunity

Reconciliation Act of 1996, P.L. 104–

193 (the Act) and related legislation. It

is also responsible for development of

regulations and guidelines and for

providing leadership, policy direction,

technical assistance and coordination of

tribal services programs. Performs inter

and intra-agency liaison functions in all

areas such as Child Support

Enforcement, Child Care, Child Welfare,

Foster Care, Low Income Home Energy

Assistance, and Family Violence to

promote family stability, economic

security, responsibility and self-support

for Native Americans. It is responsible

for conducting program reviews to

ensure compliance with the Act,

regulations and policy directives. It is

responsible for activities related to tribal

data collection reporting requirements

relating to the programs.

Dated: February 21, 1997.

Olivia A. Golden,

Principal Deputy Assistant Secretary for

Children and Families.

[FR Doc. 97–4758 Filed 2–25–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

Product, Establishment, and Biologics

License Applications, Refusal to File;

Meeting of Oversight Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

meeting of its standing oversight

committee in the Center for Biologics

Evaluation and Research (CBER) that

conducts a periodic review of CBER’s

use of its refusal to file (RTF) practices

on product license applications (PLA’s),

establishment license applications

(ELA’s), and biologics license

applications (BLA’s). CBER’s RTF

oversight committee examines all RTF

decisions that occurred during the

previous quarter to assess consistency

across CBER offices and divisions in

RTF decisions.

DATES: The meeting will be held on

April 8, 1997.

FOR FURTHER INFORMATION CONTACT: Joy

A. Cavagnaro, Center for Biologics

Evaluation and Research (HFM–5), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–0379.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 15, 1995 (60 FR

25920), FDA announced the

establishment and first meeting of

CBER’s standing oversight committee.

As explained in the notice, the

importance to the public health of

getting new biological products on the

market as efficiently as possible has

made improving the biological product

evaluation process an FDA priority.

CBER’s managed review process focuses

on specific milestones or intermediate

goals to ensure that a quality review is

conducted within a specified time

period. CBER’s RTF oversight

committee continues CBER’s effort to

promote the timely, efficient, and

consistent review of PLA’s, ELA’s, and

BLA’s.

FDA regulations on filing PLA’s,

ELA’s, and BLA’s are found in 21 CFR

601.2 and 601.3. A sponsor who

receives an RTF notification may

request an informal conference with

CBER, and thereafter may ask that the

application be filed over protest, similar

to the procedure for drugs described

under 21 CFR 314.101(a)(3).

CBER’s standing RTF oversight

committee consists of senior CBER

officials, a senior official from FDA’s

Center for Drug Evaluation and

Research, and FDA’s Chief Mediator and

Ombudsman. Meetings will ordinarily

be held once a quarter to review all of

the RTF decisions. The purpose of such

a review is to assess the consistency

within CBER in rendering RTF

decisions. If there are no RTF decisions

to review, however, the meeting may be

cancelled. Publication of any meeting

cancellation will be made only as time

permits.

Because the committee’s deliberations

will deal with confidential commercial

information, all meetings will be closed

to the public. The committee’s

deliberations will be reported in the

minutes of the meeting. Although those

minutes will not be publicly available

because they will contain confidential

commercial information, summaries of

the committee’s deliberations, with all

such confidential commercial

information omitted, may be requested

in writing from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, rm. 12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

If, following the committee’s review, an

RTF decision changes, the appropriate

division within CBER will notify the

sponsor.

Dated: February 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4731 Filed 2–25–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Document Identifier: HCFA–855]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.), 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 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