Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices 47671

Following publication of the notice of

opportunity for a hearing and in

accordance with the procedures set

forth in parts 12 and 601 (21 CFR parts

12 and 601), on June 15, 1994, the

Responsible Head of Central Georgia

submitted a request for a hearing to the

Dockets Management Branch and, on

July 15, 1994, provided additional

supplemental information to justify the

request for a hearing.

While the request for a hearing was

pending, the owner and former

Responsible Head of Central Georgia

informed the agency by letter dated July

12, 1996, that Central Georgia had

closed its facility on June 24, 1996, and

ceased operations effective June 25,

1996, and was voluntarily surrendering

both the establishment and product

licenses. FDA notified Central Georgia

by letter of August 21, 1996, that the

licenses had been revoked.

Based on the voluntary surrender of

U.S. License No. 0649–001, Central

Georgia’s request for a hearing on the

issue of license revocation became

moot. Central Georgia effectively waived

an opportunity for a hearing on the

matter (§ 601.5(a)).

Accordingly, under § 601.5(a), section

351 of the Public Health Service Act (42

U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 0649–001) and the

product license issued to Central

Georgia Plasma Lab, Inc., for the

manufacture of Source Plasma were

revoked, effective August 21, 1996.

This notice is issued and published

under § 601.8 and the redelegation at 21

CFR 5.67.

Dated: August 25, 1997.

Mark Elengold,

Acting Deputy Director, Center for Biologics

Evaluation and Research.

[FR Doc. 97–23946 Filed 9-9-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

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

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: AIDS Drug

Assistance Program [ADAP]: Monthly

Client Utilization and Program

Expenditure Assessment Project—

NEW—State AIDS Drug Assistance

Programs [ADAP], funded under section

2611 of the Public Health Service Act

(commonly known as Title II of the

Ryan White Comprehensive AIDS

Resources Emergency [CARE] Act) are

designed to provide low income,

uninsured, and underinsured

individuals with access to HIV/AIDS

medications that prevent serious

deterioration of health arising from HIV

disease, including prevention and

treatment of opportunistic diseases.

Due to the increasing need for

pharmaceuticals among uninsured and

underinsured low-income individuals

who are HIV+ or diagnosed with AIDS,

and recognizing the importance of

program planning and budget

forecasting to maximize resources, the

Division of Service Systems [DSS],

Health Resources and Services

Administration [HRSA], proposes to

collect relevant client utilization data

and program expenditure information

on a voluntary monthly reporting basis

from State ADAPs. This effort is

designed to assist Title II grantees, State

ADAPs, the DSS/HRSA funding agency

staff, and policymakers at both the

Federal and State level to better

understand the level of client need for

medications that the programs are

functioning under and the resources

used to meet the needs, and to provide

indicators of where future action may be

required and the most appropriate

response(s).

A report is proposed that will collect

monthly data on the level of

expenditures and client utilization of

services. In addition, the report will

provide a forum for tracking the most

current changes in each State ADAP

with respect to available funding,

eligibility criteria, clinical guidelines,

and formulary changes. On a quarterly

basis, the report will also request the

prices of eight specified

pharmaceuticals dispensed by each

program. The individual State reports

will be compiled into summary reports

and distributed back to grantees and

State ADAPs on a monthly basis, and

will be available for use by HRSA and

the Office of Management and Budget.

These results will be used to guide

program planning, to formulate budget

recommendations, and to monitor the

balance between available resources and

State needs. The burden estimates are as

follows:

Type of form Number of respondents

Responses

per

respondent

Hours per

response

Total burden hours

ADAP Monthly Update ................................................................................................. 54 12 1 648

ADAP Quarterly Drug Pricing Update .......................................................................... 54 4 1 216

Total ................................................................................................................... 54 16 1 864
47672 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Laura Oliven, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: September 4, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–23887 Filed 9–9–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request

A Pilot Study of Helicobacter pylori

Infection and Mode of Transmission

Among Children in Linqu County,

Shandong Province, China.

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Cancer Institute (NCI), the

National Institutes of Health (NIH) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection: Title: A Pilot

Study of Helicobacter pylori Infection

and Mode of Transmission Among

Children in Linqu County, Shandong

Province, China. Type of Information

Collection Request: NEW. Need and Use

of Information Collection: The agency

conducts and funds studies examining

risk factors for infectious and chronic

diseases that may be related to risk of

cancer. This information collection is

needed to evaluate data collection

methods and the quality of the data

collected prior to implementation with

a larger study population. The data

collection effort is needed to identify

personal practices and environmental

conditions which appear to contribute

to H. pylori transmission. Questionnaire

data obtained from mothers will be

linked with existing H. pylori status

data to investigate factors that may

influence the prevalence of H. pylori

infection in Linqu County children.

Frequency of Response: One time.

Affected Public: Individuals or

households. Type of Respondents:

Parents. The annual reporting burden is

as follows: Estimated Number of

Respondents: 98; Estimated Number of

Responses per Respondent: 1; Average

Burden Hours Per Response: .33; and

Estimated Total Annual Burden Hours

Requested: 32. The annualized cost to

respondents is estimated at: $21.33.

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report.

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies are invited

on one or more of the following points:

(1) Whether the proposed collection of

information is necessary for the proper

performance of the function of the

agency, including whether the

information will have practical utility;

(2) The accuracy of the agency’s

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used; (3) Ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4)

Ways to minimize the burden of the

collection of information on those who

are to respond, including the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

FOR FURTHER INFORMATION: To request

more information on the proposed

project or to obtain a copy of the data

collection plans and instruments,

contact Linda Morris Brown, MPH,

Assistant Director for Epidemiology and

Biostatistics, Division of Cancer

Epidemiology and Genetics, National

Cancer Institute, National Institutes of

Health, 6130 Executive Blvd., Executive

Plaza North, Room 415, Bethesda, MD,

20892, or call non-toll-free number (301)

496–4153 or E-mail your request,

including your address to:

brownl@epndce.nci.nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before November 10,

1997.

Dated: September 4, 1997.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–23899 Filed 9–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute:

Opportunities for Cooperative

Research and Development

Agreements (CRADAs) for the

Development of New Targeted Drugs,

Made Partly of Entities Provided by the

National Cancer Institute (NCI), as

Treatments for Patients With Cancer

The NCI is looking for multiple

CRADA Collaborators to develop

independently different aspects of their

targeted drug technology with the goal

of moving candidates into clinical trials.

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice of opportunities for

cooperative research and development.

SUMMARY: Pursuant to the Federal

Technology Transfer Act of 1986 (FTTA,

15 U.S.C. 3710; Executive Order 12591

of April 10, 1987 as amended by the

National Technology Transfer and

Advancement Act of 1995), the National

Cancer Institute (NCI) of the National

Institutes of Health (NIH) of the Public

Health Service (PHS) of the Department

of Health and Human Services (DHHS)

seeks Cooperative Research and

Development Agreements (CRADAs)

with pharmaceutical or biotechnology

companies or academic institutions to

create, optimize and test new targeted

drugs as therapeutics for cancer.

Any CRADA for the biomedical use of

this technology will be considered. The

CRADAs would have an expected

duration of one (1) to five (5) years. The

goals of the CRADAs include the rapid

publication of research results and

timely commercialization of products,

diagnostics and treatments that result

from the research. The CRADA

Collaborators will have an option to

negotiate the terms of an exclusive or

nonexclusive commercialization license

to subject inventions arising under the

CRADAs.

ADDRESSES: Proposals and questions

about this CRADA opportunity may be

addressed to Dr. Thomas M. Stackhouse,

Office of Technology Development,

National Cancer Institute-Frederick

Cancer Research and Development

Center, P.O. Box B, Frederick, MD

21702–1201, Telephone: (301) 846–

5465, Facsimile: (301) 846–6820.

EFFECTIVE DATE: Organizations must

submit a confidential proposal summary

preferably one page or less, to NCI

within 90 days from date of this

publication. Guidelines for preparing

full CRADA proposals will be