Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Notices 42997

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines provided in the application

kit.

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions. An applicant organization

proposing to use vertebrate animals in

CDC-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

Women and Racial and Ethnic

Minorities

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDC

supported research projects involving

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women and racial and

ethnic minority populations are

appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is not feasible, this situation must be

explained as part of the application. In

conducting the review of applications

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadlines

1. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Officer (whose address is reflected in

section 2., ‘‘Applications’’). It should be

postmarked no later than September 11,

1997. The letter should identify the

announcement number, name of

principal investigator, and specify the

priority area to be addressed by the

proposed project. The letter of intent

does not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently, and will

ensure that each applicant receives

timely and relevant information prior to

application submission.

2. Applications

Applicants should use Form PHS–398

(OMB Number 0925–0001) and adhere

to the ERRATA Instruction Sheet for

Form PHS–398 contained in the Grant

Application Kit. Please submit an

original and five copies on or before

November 11, 1997 to: Ron Van Duyne,

Grants Management Officer, ATTN:

Joanne Wojcik, Grants Management

Branch, Procurement and Grants Office,

Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 300, MS E–13, Atlanta,

GA 30305.

3. Deadlines

a. Applications shall be considered as

meeting a deadline if they are either:

(1) Received at the above address on or

before the deadline date, or

(2) Sent on or before the deadline date

to the above address, and received

in time for the review process.

Applicants should request a legibly

dated U.S. Postal Service postmark

or obtain a legibly dated receipt

from a commercial carrier or the

U.S. Postal Service. Private metered

postmarks shall not be accepted as

proof of timely mailings.

b. Applications which do not meet the

criteria above are considered late

applications and will be returned to the

applicant.

Where to Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to announcement 807. You

will receive a complete program

description, information on application

procedures, and application.

If you have questions after reviewing

the contents of all the documents,

business management information may

be obtained from Joanne Wojcik, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., MS E–13,

Atlanta, GA 30305, telephone (404)

842–6535; fax: (404) 842–6513; Internet:

jcw6@cdc.gov.

Programmatic technical assistance

may be obtained from Roy M. Fleming,

Sc.D., Associate Director for Grants,

National Institute for Occupational

Safety and Health, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Building 1, Room

3053, MS D–30, Atlanta, GA 30333,

telephone: 404–639–3343; fax: 404–

639–4616; Internet: rmf2@cdc.gov.

Please refer to announcement number

807 when requesting information and

submitting an application.

This and other CDC Announcements

can be found on the CDC home page

(http://www.cdc.gov) under the

Funding section.

CDC will not send application kits by

facsimile or express mail.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: August 5, 1997.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97–21102 Filed 8–8–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention (CDC)

Clinical Laboratory Improvement

Advisory Committee (CLIAC) Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463),the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Clinical Laboratory Improvement

Advisory Committee.

Times and Dates: 8:30 a.m.–4:30 p.m.,

September 11, 1997. 8:30 a.m.–4:30 p.m.,

September 12, 1997.

Place: CDC, Auditorium A, Building 2,

1600 Clifton Road, NE, Atlanta, Georgia

30333.

Status: Open to the public, limited only by

the space available.

Purpose: This committee is charged with

providing scientific and technical advice and

guidance to the Secretary of Health and

Human Services, the Assistant Secretary for

Health, and the Director, CDC, regarding the

need for, and the nature of, revisions to the

standards under which clinical laboratories

are regulated; the impact of proposed

revisions to the standards; and the
42998 Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Notices

modification of the standards to

accommodate the technological advances.

Matters To Be Discussed: Agenda items

include Genetics Testing; Proficiency Testing

(PT) Implementation; Data measuring the

effectiveness of CLIA in improving laboratory

performance.

Agenda items are subject to change.

Contact Person: John Ridderhof, Dr.P.H.,

Division of Laboratory Systems, Public

Health Practice Program Office, CDC, 4770

Buford Highway, NE, MS G25, Atlanta,

Georgia 30341–3724, telephone 770/488–

4674.

Dated: August 5, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–21100 Filed 8–8–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 94N–0193]

Robert E. Sacher; Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Dr. Robert E. Sacher, 117 Deer

Path Lane, Weston, MA 02193, from

providing services in any capacity to a

person that has an approved or pending

drug product application. FDA bases

this order on a finding that Dr. Sacher

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Dr. Sacher has failed to request a

hearing and, therefore, has waived his

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: August 11, 1997.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

On June 1, 1992, the U.S. district

court for the District of Massachusetts

entered judgment against Dr. Robert E.

Sacher for one count of corruptly

influencing, obstructing, and impeding

the due administration of justice in an

administrative proceeding of FDA, a

Federal felony under 18 U.S.C. 1505.

As a result of this conviction, FDA

served Dr. Sacher by certified mail on

November 25, 1994, a notice proposing

to permanently debar him from

providing services in any capacity to a

person that has an approved or pending

drug product application, and offered

him an opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 335a(a)(2)(B)), that Dr.

Sacher was convicted of a felony under

Federal law for conduct relating to the

regulation of a drug product. Dr. Sacher

did not request a hearing. His failure to

request a hearing constitutes a waiver of

his opportunity for a hearing and a

waiver of any contentions concerning

his debarment.

II. Findings and Order

Therefore, the Director of the Center

for Drug Evaluation and Research, under

section 306(a) of the act, and under

authority delegated to her (21 CFR

5.99(b)), finds that Dr. Robert E. Sacher

has been convicted of a felony under

Federal law for conduct relating to the

regulation of a drug product.

As a result of the foregoing finding,

Dr. Robert E. Sacher is permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

under sections 505, 507, 512, or 802 of

the act (21 U.S.C. 355, 357, 360b, or

382), or under section 351 of the Public

Health Service Act (42 U.S.C. 262),

effective August 11, 1997 (sections

306a(c)(1)(B) and (c)(2)(A)(ii) and

201(dd) of the act (21 U.S.C. 321(d))).

Any person with an approved or

pending drug product application who

knowingly uses the services of Dr.

Sacher, in any capacity, during his

period of debarment, will be subject to

civil money penalties (section 307(a)(6)

of the act). If Dr. Sacher, during his

period of debarment, provides services

in any capacity to a person with an

approved or pending drug product

application, he will be subject to civil

money penalties (section 307(a)(7) of the

act). In addition, FDA will not accept or

review any abbreviated new drug

applications or abbreviated antibiotic

drug applications from Dr. Sacher

during his period of debarment.

Any application by Dr. Sacher for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 94N–0193 and sent to

the Dockets Management Branch

(address above). All such submissions

are to be filed in four copies. The public

availability of information in these

submissions is governed by 21 CFR

10.20(j). Publicly available submissions

may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 18, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–21085 Filed 8–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Notice of CRADA Opportunities

National Cancer Institute: Nitric

Oxide Technology: Opportunities for

Cooperative Research and Development

Agreements (CRADAs) for the

development of medicinal agents useful

for treating a variety of disorders arising

from localized physiologic deficiencies

of the multifaceted bioregulatory

molecule, nitric oxide. The NCI is

looking for multiple CRADA

Collaborators to develop independently

different aspects of their nitric oxide

technology.

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice for CRADA

opportunities.

SUMMARY: Pursuant to the Federal

Technology Transfer Act of 1986 (FTTA,

15 U.S.C. § 3710, and 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 to develop applications of

nitric oxide technology. 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