2768 Federal Register / Vol. 60, No. 7 / Wednesday, January 11, 1995 / Notices

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Tamar S. Nordenberg, Center for Drug

Evaluation and Research (HFD–366),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION:

I. Background

Mr. Andrew Morris, a former

employee at Quad Pharmaceuticals, Inc.

(Quad), first as a bench chemist and

later as a manager in Quad’s research

and development department, pled

guilty and was sentenced on May 13,

1994, for making a false statement to a

U.S. Government agency, a Federal

felony under 18 U.S.C. 1001, and for

obstructing an agency proceeding, a

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

The basis for this conviction was as

follows:

A. False Statement to a Federal Agency

Mr. Morris, while working as a bench

chemist at Quad, made a false

representation in a certificate of analysis

regarding the potency of a particular lot

of the drug azathioprine sodium, which

was submitted to FDA in support of an

abbreviated new drug application

(ANDA) for the drug.

B. Obstruction of an Agency Proceeding

During an FDA audit of Quad’s

research and development department,

Mr. Morris gathered and destroyed

certain nonsterile samples of

colistimethate sodium. These samples

had previously been represented to FDA

as sterile in batch production records.

These records were prepared under Mr.

Morris’ supervision and were included

in the ANDA for the drug product.

Mr. Morris is subject to debarment

based on a finding, under section

306(a)(2) of the act (21 U.S.C.

335a(a)(2)), that he was convicted of

felonies under Federal law for conduct

relating to the development, approval,

and regulation of a drug product. Mr.

Morris’ false statements in documents

used to support the ANDA’s for the two

Quad drug products relate to the

development or approval of a drug

product because FDA relies on the

safety and efficacy data and information

in the ANDA’s in making its decisions

whether to approve drug products. Mr.

Morris’ false statements and destruction

of drug samples relate to the regulation

of drug products because FDA’s

regulatory decisions about Quad drug

products may have been affected by the

conduct.

In a letter received by FDA on May

16, 1994, Mr. Morris notified FDA of his

acquiescence to debarment, as provided

for in section 306(c)(2)(B) of the act. A

person subject to debarment is entitled

to an opportunity for an agency hearing

on disputed issues of material fact

under section 306(i) of the act, but by

acquiescing to debarment, Mr. Morris

waived his opportunity for a hearing

and any contentions concerning his

debarment.

II. Findings and Order

Therefore, the Interim Deputy

Commissioner for Operations, under

section 306(a) of the act, and under

authority delegated to her (21 CFR 5.20),

finds that Mr. Andrew Morris has been

convicted of a felony under Federal law

for conduct relating to the development

or approval, including the process for

development or approval, of a drug

product (21 U.S.C. 335a(a)(2)(A)); and

relating to the regulation of a drug

product (21 U.S.C. 335a(a)(2)(B)).

As a result of the foregoing findings

and based on his notification of

acquiescence, Mr. Andrew Morris is

permanently debarred from providing

services in any capacity to a person with

an approved or pending drug product

application under section 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 May 16, 1994, the date of

notification of acquiescence (21 U.S.C.

335a(c)(1)(B) and (c)(2)(A)(ii) and 21

U.S.C. 321(ee)). Any person with an

approved or pending drug product

application who knowingly uses the

services of Mr. Morris, in any capacity,

during his period of debarment, will be

subject to civil money penalties. If Mr.

Morris, 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. In

addition, FDA will not accept or review

any ANDA’s submitted by or with the

assistance of Mr. Morris during his

period of debarment.

Any application by Mr. Morris for

termination of debarment under section

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

with Docket No. 94N–0285 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: January 4, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–695 Filed 1–10–95; 8:45 am]

BILLING CODE 4160–01–F

National Institute on Deafness and

Other Communication Disorders;

National Institutes of Health

Notice of Meetings of the National

Deafness and Other Communication

Disorders Advisory Council and its

Planning Subcommittee

Pursuant to Public Law 92–463,

notice is hereby given of the meetings of

the National Deafness and Other

Communication Disorders Advisory

Council and its Planning Subcommittee

on January 25–27, 1995, at the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, Maryland. The meeting

of the full Council will be held in

Conference Room 10, Building 31C, and

the meeting of the subcommittee will be

in Conference Room 7, Building 31C.

The meeting of the Planning

Subcommittee will be open to the

public on January 25 from 2 pm until 3

pm for the discussion of policy issues.

The meeting of the full Council will be

open to the public on January 26 from

8:30 am until recess for a report from

the Institute Director and discussion of

extramural policies and procedures at

the National Institutes of Health and the

National Institute on Deafness and

Other Communication Disorders and on

January 27 from 8:30 am to

approximately 9:30 am for a report on

extramural programs of the Division of

Human Communication. Attendance by

the public will be limited to space

available.

In accordance with the provisions set

forth in sec. 552b(c)(4) and 552b(c)(6),

Title 5, U.S.C. and section 10(d) or

Public Law 92–463, the meeting of the

Planning Subcommittee on January 25

will be closed to the public from 3 pm

to adjournment. The meeting of the full

Council will be closed to the public on

January 27 from approximately 9:30 am

until adjournment. The closed portions

of the meetings will be for the review,

discussion, and evaluation of individual

grant applications. The applications and

the discussions could reveal

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Further information concerning the

Council and Subcommittee meetings
Federal Register / Vol. 60, No. 7 / Wednesday, January 11, 1995 / Notices 2769

may be obtained from Dr. Earleen F.

Elkins, Executive Secretary, National

Deafness and Other Communication

Disorders Advisory Council, National

Institute on Deafness and Other

Communication Disorders, National

Institutes of Health, Executive Plaza

South, Room 400C, Bethesda, Maryland

20892, 301–496–8693. A summary of

the meetings and rosters of the members

may also be obtained from her office.

For individuals who plan to attend and

need special assistance such as sign

language interpretation or other

reasonable accommodations, please

contact Dr. Elkins at least two weeks

prior to the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.173 Biological Research

Related to Deafness and Communication

Disorders)

Dated: January 3, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–677 Filed 1–10–95; 8:45 am]

BILLING CODE 4140–01–M

Office of Community Services

[Program Announcement No. OCS 95–

04]

Family Violence Prevention and

Services Program

AGENCY: Office of Community Services,

Administration for Children and

Families, (ACF), Department of Health

and Human Services.

ACTION: Notice of the availability of

funding to States and Native American

Tribes and Tribal organizations for

family violence prevention and services.

SUMMARY: This announcement governs

the proposed award of fiscal year (FY)

1995 formula grants under the Family

Violence Prevention and Services Act to

States (including Territories and Insular

Areas) and Native American Tribes and

Tribal organizations. The purpose of

these grants is to assist in establishing,

maintaining, and expanding programs

and projects to prevent family violence

and to provide immediate shelter and

related assistance for victims of family

violence and their dependents.

This announcement also specifies a

new expenditure period for these funds

and sets forth the application process

and requirements for grants to be

awarded for FY 1996 through FY 2000.

CLOSING DATES FOR APPLICATIONS:

Applications for FY 1995 family

violence grant awards meeting the

criteria specified in this announcement

must be received at the address

specified below by March 13, 1995.

Grant applications for FY 1996 through

FY 2000 should be received at the

address specified below by November

15 of each following fiscal year.

ADDRESSES: Applications should be sent

to: Office of Community Services,

Administration for Children and

Families, Attn: William D. Riley, 5th

Floor, West Wing, 370 L’Enfant

Promenade, SW., Washington, DC

20447.

FOR FURTHER INFORMATION CONTACT:

William D. Riley (202) 401–5529 or Al

M. Britt (202) 401–5453.

SUPPLEMENTARY INFORMATION:

Introduction

This notice for family violence

prevention and services grants to States

and Indian tribes serves two purposes.

The first is to confirm a Federal

commitment to reducing family and

intimate violence and to urge States,

localities, cities, and the private sector

to become involved in State and local

planning efforts leading to the

development of a more comprehensive

and integrated service delivery

approach (Part I). The second purpose is

to provide information on application

requirements for FY 1995 grants to

States and Indian tribes. These funds

will support prevention activities,

shelters, and related services for

battered women and their children (Part

II).

Part I. Reducing Family and Intimate

Violence Through Coordinated

Prevention and Services Strategies

A. The Importance of Coordination of

Services

A person facing family or intimate

violence may need more than

immediate medical care and shelter.

Assured protection and effective

support are essential to end ongoing

abuse.

The effects of domestic violence may

manifest themselves in varying forms,

including: substance abuse,

hopelessness, arrest, felony charges,

mental health concerns, injuries, lost

time at work, child abuse, and welfare

dependence. When programs that seek

to address these issues operate

independently of each other, a

fragmented, and consequently less

effective, service delivery and

prevention system may be the result.

Coordination and collaboration among

the police, prosecutors, the courts,

victim services providers, child welfare

and family preservation services, and

medical and mental health service

providers is needed to provide more

responsive and effective services to

victims of domestic violence and their

families. It is essential that all interested

parties are involved in the design and

improvement of protection and services

activities.

To help bring about a more effective

response to the problem of intimate

violence, the Department of Health and

Human Services (HHS) urges State

agencies and Indian tribes receiving

funds under this grant announcement to

coordinate activities funded under this

grant with other new and existing

resources for family and intimate

violence and related issues.

B. Coordination of Efforts

1. Federal Coordination

In the fall of 1993, a Federal

Interdepartmental Work Group

(including the Departments of Health

and Human Services, Justice, Education,

Housing and Urban Development,

Labor, and Agriculture) began working

together to study cross-cutting issues

related to violence, and to make

recommendations for action in areas

such as youth development, schools,

juvenile justice, family violence, sexual

assault, firearms, and the media. The

recommendations formed a framework

for ongoing policy development and

coordination within and among the

agencies involved.

The interdepartmental working group

also initiated a ‘‘Cities Project’’ (now

known as PACT, Pulling America’s

Communities Together) to help

coordinate Federal assistance to four

geographic areas (Denver; Atlanta;

Washington, DC; and the State of

Nebraska) as they develop

comprehensive plans for violence

prevention and control.

Based on these coordination efforts, a

new interdepartmental strategy was

developed for implementing the

programs and activities recently enacted

in the Violent Crime Control and Law

Enforcement Act of 1994 (Crime Bill). A

Steering Committee on Violence Against

Women is coordinating activities among

family violence-related programs and

across agencies and departments.

2. Opportunities for Coordination at the

State and Local Level

The major domestic violence

prevention activities funded by the

Federal government focus on law

enforcement and justice system

strategies; victim protection and

assistance services; and prevention

activities, including public awareness

and education. Federal programs also

serve related needs, such as housing,

family preservation and child welfare

services, substance abuse treatment, and

job training.