Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices 7977

* If an overnight carrier or express mail is used,

the Zip Code is 20816.

Evaluation and Research (HFD–310),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–2073.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Nycomed, Inc., 1250 South Collegeville

Rd., P.O. Box 5000, Collegeville, PA

19426–0900, has filed an application

requesting approval for the export of the

human drug VisipaqueTM (iodixanol)

Injection 270 mg I/mL and 320 mg I/mL

supplied in 50 mL vial, 100 mL, 150

mL, and 200 mL bottle to Canada. The

product is used in angiocardiography

(left ventriculography, aortic root

injections, and selective coronary

arteriography) and can be used in the

diagnosis of coronary artery disease as

well as evaluation of the function of the

chambers of the heart and heart valves.

The application was received and filed

in the Center for Drug Evaluation and

Research on December 28, 1994, which

shall be considered the filing date for

purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by February 21,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: January 31, 1995.

Kathy P. Mirracco,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–3443 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 1995 Funding

Opportunities for Grants From the

Center for Mental Health Services

AGENCY: Center for Mental Health

Services, Substance Abuse and Mental

Health Services Administration

(SAMHSA), HHS

ACTION: Notice of funding availability.

SUMMARY: The Center for Mental Health

Services (CMHS), SAMHSA, announces

that FY 1995 funds are available for

grants for the following activities. These

activities are discussed in more detail

under Section 4 of this notice.

Activity Application

deadline Estimated funds available

Estimated

number of

awards

Project period (years)

AIDS Provider Educ .............................................. 05/10/95 $980,000 ............................................................... 5–6 3

Innovative Child Services ..................................... 05/10/95 $2.6 million ........................................................... 6–8 3

Consumer/Family Networks .................................. 05/10/95 $750,000–1.2 million ............................................ 5–8 3

Consumer TA Center(s) ....................................... 05/10/95 $350,000–700,000 ................................................ 1–2 3

The actual amount available for

awards and their allocation may vary,

depending on unanticipated program

requirements and the volume and

quality of applications. Awards are

made for grant periods which generally

run from 1 up to 3 years in duration. FY

1995 funds for mental health services

and demonstration programs are

appropriated by the Congress under

Public Law 103–333. SAMHSA’s

policies and procedures for peer review

and Advisory Council review of grant

and cooperative agreement applications

were published in the Federal Register

(Vol. 58, No. 126) on July 2, 1993.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The Center’s mental

health services and demonstration

activities address issues related to

Healthy People 2000 objectives: to

promote the physical, social,

psychological and economic well-being

of adults with mental disorders and

children and adolescents with or at risk

for a serious emotional, behavioral, or

mental disorder.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report: Stock No. 017–001–00474–0) or

Summary Report: Stock No. 017–001–

00473–1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325

(Telephone: (202) 783–3238).

GENERAL INSTRUCTIONS: Applicants for

grants must use application form PHS

5161–1 (Rev. 7/92; OMB No. 0937–

0189). The Application Kit contains the

PHS 5161–1, Standard Form 424 (Face

Page) and complete instructions for

preparing and submitting applications.

The Kit may be obtained from the

contact person identified for each

activity covered by this notice (see

Section 4).

When requesting an Application Kit,

the applicant must specify the particular

activity(ies) for which detailed

information is desired. This is to ensure

receipt of all necessary forms and

information, including any specific

program review and award criteria.

APPLICATION SUBMISSION: Applications

must be submitted to: Center for Mental

Health Services Programs, Division of

Research Grants, NIH, Westwood

Building, Room 240, 5333 Westbard

Avenue, Bethesda, Maryland 20892.*

APPLICATION DEADLINES: The deadlines

for receipt of applications are listed in

the table above.

Competing applications must be

received by the indicated receipt dates

to be accepted for review. An
7978 Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices

application received after the deadline

may be acceptable if it carries a legible

proof-of-mailing date assigned by the

carrier and that date is not later than

one week prior to the deadline date.

Private metered postmarks are not

acceptable as proof of timely mailing. If

the receipt date falls on a weekend, it

will be extended to Monday; if the date

falls on a national holiday, it will be

extended to the following work day.

Applications received after the receipt

date(s) or those sent to an address other

than the address specified above will be

returned to the applicant without

review.

FOR FURTHER INFORMATION CONTACT:

Requests for activity-specific technical

information should be directed to the

contact person identified for each

activity covered by this notice (see

Section 4). Requests for information

concerning business management issues

should be directed to: Grants

Management Office, Center for Mental

Health Services, 5600 Fishers Lane,

Room 15C–05, Rockville, Maryland

20857, (301) 443–4456.

SUPPLEMENTARY INFORMATION: To

facilitate the use of this Notice of

Funding Availability, information in

this section has been organized, as

outlined in the Table of Contents below.

In addition, the discussion of the

specific FY 1995 funding activities is

presented under the following headings:

• Application Deadline.

• Purpose.

• Priorities.

• Eligible Applicants.

• Grants/Amounts.

• Catalog of Federal Domestic

Assistance Number.

• Program Contact.

Table of Contents

1. Program Background and Objectives

2. Special Concerns

3. Criteria for Review and Funding

3.1 General Review Criteria

3.2 Funding Criteria for Approved

Applications

4. Special FY 1995 Mental Health Services

Activities

4.1 Grants

4.1.1 Mental Health Care Provider

Education In HIV/AIDS Program

4.1.2 Evaluating Innovative Children’s

Mental Health Services

4.1.3 Grants for Consumer and Family

Networks

4.1.4 National Consumer Technical

Assistance Centers

5. Public Health System Reporting

Requirements

6. PHS Non-use of Tobacco Policy Statement

7. Executive Order 12372

1. Program Background and Objectives

The Center for Mental Health Services

(CMHS) has been given a statutory

mandate to take a national leadership

role in the development and

demonstration of improved mental

health services. Toward that end, Center

activities involve facilitating the

application of scientifically established

findings and practice-based knowledge

to prevent and treat mental disorders,

improving access, reducing barriers and

promoting high quality, effective

programs and services for people with,

or at risk for, these disorders.

2. Special Concerns

The CMHS will address a number of

special concerns in 1995. Particular

emphasis will be placed on helping

localities design and implement

comprehensive approaches to service

delivery, networking, and coordination

with other Federal and non-Federal

programs. Special emphasis will be

given to providing assistance for

individuals in varied racial and ethnic

groups; adolescents; early intervention

programs; rural populations;

adolescents involved in the juvenile

justice system; and individuals with, or

at risk for, HIV/AIDS.

3. Criteria for Review and Funding

Competing applications requesting

funding under the specific project

activities in Section 4 will be reviewed

for technical merit in accordance with

established PHS/SAMHSA peer review

procedures.

Applications that are accepted for

review will be assigned to an Initial

Review Group (IRG) composed

primarily of non-Federal experts.

Applications will be recommended for

approval or disapproval on the basis of

technical merit. Applications

recommended for approval will be

assigned scores according to level of

merit.

Notification of the IRG’s

recommendation will be sent to the

applicant upon completion of the initial

review. In addition, the IRG

recommendations on technical merit of

applications over $50,000 will undergo

a second level of review by the CMHS

National Advisory Council, whose

review may be based on policy

considerations, as well as technical

merit. Only applications recommended

for approval by the Council may be

considered for funding by CMHS.

3.1 General Review Criteria

As published in the Federal Register

on July 2, 1993 (Vol. 58, No. 126),

SAMHSA’s ‘‘Peer Review and Advisory

Council Review of Grant and

Cooperative Agreement Applications

and Contract Proposals,’’ peer review

groups will take into account, among

other factors as may be specified in the

application guidance materials, the

following general criteria:

• Potential significance of the

proposed project;

• Appropriateness of the applicant’s

proposed objectives to the goals of the

specific program;

• Adequacy and appropriateness of

the proposed approach and activities;

• Adequacy of available resources,

such as facilities and equipment;

• Qualifications and experience of the

applicant organization, the project

director, and other key personnel; and

• Reasonableness of the proposed

budget.

3.2 Funding Criteria for Approved

Applications

Applications recommended for

approval by the peer review group and

the CMHS National Advisory Council (if

applicable) will be considered for

funding on the basis of their overall

technical merit as determined through

the review process.

Other funding criteria will include;

• Availability of funds.

Additional funding criteria specific to

the programmatic activity may be

included in the application guidance

materials.

4. Special FY 1995 Mental Health

Service Activities

Project activities are grouped in this

notice under one section: Grants.

4.1 Grants

Four major activities for CMHS grant

programs are discussed below.

4.1.1 Mental Health Care Provider

Education In HIV/AIDS

• Application Deadline May 10, 1995.

• Purpose: The goal of the program is

to enhance the Nation’s ability to have

an impact upon the HIV/AIDS epidemic

by training the traditional mental health

care providers and other health care

workers who often are front-line

providers of mental health services,

such as medical students, primary care

physicians, and the clergy and other

spiritual providers.

Applicants will be expected to

propose a comprehensive training

program that addresses the mental

health needs of people with HIV/AIDS.

The program is to train traditional

mental health providers (psychiatrists,

psychologists, nurses, social workers,

counselors, and marriage and family

counselors), other first line providers of

mental health services (e.g., medical

students, primary care physicians), and

nontraditional providers (e.g., the clergy

and other spiritual providers, alternative
Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices 7979

health care workers). Training programs

proposed must target at least 5 provider

groups. The program must address the

neuropsychiatric and the psychosocial

aspects of HIV/AIDS; coping with HIV/

AIDS; and approaches to prevent the

spread the of HIV infection. Applicants

shall make appropriate use of existing

curricula.

• Priorities: None.

• Eligible Applicants: Applications

may be submitted by any public or

private nonprofit organization.

• Grants/Amounts: 5 to 6 awards,

with individual awards varying from

$125,000 to $200,000 for the first year.

• Catalog of Federal Domestic

Assistance Number: 93.244.

• Program Contact: For programmatic

or technical information contact:

Barbara J. Silver, Ph.D., Director, HIV/

AIDS Provider Education Program,

Center for Mental Health Services, 5600

Fishers Lane, Room 15–81, Rockville,

Maryland 20857, (301) 443–7817.

• Application kits and complete

instructions for submitting an

application may be obtained from:

Global Exchange, Inc., 7910 Woodmont

Avenue, Suite 400, Bethesda, Maryland

20814–3015, (301) 656–3100.

4.1.2 Evaluating Innovative Children’s

Mental Health Services

• Application Deadline: May 10,

1995.

• Purpose: The purpose of this

announcement is to encourage

demonstrations which focus on

evaluating the effectiveness of

innovative models of organizing,

delivering, and financing mental health

service systems of care for children and

adolescents with or at risk for serious

emotional, behavioral or mental

disturbances and their families,

especially those systems that include

community-based services and

interagency coordination.

• Priorities: None.

• Eligible Applicants: Centralized

state assistance is often helpful in

obtaining continued support for

successful intervention projects.

Therefore, State mental health

authorities may choose to be direct

applicants. Direct application for

funding may also be made by political

subdivisions of a State, and private

nonprofit organizations such as

community-based organizations,

universities, colleges, and hospitals. In

the case where an applicant is not the

State mental health authority, the

applicant will be required to obtain a

letter of support from the State mental

health authority.

• Grants/Amounts: 6 to 8 awards,

with individual awards varying from

$300,000 to $400,000 for the first year.

• Catalog of Federal Domestic

Assistance Number: 93.125.

• Program Contact: For application

kit and/or programmatic or technical

information contact: Ms. Diane L.

Sondheimer, Child, Adolescent and

Family Branch, Center for Mental

Health Services, 5600 Fishers Lane,

Room 11C–17, Rockville, Maryland

20857, (301) 443–1333.

4.1.3 Demonstration Grants for

Consumer and Family Networks

• Application Deadline: May 10,

1995.

• Purpose: The goals for these

demonstration grants are to implement

and evaluate strategies to: (1) Empower

consumer and family networks and

strengthen their ability to participate in

State and local mental health service

planning and health care reform policy

activities related to improving

community-based services for the target

population; and (2) foster the financial

self-sufficiency of consumer and family

organizations.

• Priorities: None.

• Eligible Applicants: CMHS is

limiting potential applicants for projects

under this announcement to State

mental health authorities. Multiple

organizations are generally involved in

implementing these initiatives; and the

State mental health authorities are

uniquely qualified to undertake the

coordination function, since they work

directly with the major consumer and

family groups and oversee a wide range

of mental health service providers.

Due to funding limitations, only

States and territories that do not have a

current, active Community Support

Programs (CSP) Service Systems

Improvement Demonstration (SSID)

grant, or those that have an active CSP

SSID grant with a project period that

ends on or before August 31, 1995,

excluding no-cost extensions, are

eligible to apply.

• Grants/Amounts: 5 to 8 awards,

with individual awards varying from

$125,000 to $150,000 for the first year.

• Catalog of Federal Domestic

Assistance Number: 93.125.

• Program Contact: For application

kit and/or programmatic or technical

information contact: Mr. Neal Brown,

Chief, Community Support Programs

Branch, Center for Mental Health

Services, 5600 Fishers Lane, Room 11C–

22, Rockville, Maryland 20857, (301)

443–3653.

4.1.4 National Consumer Technical

Assistance Centers

• Application Deadline: May 10,

1995.

• Purpose: The goals of these Centers

are to: (1) Serve as a resource center for

consumers involved in the Community

Support Programs (CSP) Service System

Improvement Demonstration (SSID)

grants, with a special emphasis on

assisting the groups to achieve financial

self-sufficiency; (2) operate a national

resource center for consumers involved

in developing consumer-operated

services by reaching out to racial and

ethnic minorities, assisting in planning,

providing, and evaluating mental health

services, and in planning for health care

reform activities; and (3) facilitate the

development of a coalition of national

or multi-state consumer organizations

involved in self-help and system

improvement efforts.

• Priorities: It is CMHS’s expectation

that the TA Center(s) will be planned,

directed, and operated by primary

mental health consumers.

• Eligible Applicants: Applications

may be submitted by States, political

subdivisions of States, and private nonprofit agencies, as well as current

CMHS/CSP TA Center grantees.

• Grants/Amounts: 1 to 2 awards,

with individual amounts varying from

$300,000 to $350,000 for the first year.

• Catalog of Federal Domestic

Assistance Number: 93.125.

• Program Contact: For application

kit and/or programmatic or technical

information contact: Mr. Neal Brown,

Chief, Community Support Programs

Branch, Center for Mental Health

Services, 5600 Fishers Lane, Room 11C–

22, Rockville, Maryland 20857, (301)

443–3653.

5. Public Health System Reporting

Requirements

The Public Health System Impact

Statement (PHSIS) is intended to keep

State and local health officials apprised

of proposed health services grant and

cooperative agreement applications

submitted by community-based

nongovernmental organizations within

their jurisdictions.

Community-based nongovernmental

service providers who are not

transmitting their applications through

the State must submit a PHSIS to the

head(s) of the appropriate State and

local health agencies in the area(s) to be

affected not later than the pertinent

receipt date for applications. This

PHSIS consists of the following

information:

a. A copy of the face page of the

application (Standard form 424).
7980 Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices

b. A summary of the project (PHSIS),

not to exceed one page, which provides:

(1) A description of the population to

be served.

(2) A summary of the services to be

provided.

(3) A description of the coordination

planned with the appropriate State or

local health agencies.

State and local governments and

Indian Tribal Authority applicants are

not subject to the Public Health System

Reporting Requirements.

Application guidance materials will

specify if a particular FY 1995 activity

described above is not subject to the

Public Health System Reporting

Requirements.

6. PHS Non-use of Tobacco Policy

Statement

The PHS strongly encourages all grant

and cooperative agreement recipients to

provide a smoke-free workplace and

promote the non-use of all tobacco

products. This is consistent with the

PHS mission to protect and advance the

physical and mental health of the

American people.

Specific application guidance

materials may include more detailed

guidance as to how the Center will

implement SAMHSA’s policy on

promoting the non-use of tobacco.

7. Executive Order 12372

Applications submitted in response to

most, if not all, of the FY 1995 activities

listed above are subject to the

intergovernmental review requirements

of Executive Order (E.O.) 12372, as

implemented through DHHS regulations

at 45 CFR Part 100. E.O. 12372 sets up

a system for State and local government

review of applications for Federal

financial assistance. Applicants (other

than Federally recognized Indian tribal

governments) should contact the State’s

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective application(s) and to receive

any necessary instructions on the State’s

review process. For proposed projects

serving more than one State, the

applicant is advised to contact the SPOC

of each affected State. A current listing

of SPOCs is included in the application

guidance materials. The SPOC should

send any State review process

recommendations directly to: Office of

Extramural Activities Review,

Substance Abuse and Mental Health

Services Administration (SAMHSA),

5600 Fishers Lane, Room 13C–06,

Rockville, Maryland 20857, ATTN:

SPOC.

The due date for State review process

recommendations is no later than 60

days after the specified deadline date for

the receipt of applications. The CMHS

does not guarantee to accommodate or

explain SPOC comments that are

received after the 60-day cut-off.

Application guidance materials will

specify if a particular FY 1995 activity

described above is not subject to the

provisions of Executive Order 12372.

Dated: February 3, 1995.

Richard Kopanda,

Acting Executive Officer, SAMHSA.

[FR Doc. 95–3342 Filed 2–9–95; 8:45 am]

BILLING CODE 4162–20–P

Fiscal Year (FY) 1995 Funding

Opportunities for Grants and

Cooperative Agreements From the

Center for Substance Abuse

Prevention

AGENCY: Center for Substance Abuse

Prevention, Substance Abuse and

Mental Health Services Administration

(SAMHSA), HHS.

ACTION: Notice of funding availability.

SUMMARY: The Center for Substance

Abuse Prevention (CSAP), SAMHSA,

announces that FY 1995 funds are

available for grants and cooperative

agreements for the following activities.

These activities are discussed in more

detail under Section 4 of this notice.

Activity Application

deadline

Estimated

funds available

(000’s)

Estimated

No. of

awards

Project

period

(years)

Knowledge Dissemination Conference Grants ................................................................ 05/10/95

09/10/95

$1,000 20 1

High-Risk Youth Demonstration Grants:

High Risk Youth ........................................................................................................ 05/10/95 11,478 36 3

Adolescent Females .................................................................................................. 05/10/95 4,079 13 3

Replications ............................................................................................................... 05/10/95 4,000 12 3

Community Prevention Coalition Demonstration Grants ................................................. 05/10/95 33,000 100–125 3

Faculty Development Grants ............................................................................................ 05/10/95 2,000 8 3

Communications Cooperative Agreements ...................................................................... 05/10/95 2,300 11 3

The actual amount available for

awards and their allocation may vary,

depending on unanticipated program

requirements and the volume and

quality of applications. Awards are

made for grant periods which generally

run from 1 up to 3 years in duration. FY

1995 funds for services demonstration

activities are appropriated by the

Congress under Public Law 103–333.

SAMHSA’s policies and procedures for

peer review and Advisory Council

review of grant and cooperative

agreement applications were published

in the Federal Register (Vol. 58, No.

126, page 35962) on July 2, 1993.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The Center’s services

demonstration activities address issues

related to Healthy People 2000

objectives for reducing the risk for using

and abusing alcohol, tobacco and other

drugs.

Additional themes include

community empowerment; changes in

the services delivery system to effect

closer collaboration among substance

abuse prevention activities, mental

health services and the health care

system; prevention and reduction of

violent actions; cultural competence of

prevention strategies; and

encouragement to reach out to female

adolescents at risk for substance abuse

and not generally served by traditional

programs.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report: Stock No. 017–001–00474–0) or

Summary Report: Stock No. 017–001–

00473–1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325

(Telephone: 202–783–3238).

GENERAL INSTRUCTIONS: Applicants for

grants and cooperative agreements must

use application form PHS 5161–1 (Rev.

7/92; OMB No. 0937–0189). The

Application Kit contains the PHS 5161–

1, Standard Form 424 (Face Page) and