Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices 32011

I. Authority and Catalog of Federal

Domestic Assistance Number

This program announcement is

authorized under Sections 391, 392,

393, and 394 [42 U.S.C. 280b, 280b–1,

280b–1a, and 280b–2] of the Public

Health Service Act, as amended. The

Catalog of Federal Domestic Assistance

number is 93.136.

J. Where To Obtain Additional

Information

The program announcement and

application forms may be downloaded

from the Internet: www.cdc.gov (look

under funding). You may also receive a

complete application kit by calling 1–

888–GRANTS4. You will be asked to

identify the program announcement

number and provide your name and

mailing address. A complete

announcement kit will be mailed to you.

Please refer to Program

Announcement 98071 when you request

information.

If you have questions after reviewing

the forms, for business management

technical assistance, contact: Joanne

Wojcik, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office,

Announcement 98071, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–13, Atlanta, GA 30305–

2209, telephone (404) 842–6535, E-mail

address jcw6@cdc.gov.

For program technical assistance,

contact Wendy Watkins, Division of

Violence Prevention, National Center for

Injury Prevention and Control, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, NE.,

Mailstop K–60, Atlanta, Georgia 30341–

3724, telephone (770) 488–4646, E-mail

address dmw7@cdc.gov.

Dated: June 5, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–15545 Filed 6–10–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98072]

The Evaluation of Interventions to

Prevent Suicide

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for a cooperative agreement

program for the Evaluation of

Interventions to Prevent Suicide. This

program addresses the ‘‘Healthy People

2000’’ priority area Violent and Abusive

Behavior.

The purpose of this cooperative

agreement is to evaluate specific

interventions that may influence one or

more of the factors that lead to suicidal

behavior among high-risk populations

(see Addendum II—Background for

additional information included in the

application kit).

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents.

Note: Effective January 1, 1996, Public Law

104–65 states that an organization described

in section 501(c)(4) of the Internal Revenue

Code of 1986 which engages in lobbying

activities shall not be eligible to receive

Federal funds constituting an award, grant

(cooperative agreement), contract, loan, or

any other form.

C. Availability of Funds

Approximately $400,000 is available

in fiscal year 1998 to fund up to two

awards. It is expected that projects

completed in three years will have an

average award of $200,000 and ranging

from $175,000 to $225,000 per year.

Awards will be made for a 12 month

budget period within a three year

project period.

Non-competing continuation awards

for new budget periods within an

approved project period are made on the

basis of satisfactory performance and

availability of funds.

Funding Preferences

In making awards, priority

consideration will be given to ensuring

a balance among types of interventions

(e.g., peer support, gatekeeper training)

and programs that target different highrisk populations (e.g., age groups, sex,

race/ethnicity).

D. Cooperative Activities

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under 1., below, and CDC shall be

responsible for the activities under 2.,

below:

1. Recipient Activities:

a. Develop a protocol for evaluating

the specific intervention.

b. Develop procedures for collecting

and compiling information relevant to

the proposed project.

c. Develop and pilot test instruments

for data collection.

d. Establish goals and realistic,

measurable, time-oriented objectives.

e. Develop, implement, and evaluate

the selected intervention.

f. Compile and disseminate the results

from the project.

2. CDC Activities:

a. Provide technical assistance in

defining the target population.

b. Collaborate in the design of all

phases of the evaluation.

c. Provide technical assistance in

sharing information among the various

evaluation projects awarded.

d. Provide up-to-date scientific

information about suicidal behavior

prevention.

e. Assist in the transfer of information

and methods developed in these

projects to other prevention programs.

E. Application Content

Use the information in the

Cooperative Activities, Other

Requirements, Evaluation Criteria

sections and the Errata Sheet

(Addendum III), included in the

application package to develop the

application content. Your application

will be evaluated on the criteria listed,

so it is important to follow them in

laying out your program plan.

The narrative should be no more than

30 double-spaced pages, printed on one

side, with one inch margins, and

unreduced font (no smaller than 10 cpi).

F. Submission and Deadline

Submit the original and five copies of

PHS–398 (OMB Number 0925–0001)

and adhere to the instructions on the

Errata Instruction Sheet for PHS 398.

Forms are in the application kit.

On or before August 4, 1998, submit

to: Joanne Wojcik, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 98072, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–13, Atlanta, GA 30305–

2209.

If your application does not arrive in

time for submission to the independent

review group, it will not be considered

in the current competition unless you

can provide proof that you mailed it on

or before the deadline (i.e., receipt from

U.S. Postal Service or a commercial

carrier; private metered postmarks are

not acceptable).

G. Evaluation Criteria

Each application will be evaluated

individually against the following
32012 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices

criteria by an independent review group

appointed by CDC.

Applicants will be evaluated

according to the following criteria

(Maximum of 100 total points):

1. Intervention Plan (35 Points)

a. Target Group

The extent to which the target group

is described and access to the target

population is demonstrated. The extent

to which the target group has a high

incidence or prevalence of the risk

factors to be influenced by the proposed

intervention and the extent to which

appropriate demographic and morbidity

data are described. The extent to which

youth, who are the direct or indirect

target group, have a high incidence of

interpersonal violence and violencerelated injuries, disabilities, and deaths.

The extent to which the applicant

demonstrates a capability to achieve a

sufficient level of participation by the

target group in order to evaluate the

intervention in an unbiased fashion. In

addition, the degree to which the

applicant has met the CDC/ATSDR

policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed project. This

includes:

i. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

ii. The proposed justification when

representation is limited or absent.

iii. A statement as to whether the

design of the evaluation is adequate to

measure differences when warranted.

iv. A statement as to whether the

plans for recruitment and outreach for

intervention participants include the

process of establishing partnerships

with community(ies) and recognition of

mutual benefits.

b. Intervention Description

The extent to which the potential

effectiveness of the intervention is

theoretically justified and supported by

epidemiologic, or social and behavioral

research. The extent to which the

intervention is feasible and can be

expected to produce the expected

results in the target group of interest.

The extent to which the intervention, its

implementation, the development of all

necessary materials, and all necessary

training are clearly described. The

extent to which the desired outcomes

are specified and definitions of

measurable endpoints are provided (e.g.,

behavioral change, injury, disability, or

death). The extent to which the setting

in which the intervention is to be

implemented is clearly described and

shown to be adequate for reaching the

target group and achieving the desired

objectives. The status of all necessary

measurement instruments or training

materials must be described; if any of

this material is not extant, methods and

time frames for their development must

be described. Necessary collaborators

must be identified, and evidence of their

ability and intention to participate must

be supplied. The extent to which the

proposed goals and objectives are

clearly stated, time-phased, and

measurable.

2. Evaluation Design and Analysis (35

Points)

The extent to which the evaluation

design and the data analysis plan are

clearly described and are appropriate for

the target group, intervention, data

collection opportunities, and proposed

project period. The extent to which the

various threats to the validity of the

evaluation are recognized and

addressed. The extent to which the

sampling methods, sample size

estimates, power estimates, and attrition

of the participating population are

clarified. The extent to which data

collection, data processing, and

management activities are clearly

described. The extent to which the

major phases of the project are clearly

presented and logically and realistically

sequenced. The extent to which the

proposed goals and objectives are

clearly stated, time-phased, and

measurable.

3. Project Management and Staffing Plan

(10 Points)

The extent to which project

management staff and their working

partners are clearly described,

appropriately assigned, and possess

pertinent skills and experiences to

conduct the project successfully to

completion. The extent to which the

applicant has arranged to involve

appropriate researchers and other

personnel who reflect the racial/ethnic

composition of the target group. The

extent to which the applicant or a full

working partner demonstrates the

capacity and facilities to design,

implement, and evaluate the proposed

intervention.

4. Collaboration (20 Points)

The extent to which the necessary

partners are clearly described and their

qualifications and intentions to

participate explicitly stated. The extent

to which the applicant provides proof of

support (e.g., letters of support and/or

memoranda of understanding) for

proposed activities. The extent to which

a full working partnership between a

community-based organization, a

university or other academic institution,

and a State or local health department

has been established for applicants

seeking funds for a three year project

period. Evidence must be provided that

these funds do not duplicate already

funded components of ongoing projects.

5. Human Subjects (Not Scored)

If human subjects will be involved,

how they will be protected, i.e., describe

the review process which will govern

their participation.

6. Proposed Budget (Not Scored)

The extent to which the budget

request is clearly explained, adequately

justified, reasonable, sufficient for the

proposed project activities, and

consistent with the intended use of the

cooperative agreement funds. Budgets

should include costs for travel for two

project staff to attend two meetings per

year in Atlanta with CDC staff.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual progress reports.

2. Financial status report, no more

than 90 days after the end of the budget

period.

3. Final financial status report and

performance report, no more than 90

days after the end of the project period.

Confidentiality of Records

All identifying information obtained

in connection with the provision of

services to any person in any program

that is being carried out with a

cooperative agreement made under this

announcement shall not be disclosed

unless required by a law of a State or

political subdivision unless written,

voluntary informed consent is provided

by persons who received services.

1. Nonpersonal identifying, unlinked

information, which preserves the

individual’s anonymity, derived from

any such program may be disclosed

without consent:

a. In summary, statistical, or other

similar form, or

b. For clinical or research purposes.

2. Personal identifying information:

Recipients of CDC funds who must

obtain and retain personal identifying

information as part of their CDCapproved work plan must:

a. Maintain the physical security of

such records and information at all

times;

b. Have procedures in place and staff

trained to prevent unauthorized

disclosure of client-identifying

information;
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices 32013

c. Obtain informed client consent by

explaining the risks of disclosure and

the recipient’s policies and procedures

for preventing unauthorized disclosure;

d. Provide written assurance to this

effect including copies of relevant

policies; and

e. Obtain assurances of confidentiality

by agencies to which referrals are made.

Assurance of compliance with these

and other processes to protect the

confidentiality of information will be

required of all recipients. A Department

of Health and Human Services (DHHS)

certificate of confidentiality may be

required for some projects.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Addendum I (included in the

application kit).

AR98–1 Human Subjects

Requirements

AR98–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

AR98–13 Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

Send all reports to: 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., Room 300,

Mailstop E–13, Atlanta, GA 30305–

2209.

I. Authority and Catalog of Federal

Domestic Assistance Number

This program announcement is

authorized under Sections 391, 392,

393, and 394 [42 U.S.C. 280b, 280b–1,

280b–1a, and 280b–2] of the Public

Health Service Act, as amended. The

Catalog of Federal Domestic Assistance

number is 93.136.

J. Where to Obtain Additional

Information

The program announcement and

application forms may be downloaded

from the Internet: www.cdc.gov (look

under funding). You may also receive a

complete application kit by calling 1–

888–GRANTS4. You will be asked to

identify the program announcement

number and provide your name and

mailing address. A complete

announcement kit will be mailed to you.

Please refer to Program

Announcement 98072 when you request

information.

If you have questions after reviewing

the forms, for business management

technical assistance, contact: Joanne

Wojcik, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office,

Announcement 98072, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–13, Atlanta, GA 30305–

2209, telephone (404) 842–6796, E-mail

address jcw6@cdc.gov.

For program technical assistance,

contact Tim Thornton, Division of

Violence Prevention, National Center for

Injury Prevention and Control, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, NE.,

Mailstop K–60, Atlanta, GA 30341–

3724, telephone, (770) 488–4646, E-mail

address, tnt1@cdc.gov.

Dated: June 5, 1998.

John L. Williams,

Director, Procurement and Grants Office

Centers, for Disease Control and Prevention

(CDC)

[FR Doc. 98–15541 Filed 6–10–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0003]

Dulal C. Chatterji; Grant of Special

Termination; Final Order Terminating

Debarment

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) granting special

termination of the debarment of Dr.

Dulal C. Chatterji, 308 Dalton Dr.,

Raleigh, NC 27615. FDA bases this order

on a finding that Dr. Chatterji provided

substantial assistance in the

investigations or prosecutions of

offenses relating to a matter under

FDA’s jurisdiction, and that special

termination of Dr. Chatterji’s debarment

serves the interest of justice and does

not threaten the integrity of the drug

approval process.

EFFECTIVE DATE: JUNE 11, 1998.

ADDRESSES: Comments should reference

Docket No. 96N–0003 and be sent 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:

In a Federal Register notice dated

January 22, 1997 (62 FR 3297), Dr. Dulal

C. Chatterji, cofounder, part owner,

vice-president for scientific affairs, and

head of the research and development

(R&D) division at the generic drug

manufacturer Quad Pharmaceuticals,

Inc. (Quad), was permanently debarred

from providing services in any capacity

to a person with an approved or

pending drug product application under

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

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

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

321(dd)). The effective date of the

debarment was November 1, 1995,

based on Dr. Chatterji’s acquiescence to

debarment. The debarment was based

on FDA’s finding that Dr. Chatterji was

convicted of a felony under Federal law

for conduct relating to the development

or approval of any drug product, or

otherwise relating to the regulation of a

drug product under section 306 of the

act. On April 7, 1997, Dr. Chatterji

applied for special termination of

debarment under section 306(d)(4) of

the act, as amended by the Generic Drug

Enforcement Act.

Under section 306(d)(4)(C) and

(d)(4)(D) of the act, FDA may limit the

period of debarment of a permanently

debarred individual if the agency finds

that the debarred individual has

provided substantial assistance in the

investigation or prosecution of offenses

described in paragraph (a) or (b) of

section 306 of the act or relating to a

matter under FDA’s jurisdiction. If

substantial assistance is found, the

extent to which debarment may be

terminated will depend upon the

agency’s assessment of whether

termination will serve the interest of

justice and not threaten the integrity of

the drug approval process. Special

termination of debarment is

discretionary with FDA.

FDA considers a determination by the

Department of Justice that an individual

provided substantial assistance

conclusive in most cases. Dr. Chatterji

fully cooperated with the Department of

Justice investigations and prosecutions

of others within Quad for offenses

related to matters under FDA

jurisdiction, as substantiated by two

letters received by FDA from the U.S.

Attorney’s Office for the District of

Maryland. Accordingly, FDA finds that

Dr. Chatterji provided substantial

assistance as described under section

306(d)(4)(C) of the act.