Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Notices 32217

Dated: June 8, 1998.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–15684 Filed 6–11–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98070]

Evaluation of Violence Prevention

Programs for High-Risk Youth

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 Violence

Prevention Programs. This program

addresses the ‘‘Healthy People 2000’’

priority area of Violent and Abusive

Behavior.

The purpose of this cooperative

agreement is to support the

implementation and evaluation of

interventions which are designed to

prevent violence-related injuries among

high-risk youth (ages 13–21). For the

purpose of this announcement, high-risk

youth does not include youth that are

detained.

Applicants may propose to implement

and evaluate interventions to prevent

injuries due to interpersonal youth (ages

13–21) violence. The aim for these

interventions is to reduce the risk of

violence related injury among high-risk

youth and refers to impact assessment of

efforts to target youths (ages 13–21) who

are in alternative schools, or have been

injured in a violent incident or have

received treatment for a violence related

assault or trauma.

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, and State and local

governments or their bona fide agents.

Note: Pub. L. 104–65, which became

effective January 1, 1996, 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 $1,500,000 is available

in FY 1998 to fund approximately four

awards. It is expected that the average

award will be $375,000 ranging from

$350,000 to $400,000. It is expected that

the awards will begin on or about

September 30, 1998 and will be made

for a 12-month budget period within a

project period of up to three years.

Funding estimates may change.

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

geographic balance, a representative

mixture of target groups, diversity of

intervention strategies, and settings.

Priority will be given to proposed

projects evaluating efforts to reduce risk

of violence related injury among highrisk youth.

D. Cooperative Activities

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for the

activities listed under B. (CDC

Activities).

1. Recipient Activities

a. Develop and implement an

intervention protocol.

b. Develop and pilot test data

collection instruments.

c. Analyze data and interpret findings.

d. Establish an advisory committee

(who represents the target population)

that will address issues related to

violence to ensure community

engagement.

e. Develop collaborative relationships

with voluntary, community-based

public and private organizations and

agencies already involved in preventing

violence.

f. Compile and disseminate the results

from the project.

2. CDC Activities

a. Collaborate on the development of

the intervention protocol.

b. Provide technical assistance on the

development and evaluation of the data

collection instruments.

c. Provide up-to-date scientific

information about youth violence

prevention.

d. 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 13, 1998,

submit to: Joanne Wojcik, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement 98070,

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

criteria by an independent reviewer

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

violence-related 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
32218 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Notices

unbiased fashion. In addition, the

degree to which the applicant has met

the CDC/Agency for Toxic Substances

and Disease Registry (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 study is adequate to

measure differences when warranted.

iv. A statement as to whether the

plans for recruitment and outreach for

study 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

(e.g., behavioral change, avoidance/

prevention of injury, disability, or

death) are specified and definitions of

measurable endpoints are provided. 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 3 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 protect, 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

1. Technical Reporting Requirements

Provide CDC with an original plus

two copies of:

a. Semi-annual progress reports.

b. Financial status report, no more

than 90 days after the end of the budget

period.

c. Final financial status report and

performance report, no more than 90

days after the end of the project period.

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.

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 or 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;

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
Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Notices 32219

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

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

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 98070 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 98070, 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, GA 30341–

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

address dmw7@cdc.gov.

Dated: June 8, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–15686 Filed 6–11–98; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0307]

Draft Guidance for Industry; Exports

and Imports Under the FDA Export

Reform and Enhancement Act of 1996

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled, ‘‘FDA Draft

Guidance for Industry on: Exports and

Imports Under the FDA Export Reform

and Enhancement Act of 1996.’’ The

draft guidance document addresses

issues pertaining to the exportation of

human drugs, animal drugs, biologics,

food additives, and devices as well as

the importation of components, parts,

accessories, or other articles for

incorporation or further processing into

articles intended for export.

DATES: Written comments on the draft

guidance document may be submitted

by August 26, 1998. General comments

on the agency’s guidance documents

may be submitted at any time.

ADDRESSES: Submit written comments

on the draft guidance document to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy (HF–23),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3380.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance document entitled, ‘‘FDA Draft

Guidance for Industry on: Exports and

Imports Under the FDA Export Reform

and Enhancement Act of 1996.’’ Enacted

and later amended in 1996, the FDA

Export Reform and Enhancement Act

(Pub. L. 104–134, as amended by Pub.

L. 104–180) significantly changed the

export requirements for human drugs,

animal drugs, biologics, devices, and, to

a limited extent, food additives. For

example, before the law was enacted,

most exports of unapproved new drug

products could only be made to 21

countries identified in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act), and these exports were subject

to various restrictions. The FDA Export

Reform and Enhancement Act amended

section 802 of the act to allow, among

other things, the export of unapproved

new drugs to any country in the world

if the drug complies with the laws of the

importing country and has valid

marketing authorization from any of the

following countries: Australia, Canada,

Israel, Japan, New Zealand, Switzerland,

South Africa, and the countries in the

European Union (EU) and the European

Economic Area (EEA). (Currently, the

EU countries are Austria, Belgium,

Denmark, Germany, Greece, Finland,

France, Ireland, Italy, Luxembourg, the

Netherlands, Portugal, Spain, Sweden,

and the United Kingdom. The EEA

countries are the EU countries, Iceland,

Liechtenstein, and Norway. The list of

countries will expand automatically if

any country accedes to the EU or

becomes a member of the EEA.)

The draft guidance document

provides information on the statutory

requirements for exporting human

drugs, animal drugs, biologics, and

medical devices, general requirements

for products exported under section 801

of the act (21 U.S.C. 381), labeling

requirements for drugs and biologics

exported under section 801(e) of the act,

export requirements for unapproved

drugs, biologics, and devices under

section 802(b) of the act (21 U.S.C.

382(b)), exports of unapproved drugs

and devices for investigational use,

exports of unapproved drugs and

devices in anticipation of foreign

approval; exports of drugs and devices

for diagnosing, preventing, or treating a

tropical disease or a disease ‘‘not of

significant prevalence in the United

States,’’ export notifications to FDA, and

‘‘import for export.’’ The draft guidance document

represents the agency’s current thinking

on exports and imports-for-export under

sections 801 and 802 of the act. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both. Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. A copy of the

draft guidance document and received

comments may be seen in the office