Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices 32101

Americans have been infected with

hepatitis C virus (HCV), 2.7 million of

which are chronically infected. Not

including the cost of liver

transplantation, the estimated cost

associated with HCV infections is $600

million a year in medical care and lost

work days.

The annual burden hours are

estimated to be 2403.

Form name Number of

respondents

Number of responses/respondentAvg. burden

per responses

(in hours)

Phone ........................................................................................................................................... 20 1 10/60

Written .......................................................................................................................................... 14400 1 10/60

Dated: May 16, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–12739 Filed 5–19–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00080]

Optimizing Strategies To Provide

Sexually Transmitted Disease (STD)

Partner Services; Notice of Availability

of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

research program for Optimizing

Strategies to Provide STD Partner

Services. CDC is committed to achieving

the health promotion and disease

prevention objective of ‘‘Healthy People

2010’’, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the focus area(s) of Sexually

Transmitted Diseases. For the

conference copy of ‘‘Healthy People

2010’’, visit the Internet site: http://

www.health.gov/healthypeople. The

goal of this cooperative agreement

research program is to develop and

evaluate the delivery of cost-effective,

innovative, and confidential approaches

to providing effective partner services

within a time frame that interrupts the

chain of STD transmission. Partner

services (PS) are a critical component of

STD control and prevention in public

health practice.

Initially, this process was named

‘‘contact tracing,’’ but was renamed

‘‘partner notification’’ in the past two

decades. Three primary strategies for

partner notification are described in the

literature, although other variations are

also employed. The most common

strategies are patient referral (patients

are encouraged to notify sexual

partners); provider referral, (health care

staff, traditionally in the health

department, notify partners); or contract

referral (a time limit is agreed upon for

patient referral, after which provider

referral is initiated). In this program

announcement, ‘‘partner services’’ is

used to describe the constellation of

services that should be provided to the

sexual partners of individuals in whom

a sexually transmitted disease has been

detected and treated.

The purpose of PS is to break the

chain of infection and re-infection that

can occur when a STD is treated in only

a part of a sexual dyad or network. STDs

are often asymptomatic, many infected

individuals are unaware of their

infection, thus symptom-driven patient

presentation for diagnosis and treatment

fails to reach many people with STDs.

PS may shorten the duration of infection

in many additional individuals by

identifying, treating, and counseling the

sex partners of patients with STDs.

Furthermore, PS offers a unique

opportunity to assist at-risk, infected

and uninfected people to adopt safer

behaviors that will enable them to

remain STD-free and is a key

component of public health practice.

The objectives of partner services

include identifying, locating, notifying,

testing, treating, and providing

counseling to reduce STD risk for the

sex partners of an individual diagnosed

with chlamydia, gonorrhea, syphilis,

trichomoniasis, herpes, or human

immunodeficiency virus (HIV).

Despite the importance of partner

services in public health practice,

relatively little scientific information is

available on the impact on disease

transmission or cost effectiveness of

various approaches, particularly for

STDs that are treated in the private

sector. Another limitation of the current

science base is that existing data on

partner services has been generated

from federal, state, and local public

health programs that have a legal

responsibility to provide PS. This

information does not reflect partner

services in other clinical settings where

the majority of STD diagnosis and

treatment take place. At least half of

STD care is sought from private

providers. Therefore, further research

across the full spectrum of STD

treatment providers with respect to PS

is clearly needed. Current data from a

national survey of providers suggests

that the most common method of

notification in the private sector is

patient referral, although the rate of new

infections uncovered in the private

sector from this method is not known.

Fewer than 5 percent of providers

reported engaging in provider referral

and less than 50 percent consistently

reported patients’ names to health

departments after a diagnosis of

chlamydia, gonorrhea, syphilis, or HIV

infection. Case reporting from providers

and from laboratories enables the local

health department to provide partner

services. However, providers may also

diagnose and treat presumptively

without performing a laboratory test,

and relatively little is known about case

reporting or partner services following

presumptive treatment.

Provider-perceived barriers to offering

partner services include concerns about

negative effects on relationships with

patients and their partners, lack of

training and time for these activities,

and lack of reimbursement.

Nevertheless, providers agreed that PS

could promote appropriate behavior and

attitude change, and reduce (re)infection

rates. In summary, this survey

confirmed that the effectiveness of PS in

the private sector is unknown and

reporting of names to agencies that

conduct PS is limited.

Current methods of PS require

substantial time and effort from public

health staff, although data estimating

the magnitude of the reduction in STD

incidence or prevalence within

communities that is attributable to PS

are currently lacking. Recent advances

in STD detection and treatment,

information system hardware and

software, and behavioral interventions

offer an unprecedented opportunity to:

(1) Design and evaluate innovative

strategies that increase the effectiveness

of partner elicitation;

32102 Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices

(2) Improve the timely connection of

partners with appropriate detection,

treatment, and counseling services;

(3) Intervene to lower STD risk among

sex partners; and

(4) Evaluate the cost-effectiveness of

new methods in comparison to current

strategies.

This is likely to require complex

evaluation that moves from the index

patient to the patient-partner dyad, to

sexual networks, and to community

levels of evaluation.

CDC envisions that data from this

research program will be used to design

cost-effective strategies that

(a) Augment the effectiveness of PS in

the public and private sectors;

(b) Reduce the incidence and the

prevalence of curable STDs; and

(c) Utilize the opportunities inherent

in partner services to lower partners’

risk behaviors.

Incidence and prevalence reductions

should be demonstrably attributable to

innovations in PS.

This program has four general

objectives:

1. To develop, apply, and evaluate

confidential and innovative partner

services across a variety of practice

settings using new techniques or

technologies and to assess their

effectiveness and acceptability in

comparison with current PS methods;

2. To develop and assess the

feasibility of policy level interventions

that may be needed to make innovative

strategies feasible;

3. To assess the cost-effectiveness of

proposed alternatives in comparison

with current methods of partner

services; and

4. To develop mathematical models

that assess the impact of current and

alternative partner service approaches

on rates of incident and prevalent

infections.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit and forprofit organizations; governments and

their agencies; that is, universities,

colleges, research institutions, managed

care organizations, hospitals; State and

local governments or their bona fide

agents; and federally recognized Indian

tribal governments, Indian tribes, or

Indian tribal organizations. Eligible

applicants should collaborate with their

local or state health department because

this linkage is critical to the successful

conduct of this research.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $750,000 is available

in FY 2000 to fund the first year of

approximately 2–3 awards. It is

expected that the average award will be

$250,000, ranging from $100,000 to

$350,000. It is expected that the awards

will begin by September 30, 2000 and

will be made for a 12-month budget

period for a maximum project period of

four years. Funding estimates may

change. Continuation awards within an

approved project period will be based

on satisfactory progress as evidenced by

required reports and on the availability

of funds.

Funding Preferences

Funding preference will be given:

1. To applicants with access to

subjects in public and private settings

where STDs are diagnosed and treated;

2. To achieve geographic distribution;

3. To applications that address more

than one STD;

4. To applications that involve

collaboration with health departments;

and

5. To applications that incorporate a

mix of provider settings where

chlamydia, gonorrhea, syphilis,

trichomoniasis, herpes, or human

immunodeficiency virus (HIV) are

detected and treated.

Collaborative partnerships are

strongly encouraged with managed care

organizations, private practice settings,

family planning clinics, or community

and migrant health centers in addition

to traditional public STD clinics.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

a. Design and conduct research to

address the study question(s) as listed

below. Applicants may address one or

more of the study questions listed and

are encouraged to address at least two.

Study Questions

(1) In comparison to current

strategies, what innovative methods can

be developed and evaluated to increase

the timeliness, effectiveness, and costeffectiveness of partner services across a

variety of practice settings?

PS interventions should be tailored to

patient, partner, or provider

characteristics, to specific STDs, and to

different practice settings in order to

produce the most effective partner

services. It is also important to assess

methods that increase patient’s

cooperation, recall, and accuracy with

respect to (a) providing names and

locating information for partners or (b)

following through with patient referral.

Evaluation of the barriers that inhibit

patients from naming partners or

delivering patient referral in

conjunction with interventions that

overcome those barriers and increase

the proportion of partners who receive

medical evaluation, treatment, and

counseling are encouraged.

Development and evaluation of

strategies that promote the timely and

appropriate delivery of partner services

are encouraged. There is also interest in

identifying methods for delivering

partner services that promote changes in

partners’ risk behaviors and how this

may vary by whether or not the exposed

partner had acquired an STD.

For new strategies, techniques, or

technologies, identify how they can be

implemented in public and private

health care settings. Evaluations should

address to what extent and how the use

of the new technologies or techniques

increase the productivity of staff and

reduce the barriers to timely and

effective partner services for staff,

patients, and partners.

Finally, there is programmatic interest

in assessing the cost-effectiveness of

innovative strategies, new techniques,

and new technologies. Such interest

includes accurately determining the

incremental cost of identifying and

locating partners and infections using

innovative strategies and their

comparison with the cost of current

strategies. Cost-effectiveness measures

should include research, training, and

program costs separately so that

implementation can be examined

independently of research costs.

Applications that combine some or all

of the above elements are encouraged.

Preference will be given to applications

that:

(a) Propose the development,

implementation, and evaluation of

innovative strategies;

(b) Present a detailed plan for

measuring and evaluating outcomes;

(c) Will be able to identify which

elements of a proposed strategy account

for its effectiveness;

(d) Make the incremental value of the

strategy visible; and

(e) Incorporate technology transfer to

settings where STDs are diagnosed and

treated.

(f) Compare proposed innovative

strategies with traditional methods of

partner services and clarify whether

Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices 32103

these new techniques or technologies

offer any added value to current partner

service activities.

(2) What policy level interventions

can be developed, implemented, and

evaluated to promote partner services

across a broad spectrum of health care

settings?

This may include identification of the

policy sources, their policy function

(advisory, regulatory, implementation),

and the introduction and evaluation of

policy-level changes that promote the

improved delivery of partner services.

There is interest in funding

interventions that can produce the

necessary policy changes, including

linking the process of such

interventions with specific outcomes

(e.g., policy changes in health care plans

that make partner services

reimbursable).

(3) Apply mathematical models to

assess the impact of current and

alternative partner service approaches

on rates of incident and prevalent

infections?

The application of mathematical

models to assess which current

strategies and proposed alternatives may

be most valuable in increasing the

timeliness and effectiveness of partner

services are also encouraged.

Consideration will be given to the use

of existing databases. The use of costeffectiveness data as part of a model (or

series of models) is encouraged.

b. Evaluate and analyze the research

data.

c. Disseminate study findings through

presentations at scientific meetings and

publications in peer-reviewed journals.

2. CDC Activities

A cooperative agreement reflects an

assistance relationship between the

Federal Government and the recipient

in which substantial programmatic

involvement is anticipated about the

scientific or technical management of an

activity during its performance. The

CDC program office will:

a. Provide up-to date scientific

information, technical assistance, and

guidance in the design and conduct of

the research.

b. As needed, assist in the

development of a research protocol for

local IRB review at cooperating

institutions participating in the research

project. The CDC IRB will review and

approve the protocol initially and on at

least an annual basis until the research

project is completed.

c. As needed, assist in data analysis

and the preparation of manuscripts.

d. Convene meetings of all grantees

for the exchange of information.

E. Application Content

Applications must be developed in

accordance with the information

contained in this program

announcement, the PHS 398 Grant

Application, and the instructions

provided in this section. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan.

Instructions

The program narrative for sections 1–

5 below should be no more than 25

single-spaced pages, printed on one

side, with one-inch margins, and 10 or

12 cpi typeface. All pages, including

appendices, should be numbered

sequentially. The narrative must contain

the following sections in the order

presented below:

1. Abstract: Provide a brief abstract of

the project. The abstract must reflect the

project’s focus and the length of the

project period (maximum is 4 years) for

which assistance is being requested (see

‘‘Availability of Funds’’ for additional

information).

2. Specific Aims: List the broad, longterm objectives and what the specific

research proposed in this application is

intended to accomplish. State the

hypotheses to be tested. One page is

recommended.

3. Background and Significance:

Briefly sketch the background leading to

the present application, critically

evaluate existing knowledge, and

specifically identify the gaps which the

project is intended to fill. State

concisely the importance and health

relevance of the research described in

this application by relating the specific

aims to the broad, long-term objections.

Two to three pages are recommended.

4. Preliminary Studies: Use this

section to provide an account of the

principal investigator/program

director’s preliminary studies pertinent

to the application information that will

help to establish the experience and

competence of the investigator to pursue

the proposed project. The complete

references to appropriate publications

and manuscripts submitted or accepted

for publication may be listed and are not

part of the page limitations. Five

collated sets of no more than 10 such

items of background material may be

submitted in an appendix. Six to eight

pages are recommended for the

narrative portion of the Preliminary

Studies section.

5. Research Design and Methods:

Describe the research design and the

procedures to be used to accomplish the

specific aims of the project. Include how

the data will be collected, analyzed, and

interpreted. Describe any new

methodology and its advantage over

existing methodologies. Discuss the

potential difficulties and limitations of

the proposed procedures and alternative

approaches to achieve the aims. As part

of this section, provide a tentative

sequence or timetable for the project.

Describe specific study protocols or

plans for the development of study

protocols. Describe the nature and

extent of collaboration with CDC and/or

others during various phases of the

project. Describe in detail a plan for

evaluating study results and for

evaluating progress toward achieving

project objectives.

6. Inclusion of Racial and Ethnic

Populations: Describe the degree to

which applicant will meet requirements

regarding the inclusion of women, and

members of minority groups in the

proposed study.

7. Human Subject Involvement:

Describe procedures that will provide

for the protection of human subjects.

Address how these procedures are in

compliance with Federal regulations.

F. Submission and Deadline

Letter of Intent (LOI)

For planning purposes, a letter of

intent to apply is requested and needed

to staff the review panels, but not

required, from potential applicants.

Your letter of intent should include the

following information: Program

Announcement Number [00080], name

and address of institution; name

address, and telephone number of

contact person; and specific objectives

to be addressed by the proposed project.

The letter of intent must be submitted

on or before June 12, 2000 to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Application

Applicants should submit five copies

of PHS–398 (OMB Number 0925–0001)

and adhere to the instructions on the

Errata Instruction Sheet for PHS 398.

Forms are available at the following

Internet address: www.cdc.gov/...Forms,

or in the application kit. On or before

July 14, 2000 submit the application to

the Grants Management Specialist

identified in the ‘‘Where to Obtain

Additional Information’’ section of this

announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

32104 Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices

(b) Sent on or before the deadline date

and received in time for distribution to

the review panel. (Applicants must

request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

Late Applications: Applications,

which do not meet the criteria in (a) or

(b) above, are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Upon receipt, applications will be

reviewed by CDC for completeness and

responsiveness to the purpose of this

request for applications (RFA) (as

described in Section A), and as outlined

under Eligible Applicants and Program

Requirements (Items A to B). Incomplete

applications and applications that are

not responsive will be returned to the

applicant without further consideration.

It is important that the applicant’s

abstract reflects the project’s focus,

because the abstract will be used to help

determine the responsiveness of the

application.

All proposals will be independently

reviewed for scientific merit by no less

than three reviewers with appropriate

expertise using current National

Institutes of Health (NIH) review criteria

to evaluate the methods and scientific

quality of the proposal. Factors to be

considered will include:

1. The specific aims of the research

project, i.e., the intended

accomplishment of the specific research

proposal, and the hypothesis to be

tested. (5 percent)

2. The background of the proposal,

i.e., the basis for the present proposal,

the critical evaluation of existing

knowledge, and identification of

specific knowledge gaps which the

proposal is intended to fill. (10 percent)

3. The significance and innovation

from scientific and programmatic

standpoints of the proposed research,

including the adequacy of the

theoretical and conceptual framework

for the research. (20 percent)

4. The adequacy of the proposed

research design, approaches, and

methodology to carry out the research,

including quality assurance procedures,

plan for data management, statistical

analysis plan, and evaluation plan. (40

percent)

5. The extent to which the research

will lead to feasible, cost-effective

interventions. (10 percent)

6. Qualifications and appropriateness

of the proposed personnel to

accomplish the proposed activities as

well as the degree of commitment and

cooperation of proposed collaborators

and organizations (as evidenced by

letters detailing the nature and extent of

the involvement). (10 percent)

7. Research Capacity—adequacy of

existing and proposed facilities and

resources. (5 percent)

8. Gender and minority issues. Does

the application include:

a. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

b. The proposed justification when

representation is limited or absent.

c. A statement as to whether the

design of the study is adequate to

measure differences when warranted.

d. 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.

9. Human Subjects—What are the

strategies for the recruitment and

retention of human subjects? Are the

procedures proposed adequate for the

protection of human subjects and are

they fully documented? Are all

procedures in compliance with

applicable published regulations and 45

CFR 46?

10. The reasonableness of the

proposed budget to the proposed

research and demonstration program.

Applications that propose to address

more than one of the study questions

described in Section D: Program

Requirements should include a separate

budget breakdown for each study

question to be addressed.

Final awards will be determined by

the Director of the Division of STD

Prevention (DSTD) based on priority

scores assigned by the independent

review group appointed by CDC,

consultation with DSTD senior staff, the

match between the proposal and the

program announcement, the relevance

and balance of proposed research

relative to DSTD priorities, and the

availability of funds.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with an original plus

two copies of:

1. Progress reports annually, no later

than 90 days after the end of the budget

period;

2. Financial status report, no later

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Additional Requirements

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

Requirements

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting System

Requirements

AR–21 Small, Minority, And Womenowned Business

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 318 of the Public Health Service

Act, [42 U.S.C. Section 247c, as

amended. The Catalog of Federal

Domestic Assistance Number is 93.978.

J. Where To Obtain Additional

Information

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888 472–6874). You will be asked to

leave you name and address and will be

instructed to identify the

Announcement number of interest.

To obtain additional information,

contact: Kang W. Lee, Grants

Management Specialist, Procurement

and Grants Office, Grants Management

Branch, Centers for Disease Control and

Prevention, Room 3000, 2920

Brandywine Road, Atlanta, GA 30341–

4146; Telephone number (770) 488–

2733; FAX number (770) 488–2847;

Email address kil8@cdc.gov.

See also the CDC home page on the

Internet: http://www.cdc.gov.

For program technical assistance,

contact: Janet S. St. Lawrence, Division

of STD Prevention, Centers for Disease

Control and Prevention (CDC), Mail

Stop E44, 1600 Clifton Road NE,

Atlanta, GA 30333, (404) 639–8298;

FAX: (404) 639–8622; Email address:

nzs4@cdc.gov.

Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices 32105

Dated: May 16, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–12742 Filed 5–17–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00072]

Project CHOICES Efficacy Study;

Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for Project CHOICES (Changing

High-risk AlcOhol Use and Increasing

Contraception Effectiveness Study)

Efficacy Study. The purpose of the

study is to establish efficacy of Project

CHOICES, a behavioral intervention

approach to reducing alcohol-exposed

pregnancies, in a multi-site, randomized

clinical trial. Project CHOICES targets

non-pregnant women at high risk for an

alcohol-exposed pregnancy with a dual

focused intervention aimed at reducing

risk drinking and engaging in effective

contraception until risk drinking is

resolved. High-risk women will be

accessed in high prevalence,

community-based settings. CDC is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2010,’’ a

national activity to reduce morbidity

and morality and improve the quality of

life.

This announcement is related to the

focus areas of Substance Abuse: Alcohol

and Other Drugs; and Maternal, Infant,

and Child Health. For the conference

copy of ‘‘Healthy People 2010,’’ visit the

internet site: ≤http://www.health.gov/

healthypeople>

B. Eligible Applicants

Eligible applicants are limited to

those previously funded under Program

Announcement No. 746: Nova

Southeastern University, The University

of Texas—Houston, and Virginia

Commonwealth University.

These applicants have been funded by

CDC since 1997 to develop and

implement the Project CHOICES

Feasibility Study. This new cooperative

agreement would allow the grantees to

implement the study as a clinical trial.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $900,000 is available

in FY 2000 to fund approximately 3

awards. It is expected that the average

award will be $300,000, ranging from

$250,000 to $350,000. It is expected that

the awards will begin on or about

September 30, 2000, and will be made

for a 12-month budget period within a

project period of up to 3 years. Funding

estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

Project CHOICES targets nonpregnant, fertile women, 18–44 years of

age, who are moderate to heavy alcohol

consumers. Potentially high prevalence

populations of targeted women have

been defined from previous studies,

including the Project CHOICES

Feasibility Study which is currently

underway. Applicants must select from

the following list of high prevalence

populations two settings in which they

will conduct the Project CHOICES

Efficacy Study: A jail; an alcohol and

drug treatment center; an ObstetricalGynecological clinic; a Sexually

Transmitted Disease (STD) Clinic; a

media-recruited population of high-risk

women; a Women, Infants, and Children

(WIC) clinic; or an HMO. Applicants

will then implement a behavior

intervention protocol drawn from the

Project CHOICES Feasibility study in

two selected settings. Applicants must

demonstrate the ability to maintain a

minimum of 200 women from each

selected setting (to be equally

randomized to experimental and control

groups) in the clinical study.

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

a. Refine Project CHOICES protocol

and implement as a clinical trial in two

diverse settings.

b. Recruit and train staff in a timely

manner to ensure study implementation

within the 3-year project period.

c. Implement appropriate quality

assurance procedures to assure that

protocols for the efficacy study are being

properly implemented.

d. Develop manuscripts and

presentations describing the Project

CHOICES Efficacy Study, results and

recommendations.

2. CDC Activities

a. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

cooperating institutions participating in

the research project.

b. The CDC IRB will review and

approve the protocol initially and on at

least an annual basis until the research

project is completed.

c. Assist in the overall coordination of

the implementation and evaluation of

the intervention protocol.

d. Provide current scientific

information, and ensure adherence to

appropriate scientific standards

including human subject regulations.

E. Application Content

Applications

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out the program

plan. The narrative should be no more

than 25 double-spaced pages (excluding

attachments), printed on one side, with

one inch margins, and unreduced font.

Do not include any spiral or bound

materials or pamphlets.

Program Narrative (not to exceed 25

pages):

The Program narrative should follow

the PHS–398 (Rev. 4/98) application

and Errata sheet, and should include the

following information:

1. A demonstrated understanding of

the problem of FAS and other prenatal

alcohol-related conditions, and the role

of brief intervention and treatment

approaches to preventing these

disorders; a justification of the need for

the proposed study and the grantee’s

rationale for targeting the two selected

settings as ones in which high

prevalence populations of women at

risk for a alcohol-exposed pregnancy

can be accessed; and a description of

how this study addresses Health People

2010 Objectives and the

recommendations of the Institute of

Medicine report: Fetal Alcohol

Syndrome: Diagnosis, Epidemiology,

Prevention and Treatment.

2. Specific, measurable, and timeframed objectives.

3. A detailed plan describing the

approach to be taken in implementing