FY 1997 Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 735]

FY 1997 Epidemiologic Research Studies of Acquired

Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)

Infection

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1997 funds for a cooperative agreement

program for epidemiologic and behavioral research studies of AIDS and

HIV infection. These include studies to examine factors related to: (I)

manifestations and medical management of HIV infection in children and

(II) acceptability of new prevention methods currently being tested

that offer alternatives to male condoms for HIV/STD protection. The

study of these research areas as they pertain to racial and ethnic

minority populations (defined as Alaskan Native, African-American,

Hispanic, Asian/Pacific Islander, and American Indian) is encouraged

because minorities constitute more than 53 percent of all reported

cases of AIDS and approximately 77 percent of all women and children

with AIDS.

CDC is committed to achieving the health promotion and disease

prevention objectives of Healthy People 2000, a national activity to

reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of HIV Infection. (To

order a copy of ``Healthy People 2000,'' see the section Where to

Obtain Additional Information.)

Authority

This program is authorized under Sections 301(a) and 317(k)(2) of

the Public Health Service Act [42 U.S.C. 241(a) and 247b(k)(2)], as

amended. Applicable program regulations are set forth in 42 CFR Part

52, entitled ``Grants for Research Projects.''

Smoke-Free Workplace

CDC strongly encourages all cooperative agreement recipients to

provide a smoke-free workplace and promote the non-use of all tobacco

products. Public Law 103-227, the Pro-Children Act of 1994, prohibits

smoking in certain facilities that receive Federal funds in which

education, library, day care, health care, and early childhood

development services are provided to children.

Eligible Applicants

Eligible applicants include all public and private nonprofit

organizations and governments and their agencies. Thus, universities;

colleges; research institutions; hospitals and other public and private

organizations; territories, District of Columbia, and State and local

governments or their bona fide agents; federally recognized Indian

tribal governments; Indian tribes or Indian tribal organizations; and

small minority-or women-owned nonprofit businesses are eligible to

apply.

Note: Organizations described in section 501(c)(4) of the

Internal Revenue Code of 1986 that engage in lobbying are not

eligible to receive Federal grant/cooperative agreement funds.

[[Page 36515]]

Availability of Funds

Approximately $1 million is available in FY 1997 to fund

approximately two new awards and approximately $2 million is available

to fund six competing continuation projects. It is expected that the

average new awards will be range from $300,000 to $700,000 and

continuation awards will be approximately $300,000. It is expected that

awards will begin on or about September 30, 1997. Successful grantees

will be funded for a 12-month budget period within a project period of

up to three years. Continuation awards within the project period will

be made on the basis of satisfactory programmatic progress and the

availability of funds. Funding estimates may vary and are subject to

change.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of Department

of Health and Human Services (HHS) funds for lobbying of Federal or

State legislative bodies. Under the provisions of 31 U.S.C. Section

1352 (which has been in effect since December 23, 1989), recipients

(and their subtier contractors) are prohibited from using appropriated

Federal funds (other than profits from a Federal contract) for lobbying

Congress or any Federal agency in connection with the award of a

particular contract, grant, cooperative agreement, or loan. This

includes grants/cooperative agreements that, in whole or in part,

involve conferences for which Federal funds cannot be used directly or

indirectly to encourage participants to lobby or to instruct

participants on how to lobby.

In addition, the FY 1997 Departments of Labor, HHS, and Education,

and Related Agencies Appropriations Act, which became effective October

1, 1996, expressly prohibits the use of 1997 appropriated funds for

indirect or ``grass roots'' lobbying efforts that are designed to

support or defeat legislation pending before State legislatures.

Section 503 of this new law, as enacted by the Omnibus Consolidated

Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.

No. 104-208 (September 30, 1996), provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act

shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * * except

in presentation to the Congress or any State legislative body itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract recipient,

or agent acting for such recipient, related to any activity designed to

influence legislation or appropriations pending before the Congress or

any State legislature.

Background

The AIDS epidemic continues in the United States with 581,429 cases

of AIDS, including 7,629 cases in children, 85,500 cases in women and

324,728 cases in men who have sex with men reported to the CDC as of

December 1996. Approximately 62 percent of persons with AIDS have died.

Current estimates reflect that approximately 700,000 Americans have

been infected with HIV, the etiologic agent of AIDS. More difficult to

estimate is the number of incident HIV infections occurring yearly.

Heterosexual transmission is now the leading cause of AIDS cases among

U.S. women and is the fastest growing mode of transmission in newly

infected persons. However, male-to-male exposure continues as the

single greatest risk category among men. Fifty percent of cumulative

AIDS cases and 40 percent of annual AIDS cases in 1996 were attributed

exclusively to male-to-male sexual exposure. African-Americans,

Hispanics, women, and adolescents are increasingly represented in both

AIDS cases and new HIV infections.

Although it now may be possible to prevent most HIV transmission to

children, there are approximately 15,000 children living with HIV

infection in the U.S. and infected children will continue to be born

despite prevention efforts. Timely prophylaxis and treatment are

improving survival of these children but advances in diagnostics,

prophylactic and treatment options, as well as ongoing changes in

health care delivery (e.g., managed care) may add complexity to their

medical management. Information is needed to monitor trends in medical

management and progression of disease to evaluate implementation of

treatment recommendations and their impact. Information is also needed

to characterize HIV disease and social impact in children with long-

term survival (into adolescence).

Additional studies of the epidemic of HIV are needed to guide

prevention and control efforts. In particular, information that will

guide development of new prevention technologies, including

microbicides to prevent sexual transmission in women and men, is

needed.

Purpose

The purpose of these awards is to help support researchers in the

conduct of HIV-related epidemiologic and behavioral research studies

that foster prevention of HIV infection or HIV-related disease. These

include studies to monitor medical care, social circumstances, and

clinical course of HIV-infected children and adolescents infected in

childhood; and studies to examine behavioral and biomedical factors

related to the acceptability of new products to prevent sexual

transmission of HIV infection such as vaginal and rectal microbicides.

The study of these research areas as they pertain to minority

populations are of special interest.

Research Issues

Three research issues of programmatic interest to the health care

community and to CDC for FY 1997 are listed below and are considered of

significant importance in gaining a greater understanding of the

epidemiology of AIDS and HIV infection. However, applications submitted

by organizations that examine additional important HIV-related

epidemiologic research issues will also be accepted and considered for

funding.

Applicants addressing the same research issue should be willing to

participate in collaborative studies with other CDC-sponsored

researchers, including the use of common data collection instruments,

specimen collection protocols, and data management procedures, as

determined in post-award grantee planning conferences. Applicants are

required to identify their proposed research issue on line one of the

face page of the application form. (For more information on which form

to use, see the section Application Submission and Deadline)

1. Pediatric HIV Infection: Spectrum of Disease, Medical Management,

Secondary Prevention, and Social Impact

Applications are solicited for participation in an ongoing multi-

site longitudinal medical record review study, the Pediatric Spectrum

of HIV Disease (PSD) Project. Applications must address both Parts A

and B below.

A. Prospective Studies Monitoring HIV-Infected Children

Applications are solicited for continued prospective monitoring,

through repeated medical record review,

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of: (i) trends in medical management of pediatric HIV infection

(including treatment, prophylaxis for opportunistic infections,

diagnostic testing and immunologic and virologic monitoring); (ii)

clinical course of HIV infection,(e.g., occurrence of AIDS-defining

conditions, other manifestations, and death); (iii) long-term outcomes,

(i.e. clinical course in perinatally infected children who survive to

adolescence); and (iv) social circumstances, (i.e. changes in

caretakers and living arrangements, school attendance and knowledge/

disclosure of HIV status).

Preference will be given to currently funded applicants with

studies in which HIV-infected children have already been identified and

are being systematically monitored, and with the capacity to begin

monitoring newly identified HIV-infected children. Applicants must

demonstrate adequate rates of follow-up of HIV-infected children, the

capacity for timely completion of biannual medical record review, and

must be willing to collaborate with other CDC PSD grantees in the study

of HIV-infected children, including use of common data collection

instruments and protocols and data management.

B. Monitoring HIV-Exposed Infants in the First Year of Life

Applicants must be able to identify infants born to HIV-infected

mothers after December 1995, and to monitor their HIV-specific medical

management in the first year of life through retrospective medical

record review initiated after a child's first birthday, including (i)

antiretroviral prophylaxis and treatment, (ii) prophylaxis to prevent

opportunistic infections, (iii) diagnostic testing, and (iv)

immunologic and virologic monitoring.

Applicants must have a plan for reporting (where required by law)

HIV exposure, HIV infection status, or AIDS in children, including

completion of CDC HIV/AIDS report forms, and entry and complete and

timely transfer of case reports/updates to the State or local health

department.

Acceptability of HIV/STD Prevention Methods Among Women and Men Who

Have Sex With Men

Studies are underway to determine the safety and efficacy of

prevention methods that may offer options for HIV/STD protection other

than the male condom (e.g., female condom, vaginal and rectal products

that might be used as microbicides). As new methods for HIV/STD

prevention become available, information is needed on the acceptability

of the methods to different populations and effective communication

strategies for informing persons of multiple options for protection

from HIV and other STDs. Applications are solicited that address: (1)

acceptability of various HIV/STD prevention methods, characteristics of

persons choosing different methods, and the conditions under which

different methods are preferred; (2) comprehension and interpretation

of prevention messages offering multiple HIV/STD prevention options and

the impact of these messages on sexual behaviors and intentions; and

(3) strategies for integrating multiple-option HIV/STD prevention

messages into more conventional interventions that exclusively promote

male condom use.

2. Acceptability of Prevention Methods Among Women at Risk for HIV/STD

Applications are sought that: (1) implement an HIV/STD prevention

intervention that has previously been shown to be effective at

increasing male condom use; (2) examine barriers to consistent condom

use among women who have participated in the intervention; (3) describe

characteristics of women who are unable to negotiate consistent condom

use with male partners; and (4) determine if new HIV/STD prevention

methods under development (e.g., female condom, products that might be

used as vaginal microbicides) would be acceptable to these women.

Applicants are sought who can enroll at least 750 women at risk for HIV

or other STDs in a short-term longitudinal study to: (1) examine

barriers to male condom use among women participating in a short-term

intervention promoting male condom use; (2) determine acceptability of

new HIV/STD prevention methods to women whose male partners are not

using condoms after the intervention; (3) determine the conditions

under which new methods would be acceptable and the characteristics of

women and their partners who prefer the different methods; and (4)

develop and test methods for presenting multiple HIV/STD options to

women and for integrating these complex prevention messages into

interventions promoting only male condom use.

3. Acceptability of HIV/STD Prevention Methods Among Men Who Have Sex

With Men

To better understand the acceptability of alternative methods to

condoms currently being tested for HIV/STD prevention among men who

have sex with men, applications are solicited that propose examination

of (1) features that are important in a prevention method for men who

have sex with men, (2) the extent to which alternative prevention

methods being tested would be used and the conditions under which these

methods would be preferred over condom use, (3) the characteristics of

men and their partners who are likely to use alternative methods, (4)

effective messages for presenting risks and benefits of various

prevention methods and (5) effect of message content and format on

behavioral intentions.

Applicants are sought who can enroll at least 400 men who have sex

with men in a cross-sectional study. Proposal should include study

designs to collect: (1) survey data on current HIV/STD prevention

practices among men who have sex with men, features that are desired in

a prevention method, extent to which prevention methods being tested

(e.g., products that could be used as rectal microbicide) are

desirable, and the conditions under which these methods would be

chosen; and (2) data on the influence of HIV/STD prevention message

content, structure, and complexity on comprehension of the message,

interpretation of effectiveness and potential risks associated with

each HIV/STD prevention method contained in the message, and

acceptability of the different methods.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities listed under

subparagraph 1., below, and CDC will be responsible for conducting

activities listed under subparagraph 2., below:

1. Recipient Activities

A. Develop the research study protocol and data collection forms.

B. Identify, recruit, obtain informed consent from, and enroll an

adequate number of study participants as determined by the study

protocol and the program requirements.

C. Continue to follow study participants as determined by the study

protocol.

D. Establish procedures to maintain the rights and confidentiality

of all study participants.

E. Perform laboratory tests (when appropriate) and data analysis as

determined in the study protocol.

F. Collaborate and share data and specimens (when appropriate) with

other collaborators to answer specific research questions.

G. Conduct data analysis with all collaborators as well as present

and publish research findings.

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2. CDC Activities

A. Provide technical assistance in the design and conduct of the

research.

B. Provide technical guidance in the development of study

protocols, consent forms, and data collection forms.

C. Assist in designing a data management system.

D. Assist in performance of selected laboratory tests.

E. Coordinate research activities among the different sites.

F. Assist in the analysis of research information and the

presentation and publication of research findings.

Technical Reporting Requirements

An original and two copies of the following reports are required to

be submitted to the Grants Management Branch (GMB), CDC in accordance

with the following guidelines. See the section Where to Obtain

Additional Information for the address of the GMB.

1. Annual Progress Report

An annual progress report is required to be included in

continuation applications for each year of the project. Continuation

applications will be solicited each year by the Grants Management

Branch, CDC. The progress reports must include the following for each

program, function, or activity involved: (1) a comparison of actual

accomplishments to the goals established for the period, including

estimated performance for any time remaining in the budget period after

submission of the application; (2) reasons for slippage if established

goals are not likely to be met by the end of the budget period; and (3)

other pertinent information including, when appropriate, analysis and

explanation of any actual costs that significantly exceed budgeted

levels.

2. Financial Status Reports (Standard Forms 269)

Financial Status Reports (FSRs) are required to be submitted

annually within 90 days after the end of each budget period. The

purpose of the FSR is to report actual costs incurred as opposed to

budgeted and to establish any unobligated balances of prior-year funds.

A final progress report summarizing the progress for the entire project

is required within 90 days after the end of the project period.

Application Content

Applications must be developed in accordance with PHS Form 398,

information contained in the program announcement and the instructions

and format provided below.

Applicants are required to submit an original and five copies of

the application. The application may not exceed 25 double-spaced pages

in length, excluding appendices. Applicants should provide a one-page

abstract of the proposal. Number all pages clearly and sequentially and

include a complete index to the application and its appendices. The

original and each copy of the application must be submitted UNSTAPLED

and UNBOUND. Print all material, double spaced, in a 12-point or larger

font on 8\1/2\'' by 11'' paper, with at least 1'' margins and printed

on one side only.

The application should include a general introduction, followed by

one narrative subsection per application content element in the order

in which the elements appear below. Each narrative subsection should be

labeled with the element title and contain all of the information

needed to evaluate that element of the application (except for

curriculum vita, references, and letters of support, which are

appropriate for the appendices). The application content elements are

outlined below for all research issues:

1. Pediatric HIV Infection: Spectrum of Disease, Medical Management,

Secondary Prevention, and Social Impact

A. Familiarity With and Access to Study Population

(1) Describe the population to be prospectively monitored,

including number, age distribution, and other relevant demographic

characteristics for Part A; note procedures for identifying HIV-

infected children (including, for example, death certificate review).

(2) Describe procedures for identifying children born to HIV-

exposed mothers for Part B.

(3) Describe prior research with or service provision to the study

populations for Part A and Part B.

(4) Demonstrate familiarity with issues regarding medical care for

HIV exposure and infection in children, and progression of disease

among and social circumstances of HIV-infected children.

(5) Describe linkages and collaboration with organizations

providing medical and psychosocial services to the study population

including plans to improve PSD's case finding and follow up of exposed

and infected children.

(6) Document ability to monitor the study population prospectively

for Part A and for the first year of life for Part B. As appropriate,

include memoranda of agreement to document collaboration with

organizations providing services to the study population; document

ability to complete biannual review of medical records, and describe

ability to track children who change care providers.

(7) Describe procedures for involving the service providers in the

design and implementation of research activities under Part B and for

reporting results of the research to collaborating service providers

(Parts A and B).

B. Description and Justification of a Research Plan

(1) Based on review of the scientific literature, describe

understanding of the overall research issues to be addressed by PSD and

any specific research focus of interest to the applicant (Parts A and

B). Research issues/topics may include participant characteristics

(e.g., ethnicity, year of birth, clinical, immunologic, or social

status), disease progression, survival, medical management, and

developing and evaluating recommendations for medical care, including

recommendations for preventing opportunistic infections.

(2) Specify the number of HIV-infected enrollees to be

prospectively monitored, and expected attrition from deaths and losses

to follow-up over the study period based on prior experience (Part A).

(3) Describe methods and procedures for data abstraction and

assuring adequate follow-up and timely completion of data forms (Parts

A and B).

(4) Describe proposed quality assurance measures including methods;

protocols; supervision of data abstraction, entry, and cleaning;

maintaining consistency of data abstraction; accuracy and completeness

of record keeping; monitoring of study progress; and forming and

maintaining collaborative relationships (Parts A and B).

(5) Describe plans to analyze local data using quantitative methods

and statistical techniques and submit results and all data to CDC

(Parts A and B).

(6) Describe procedures for tracking follow-up of HIV-infected

children.

(7) Describe previous experience conducting data collection and

management for PSD and PSD supplemental research projects.

(8) Describe procedures for obtaining Institutional Review Board

(IRB) approval and maintaining participant confidentiality (Parts A and

B).

(9) Identify and discuss any potential ethical issues associated

with the proposed research and describe how these issues will be

resolved (Parts A and B).

[[Page 36518]]

(10) Describe plans to disseminate research findings (Parts A and

B).

C. Provision of HIV/AIDS Report Data to and Collaboration With Local

Pediatric HIV/AIDS Surveillance Activities

(1) Describe procedures for collaborating with local health

department pediatric HIV/AIDS surveillance staff to report children

with HIV exposure, infection, and AIDS (depending on State law),

including specific responsibilities and schedules for completion and

computer entry of HIV/AIDS report forms, schedule for transfer of HIV/

AIDS report data to State/local health department surveillance unit,

and measures to protect confidentiality of HIV/AIDS report data. (For

applicants in States without HIV reporting laws, describe intentions

for use of HIV infection data.) Include a signed memorandum of

agreement detailing the outlined division of responsibilities, joint

activities to evaluate completeness, timeliness, validity of the HIV/

AIDS report data, methods to ensure security and confidentiality of

HIV/AIDS report data, and use of data.

(2) Describe measures to assure completeness of HIV/AIDS report

forms, and quality and timeliness of data.

D. Demonstration of Staff's Capability to Conduct Research

(1) Summarize briefly the professional training and relevant

research experience of the staff as it relates to their main

responsibilities.

(2) Provide brief descriptions and major findings of HIV-related

research studies conducted by members of the research staff.

(3) Include a table of current and previous relevant research

projects, their status, sources and levels of funding, and principal

investigators.

(4) Include in the appendix the curriculum vitae for key staff

members as well as memoranda of agreement that clearly and specifically

document activities to be performed by any external experts,

consultants, or collaborating agencies under the cooperative agreement.

(5) Include copies of any publications on related research by study

staff.

E. Staffing, Facilities, and Time Line

(1) Explain the proposed staffing, percentage of time each staff

member commits to this and other projects, and division of duties and

responsibilities for the project; include brief position descriptions

for existing and proposed personnel.

(2) Identify and describe key roles of all study staff.

(3) Provide justification that base staffing is adequate to keep

pace with biannual medical record review for the number of children to

be monitored prospectively for Part A, and to complete abstraction of

records for all children studied in Part B by 15 months of age.

(4) Describe support activities such as project oversight or data

management that will contribute to the completion of all research

activities.

(5) Provide a statement of willingness of project staff to work

collaboratively with other study sites to develop final research

protocols and to disseminate findings.

(6) Describe existing facilities, equipment, computer software, and

data processing capacity.

(7) Describe the procedures to ensure the security of research

data.

(8) Describe equipment and facilities to be used for data

abstraction and follow-up tracking, data entry and analysis, and

project management.

(9) Justify the need for any proposed consultants.

(10) Describe plans to communicate, ensure quality control and

consistency, identify and resolve problems, and analyze data in

collaboration with other sites.

(11) Provide a time line showing plan for completion of research

activities and goals.

F. Budget

Provide a detailed, line-item budget for the project; justify each

line-item with a budget narrative. Plan for at least one trip per year

to Atlanta to meet with CDC representatives.

2. Acceptability of Prevention Methods Among Women At Risk for HIV/STD;

3. Acceptability of HIV/STD Prevention Methods Among Men Who Have Sex

With Men; and 4. Other HIV/AIDS Epidemiology Research Studies

A. Familiarity With and Access to Study Population

(1) Describe prior research with or service provision to this

population.

(2) Demonstrate familiarity with issues faced by the study

population regarding prevention of sexually transmitted infections,

sexual behaviors, and reproductive decisions and contraception through

experience or review of the scientific literature.

(3) Describe how study participants will be referred to medical and

psychosocial services that are requested by participants during study

participation.

(4) Document ability to recruit the study population for the

proposed research study. As appropriate, include memoranda of agreement

to document collaboration with organizations providing services to the

study population.

(5) Describe the characteristics of the study population and define

the specific subgroup(s) that will be the primary focus of the proposed

research. Using available data, provide a rationale for focusing on the

proposed subgroup(s).

(6) Describe procedures for involving the target population, their

advocates, or service providers in the design and implementation of

research activities.

(7) 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

will be documented.

(8) The proposed plan for the inclusion of racial and ethnic

minority populations for appropriate representation.

(9) The proposed justification when representation is limited or

absent.

B. Description and Justification of Research Plans

(1) Based on review of the scientific literature, if relevant,

describe the theoretical framework or previous research on which your

plan is based and how this framework has been applied to the study

design.

(2) Describe factors to be examined, including specific research

questions and hypotheses to be tested.

(3) Define and describe type of study design.

(4) Describe methods for collecting qualitative and quantitative

data, including outcome measures, types and content of data collection

instruments, and data collection schedules.

(5) Specify the number research participants required, the

recruitment and sampling plan, sample size estimates and power

calculations based on justifiable assumptions about distributions of

participant characteristics, and randomizations procedures, if

appropriate.

(6) Describe proposed quality assurance measures including methods,

protocols, supervision, quality assurance, consistency, confidentiality

of participant information, accuracy and completeness of record

keeping, documentation of study visits, monitoring of study progress,

field safety, and forming and maintaining collaborative relationships.

(7) Describe procedures for obtaining informed consent and

maintaining participant confidentiality.

(8) Identify and discuss potential ethical issues associated with

the

[[Page 36519]]

proposed research and describe how these issues will be resolved.

(9) Discuss if design of the study is adequate to measure racial

and ethnic differences, when warranted.

(10) Describe plans to analyze data using qualitative or

quantitative methods and statistical techniques.

(11) Describe a plan to disseminate research findings.

C. Demonstrate Staff's Capability to Conduct Research

(1) Describe the professional training and relevant research

experience of the staff.

(2) Provide descriptions and major findings of HIV-related

research, behavioral and epidemiologic research studies conducted by

members of the research staff.

(3) Include a table of current and previous relevant research

projects, their status, sources and levels of funding, and principal

investigators.

(4) Include in the appendix, the curriculum vitae for key staff

members as well as memoranda of agreement that clearly and specifically

document activities to be performed by any external experts,

consultants, or collaborating agencies under the cooperative agreement.

(5) Include copies of any publications on related research by study

staff.

D. Staffing, Facilities, and Time Line

(1) Explain the proposed staffing, percentage of time each staff

member commits to this and other projects, and division of duties and

responsibilities for the project; include brief position descriptions

for existing and proposed personnel.

(2) Identify and describe key roles of all study staff.

(3) Describe support activities such as project oversight or data

management that will contribute to the completion of all research

activities.

(4) Provide a statement of willingness of project staff to work

collaboratively with other study sites.

(5) Describe facilities, equipment, computer software, and data

processing capacity.

(6) Describe the procedures to ensure the security of research

data.

(7) Provide a time line for developing, implementing, and

completing the research study, including data analysis and

dissemination.

(8) Describe equipment and facilities to be used for participant

recruitment and interviews, clinical and laboratory assessment, data

entry and analysis, and project management.

(9) Justify the need for any proposed consultants.

(10) If project is multisite, describe experience with multisite

research projects. Describe plans to communicate, ensure quality

control and consistency, identify and resolve problems, and analyze

data in collaboration with other sites.

E. Budget

Provide a detailed, line-item budget for the project; justify each

line-item with a budget narrative. Plan for at least one trip to

Atlanta to meet with CDC representatives.

Evaluation Criteria

All applications will be reviewed according to the criteria listed

below for each research issue. Applicants will be ranked on a scale of

100 maximum points according to the three research issues listed above

and a fourth category for all other HIV-related epidemiologic studies.

All applicants must state which research category they are addressing.

Applications should demonstrate the applicant's ability to address the

research problem in a collaborative manner with other collaborators.

Applications will be reviewed and evaluated based on the evidence

submitted, which specifically describes the applicant's abilities to

meet the following criteria:

1. Pediatric HIV Infection: Spectrum of Disease, Medical Management,

Secondary Prevention, and Social Impact

A. Familiarity With and Access to Study Population (25 points)

(1) Extent of applicant's knowledge of issues faced by study

population and experience in working with medical records of this

population (Parts A and B).

(2) Existence of linkages to facilitate monitoring the study

population (Parts A and B), including memoranda of agreement from the

clinical facilities to permit record review.

(3) Ability to identify and follow for one year all HIV-exposed

children in the catchment area.

(4) Feasibility of plans to improve linkages for PSD's follow-up of

HIV-infected children (Part B).

(5) Feasibility of plans to involve service providers in the

development and implementation of research activities and to inform

them of research results (Parts A and B).

(6) Ability to monitor newly identified HIV-exposed children.

(7) Demonstrated collaboration with local health departments and

pediatric HIV/AIDS surveillance staff.

B. Description and Justification of Research Plans (15 Points)

(1) Quality of the review of the scientific literature pertinent to

the proposed activities, including justification for and relevance of

research questions (Parts A and B).

(2) The applicant's understanding of the research objectives as

evidenced by high quality of the proposed research plan (Parts A and

B).

(3) Feasibility of plans to monitor study participants as evidenced

by the experience of the investigator in enrolling and monitoring such

children, and the comprehensiveness of the plan to protect the

confidentiality of all participants (Parts A and B).

(4) Creativity and thoroughness of analysis plans and

reasonableness for data collected (Parts A and B).

(5) Extent to which the study proposal demonstrates assurance of

compliance with multisite research requirements (common protocol, data

collection, and computer and data management systems) (Parts A and B).

(6) The degree to which the applicant has met the requirements

regarding plans for the inclusion of ethnic and racial groups in the

proposed research, and comprehensiveness of the plan to protect the

rights and confidentiality of all participants.

C. Provision of HIV/AIDS Report Data To and Collaboration With Local

Pediatric HIV/AIDS Surveillance Activities (20 Points)

(1) Feasibility of plans for completion and computer entry of HIV/

AIDS report forms and complete and timely transfer of HIV/AIDS case

reports to local HIV/AIDS surveillance unit.

(2) Adequacy of measures to assure completeness of HIV/AIDS report

forms, data quality and timeliness, and protection of confidentiality.

D. Demonstration of Staff's Capability to Conduct Research (20 Points)

(1) Capacity to conduct the proposed activities as evidenced by

previous experience with PSD and PSD supplemental studies (Parts A and

B).

(2) Adequacy of base staff to keep pace with anticipated workload

(Part A).

E. Staffing, Facilities, and Time Line (20 points)

(1) Availability of qualified personnel with realistic and

sufficient percentage-time commitments; clarity of the described duties

and responsibilities of project personnel with epidemiologic,

administrative, clinical, laboratory, data management (including HIV/

AIDS case reporting to local surveillance unit), and statistical

responsibilities; adequacy of

[[Page 36520]]

clinical oversight of the project, especially supervision of data

abstraction and entry.

(2) Adequacy of the facilities, equipment, data processing and

analysis capacity, and systems for management of data security and

participant confidentiality.

(3) Ability, willingness, and need to collaborate with researchers

from other study sites in study design and analysis, including use of

common forms, and sharing of data (Parts A and B).

F. Other (Not Scored)

(1) Budget: Will be reviewed to determine the extent to which it is

reasonable, clearly justified, consistent with the intended use of

funds, and allowable. All budget categories should be itemized.

(2) Human Subjects: Whether or not exempt from the DHHS

regulations, are procedures adequate for the protection of human

subjects? Recommendations on the adequacy of protections include the

following: (a) protections appear adequate and there are no comments to

make or concerns to raise, (b) protections appear adequate, but there

are comments regarding the protocol, (c) protections appear inadequate

and the Objective Review Group (ORG) has concerns related to human

subjects; or (d) disapproval of the application is recommended because

the research risks are sufficiently serious and protection against the

risks are inadequate as to make the entire application unacceptable.

2. Acceptability of Prevention Methods Among Women at Risk for HIV/STD;

3. Acceptability of HIV/STD Prevention Methods Among Men Who Have Sex

With Men; and 4. Other HIV/AIDS Epidemiology Research Studies

Evaluation Criteria Include

A. Familiarity With and Access to Study Population (25 Points)

(1) Extent of applicant's knowledge of issues faced by study

population and experience in working with this population.

(2) Existence of linkages to facilitate recruitment from and

referral to programs providing services for the study population and

letters of support.

(3) Feasibility of plans to involve the study population, their

advocates, or service providers in the development of research and

intervention activities and to inform them of research results.

(4) Evidence that plans for recruitment and outreach for study

participants will include establishing partnerships with communities.

B. Description and Justification of a Research Plan (40 points)

(1) Quality of the review of the scientific literature pertinent to

the proposed study, including theoretical basis for research, and

relevance of research questions.

(2) The originality of research, the extent to which it does not

replicate past or present research efforts (including ongoing efforts

not yet described in publications), and relevance to guiding current

HIV prevention efforts.

(3) Applicant's understanding of the research objectives as

evidence by high quality of the proposed research plan with a study

design that is appropriate to answer research questions.

(4) Quality of the study design, including appropriateness for

answering the proposed research questions.

(5) Feasibility of plans to sample, recruit, enroll, test,

interview and follow study participants, adequacy of sample size to

address research questions. This includes demonstration of the

availability of HIV-infected potential study participants and persons

at risk for HIV infection and the experience of the investigator in

enrolling and following such persons in a culturally and linguistically

appropriate manner; the degree to which the applicant has met the CDC

Policy requirements regarding the inclusion of women, ethnic, and

racial groups in the proposed research, and comprehensiveness of the

plan to protect the rights and confidentiality of all participants; and

proposed justification when representation is limited or absent.

(6) Thoroughness of analysis plans, reasonableness for data

collected, statistical rigor and complexity.

(7) Extent to which study proposal demonstrates assurance of

compliance with multisite research requirements (e.g., common protocol,

data collection, and computer and data management systems), if

appropriate.

C. Demonstrate Staff's Capability To Conduct Research (20 points)

(1) Capacity to conduct study as evidenced by experience with

similar or related research as evidenced by their previous related

research.

(2) Extent of the team's productive working relations with proposed

collaborators.

(3) Ability, willingness, and need to collaborate with researchers

from other study sites in study design and analysis, including use of

common forms, and sharing of specimens (when appropriate) and data.

D. Staffing, Facilities, and Time Line (15 points)

(1) Availability of qualified personnel with realistic and

sufficient percentage-time commitments; clarity of the described duties

and responsibilities of project personnel, with behavioral,

epidemiologic, administrative, clinical, laboratory, data management,

and statistical responsibilities.

(2) Adequacy of the facilities, equipment, data processing and

analysis capacity, and systems for management of data security and

participant confidentiality.

(3) Adequacy of time line.

E. Other (not scored)

(1) Budget: Will be reviewed to determine the extent to which it is

reasonable, clearly justified, consistent with the intended use of

funds, and allowable. All budget categories should be itemized.

(2) Human Subjects: Whether or not exempt from the DHHS

regulations, are procedures adequate for the protection of human

subjects? Recommendations on the adequacy of protections include the

following: (a) protections appear adequate and there are no comments to

make or concerns to raise, (b) protections appear adequate, but there

are comments regarding the protocol, (c) protections appear inadequate

and the Objective Review (OR) Group has concerns related to human

subjects; or (d) disapproval of the application is recommended because

the research risks are sufficiently serious and protection against the

risks are inadequate as to make the entire application unacceptable.

Funding Preferences

Preference will be given to competing continuation applications

from satisfactorily performing projects over applications for projects

not already receiving support under the program. Projects will be

awarded so that the composite of projects represents the geographic and

demographic characteristics of the HIV-infected population.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets

up a system for State and local government review of proposed Federal

assistance applications. Applicants (other than Federally recognized

Indian tribal governments) should contact their State Single Point of

Contact (SPOC) as early as possible to alert them to the prospective

applications and receive

[[Page 36521]]

any necessary instructions on the State process. For proposed projects

serving more than one State, the applicant is advised to contact the

SPOC for each affected State. A current list of SPOCs is included in

the application kit. If SPOCs have any State process recommendations on

applications submitted to CDC, they should send them to Mr. Van Malone,

Grants Management Officer, Grants Management Branch, Procurement and

Grants Office, Centers for Disease Control and Prevention (CDC), Room

300, Mail Stop E-15, 255 East Paces Ferry Road, NE, Atlanta, GA 30305.

Correspondence should arrive at CDC no later than 45 days after the

application deadline date. The Program Announcement Number and Program

Title should be referenced on the document. The granting agency does

not guarantee to accommodate or explain State process recommendations

it receives after that date.

Indian tribes are strongly encouraged to request tribal government

review of the proposed application. If tribal governments have any

tribal process recommendations on applications submitted to the CDC,

they should forward them to Van Malone, Grants Management Officer,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later

than 30 days after the application deadline date. The granting agency

does not guarantee to accommodate or explain for tribal process

recommendations it receives after that date.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting

Requirements. Under these requirements, all community-based

nongovernmental applicants must prepare and submit the items identified

below to the head of the appropriate State and/or local health

agency(ies) in the program area(s) that may be impacted by the proposed

project no later than the receipt date of the Federal application. The

appropriate State and/or local health agency is determined by the

applicant. The following in information must be provided:

1. A copy of the face page of the application.

2. A summary of the project that should be titled ``Public Health

System Impact Statement'' (PHSIS), not to exceed one page, and include

the following:

A. A description of the population to be served;

B. A summary of the services to be provided; and

C. A description of the coordination plans with the appropriate

State and/or local health agencies.

If the State and/or local health official should desire a copy of

the entire application, it may be obtained from the State Single Point

of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance Number is 93.943,

Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome

(AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected

Population Groups.

Other Requirements

1. Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by the cooperative agreement will be subject to

review by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act.

2. Human Subjects

This program involves research on human subjects. Therefore, all

applicants must comply with the Department of Health and Human Services

Regulations, 45 CFR Part 46, regarding the protection of human

subjects. Assurance must be provided to demonstrate that the project or

activity will be subject to initial and continuing review by an

appropriate institutional review committee. The applicant will be

responsible for providing assurance in accordance with the appropriate

guidelines and form provided in the application kit.

In addition to other applicable committees, Indian Health Service

(IHS) institutional review committees also must review the project if

any component of IHS will be involved with or support the research. If

any American Indian community is involved, its tribal government must

also approve that portion of the project applicable to it.

3. HIV Program Review Panel

Recipients must comply with the document entitled Content of AIDS-

Related Written Materials, Pictorials, Audiovisuals, Questionnaires,

Survey Instruments, and Educational Sessions (June 1992) (a copy is in

the application kit). To meet the requirements for a program review

panel, recipients are encouraged to use an existing program review

panel, such as the one created by the State health department's HIV/

AIDS prevention program. If the recipient forms its own program review

panel, at least one member must be an employee (or a designated

representative) of a State or local health department. The names of the

review panel members must be listed on the Assurance of Compliance form

CDC 0.1113, which is also included in the application kit. The

recipient must submit the program review panel's report that indicates

all materials have been reviewed and approved.

4. Patient Care

Applicants must provide assurance that all HIV-infected patients

enrolled in their studies will be linked to an appropriate local HIV

care system that can address their specific needs such as medical care,

counseling, social services, and therapy. Details of the HIV care

system should be provided, describing how patients will be linked to

the system. Funds will not be made available to support the provision

of direct care for study participants.

5. Women, Racial and Ethnic Minorities

It is the policy of the CDC to ensure that individuals of both

sexes and the various racial and ethnic groups will be included in CDC-

supported research projects involving human subjects, whenever feasible

and appropriate. Racial and ethnic groups are those defined in OMB

Directive No. 15 and include American Indian, Alaskan Native, Asian/

Pacific Islander, Black and Hispanic. Applicants shall ensure that

women, racial and ethnic minority populations are appropriately

represented in applications for research involving human subjects.

Where clear and compelling rationale exist that inclusion is

inappropriate or not feasible, this situation must be explained as part

of the application. This policy does not apply to research studies when

the investigator cannot control the race, ethnicity or sex of subjects.

Further guidance to this policy is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-47951 (a copy

is included in the application kit).

Application Submission and Deadline

The original and five copies of the application packet PHS-398

(Revised 5/95, OMB No. 0925-0001) must be submitted to Van Malone,

Grants Management Officer (ATTN: Kevin Moore, PA #735), Grants

Management Branch, Procurement and Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East Paces Ferry

[[Page 36522]]

Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia 30305, on or

before August 8, 1997.

1. Deadline: Applications will be considered as meeting the

deadline if they are either:

A. Received on or before the stated deadline date; or

B. Sent on or before the deadline date and received in time for

submission to the independent review group. (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 will not be accepted as proof of timely mailing.

2. Late Applications: Applications that do not meet the criteria in

1.A. or 1.B. are considered late applications. Late applications will

not be considered in the current competition and will be returned to

the applicant.

Where to Obtain Additional Information

A complete program description, information on application

procedures, an application package, and business management technical

assistance may be obtained from Kevin Moore, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia 30305, telephone

(404) 842-6550, E-mail address [email protected]. The announcement will be

available on one of two Internet sites on the publication date: CDC's

home page at http://www.cdc.gov, or at the Government Printing Office

home page (including free access to the Federal Register) at http://

www.access.gpo.gov.

Programmatic technical assistance may be obtained from Jeff Efird,

Division of HIV/AIDS Prevention, National Center for HIV, STD, TB

Prevention, Centers for Disease Control and Prevention (CDC), 1600

Clifton Road, NE., Mail Stop E-45, Atlanta, Georgia 30333, telephone

(404) 639-6130, E-mail address [email protected]. Eligible applicants are

encouraged to call before developing and submitting their application.

Please refer to Announcement Number 735 when requesting information.

Potential applicants may obtain a copy of ``Healthy People 2000''

(Full Report: Stock No. 017-001-00474-0) or ``Healthy People 2000''

(Summary Report: Stock No. 017-001-00473-1) referenced in the

Introduction from the Superintendent of Documents, Government Printing

Office, Washington, DC 20402-9325, telephone (202) 512-1800.

Dated: July 1, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-17702 Filed 7-7-97; 8:45 am]

BILLING CODE 4163-18-P