[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Notices]
[Pages 27994-27999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99102]


Interventional Epidemiologic Research Studies of HIV/AIDS Among 
Pregnant Women, Children, and Adolescents; Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for new and competitive continuation cooperative agreements for 
interventional epidemiologic research studies of HIV/AIDS among 
pregnant women, children, and adolescents. This program addresses the 
``Healthy People 2000'' priority areas of HIV Infection and Maternal 
and Infant Health. The purpose of the program is to support researchers 
in the conduct of HIV interventional epidemiologic research studies 
that foster prevention of HIV infection or HIV-related disease in 
infants, children, and adolescents. These include studies that address: 
(I) Mother infant rapid intervention at delivery (MIRIAD), (II) follow-
up of perinatally HIV-infected children, and (III) parent communication 
training interventions with longitudinal follow-up among populations of 
color at high risk for infection for sexually transmitted diseases 
(STD) including HIV.

Research Studies

(I) Mother Infant Rapid Intervention at Delivery (MIRIAD)

    Most HIV-infected pregnant women in the United States use hospitals 
for delivery, providing a crucial opportunity for systematic screening 
and intervention when indicated. In

[[Page 27995]]

some parts of the country, more infants might be spared HIV infection 
if the benefits of intrapartum/neonatal zidovudine (ZDV) were extended 
to pregnant women with little or no prenatal care than if transmission 
rates were further reduced among cohorts already receiving standard 
ACTG-076 therapy.
    The MIRIAD Project should assess (1) a 24-hour counseling and 
voluntary rapid HIV testing program among women in labor presenting 
with unknown HIV status; (2) the feasibility of obtaining informed 
consent during labor (or, if not feasible, soon after birth); (3) 
reasons for lack of prenatal care among these women; (4) the rapid 
implementation and assessment of antiretroviral therapy--mono therapy 
or more intensive regimens--given at labor and delivery or to the 
neonate; (5) adherence to neonatal therapy; and (6) subsequent receipt 
of antiretroviral treatment and other services for women identified as 
HIV infected.
    Innovative implementation strategies for the prevention of 
perinatal HIV transmission in settings where many HIV-infected women 
continue to receive little or no prenatal care are encouraged. Novel 
approaches for rapid bedside testing of women in labor and post-test 
counseling and referral/connection to care for HIV positive women and 
their infants should be carefully piloted at each site during the first 
12-18 months of the funding period. A sustainable full-time in-labor 
(or, if not feasible, postpartum) counseling, testing and ZDV 
chemoprophylaxis intervention program should be instituted according to 
the standard of care at each participating site no later than 18 months 
into the funding period. Late-registrant mothers presenting after 36 
weeks of pregnancy with unknown HIV status should also be offered rapid 
HIV testing and antiretroviral therapy during late pregnancy, 
intrapartum and to the neonate.
    Administration of intravenous ZDV intrapartum (if possible) and 
oral ZDV to the neonate as soon as possible and within 48 hours of 
birth should be recommended as the minimum standard of perinatal HIV 
preventive care for HIV-infected women presenting in labor. More 
intensive antiretroviral therapy such as combination therapy should be 
presented as an option with possible post exposure prophylaxis benefit 
over mono therapy. Perinatal HIV transmission risk associated with 
various components of the antiretroviral intervention (e.g., neonatal 
only administration versus intrapartum + neonatal) will be compared 
while attempting to control for possible confounders. Results from 
these studies should facilitate recommendations and provide 
effectiveness and operational research data on rapid HIV testing and 
administration of antiretrovirals among late-registrant women 
presenting in delivery rooms with unknown HIV status.
    At each Project site, it is expected that a minimum of 1000 women 
will receive rapid HIV testing and counseling per year; and that a 
minimum of 20 HIV positive mother-infant pairs will be identified 
(after 36 weeks of pregnancy, during labor or within 48 hours after 
birth) and enrolled in MIRIAD annually. In order to reach these numbers 
and serve a large, population-based sample of disadvantaged women with 
high HIV sero prevalence and inadequate prenatal care, primary project 
sites are encouraged to collaborate with 2-3 other hospitals or 
maternity clinics within their geographic area. In the second and third 
year of the project, based on experience gained from the MIRIAD 
project, funded sites will be asked to develop outreach programs to 
assist other hospitals in their area implement rapid counseling and HIV 
testing at labor, and delivery of peripartum antiretroviral 
interventions.
    Rapid testing for HIV during the peripartum period has the 
potential to improve clinical outcomes for both women and their infants 
but the question of how best to provide rapid HIV testing, how to 
perform urgent confirmatory testing in this setting, and how to best 
present women with risk/benefit information and treatment options needs 
systematic research. Integration of behavioral (i.e., to assess factors 
related to lack of prenatal care, counseling and testing in the 
delivery setting, informed consent issues, adherence to antiretroviral 
therapy in the neonatal period, enhancement of social support 
mechanisms) and biomedical sciences and a multi disciplinary research 
team is strongly encouraged.

II. Follow-up of Perinatally HIV-Infected Children

    Competing continuation applications are invited for the continued 
prospective follow-up of HIV-infected children enrolled in the 
Perinatal AIDS Collaborative Transmission Study (PACTS) between 1986 
and 1998. Continued research areas of interest should include 
identifying maternal and early infant markers of rapid versus chronic 
pediatric disease progression, investigating host-related genetic 
factors related to disease progression, and assessing adherence and 
responses to the newest therapeutic interventions. As this unique and 
well-characterized cohort of HIV-infected children ages into 
adolescence, opportunities will arise for in-depth analysis of the 
interrelationships among psycho social factors, pubertal development, 
and disease progression, as well as for research into behavioral 
interventions to prevent sexual HIV transmission.
    This continuation project will support ongoing data collection and 
analysis for the HIV-infected children and up to two comparison groups: 
an HIV exposed but uninfected group (1:1 ratio matched for gender, site 
and closest in birth date to infected child) originally followed in 
PACTS, and a newly HIV-infected comparison group of children and 
adolescents, to compare psycho social development of perinatally 
infected children to these other groups. Follow-up should be done at 
least every 6 months, and include at a minimum: (1) Information on HIV-
related clinical conditions, HIV-related medication use/adherence, 
hospitalizations, and survival; (2) all data points available from 
charts on viral load testing and lymphocyte immuno phenotyping as part 
of treatment protocols or clinical care; (3) storage of blood specimens 
for other HIV-related testing; (4) data on growth, pubertal 
development, neurocognitive functioning, and quality of life; and (5) 
data on school related outcomes such as grade failure, receipt of 
specific special services, and any available results of school 
achievement or developmental testing.

III. Parent Communication Training Interventions With Longitudinal 
Follow-up Among Populations of Color at High Risk for Infection for 
STD's Including HIV

    HIV Prevention messages must reach individuals early in life when 
healthy attitudes are still developing which most likely will lead to 
lifelong behavioral practices. Parents are in a unique and powerful 
position to shape young people's attitudes, values, and behaviors, and 
to socialize them to become healthy adults. Recent research suggests 
that giving parents information and communication skills about 
sexuality and HIV risk can be an effective HIV/AIDS prevention 
strategy. Applications are invited to conduct randomized intervention 
trials of parent communication training interventions with longitudinal 
follow-up among populations of color at high risk for infection for 
STD's including HIV. The intent is to examine the impact of a parental 
communication training program (i.e., minimal, basic, enhanced skills 
training) on parents' communication with their children and

[[Page 27996]]

the subsequent attitudes, beliefs and behaviors about sex and drug use 
of their children over time.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations.
    For the MIRIAD study, only institutions serving disadvantaged 
communities with high HIV seroprevalence among women of childbearing 
age (i.e., approximately 1 percent prevalence or higher) and the 
ability to recruit and retain a minimum of 20 HIV-infected pregnant 
women per year not receiving prenatal care or with unknown HIV 
serostatus before 36 weeks are invited to participate in this study.

    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

    I. Approximately $2.7 million is available in FY 1999 to fund 
approximately 5 to 6 awards for mother infant rapid intervention at 
delivery (MIRIAD). It is expected that the average award will be 
$500,000, ranging from $300,000 to $700,000.
    II. Approximately $800,000 is available in FY 1999 to fund 
approximately 4 competitive continuation projects for follow-up of 
Perinatally HIV-infected children and a comparison group. It is 
expected that the average award will be $200,000, ranging from $150,000 
to $250,000.
    III. Approximately $900,000 is available in FY 1999 to fund 
approximately 3 awards for intervention trials of parent communication 
training. It is expected that the average award will be $300,000, 
ranging from $200,000 to $400,000.
    It is expected that all awards will begin on or about September 1, 
1999, and will be made for a 12-month budget period within a project 
period of up to 5 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.

Funding Preference

    Preference will be given to achieve geographical diversity (e.g., 
Northeast, South, Central, and West).
    For the Perinatally-HIV Infected Children Study, preference will be 
given to competing continuation applications from satisfactorily 
performing projects over applications for projects not already 
receiving support for follow-up of perinatally-HIV infected children.

D. Program Requirements

    In conducting activities to achieve the purpose of these programs, 
the recipient will be responsible for the activities listed under 
Recipient Activities and CDC will be responsible for conducting 
activities listed under CDC Activities:

1. Recipient Activities

    Recipients addressing the same research issue should be willing to 
participate in collaborative studies with other CDC-sponsored 
researchers, including using common data collection instruments, 
specimen collection protocols, and data management procedures, as 
determined in post-award grantee planning conferences. Recipients will 
be required to pool data for analysis and publication. Recipients are 
also required to work collaboratively as a study wide group to:
    a. Develop the research study protocols and standardized data 
collection forms across sites.
    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. Contribute blood specimens (at least every 6-12 months depending 
on the protocol requirements) for shipment and storage at a centralized 
repository system at CDC.
    h. Conduct data analysis with all collaborators as well as present 
and publish research findings.

2. CDC Activities

    a. Provide technical assistance in the design and facilitate in the 
overall research project.
    b. Facilitate and assist in the development of a research protocol 
for IRB (institutional review board) review by all 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. Assist in designing a data management system.
    d. Assist in performance of selected laboratory tests.
    e. Work collaboratively with investigators to help coordinate 
research activities across sites involved in the same research project.
    f. Assist in the analysis of research information and the 
presentation and publication of research findings.

E. Application Content

    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 your program 
plan. Follow the directions for completing the application that are 
found in the Public Health Service (PHS) 398 kit.

F. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are in the application kit. On or before July 19, 1999, 
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
    (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 shall not be acceptable as proof of timely mailing.) 
Applications which do not meet the criteria in (a) and (b) above will 
not be considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. 
Applicants will be

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ranked on a scale of 100 maximum points according to the research area 
identified. All applicants must state which research category they are 
addressing.

I. Mother Infant Rapid Intervention At Delivery (MIRIAD)

    1. Recruitment, Retention and Adherence to Study Protocol (30 
points).
    a. Extent of applicant's experience in perinatal and pediatric HIV 
infection epidemiologic research.
    b. Evidence of ability to successfully recruit and follow HIV-
infected mothers and infants in longitudinal research studies.
    c. Evidence of approximately 1% or greater HIV sero prevalence 
among pregnant women in the catchment area described in the 
application.
    d. Ability to recruit and retain at least 20 and ideally over 30 
HIV-infected pregnant women annually fulfilling the objectives of the 
MIRIAD study. Linkages with other area hospitals and a Community 
Advisory Board are strongly encouraged.
    e. Ability to organize and provide a round-the-clock counseling and 
voluntary rapid HIV testing program among women in labor presenting 
with unknown HIV status; or immediately postpartum in first two days 
following delivery.
    f. Evidence of ability to collect complete data including 
interviews of mothers in the immediate postpartum period and to obtain 
a sufficiently large blood sample from HIV-infected mothers enrolled in 
MIRIAD around the time of delivery.
    g. Evidence of ability to collect complete data and to obtain 
regular blood samples from HIV-exposed infants, with at least one blood 
sample during the first 48 hours after birth.
    h. Ability to oversee specimen collection for the timely 
processing, storage, and retrieval of laboratory specimens as needed 
for MIRIAD studies. This includes transfer of certain specimens to a 
central repository at CDC and transfer of other specimens to designated 
laboratories for specific laboratory studies.
    i. Evidence of capability to address informed consent issues, 
enhance social support and foster adherence to the antiretroviral 
prophylaxis regimen, with special attention directed at adherence to 
the neonatal component of the regimen.
    2. Description and Justification of Research Plans (30 points).
    a. Extent of familiarity and quality of experience pertinent to 
proposed research activities.
    b. Understanding of the research objectives as evidenced by the 
high quality and scientific rigor of the proposed plan for research and 
a study design that is appropriate to answer research questions.
    c. The inclusion of innovative approaches to investigate the 
feasibility of obtaining informed consent during labor for voluntary 
rapid HIV testing, rapid implementation of antiretroviral therapy given 
at labor and delivery or to the neonate, and adherence to neonatal 
antiretroviral therapy.
    d. Extent to which the applicant demonstrates willingness to work 
with all successful applicants on development of a common core research 
protocol across funded sites.
    e. Feasibility of plans to follow study participants. This includes 
demonstration of the experience of the investigator in following HIV-
infected mothers and infants, and the comprehensiveness of the plan to 
protect the rights and confidentiality of all participants.
    f. Thoroughness of plans for data management, data analysis, and 
laboratory analysis; reasonableness of data collected; and statistical 
rigor.
    g. Extent to which proposal demonstrates feasible plans for 
coordinating research activities of multiple local clinical sites, 
where appropriate, and with CDC. Letters of support from cooperating 
organizations that demonstrate the nature and extent of such 
cooperation should be included.
    h. 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. This includes:
    (i) The proposed plan for the inclusion of 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 communities and recognition of mutual benefits.
    3. Research and Intervention Capability (20 points).
    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training and experience of the proposed research 
team and organizational setting, including demonstration of ability to 
collect, manage, and analyze accurate data in a timely manner.
    b. Demonstration of working relationships with proposed 
investigators and extent to which services to be provided by external 
experts or consultants are documented by memoranda of agreement.
    c. Demonstration of epidemiologic, behavioral, clinical, 
administrative, laboratory, data management and statistical analysis 
expertise needed to conduct proposed research.
    4. Staffing, Facilities and Time line (20 points).
    a. Availability of qualified and experienced personnel with 
sufficient time dedicated to the proposed project.
    b. Clarity of the described duties and responsibilities of project 
personnel.
    c. Adequacy of plans for project oversight to assure quality of 
data.
    d. Adequacy of facilities, equipment, data management resources, 
and systems for ensuring data security and patient confidentiality.
    e. Adequacy of time line for completion of project activities.
    5. Other (not scored)
    a. Budget: The extent to which it is reasonable, clearly justified, 
consistent with the intended use of funds, and allowable. All budget 
categories should be itemized.
    b. Human Subjects: Does the application adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects? ____Yes ____No  Comments:

II. Follow-up of Perinatally HIV-Infected Children

    1. Retention and Adherence to Study Protocol (20 points).
    a. Extent of applicant's experience in perinatal and pediatric HIV 
infection epidemiologic research.
    b. Evidence of ability to successfully follow HIV-infected children 
in longitudinal research studies.
    c. Evidence of ability to collect complete clinical, laboratory and 
behavioral data and to obtain regular blood samples from HIV-infected 
children; and demonstration of capability to re-enroll and follow a 1:1 
ratio of HIV exposed but uninfected children from the PACTS cohort 
originally followed at the site and/or a comparison group of newly HIV-
infected children and adolescents.
    2. Description and Justification of Research Plans (30 points).
    a. Extent of familiarity and quality of experience pertinent to 
proposed research activities.
    b. Understanding of the research objectives as evidenced by the 
high quality of the proposed plan for research.
    c. Originality of research, extent to which it does not replicate 
past or

[[Page 27998]]

present research efforts, and direct relevance of research to guiding 
current efforts to prevent HIV disease progression in children.
    d. Feasibility of plans to follow study participants, and adequacy 
of sample size to address research questions. This includes 
demonstration of the experience of the investigator in following such 
persons, and the comprehensiveness of the plan to protect the rights 
and confidentiality of all participants.
    e. Thoroughness of plans for data management, data analysis, and 
laboratory analysis; reasonableness of data collected; and statistical 
rigor.
    f. Extent to which proposal demonstrates feasible plans for 
coordinating research activities across multiple clinical sites, where 
appropriate, and with CDC. Letters of support from cooperating 
organizations that demonstrate the nature and extent of such 
cooperation should be included.
    g. 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. This includes:
    (i) The proposed plan for the inclusion of 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 communities and recognition of mutual benefits.
    3. Research Capability (30 points).
    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training and experience of the proposed research 
team, including demonstration of ability to collect, manage, and 
analyze accurate data in a timely manner.
    b. Demonstration of working relationships with proposed 
investigators.
    c. Demonstration of epidemiologic, behavioral, clinical, 
administrative, laboratory, data management and statistical analysis 
expertise needed to conduct proposed research.
    4. Staffing, Facilities and Time Line (20 points).
    a. Availability of qualified and experienced personnel, including 
individuals with biomedical, behavioral, and epidemiological expertise.
    b. Clarity of the described duties and responsibilities of project 
personnel.
    c. Adequacy of plans for project oversight to assure quality of 
data.
    d. Adequacy of facilities, equipment, data management resources, 
and systems for ensuring data security and patient confidentiality.
    e. Adequacy of time line for completion of project activities.
    5. Other (not scored).
    a. Budget: The extent to which it is reasonable, clearly justified, 
consistent with the intended use of funds, and allowable. All budget 
categories should be itemized.
    b. Human Subjects: Does the application adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects? ____Yes ____No  Comments:

III. Parent Communication Training Interventions With Longitudinal 
Follow-up Among Populations of Color at High Risk for Infection for 
STD's Including HIV

    1. Description, Justification and Originality of Research Plans (25 
points).
    a. The inclusion of a detailed review of the scientific literature 
and theoretical underpinnings on which the proposed research plan and 
intervention are based. Application of science and theory to guide/
justify the generation and articulation of specific research questions 
and hypotheses.
    b. The originality of the proposed research and the extent to which 
it builds on old science, extends or creates new science and does not 
replicate past or present research efforts.
    2. Familiarity with developmental and behavioral issues of children 
and families. Access and ability to recruit, retain, and conduct 
research with cohorts of 8 and 11 year old children and their families 
(25 points).
    a. The inclusion of abstracts, presentations, and manuscripts that 
demonstrate the applicant's prior research expertise with children and 
families, with particular regard to family communication, family based 
interventions, and familial factors influencing risk taking behaviors.
    b. Quality and description of methods used to identify, recruit , 
retain, and longitudinally follow cohorts of 8 and 11 year old children 
and their families for 5 years, including the documented ability to 
recruit and retain adequate numbers of study participants.
    c. Quality, diversity, and description of methods used to collect 
quantitative data during research, intervention, longitudinal tracking, 
and evaluation phases of the research study with cohorts of 8 and 11 
year old children and their families for 5 years.
    d. The inclusion of abstracts, presentations, and manuscripts that 
demonstrate the applicants ability to conduct longitudinal research 
with children and families.
    3. Intervention research plan (25 points).
    a. Extent to which the proposed research design and methods are 
appropriate for an intervention trial responsive to this request, 
including randomization procedures, statistical power to detect 
hypothesized differences, primary (attitudinal, cognitive, behavioral 
and biological) and secondary (relevant mediating variables) outcome 
measures, the reliability and validity of measures that will be used, 
and procedures for maximizing external and internal validity (e.g., 
sampling strategies and retention procedures, respectively).
    b. Appropriateness of description and justification of the proposed 
research hypotheses, intervention plan, and intervention outcome 
measures that will be addressed as part of the intervention trial.
    c. Quality and scientific rigor of the research design, methods, 
hypotheses, plan, and outcome measures that will be employed in the 
intervention trial.
    d. Extent to which the applicant demonstrates willingness to work 
with CDC staff and consultants on development of a common research and 
intervention protocol across sites.
    e. Adequacy of procedures for obtaining informed consent and 
maintaining participant confidentiality.
    f. 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. This includes:
    (i) The proposed plan for the inclusion of 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 communities and recognition of mutual benefits.
    4. Research and intervention capability (15 points).
    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training and experience of the proposed research 
team and organizational setting, including

[[Page 27999]]

demonstration of previous behavioral/clinical interventions carried 
out.
    b. Ability of the applicant to conduct the proposed research as 
reflected in the training, research, and behavioral intervention 
experience of staff members.
    c. Extent to which services to be provided by external experts, 
consultants, or collaborating agencies are documented by memoranda of 
agreement in the appendix.
    5. Staffing, facilities, and time line (10 points).
    a. Availability of qualified and experienced personnel with 
sufficient time dedicated to the proposed project. Presence of 
behavioral scientists in key leadership positions on the project.
    b. Clarity of the described duties and responsibilities of project 
personnel.
    c. Adequacy of the facilities, equipment, data management 
resources, and systems for ensuring data security.
    d. Specificity and reasonableness of time line.
    6. Other (not scored).
    a. Budget: The extent to which it is reasonable, clearly justified, 
consistent with the intended use of funds, and allowable. All budget 
categories should be itemized.
    b. Human Subjects: Does the application adequately address the 
requirements of Title 45 CFR part 46 for the protection of human 
subjects? ____Yes ____No  Comments:

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of
    1. Annual progress report;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial status 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see the document entitled 
``Descriptions of Other Requirements'' in the GMB homepage under 
Program Announcements.

    AR-1  Human Subjects Requirements.
    AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research.
    AR-4  HIV/AIDS Confidentiality Provisions.
    AR-5  HIV Program Review Panel Requirements.
    AR-6  Patient Care
    AR-7  Executive Order 12372 Review
    AR-8  Public Health System Reporting Requirements
    AR-9  Paperwork Reduction Act Requirements
      R-10  Smoke-Free Workplace Requirements
    AR-11  Healthy People 2000
    AR-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    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 247(k) (2)), as 
amended. The Catalog of Federal Domestic Assistance number is 93.943.

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 your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Curtis Meusel, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Announcement 99102, Centers for 
Disease Control and Prevention (CDC), Colgate Building Room 3000, 2920 
Brandywine Road, M/S E-15, Atlanta, GA 30341, Telephone (770) 488-2738, 
Email address [email protected].
    For program technical assistance, contact: Jeff Efird, MPA, Deputy 
Chief, Epidemiology Branch, Division of HIV/AIDS Prevention 
Surveillance & Epidemiology, National Center for HIV, STD, TB 
Prevention, Centers for Disease Control and Prevention (CDC), 1600 
Clifton Road, NE., Mailstop E-45 Atlanta, Georgia 30333, Telephone 
(404) 639-6130, E-mail [email protected].
    See also the CDC home page on the Internet to view and download all 
CDC funding opportunities (i.e., program announcements) and applicable 
application forms: HTTP://WWW.CDC.GOV.
    Eligible applicants are encouraged to call before developing and 
submitting their applications.

    Dated: May 18, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-12996 Filed 5-21-99; 8:45 am]
BILLING CODE 4163-18-P