[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36514-36522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17702]
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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,
[[Page 36516]]
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.
[[Page 36517]]
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