[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Notices]
[Pages 38150-38152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Request for Application (RFA) PS05-083]


Adaptation and Evaluation of a Brief, Nurse-Delivered Sexual Risk 
Reduction Intervention for HIV-Positive Women in the South; Notice of 
Availability of Funds--Amendment

    A notice announcing the availability of Fiscal year (FY) 2005 funds 
to award a Cooperative Agreement for Adaptation and Evaluation of a 
Brief, Nurse-Delivered Sexual Risk Reduction Intervention for HIV-
Positive Women in the South published in the Federal Register, on June 
3, 2005, Volume 70, Number 106, pages 32624-32629].
    The notice is amended as follows: On page 32624, Third column, 
please change application deadline date to: July 22, 2005.
    On page 32627, First column, Section IV.2 Content and Form of 
Application Submission, please delete the following: ``This 
announcement uses the modular budgeting as well as non-modular 
budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm for additional guidance on modular budgets. Specifically, 
if you are submitting an application with direct costs in each year of 
$250,000 or less, use the modular budget format. Otherwise, follow the 
instructions for non-modular budget research grant applications''; and 
replace with the following sentence: ``This announcement uses the non-
modular budgeting format.''
    On page 32627, First column, Section IV.3. Submission Dates and 
Times, please change application deadline date to: July 22, 2005.
    On page 32627, Second column, Section IV.6. Other Submission 
Requirements, please delete the following: ``Submit you LOI by express 
mail or delivery service to: Mary Lerchen, DrPH, Scientific Review 
Administrator, Centers for Disease Control and Prevention, One West 
Court Square, Suite 7000, MS D-72, Decatur, GA 30030, Telephone: 404-
371-5277, Fax: 404-371-5215, Email: [email protected]''; and replace 
with the following: ``Submit your LOI by express mail or delivery 
service to: Kim Williams PhD, Project Officer, 1600 Clifton Road NE., 
M.S. E-37, Atlanta, GA 30333, Telephone: 404-639-6157, Fax: 404-639-
1950, E-mail: [email protected].''
    On page 32627, Third column, Section IV.6. Other Submission 
Requirements, please delete the following: ``At the time of submission, 
four additional copies of the application and all appendices must be 
sent to: Mary Lerchen, DrPH, Scientific Review Administrator, Centers 
for Disease Control and Prevention, One West Court Square, Suite 7000, 
MS DZ-27, Decatur, GA 30030, Telephone: 404-371-5277, Fax: 404-371-
5215, E-mail: [email protected].''
    On page 32627, Third column and on page 32628, First and Second 
columns, Section V.1 Criteria, delete the following: ``The goals of 
CDC-supported research are to advance the understanding of biological 
systems, improve the control and prevention of disease and injury, and 
enhance health. In the written comments, reviewers will be asked to 
evaluate the application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of the 
goals appropriate to this announcement.
    The scientific review group will address and consider each of the 
following criteria in assigning the application's overall score, 
weighting them as appropriate for each application. The application 
does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score. 
For example, an investigator may propose to carry out important work 
that by its nature is not innovative, but is essential to move a field 
forward.
    The review criteria are as follows:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field? Does the applicant demonstrate an 
understanding of the need for and intent of the research? Does the 
applicant provide a description of study activities that are likely to 
lead to meeting the objectives of this project? Are the proposed study 
activities likely to have a positive impact on the field of HIV 
prevention for HIV positive women in the southern U.S.?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? Does the applicant address all 
of the activities listed on pages four through eight of this 
announcement? Will the applicant establish a community advisory board 
to assist on all aspects of conducting the study? Does the applicant 
agency demonstrate adequate knowledge of the

[[Page 38151]]

epidemic in its geographic area and the target population? Does the 
applicant provide a timeframe for the proposed project? Does the 
applicant propose an adequate plan to recruit the required minimum 
number of eligible participants? Does the applicant propose an adequate 
plan to retain at least 85 percent of the study sample across the 
follow-up period? Does the applicant present an adequate plan for 
recruitment and organizational support of nurses to deliver the 
intervention? Does the applicant present an adequate plan for quality 
assurance of the delivery of the intervention? Does the applicant 
present an adequate plan for assuring client and data confidentially?
    Innovation: Does the project employ novel concepts, approaches, or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)? Does the investigator have and demonstrate an understanding 
of the issues relating to the proposed target population and experience 
working with this population? Does the investigator have experience 
recruiting the targeted study population and retaining this group in a 
study? Does the investigator have experience with delivery and 
evaluation of behavioral interventions? Does the investigator have 
previous experience conducting a randomized controlled trial? Does the 
key staff have sufficient time devoted to this project to ensure 
success? Does the investigator have experience collaborating with 
community advisory boards? Does the investigator demonstrate a 
willingness to collaborate with CDC and, if applicable, other health 
departments, to adapt the intervention and design the intervention 
evaluation and qualitative interviews?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Is the planned location for the 
study in an area with access to adequate numbers of the target 
population? Does the applicant include letters of support demonstrating 
a strong partnership with health care facilities and/or the agencies 
with which it proposes collaboration, including proposed locations of 
intervention delivery? Does the applicant demonstrate how levels of 
administrative support, community involvement, facilities, and other 
resources at the research site(s) will contribute to the probability of 
success of the project?''; and replace with the following:
    Your application will be evaluated against the following criteria:
    Approach (35 points): Are the conceptual framework, design, 
methods, and analyses adequately developed, well-integrated, and 
appropriate to the aims of the project? Does the applicant acknowledge 
potential problem areas and consider alternative tactics? Does the 
applicant address all of the activities listed in this announcement? 
Will the applicant establish a community advisory board to assist on 
all aspects of conducting the study? Does the applicant agency 
demonstrate adequate knowledge of the epidemic in its geographic area 
and the target population? Does the applicant provide a timeframe for 
the proposed project? Does the applicant propose an adequate plan to 
recruit the required minimum number of eligible participants? Does the 
applicant propose an adequate plan to retain at least 85 percent of the 
study sample across the follow-up period? Does the applicant present an 
adequate plan for recruitment and organizational support of nurses to 
deliver the intervention? Does the applicant present an adequate plan 
for quality assurance of the delivery of the intervention? Does the 
applicant present an adequate plan for assuring client and data 
confidentiality?
    Investigator (25 points): Is the investigator appropriately trained 
and well suited to carry out this work? Is the work proposed 
appropriate to the experience level of the principal investigator and 
other researchers (if any)? Does the investigator have and demonstrate 
an understanding of the issue relating to the proposed target 
population and experience working with this population? Does the 
investigator have experience recruiting the targeted study population 
and retaining this group in a study? Does the investigator have 
experience with delivery and evaluation of behavioral interventions? 
Does the key staff have sufficient time devoted to this project to 
ensure success? Does the investigator have experience collaborating 
with community advisory boards? Does the investigator demonstrate a 
willingness to collaborate with CDC and, if applicable, other health 
departments, to adapt the intervention and design the intervention 
evaluation and qualitative interviews?
    Significance (20 points): Does this study address an important 
problem? If the aims of the application are achieved, how will 
scientific knowledge be advanced? What will be the effect of these 
studies on the concepts or methods that drive this field? Does the 
applicant demonstrate an understanding of the need for and intent of 
the research? Does the applicant provide a description of study 
activities that are likely to lead to meeting the objectives of this 
project? Are the proposed study activities likely to have a positive 
impact on the field of HIV prevention for HIV positive women in the 
southern U.S.?
    Environment (15 points): Does the scientific environment in which 
the work will be done contribute to the probability of success? Do the 
proposed experiments take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements? Is 
there evidence of institutional support? Is the planned location for 
the study in an area which with access to adequate numbers of the 
target population? Does the applicant include letters of support 
demonstrating a strong partnership with health care facilities and/or 
the agencies with which it proposes collaboration, including proposed 
locations of intervention delivery? Does the applicant demonstrate how 
levels of administrative support, community involvement, facilities, 
and other resources at the research site(s) will contribute to the 
probability of success of the project?
    Innovation (5 points): Does the project employ novel concepts, 
approaches or methods? Are the aims original and innovative? Does the 
project challenge existing paradigms or develop new methodologies or 
technologies?''
    On page 32628, Second column, Section V.1. Criteria, Additional 
Review Criteria, Protection of Human Subjects from Research Risks, 
please add in brackets: ``Reviewed but not scored.''
    On page 32628, Second column, Section V.1. Criteria, Additional 
Review Criteria, Inclusion of Women and Minorities in Research, please 
add in brackets: ``Reviewed but not scored.''
    On page 32628, Third column, Section V.1. Criteria, Additional 
Review Criteria, Budget, please add in brackets ``Reviewed but not 
scored.''
    On page 32628, Third column, Section V.2 Review and Selection 
Process, second paragraph, please delete the following: ``Applications 
that are complete and responsive to the announcement will be evaluated 
for scientific and technical merit by an appropriate peer review group 
or charter

[[Page 38152]]

study section convened by NCHSTP in accordance with the review criteria 
listed above. As part of the initial merit review, all applications 
may:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit by the review group, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique.
     Receive a second programmatic level review by the NCHSTP.
    Award Criteria: Criteria that will be used to make award decisions 
during the programmatic review include:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities.''
    And replace with: ``An objective review panel will evaluate 
complete and responsive applications according to the criteria listed 
in Section V.1. Criteria, above. The objective review will be performed 
by CDC employees, at least three voting panelists, and a nonvoting 
chairperson. All panelists will be from outside of the funding center. 
Each objective reviewer will have expertise in research, disease 
prevention behavioral interventions, or disease prevention programs. 
Each application will be worth 100 points and the panel will assign 
your application a score using the scored evaluation criteria as 
specified in the ``V.1. Criteria'' section above. Your application will 
be ranked based on this score. Applications will be considered for 
funding in order of score and rank as determined by the review panel.''
    On page 32629, Second column, Section VII. Agency Contacts, please 
delete the following: ``For questions about peer review, contact: Mary 
Lerchen, DrPH, Scientific Review Administrator, Office of Public Health 
Research, Centers for Disease Control and Prevention, 1600 Clifton 
Road, Mailstop D72, Atlanta, GA 30333, Telephone: 404-371-5277, Fax: 
404-371-5215, E-mail: [email protected]''; and replace with: ``For 
questions about the objective review, contact: Beth Wolfe, CDC, NCHSTP, 
OD, FASO; 1600 Clifton Road NE. M.S. E-07; Atlanta, GA 30333; 
Telephone: 404-639-8531; E-mail: [email protected].
    On page number 32629, Second column, Section VII. Agency Contacts, 
please delete the following: ``For scientific/research issues, contact: 
Amy L. Sandul, Extramural Program Official, Office of the Associate 
Director for Science, National Center for HIV, STD, and TB Prevention, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS 
E07, Atlanta, Georgia 30333, Telephone: 404-639-6485, Fax: 404-639-
8600, E-mail: [email protected]''; and replace with: ``For scientific/
research issues, contact Kim Williams, PhD, Project Officer, CDC, 
NCHSTP, DHAP, IRS, PRB; 1600 Clifton Road N.E. M.S. E-37; Atlanta, GA 
30333; Telephone: 404-639-6157; E-mail: [email protected]..''

    Dated: June 27, 2005.
Alan A. Kotch,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 05-13014 Filed 6-30-05; 8:45 am]
BILLING CODE 4163-18-M