[Federal Register: July 1, 2005 (Volume 70, Number 126)]
[Notices]
[Page 38150-38152]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy05-99]
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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: Mlerchen@cdc.gov''; 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: ktw5@cdc.gov.''
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: Mlerchen@cdc.gov.''
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: mlerchen@cdc.gov''; 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: eow1@cdc.gov.
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: ASandul@cdc.gov''; 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: ktw5@cdc.gov..''
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