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38150 Federal Register / Vol. 70, No.

126 / Friday, July 1, 2005 / Notices

On pages 31476 and 31477, Third and DEPARTMENT OF HEALTH AND Requirements, please delete the
First columns respectively, V.2. Review HUMAN SERVICES following: ‘‘At the time of submission,
and Selection Process, please delete all four additional copies of the application
the information in this section and Centers for Disease Control and and all appendices must be sent to:
replace with the following: Prevention Mary Lerchen, DrPH, Scientific Review
‘‘Applications will be reviewed for [Request for Application (RFA) PS05–083] Administrator, Centers for Disease
completeness by the Procurement and Control and Prevention, One West Court
Grants Office (PGO) staff, and for Adaptation and Evaluation of a Brief, Square, Suite 7000, MS DZ–27, Decatur,
responsiveness by NCHSTP. Incomplete Nurse-Delivered Sexual Risk GA 30030, Telephone: 404–371–5277,
Reduction Intervention for HIV-Positive Fax: 404–371–5215, E-mail:
applications and applications that are
Women in the South; Notice of Mlerchen@cdc.gov.’’
non-responsive to the eligibility criteria On page 32627, Third column and on
will not advance through the review Availability of Funds—Amendment
page 32628, First and Second columns,
process. Applicants will be notified that A notice announcing the availability Section V.1 Criteria, delete the
their application did not meet of Fiscal year (FY) 2005 funds to award following: ‘‘The goals of CDC-supported
submission requirements.’’ a Cooperative Agreement for Adaptation research are to advance the
On page 31477, Second column, VII. and Evaluation of a Brief, Nurse- understanding of biological systems,
Agency Contacts, please delete the Delivered Sexual Risk Reduction improve the control and prevention of
following: ‘‘For scientific/research Intervention for HIV-Positive Women in disease and injury, and enhance health.
issues, contact: Amy L. Sandul, Health the South published in the Federal In the written comments, reviewers will
Science Administrator, Centers for Register, on June 3, 2005, Volume 70, be asked to evaluate the application in
Number 106, pages 32624–32629]. order to judge the likelihood that the
Disease Control and Prevention, The notice is amended as follows: On
National Center for HIV, STD, and TB proposed research will have a
page 32624, Third column, please substantial impact on the pursuit of the
Prevention, 1600 Clifton Road, NE., MS change application deadline date to: goals appropriate to this announcement.
E–07, Atlanta, GA 30333, Telephone: July 22, 2005. The scientific review group will
404–639–6485, E-mail: On page 32627, First column, Section address and consider each of the
ASandul@cdc.gov’’; and replace with: IV.2 Content and Form of Application following criteria in assigning the
‘‘For scientific/research issues contact: Submission, please delete the following: application’s overall score, weighting
Marta Ackers, MD, Project Officer, 1600 ‘‘This announcement uses the modular them as appropriate for each
Clifton Road, Mailstop E–45, Atlanta, budgeting as well as non-modular application. The application does not
Georgia 30333, Telephone: 404–639– budgeting formats. See: need to be strong in all categories to be
6117, Fax 404–639–6127, E-mail: http://grants.nih.gov/grants/funding/ judged likely to have major scientific
MAckers@cdc.gov.’’ modular/modular.htm for additional impact and thus deserve a high priority
On page 31477, Second column, VIII. guidance on modular budgets. score. For example, an investigator may
Agency Contacts, please delete the Specifically, if you are submitting an propose to carry out important work
application with direct costs in each that by its nature is not innovative, but
following: ‘‘For questions about peer
year of $250,000 or less, use the is essential to move a field forward.
review, contact: Mary Lerchen, DrPH, The review criteria are as follows:
modular budget format. Otherwise,
Scientific Review Administrator, follow the instructions for non-modular Significance: Does this study address
Centers for Disease Control and budget research grant applications’’; and an important problem? If the aims of the
Prevention, 1 West Court Square, Suite replace with the following sentence: application are achieved, how will
7000, Mailstop D–72, Decatur, Georgia ‘‘This announcement uses the non- scientific knowledge be advanced? What
30030, Telephone: 404–371–5277, Fax modular budgeting format.’’ will be the effect of these studies on the
404–371–5215, E-mail: mlerchen On page 32627, First column, Section concepts or methods that drive this
@cdc.gov’’; and replace with: ‘‘For IV.3. Submission Dates and Times, field? Does the applicant demonstrate
questions about objective review, please change application deadline date an understanding of the need for and
contact: Beth Wolfe, Centers for Disease to: July 22, 2005. intent of the research? Does the
Control and Prevention, 1600 Clifton On page 32627, Second column, applicant provide a description of study
Road, Mailstop E–07, Atlanta, GA Section IV.6. Other Submission activities that are likely to lead to
30333; Telephone: 404–639–8531, E- Requirements, please delete the meeting the objectives of this project?
mail: eow1@cdc.gov’’. following: ‘‘Submit you LOI by express Are the proposed study activities likely
mail or delivery service to: Mary to have a positive impact on the field of
Dated: June 27, 2005.
Lerchen, DrPH, Scientific Review HIV prevention for HIV positive women
Alan A. Kotch, Administrator, Centers for Disease in the southern U.S.?
Director, Procurement and Grants Office, Control and Prevention, One West Court Approach: Are the conceptual
Centers for Disease Control and Prevention. Square, Suite 7000, MS D–72, Decatur, framework, design, methods, and
[FR Doc. 05–13011 Filed 6–30–05; 8:45 am] GA 30030, Telephone: 404–371–5277, analyses adequately developed, well-
BILLING CODE 4163–18–P Fax: 404–371–5215, Email: integrated, and appropriate to the aims
Mlerchen@cdc.gov’’; and replace with of the project? Does the applicant
the following: ‘‘Submit your LOI by acknowledge potential problem areas
express mail or delivery service to: Kim and consider alternative tactics? Does
Williams PhD, Project Officer, 1600 the applicant address all of the activities
Clifton Road NE., M.S. E–37, Atlanta, listed on pages four through eight of this
GA 30333, Telephone: 404–639–6157, announcement? Will the applicant
Fax: 404–639–1950, E-mail: establish a community advisory board to
ktw5@cdc.gov.’’ assist on all aspects of conducting the
On page 32627, Third column, study? Does the applicant agency
Section IV.6. Other Submission demonstrate adequate knowledge of the

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Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices 38151

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

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38152 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices

study section convened by NCHSTP in 404–639–8600, E-mail: estimating the community’s resource
accordance with the review criteria ASandul@cdc.gov’’; and replace with: needs. Of the estimated 850,000–
listed above. As part of the initial merit ‘‘For scientific/research issues, contact 950,000 HIV-infected persons in the
review, all applications may: Kim Williams, PhD, Project Officer, United States, an estimated 75 percent
• Undergo a process in which only CDC, NCHSTP, DHAP, IRS, PRB; 1600 know they are infected. Of these, an
those applications deemed to have the Clifton Road N.E. M.S. E–37; Atlanta, estimated 50 percent do not have
highest scientific merit by the review GA 30333; Telephone: 404–639–6157; evidence of having received any
group, generally the top half of the E-mail: ktw5@cdc.gov..’’ medical care for their HIV infection.
applications under review, will be Dated: June 27, 2005. One of the goals of CDC’s Advancing
discussed and assigned a priority score. HIV Prevention initiative is to provide
Alan A. Kotch,
• Receive a written critique.
• Receive a second programmatic Acting Director, Procurement and Grants HIV testing outside of traditional
level review by the NCHSTP. Office, Centers for Disease Control and medical settings, and to increase linkage
Award Criteria: Criteria that will be Prevention. to HIV care for those whose HIV test
used to make award decisions during [FR Doc. 05–13014 Filed 6–30–05; 8:45 am] results are positive. Because of
the programmatic review include: BILLING CODE 4163–18–M treatment advances, more people with
• Scientific merit (as determined by HIV infection are living longer and
peer review) healthier lives. Persons who know they
• Availability of funds DEPARTMENT OF HEALTH AND are infected can benefit from
• Programmatic priorities.’’ HUMAN SERVICES prophylaxis for opportunistic infections,
And replace with: ‘‘An objective monitoring of their immune status, and,
review panel will evaluate complete and Centers for Disease Control and
Prevention when recommended, treatment with
responsive applications according to the
antiretroviral drugs. Additionally, new
criteria listed in Section V.1. Criteria,
Surveillance of HIV/AIDS Related HIV therapies may reduce the degree of
above. The objective review will be
performed by CDC employees, at least Events Among Persons Not Receiving infectiousness by lowering viral load
three voting panelists, and a nonvoting Care and thereby reducing HIV transmission.
chairperson. All panelists will be from Announcement Type: New. Therefore, to determine the extent of
outside of the funding center. Each Funding Opportunity Number: PS05– medical services and resources that will
objective reviewer will have expertise in 085. be needed for persons who are infected
research, disease prevention behavioral Catalog of Federal Domestic with HIV, but who have not received
interventions, or disease prevention Assistance Number: 93.944. medical care, it is critically important to
programs. Each application will be Key Dates: Application Deadline: quantify and describe the number in
worth 100 points and the panel will August 1, 2005. this population. In addition,
assign your application a score using the Executive Summary: HIV/AIDS determining factors related to not
scored evaluation criteria as specified in surveillance data have been used for receiving care will be important in
the ‘‘V.1. Criteria’’ section above. Your describing the epidemic, planning designing effective interventions for
application will be ranked based on this prevention and treatment activities, linking persons to care.
score. Applications will be considered developing treatment guidelines,
for funding in order of score and rank advocating for resources, and allocating A supplemental surveillance system
as determined by the review panel.’’ and prioritizing available resources designed to produce population-based
On page 32629, Second column, within communities. The Health estimates of persons who have a
Section VII. Agency Contacts, please Resources Services Administration diagnosis of HIV and are receiving care
delete the following: ‘‘For questions (HRSA) uses HIV/AIDS surveillance has been developed. Federal awards
about peer review, contact: Mary data from states to estimate severity of were made to 26 health departments to
Lerchen, DrPH, Scientific Review need to allocate nearly two billion in collect clinical and behavioral data
Administrator, Office of Public Health funding for HIV-related ambulatory care among persons who have a diagnosis of
Research, Centers for Disease Control and support services available annually HIV and are receiving care.
and Prevention, 1600 Clifton Road, through the Ryan White Comprehensive Supplemental surveillance systems that
Mailstop D72, Atlanta, GA 30333, AIDS Resources Emergency (CARE) Act. collect data about those persons infected
Telephone: 404–371–5277, Fax: 404– A committee from the Institute of with HIV who are and are not receiving
371–5215, E-mail: mlerchen@cdc.gov’’; Medicine (IOM) recently reviewed, at care will provide critically needed
and replace with: ‘‘For questions about the request of Congress, the status of information on the quality of care and
the objective review, contact: Beth HIV/AIDS surveillance. In the resulting severity of need for care; barriers to
Wolfe, CDC, NCHSTP, OD, FASO; 1600 report, three populations of interest receiving care; prevention; and support
Clifton Road NE. M.S. E–07; Atlanta, GA were outlined; services at the local level. This
30333; Telephone: 404–639–8531; E- • Persons infected with HIV, who do information will assist local planning
mail: eow1@cdc.gov. not have a diagnosis of HIV and are not groups (i.e., community planning
On page number 32629, Second receiving care.
groups and local planning councils) in
column, Section VII. Agency Contacts, • Persons infected with HIV, who
please delete the following: ‘‘For determining local allocation of CDC and
have a diagnosis of HIV but are not
scientific/research issues, contact: Amy receiving care. Ryan White CARE Act funds.
L. Sandul, Extramural Program Official, • Persons infected with HIV, who Additionally, this type of supplemental
Office of the Associate Director for have a diagnosis of HIV and are surveillance data will provide a means
Science, National Center for HIV, STD, receiving care. of evaluating new prevention initiatives
and TB Prevention, Centers for Disease Understanding how many and which (e.g., Advancing HIV Prevention) that
Control and Prevention, 1600 Clifton persons in a community have a focus on the provision of prevention
Road, NE., MS E07, Atlanta, Georgia diagnosis of HIV but are not receiving services and linkage to care for persons
30333, Telephone: 404–639–6485, Fax: care is critically important for living with HIV (PLWHA) infection.

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