05-13014. 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: [phone], Fax: [phone], Email: [e-mail]”; 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: [phone], Fax: [phone], E-mail: [e-mail].”

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: [phone], Fax: [phone], E-mail: [e-mail].”

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 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 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: [phone], Fax: [phone], E-mail: [e-mail]”; 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: [phone]; E-mail: [e-mail].

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: [phone], Fax: [phone], E-mail: [e-mail]”; 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: [phone]; E-mail: [e-mail]..”

Dated: June 27, 2005.

Alan A. Kotch,

Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.