04-5433. Participatory Research on Community Interventions To Increase the Utilization of Effective Cancer Preventive and Treatment Services

Announcement Type: New.

Funding Opportunity Number: PA 04087.

Catalog of Federal Domestic Assistance Number: 93.945.

Key Dates:

Letter of Intent Deadline: March 26, 2004.

Application Deadline: May 10, 2004.

Executive Summary: None.

I. Funding Opportunity Description

Authority: Public Health Service Act, sections 301(a) and 317(k)(2), as amended.

Purpose: The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2004 funds for a grant program from the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Division of Cancer Prevention and Control (DCPC) and the Public Health Practice Program Office (PHPPO) Office of Science and Extramural Research. This announcement supports research to evaluate the effectiveness of community interventions to increase the use by health plans, health insurers, and/or health care providers of evidence-based cancer screening and treatment services in the following three areas: (1) To increase provision of colorectal cancer screening; (2) to increase use of shared decision making for prostate cancer screening; or (3) to increase use of systematically developed guidelines for the diagnosis and treatment of ovarian cancer. Applicants may submit separate applications for one or more of the three above areas of research. Findings from the funded projects will contribute to reductions in cancer morbidity and mortality, improvements in the quality of life for cancer patients, and increases in the use of public health and prevention research in everyday health practice.

This program announcement addresses the United States Department of Health and Human Services (DHHS) Strategic Plan Goal to improve the quality of health care services; the HealthierUS Initiative “Prevention: Getting Preventive Screening; and “Healthy People 2010” focus areas of Cancer, Access to Quality Health Services, Educational and Community-Based Programs, and Public Health Infrastructure.

Measurable outcomes of the program will be in alignment with the following performance goal for NCCDPHP: Support prevention research to develop sustainable and transferable community-based behavioral interventions: The following performance goal will be in alignment with PHPPO: Strengthen the public health infrastructure by stimulating extramural prevention research to discover how to apply the latest biomedical research at the local level and how to supply frontline public health workers with evidence of what works.

Research Objectives: The specific research objective for this program announcement is to stimulate investigator-initiated, participatory research to evaluate the effectiveness of community interventions to: (1) Increase provision of colorectal cancer screening; (2) increase use of shared decision making for prostate cancer screening; or (3) increase use of systematically developed guidelines for the diagnosis and treatment of ovarian cancer.

This objective addresses research gaps identified in recent reviews conducted by the Institute of Medicine (IOM), the Cochrane Effective Practice and Organization of Care group, and the Agency for Healthcare Research and Quality (AHRQ). In Fulfilling the Potential of Cancer Prevention and Early Detection, the IOM identified the possibility of substantial near term reductions in cancer incidence and mortality if health plans, health care providers, and health insurers implemented evidence-based cancer screening services. The report also illustrated problems for insurers, plans, providers and patients that result from implementing new screening technologies when evidence on the balance of benefits and harms from screening is uncertain. In Ensuring Quality Cancer Care, the IOM concluded that for many cancer patients, a wide gap exists between patients' experiences with cancer care and the evidence-based quality diagnostic and treatment services that are recommended. In The Unequal Burden of Cancer, the IOM provided evidence that the cancer burden was greater and the provision of services was less for many racial, ethnic and underserved populations.

Although a Cochrane systematic review of research on the effectiveness of interventions to change health care systems or health care provider practices found that some interventions are effective in certain circumstances, a recent systematic review for AHRQ that focused specifically on interventions to increase the use of evidence-based cancer control practices found that evidence was insufficient to make recommendations. In addition, interventions found to be efficacious in research may not be translated into practice because the research often does not involve the communities of interest in the research and does not address community needs. Therefore, additional research is needed on the effectiveness of community interventions to increase use of evidence-based cancer screening and treatment services. This research should also involve the affected communities of health plans, providers, and insurers in the research process to increase the likelihood that resulting interventions can be adopted into practice.

Activities: Awardee activities for this program are as follows:

(1) Conduct studies to evaluate the effectiveness of community interventions to increase use of evidence-based cancer screening and treatment services, specifically to:

(a) Increase provision of colorectal cancer screening.

(b) Increase use of shared decision making for prostate cancer screening.

(c) Increase utilization of systematically developed guidelines for the diagnosis and treatment of ovarian cancer.

(2) Involve the affected communities, i.e., health plans, health care providers, and health insurers in the research process.

For purposes of this announcement the following definitions are used:

Community refers to health plans, health care providers, and/or health insurers, i.e., the people, organizations or networks (including faith-based) that would be affected by the community interventions and/or that would implement such interventions. The investigator for each research proposal must define the relevant community or communities using a set of tangible criteria. The criteria can include a common interest, identity, or characteristic. These communities need not be defined geographically.

Community interventions can include any of a variety of activities implemented to change health system or health care provider behavior to increase the use of evidence-based cancer screening and treatment services. These may include, but are not limited to, changes in insurance coverage, incentives, health care provider training, reminders to providers or patients, audits and feedback, opinion leaders, academic detailing, role modeling, or standardized performance measures, e.g., the Health Employer Data and Information Set provided at: http://www.ncqa.org/​communications/​publications/​hedispub.htm).

Participatory research involves collaboration with the community being studied, at least in formulating the research questions and in interpreting and applying the findings, and possibly also in developing study methods and interventions and/or analyzing data, according to the community's interests, time, and expertise. The community or communities that are to be involved, as participants in the research process must be explicitly identified. This announcement is not limited to any particular model of participatory research. Applicants should also consult guidelines on participatory research, such as those provided at: http://www.ihpr.ubc.ca/​guidelines.html and the campus-community partnership principles at: http://futurehealth.ucsf.edu/​ccph/​principles.html#principles.

Effectiveness of community interventions means that the community intervention in an intervention group results in a measurable and statistically significant increase in the use of evidence-based colorectal screening services, shared decision making for prostate cancer screening, or evidence-based diagnostic and treatment services for ovarian cancer. Effectiveness is determined when comparing the intervention group to the comparison group or groups.

Evidence-based colorectal cancer screening services include only tests evaluated and recommended by the U.S. Preventive Services Task Force (USPSTF). Such tests are performed in the absence of symptoms or signs in order to identify cancer at an early stage or to identify precursor lesions. The USPSTF has found evidence that these tests are effective in reducing mortality and that the balance of risks and benefits is positive.

Shared decision making for prostate cancer screening, for purposes of this announcement, refers only to definitions provided in the Guide to Community Preventive Services recommendations on the effectiveness of community interventions to increase the use of informed decision making for cancer screening and in the U.S. Preventive Services Task Force recommendations on shared decision making. Shared decision making occurs when a patient and his health care provider discuss screening in a clinical setting and decide together whether to screen or not. For shared decision making to occur, the patient must understand the nature and risks of the cancer, the screening test(s) and treatments and their likely consequences, including risks (harms), limitations, benefits, alternatives, and uncertainties. Further, the patient must consider his or her preferences as appropriate, participate in decision making at a personally desirable level, and either make a decision consistent with his or her preferences and values or elect to defer the decision to a later time. For prostate cancer screening, shared decision making must include making patients aware of the following from the USPSTF: There is good evidence that Prostate Specific Antigen screening can detect early-stage prostate cancer, but there is mixed and inconclusive evidence that early detection improves health outcomes; screening is associated with important harms, including frequent false-positive results and unnecessary anxiety, biopsies, and potential complications of treatment of some cancers that may never affect or have affected a patient's health; and evidence is insufficient to determine whether the benefits outweigh the harms.

Systematically developed guidelines for the diagnosis and treatment of ovarian cancer include only diagnostic and treatment services for ovarian cancer recommended by a National Institutes of Health (NIH) consensus panel or by a review group for the National Cancer Institute Physician Data Query System. These guidelines include referral to a gynecologic oncologist.

Health care involves the care, services, and supplies related to the health of an individual. Health care includes preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, among other services. Health care also includes the sale and dispensing of prescription drugs or devices.

Health plans are individual or group plans that provide or pay the cost of health care. This includes private and public health plans, and includes, for example, health maintenance organizations, preferred provider organizations, long term care and health insurance companies, employee health benefit plans, and any other plan that provides or pays for the costs of health care.

Health care provider is a person who is trained and licensed to give health care, or a place licensed to give health care. Doctors, nurses, hospitals, skilled nursing facilities, some assisted living facilities, and certain kinds of home health agencies are examples of health care providers.

Health insurers/Health insurance—Insurance against financial losses resulting from health issues, preventing, diagnosing and/or treating disease, sickness or accidental bodily injury, as well as from therapeutic, rehabilitative, maintenance, or palliative care.

II. Award Information

Type of Award: Grant.

Fiscal Year Funds: 2004.

Approximate Total Funding: $650,000 for Colorectal Cancer, 650,000 for Ovarian Cancer, 650,000 for Prostate Cancer, $1,950,000 Total.

Approximate Number of Awards: At least three total, including a minimum of one for colorectal cancer, one for ovarian cancer, and one for prostate cancer.

Approximate Average Award: $650,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.).

Floor of Award Range: None.

Ceiling of Award Range: $650,000.

Anticipated Award Date: September 1, 2004.

Budget Period Length: 12 months.

Project Period Length: Four years.

Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

III. Eligibility Information

III.1. Eligible applicants

Applications may be submitted by the following entities:

• Public nonprofit organizations.
• Private nonprofit organizations.
• Universities.
• Colleges.
• Research institutions.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Others

CDC requires that you submit a Letter of Intent (LOI) if you intend to apply to this Program Announcement. If CDC does not receive your LOI by the LOI deadline specified under IV.3. Submission Dates and Times, your application will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

If your application is incomplete, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

If your application does not include a plan for measures of effectiveness to demonstrate the accomplishment of the various identified objectives of the grant, as noted in the review criteria below, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

In addition, if your application does not meet the following three eligibility criteria, it will not be entered into the review process and you will be notified that your application did not meet submission requirements:

1. The principal investigator or co-principal investigator must have conducted five or more years of competitively funded peer reviewed research community interventions with health plans, health insurers, and/or health care providers, and have published the findings from that research in peer reviewed journals within the last three years.

2. The applicant's project team must include significant expertise in research in the area of evidence-based cancer preventive or treatment services relevant to the project that will be conducted.

a. For applications related to colorectal cancer, the project team must have significant experience in researching or promoting the use of cancer screening.

b. For applications related to prostate cancer, the project team must have significant experience in researching or promoting shared decision making for cancer screening.

c. For applications related to ovarian cancer, the project team must have significant experience in researching or providing diagnosis and treatment of ovarian cancer.

Such expertise must be evidenced by a history of competitively funded peer reviewed research in that area and publication of the outcomes from this research in peer reviewed journals.

3. The applicant must demonstrate an effective and well-defined working relationship between the research organization and the partnering communities of health care providers, insurers, or plans. One source of documentation of this relationship must be provided in the form of Letters of Support from each partnering community, briefly describing the working relationship.

Documentation of Eligibility

Evidence of meeting the three additional eligibility criteria stated above must be provided as a separate appendix to the application, labeled “Documentation of Eligibility,” and the location of the appendix must be identified in the table of contents. This appendix should broadly summarize the additional eligibility criteria listed above including institutional affiliations, and experience and expertise as they relate to the application. However, this appendix should not reiterate or itemize specific details included in the Biographical Sketch provided for each of the key personnel.

These eligibility criteria are to ensure that the proposed research will be of significant quality. Proposed research must meet the rigorous methodological guidelines required of the research to be included in evidence reviews conducted by the USPSTF, AHRQ, and the Guide to Community Preventive Services. Furthermore, proposed research should contribute to strong evidence on the effectiveness of interventions to increase the use of evidence-based cancer control practices.

Individuals Eligible to Become Principal Investigators: Any individual with the skills, knowledge, and resources necessary to carry out the proposed research, and who meets the eligibility criteria specified above for the principal investigator or co-principal investigator, is invited to work with his or her eligible applicant institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

Note:

Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

To apply for this funding opportunity, use application form PHS 398 (OMB number 0925-0001 rev. 5/2001). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm

Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) Web site at the following Internet address: http://grants.nih.gov/​grants/​funding/​phs398/​phs398.html.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Application Submission

Letter of Intent (LOI): CDC requires that you submit an LOI if you intend to apply to this Program Announcement. If you fail to submit an LOI, any subsequent application will not be entered into the review process. Although the LOI is not binding, and does not enter into the review of your subsequent application, it will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.

Your LOI must be written in the following format:

• Maximum number of pages: Three pages
• Font size: 12-point unreduced
• Single spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid jargon

Your LOI must contain the following information:

Page 1

• Descriptive title of the proposed research
• Name, address, E-mail address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this Program Announcement (PA)

Pages 2-3

• A non-binding summary of the proposed project, which will be used in planning for peer review of the applications. The summary should include information about the area of research interest (colorectal cancer screening, prostate cancer shared decision making, or researching or providing diagnosis and treatment of ovarian cancer), the communities with which the investigators will collaborate, the community intervention(s), and the basic study design.

Application: Follow the PHS 398 application instructions for content and formatting of your application. For further assistance with the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or contact GrantsInfo, Telephone [phone], E-mail: [e-mail].

Your research plan should address activities to be conducted over the entire project period. It should also describe an effective and well-defined working relationship between the researchers and the partnering community or communities (of health care providers, insurers, or plans) in which these partnering communities are active participants with the researcher in the research process. The research application should also include a clear statement of the roles of the community participants. In addition, be sure to address the criteria that will be used to review your application. These criteria are listed at V. Application Review Information.

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC web site at: http://www.cdc.gov/​od/​pgo/​funding/​pubcommt.htm.

This PA uses just-in-time concepts. It also 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.

Additional requirements that may require you to submit additional documentation with your application are listed in section VI.2. Administrative and National Policy Requirements.

IV.3. Submission Dates and Times

LOI Deadline Date: March 26, 2004.

Application Deadline Date: May 10, 2004.

Explanation of Deadlines: LOIs or Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. If you send your LOI or application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery of the LOI or application by the closing date and time. If CDC receives your LOI or application after closing due to: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, CDC will consider the LOI or application as having been received by the deadline.

This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.

CDC will not notify you upon receipt of your LOI or application. If you have a question about the receipt of your LOI or application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the LOI or application deadline. This will allow time for LOIs or applications to be processed and logged.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing your budget, are as follows:

• Construction costs and pieces of equipment costing more than $10,000.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

Awards will not allow reimbursement of pre-award costs.

IV.6. Other Submission Requirements

LOI Submission Address: Submit your LOI by express mail or delivery service to: Technical Information Management—PA# 04087, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

LOI's may not be submitted electronically at this time.

Application Submission Address: Submit the original and five hard copies of your application by express mail or delivery service to: Technical Information Management—PA# 04087, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

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 their 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 these goals.

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 criteria are as follows:

Measures of Effectiveness: You are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

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?

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 methods?

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? Does the principal investigator have significant and successful experience in conducting community intervention research with health plans, health insurers, and/or health care providers? Does the project team have expertise in research in the area of evidence-based cancer preventive or treatment services in which the project will be conducted (in increasing cancer screening use, for colorectal cancer projects; in shared decision making for cancer screening, for prostate projects; and in diagnosis and treatment of ovarian cancer, for ovarian cancer projects)?

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?

Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and priority score:

1. Study design and methods used for the proposed community intervention research must be of sufficient quality to qualify for inclusion in evidence-based reviews conducted for the Guide to Community Preventive Services. Those quality criteria are described in an early Community Guide publication in the American Journal of Preventive Medicine.

2. Proposed screening tests, informed decision making interventions, treatments, and diagnostic services, must be consistent with systematic reviews, recommendations and definitions, as noted in the definitions section above.

3. The applicant must demonstrate an effective and well-defined working relationship between the researchers and the partnering community or communities (of health care providers, or one or more insurers or plans) in which these partnering communities are active participants with the researchers in the research process. Reviewers will refer to both the research plan of the application and Letters of Support (Section III.3.) from the community.

4. The development, implementation, and maintenance of an annual information-exchange program between the institutional researchers and the community members (even if the institutional researchers are also community members) is required. This information-exchange program must describe the project's current level of community input and involvement, its progress in accomplishing its objectives, and a summary of the relevant findings the research has produced. Documentation of this program must be in the form of annual reports that use plain language, as specified by Section 508 of the Workforce Rehabilitation Act, are easily comprehendible, and readily accessible to Community Members. Applicant's budgets must reflect the cost required for their information-exchange program.

(5) The proposed research must be judged by the reviewers as likely to have a substantial impact on the pursuit of the project's goals.

Protection of Human Subjects from Research Risks: Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? This will not be scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

Inclusion of Women and Minorities in Research: Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) 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.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO), and for responsiveness by PHPPO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.

Applications that are complete and responsive to the Program Announcement will be evaluated for scientific and technical merit by an appropriate peer review group or charter study section convened by PHPPO in accordance with Department of Health and Human Services requirements, and according to 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, generally the top half of the applications under review, will be discussed and assigned a priority score.
• Receive a written critique summarizing the discussion of the review panel.
• Receive a second level review by the Secondary Review Panel to be appointed by CDC.

Award Criteria: Criteria that will be used to make award decisions include:

• Scientific merit (as determined by peer review)
• Availability of funds
• Programmatic priorities
• Recommendations by the Secondary Review Panel

V.3. Anticipated Announcement and Award Dates

September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/​nara/​cfr/​cfr-table-search.html

The following additional requirements apply to this project:

• AR-1 Human Subjects Requirements
• AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
• AR-6 Patient Care
• AR-8 Public Health System Reporting Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-13 Prohibition on Use of CDC Funds for Certain Gun Control Activities
• AR-14 Accounting System Requirements
• AR-15 Proof of Non-Profit Status
• AR-16 Security Clearance Requirement
• AR-22 Research Integrity
• AR-23 States and Faith-Based Organizations
• AR-24 Health Insurance Portability and Accountability Act Requirements
• AR-25 Release and Sharing of Data

Additional information on these requirements can be found on the CDC web site at the following Internet address: http://www.cdc.gov/​od/​pgo/​funding/​ARs.htm.

VI.3. Reporting

If awarded, you must provide CDC with an original, plus two hard copies of the following reports:

1. Interim progress report, (use form PHS 2590, OMB Number 0925-0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days before the end of the budget period. This annual progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Budget.

e. Measures of Effectiveness Progress Report.

f. Annual Report from Information-Exchange Program.

g. Additional Requested Information.

2. Financial status report no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be mailed to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

For general questions about this announcement, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: [phone].

For scientific/research issues, contact: Ralph Coates, Ph.D., Extramural Project Officer, Centers for Disease Control and Prevention, NCCDPHP/DCPC/OD, 4770 Buford Highway, NE, MS K-52, Atlanta, GA 30341-3717, Telephone: [phone], E-mail: [e-mail].

For questions about peer review, contact: Joan Karr, Ph.D., Scientific Review Administrator, Centers for Disease Control and Prevention, PHPPO/OD/ESA, 4770 Buford Highway, NE (MS K-38), Atlanta, GA 30341, Telephone number: 770-488-2597, Fax: [phone], E-mail address: [e-mail].

For financial, grants management, or budget assistance, contact: Sharon Robertson, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: [phone], E-mail: [e-mail].

VIII. Other Information

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Dated: March 4, 2004.

Sandra R. Manning,

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