U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Genomic Applications in Practice and Prevention (GAPP): Translation Programs in Education, Surveillance, and Policy
Announcement Type: New – Type 1
Funding Opportunity Announcement (FOA) Number: CDC-RFA-GD08-801
Catalog of Federal Domestic Assistance Number: 93.283 Centers for Disease Control and Prevention Investigations and Technical Assistance
Letter of Intent Deadline: May 7, 2008
Application Deadline: June 6, 2008
Peer Review Date:July 2008
Earliest Anticipated Start Date: September 30, 2008
Expiration Date: October 1st, 2008
This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance. The applicant will be notified the application did not meet the submission requirements.
The Centers for Disease Control and Prevention (CDC), National Office on Public Health Genomics announces the opportunity for applications in the form of cooperative agreements to conduct and evaluate programs in health education, surveillance, or policy interventions, or a combination of those programs, in large, well-defined populations or clinical practice settings in the United States. The purpose is to help move evidence-based human genomic tests and other genomic interventions into health practice in a manner that maximizes health benefits and minimizes harm to individuals and populations.
Authority: This program is authorized under sections 301 (a) and 317 (k) (2) of the Public Health Service Act, [42 U.S.C. section 241 (a) and 347b (k) (2), as amended.
Advances in research in genomics have led to mounting expectations in regard to the application of those research results in health care and in disease prevention (Genet Med 2007:9(10):665-674). To date, however, few human genome discoveries have led to evidence-based genomic applications in medicine or in public health. The only genomic test recommended by the U.S. Preventive Services Task Force (USPSTF) for use in primary care practice is BRCA1 & 2 testing for breast and ovarian cancer susceptibility (http://www.ahrq.gov/clinic/uspstfix.htm). Neither the National Committee for Quality Assurance (http://web.ncqa.org/) nor the National Quality Forum (http://www.qualityforum.org/) has performance measures for the use of genomic applications in clinical practice.
Due to limited scientific evidence, there is much skepticism on the validity and/or utility of many genomic tests (http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.shtm). However, hundreds of these tests are currently available for use and many are being directly marketed to the public and to health professionals. Nevertheless, there is substantial interest within medicine and public health in the translation of promising genomic applications into practice. In 2004, the non-profit Personalized Medicine Coalition, with members from academia, industry, and patient, provider, and payer organizations, was formed to advance the understanding and adoption of personalized medicine concepts and products, including genomic applications, to better manage a patient’s disease or predisposition towards a disease (http://www.personalizedmedicinecoalition.org/). In 2005, the American Academy of Family Physicians in collaboration with the American College of Physicians and other primary and specialty care medical associations conducted an educational initiative on genomics for practitioners (http://www.aafp.org/online/en/home/clinical/acf/genomics.html). Most state Comprehensive Cancer Control coalitions supported by CDC now include language on genomics or family history in their state plans (www.cdc.gov/cancer/nccdphp/).
To provide guidance on the validity and utility of genomic applications and recommendations about their uses in medicine and public health, CDC initiated a project entitled “Evaluation of Genomic Applications in Practice and Prevention” (EGAPP). The primary purpose of EGAPP is to develop, implement, and evaluate a systematic process of assessing the evidence on genomic applications. A federal EGAPP Steering Committee, with representation that includes the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the National Institutes of Health and the Agency for Healthcare Research and Quality (AHRQ) provides guidance to the EGAPP project and will work with CDC to determine how to best develop a sustainable assessment process. An independent, non-federal, multidisciplinary EGAPP Working Group was established in 2005. The roles of this multidisciplinary panel include prioritizing genomic applications for evaluation, establishing methods for evaluation, overseeing the evidence review process, reviewing the body and strength of the evidence, and developing recommendations based on a thorough evaluation of the analytic and clinical validity, clinical utility, and associated ethical, legal, and social implications. The Working Group is currently developing reports and recommendations on the use of genomic tests in cardiovascular disease, depression, and cancer among others. This program is described in more detail at (http://www.cdc.gov/genomics/gTesting.htm) Evidence reports and recommendations for use are available at http://www.egappreviews.org/.
CDC and AHRQ have contracted with Evidence-based Practice Centers to have systematic evidence reviews conducted on the analytic and clinical validity and the clinical utility of family medical history tools (http://www.ahrq.gov/clinic/epcix.htm). In addition, CDC is conducting research on the utility of Family Healthware,TM a family history, risk assessment, and intervention tool designed to promote changes in the use of clinical preventive services or behavioral risk factors for several chronic diseases, including coronary heart disease, stroke, diabetes, breast and ovarian cancer and colorectal cancer (http://www.cdc.gov/genomics/activities/famhx.htm).
To provide additional evidence on the validity and utility of genomic applications, including family history tools, CDC has an open research funding opportunity announcement on the translation of genomics into public health practice: (http://www07.grants.gov/search/search.do;jsessionid=HLHJnKsTGktmyTnSm9B1vv4W3VVQR1T2Td2FDTVR3nHZbXyFyyHt!-1797286335?oppId=16029&flag2006=true&mode=VIEW).
To maximize health benefits and reduce harms to the public and to individuals, clinical practice and public health programs related to genomics, including family history, are needed, in addition to research. Programs in policy and education are needed in public health and clinical practice to help facilitate the translation of evidence-based genomic applications into practice, to support the development of appropriate evidence for use of genomic applications in practice, and to increase the understanding by health professionals and the public of the potential harms as well as benefits of use of applications for which evidence on validity and utility is limited. In addition, surveillance is needed on the use of genomic applications and outcomes of their use, both positive and negative.
Purpose: The purpose of the program is to move human genome applications, including family history applications, into health practice in a manner that maximizes health benefits and minimizes harm to individuals and populations. The FOA will support programs in policy, surveillance, or education related to genomic tests, family history, and other genomic interventions with the goal of improving health and preventing disease in large, well-defined populations or practice settings in the United States.
This program addresses the “Healthy People 2010” focus area of cancer, diabetes, heart disease and stroke, mental health and mental disorders, increasing quality and years of healthy life,community-based programs, and public health infrastructure.
Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion: Enhance the potential for full, satisfying, and productive living across the lifespan for all people in all communities.
This FOA integrates genomics with public health programs and is in alignment with NCCDPHP performance goals, including those of GPRA. For more information, see http://intra-apps.cdc.gov/fmo/.
This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm
Recipients may conduct programs in either 1) health education, 2) surveillance, 3) policy, or 4) a combination of 1-3. Programs in any of these three areas (policy, surveillance, or education) will include a program evaluation component and are to be conducted in large, geographically defined populations or clinical practice settings in the U.S.
1. Health Education Programs
Programs in health education and evaluation are limited to the following two areas of education:
a. Public and provider education to increase awareness about current knowledge of the validity and utility of one of the tests for which an EGAPP-commissioned evidence review has been completed or an EGAPP Working Group recommendation statement has been issued (http://www.egappreviews.org/workingrp.htm) and the potential implications in terms of benefits and harms from use of that test.
Performance measures for this area:
By the end of the project period, CDC expects:
b. Public and provider education to increase use of the clinical practices recommended by the USPSTF on the use of BRCA1 & 2 testing, including the collection and evaluation of family health history to determine eligibility for counseling, counseling prior to testing, and counseling prior to the use of medical interventions based on test results (http://www.ahrq.gov/clinic/uspstf/uspsbrgen.htm);
Performance measures for this area:
By the end of the project period, CDC expects:
These public or provider health education programs are to have program evaluation by the applicant organization using methods consistent with those recommended by the Guide to Community Preventive Services (http://www.thecommunityguide.org/methods/default.htm).
Examples of education programs are the following:
Conducting public education campaign with a state, tribal, or territorial Comprehensive Cancer Control Coalition to increase awareness of use of BRCA 1 & 2 testing as recommended by USPSTF, Including USPSTF-recommended use of family history, counseling, and testing, with a program evaluation using methods recommended by the Community Guide.
Conducting a provider education campaign with an association of primary medical care providers to increase awareness of the evidence regarding the use of multigene test panels among the general population to predict cardiovascular disease risk and inform lifestyle management, with an evaluation using methods recommended by the Community Guide.
2. Surveillance Programs
Surveillance programs are limited to the following 4 areas of surveillance:
The following is the current list of tests under review or under consideration by the EGAPP Working Group:
a. Gene expression profiling tests for use among women with breast cancer, for treatment decisions and to assess the risk of recurrence.
b. Use of multigene test panels, including e.g., MTHFR, Apolipoprotein E (ApoE), and others, among the general population to predict cardiovascular disease risk and inform lifestyle management.
c. GT1A1 testing for individuals diagnosed with colorectal cancer for use in decisions to treat with irinotecan.
d. Testing for polymorphisms in the Cytochrome P450 (CYP450) family of drug-metabolizing genes, for individuals diagnosed with depression for use in decisions to treat with SSRIs.
e. Hereditary nonpolyposis colorectal cancer/Lynch syndrome mismatch repair gene mutation testing for individuals diagnosed with colorectal cancer in disease management and for use in patients’ family members for prevention.
f. Factor V Leiden mutation testing for use in individuals with a personal or family history of venous thromboembolism, or a family history of Factor V Leiden mutation, for diagnosis and management, or for prevention in family members.
g. The breast cancer multigene panel for use in the general population for predictive testing and risk assessment.
h. Fecal DNA testing for colorectal cancer, for screening in the general population.
i. TCF7L2 for the general population for predictive testing and risk assessment for type 2 diabetes.
j. Mature-onset diabetes of the young (MODY) multigene panel, for individuals suspected of having, or diagnosed with MODY, for diagnosis and management.
k. HFE testing for individuals with clinical suspicion of hereditary hemochromatosis for diagnosis, and for the general population for predictive testing and risk assessment (USPSTF recommendation).
l. VKORC1 and CYP2C9 testing for individuals with thrombophilia prior to treatment with warfarin. (American College of Medical Genetics).
m. CYP2D6 testing and use of tamoxifen among women with breast cancer.
n. HLA-B*5701 testing in HIV patients prior to treatment with abacavir.
o. Testing for polymorphisms in the Cytochrome P450 (CYP450) family of drug- metabolizing genes, for individuals, to predict response to pain management with codeine.
Performance Measures for surveillance programs:
By the end of the project period, CDC expects that:
·The applicant will have established a surveillance system and produced reports on: 1) use of counseling and testing for BRCA 1 & 2, 2) use of the identified family medical history tools, 3) knowledge and attitudes of the public or clinical practitioners on use of BRCA1 & 2 or identified EGAPP-related genomic tests, or 4) use of one of the EGAPP related tests. The surveillance system will be based on a population defined geographically or on the basis of a clinical practice setting.
·A surveillance report will have been provided back to the public and/or practitioners in the setting and that the program will have been evaluated.
·Identification of a model policy implementation programs that may be used by other public health or clinical practice organizations.
These surveillance programs are to have program evaluation by the applicant organization using methods consistent with those recommended by CDC,
Examples of surveillance programs are the following:
Surveillance of BRCA1 & 2 genetic testing among women members of a managed care organization, with program evaluation.
A state-wide Behavioral Risk Factor Surveillance Survey of knowledge and attitudes among the public about the use of BRCA1 & 2 testing, with program evaluation.
A survey among patients treated for depression in a large HMO on the use of genetic testing for polymorphisms in the genes of the CYP450 family of drug-metabolizing enzymes on their understanding of the potential benefits and harms of the use of the tests, with program evaluation.
A state-wide survey of health care providers to assess collection and use of family history information for diabetes, coronary heart disease, stroke, and breast, ovarian, or colorectal cancers, with program evaluation.
3. Policy Programs
Programs in policy intervention with evaluation are limited to the following policy area:
Promoting increased use of the clinical practices recommended by the USPSTF on the use of BRCA1 & 2 testing, including the collection and evaluation of family health history to determine eligibility for counseling, counseling prior to testing, and counseling prior to the use of medical interventions based on test results
Performance Measures for Policy Programs:
By the end of the project period, CDC expects that:
·Use of family history, genomic counseling, and BRCA1 & 2 testing, each specifically as recommended by the USPSTF, will have increased from baseline for the applicant’s population, defined either geographically or by practice setting.
·Identification of model policy implementation programs that may be used by other public health or clinical practice organizations.
Programs of policy interventions are to have program evaluations by the applicant organization using methods consistent with those recommended by the Guide to Community Preventive Services (Community Guide): http://www.thecommunityguide.org/methods/default.htm
Examples of policy programs are the following:
Conducting a policy intervention with a health professional medical society to increase a) the collection of family history of breast and ovarian cancers, b) assessment of family history, c) referral of women with high risk family histories to counseling, and d) genetic counseling for the use of BRCA1 & 2 testing, all in accordance with USPSTF recommendations, combined with a program evaluation conducted in accordance with guidance from the Community Guide.
Conducting a policy intervention in a managed care organization to increase a) the collection of family history of breast and ovarian cancers, b) assessment of family history, c) referral of women with high risk family histories to counseling, and d) genetic counseling for the use of BRCA1 & 2 testing, all in accordance with USPSTF recommendations, combined with a program evaluation conducted in accordance with guidance from the Community Guide.
For cancer-related policy, surveillance, or education programs
Priority will be given to programs related to the use of family history of colorectal cancer and to the use of BRCA1 & 2; gene expression profiling tests for use among women with breast cancer, for treatment decisions and to assess the risk of recurrence, genomic tests for ovarian cancer, in the general population or in women at increased risk for ovarian cancer, for detection and management, and fecal DNA testing for colorectal cancer, for screening in the general population.
B. Program Management and Staffing
The Recipient is responsible for assuring that the programs and activities are soundly managed in a manner to assure the accomplishment of Recipient Activities:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.
CDC activities for this program are as follows:
Provide consultation and technical assistance in planning, implementing, and evaluating each component of the program.
Provide technical assistance to support program delivery.
Provide current information on the status of National efforts as they relate to the implementation of recipient activities.
Facilitate communication among recipients and other government agencies and other organizations involved in genomics programs.
Collaborate across other CDC programs to support program integration efforts.
Participate in presentation of results of programs.
Type of Award: Cooperative Agreement.
CDC’s involvement in this program is listed in the Activities Section above.
Award Mechanism: U38 Cooperative Agreements to Develop or Improve Public Health Information
Fiscal Year Funds: 2008
Approximate Current Fiscal Year Funding: $ 1,200,000
Approximate Total Project Period Funding: $ 3,600,000 (This amount is an estimate, and is subject to availability of funds.) This includes both direct and indirect costs.
Approximate Number of Awards: 4-8
Approximate Average Award: $ 150,000–300,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)
Floor of Individual Award Range: None
Ceiling of Individual Award Range: $ 350,000 (This ceiling is for the first 12-month budget period. This includes both direct and indirect costs)
Anticipated Award Date: 9/30/08
Budget Period Length: 12 months
Project Period Length: Three 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.1. Eligible Applicants
Eligible applicants that can apply for this funding opportunity are listed below:
·For-profit organizations (other than small business)
·Small, minority, and women-owned businesses
·Managed Care Organizations
·Federally recognized or state-recognized American Indian/Alaska Native tribal governments
·American Indian/Alaska native tribally designated organizations
·Alaska Native health corporations
·Urban Indian health organizations
·Tribal epidemiology centers
·State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a letter from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.
III.2. Cost Sharing or Matching
Cost sharing or matching funds are not required for this program.
If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the submission requirements.
If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.
Programs must be conducted in large (n > 100,000), well defined U.S. populations, within either a geographically defined area or within a large clinic practice setting. The application must document the ability to describe and define the population for which the program is to be implemented and document the ability of the applicant to collect information on numbers of individuals eligible for the programmatic activity, the number included in the program, and the results.
IV.1. Address to Request Application Package
To apply for this funding opportunity use the application forms package posted in Grants.gov.
CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site. Only applicants who apply on-line are permitted to forego paper copy submission of all application forms.
Registering your organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, we strongly encourage you to use this online tool.
Please visit www.Grants.gov at least 30 days prior to filing your application to familiarize yourself with the registration and submission processes. Under “Get Registered,” the one-time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering your organization with the Central Contractor Registry (CCR) annually, could take an additional one to two days to complete. We suggest submitting electronic applications prior to the closing date so if difficulties are encountered, you can submit a hard copy of the application prior to the deadline.
Application forms and instructions are available on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm
If access to the Internet is not available, or if there is difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIMS) staff at 770-488-2700 and the application forms can be mailed.
IV.2. Content and Form of Submission
Letter of Intent (LOI):
Prospective applicants are asked to submit a letter of intent that includes the following information:
A. Project Abstract must be submitted with the application forms. All electronic project abstracts must be uploaded in a PDF file format when submitting via Grants.gov. The abstract must be submitted in the following format, if submitting a paper application:
The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This Abstract must not include any proprietary/confidential information.
The abstract must specify the category of the proposal, chosen among the following categories: policy, surveillance, health education, or any combination of those three categories.
B. A project narrative must be submitted with the application forms. All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format, if submitting a paper application:
The narrative should include a comprehensive workplan that describes how the grantee will address each recipient activity and its respective performance measures over the entire project period and must include the following items in the order listed: Relevance, objectives ,Timeline, and Performance Measures; Methods; and Management and Staffing Plan.
C. Itemized Budget and Justification
Submit an detailed budget and line item justification that is consistent the recipient activities, performance measures, and proposed project objectives and actities, using the format of the sample budget provided at http://www.cdc.gov/od/pgo/funding/grants/Budget_Guidelines.doc.
Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes: Curriculum vitas or resumes of program directors and key staff, organizational charts, and any letters of support needed from collaborating organizations.
Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named: “Curriculum vitae,” “Letters of Support,” “Organizational Chart,” etc.
No more than 12 attachments should be uploaded per application.
The agency or organization is 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. 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 the Dun and Bradstreet website or call 1-866-705-5711.
Additional requirements that may request submission of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”
Letter of Intent (LOI) Deadline Date: May 7, 2008
Application Deadline Date: June 6, 2008
Explanation of Deadlines: LOIs and Applications must be received in the CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.
Applications may be submitted electronically at www.Grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s AOR to Grants.gov on or before the deadline date and time.
When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission. The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application.
If submittal of the application is by the United States Postal Service or commercial delivery service, the applicant must ensure that the carrier will be able to guarantee delivery by the closing date and time. The applicant will be given the opportunity to submit documentation of the carrier’s guarantee, if HHS/CDC receives the submission after the closing date 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. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
If a hard copy application is submitted, HHS/CDC will not notify the applicant upon receipt of the submission. If questions arise on the receipt of the application, the applicant should first contact the carrier. If the applicant still has questions, contact the PGOTIMS staff at (770) 488-2700. The applicant should wait two to three days after the submission deadline before calling. This will allow time for submissions 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 the budget, are as follows:
If requesting indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.
The recommended guidance for completing a detailed justified budget can be found on the CDC Web site, at the following Internet address:
IV.6. Other Submission Requirements
LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:
Millie Trotter M.Ed.
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-8390
Fax: (770) 488-8046
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed in Section IV.3.A.
Application Submission Address:
HHS/CDC strongly encourages applicants to submit applications electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. E-mail submissions will not be accepted. If the applicant has technical difficulties in Grants.gov, customer service can be reached by E-mail at firstname.lastname@example.org or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday.
HHS/CDC recommends that submittal of the application to Grants.gov should be prior to the closing date to resolve any unanticipated difficulties prior to the deadline. Applicants may also submit a back-up paper submission of the application. Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked: “BACK-UP FOR ELECTRONIC SUBMISSION.” The paper submission must conform to all requirements for non-electronic submissions. If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.
The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.
Applicants should submit the original and two hard copies of the application by mail or express delivery service to:
2920 Brandywine Road, MS E-14
Atlanta, GA 30341
Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. 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. The measures of effectiveness must be submitted with the application and will be an element of evaluation.
LOIs are evaluated for completeness of information requested.
The application will be evaluated against the following criteria:
Relevance (20 Points): If the applicant achieves the aims of the application, will it advance public health? Will the population served by the program benefit? Does the program make appropriate use of systematic reviews and recommendations conducted by EGAPP, an AHRQ, USPSTF, or Cochrane?
Objectives, Timelines, and Performance Measures (30 Points): Is the planned program adequate to fulfill the proposed objectives? Does the program plan include quantitative process and outcome measures? Does the program plan specify how the recipient activities, including CDC expectations for program outcomes, and primary recipient responsibilities, both as identified in this announcement, will be accomplished? How complete and comprehensive is the plan for the entire project period? Does the program have a well-defined geographic- or clinic-based population with adequate numbers to demonstrate success in meeting its objectives?
Methods (30 Points): Are the proposed methods for implementing the plan feasible? To what extent will they accomplish the program goals? Are the conceptual framework, program design, and evaluation methods adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Will the proposed methods accomplish the proposed recipient activities and primary responsibilities?
Management and Staffing Plan (20 Points): Do the staff members have appropriate training and experience to complete the proposed program? Are the staff roles clearly defined? As described, will the staff be sufficient to accomplish the program goals? Does the team bring together complementary and integrated expertise needed to successfully complete the program?
Budget (SF 424A) and Budget Justification (Reviewed, but not scored)
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff and for responsiveness jointly by CoCHP and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet submission requirements.
Applications that are complete and responsive to the FOA
will be evaluated for merit by an appropriate peer review
group convened by CoCHP in accordance with the review
criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.
The goals of HHS/CDC-supported programs are to increase health promotion and the prevention of disease, injury, and disability and to enhance preparedness. In their written comments, reviewers will evaluate the application to judge the likelihood the proposed program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications.
Note that an 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. In addition, the following factors may affect the funding decision:
·Availability of funds
·Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services
·Diversity of genetic applications/tests and of diseases.
CDC will provide justification for any decision to fund out of rank order.
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and emailed to the program director and a hard copy 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
Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate. The following additional requirements apply to this project:
(Public Law 89-665, 80 Stat. 915)
Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.
CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm
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
VI.3. Reporting Requirements
The applicant must provide CDC with an annual interim progress report via www.grants.gov:1. The interim progress report is due no less than 90 days before the end of the budget period. The progress report will serve as the non-competing continuation application, and must contain the following elements: a. Standard Form (“SF”) 424S Form. b. SF-424A Budget Information-Non-Construction Programs. c. Budget Narrative. d. Indirect Cost Rate Agreement. e. Project Narrative.
Additionally, the applicant must provide CDC with an original, plus two hard copies of the following reports:2. Semi-annual progress reports, due semi-annually, due 210 days after the beginning of the budget period. This report will provide information on the progress of the program, in quantifiable terms, in terms of milestones achieved and their outcomes in comparison with the timeline initially proposed for the project. See “Awardee activities for the program.” 3. Annual progress report, due 60 days after the end of the budget period. This annual progress report will provide information about the progress of the program and the program evaluation, in quantifiable terms, in terms of milestones achieved and their outcomes in comparison with the timeline initially proposed for the project. See “Awardee activities for the program.” 4. Financial status report no more than 90 days after the end of the budget period.
These reports must be submitted to the attention of the Grants Management Specialist listed in the “VII. Agency Contacts” section of this announcement.
CDC encourages inquiries concerning this announcement.
For general questions, contact:
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-14
Atlanta, GA 30341
For program technical assistance, contact:
Rodolfo Valdez, Ph.D., Project Officer
For financial, grants management, or budget assistance, contact:
William Ryan, Grants Management Officer
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-09
CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.
VIII. Other Information
Other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm.
Applicants may access the application process and other awarding documents using the Electronic Research Administration System (eRA Commons). A one-time registration is required for interested institutions/organizations at http://era.nih.gov/ElectronicReceipt/preparing.htm
Program Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the eRA Commons.
1. Organizational/Institutional Registration in the eRA Commons
2. Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should check with their business official to determine whether their organization/institution is already registered in the eRA Commons. HHS/CDC strongly encourages applicants to register to utilize these helpful on-line tools when applying for funding opportunities.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm