Part I Overview Information


Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov

Components of Participating Organizations
National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC) at http://www.cdc.gov/ncbddd/

Title: Prevention of the Complications of Bleeding Disorders through Hemophilia Treatment Centers

The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. 

Authority: This program is authorized under Sections 311, 317(k)(2) and 317(C)  of the Public Health Service Act , (42 U.S.C., Section 243, 247b(k)(2) and 247b-4), as amended.

Announcement Type: 
New

Request For Applications (RFA) Number: RFA-DD-06-005

Catalog of Federal Domestic Assistance Number(s):
93.283
Centers for Disease Control and Prevention – Investigations and Technical Assistance See available CFDA numbers at http://12.46.245.173/cfda/cfda.html

Key Dates
Release Date: March 24, 2006
Letter of Intent Receipt Date: April 5, 2006
Application Receipt Date: May 5, 2006  
Peer Review Date: Approximately eight (8) weeks after application receipt date
Secondary Review Date: Approximately three (3) weeks after peer review date 
Earliest Anticipated Start Date: September 1, 2006
Additional Information to Be Available Date: N/A
Expiration Date: May 6, 2006

Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

The purpose of this program is to:

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
     A. Receipt and Review and Anticipated Start Dates
         1. Letter of Intent
     B. Sending an Application
     C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements  
     A. Cooperative Agreement Terms and Conditions of Award
          1. Principal Investigator Rights and Responsibilities
          2. CDC Responsibilities
          3. Collaborative Responsibilities
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The CDC and NCBDDD are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area(s) of Maternal, Infant, and Child Health, and is in alignment with NCBDDD performance goal(s) to prevent birth defects and developmental disabilities. The specific goal is to work toward results   that all people, and especially those at greatest risk for health disparities, will achieve their optimal lifespan with the best possible health at every stage of life. 

For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/

Hereditary defects in one or more of the clotting factors cause abnormal and sometimes life-threatening bleeding.  Approximately 18,000 U.S. persons, primarily males, are affected by hemophilia A or B, the most common and severe of the clotting factor deficiencies.  An estimated 1% of the U.S. population (2.5 million) has von Willebrand Disease (VWD), a hereditary disorder that affects both men and women equally and is characterized by excessive bleeding following trauma and during menstruation for reproductive-aged women. 

Hemophilia is a complex disorder that can have chronic disease manifestations that are difficult and expensive to treat. Optimal care to prevent these complications requires a multi-disciplinary team approach. In the United States, hemophilia treatment centers (HTCs) have developed a model of care delivery called comprehensive care which includes specialized prevention, diagnostic, and treatment programs designed to provide family-centered education, state-of-the-art treatment, research, and support services for individuals and families living with bleeding disorders.

Since 1975, Congress has provided federal funding through the Maternal and Child Health Bureau and the Centers for Disease Control and Prevention (CDC) for infrastructure support to hemophilia treatment centers for both care and prevention services as well as public health programs including education, outreach, and surveillance for persons with bleeding disorders.  CDC has provided support to this network of HTCs through regional grants since 1996. Currently, the federal HTC system comprises 135 centers throughout the United States and its territories. Of the approximately 18,000 persons with hemophilia in the United States, 67% attend a local HTC for preventive care and management. 

The application should be constructed so as to enhance the capacity of hemophilia treatment centers as a public health prevention network to monitor blood safety among recipients of blood products; monitor the extent and progression of joint disease; and to provide data to describe the health status and extent of complications of the target populations of persons with bleeding disorders.  Expansion of the original data protocol will provide information about newborns, delivery, women with bleeding disorders, rare bleeding disorders, quality of life, and physical activity.  These are the major components of the program that all applicants should address in their proposals.

CDC has established the Universal Data Collection (UDC) project to monitor the safety of the nation's blood supply for persons being treated with blood products, as well as to monitor the occurrence of joint complications experienced by persons with hemophilia.  The UDC is conducted through the network of specialized health-care centers that serve persons with various blood disorders covered by this announcement.

The types of data gathered through the UDC project consist of:

In developing the application and work plan, applicants should include a potential research focus on at least one of the opportunities listed below to enhance program impact.  Program goals to be addressed include:

To meet the purposes of this announcement, applicants should be prepared and indicate in their application how they will conduct specific objectives and activities within prescribed timeframes.  The regional core center applicants should indicate how they will:

  1. Develop and coordinate a plan where HTCs within the region would provide comprehensive prevention services to persons with bleeding disorders directed at attaining and measuring specific outcomes to reduce complications by using a multi-disciplinary team approach. HTC services are provided by a multi-disciplinary team.  The core team includes adult or pediatric hematologist, nurse coordinator, social worker and physical therapist. HTC services include medical and psycho-social assessment and monitoring, home therapy teaching and monitoring, infectious disease management, physical therapy, dental services, rehabilitation and support services; 
  2. Identify new patients eligible for care, and to re-establish contact with patients lost to follow-up;
  3. Encourage expansion of HTC populations to include services to women with  bleeding disorders and rare bleeding disorders and develop programs to identify underserved populations including minorities and women;
  4. Facilitate access to appropriate training resources and opportunities to orient new HTC personnel, and enhance the skills of current HTC personnel to increase the quality of prevention services;
  5. Promote referral to the centers and provide access to educational and support services;
  6. Promote and facilitate the exchange of information among health care providers;
  7. Coordinate development of HTC program plans, goals and objectives, and progress tracking and reporting for HTCs in the region;
  8. Develop appropriate management and evaluation systems to ensure that HTCs within their geographic region implement the activities of this program appropriately and comply with federal and other required regulations. Conduct program assessments, site visits, assist HTCs with problem solving,  assess local needs and recommend support for subcontracts to a network of centers in their region, and provide technical assistance when needed;
  9. With CDC, the HTC network in the United States has conducted surveillance for complications of bleeding disorders including monitoring for blood-borne infections. As part of this project, HTC will collect data related to infectious and bleeding complications that could be used for clinical research leading to improved care for the patients using these centers.  Applicants should include proposals based on UDC data that could be used by researchers in order to fully use the capacity that has been built over the years of the network.  For example, within the UDC system, it has been shown that: (1) increased body mass index is independently associated with a greater degree of joint range of motion limitation among young men with hemophilia; and (2) that both care in an HTC and home treatment with factor concentrates independently decreased the rate of hospitalizations for bleeding complications among men with hemophilia; and  
  10. Coordinate, annually or bi-annually, with CDC participation, a regional meeting for HTCs and CBOs or ad hoc consumer consultation committees to share information and plan programs.  Regional meetings may be jointly sponsored with other regions with similar needs.
  11. Participate fully in the Coordinating Committee outlined in Section VI.2.A.3.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U01 award mechanism.  

This funding opportunity uses the just in time budget concepts.  It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).  A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The CDC U01 is a cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The NCBDDD intends to commit approximately $6,800,000 in FY 2006 to fund approximately 12 awards.  Awards are expected to range between $300,000 and $850,000 with an average award of $567,000, and will include both direct and indirect costs.  An applicant may request up to a five year project period.  Awards are expected to be made to support the core center and other collaborating HTC performance sites in that region. 

All estimated funding amounts are subject to availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Assistance will be provided only to hemophilia regional core centers, defined as public or private non-profit entities that provide regional services and support to a network of comprehensive hemophilia treatment centers (HTCs) within their regional catchment area.  A HTC is defined as a specialty, prevention, diagnostic and treatment program with the goal of providing family-centered, state-of-the-art medical and psycho-social evaluation and care, dental, education, genetic, research, and support services for individuals and families with bleeding disorders.  The eligible applicants noted below must provide continuing evidence of this status and declaration as the regional HTC to be eligible.  Such evidence should be provided in the application to included directly behind the face (cover) page of the application (PHS 398).

Eligible applicants are limited to those previously funded under CDC Program Announcement 01049.  They include: (1) University of Massachusetts-Worcester; (2) Mt. Sinai School of Medicine, New York; (3) University of Pennsylvania; (4) University of North Carolina at Chapel Hill;  (5) Hemophilia Foundation of Georgia; (6) Hemophilia Foundation of Michigan; (7) Great Lake Hemophilia Foundation Inc: (8) University of Colorado Health Science Center; (9) University of Texas at Houston; (10) Children’s Mercy Hospitals and Clinics (11) Children’s Hospital of Orange County; and (12) Oregon Health Sciences University.

The foundation work developed by these institutions and begun five years ago was an investment in that concept with precisely the goals that this RFA intends to accomplish.  There is great advantage to the government and to the individuals at risk for hemophilia and bleeding disorders to have these  institutions continue to serve as the fulcrum of resources and capacity to extend, expand, and grow on what these projects have achieved over the past five years. It is appropriate to now permit these projects to take the many approached identified and found successful and continue to direct it to the populations that can now benefit from these established programs and the large client base that these institutions can reach.  That is the primary purpose of this work as CDC sustains this foundation of knowledge and builds upon it to achieve greater understanding of hemophilia allowing prompt intervention and action.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

2. Cost Sharing or Matching

Cost sharing, matching funds, or cost participation is not required under this announcement.  

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/

3. Other Special Eligibility Criteria

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. 

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.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date. If you submit your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If CDC receives your submission 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 carrier’s guarantee.  If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline. 

This announcement is the definitive guide on LOI and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A,, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: April 5, 2006
Application Receipt Date(s): May 5, 2006
Peer Review Date: Eight (8) weeks after receipt of the applications under this announcement
Secondary Review Date: Three (3) weeks after the conclusion of the peer review
Earliest Anticipated Start Date: September 1, 2006 

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 CIO 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.

The letter of intent should be sent to:

Dr. M. Chris Langub
Office of Public Health Research/Office of the Director
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone: (404) 639-4640
Fax: (404) 639-4903
E-Mail: eeo6@cdc.gov

3.B. Sending an Application

Applications follow the PHS 398 application instructions for content and formatting of your applications.  If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and one signed photocopy in one package to:

Technical Information Management Section – RFA DD06-005
Procurements and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA 30341

At the time of submission, four additional copies of the application, and all appendices must be sent to:

Dr. M. Chris Langub
Office of Public Health Research/Office of the Director
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone: (404) 639-4640
Fax: (404) 639-4903
E-Mail: eeo6@cdc.gov

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness responsiveness by the NCBDDD and PGO. Incomplete and non-responsive applications will not be reviewed.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement.

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

6. Other Submission Requirements

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI "Award Administration Information".

Your research plan should address activities to be conducted over the entire project period.   If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your rate is a provisional rate, the agreement should be less than 12 months of age. 

Your project plan should address activities to be conducted over the entire project period.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data.  Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

PHS policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible. 

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications.  The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590. http://www.cdc.gov/od/pgo/forminfo.htm).   See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by OPHR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness.  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 these goals. 

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses 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?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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 investigative team bring complementary and integrated expertise to the project (if applicable)? 

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).    http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.   Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

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, and children in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations, and children 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.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

PHS policy requires that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible. 

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm ). See Section VI.3.Reporting.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

3. Anticipated Announcement and Award Dates

The CDC Procurement and Grants will notify successful applicants in a pre-award conference call and providing the notice of award.  The anticipated award date is September 1, 2006.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

Those applicants under consideration for funding will be contacted by CDC for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  This document will be mailed and/or emailed to the recipient fiscal officer identified in the application. 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Parts 74 and 92 have details about policy requirements.  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

Additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.  These will be incorporated into the NoA by reference.
 
2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the CDC as defined below.

2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for oversight of all management, administrative, and scientific aspects of the project.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and CDC policies.

2.A.2. CDC Responsibilities

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine project monitoring. 

There are two separate CDC scientific roles – Scientific Collaborator and Scientific Program Administrator

In this cooperative agreement, a CDC Scientist (Scientific Collaborator) within the National Center on Birth Defects and Developmental Disabilities (NCBDDD) is an equal partner with scientific and programmatic involvement during the conduct of the project through technical assistance, advice, and coordination. 

Scientific Collaborators will:

  1. Use their experience in studies of this nature to advise the project on specific questions regarding the project-developed protocol;
  2. As requested, assist the project in responding to inquiries regarding such areas as data management, data analysis, intervention design, formats for presenting research findings, and in comparing project-developed evaluation formats with other research projects and activities known to CDC;  
  3. Provide scientific consultation and technical assistance as requested on questions related to epidemiology, statistical and power calculations, and data storage and tracking formats used in other CDC sponsored research that could be advantageous to the project; and
  4. Suggest to the project upon request; processes for analysis, interpretation, and reporting of findings in the literature that can serve a broad range of scientific interests.

CDC Scientific Program Administrator (SPA)
The CDC NCBDDD Office of Extramural Research (OER) will appoint a SPA, apart from the NCBDDD Scientific Collaborator who will:

  1. Serve as the Program Official for the funded research institutions.
  2. Carry out continuous review of all activities to ensure objectives are being met.  
  3. Attend Coordinating Committee meetings for purposes of assessing overall progress and for program evaluation purposes.
  4. Provide scientific consultation and technical assistance in the conduct of the project as requested.
  5. Conduct site visits to recipient institutions to monitor performance against approved project objectives.

2.A.3. Collaborative Responsibilities

The planning and implementation of the cooperative aspects of the study will be effected by a Coordinating Committee consisting of the Principal Investigator from organizations receiving awards under this announcement and the CDC Scientific Collaborator; and will address issues of common concern throughout the life of the project.   Organizations serving as sub-contractors under awarded projects are not considered members of the Coordinating Committee.  

At periodic Coordination Committee meetings among recipients, the group will: (1) make recommendations on the study protocol and data collection approaches; (2) discuss common protocols as they relate to all data; (3) discuss the target populations that have been or will be recruited; (4) identify and recommend solutions to unexpected study problems; and (5) discuss ways to efficiently coordinate study activities and best practices.

Each full member will have one vote.  Awardee members of the Coordinating Committee (including a CDC member) should accept and implement policies approved by the Committee. The Committee decisions are used to implement the objectives of the project activities in a consistent way.

3. Reporting

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 0925-001, rev. 9/04 as posted on the CDC website no less than 120 days prior to the end of the current budget period.  The progress report will serve as your non-competing application.
  2. Annual Progress Report, due 90 days after the end of the budget period. 
  3. Financial status report, no more than 90 days after the end of the budget period.
  4. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon 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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Don Lollar
Acting, Director Office of Extramural Programs
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
1600 Clifton Road, MS E87
Atlanta, GA  30333
Telephone: (404) 498-3041
Fax: (404)-498-3050
E-Mail: dcl5@cdc.gov

2. Peer Review Contacts:

Dr. M. Chris Langub
Office of Public Health Research/Office of the Director
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone: (404) 639-4640
Fax: (404) 639-4903
E-Mail: eeo6@cdc.gov

3. Financial or Grants Management Contacts:

LaKasa Wyatt
Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-2728
E-Mail: lwyatt@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  (770) 488-2700
Email:  PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).   Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace Requirements
CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 2010
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

  1. Place small, minority, women-owned business firms on bidders mailing lists.
  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (http://ori.hhs.gov./policies/statutes.shtml).

For example:
Section 93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. 

A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. 

For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/.

Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

a.      In a timely manner.
b.      Completely, and as accurately as possible.
c.      To facilitate the broader community.
d.      Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA), www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

In cooperative endeavors CDC supports the efforts of NIH on the following:

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.