Part I Overview Information


Department of Health and Human Services

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

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:  Surveillance and Epidemiologic Research of Duchenne and Becker Muscular Dystrophy 

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 and 317(k)(2) and 317(C) of the Public Health Service Act, (42 U.S.C., Sections 243 and 247b(kl)(2), and 2347b-4), as amended.

Announcement Type: 

Update: The following update relating to this notice has been issued:

Request For Applications (RFA) Number: RFA-DD-06-002

Catalog of Federal Domestic Assistance Number(s): 93.283.  Centers for Disease Control and Prevention - Investigations and Technical Assistance.

Key Dates
Release Date: March 16, 2006
Letter of Intent Receipt Date:  March 27, 2006   
Application Receipt Date: April 24, 2006  
Peer Review Date: Approximately eight (8) weeks after application receipt date
Council Review Date: Approximately three (3) weeks after peer review date 
Earliest Anticipated Start Date: September 1, 2006
Expiration Date: One day after the application receipt date

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

Additional Overview Content

Executive Summary

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
            4. 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 the program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area of Disability and Secondary Conditions. 

Phase I - Under this announcement, CDC plans to add one additional state or geographic area as a Phase I project to the system in order to achieve a nationally-representative study population.  Specifically, Asian American and Pacific Islanders are under-represented in the current study population.  The new state will be considered a Phase I site.   A state or geographic area must demonstrate: (a) a birth rate of 15,000 with; (b) at least 65% of the births to mothers who are Asian or Pacific Islander (according to 2000 Census) to ensure that the study population of MD STARnet is nationally-representative. 

The new state or geographical area project approach should include existing active case ascertainment and medical record abstraction methods employed in the existing MD STARnet sites.   The newly funded project will be expected to work toward implementing congruent protocols for surveillance, data collection and pooling already supported in the existing state programs.  Phase I and Phase II applicants should participate fully as members of the MD STARnet Coordinating Committee as outlined in Section VI.2.A.3.

Phase II - As part of the Muscular Dystrophy Surveillance Tracking and Research Network, or MD STARnet, the CDC has worked with researchers in Arizona, Colorado, Iowa, and western New York State to set up surveillance systems for DMD and BMD under an original CDC cooperative agreement (RFA 02172).  For the purposes of this announcement these institutions are considered under the limited eligibility as Phase II projects.  The goal of these projects was to locate and identify all DMD and BMD patients in these areas by using information from different sources, such as clinic medical records and hospital records.  Information about each child's treatments and ongoing medical status is being collected from his medical records.  Because many DMD and BMD patients are seen in Muscular Dystrophy Association clinics, the researchers are working closely with the Muscular Dystrophy Association clinics in their states. 

In addition, the researchers will be searching for DMD and BMD patients through other neuromuscular clinics, emergency rooms, pathology laboratories, orthopedists, and other muscular dystrophy associations to ensure that all patients with DMD and BMD are included in the project.  The project sites have worked together to develop in the targeted population a common system that can be used to find patients and collect information.  Families who are identified in these areas will be asked to take part in interviews with public health workers to provide information related to DMD and BMD that might not be found in the medical records.  Applicants should outline and describe these procedures and processes in the application.

In April 2004, researchers at the four sites began collecting information from medical records.  The types of information collected include basic demographic information (such as race and ethnicity), the treatments that have been received, the clinics where the care was received, and any medical problems associated with DMD and BMD.  The four projects began to pool de-identified data in FY 2005.  The plan and objectives for implementation of these methods and procedures should be included in the application.

The research should continue to implement and evaluate methods and approaches to ascertain cases and generate timely population-based date of DMD and BMD and their complications, and should be included in the application.    

In implementing this work, all Phase I and the Phase II applications should outline the methods that will answer these research questions:

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(s).

This funding opportunity uses the just-in-time budget concept.  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 award mechanism. In the 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 National Center on Birth Defects and Developmental Disabilities (NCBDDD) intends to commit up to $2,850,000 in FY 2006 direct and indirect costs.

Phase I Awards:  Up to $450,000 (direct and indirect cost) will be available to fund one site. 

Phase II Awards:  Up to four applications may be awarded.  The average award amount will be between $500,000 and $600,000 (including both direct and indirect cost) per year for each year of the project. 

The project period is up to five years.  The anticipated start date for the new awards is September 1, 2006. 

All estimated funding amounts are subject to availability of funds.

Section III. Eligibility Information



1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application for the Phase I award if your organization has any of the following characteristics: 

State health departments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, the Republic of Palau), and federally recognized Indian tribal governments. 

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 you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Place this documentation behind the first page of your application form. 

As a requirement, applicants for the Phase I award must include and document a study population of at least 15,000 live births per year with at least 65% of the births to mothers who are Asian or Pacific Islander within a state or a contiguous area of a state (such as the catchment of a local or municipal health agency), based on U.S. Census Data. 

All applicants for the Phase I award that fail to submit the evidence requested above will be considered non-responsive and returned without review.

Eligible applicants for Phase II are limited to those previously funded under Program Announcement Number 02172.  They are: (1) University of Arizona College of Medicine, (2) Colorado Department of Public Health and Environment, (3) University of Iowa College of Medicine, and (4) the New York State Department of Health.  This limited eligibility is based on sustaining support to already well-established programs, and to take advantage of the foundation, collaborations in place, and the multiple systems developed over time and now operational to conduct this research.

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 are not required under this announcement.  The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/2glossar.htm

3. Other-Special Eligibility Criteria

Phase I documentation of the required birth rate to mothers who are Asian or Pacific Islanders must be placed directly behind the face page of the application. 

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: March 27, 2006
Application Receipt Date(s): April 24, 2006
Peer Review Date: 8 weeks after receipt of the applications under this announcement
Secondary Review Date: 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 (OPHR)
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Tel: (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 – RFA DD06-002
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, including the appendix materials, must be sent to:

Dr. M. Chris Langub
Office of Public Health Research (OPHR)
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Tel: (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 by the PGO and responsiveness by the NCBDDD. Incomplete and non-responsive applications will not be reviewed.

CDC will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.  However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application.  That is, the application for funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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:

Funds relating to the conduct of research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

6. Other Submission Requirements

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

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

Your research 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.) 

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 Grants 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 NCBDDD 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:

1. Demonstrate collaborative efforts with the widest range of appropriate stakeholders that provide diagnosis of genetic conditions as well as with other funded projects funded through this announcement to develop common protocols in program implementation and evaluation. 

2. Conduct active case ascertainment of DMD and BMD among reporting sources to determine prevalence of the genetic conditions in the defined geographic area, including a complete count of all prevalent cases, including age birth to 21 years and supplemented in later years by newly diagnosed cases.  

3. Describe the source, frequency, and type of preventive and medical care among persons with DMD and BMD as well as the prevalence of related complications. 

4. Implement population-based long term follow-up of persons with DMD and BMD to relate health outcomes to the source, frequency, and types of preventive and therapeutic care with a capacity to evaluate and disseminate all findings.   

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

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.

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 Part 74 and Part 92 has 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

The following 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 U01, 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 above.

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

A CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

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 Division of Human Development and Disability, 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;

2.  As requested, assist the project in responding to inquiries regarding such areas as data management, data analysis, or other methodological issues;

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 will appoint an 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 determine the adequacy of the research and to monitor performance against approved project objectives.  

Additionally, an agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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 the organizations receiving this award under this program and the CDC Scientific Collaborator. 

The Coordinating Committee will formulate plans for cooperative research and address issues of common concern throughout the life of the project.  At periodic Coordination Committee meetings among recipients, the group will: (1) make recommendations on the study protocol and data collection approaches; (2) discuss any difficulties in implementing the methodology of the study; (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.

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

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

LaKasa Wyatt
Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
Telephone: 770-488-2814
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.

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.

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:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. 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.


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NIH Funding Opportunities and Notices


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