Part I Overview Information

Department of Health and Human Services

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

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

Title: Developing Methodologies to Determine the Prevalence of Autism Spectrum Disorders in Early Childhood and Young Adult Populations

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

Authority
This program is authorized under Sections 301, 311 and 317(C) of the Public Health Service Act, (42 U.S.C., Sections 241, 243 and 247b-4), as amended.

Announcement Type
New

Request For Applications (RFA) Number: RFA-DD-06-001

Catalog of Federal Domestic Assistance Number(s)
93.283
 

Key Dates
Release Date: November 4, 2005
Letter of Intent Receipt Date:  December 5, 2005    
Application Receipt Date: January 5, 2006   
Peer Review Date: March 6, 2006
Secondary Review Date: March 27, 2006 
Earliest Anticipated Start Date: August 1, 2006
Additional Information to Be Available Date: N/A
Expiration Date: January 6, 2006

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

Since 1968, the Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects (i.e., structural malformations and genetic diseases) in metropolitan Atlanta through review of hospital newborn medical records and records from various other medical sources in the five-county area.  However, birth defects such as cleft palate and spina bifida, which are evident at birth, represent only a portion of the spectrum of developmental problems that children may face.  Other conditions, such as autism, mental retardation and cerebral palsy, are usually manifested after infancy.  These types of developmental problems are often severe enough that affected individuals require specialized medical, educational, and other intervention services throughout the lifespan, incurring substantial financial and societal costs. 

The success of a Metropolitan Atlanta Study from1985-1987 prompted investigators to establish the Metropolitan Atlanta Developmental Disabilities Program (MADDSP) in 1991.  MADDSP is a population-based, multiple source case ascertainment developmental disabilities surveillance system covering a five-county metropolitan area that includes the city of Atlanta (Clayton, Cobb, DeKalb, Fulton, and Gwinnett counties).  MADDSP was designed to monitor the prevalence and associated features of serious developmental disabilities, defined as conditions leading to lifetime need for specialized medical, educational, or social services.  Children with these developmental disabilities are identified by screening the records of various sources in the community which provide services to such children. 

Throughout the early 1990’s, MADDSP monitored the occurrence of four developmental disabilities: mental retardation, cerebral palsy, hearing impairment and vision impairment.  In 1996 investigators began developing methods to modify MADDSP to incorporate a fifth developmental disability, autism.  Autism, like the other disabilities monitored by MADDSP, is a serious neuro-developmental condition associated with a lifetime of disability and incurring financial and societal costs.  Further, autism frequently affects individuals diagnosed with one or more of the other developmental disabilities monitored by MADDSP.  Since the 1996 study year, autism monitoring has become a permanent component of MADDSP.  Currently, MADDSP tracks prevalence of select disabilities for children at age 8.

CDC currently funds a total of 16 sites in 17 states (including CDC’s sites in metro Atlanta) through FY05 to conduct surveillance of autism spectrum disorders and related developmental disabilities as part of the Autism and Developmental Disabilities Monitoring (ADDM) activities and the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Surveillance Network. The goals of the network include: (1) to develop or improve programs to track the number of children with an autism spectrum disorder (ASF) in their states and (2) to provide comparable, population-based estimates of the prevalence rates of autism and related disorders in different sites over time. 

The following states are part of the ADDM CADDRE network: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Maryland, Missouri/Illinois, New Jersey, North Carolina, Pennsylvania, South Carolina, Utah, West V irginia and Wisconsin.  These surveillance sites have been identifying a baseline prevalence of the Autism Spectrum Disorders (ASD) in children who are age 8 since this is the age at which MADDSP identified the highest prevalence of ASD. 

Although tracking peak prevalence is important to understanding trends in the prevalence of ASD, there is also a great deal of interest in being able to understand the population prevalence of ASD at young ages (below the age of 4) and in older adolescent and young adult populations (age 17 to 25).  In order to determine the population-based prevalence of ASD in early childhood or young adult populations, using the MADDSP record review methodology may not be the most adequate model given differences in the information available via records for surveillance. 

If applicants propose a prevalence and surveillance methodology that involves human subjects research, this should be clearly stated in the application and all appropriate Institutional Review Board (IRB) requirements should be addressed in the timeline.

Applicants may address either early childhood or young adults in their applications. However, in such a case separate applications must be submitted for each age group.  It is possible that one applicant could be awarded two cooperative agreements (one for each interest area; namely, both early childhood and young adult).  Such a circumstance could occur on the basis of the overall priority scores and ranking under the peer review process.

During the year of funding, each funded site will develop a protocol and identify the personnel, permissions, and resources that would be needed to implement the project.  Minimum requirements for the application include:

1. Develop or enhance a methodology to determine the prevalence of ASD in an early childhood or young adult population with an evaluation of the feasibility for using this methodology as a population-based epidemiologic surveillance system for ASDs.  ASD should include Autistic Disorder, Pervasive Developmental Disorder – Not Otherwise Specified (PDD-NOS) and Asperger’s Disorder.  Sites can propose including additional developmental disabilities, such as MR, cerebral palsy, hearing loss, vision impairment, and/or epilepsy, but this is optional.

2. Develop and implement a plan to identify and access potential sources for ASD/DD surveillance.

3. Determine data linkages that may be needed to supplement the ASD/DD prevalence study and surveillance system.

4. Develop or enhance collaborative relationships with appropriate professionals and organizations to establish a multiple-source methodology for case ascertainment.

5. Identify a project team capable of conducting ASD and DD surveillance.

6. Develop and implement a plan for quality assurance procedures.

7. Develop and implement an evaluation plan for estimating the validity and completeness of the prevalence results for a single study year and for use in an   ongoing surveillance system. Consideration should be given to the generalizability of the model to include geographical balance and urban/rural distribution.

8. Cooperate with funded CDC ASD surveillance partners and participate in surveillance development workshop(s) and meetings with CDC staff and ADDM network members concerning population-based surveillance of ASDs/DDs.

9. Include strategies for increasing community and public health awareness of ASD/DDs to improve consistent identification or the selected population.

10. Include plans to disseminate the findings of the project to stakeholders.

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 U10 award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  

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.

In the CDC 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

Approximately four awards will be made.  Plans are for the top two applicants in the categories of early childhood and young adult populations to receive awards.  The amount of each award for the first budget year is expected to be $150,000. The total funds expected to be awarded to the four new projects will be $600,000.  These award amounts include both direct and indirect costs.  This amount is an estimate, and is subject to availability of funds.

The projects are proposed to be funded for an initial one year project period.  Funding        to implement the system beyond that initial year is possible based on the availability of future funding, and will be competed through limited competition for two awards, one in each age group.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

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.

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 is 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

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: December 5, 2005
Application Receipt Date(s): January 5, 2006
Peer Review Date: March 6, 2006
Secondary Review Date: March 27, 2006
Earliest Anticipated Start Date: August 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)
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Tel: (404) 371-5992, Fax: (404) 371-5215
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-DD-06-001
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA 30341

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

Dr. M. Chris Langub
Office of Public Health Research (OPHR)
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Tel: (404) 371-5992, Fax: (404) 371-5215
E-Mail: eeo6@cdc.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

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.

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".

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.)  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

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. 

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

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, 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 neuro-developmental 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 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
1600 Clifton Road, MS E87
Atlanta, GA  30333
Tel: (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 (OPHR)
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Tel: (404) 371-5992; Fax: (404) 371-5215
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) 488-2728
E-Mail: LWyatt@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
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 Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science."

The regulation places several requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity's (ORI) Assurance Program.

For examples:

Section 50.103(a) of the regulation states: "Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant; and (2) Will comply with its own administrative process and the requirements of this Subpart."

Section 50.103(b) of the regulation states that: "an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution's assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe."

An additional policy is added in the year 2000 that "requires research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds.

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.

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 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


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