and Human Services (HHS)
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Part I Overview Information
Issuing Organization
Centers
for Disease Control and Prevention, (NCBDDD/CDC) at http://www.cdc.gov
Participating Organizations
Centers
for Disease Control and Prevention, (CDC) at http://www.cdc.gov
Organizations Components of
Participating Organizations
National Center on Birth Defects and
Developmental Disabilities (NCBDDD/CDC) at http://www.cdc.gov/ncbddd/
Title: Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE): A Case-Cohort Study.
The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Authority: This program is authorized under Sections 311, 317(k)(2) and 317(C) of the Public Health Service Act , (42 U.S.C., Section 243, 47b(k)(2) and 247b-4), as amended.
Announcement Type: New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-DD-06-003
Catalog of Federal Domestic Assistance Number(s):
93.283; Centers for Disease
Control and Prevention Investigations and Technical Assistance
Key Dates
Release
Date: February 24, 2006
Letter of Intent Receipt Date: March 20, 2006
Application
Receipt Date: April 18, 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: April 19, 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
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 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 www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
Under the provisions of the Children’s Health Act of 2000, NCBDDD funded five Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) through program announcements in 2001 and 2002. The CADDRE sites are: Johns Hopkins University, the California Department of Health Services, the University of Pennsylvania, the Colorado Department of Public Health and Environment, and the University of North Carolina at Chapel Hill. The NCBDDD serves as the sixth CADDRE site.
The focus of the second CADDRE funding cycle will be the conduct of a multi-site collaborative study. The specific purpose of the National CADDRE Study is to investigate risk and causal factors for ASDs and phenotypic subgroups of ASDs using a population-based, case-cohort study design. This study will be one of the largest collaborative scientific studies to collect and analyze epidemiologic data on the correlates and causes of autism including approximately 2,000 children, and their parents. The ultimate value in a study of this caliber and size is that it will advance efforts to identify causes of autism an essential step toward determining strategies for preventing this condition and improving the lives of children and adults living with autism.
The currently operational National CADDRE Study sets the stage for investigators to estimate for each specific causal factor the prevalence of the factor, the magnitude of the risk associated with that factor, and the proportion of individuals with ASDs attributable to the factor across sites. This knowledge will ultimately assist CDC to develop recommendations concerning identification of individuals with ASDs, identify interventions, and design more effective programs for prevention of ASDs.
The five members of the CADDRE group developed the protocol for the National CADDRE Study. Collaboration for protocol development among the CADDRE sites has been achieved through working groups, monthly meetings, and biannual face-to-face meetings. CADDRE site activities during the first funding cycle towards the National CADDRE Study protocol development and implementation also included: (1) establishing site-specific (California, University of Pennsylvania, and Johns Hopkins University) advisory boards, including parents of children with autism, to review the study materials and the study design; (2) conducting focus groups with parents of children with and without developmental disabilities to obtain additional feedback on the study design and feasibility of the study; (3) pilot testing the study instruments and materials, including recruitment methodology and materials, medical record ascertainment and abstraction, laboratory methods, self-administered questionnaires, and the caregiver interview; (4) developing field manuals, field staff training protocols, and quality control protocols for all aspects of the National CADDRE Study field work; and (5) establishing data sharing protocols and analysis plans.
The CADDRE group collaborated with the Data Coordinating Center (DCC) and a central laboratory and bio-sample repository in the development of the study. The CADDRE DCC was funded through CDC Announcement RFA 04014, and was awarded in May 2004 to Michigan State University Data Coordinating Center. Among its duties, the DCC is developing a multi-site tracking and data entry system for the National CADDRE Study called the CADDRE Information System (CIS). The central laboratory and bio-sample repository will be responsible for developing, implementing and coordinating protocols for the collection, shipping, intake, processing, storage, and subsequent shipping for analyses (as needed) of all bio-samples from all sites for the National CADDRE Study.
The approach of the proposed cooperative agreement will be for all study sites (up to five funded grantees and CDC as an additional study site) to complete implementation of the collaborative National CADDRE Study protocol. Each site will contribute to the joint pooled data set and are expected to achieve complete data collection on at least 330 child-parent units (i.e., 110 child-parent units for each of the three subject groups: (1) autism spectrum disorder cases; (2) neuron-developmentally impaired control; and (3) sub-cohort control groups).
The recruitment per site should be higher (e.g., at least 150 child-parent units enrolled per subject group, and possibly higher) to account for attrition and incomplete data collection. The target age range for completed data collection of all children is 30-60 months. Data collection will consist of six main components: (1) primary caregiver telephone interview, (2) medical record abstraction, (3) primary caregiver completed self-administered questionnaires, (4) child developmental evaluation, (5) child physical exam, and (6) bio-sampling from biological parents and child. Common data elements across all sites will be pooled for analysis. The central laboratory and bio-sample repository will coordinate and oversee the collection, shipping, intake, processing, storage, and subsequent shipping for analyses (as needed) of all National CADDRE Study bio-samples from all sites. The central laboratory and bio-sample repository activities will be included as the supplementary CADDRE site activity.
To meet these objectives the funded applicants of the proposed program will build upon the accomplishments of the previous cooperative agreement objectives. The funded applicants within the proposed program will build upon the accomplishments of their previous work. Each applicant should:
Applicants considering development and operation of the laboratory component must provide its operational plan and budget, and describe how it will function as the central laboratory and biosample repository. This proposal should be included as a separate component of the application with its own narrative and budget. It should outline how it will complement the required activities for a CADDRE site and provide evidence of its capacity and resources to serve in this role for all sites. If this central laboratory component is funded, both the budget for the CADDRE site and laboratory will be combined to comprise the new award.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
See
Section V, Application Review Information 2.A. Additional Review Criteria for
added areas for consideration.
Section II. Award Information
This funding opportunity will use the U10 award mechanism(s).
This funding opportunity uses the just in time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
The CDC U10 is a cooperative agreement award mechanism the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The NCBDDD intends to commit approximately $6,700,000 in FY 2006 to fund up to five awards. The average award will be $1,200,000 including direct and indirect costs for the first budget period. An applicant may request a project period of up to five years. Approximately $700,000 in additional funds will be awarded to one of these institutions to establish and operate the central laboratory and biosample repository. The anticipated start date for 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
Eligible applicants are limited to those previously funded under Program Announcements 01086 and 02199: (1) Johns Hopkins University, (2) the California Department of Health Services, (3) the University of Pennsylvania, (4) the Colorado Department of Public Health and Environment, and (5) the University of North Carolina at Chapel Hill. This limited eligibility is based on sustaining support to well-established programs, and to take advantage of the foundation and multiple systems developed over time and now in place to conduct the National CADDRE Study.
The foundation work developed by these five institutions and begun several years ago was an investment in that concept with precisely the goals that this RFA intends to accomplish. There is great advantage to the government and to the individuals at risk for autism spectrum disorders to have these five institutions receive funding to extend, expand, and grow on what these projects have achieved over the past years. Thus, this announcement seeks to build upon previous research and surveillance activities and foundation building in partnering with these five existing institutions and a new data coordinating center for autism to benefit from the breadth of work to date and enhance that investment to build a broader network and volume of source data. That work will ultimately assist CDC to develop recommendations concerning identification of individuals with ASDs, identify interventions, and design more effective programs for prevention of ASDs. Without these data, CDC would be limited in its ability to identify interventions that are likely to have the greatest effect on the prevention of ASDs and apply them on a national scale.
1.B.
Eligible Individuals
Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.
2. Cost Sharing or Matching
Cost Sharing,
matching funds, or cost participation is not required under this announcement. The most
current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/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
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 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 20, 2006
Application Receipt Date(s): April 18, 2006
Peer
Review Date: Eight (8) weeks after receipt of the applications under this
announcement
Secondary
Review Date: Three (3) weeks after the conclusion of the peer review
Earliest Anticipated Start Date: September 1, 2006
3.A.1. Letter
of Intent
Letters of Intent are
not required for this program
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 CDC-RFA-DD06-003
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 material must be sent by overnight
commercial carrier 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 the 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:
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.
The Data Sharing Plan will be consistent with the protocol developed by the CADDRE network and the DCC.
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 plan for sharing research resources addressing how
unique research resources will be shared or explain why 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 Progress Report (PHS 2590, http:www.cdc.gov/od/pgo/forminfo.htm).
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:
In order to achieve the aforementioned goals, successful applicants must demonstrate in their application:
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 in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.
Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.
2.B. Additional
Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data will be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D.
Sharing Research Resources
PHS policy require
that awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs
Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan will be
considered by OER 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
U10, 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 in collaboration with other CADDRE sites.
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) from the National Center on Birth Defects and Developmental Disabilities (NCBDDD) Developmental Disabilities Team 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.
5. Participate in site visits as requested by the CDC Scientific Program Administrator (SPA).
CDC Scientific
Program Administrator (SPA)
The CDC NCBDDD Office of Extramural Research will appoint an SPA, apart from
the NCBDDD Scientific Collaborator whose responsibilities are to:
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 project 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.
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 awards under this program and the CDC
Scientific Collaborator. Organizations serving as sub-contractors under
awarded projects are not considered members of the coordinating committee.
This Coordinating Committee will formulate plans for cooperative research and address issues of common concern throughout the life of the project. At periodic Coordinating Committee meetings among all recipients, the group will: (1) make recommendations about any changes to the study protocol and data collection approaches; (2) discuss any difficulties in implementing the methodology for the study; (3) identify how to reconcile differences in approaches to the study; (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 NCBDDD/DD member) should accept and implement policies approved by the
Committee. The Committee decisions are used only 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:
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
E-Mail: dlollar@cdc.gov
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
Procurement and Grants Office
Centers for Disease Control and Prevention
2920
Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2814
E-Mail: naustin@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 and children 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, and children 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.
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).
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see
http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Children as Participants in Clinical Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Public Access to Research Data through the Freedom of Information Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs in NIH Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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