Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Center for Injury Prevention and Control (NCIPC), (http://www.cdc.gov/ncipc/)  

Title: Evaluation of Community-based Approaches to Increasing Seat Belt Use Among Adolescent Drivers and their Passengers

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 section 301(a) [42 U.S.C. 241(a)] of the Public Health Service Act, and section 391(a) [42 U.S.C. 280 b(a)] of the Public Service Health Act, as amended.

Announcement Type
New

Request For Applications (RFA) Number: RFA-CE-06-007

Catalog of Federal Domestic Assistance Number(s)
93.136

Key Dates:
Release Date: December 27, 2005
Letter of Intent Receipt Date: January 3, 2006
Application Receipt Date: February 1, 2006
Peer Review Date: April, 2006
Council Review Date: June, 2006
Earliest Anticipated Start Date: September, 2006
Expiration Date: February 2, 2006

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

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 NCIPC 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) 15-19 (Increase use of safety belts) and 15-15 (Reduce deaths caused by motor vehicle crashes) and is in alignment with NCIPC performance goal(s) to conduct a targeted program of research to reduce injury-related death and disability. For more information, see www.health.gov/healthypeople  and www.whitehouse.gov/omb/mgmt-gpra/.

Background: 

Two out of five deaths among U.S. teens result from motor vehicle crashes. In 2003, 5,691 teens ages 13 to 19 died of injuries caused by motor vehicle crashes (1). Fifty-four percent of the teens killed in crashes were drivers.  Of the teen passenger deaths, 59 percent occurred in crashes in which another teen was driving. 

The risk of motor vehicle crashes is higher among 16- to 19-year-olds than other age groups. Per mile driven, teen drivers ages 16 to 19 are 4 times more likely than older drivers to crash (1). 

Seat belts are the single most effective means of reducing deaths and serious injuries in crashes. Teens have the lowest belt use rates of any age group, and teens are less likely to buckle up when riding with a teen driver than with an adult.  In 2003, only 39% of high school students reported they always wear seat belts when riding with someone else (2). Male high school students (36%) were less likely than female students (42%) to always wear seat belts (2).  Systematic reviews of some interventions to increase the use of safety belts are available (3,4), as well as specific policy guides (5,6).

(1) Insurance Institute for Highway Safety.  Fatality Facts 2003: Teenagers.  Analysis of data from the U.S. Department of Transportation's Fatality Analysis Reporting System and the National Household Travel Survey. Arlington, VA., 2005

(2) CDC. Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2004.

(3) Dinh-Zarr TB, Sleet DA, Shults RA, Zaza S, Elder RW, Nichols JL, Thompson RS, Sosin DM, Task Force on Community Preventive Services.  Reviews of evidence regarding interventions to increase use of safety belts.  Am J Prev Med: 21(4S);48-65, 2001.

(4) Shults RA, Elder RW, Sleet DA, Thompson RS, Nichols JL.  Primary enforcement seat belt laws are effective even in the face of rising belt use rates.  Accident analysis and Prevention, 36(3):491-3, 2004.

(5) CDC. School Health Guidelines to Prevent Unintentional Injuries and Violence.  MMWR Recommendations and Reports, Vol 50, No. RR-22:1-74, Dec. 7, 2001.

(6) Transportation Research Board. NCHRP Report 500: Guidance for Implementation of the AASHTO Strategic Highway Safety Plan Transportation Research.  Volume 11: A Guide for Increasing Seatbelt Use.  Available at: http://trb.org/publications/nchrp/nchrp_rpt_500v11.pdf

Scientific Knowledge to be achieved:

Although teens have the lowest seat belt use rates and highest crash risk any age group, few examples of well designed community-based interventions to increase seat belt use among teens are available in the peer-reviewed literature.  This proposal will fund the implementation and evaluation of one or more multi-component community-based interventions to increase seat belt use among adolescent drivers and their passengers.

Research Objectives:

The objectives of this research are to:

This process and outcome information will be used to inform future community-based interventions to increase seat belt use among adolescents.

Rigorous evaluations are needed to determine the effectiveness of interventions, programs, and policies addressing the prevention of unintentional injuries. The preferred approaches to assessing the effectiveness of the interventions include quasi-experimental research designs using time series data, comparison communities, or both. Baseline measures of variables related to seat belt use among teen drivers and passengers should be collected before implementation of the intervention. Direct assessment of seat belt use, rather than self-reported use, levels is the preferred outcome variable. 

Research Approaches to Achieve the Objectives:

To achieve the objectives of this research, the intervention design must:

The intervention activities must be rooted in a solid foundation of behavioral and social science theory. 

The intervention will use a core coalition that includes representatives from each of the sectors involved such as:

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

Preference will be given to applications from geographic areas where teen seat belt use rates are lower or rates of crash-related serious injuries or deaths are higher than the national average. 

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U49 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 U49 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The participating CIO(s) NCIPC intends to commit approximately $300,000 (including both direct and indirect costs) in FY 2006 to fund 1 award. The average award amount will be $300,000.  An applicant may request a project period of up to five years and a maximum budget of $300,000 (including both direct and indirect costs) per year or $1,500,000 for the five year project period.  The approximate total project period funded amount is $1,500,000. The anticipated start date for new awards is September, 2006.

All estimated funding amounts are subject to availability of funds.

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.

Although the financial plans of NCIPC 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 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

No cost sharing, matching, or cost participation is required.

The most current Grants Policy Statement can be found at:
http://grants.nih.gov/grants/policy/gps/2glossar.htm

3. Other-Special Eligibility Criteria

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

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700.  Application forms can be mailed to you.

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.

Abstract (Project Summary and Relevance)

It is especially important that the abstract (Description, PHS-398 form page 2) of your grant application reflects the project’s focus.  The following instructions supercede those provided in the PHS 398 instructions.  If your application is funded, your abstract will become public information.

The abstract should contain the following sections:

For more information on how to write an abstract please the “Structured Abstracts” section at: http://jama.ama-assn.org/ifora_current.dtl

Research Plan

You must include a research plan in your application.  The research plan should address activities to be conducted over the entire project period.  The research plan should include the following 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 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.

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: January 3, 2006
Application Receipt Date(s): February 1, 2006
Peer Review Date:  April, 2006
Council Review Date:  June, 2006
Earliest Anticipated Start Date: September, 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:

NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control

Address for Express Mail or Delivery Service:
2945 Flowers Rd.
Yale Building, Room 2054
Atlanta, GA  30341

Address for U.S. Postal Service Mail:
4770 Buford Hwy., NE, Mailstop K-62
Atlanta, GA 30341

Telephone: (770) 488-4037
FAX: (770) 488-1662
Email: CIPERT@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 and all appendices, including the checklist, and one signed photocopy in one package to:

Technical Information Management Section – CDC-RFA-CE06-007
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA  30341

At the time of submission, four (4) additional copies of the application, including the appendix material, must be sent to:

NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control

Address for Express Mail or Delivery Service:
2945 Flowers Rd.
Yale Building, Room 2054
Atlanta, GA  30341

Address for U.S. Postal Service Mail:
4770 Buford Hwy., NE, Mailstop K-62
Atlanta, GA  3034

Fax:  770-488-1662
Email:  CIPERT@cdc.gov

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.

Note:  Applications must be sent to CDC in Atlanta, GA not NIH in Bethesda, MD.

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 NCIPC. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html

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.

Note: Only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan.  Because the ceiling for this RFA is $300,000, a data sharing plan is not required.

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 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:

In addition, applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement.  Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement.  Measures must be objective and quantitative, and must measure the intended outcome.  These measures of effectiveness must be submitted with the application and will be an element of evaluation.

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 NCIPC 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?

To what extent do the applicant’s work plan and timetable include: 

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? If new, innovative strategies to increase seat belt use among teen drivers and passengers are tried, what is the rationale for selecting them and the likelihood they will succeed?

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)? Does the Principal Investigator have the authority to manage the project?

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? 

To what extent have the applicant and proposed collaborators documented:

Application Review

The primary review will be a peer review conducted by NCIPC Initial Review Group (IRG). Applications may be subjected to a preliminary evaluation (streamline review) by the IRG to determine if the application is of sufficient technical and scientific merit to warrant further review.  NCIPC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization.  Those applications judged to be competitive will be further evaluated by the IRG. These applications will be reviewed for scientific merit using current NIH criteria (a scoring system of 100 - 500 points) to evaluate the methods and scientific quality of the application. 

The secondary review will be conducted by the Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC).  The ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and project officer’s briefing materials).  ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in federally-funded research can be avoided and special subject area expertise can be shared.  The NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review in a similar capacity as the ACIPC Federal agency experts to assure that research priorities of the announcement are understood and to provide background regarding current research activities.  Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session.  If any further review is needed by the ACIPC, regarding the recommendations of the SPRS, the factors considered will be the same as those considered by the SPRS.

The ACIPC committee’s responsibility is to develop funding recommendations for the NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the NCIPC programs and priorities, and to assure that unwarranted duplication of federally-funded research does not occur.  The secondary review committee has the latitude to recommend to the NCIPC Director, to reach over better ranked proposals in order to assure maximal impact and balance of proposed research.  The factors to be considered will include:

All awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee IRG, recommendations by the secondary review committee of the Science and Program Review Subcommittee of the ACIPC, consultation with NCIPC senior staff, and the availability of funds.

Continued Funding

Continuation awards made after FY 2006, but within the project period, will be made on the basis of the availability of funds and the following criteria:

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 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.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed. Additional CDC Requirements under AR-3 Animal Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

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.

Note:  A data sharing plan is required by NCIPC only for applications requesting total (direct and indirect) costs of $500,000 or more per year.  Because the ceiling for this RFA is $300,000, a data sharing plan is not required.

2.D. 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. 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 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). SeeSection VI.3. Reporting .

3. Anticipated Announcement and Award Dates

Grantees will be notified in September 2006 by CDC’s procurement and Grants Office (PGO) if their applications were funded.

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, 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 and dominant role for:

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

2.A.2. CDC Responsibilities

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

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

3. Reporting

You must provide CDC with an original, plus two hard copies of the following reports:

1. Interim/Grant Progress Report, (use form PHS 2590, OMB Number 0925-0001, 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 continuation application.

2 .Annual Progress Report, due 90 days after the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

A.Current Budget Period Activities Objectives.

B. Current Budget Period Financial Progress.

C. New Budget Period Program Proposed Activity Objectives.

D. Budget.

E. Measures of Effectiveness.

F. Dissemination activities.

G. Additional Requested Information.

H. Financial status report, no more than 90 days after the end of the budget period.

I. Final financial and performance reports, no more than 90 days after the end of the project period.

3. Yearly outcome report summarizing the results, including publications, and impact resulting from the research.  An outcome report form will be sent by NCIPC to the grantees. The outcome report will be due at the same time as the Interim/Grant Progress Report.

4. Financial status report, no more than 90 days after the end of the budget period.

5. Final financial and performance reports, no more than 90 days after the end of the project period.

6. At the completion of the project, the grant recipient will submit a brief summary (2,500 to 4,000 words) written in non-scientific [laymen’s] terms.  The narrative should highlight the findings and their implications for injury prevention programs, policies, environmental changes, etc.  The grant recipient will also include a description of the dissemination plan for research findings.  This plan will include publications in peer-reviewed journals and ways in which research findings will be made available to stakeholders outside of academia (e.g., state injury prevention program staff, community groups, public health injury prevention practitioners, and others).  CDC will place the summary report and each grant recipient’s final report with the National Technical Information Service (NTIS) to further the agency’s efforts to make the information more available and accessible to the public.

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:

Arlene Greenspan, DrPH, MS, MPH
Division of Unintentional Injury Prevention
National Center for Injury Prevention and Control
MS K63
4770 Buford Highway, N.E.
Atlanta,a GA 30341
770-488-4652
770-488-1317
Email: AIG0@cdc.gov

2. Peer Review Contacts:

Gwendolyn Cattledge, Ph.D.
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop K-02
Atlanta, GA  30341
Telephone: (770) 488-4655
FAX: (770) 488-4422
Email: gxc8@cdc.gov

3. Financial or Grants Management Contacts:

Pam Render, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Rd.
Atlanta, GA  30341
Telephone: (770) 488-2712
FAX: (770) 488-2670
Email: PLR3@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.

Use of Animals in Research:
Recipients of PHS support for activated involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional CDC Requirements under AR-3 Animal 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.

Article I.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.

Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying Act, CDC interprets the language in the CDC's Appropriations Act to mean that CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

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

1. Place small, minority, women-owned business firms on bidders mailing lists.

2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.

4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity
The signature of the institution official on the face page of the application submitted under this 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/

Release and Sharing of Data
All “Requests for Applications (RFA)/Program Announcements (PA)” soliciting proposals for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a plan describing how the final research data will be shared/ released or explain why data sharing is not possible.

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 requesting total (direct and indirect) costs of $500,000 or more per year 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. 


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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