Cdc Grants For Public Health Research Dissertation 2010

Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Office of Public Health Research, (http://www.cdc.gov/od/science/PHResearch/)

Title:CDC Grants for Public Health Research Dissertation (R36)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH).  If a CDC policy does not exist to cover an applicable topic, or is in the process of being drafted, then for purposes of this announcement, the NIH policy is hereby adopted by CDC and will be applicable to that particular topic.  In addition, if written guidance for completing this application is not available on the CDC website, then applicants will be directed elsewhere for that information.

Authority: Section 301 of the Public Health Service Act (42 U.S.C. Section 241), as amended.

Announcement Type
New

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

  • July 31, 2009 - See Notice NOT-CD-09-002 Revised Application Receipt Date.
  • January 13, 2009 - See Notice (NOT-CD-09-001) The purpose of this notice is to notify applicants of the revised FY 2009 receipt date and provide clarification on submission requirements.
  • March 4, 2008 - See Notice (NOT-CD-07-232) Notice of Application Submission Clarification.
  • September 24, 2007 - See Notice (NOT-CD-07-231) Notice of Application and Submission Information Clarification.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-231

Catalog of Federal Domestic Assistance Number(s):
93.061

Key Dates
Release/Posted Date:   February 23, 2007
Opening Date:   February 23, 2007 
Letters of Intent Receipt Date(s):30 days before receipt date.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
ApplicationSubmission/Receipt Date(s):April 10, August 10, annually New Date September 8, 2009 per NOT-CD-09-002, (Changed to February 9 and August 10 for 2009 per NOT-CD-09-001).
Peer Review Date(s):within 3 months of submission.
Council Review Date(s):within 4 weeks following peer review
Earliest Anticipated Start Date(s):within 5 months of submission
Additional Information To Be Available Date (Activation Date):Not Applicable
Expiration Date: New Date September 9, 2009 per NOT-CD-09-002, Original Date: August 11, 2009

Due Dates for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

  • Purpose. The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for support of public health dissertation research.  This program supports research undertaken as part of an academic program to qualify for a doctorate. The CDC dissertation award supports dissertation research costs for students in accredited research doctoral programs in the United States (including Puerto Rico, and other U.S. Territories or possessions).  Dissertation applications must focus on methodological and research topics that address the mission and research interests of CDC noted below.
  • Grants to support dissertation research will provide no more than $35,000 in direct costs per year, and are awarded for up to one year, with the possibility of extension without additional funds for up to 12 months.
  • Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
  • Mechanism of Support. This FOA provides funding support of dissertation research through the CDC Dissertation Award (R36) mechanism.
  • Eligible Institutions/Organizations.Any domestic public or private university, college, or professional school is eligible to apply, given that it has the staff and facilities available to provide a suitable environment for the candidate to perform high-quality research.
  • Eligible Project Directors/Principal Investigators (PDs/PIs).The applicant for a dissertation research grant must be enrolled in an accredited doctoral degree program and must propose to conduct research in one of the areas specified in this FOA. (These awards do not support study leading to the M.D., D.O., or D.D.S., or similar professional degrees unless they are part of a combined degree program.) The doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC support.
  • Number of Applications. Only one application may be submitted per doctoral candidate in response to this announcement. Two resubmissions will be allowed in response to this FOA.  Resubmission applications must include an Introduction addressing the previous critique.  Resubmission receipt dates are April 10 and August 10.
  • Application Materials.SeeSection IV.1for application materials.
  • General Information.For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • Hearing Impaired.Telecommunications for the hearing impaired is available at: TTY 770-4882783.

Funding Opportunity Announcement Glossary:FOA Glossary Terminology

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 of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the CDC
    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
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The Office of Public Health Research (OPHR) of CDC within HHS is 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 PAR addresses “Healthy People 2010” priority area Prevention Research (Chapter 23-Section 17) and is in alignment with CDC’s performance goal(s) to increase the number of frontline public health workers at the State and local level that are competent and prepared to respond to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies and prepare frontline State and local health departments and laboratories to respond to current and emerging public health threats. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

The Centers for Disease Control and Prevention (CDC) announces the availability of CDC Public Health Research Dissertation Award grants (R36) to support public health doctoral dissertation research. Grant support is designed to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to CDC. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the field of public health research.

Research Objectives

The mission of CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability. The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of public health.  It addresses issues of basic, behavioral, and applied sciences(i.e., health statistics and research methodology) related to health promotion, disease prevention, injury and disability prevention, and health protection from infectious, environmental and terrorist health threats.  It evaluates both public health services and the system in which these services are provided.  These scientific results improve the evidence base to enable better decisions about health and help CDC achieve true improvements in people’s lives by accelerating health impact and reducing health disparities.

CDC is committed to achieving true improvements in people’s health. To do this, the agency is defining specific health impact goals to prioritize and focus its work and investments and measure progress. Research applications must address one of these four goals and reference at least one starter objective.  Applicants are strongly encouraged to focus on topical areas unique to CDC, demonstrating how expected results can be used or made available for use to enhance public health and quality of life.  Results should be directly relevant to customers, such as consumers, public health agencies and organizations such as state/local departments of health and community-based organizations, targeted populations, providers and practitioners, administrators, and policymakers. CDC’s Health Protection Goals are:

  • Healthy People in Every Stage of Life - All people, and especially those at greater risk of health disparities, will achieve their optimal lifespan with the best possible quality of health in every stage of life.
  • Healthy People in Healthy Places – The places where people live, work, learn, and play will protect and promote their health and safety, especially those at greater risk of health disparities.
  • People Prepared for Emerging Health Threats – People in all communities will be protected from infectious, occupational, environmental, and terrorist threats.
  • Healthy People in a Healthy World - People around the world will live safer, healthier and longer lives through health promotion, health protection, and health diplomacy.

Applicants are further encouraged to address public health research issues critical to CDC priority populations, including: low-income and minority groups; women, children, the elderly; and individuals with disabilities.

CDC has also developed a critical resource that can be used to identify research priorities and support CDC’s Health Protection Goals.  Applicants are encouraged to use the Guide to Public Health Research Needs (http://www.cdc.gov/od/science/PHResearch/cdcra/index.htm) to help identify areas of research that support CDC’s Health Protection Goals.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement will use the Centers for Disease Control and Prevention (CDC) Dissertation Award (R36) mechanism. The predoctoral student is the Project Director/Principal Investigator (PD/PI) of the application. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project under the supervision, and with the approval, of a university-approved and appointed doctoral committee. The student-PD/PI must have an appointment at the applicant institution (e.g., research assistant).

These awards support research activities related to preparation of a dissertation and do not support study leading to the M.D., D.O., D.D.S., or similar professional degrees unless they are part of a combined degree program.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format. This budget is found in the SF424 (R&R) Budget Component described in the SF424 (R&R) Application Package and Instructions Guide.

Dissertation awards are not renewable nor may they be transferred to another PD/PI. Applicants may submit up to two resubmissions in response to this FOA.

2. Funds Available

The average award amount will be $35,000 in direct costs per year, and are awarded for up to one year, with the possibility of extension without additional funds for up to 12 months.  The anticipated start date for new awards is within 5 months of submission.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Centers, Institutes, and Offices (CIOs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.  The total project period for an application submitted in response to this FOA may not exceed one year and may be extended without additional funds for up to 12 months.  Grants to support dissertation research will provide no more than $35,000 in direct costs per year.

Allowable Costs: Expenses usually allowed under PHS research grants will be covered by the CDC dissertation research grant, but may not exceed $35,000 per year in direct costs. An application that requests more than $35,000 per year in direct costs will be returned to the applicant. Allowable costs include the investigator's salary (not to exceed the current predoctoral fellow level for 12 months full-time effort approved by the Secretary of the Department of Health and Human Services). Stipend/salary levels are adjusted nearly every year and the current levels are available on the NIH website: https://grants.nih.gov/training/nrsa.htm. In developing the non-modular budget, applicants may also include costs for research assistants' salaries, and direct research project expenses, such as data processing, payments to subjects, supplies, consultants, and dissertation costs (e.g., printing and binding of the dissertation). No tuition, alteration/renovations, contracting costs, faculty salary, or space rental are allowed on dissertation research grants. Indirect costs are limited to eight percent of requested direct costs, less equipment.

Any level of effort by the investigator that is less than full time (40 hours per week) must be fully justified, and the investigator's salary must be prorated accordingly.

HHS grants policies as described in the  http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA.

If the application requests funding greater than the ceiling amount, it will be considered non-responsive and will not enter into the review process.

F&Acosts requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

  • Public/State Controlled Institution of Higher Education
  • Private Institution of Higher Education

Eligible applicant institutions are those that are domestic public or private non-profit universities, colleges, or professional schools with accredited doctoral degree granting programs. Institutions must have staff and facilities available on site to provide a suitable environment for performing high-quality research.

The applicant organization must be the doctoral granting institution at which the student is registered and matriculating.  Individuals cannot apply directly.

1.B. Eligible Investigators

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 support.

The PD/PI doctoral student for a dissertation research grant:

  • must be enrolled in an accredited doctoral degree program and must propose to conduct research in one of the areas specified in this funding opportunity announcement.
  • must be a registered doctoral student in good standing.
  • must have an approved dissertation proposal by doctoral committee by the time of the grant award.
  • must have completed all non-dissertation requirements for degree by the anticipated start date of the award (except clinical internship where that is required to follow the dissertation phase).
  • must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application.

A doctoral student who receives support for dissertation research under a grant from the CDC may not hold concurrently another federally sponsored fellowship or similar Federal award, such as a National Research Service Award (NRSA) that provides a stipend or otherwise duplicates provisions of this grant program. A CDC dissertation grant recipient may, however, accept concurrent educational remuneration from the Department of Veterans Affairs (VA) and loans from Federal funds. Receipt of non-Federal funds during the grant period is also allowable if it is in accordance with the sponsoring institution's policy and does not detract from or prolong the approved doctoral training program.  Recipients of mentored career development awards are not eligible for dissertation support.

2. Cost Sharing or Matching

This program does not require cost sharing or matching.

The HHS Grants Policy Statement is available at:http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

3. Other-Special Eligibility Criteria

A doctoral candidate may submit only one application in response to this announcement. Projects funded through the CDC Dissertation Award mechanism must support research activities related to preparation of a dissertation.

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter 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


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.  The SF424 (R&R) Application Guide contains the detailed instructions that apply to this FOA for filling out the SF424 (R&R) Application Form.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

  • Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
  • If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
  • The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
  • Direct questions regarding Grants.gov registration to:
    Grants.gov Customer Support
    Contact Center Phone: 800-518-4726
    Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
    Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

  • The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
  • The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
  • This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
  • Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The CDC will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact CDC PGO TIMS: Telephone 770-488-2700, Email: PGOTIM@cdc.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLYwill include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Checklist
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan (Including Letters of Support, Letter of Certification of Applicant Eligibility, and Academic Transcript attachments)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC R36 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 22, 2007
Letters of Intent Receipt Date(s): 30 days before receipt date
Application Submission/Receipt Date(s): April 10, August 10, annually
Peer Review Date(s): within 3 months of submission
Council Review Date(s): within 4 weeks of peer review
Earliest Anticipated Start Date(s): within 5 months of submission

3.A.1. Letter of Intent

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

  • Descriptive title of proposed research.
  • Name, address, and telephone number of the PD(s)/PI(s).
  • Names of other key personnel.
  • Participating institutions.
  • Number and title of this funding opportunity.

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 CDC 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:

Scientific Review Service
Office of Public Health Research
CDC Office of the Chief Science Officer
1600 Clifton Rd.
MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4621
Fax: 404-639-4903
Email: ophrinfo@cdc.gov

3.B. Submitting an Application Electronically to the CDC

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

  • If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, after two business days.
  • Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed or if information was lost or compromised during transmission. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
  • If the two-day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.
  • Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the CDC and responsiveness by the Office of Public Health Research. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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 HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

  • Funds relating to the conduct of research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.
  • Reimbursement of pre-award costs is not allowed.
  • Specific costs not allowed on dissertation research grants are tuition, matriculation fees, alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees and costs associated with faculty/advisor mentor supervision. This listing is not exclusive, and the applicant institutions should contact CDC staff regarding any other cost item being considered.  

6. Other Submission Requirements

Letter of Certification: A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must: (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without CDC support; and (d) briefly describe the facilities and resources for the project and certify that they are adequate to conduct the proposed research. This should be placed in the Letters of Support attachment.

Official Transcript: A copy of an official transcript of the applicant's graduate school record should be included with the application. The transcript should be placed in the Appendix.

Information on the student's academic standing as well as a commitment from the school to implement the study as proposed must be included in the application. The student's advisor must submit with the grant application a letter of recommendation in support of the candidate and the proposed research dissertation.

Statement of Career Goals: Applicants must provide a statement of career goals, including reference to their interest in the specific areas of research designated in this FOA and a description of their intended career trajectory. This information will be used by OPHR program staff to determine how the proposed study addresses program priorities.

Mentor’s Biographical Sketch: The mentor is considered a key person on the proposed project and his/her profile must be included under the Senior/Key Person Profile(s) Component.

Project Description: The applicant must provide a narrative project description (not to exceed 10 pages in sections 2-5 of the Research Plan) that contains a detailed scientific and technical discussion of the following specific points:

a. A description of the research project and what it is intended to be accomplished.

b. A summary of related published research that addresses the identified problem(s).

c. The questions to be answered or the hypotheses to be tested by the project.

d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be used, and steps that will be taken to protect human subjects.

e. The management of the project including a schedule of the main steps of the proposed investigation.

The CDC requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to CDC in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Applicants may submit up to two resubmissions in response to this FOA. Resubmissions must include an introduction to the Research Plan as part of the application. For an electronic application, use the item called Introduction to Application of the PHS 398 Research Plan form. The Introduction to the resubmission may be no more than one page and must include:

  • Summary of all additions, deletions, and changes to the old application.
  • Response to reviewers' comments that addresses the criticisms in the summary statement.

Research Plan Component, Item 15, Appendix. The only materials allowed in the Appendix are:

  • A transcript of the predoctoral student's record in the doctoral program to date;
  • The appendix may include photographs or color images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the 10-page limit of Items 2 -5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan. No publications or other printed material, with the exception of preprinted questionnaires or surveys, may be included in the appendix.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to CDC in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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 who are planning to share data 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 Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm. 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

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm ).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 the HHS/CDC 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,https://grants.nih.gov/grants/funding/2590/2590.htm).  See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).  

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

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

  • Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
  • Receive a written critique.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

  • Scientific merit of the proposed project as determined by peer review.
  • Availability of funds.
  • Relevance of program priorities as determined by a second level review committee.

The goals of CDC supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

  • Significance
  • Approach
  • Innovation
  • Investigator/Mentor
  • Environment

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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?

Investigator/Mentor:Is the work proposed appropriate to the experience level of the doctoral candidate-investigator? Does the student show promise as a research investigator in areas relevant to the proposal? Is the proposed research project consistent with the long-term research interests of the applicant? Are the faculty advisor/dissertation chair and other doctoral committee members appropriately qualified to provide guidance as needed? Have the faculty advisor/dissertation chair and any other participating members of the committee indicated that they will provide sufficient time to allow completion of the dissertation? Will the faculty advisor/dissertation chair provide the necessary supervision and mentoring to the student?

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

2.A. Additional Review Criteria

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

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available  on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/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 (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R).  Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not effect the priority score.

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

HHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.   Please see http://www.hhs.gov/grantsnet/adminis/gpd/index.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources.

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

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), See Section VI.3., “Reporting.”

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons. 

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 is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about   requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other Information of this document or on the HHS/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.

Terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.

3. Reporting

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

1.      If multiple years are involved, submit the Non-Competing Grant Progress Report form PHS 2590, (posted on the CDC website http://www.cdc.gov/od/pgo/funding/forms.htm), no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

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

3.      Final financial and performance reports (Award Closeout Procedures – Final Report Guidance), no more than 90 days after the end of the project period.

Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this NoA.

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 Contact(s):

Susan Clark, MPH, CHES
Office of Public Health Research
CDC Office of the Chief Science Officer
1600 Clifton Rd.
MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4795
Fax: 404-639-4903
Email:SKC4@cdc.gov

2. Peer Review Contact(s):

Christine Morrison, PhD
Office of Public Health Research
CDC Office of the Chief Science Officer
1600 Clifton Rd.
MS D-72
Atlanta, GA 30333
Telephone: (404) 639-3098
Fax: 404-639-4903
Email:CJM3@cdc.gov

3. Financial/Grants Management Contact(s):

Mattie Jackson
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770)-488-2696
FAX: 770-488-2777
Email: MIJ3@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
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 (45 CFR Part 46) 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 HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://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 HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found on at 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.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

HIV/AIDS Confidentiality Provisions
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

HIV Program Review Panel Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.

Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National Prevention Information Network (NPIN).  The website can be found at; http://www.cdcnpin.org/scripts/index.asp.

Patient Care
Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.

Click on the following link to get the current SPOC list http://www.whitehouse.gov/omb/grants/spoc.html

Indian tribes must request tribal government review of their applications.

Specs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:

Mattie Jackson, Grants Management Specialist
Procurement and Grants Office
Announcement Number PAR-CD-07-002
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146

HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1.           A description of the population to be served.

2.           A summary of the services to be provided.

3.           A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

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

HHS/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 FOA 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 HHS/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, HHS/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 HHS/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 HHS/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 HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Prohibition on Use of HHS/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.

Volume 7: No. 4, July 2010

SPECIAL TOPIC
Measuring the Impact of Public Health Policy

Ross C. Brownson, PhD; Rachel Seiler, MPH; Amy A. Eyler, PhD

Suggested citation for this article: Brownson RC, Seiler R, Eyler AA. Measuring the impact of public health policy. Prev Chronic Dis 2010;7(4):A77. http://www.cdc.gov/pcd/issues/2010/jul/09_0249.htm. Accessed [date].

PEER REVIEWED

Abstract

Effective health policies and allocation of public health resources can substantially improve public health. An objective of public health practitioners and researchers is to identify key metrics that would help improve effective policies and terminate poor ones. We review articles published in 2008 surrounding measurement issues for public health policy and present a set of recommendations for future emphasis. We found that a set of consensus metrics for population health performance should be developed. However, considerable work is needed to develop appropriate metrics covering policy approaches that can affect large populations, intervention approaches within organizations, and individual-level behavioral approaches for prevention or disease management.

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Introduction

Effective health policies and allocation of public health resources can substantially improve public health (1). For example, each of the 10 great public health achievements of the 20th century (2) was influenced by policy change, such as seat belt laws or regulations governing permissible workplace exposures. To improve public health outcomes, evidence-based policy is developed through a continuous process that uses the best available quantitative and qualitative evidence (3). To broaden the evidence base, a “pay-for-performance” concept that has been widely applied to medical care (4) should be considered for population- and policy-related outcomes (5). In the pay-for-performance approach, providers are rewarded for meeting targets for health care services. For public health, the analogous example might be if public health laws were based in part on policies that are the most cost-effective.

A difference between individual-level health care and population-level approaches for improving health is that public health interventions often occur at multiple levels (6). Upstream interventions involve policy approaches that can affect large populations through regulation, increased access, or economic incentives. For example, increasing tobacco taxes is an effective method for controlling tobacco-related diseases (7). Midstream interventions occur within organizations. For example, worksite-based programs that increase employee access to facilities for physical activity show promise in improving health. Most research has been conducted on downstream interventions, which often involve individual-level behavioral approaches for prevention or disease management. A set of metrics (ie, a group of related measures to quantify some characteristic) can be developed corresponding to these 3 levels. For example, for tobacco control, 3 metrics might be the number of state laws that ban smoking (upstream), the number of private worksites that ban smoking in states with weak laws (midstream), and the rate of self-reported exposure to secondhand smoke (downstream).

In addition to these levels of change, the policy process also must be considered. The framework of Kingdon (8) is useful in illustrating the policy-making process. Kingdon suggests that policies move forward when elements of 3 “streams” come together. (These “streams” are different than the upstream, midstream, and downstream metrics noted above.) The first of these streams is the definition of the problem (eg, a high cancer rate). The second is the development of potential policies to solve that problem (eg, identification of policy measures to achieve an effective cancer control strategy). The third is the role of politics and public opinion (eg, interest groups supporting or opposing the policy). Policy change occurs when a “window of opportunity” opens and the 3 streams push through policy change. A tenet of Kingdon’s model is that policy makers are on the receiving end of sometimes disconnected, random, and chaotic data (8,9). Therefore, a key objective of public health practitioners and researchers is to identify metrics for assessing burden, setting priorities, and measuring progress. Such a set of metrics would help public health decision makers as they seek to improve, expand, or terminate policies.

To illustrate the measurement-related issues for public health policy, we review the literature that sets up recommendations. To reach public health goals, we need metrics for the policy environment, just as we do for other environments relevant to public health progress (eg, air, water, the built environment, health care settings).

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Analysis of Metrics in the Literature

Methods

To better understand the use of policy metrics, we reviewed articles published in 14 public health and preventive medicine journals. The journals chosen were broad, general public health journals and not specific to a single topic such as nutrition or disease. Journals that focused solely on policy and journal supplements were not included. We examined the following journals:

  1. American Journal of Health Behavior
  2. American Journal of Health Promotion
  3. American Journal of Preventive Medicine
  4. American Journal of Public Health
  5. Australian and New Zealand Journal of Public Health
  6. Health Education and Behavior
  7. Health Education Research
  8. Health Promotion International
  9. Health Psychology
  10. Journal of Behavioral Medicine
  11. Journal of Public Health Management and Practice
  12. Journal of School Health
  13. Public Health Reports
  14. Social Science and Medicine

We defined a policy article as one that explicitly describes a policy, law, or regulation (including development, implementation, and evaluation). Using online archives, we conducted a systematic audit of articles published in 2008. Tables of contents were collected from each journal issue for that year. Two researchers reviewed the table of contents in each issue and compiled a list of policy-related articles. If the policy content was unclear from the title of the article, the abstract or full text was used. Any articles in question were reconciled by the research team until consensus was reached.

Once the list of policy articles was compiled, the titles were sorted by policy category. To examine policy metrics in detail, 78 articles from 2008 were analyzed. Editorials, commentaries, and reviews were excluded, resulting in 47 articles from which metrics were summarized. For articles that presented data analysis, we assessed policy metrics across several categories:

  • the evaluation design
  • whether the evaluation was quantitative, qualitative, or both
  • the outcome (dependent) variables
  • whether metrics were at an upstream, midstream, or downstream level
  • whether measurement properties of the metrics were reported
  • whether there was specific attention to health disparities
  • presence or absence of economic data

Results

The articles examined were a mixture of both “big P” policy studies (eg, formal laws, rules, regulations enacted by elected officials) and “small p” policy research (eg, organizational guidelines, internal agency decisions or memoranda, social norms guiding behavior) (3). Articles were categorized as child health; maternal health; HIV/AIDS; drug use prevention; tobacco control; violence control; environmental and disaster preparedness and biosecurity; school health; special populations; worksite health; international health; advocacy; general policy; or health care.

The topics that were most represented were tobacco control, international health, and school health. Among international articles, health care was the most common topic. The Journal of School Health and the American Journal of Public Health published the most policy-related articles.

Most articles (74.5%) relied on a cross-sectional design (Table 1). Only 3 studies reported any economic or cost data. Fourteen studies reported on psychometric properties of the metrics. Most presented new data on psychometric testing (n = 10), while some referred to previous articles (n = 4). The testing most often reported was for reliability (eg, interrater reliability), internal consistency, or key informant validation of methods. When categorizing according to 3 levels of outcomes, most were downstream (n = 31), followed by midstream (n = 13) and upstream (n = 3). Detailed data on health disparities (eg, subgroup analysis for vulnerable populations) were available for only 2 studies. Both of these studies (10,11) explicitly investigated differences among disparate groups; 1 studied how national laws that increased tobacco prices affected smoking prevalence among different socioeconomic groups (by sex, occupation, and birth cohort), and the other investigated differences in the use of skilled birth attendants by women of varying wealth in several countries.

Most of these studies dealt with the effectiveness or evaluation of a given policy that is in effect. Three studies focused on characteristics of or influences on policies that are successfully “passed.”

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Recommendations for Policy-Related Metrics

Expand sources of evidence

Policy outcomes can be monitored by accumulating evidence from many sources to gain insight into a particular topic, often combining quantitative and qualitative data to understand content and track progress. Consensus on valid and useful measures is needed (12). Successfully monitoring outcomes will also require sources beyond the usual public health data sets (eg, tax revenue, polling, and marketing data). We used the 3 domains of evidence-based policy (process, content, outcome) to present sample metrics across the 3 domains (Table 2). Metrics are quantitative (eg, the percentage of the population with a particular health behavior) and qualitative (eg, the content of a certain policy). Most studies in this review were cross-sectional; stronger study designs are needed to improve the evidence base.

Consider the paradox of local policy evidence

Although much of the effect of public health policy occurs locally, in many jurisdictions high-quality data are lacking at the city, county, or metropolitan levels. Some attempts have been made to identify local-level indicators (13), but a set of consensus policy metrics needs to be developed for local areas, as has been done at the national and state levels.

Develop systems for policy surveillance

A public health adage is “what gets measured gets done” (14). This has typically been applied to downstream endpoints; however, for policy approaches, midstream and upstream metrics are needed. A few efforts are under way to develop public health policy surveillance systems. For example, a group of federal and voluntary agencies has developed policy surveillance systems for tobacco, alcohol, and more recently, school-based nutrition and physical education (3).

Increase understanding of practice-based evidence

Policy-relevant evidence should come from settings and organizations that reflect public health practice and policy. For example, efforts such as the Steps to a HealthierUS initiative, YMCA’s Activate America, and faith-based interventions demonstrate that existing approaches for leadership development can enhance the use of evidence for promoting physical activity (15). As these efforts are documented, specific attention should be given to the key metrics for measuring progress.

Make research more accessible for policy audiences

Researchers and policy makers sometimes exist in parallel universes because of decision-making differences, poor timing, ambiguous findings, and lack of relevant data (16). Metrics may become relevant to policy makers when the effects of a health outcome are framed in terms of the direct impact on one’s community, family, or constituents (17). An excellent example comes from the Rudd Center Revenue Calculator (www.yaleruddcenter.org/sodatax.aspx), which shows the revenue that could be generated from a 1-cent excise tax per ounce of sugar-sweetened beverages by state or municipality.

Improve and clarify metrics relevant to health disparities

Eliminating health disparities is a policy imperative. To achieve this goal, we need to better articulate the key domains of inequality. For example, variables have included race/ethnicity, socioeconomic status or social class, geography, age, and sex (18). Our review of the existing literature showed sparse attention to metrics for health disparities and policy.

Improve incorporation of economic metrics

In deciding whether to take action and how to prioritize resources, policy makers often ask 3 questions: 1) Is there a problem? 2) Do we know how to fix the problem? and 3) How much will it cost? We probably have the most data for answering the first question (19), an intermediate amount for the second (20), and the least data for the economic issues (21). Studies of disease burden that use comparative units of analysis (eg, quality-adjusted life years) provide a basis for economic evaluations (22). Since much of the literature on pay-for-performance has focused on financial incentives, more work is needed to understand how the concepts apply to population-level public health policy.

Learn by analogy

Although public health research and practice are often segregated into “silos” because of categorical funding streams and interest groups (23), much can be learned across content areas. For example, several authors have examined the lessons from tobacco control that can be applied to the obesity epidemic (24,25). Similar areas in public health where policy measurement is advanced may provide beneficial insights to developing topics.

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Conclusion

Much of what has been learned from surveillance of diseases and risk factors can probably be applied in the policy arena. A full spectrum of outcomes is needed spanning upstream, midstream, and downstream domains. Arriving at these metrics will require creative thinking and application of alternative study designs. For example, adherence to a strict hierarchy of study designs may reinforce an “inverse evidence law” by which interventions most likely to influence whole populations (eg, policy change) are least valued in an evidence matrix emphasizing randomized designs (26). To establish a system that rewards policies for improved population health (5), considerable work is needed on the appropriate metrics.

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Acknowledgments

This manuscript was developed as part of the Mobilizing Action Toward Community Health (MATCH) project funded by the Robert Wood Johnson Foundation.

This work was partially funded through Centers for Disease Control and Prevention award U48 DP00060 (Prevention Research Centers Program) and support from the National Institutes of Health (grant NCI 1R01CA124404-02).

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Author Information

Corresponding Author: Ross C. Brownson, PhD, Prevention Research Center in St Louis, George Warren Brown School of Social Work, Washington University in St Louis, 660 S Euclid, Campus Box 8109, Saint Louis, MO 63110. Telephone: 314-362-9641. E-mail: rbrownson@wustl.edu. Dr Brownson is also affiliated with the Department of Surgery and Alvin J. Siteman Cancer Center, Washington University School of Medicine, Washington University in St Louis, Saint Louis, Missouri.

Author Affiliations: Rachel Seiler, Prevention Research Center in St Louis, Saint Louis University School of Public Health, Saint Louis, Missouri; Amy A. Eyler, Department of Surgery and Alvin J. Siteman Cancer Center, Washington University School of Medicine, Washington University in St Louis, Saint Louis, Missouri.

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