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 (OPHR), (http://www.cdc.gov/od/science/PHResearch/)

Title: CDC Mentored Public Health Research Scientist Development Award (K01)

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

Request For Applications (RFA) Number: RFA-CD-07-003

Catalog of Federal Domestic Assistance Number(s)
93.061 Innovations in Applied Public Health Research, http://12.46.245.173/cfda/cfda.html 

Key Dates
Release Date: January 11, 2007
Letters of Intent Receipt Date(s): March 1, 2007
Application Receipt Dates(s): March 30, 2007
Peer Review Date(s): June 2007.
Council Review Date(s): July 2007
Earliest Anticipated Start Date: August 31, 2007
Expiration Date: March 31, 2007

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

Additional Overview Content

Executive Summary

The goals of CDC-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's public health research needs.

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(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
      A. Eligible Institutions
  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. Receipt and Review and Anticipated Start Dates
          1. Letter of Intent
      B. Sending an Application 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 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 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 FOA 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 Mentored Research Scientist Development Award (K01) provides support for a sustained period of “protected time” for intensive research career development under the guidance of an experienced mentor, or sponsor, in areas addressing basic, behavioral, and applied sciences related to health promotion, disease prevention, injury and disability prevention, and health protection from infectious, environmental and terrorist health threats leading to research independence. The expectation is that through this sustained period of research career development and training, awardees will launch independent public health research careers and become competitive for new research project grant (R01) funding.

The candidate must devote a minimum of 75% of full-time professional effort to the goals of this award. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. Both the didactic and research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.

All career development programs must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. Applicants must justify the need for this award and provide a convincing case that the proposed period of support will substantially enhance their careers as independent investigators in their chosen area of public health research. The sponsoring institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator.

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 helping 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:

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(s) of Support

This funding opportunity will use the K01 award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
 
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The participating organization, the Office of Public Health Research (OPHR) intends to commit approximately $3,000,000 in total dollars (direct and indirect) in fiscal year 2007 to fund up to 20 applications.  The average award amount will be $150,000 in total costs (direct and indirect) per year, and are awarded for up to three years. The anticipated start date for new awards is August 31, 2007.

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 three years.  Grants to support Mentored Research Scientist Development will provide no more than $150,000 in total costs (direct and indirect) per year.

Allowable Costs

Salary: The CDC will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12-month staff appointment. The award requires the candidate to devote a minimum of 75% of full-time professional effort to conducting the research career development plan described in the application; the remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. For additional guidance on determining full-time professional effort for career awards, see the NIH policy which the CDC has adopted for the purposes of this FOA:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution's rate and the percent of effort, are provided in addition to the salary.

The sponsoring institution may supplement the CDC salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the K01 award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See the NIH guidance which the CDC has adopted for the purposes of this FOA http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-024.html.

Effective for all new competing research project grant applications, mentored career award recipients in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing CDC research grant if they are recognized as a Principal Investigator or Subproject Director. This new NIH policy which the CDC has adopted for the purposes of this FOA can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Development Support: CDC provides support for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings, or training; (d) statistical services including personnel and computer time.

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process.  HHS/CDC will notify the applicant that the application did not meet the submission requirements. 

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

F&A costs 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 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.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

Foreign institutions are not eligible to apply.

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.

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible.

Candidates for this award must have a research or health-professional doctoral degree or its equivalent. 

Candidates must identify mentor(s) with extensive and appropriate research experience for the proposed research development plan.

Candidates must be able to commit a minimum of 75% of full-time professional effort conducting research career development and research activities associated with this award. The remaining 25 % effort can be divided among other research, clinical and teaching activities only if these activities are in a fashion consistent with the goals of the K01 Award, i.e., the candidate's development into an independent investigator. The candidate must have a “full time” appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution.

2. Cost Sharing or Matching

This program does not require cost sharing or matching.

The most current HHS Grants Policy Statement can be found at: http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc.

3. Other-Special Eligibility Criteria

A candidate for a CDC K01 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K07, K08, K22, K23) or award that duplicates any of the provisions of the K01 award. Current principal investigators on CDC career awards are not eligible.

Candidates for the K01, under some circumstances, may have been principal investigators on CDC research or career development awards, provided the research experience proposed in the K01 application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations.

Special Requirements:

Each career development program must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career development program. It is anticipated that K01 awardees will apply for independent funding during the latter period of this award, and that sponsoring institutions will provide the resources required for them to do so.

Key elements for the award, in addition to information about the applicant candidate, include:

Environment: The applicant institution must have a well-established record of research career development activities and qualified research faculty to serve as mentors. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program that maximizes the use of relevant research and educational resources, and propose qualified faculty as mentors in the specific research area.

Career Development Program: The award provides three consecutive 12-month budget periods. At least 75 percent of the recipient's full-time professional effort must be devoted to the program, although 100% effort may be requested. The remainder of the applicant's time should be devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate is expected to further develop knowledge in the basic, behavioral, and applied sciences related to health promotion, disease prevention, injury and disability prevention, and health protection from infectious, environmental and terrorist health threats and enhance research skills relevant to his/her career goals. The candidate may find it necessary to include relevant courses and didactic experiences.

Mentor(s): The candidate must name a primary sponsor/mentor, who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program.  Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

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


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 CDC PGO, Telephone 770-488-2700, Email: PGOTIM@cdc.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) 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.

See also Section VI.2. for additional information.

SUPPLEMENTARY INSTRUCTIONS for Career Development Awards (CDA) are located in the PHS 398, Section III, starting on page 51.

Note that applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.  

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 1, 2007
Application Receipt Date(s):  March 30, 2007
Peer Review Date:   June 2007
Council Review Date:  July 2007
Earliest Anticipated Start Date: August 31, 2007

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 CDC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

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. Sending an Application to the CDC

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Technical Information Management Section – RFA-CD-07-003

CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Phone:  770-488-2700

3.C. Application Processing

Applications must be received on or before 5:00 pm Eastern Standard Time on the application receipt/submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be evaluated for completeness and responsiveness by OPHR and HHS/CDC Procurement and Grants Office (PGO).  HHS/CDC will not review incomplete and non-responsive applications.

The CDC will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The CDC will not accept any application that is essentially the same as one already reviewed.

4. Intergovernmental Review
Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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

6. Other Submission Requirements

Applicants’ research plan(s) should address activities they will conduct over the entire project period.

Using the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Section III), the following information must be included in the application.

Candidate

Describe the candidate's commitment to a health-related research career. Include a description of all the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.

Career Development Plan

Research Plan

A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided.

Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods.  The candidate should consult with mentor(s) regarding the development of this section. 

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the CDC does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 56 of the PHS-398 application package.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction.  An award cannot be made if an application lacks this component.

Statement(s) by Mentors(s)/Consultant(s)/Collaborator(s)

Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles.  Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

Environment and Institutional Commitment to the Candidate

The sponsoring institution must define and document a strong, well-established research and training program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K01 award.

Letters of Reference

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and providing any other evidence that the candidate has a high potential for becoming an independent investigator. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. All sealed letters of reference should be attached to the face page of the application.

Budget for Entire Proposed Period of Support

Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. Within the direct costs limitation for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award. 

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. 

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.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc).  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,http://grants.nih.gov/grants/funding/2590/2590.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.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by OPHR in accordance with the review criteria stated below and in accordance with the CDC peer review procedures (http://www.cdc.gov/od/science/PHResearch/peerreview.htm).

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

The goals of CDC supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. 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.

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority. 

Candidate

Career Development Plan

Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence, based on:

Research Plan

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator.  Nevertheless, a fundamentally sound research plan must be provided. 

Training in the Responsible Conduct of Research

Statements by Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s)

Environment and Institutional Commitment to the Candidate

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)] located at, 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 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://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. 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

Anticipated start date is August 31, 2007.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.” 

HHS/CDC will contact those applicants under consideration for funding 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. HHS/CDC will mail and/or e-mail this document 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 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 courtesy copy to the PD/PI at the time of award.

The following related administrative policies apply to CDC Research Career Award (“K”) programs:

A. Evaluation:

In carrying out its stewardship of human resource-related programs, the CDC may begin requesting information essential to an assessment of the effectiveness of this program.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an CDC supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the CDC awarding component.

C. Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months.  For longer periods, prior written approval of the CDC awarding center, institute or office is required. 

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the K01 award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the CDC component Center, Institute, or Office and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50% effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 75% effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

Individual awards are made for career development at a specific institution in a specific research program.  A change in the specified scientific area of the research component of the career development program requires prior approval by the awarding CDC Center, Institute, or Office.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the awarding CDC component Center, Institute, or Office to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable CDC program staff is strongly encouraged when either termination or a change of institution is being considered.

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, CDC will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the CDC awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the CDC may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, CDC shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period. 

3. Reporting

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

1.      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 90 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.

Note that the instructions for Research Career Development applications must be followed for this program.

The Progress Report must include Sections a through f as described on pages 11-15 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV, pages 19-20 of the PHS 2590 instructions.

Evaluation of the awardee's progress will encompass the following:

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 FOA.

Although the financial plans of the HHS/CDC 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


The CDC encourages your inquiries concerning this funding opportunity and welcomes 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:

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 Contacts:

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 or Grants Management Contacts:

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: 770-488-2670
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 (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 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
RFA -CD-07-003
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.

In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/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.

Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.

Peer and Technical Reviews of Final Reports of Health Studies – HHS/ATSDR
Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104 (I)(13), and [42 U.S.C. 9604 (I)] requires all studies and results of research (other than public health assessments) that ATSDR carries out or funds in whole or in part will be peer reviewed by ATSDR. The ATSDR peer review process for final reports requires that:

1. Studies must be reported or adopted only after appropriate peer review.

2. Studies shall be peer reviewed within a period of 60 days to the maximum extent practical.

3. Studies shall be reviewed by no fewer than three or more than seven reviewers who:

a.                    Are selected by the Assistant Administrator, ATSDR;

b.                    Are disinterested scientific experts;

c.                    Have a reputation for scientific objectivity; and

d.                    Who lack institutional ties with any person involved in the conduct of the study or research under review.

HHS/ATSDR encourages rapid reporting and interpretation of laboratory results and reference ranges back to individual participants. However, if summary tables or distribution of laboratory results are prepared using the study data, this is considered a preliminary finding and will require ATSDR technical and peer review prior to release.

When, in the opinion of the investigator(s), a public health concern exists requiring the release of summary study statistics prior to the completion of the study, the investigator must obtain concurrence from HHS/ATSDR prior to releasing the summary statistics. A request for HHS/ATSDR concurrence for the release of information must be documented in a letter to HHS/ATSDR and should outline the public health concern, the investigator's interpretation of the concern and recommended response, and the draft document proposed for release by the investigator. HHS/ATSDR will provide a technical review and peer review within ten working days to the maximum extent possible. At sites where HHS/ATSDR must coordinate with another Federal agency, this requires additional time. Summary statistics may be released only after peer review. The release of summary statistics does not preclude the requirement for a final report.

By statute, the reporting of preliminary studies and preliminary research results to the public is not acceptable without prior review by HHS/ATSDR. This includes manuscripts prepared for publication, presentations at scientific meetings and reporting of preliminary findings to the community or the media.

Final Report

1. The final report for every study should include a detailed description of the problem, hypothesis, methods, results, conclusions, and recommendations that constitute a complete performance record of the study. A copy of the suggested format for the final report will be supplied by HHS/ATSDR to the investigator.

2. HHS/ATSDR is responsible for the technical and peer review of the draft final reports of any study that it funds prior to the submission of the final report. This will allow the recipient to incorporate technical and peer review comments into the final report. Responses to all HHS/ATSDR required technical and peer review comments should be summarized in a letter to HHS/ATSDR. This letter should also include the investigator's response to each comment and a rationale for those responses. Based upon the comments of the technical and peer reviewers, modifications in the study report may result. The modified study report should accompany the letter to HHS/ATSDR.

3. Following the steps outlined above, a final report of all studies and results of research carried out or supported by HHS/ATSDR must be submitted to the Procurement and Grants Office with a copy furnished to HHS/ATSDR.

All requirements, including peer review, technical review, and cost recovery, are applicable to award recipients and any subcontractors employed by the award recipient. Failure to comply with these requirements could adversely affect future funding.

Cost Recovery – HHS/ATSDR
CERCLA, as amended by SARA, provides for the recovery of costs incurred for response actions at each Superfund site from potentially responsible parties. The recipient would agree to maintain an accounting system that will keep an accurate, complete, and current accounting of all financial transactions on a site-specific basis, i.e., individual time, travel, and associated cost including indirect cost, as appropriate for the site. The recipient would also maintain documentation that describes the site-specific response actions taken with respect to the site, e.g., contracts, work assignments, progress reports, and other documents that describe the work performed at a site. The recipient will provide the site-specific costs and description of response actions taken with the supporting documentation upon request by HHS/ATSDR. The recipient will retain the documents and records to support these financial transactions and documentation of work performed, for possible use in a cost recovery case, for a minimum of ten years after submission of a final financial status report, unless there is litigation, claim, negotiation, audit or other action involving the specific site, then the records will be maintained until resolution of all issues on the specific site.

Third Party Agreements – HHS/ATSDR
Applicant must justify the need to use a contractor. If contractors are proposed, the following must be provided: (1) name of contractor, (2) method of selection, (3) period of performance, (4) detailed budget, (5) justification for use of contractor, and (6) assurance of non-conflict of interest.

Project activities which are approved for contracting pursuant to the prior approval provisions shall be formalized in a written agreement that clearly establishes the relationship between the recipient and the third party.

The written agreement shall, at a minimum:

1. State or incorporate by reference all applicable requirements imposed on the contractors under the terms of the grant and/or cooperative agreement, including requirements concerning technical review (ATSDR selected reviewers), ownership of data, and the arrangement for copyright when publications, data, or other copyrightable works are developed under or in the course of work under a PHS grant-supported project or activity.

2. State that any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal government purposes.

3. State that whenever any work subject to this copyright policy may be developed in the course of a grant by a contractor under a grant, the written agreement (contract) must require the contractor to comply with these requirements and can in no way diminish the government's right in that work.

4. State the activities to be performed, the time schedule for those activities, the policies and procedures to be followed in carrying out the agreement, and the maximum amount of money for which the grantee may become liable to the third party under the agreement.

5. State non-conflict of interest concerning activities conducted for HHS/ATSDR and site-remediation activities for other parties.

The written agreement required shall not relieve the recipient of any part of its responsibility or accountability to PHS under the cooperative agreement. The agreement shall, therefore, retain sufficient rights and control to the recipient to enable it to fulfill this responsibility and accountability.

Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.  For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:

http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide HHS/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.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

National Historic Preservation Act of 1966
(Public Law 89-665, 80 Stat. 915)
The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

  1. Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

  1. Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.