and Human Services (HHS)
EXPIRED
United States Department of Health and Human Services (HHS)
Participating Organizations
Centers for Disease Control and Prevention
(CDC), (http://www.cdc.gov)
Components of Participating Organizations
National Institute for Occupational Safety
and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)
Title: Career Development Grants in Occupational Safety and Health Research (K01)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.
Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Authority: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Announcement Type:
This announcement is a reissue of
PAR-04-105
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-08-070
Catalog
of Federal Domestic Assistance Number(s):
93.262
Key Dates
Release/Posted Date: January 11, 2008
Letter of Intent Receipt Date: Not required
Application Submission Dates: Standard dates apply. For details, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewand award.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date: See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Expiration Date: (New Expiration Date November 30, 2009 per NOT OH-10-003)Original Date: January 8, 2011 (Standard Closing Date).
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) invite grant applications for research career development related to occupational safety and health. The goal of the NIOSH research program is to support research that is relevant and of high quality, and will have an impact in reducing occupational disease and injury. This program is intended to contribute to this goal by facilitating the preparation of the next generation of occupational safety and health researchers. Emphasis for funding is placed on projects that specifically address the priority goals of the NIOSH National Occupational Research Agenda (NORA) which is described at http://www.cdc.gov/niosh/programs/. This industrial sector-based agenda has been developed to focus resources on priority problems that significantly impact the illness and injury burden on United States (US) workers. Research training supported by this announcement may include a wide range of training modalities reflecting the diverse approaches needed to effectively address occupational safety and health problems.
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
Section
II. Award Information
1.
Mechanism(s) of Support
2.
Funds Available
Section
III. Eligibility Information
1.
Eligible Applicants
A. Eligible Institutions
B. Eligible
Individuals
2.Cost
Sharing or Matching
3.Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1.
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. Submitting an Application to NIH
C. Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6.
Other Submission Requirements
Section
V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1.
Award Notices
2.
Administrative and National Policy Requirements
A. Cooperative Agreement
1. Recipient
Rights and Responsibilities
2. HHS/CDC Responsibilities
3. Collaborative Responsibilities
3. Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2.
Peer Review Contact(s)
3.
Financial/ Grants Management Contact(s)
4. General Questions Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Background
Each day, approximately 200 million U.S. workers go to work with the expectation that they will return home healthy and safe. However, the workplace environment has a significant impact on a worker’s physical and psychological health. Depending on the job, a worker may be at risk for many different kinds of injuries and illnesses. Recent estimates are that 9,000 workers sustain disabling injuries every day, and that 16 workers die each day from an injury suffered on the job while another 137 die from diseases they suffer as the result of their current or former occupations. Such statistics translate into tremendous economic costs and societal burdens. In addition to the personal and social consequences, work-related injuries and illnesses result in a significant economic burden to employers. The Liberty Mutual 2005 Workplace Safety Index estimates that employers spent $50.8 billion in 2003 on wage payments and medical care for workers hurt on the job. All of these figures may be significantly underestimated given that many illnesses and diseases such as cancer, diabetes, heart disease, and asthma are only now becoming recognized as being associated with occupational exposures that occurred in the past.
Research Objectives
The National Occupational Research Agenda (NORA) is used by NIOSH for determining how best to carry out its mission of providing national and world leadership in preventing work-related illnesses and injuries. Detailed information about NORA can be found at http://www.cdc.gov/niosh/nora/. The research objectives supported by NIOSH include, but are not limited to: (1) the identification and investigation of the relationships between hazardous working conditions and associated occupational diseases and injuries; (2) the development of more sensitive means of evaluating hazards at work sites; (3) the development of methods for measuring early markers of adverse health effects and injuries; (4) the development of new protective equipment and engineering control technology to reduce work-related illnesses and injuries; (5) the development of work practices that reduce the risks of occupational hazards; (6) the evaluation of the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces. Further information about NIOSH support for extramural research can be found at http://www.cdc.gov/niosh/oep/funding.
In concert with NORA, NIOSH has initiated a Research to Practice (r2p) initiative to reduce or eliminate occupational disease and injury by increasing the use and translation of effective NIOSH-funded research findings in the workplace and through stakeholder involvement in the research process. NIOSH supports research approaches that maintain the ultimate application of risk reduction methods as a central focus. Further information about r2p is available at: http://www.cdc.gov/niosh/r2p/.
The purpose of the NIOSH Mentored Research Scientist Development Award (K01) is to provide "protected time" for junior research scientists to facilitate their transition from the mentored to the independent stages of their careers in occupational health and safety research. The NIOSH invites K01 applications from advanced postdoctoral and/or newly independent research scientists (usually with a Ph.D. degree) in biomedical or behavioral sciences who are pursuing careers in research areas supported by the NIOSH. By providing support for the critical transition period between postdoctoral training and independent R01 funding for non-clinical investigators, the NIOSH hopes to foster the careers of these investigators who are vital for the future excellence of the NIOSH research endeavor. Applicants must justify the need for a period of mentored research experience and provide a convincing case that the proposed period of support will substantially enhance their careers as independent investigators.
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 will use the K01 activity code.
The applicant, the candidate and his/her mentor will be jointly responsible for planning, directing, and executing the proposed project and career development activities.
The K01 award is not renewable, nor is it transferable from one principal investigator to another.
This FOA uses Just-in-Time information concepts. It also uses the non-modular budget
formats. Follow the Research & Related Budget Component Instructions. Complete and submit the RESEARCH & RELATED BUDGET forms. A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application. Do not complete or submit the PHS 398 Modular Budget component.
2. Funds Available
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.
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 NIOSH provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
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:
1.B. Eligible Individuals
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 support.
Eligible individuals must be new investigators. For the purpose of review and funding, applicants are considered new investigators if they have not previously served as the principal investigators (PI) on any Public Health Service-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career (K01, K08, and K12). Current or past recipients of Independent Scientist and other non-mentored career awards (K02, K04) are not considered new investigators. (See http://grants.nih.gov/grants/guide/notice-files/not97-231.html).
Candidates up to and including the rank of associate professor are eligible.
2. Cost Sharing or Matching
Cost
Sharing or Matching is not required.
The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/adminis/gpd
3. Other-Special Eligibility Criteria
Applicants may not submit more than one application.
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 GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
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
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.
Supplementary Instructions for Career Development Awards are located in the PHS 398, Section III. The application must:
Support Letters
Training in Responsible Conduct of Research
Institutional Commitments
Budget
Concurrent Applications
Subsequent Applications for NIOSH Research Support
3. Submission Dates and Times
See Section IV.3.A for details
3. A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not required
Application Submission Dates: Standard dates apply. For details, please see .
Peer Review Date(s): See .
Council Review Date(s): See .
Earliest Anticipated Start Date: See .
Expiration Date/Closing Date: January 8, 2011 (Standard Closing Date).
3.A.1.
Letter of Intent
A
letter of intent is not applicable to this funding opportunity announcement.
3.B. Submitting 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:
Center
for Scientific Review
National
Institutes of Health
6701
Rockledge Drive, Room 1040, MSC 7710
Bethesda,
MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda,
MD 20817 (for express/courier service; non-USPS service)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be received on or before the application
receipt/submission date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review.
Upon
receipt applications will be evaluated for completeness by CSR. Incomplete
applications will not be reviewed.
The
NIH 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 NIH will not accept
any application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application already
reviewed, but such application must include an Introduction addressing the
previous critique.
Information
on the status of an application should be checked by the Principal Investigator
in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
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.
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. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
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 CDC NIOSH does not establish specific curricula or formal requirements, we encourage consideration of 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 may refer to application instructions found on page 49 of the PHS-398 application package and refer to http://www.nih.gov/sigs/bioethics/researchethics/html for additional guidance.
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 Mentor(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.
Environmental 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 letters of reference from well-established scientists addressing the above areas and 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 letters of reference should be attached to the face page of the application.
Appendix
The following materials may be included in the Appendix:
Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.
NIOSH (with AHRQ and NIH) has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
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 should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, 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 the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research
data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators
responding to this funding opportunity should include a description of how
final research data will be shared, or explain why data sharing is not
possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
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/docs/HHSGPS_107.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 (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.
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 NIOSH in
accordance with the review criteria stated below.
As
part of the initial merit review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other eligible applications.
The goal of the NIOSH research program is to develop an understanding of the risks and conditions that are associated with occupational diseases and injuries, to explore methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. Specific research priorities are derived from the National Occupational Research Agenda (NORA) which is used by NIOSH for determining how best to carry out its mission of providing national and world leadership in preventing work-related illnesses and injuries. Detailed information about NORA can be found at http://www.cdc.gov/niosh/nora/. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's 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 be considered in the
determination of scientific merit and the priority score:
Resubmission Applications (formerly
revised/amended applications):
Are
the responses to comments from the previous scientific review group adequate?
Are the improvements in the resubmission application appropriate?
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan.
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan.
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 PHS
398 Research Plan. 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. The evaluation of the budget should not effect the priority score.
2.C. Sharing
Research Data
Not
applicable
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 addressing
how unique research resources will be shared or explain why sharing is not
possible.
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 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 .
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 applicant organization
will receive a written critique called a Summary Statement. The applicant
organization and the PD/PI will be able to access the Summary Statement via the
eRA Commons.
HHS/CDC will contact those applicants under consideration for funding for additional information.
If the application is under consideration for funding, CDC/NIOSH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
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.
The 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.
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, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.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, no more than 90 days after the end of the project period.
4. Final Invention Statement and Certification Form
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.
The Progress Report must include Sections (a) through (f) as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections (g) through (j) as described in Section IV of the 2590 instructions. Evaluation of the awardees progress will encompass the following:
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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.
HHS/CDC encourages your inquiries
concerning this FOA and welcomes the opportunity to answer questions from
potential applicants. Inquiries can fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Lata Kumar
Scientific Program Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control
1600 Clifton Road NE, Mailstop E74
Atlanta, GA 30333
Phone: 404-498-2530
Fax: 404-498-2571
e-mail:[email protected]
Overnight
Mail Address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
2. Peer Review Contacts:
Price
Connor, Ph.D.
Scientific Review Administrator
Office
of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX:
(404) 498-2571
Email: [email protected]
Overnight Mail Address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
3. Financial or Grants Management Contacts:
Cynthia Y. Mitchell
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6434
FAX: (412) 386- 6429
Email: [email protected]
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: [email protected]
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 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 ProvisionsDescribe 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.nchstp.cdc.gov/od/infocenter/npin.htm.
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.
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 2010The 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 www.healthypeople.gov
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.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
1. Place small, minority, women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
Research Integrity
The signature of the institution official on the face page of the application submitted under this 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.
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:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.
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
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:
a. 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.
b. 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.
Conference Disclaimer and Use of Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
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
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