and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
Centers
for Disease Control and Prevention (CDC) (http://www.cdc.gov/)
Components of Participating Organizations
Office
of Public Health Research, (http://www.cdc.gov/od/science/PHResearch/)
Title: CDC
Grants for Public Health Research Dissertation (R36)
The
policies, guidelines, terms, and conditions of the HHS Centers for Disease
Control and Prevention (CDC) stated in this announcement may differ from those
used by the HHS National Institutes of Health (NIH). If a CDC
policy does not exist to cover an applicable topic, or is in the process of
being drafted, then for purposes of this announcement, the NIH policy is hereby
adopted by CDC and will be applicable to that particular topic. In addition, if written
guidance for completing this application is not available on the CDC website,
then applicants will be directed elsewhere for that information.
Authority: Section 301 of the Public Health Service Act (42 U.S.C. Section 241), as amended.
Announcement Type
New
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-07-231Key Dates
Release/Posted Date: February 23, 2007
Opening Date: February 23, 2007
Letters of Intent Receipt
Date(s): 30 days before receipt date.
NOTE:
On time submission requires that applications be successfully submitted to
Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): April 10, August 10, annually New Date September 8, 2009 per NOT-CD-09-002, (Changed to February 9 and August 10 for 2009 per NOT-CD-09-001).
Peer Review Date(s): within 3 months of submission.
Council Review Date(s): within 4 weeks following peer review
Earliest Anticipated Start Date(s): within 5 months of submission
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration
Date: New Date September 9, 2009 per NOT-CD-09-002, Original Date: August 11, 2009
Due
Dates for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional
Overview Content
Executive Summary
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Investigators
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically
to the CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
4.
General Questions Contact
Section VIII. Other Information - Required Federal
Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The Office of Public Health Research (OPHR) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This PAR addresses Healthy People 2010 priority area Prevention Research (Chapter 23-Section 17) and is in alignment with CDC’s performance goal(s) to increase the number of frontline public health workers at the State and local level that are competent and prepared to respond to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies and prepare frontline State and local health departments and laboratories to respond to current and emerging public health threats. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
The Centers for Disease Control and Prevention (CDC) announces the availability of CDC Public Health Research Dissertation Award grants (R36) to support public health doctoral dissertation research. Grant support is designed to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to CDC. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the field of public health research.
Research Objectives
The mission of CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability. The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of public health. It addresses issues of basic, behavioral, and applied sciences (i.e., health statistics and research methodology) related to health promotion, disease prevention, injury and disability prevention, and health protection from infectious, environmental and terrorist health threats. It evaluates both public health services and the system in which these services are provided. These scientific results improve the evidence base to enable better decisions about health and help CDC achieve true improvements in people’s lives by accelerating health impact and reducing health disparities.
CDC is committed to achieving true improvements in people’s health. To do this, the agency is defining specific health impact goals to prioritize and focus its work and investments and measure progress. Research applications must address one of these four goals and reference at least one starter objective. Applicants are strongly encouraged to focus on topical areas unique to CDC, demonstrating how expected results can be used or made available for use to enhance public health and quality of life. Results should be directly relevant to customers, such as consumers, public health agencies and organizations such as state/local departments of health and community-based organizations, targeted populations, providers and practitioners, administrators, and policymakers. CDC’s Health Protection Goals are:
Applicants are further encouraged to address public health research issues critical to CDC priority populations, including: low-income and minority groups; women, children, the elderly; and individuals with disabilities.
CDC has also developed a critical resource that can be used to identify research priorities and support CDC’s Health Protection Goals. Applicants are encouraged to use the Guide to Public Health Research Needs (http://www.cdc.gov/od/science/PHResearch/cdcra/index.htm) to help identify areas of research that support CDC’s Health Protection Goals.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1.
Mechanism of Support
This funding opportunity announcement will use the Centers for Disease Control and
Prevention (CDC) Dissertation Award (R36) mechanism. The predoctoral student is
the Project Director/Principal Investigator (PD/PI) of the application. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project under the supervision, and with the approval, of
a university-approved and appointed doctoral committee. The student-PD/PI must
have an appointment at the applicant institution (e.g., research assistant).
These awards support research activities related to preparation of a dissertation and do not support study leading to the M.D., D.O., D.D.S., or similar professional degrees unless they are part of a combined degree program.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format. This budget is found in the SF424 (R&R) Budget Component described in the SF424 (R&R) Application Package and Instructions Guide.
Dissertation awards are not renewable nor may they be transferred to another PD/PI. Applicants may submit up to two resubmissions in response to this FOA.
2. Funds Available
The average award amount will be $35,000 in direct costs per year, and are awarded for up to one year, with the possibility of extension without additional funds for up to 12 months. The anticipated start date for new awards is within 5 months of submission.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Centers, Institutes, and Offices (CIOs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total project period for an application submitted in response to this FOA may not exceed one year and may be extended without additional funds for up to 12 months. Grants to support dissertation research will provide no more than $35,000 in direct costs per year.
Allowable Costs: Expenses usually allowed under PHS research grants will be covered by the CDC dissertation research grant, but may not exceed $35,000 per year in direct costs. An application that requests more than $35,000 per year in direct costs will be returned to the applicant. Allowable costs include the investigator's salary (not to exceed the current predoctoral fellow level for 12 months full-time effort approved by the Secretary of the Department of Health and Human Services). Stipend/salary levels are adjusted nearly every year and the current levels are available on the NIH website: http://grants.nih.gov/training/nrsa.htm. In developing the non-modular budget, applicants may also include costs for research assistants' salaries, and direct research project expenses, such as data processing, payments to subjects, supplies, consultants, and dissertation costs (e.g., printing and binding of the dissertation). No tuition, alteration/renovations, contracting costs, faculty salary, or space rental are allowed on dissertation research grants. Indirect costs are limited to eight percent of requested direct costs, less equipment.
Any level of effort by the investigator that is less than full time (40 hours per week) must be fully justified, and the investigator's salary must be prorated accordingly.
HHS grants policies as described in the http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA.
If the application requests funding greater than the ceiling amount, it will be considered non-responsive and will not enter into the review process.
F&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 institution/organization has any of the following
characteristics:
Eligible applicant institutions are those that are domestic public or private non-profit universities, colleges, or professional schools with accredited doctoral degree granting programs. Institutions must have staff and facilities available on site to provide a suitable environment for performing high-quality research.
The applicant organization must be the doctoral granting institution at which the student is registered and matriculating. Individuals cannot apply directly.
1.B. Eligible Investigators
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC support.
The PD/PI doctoral student for a dissertation research grant:
A doctoral student who receives support for dissertation research under a grant from the CDC may not hold concurrently another federally sponsored fellowship or similar Federal award, such as a National Research Service Award (NRSA) that provides a stipend or otherwise duplicates provisions of this grant program. A CDC dissertation grant recipient may, however, accept concurrent educational remuneration from the Department of Veterans Affairs (VA) and loans from Federal funds. Receipt of non-Federal funds during the grant period is also allowable if it is in accordance with the sponsoring institution's policy and does not detract from or prolong the approved doctoral training program. Recipients of mentored career development awards are not eligible for dissertation support.
2.
Cost Sharing or Matching
This program does not require cost
sharing or matching.
The HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm
3. Other-Special Eligibility Criteria
A doctoral candidate may submit only one application in response to this announcement. Projects funded through the CDC Dissertation Award mechanism must support research activities related to preparation of a dissertation.
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
Section IV. Application and Submission Information
To download a SF424
(R&R) Application Package and SF424 (R&R) Application Guide for
completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site. The SF424 (R&R) Application Guide contains the detailed instructions that apply to this FOA for filling out the
SF424 (R&R) Application Form.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The CDC will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application InformationNote: Only the forms
package directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from another
FOA), although some of the "Attachment" files may be useable for more
than one FOA.
For further assistance, contact CDC PGO TIMS: Telephone 770-488-2700, Email: [email protected].
Telecommunications for the hearing impaired: TTY 770-488-2783.
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by CDC (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R)
application is comprised of data arranged in separate components. Some
components are required, others are optional. The forms package associated with
this FOA in Grants.gov/APPLY will
include all applicable components, required and optional. A completed
application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Checklist
Research & Related Budget
PHS398 Cover
Page Supplement
PHS398 Research Plan (Including Letters of Support, Letter of Certification of
Applicant Eligibility, and Academic Transcript attachments)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the CDC R36 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening
Date: February 22, 2007
Letters of Intent Receipt Date(s): 30 days before receipt date
Application Submission/Receipt
Date(s): April 10, August 10,
annually
Peer
Review Date(s): within 3 months of
submission
Council
Review Date(s): within 4 weeks of peer review
Earliest
Anticipated Start Date(s): within 5
months of submission
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows CDC
staff to estimate the potential review workload and plan the review.
The letter of
intent is to be sent by the date listed in Section
IV.3.A.
The letter of
intent should be sent to:
Scientific Review Service
Office
of Public Health Research
CDC
Office of the Chief Science Officer
1600
Clifton Rd.
MS
D-72
Atlanta,
GA 30333
Telephone:
(404) 639-4621
Fax: 404-639-4903
Email: [email protected]
3.B. Submitting an Application Electronically to the CDC
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by the CDC and responsiveness by the Office of Public Health
Research. Incomplete and non-responsive applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
5.
Funding Restrictions
All CDC awards are subject to the terms and conditions, cost principles, and
other considerations described in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
6. Other Submission
Requirements
Letter
of Certification: A
letter from the faculty committee or university official directly responsible
for supervising the development and progress of the dissertation research must
be submitted with the application. The letter must: (a) fully identify the
members of the dissertation committee and certify their approval of the
dissertation proposal; (b) certify that all requirements for the doctoral
degree, except the dissertation and, if necessary, the clinical internship, are
completed or will be completed by the time the grant award starts; (c) note
that the university official or faculty committee expects the doctoral
candidate to proceed with the approved project proposal with or without CDC
support; and (d) briefly describe the facilities and resources for the project
and certify that they are adequate to conduct the proposed research. This
should be placed in the Letters of Support attachment.
Official Transcript: A copy of an official transcript of the applicant's graduate school record should be included with the application. The transcript should be placed in the Appendix.
Information on the student's academic standing as well as a commitment from the school to implement the study as proposed must be included in the application. The student's advisor must submit with the grant application a letter of recommendation in support of the candidate and the proposed research dissertation.
Statement of Career Goals: Applicants must provide a statement of career goals, including reference to their interest in the specific areas of research designated in this FOA and a description of their intended career trajectory. This information will be used by OPHR program staff to determine how the proposed study addresses program priorities.
Mentor’s Biographical Sketch: The mentor is considered a key person on the proposed project and his/her profile must be included under the Senior/Key Person Profile(s) Component.
Project Description: The applicant must provide a narrative project description (not to exceed 10 pages in sections 2-5 of the Research Plan) that contains a detailed scientific and technical discussion of the following specific points:
a. A description of the research project and what it is intended to be accomplished.
b. A summary of related published research that addresses the identified problem(s).
c. The questions to be answered or the hypotheses to be tested by the project.
d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be used, and steps that will be taken to protect human subjects.
e. The management of the project including a schedule of the main steps of the proposed investigation.
The CDC requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to CDC in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Applicants may submit up to two resubmissions in response to this FOA. Resubmissions must include an introduction to the Research Plan as part of the application. For an electronic application, use the item called Introduction to Application of the PHS 398 Research Plan form. The Introduction to the resubmission may be no more than one page and must include:
Research Plan Component, Item 15, Appendix. The only materials allowed in the Appendix are:
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to CDC in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research DataThe 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.
HHS policy
requires that grant award recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm ). Investigators responding to this funding opportunity
should include a plan for sharing research resources addressing how unique
research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data
sharing plans will be considered by the HHS/CDC Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590,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 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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of CDC supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigator/Mentor: Is the work proposed appropriate to the experience
level of the doctoral candidate-investigator? Does the student show promise as
a research investigator in areas relevant to the proposal? Is the proposed
research project consistent with the long-term research interests of the
applicant? Are the faculty advisor/dissertation chair and other doctoral
committee members appropriately qualified to provide guidance as needed? Have
the faculty advisor/dissertation chair and any other participating members of
the committee indicated that they will provide sufficient time to allow
completion of the dissertation? Will the faculty advisor/dissertation chair
provide the necessary supervision and mentoring to the student?
Environment: Do(es) the
scientific environment(s) in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A.
Additional Review Criteria
In addition to the above criteria, the
following items will continue to be considered in the determination of
scientific merit and the priority score:
Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research:
Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If applicants plan to use
vertebrate animals in the project, HHS/CDC will assess the five items described
under Section 2, item 12 Vertebrate Animals of the Research Plan component of
the SF424 (R&R). Additional HHS/CDC Requirements under AR-3 Animal Subjects
Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Biohazards: If applicants propose the
applicant has proposed materials or procedures that are potentially hazardous
to research personnel and/or the environment, HHS/CDC will determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of
Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. Is the number of person months listed for the effort of the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods? The evaluation of the budget
should not effect the priority score.
2.C. Sharing Research Data
Data
Sharing Plan: The reasonableness of the data sharing plan or the rationale for not
sharing research data will be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or the priority score. The presence of a data sharing plan
will be part of the terms and conditions of the award. The funding organization
will be responsible for monitoring the data sharing policy.
2.D. Sharing Research
Resources
HHS policy requires that recipients of grant
awards make unique research resources readily available for research purposes
to qualified individuals within the scientific community after
publication. Please see http://www.hhs.gov/grantsnet/adminis/gpd/index.htm. Investigators responding to this funding opportunity
should include a plan on sharing research resources.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
3.
Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
The Code of Federal
Regulations 45 CFR Part 74 and Part 92 have details about requirements. For
more information on the Code of Federal Regulations, see the National Archives
and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
Additional requirements are available Section VIII. Other Information of this
document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
These will be incorporated into the NoA by reference.
Terms and
conditions will be incorporated into the NoA and will be provided to the
appropriate institutional official and a courteous copy to the PD/PI at the
time of award.
Recipient Organization must provide CDC with an original, plus two hard copies of the following reports:
1. If multiple years are involved, submit the Non-Competing Grant Progress Report form PHS 2590, (posted on the CDC website http://www.cdc.gov/od/pgo/funding/forms.htm), no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.
2. Financial status report, no more than 90 days after the end of the budget period.
3. Final financial and performance reports (Award Closeout Procedures Final Report Guidance), no more than 90 days after the end of the project period.
Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the Agency Contacts section of this NoA.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Susan Clark, MPH, CHES
Office of Public Health Research
CDC Office of the Chief Science Officer
1600 Clifton Rd.
MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4795
Fax: 404-639-4903
Email: [email protected]
2. Peer Review Contact(s):
Christine Morrison, PhD
Office
of Public Health Research
CDC
Office of the Chief Science Officer
1600
Clifton Rd.
MS
D-72
Atlanta,
GA 30333
Telephone:
(404) 639-3098
Fax: 404-639-4903
Email: [email protected]
3. Financial/Grants Management Contact(s):
Mattie Jackson
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770)-488-2696
FAX: 770-488-2777
Email: [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 on at http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements
for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the
policy of the Centers for Disease Control and Prevention (CDC) and the Agency
for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of
both sexes and the various racial and ethnic groups will be included in
CDC/ATSDR-supported research projects involving human subjects, whenever
feasible and appropriate. Racial and ethnic groups are those defined in OMB
Directive No. 15 and include American Indian or Alaska Native, Asian, Black or
African American, Hispanic or Latino, Native Hawaiian or Other Pacific
Islander. Applicants shall ensure that women, racial and ethnic minority
populations are appropriately represented in applications for research
involving human subjects. Where clear and compelling rationale exist that
inclusion is inappropriate or not feasible, this situation must be explained as
part of the application. This policy does not apply to research studies when
the investigator cannot control the race, ethnicity, and/or sex of subjects.
Further guidance to this policy is contained in the Federal Register, Vol. 60,
No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
INCLUSION
OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all
human subjects research that is conducted or supported by CDC, unless there are
scientific and ethical reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human subjects, including
research that is otherwise exempt in accordance with Sections 101(b) and 401(b)
of 45
C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore,
proposals for research involving human subjects must include a description of
plans for including persons under the age of 21. If persons under the age of 21
will be excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
HIV/AIDS
Confidentiality Provisions
Recipients
must have confidentiality and security provisions to protect data collected
through HIV/AIDS surveillance, including copies of local data release policies;
employee training in confidentiality provisions; State laws, rules, or
regulations pertaining to the protection or release of surveillance
information; and physical security of hard copies and electronic files
containing confidential surveillance information.
Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.
Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.
HIV Program Review Panel Requirements
Compliance
with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals,
Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is
required.
To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.
If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.
Before
funds are used to develop educational materials, determine whether suitable
materials already exist in the CDC National Prevention Information Network
(NPIN). The website can be found at; http://www.cdcnpin.org/scripts/index.asp.
Patient
Care
Ensure that
all STD or HIV infected patients enrolled in the proposed project will be
linked to an appropriate local care system that can address their specific
needs, such as medical care, counseling, social services, and therapy.
Executive Order 12372 Review
Applications
are subject to Intergovernmental Review of Federal Programs, as governed by
Executive Order (E.O.) 12372. The order sets up a system for State and local
governmental review of proposed Federal assistance applications. Applicants
should contact their State single point of contact (SPOC) as early as possible
to alert the SPOC to prospective applications and to receive instructions on
the State process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each State affected.
Click on the following link to get the current SPOC list http://www.whitehouse.gov/omb/grants/spoc.html
Indian tribes must request tribal government review of their applications.
Specs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:
Mattie Jackson, Grants Management Specialist
Procurement and Grants Office
Announcement Number PAR-CD-07-002
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146
HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:
A. A copy of the face page of the application (SF 424).
B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:
1. A description of the population to be served.
2. A summary of the services to be provided.
3. A description of the coordination plans with the appropriate state and/or local health agencies.
If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.
Healthy People 2010
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Lobbying
Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
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.
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:
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:
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:
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.
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.
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NIH Funding Opportunities and Notices
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