Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Agency for Toxic Substances and Disease Registry (DHAC/ATSDR) at http://www.atsdr.cdc.gov
Participating Organizations
Agency for Toxic Substances and Disease Registry (ATSDR), at http://www.atsdr.cdc.gov
Components of Participating Organizations
Division of Health Assessment and Consultation (DHAC/ATSDR), at http://www.atsdr.cdc.gov
Title: Program on Exposure-Dose Reconstruction and Computational Methods to Quantify Exposures to Hazardous Substances (U01)
The policies, guidelines, terms, and conditions of the HHS
Centers for Disease Control and Prevention/Agency for Toxic
Substances and Disease Registry (CDC/ATSDR) 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.
Authority:
This program is
authorized under Sections 104(i)(5)(A) and (15) of the
Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (CERCLA), as amended by the Superfund
Amendments and Reauthorization Act of 1986 (SARA) : 42
U.S.C. Sections 9604(i)(5)(A) and (15).
Announcement Type: This is a new cooperative agreement announcement
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may 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.This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)
A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)
2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.
Funding Opportunity Announcement (FOA) Number: RFA-TS-08-001
Catalog of Federal Domestic Assistance Number(s): 93.161
Health Program for Toxic Substances and Disease Registry
Key
Dates
Release/Posted Date: January 30, 2008
Letter of Intent Receipt Date: A letter of intent is not
applicable.
Application
Submission Receipt Date(s):
March 31, 2008
Peer Review
Date(s):
May 9, 2008
Council Review
Date(s):
June 9, 2008
Earliest Anticipated Start Date(s): September 1, 2008
Expiration Date: April 1, 2008
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.
Additional Overview Content
Executive Summary
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview Information
Part II Full Text
of Announcement
Section I.
Funding Opportunity Description
1. Research
Objectives
Section II. Award
Information
1.
Mechanism(s) of Support
2. Funds
Available
Section III.
Eligibility Information
1. Eligible
Applicants
A.
Eligible Institutions
2.Cost
Sharing or Matching
3.Other -
Special Eligibility Criteria
Section IV.
Application and Submission Information
1. Request
Application Information
2. Content
and Form of Application Submission
3. Submission
Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Submitting an Application to 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
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
The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2008 funds for a cooperative agreement research program for exposure-dose reconstruction. The ATSDR 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 RFA addresses “Healthy People 2010” priority area(s) Goal 8 for Environmental Health- [to] Promote Health for all Through a Healthy Environment, Objectives 8.12 and 8-14 for minimizing “Risks posed by hazardous sites” and “Toxic pollutants,” and is in alignment with ATSDR performance Goal 3 – Mitigate the Risks of Human Health Effects from Toxic Waste sites with documented exposures For more information, www.healthypeople.gov. and http://intra-apps.cdc.gov/fmo/.
The purpose of this program is to develop and evaluate exposure-dose reconstruction methods. These methods are required to reconstruct, estimate, predict, and evaluate human exposures that may occur at sites on the National Priorities List (NPL), at Resource Conservation and Recovery Act (RCRA) facilities, or at other sites or facilities where a hazardous substance has been released into the environment. Within an exposed population, there can be exposures that result from widely varying contaminant concentrations, with varying exposure frequencies and durations. Moreover, the emission characteristics of contaminants at these sites can vary widely contributing to the multiple parameters that need to be modeled. This program will advance the development, evaluation, application, and maintenance of computational methodologies and decision support systems for estimating human exposure-dose relations from contaminated environmental media and hazardous substances.
A critical aspect of assessing human health effects associated with hazardous waste sites is the evaluation of past, current, and future human exposures to hazardous substances. In order to accurately and meaningfully evaluate such exposures, more sensitive, media specific, and integrated methods must be developed through a program of research coordinated across multiple relevant, intra-related environmental, geochemical, and biomedical disciplines. Applications describing research involving human subjects will not be considered for funding.
Hazardous waste sites present a number of unique circumstances and problems for the ATSDR in the public health assessment process. Foremost among these circumstances is the widespread occurrence where numerous hazardous chemicals are present and/or the presence of mixtures of hazardous chemical compounds. In addition, some of the more complex hazardous waste sites to asses may contain waste disposal areas that are in multiple locations within the site. Thus, the health assessor may be confronted with the need to evaluate exposures to a wide range of concentrations for multiple chemicals, and varying exposure frequencies and durations that can result from a site where there may also be a wide variance in geochemical characteristics. More novel, reliable, and expedient exposure-dose assessment methods must be developed in order to adequately address these complex and multi-faceted site-specific issues.
Examples of research topics that may be considered include, but are not limited:
· Research to Quantify historical exposures through the development of state-of-the-art computational tools. For examples see (http://www.atsdr.cdc.gov/HS/dover2/doverhtml; http://www.atsdr.cdc.gov/sites/lejeune/watermodeling.html).· The development of computational tools that use analytical methods for quantifying contaminant concentrations in multimedia environmental settings under deterministic and uncertain conditions. (e.g., the ACTS model described at http://ascelibrary.aip.org/dbt/dbt.jsp?KEY=PPHMF8&Volume=8&Issue=3).
· The development of computational tools that include numerical methods for quantifying multiphase fluid flow and multispecies mass transport in the subsurface (e.g., the TechFlowMP model described at http://www.springerlink.com/content/12942805pv8u3t32/?p=90fcf8345f684a7a893f2686a2ae7885&pi=1)
·
The development of methods and analysis tools for source identification and simulation/optimization models described at http://ascelibrary.aip.org/vsearch/servlet/VerityServlet?KEY=ASCERL&possible1=Maslia%2C+Morris+L.&possible1zone=author&maxdisp=25&smode=strresults&aqs=true; and http://ascelibrary.aip.org/getabs/servlet/GetabsServlet?prog=normal&id=JWRMD5000132000004000252000001&idtype=cvips&gifs=Yes
In conducting research in this program, applicants are expected to accomplish the following objectives and work collaboratively with agency scientists.
Objectives
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity is a cooperative agreement for
research and will use the
U01 activity code.
The HHS/ATSDR U01 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and HHS/ATSDR staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”
2. Funds Available
The ATSDR intends to commit approximately $500,000 for direct and indirect cost dollars in FY2008 to fund 1 application. It is expected that the average award amount will be $500,000 to include direct and indirect costs. The amount is for the first 12-month budget period. An applicant may request a project period of up to 5 years or 60 months. An applicant may request up to $500,000 for the first 12-month budget period. The approximate total project period funded amount is $2,500,000 over the 5-year project period. The anticipated start date for new awards is September 1, 2008.
All estimated funding amounts are subject to availability of funds.
If an applicant requests a funding amount greater than the ceiling of the award range, HHS/ATSDR will consider the application non-responsive, and it will not enter into the review process. HHS/ATSDR will notify the applicant that the application did not meet the submission requirements.
Section III. Eligibility
Information
1.
Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization has any of the following characteristics:
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.
Eligible applicants are limited to states, or political subdivisions thereof, in accordance with authorization for ATSDR activities under section 104 (i)(5)(A) and (15) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) (42 U.S.C. 9604(i)(5)(A) and (15)).
Failure to meet the stated eligibility criteria by the time of the application deadline will result in the return of the application without review.
2. Cost
Sharing or Matching
Although cost sharing or matching funds are not required, applicants may demonstrate contributions to the research effort through administrative or in-kind support.
3. Other-Special Eligibility Criteria
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at the following:
· Grants.gov Get Registered,http://www.grants.gov/applicants/get_registered.jsp · eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
IMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp
2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS 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 eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.
1. Request Application
Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through
Grants.gov/Apply.
Note: Only the
forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA); although
some of the "Attachment" files may be useable for more than
one FOA.
For
further assistance, contact PGO TIMS: Telephone
770-488-2700, Email: PGOTIM@cdc.gov
HHS/CDC
Telecommunications for the hearing impaired: TTY
770-488-2783.
2.
Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the
SF424 (R&R) Application Guide (MS Word or PDF).The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI 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, mandatory 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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover
Letter File
Research & Related Sub award Budget Attachment(s) Form
3. Submission Dates and Times
See Section IV.3.A for details
3. A. Submission, Review and
Anticipated Start Dates
Application Submission Receipt Date(s):
March 31, 2008
Peer Review
Date(s):
May 9, 2008
Council Review
Date(s):
June 9, 2008
Earliest Anticipated Start Date(s): September 1, 2008
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.
To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov. The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.
Otherwise, HHS/CDC will not notify you upon receipt of your
paper submission. If you have a question about the receipt
of your application, first contact your courier. If you
still have a question, contact the PGO-TIMS staff at:
770-488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for HHS/CDC
to process and log submissions.
If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and original signed copy plus two photocopies to the following address:
Technical Information Management Section – TS-08-001
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: 770-488-2700 EST
3.C. Application Processing
HHS/CDC must receive
applications on
or before 5:00 P.M. Eastern Standard Time on the application
submission date(s) described above (Section IV.3.A.). If HHS/CDC
receives an application after that submission date and time,
the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
· If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.
· Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
· If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.
· If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.
· Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.
Upon receipt, applications will be evaluated for completeness and responsiveness by ATSDR and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.
There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.
4. Intergovernmental Review
Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.
5. Funding Restrictions
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
· Reimbursement of pre-award costs is not authorized.
The research required in this announcement requires the leadership of a scientist with senior level experience and skilled expertise in the computational modeling field (comparable to a full professor or equivalent). Applicants must provide evidence to document that the principal investigator is a senior level scientist in this field. In addition, the principal investigator must demonstrate that their experience has included responsibilities for directing a computational or simulations laboratory where analysis to quantify multimedia environmental exposures to hazardous substances has been successfully conducted.
Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information”
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PD/PI to fill in his/her eRA 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 Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
While each section of the 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 better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. 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.
The following materials may be included in the Appendix:
· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article. · Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment. · Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment. · Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. · Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.
Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”
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.
Applicants should include in the research plan information to adequately describe computational models proposed for the research to support ATSDR historical reconstruction activities (e.g., http://www.atsdr.cdc.gov/HS/dover2/doverhtml; http://www.atsdr.cdc.gov/sites/lejeune/watermodeling.html). Applicants should describe their experience with, and their ability to develop, support, and modify existing computational models such as the analytical contaminant transport analysis system (ACTS) software (e.g., http://ascelibrary.aip.org/dbt/dbt.jsp?KEY=PPHMF8&Volume=8&Issue=3).
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.
Methods and any data developed in the modification or improvement of computational models within the conduct of this research must be provided to ATSDR . The acceptance of ATSDR cooperative agreement funds in support of this research indicates that the applicant has agreed for methods and/or data to be placed in the public domain for application to the assessment of human health risks from exposures to toxic substances at sites and elsewhere in the environment.
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.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the RFA
will be evaluated for scientific and technical merit by an
appropriate peer review group convened by ATSDR in
accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
· Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
· Receive a written critique.
· Receive a second level of review by the ATSDR Secondary Review Committee.· Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.
The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers 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
applicant achieves the aims of the application, how will it
advance scientific knowledge or clinical practice? What will
be the effect of these studies on the concepts, methods,
technologies, treatments, or preventative interventions that
drive this field?
Approach:
Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well
reasoned, and appropriate to the aims of the project? Does
the applicant acknowledge potential problem areas and
consider alternative tactics?
To what extent does the applicant demonstrate knowledge and
experience with methods needed to achieve the stated
objectives of research project?
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?
To what extent does
applicant present and document innovative approaches and
programs and describe how these innovations will assist
ATSDR in achieving agency objectives for assessing and
mitigating human health effects from exposures to toxic
substances?
Investigators:
Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers? Does the investigative team)? To what extent do
the investigators
demonstrate first-hand capability and experience in
quantifying historical or past exposures through the
development of state-of-the-art computational tools and
provide evidence that demonstrates capability to develop
computational tools that include analytical and numerical
methods for quantifying contaminant concentrations in
multimedia environmental settings and engineered systems
(e.g., water-distribution systems) under deterministic and
uncertain conditions
Environment:
Does the scientific environment in which the work will be
done contribute to the probability of success? Do the
proposed studies benefit from unique features of the
scientific environment, or subject populations, or employ
useful collaborative arrangements? Is there evidence of
institutional support?
Does the
applicant adequately
describe the computational capabilities of an existing
facility and their ability to direct a computational and
simulation laboratory that will be used to quantify
exposures to multimedia environmental hazardous substances?
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:
· Applicant must provide evidence that demonstrates the ability to develop multimedia environmental computational tools which are capable of providing deterministic and probabilistic analysis without resorting to using third-party proprietary software. · Applicant must provide evidence that demonstrates senior-level academic or other research experience in developing complex, numerical computational tools that can be used for historical exposure quantification. It should be demonstrated that these tools are capable of providing information on multiphase flow and multi-species fate and transport. · Applicant must provide evidence of experience in developing computational methods that can be used for predicting and providing early-warning of intentional and unintentional attacks on water-distribution systems. · Applicant should provide evidence of experience in and understanding of concepts related to historical exposure reconstruction and applying these concepts for use with epidemiological studies for populations exposed to environmental contaminants.
Application Review
· The results of the primary review including the application’s priority score as the primary factor in the selection process. · The relevance and balance of proposed research relative to the HHS/ATSDR programs and priorities. · The significance of the proposed activities in relation to the priorities and objectives stated in the mission and goals of ATSDR programs, in “Healthy People 2010, and in " the CDC “Health Protection Research Goals.” · Budgetary considerations. · The accomplishments reflected in the progress report of the continuation application indicate that the applicant is meeting previously stated objectives or milestones contained in the project’s annual work plan and satisfactory progress is being demonstrated through · The objectives for the new budget period are realistic, specific, and measurable. · The methods described will clearly lead to achievement of these objectives. · The evaluation plan will allow management to monitor whether the methods are effective. · Any impediments to progress are described, e.g., milestones that are deficient or deferred are fully explained, and the corrective action was taken to address the impediment is described including specific information on revised dates of completion of the milestones impacted. · The budget request is clearly explained, adequately justified, reasonable and consistent with the intended use of grant funds.
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:
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 affect the priority score.
2.C. Sharing Research Data
Data Sharing Plan: HHS/ATSDR will assess the reasonableness of the data sharing plan. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
HHS
policy requires that recipients of grant awards make unique
research resources readily available for research purposes
to qualified individuals within the scientific community
after publication. Please see
http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.
Investigators responding to this funding opportunity should
include a plan on sharing research resources.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan 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 (HHS/PHS 2590
http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting .
3. Anticipated Announcement and Award Dates
Applicants will be notified in October by HHS/CDC’s
Procurement and Grants Office (PGO) if their application was
selected for funding.
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 t
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 following 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.
2.A. Cooperative Agreement
The following terms of award are in addition to, and not in
lieu of, otherwise applicable Office of Management and
Budget (OMB) administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part
92 is applicable when State and local Governments are
eligible to apply), and other HHS/CDC grant administration
policies.
The
administrative and funding instrument used for this program
will be the cooperative agreement U01 an "assistance"
instrument (rather than an "acquisition" instrument), in
which substantial HHS/CDC programmatic involvement with the
awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the HHS/CDC
purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly
with the award recipients in a partnership role; it is not
to assume direction, prime responsibility, or a dominant
role in the activities.
Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as
a whole, although specific tasks and activities may be
shared among the awardees and the HHS/CDC may share specific
tasks and activities, as defined above.
2.A.1. Recipient Rights and Responsibilities
The Recipient will have the primary responsibility for the
following:
a. Identify, pursue, and enhance where appropriate, emerging technical advances in exposure-dose reconstruction to encompass reconstruction of exposure histories and determination of biologically effective doses. These advances should include (but not be limited to) assessment of methods such as:
(1) environmental multimedia exposure (including such pathways as groundwater, surface water, air, soil, and biota),
(2) assessment of exposure and dose through bioavailability, accumulation, and transformation,
(3) delivery of past, current, or potential future exposure and related dose through water-distribution systems,
(4) kinetic networks,
(5) genetic algorithms,
(6) simulation/optimization methods,
(7) dose reconstruction, and
(8) spatial analysis techniques integrated with (1) through (7) above, as a means to bridge the gap between the release of hazardous substances into the environment, potential dose (exposure), and resulting health effects.
b. Reconstruct past population exposures (and potential dose histories) and determine the potential for future exposures to hazardous substances in the environment around hazardous waste sites, or other sources by use of methodology driven environmental assessment tools. These tools must include, at a minimum, simulators such as:
(1) analytical contaminant transport analysis system (ACTS)
(2) three dimensional multiphase flow and multispecies simulators (TechFlowMP); and
(3) water-distribution system network hydraulic and water-quality simulators integrated with spatial analysis interface and progressive optimality genetic algorithm (POGA) optimization.
These tools must be compatible with the desktop computing devices and operating systems currently in use by the agency and its exposure-dose reconstruction computational laboratory. The generalized description of the theory of these assessment tools can be found in the public domain literature.
c. Identify, characterize, and integrate uncertainty analysis techniques such as Monte Carlo simulation into environmental assessment simulator tools so that environmental exposures and health-based risk assessment analyses can be conducted. This combined deterministic-probabilistic computational methodology must include a user-friendly interface and should not rely on third-party or proprietary software programs or licensing to accomplish this task.
d. Serve as a leading technical resource that can provide the ATSDR information and assist in developing methodologies and setting the standard for use of methods for incorporating fuzzy system mathematics and modeling in the area of exposure assessment and exposure-dose reconstruction.
e. Provide technical consultation and assistance in the development of a user friendly decision support system that considers, but is not limited to, the following:
(1)Site characterization and exposure scenario data.
(2)Environmental-media fate and transport computations.
(3)Exposure-route analysis and computations.
(4)Chemical-compound intake and exposure-dose computations.
(5)Probability distributions and uncertainty analyses.
(6)Spatial analysis computations and a geographic information systems interface.
(7)Access to the decision support system by means of desktop computational devices available throughout the agency and in its exposure-dose reconstruction computational laboratory.
f. Provide information on development of methodologies related to exposure-dose reconstruction by submitting, as progress warrants, manuscripts to symposia, conferences, and peer-reviewed scientific journals, on the developments and methodology describing aspects of the research on exposure-dose reconstruction.
h. Provide technical assistance and consultation in applying innovative methodologies in quantifying and reconstructing historical exposures through the development of state-of-the-art computational tools at specific ATSDR sites of interest, for example such areas as Dover Township, New Jersey and Camp Lejeune, North Carolina.
i. Plan, organize, and conduct workshops, conferences, or symposia to publicize and promote the methodologies developed as part of this research project and assist with the transfer of technology as part of the program on exposure-dose reconstruction and computational methods to quantify exposures to hazardous substances.
Recipient Organization will retain custody of and have
primary rights to the information, data and software
developed under this award, subject to U.S. Government
rights of access consistent with current HHS/CDC policies.
2.A.2. HHS/ATSDR Responsibilities
An HHS/ATSDR Project Scientist will have substantial
programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below:
a. Collaborate with and assist in the development of plausible exposure-dose methodologies, relations, and criteria for the selection and application of computational tools, and define appropriate assumptions.
b. Serve as a direct conduit for accessing environmental and exposure data and hazardous waste site information that would be of value to recipient organization to test and validate the acceptability of the environmental assessment simulator tools developed as part of the exposure-dose reconstruction research program.
c. Collaborate with and assist recipient organization with benchmarking, testing, and evaluation of methodology driven exposure-dose reconstruction assessment computational tools by providing recipient organization with results derived from application of methodology driven exposure-dose reconstruction assessment computational tools when applied to hazardous waste sites.
d. Collaborate with and assist recipient with identifying and pursuing emerging disciplines related to advances in assessment of exposure to hazardous chemicals and mixed wastes typically associated with hazardous waste sites.
e. Provide technical assistance to recipient organization to extend the appropriate use of novel exposure characterization and dose relations protocols to hazard characterization and communication efforts.
f. Assist recipient organization in communicating information on development of methodologies related to exposure-dose reconstruction by submitting, as progress warrants, manuscripts to symposia, conferences, and peer-reviewed scientific journals, on the developments and methodology describing aspects of the research on exposure-dose reconstruction.
g. Assist in the development and dissemination of advances in the areas of exposure-dose reconstruction methodologies to all relevant scientific and technical groups and communities including State and local governments and the public.
h. Collaborate with recipient organization by providing site-specific information and data on historical contaminant concentrations and population exposure to hazardous substances to enable the reconstruction of historical exposures.
i. Assist in the planning, organization, and conduct of workshops, conferences, or symposia to publicize and promote benefits of methodologies developed and assist with the transfer of technology as part of the program on exposure-dose reconstruction and computational methods to quantify exposures to hazardous substances.
Additionally, an HHS/ATSDR agency Program Official and the
Collaborating Scientist will be responsible for the normal
scientific and programmatic stewardship of the award and
will be named in the NoA.
2.A.3. Collaborative Responsibilities
Applicants will work collaboratively with the agency program
official and scientific collaborator in the conduct of this
research
3. Reporting
Recipient Organization
must provide HHS/ATSDR 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.
Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.
Although the financial plans of the HHS/ATSDR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
Section VII. Agency Contacts
HHS/ATSDR 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:
Mildred Williams-Johnson, Ph.D.
Scientific Program Administrator (Program Official)
CCEHIP Extramural Research Program Office
Centers for Disease Control and Prevention/
Agency for Toxic Substances and Disease Registry
U.S. Department of Health and Human Services
1825 Century Center Blvd.
Atlanta, GA 3034526
Telephone: (404) 4898-06394668
Email: MWilliams-Johnson@cdc.gov
Morris L. Maslia, MSCE
Scientific Collaborator
Centers for Disease Control and Prevention/
Agency for Toxic Substances and Disease Registry
U.S. Department of Health and Human Services
1825 Century Center
Atlanta, Georgia 30345
Telephone: 404-498-0415
Email:MMaslia@cdc.gov
2. Peer Review Contacts:
J. Felix Rogers, Ph.D.
Scientific Review Administrator
Extramural Research Program Office
Coordinating Center for Environmental Health and Injury Prevention
Centers for Disease Control and Prevention (CDC)
U.S. Department of Health and Human Services
4770 Buford Hwy, NE, Mailstop K-02
Atlanta, GA 30341
Telephone: (770) 488-4668
Lisa Williams
Procurement and
Grants Office
Center for Disease Control and Prevention
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2897
Fax: (770) 488-2670
Email: lrw3@cdc.gov
4.
General Questions Contacts:
Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
Email: PGOTIM@cdc.gov
Section VIII. Other Information
Required Federal Citations
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:
Lisa Williams, Grants Management Specialist
Procurement and Grants Office
Announcement Number TS08-001
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.
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.
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
www.healthypeople.gov
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.
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.
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.
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 reviewer 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.
CERCLA, as amended by SARA, provides for the recovery of costs incurred for response actions at each Superfund site from potentially responsible parties. The recipient would agree to maintain an accounting system that will keep an accurate, complete, and current accounting of all financial transactions on a site-specific basis, i.e., individual time, travel, and associated cost including indirect cost, as appropriate for the site. The recipient would also maintain documentation that describes the site-specific response actions taken with respect to the site, e.g., contracts, work assignments, progress reports, and other documents that describe the work performed at a site. The recipient will provide the site-specific costs and description of response actions taken with the supporting documentation upon request by HHS/ATSDR. The recipient will retain the documents and records to support these financial transactions and documentation of work performed, for possible use in a cost recovery case, for a minimum of ten years after submission of a final financial status report, unless there is litigation, claim, negotiation, audit or other action involving the specific site, then the records will be maintained until resolution of all issues on the specific site.
Third Party Agreements – HHS/ATSDR
Applicant must justify the need to use a contractor. If contractors are proposed, the following must be provided: (1) name of contractor, (2) method of selection, (3) period of performance, (4) detailed budget, (5) justification for use of contractor, and (6) assurance of non-conflict of interest.
Project activities which are approved for contracting pursuant to the prior approval provisions shall be formalized in a written agreement that clearly establishes the relationship between the recipient and the third party.
The written agreement shall, at a minimum:
1. State or incorporate by reference all applicable requirements imposed on the contractors under the terms of the grant and/or cooperative agreement, including requirements concerning technical review (ATSDR selected reviewers), ownership of data, and the arrangement for copyright when publications, data, or other copyrightable works are developed under or in the course of work under a PHS grant-supported project or activity.
2. State that any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal government purposes.
3. State that whenever any work subject to this copyright policy may be developed in the course of a grant by a contractor under a grant, the written agreement (contract) must require the contractor to comply with these requirements and can in no way diminish the government's right in that work.
4. State the activities to be performed, the time schedule for those activities, the policies and procedures to be followed in carrying out the agreement, and the maximum amount of money for which the grantee may become liable to the third party under the agreement.
5. State non-conflict of interest concerning activities conducted for HHS/ATSDR and site-remediation activities for other parties.
The written agreement required shall not relieve the recipient of any part of its responsibility or accountability to PHS under the cooperative agreement. The agreement shall, therefore, retain sufficient rights and control to the recipient to enable it to fulfill this responsibility and accountability.
Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
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.
Conference Disclaimer and Use of Logos {Mandatory for all grants and cooperative agreements.}
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.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm