and Human Services (HHS)
EXPIRED
Title: Long-Term Weight Maintenance: Basic and Clinical Studies (R21)
Announcement Type
This is a reissue of PA-04-092 which was
previously released April 13, 2004.
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 SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines provided 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.
Two steps are required for on time submission:
1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number: PA-06-144
Catalog of Federal Domestic Assistance Number(s)
93.847, 93.848, 93.866, 93.361
Key Dates
Release/Posted Date: March 2,
2006
Opening Date: May 2, 2006
(Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A Application
Application Submission
Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard
dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Expiration Date: November 15, 2006
(see NOT-DK-06-009)
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
The goal of this funding opportunity announcement (FOA) is to invite research applications investigating basic and clinical aspects of long-term weight maintenance. Applications investigating mechanisms underlying weight stability and/or weight regain after intentional weight loss, as well as clinical studies investigating the role of behavioral, nutritional, exercise, or other interventions in enhancing long-term weight maintenance will be supported. Collaborations between basic and clinical researchers are particularly encouraged under this solicitation.
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
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application
Information
2. Content and Form of
Application Submission
3. Submission Dates
and Times
A. Submission,
Review and Anticipated Start Dates
1. Letter of
Intent
B. Sending an
Application to the NIH
C.
Application Processing
4. Intergovernmental
Review
5. Funding
Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing
Research Data
D. Sharing
Research Resources
3. Anticipated
Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information -
Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Objectives and Scope
Although there are many well-accepted methods to reduce initial body weight by 7-10%, long-term maintenance of that lost weight is more problematic. On average, among treatment-seeking populations, approximately 1/3 of lost weight is regained by one year; by 5 years most or all previously lost weight is regained. Although an ongoing registry using a convenience sample of long-term weight maintainers is providing valuable information about behaviors endorsed by those with long-term success, more systematic characterization of long-term mechanisms underlying long-term regain or weight stability is not available. Studies are needed to elucidate pathophysiologic mechanisms underlying weight regain after intentional weight loss, to investigate intake and energy expenditure during weight maintenance and regain periods, and to characterize the behavioral and psychological factors predictive of weight regain. Investigations into strategies for promoting long-term weight maintenance may lead to improved long-term outcomes after weight loss through a variety of methodologies.
This funding opportunity invites research applications investigating the factors involved in long-term weight stability and/or weight regain after intentional weight loss, including studies in both animals and humans. Clinical studies investigating the role of behavioral, nutritional (including dietary supplements), exercise, or other interventions in enhancing long-term weight maintenance will be supported. Collaborations between basic and clinical researchers that explore mechanisms underlying differences in weight regain after intentional weight loss are particularly encouraged. Examples of the type of research topics and approaches that would be solicited under this funding opportunity include (but are not limited to):
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
The R21 mechanism is intended to encourage new exploratory and developmental research projects and/or exploration of novel hypotheses and strategies. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system. These projects should be exploratory and novel, and distinct from the type of project supported through the traditional R01. For further information on the R21 mechanism, go to http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.
The R21 grant support is for new projects only, and will not be renewed. Continuation of projects developed under this program will be through the regular research grant (R01) program. Two resubmissions (formerly called revisions) of a previously reviewed R21 grant application may be submitted as defined in the NIH policy at http://grants.nih.gov/grants/policy/amendedapps.htm.
This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm
2. Funds Available
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 Institutes and Centers (ICs) 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 funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if
your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current
NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Not applicable.
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
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.
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 NIH 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 institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application forms
and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use any
other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than one
FOA.
For further assistance contact
GrantsInfo, Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
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 NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (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 Cover Page Supplement
PHS398 Research
Plan
PHS398 Checklist
PHS398 Modular Budget
Optional Components:
PHS398 Cover Letter File
R&R Subaward Budget Attachment(s) Form
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a
unique research opportunity not available in the United
States.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: May
2, 2006 (Earliest date an application may
be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not applicable
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
for details
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details
Council Review Date(s) : Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details
Earliest Anticipated Start Date: Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
To submit an application in response to this FOA, applicants
should access this FOA via http://www.grants.gov/Apply 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 to
Grants.gov on or after the opening date and must be submitted no
later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date(s). (See Section IV.3.A. for all dates.)
If an application is not submitted by the submission date(s) and time,
the application may be delayed in the review process or not reviewed.
Upon receipt, applications will be
transferred from Grants.gov to the NIH Electronic Research Administration
process for validation. Both the PD/PI and the Signing Official for the
organization must verify the submission via Commons within 2 business days
of notification of the NIH validation.
Upon receipt, applications will be evaluated for completeness
by the Center for Scientific Review, NIH. Incomplete applications will not be
reviewed.
The NIH will not accept
any application in response to this FOA that is essentially the same as one
currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is essentially
the same as one already reviewed. This does not preclude the submission of an
application already reviewed with substantial changes, but such application must
include an Introduction addressing the previous critique. Note that such an
application is considered a "resubmission" for the SF424 (R&R).
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms
and conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-Award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days before
the beginning date of the initial budget period of a new award if such costs:
are necessary to conduct the project and would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in
anticipation of a competing or non-competing award imposes no obligation on NIH
either to make the award or to increase the amount of the approved budget if an
award is made for less than the amount anticipated and is inadequate to cover
the pre-award costs incurred. NIH expects the grantee to be fully aware that
pre-award costs result in borrowing against future support and that such
borrowing must not impair the grantee's ability to accomplish the project
objectives in the approved time frame or in any way adversely affect the conduct
of the project. See the NIH
Grants Policy Statement.
6. Other Submission Requirements
The NIH 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.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 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 NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
o Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. Do not include manuscripts submitted for publication.
- Publications in press: Include only a publication list with a link to the on-line journal article or the PubMed 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 an online journal link is not available: The entire article may be submitted electronically as a PDF attachment.
o Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
o Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the 15-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan.
o Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.
Plan for
Sharing Research Data
N/A
Sharing Research
Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3.
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in
the review process.
2. Review and
Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
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 NIH supported research
are to advance our understanding of biological systems, to improve the control
of disease, and to enhance health. In their written critiques, reviewers will be
asked to comment on each of the following criteria in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, weighting them as appropriate for each
application. 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?
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 bring
complementary and integrated expertise to the project (if applicable)?
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?
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: The involvement of human subjects and
protections from research risk relating to their participation in the proposed
research will be assessed. See item 6 of the Research Plan component of
the SF424 (R&R).
Inclusion of Women,
Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. See item 7 of the Research Plan component
of the SF424 (R&R).
Care and Use of Vertebrate Animals
in Research: If vertebrate animals are to be
used in the project, the five items described under item 11 of the Research Plan
component of the SF424 (R&R) will be
assessed.
Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.
2.B. Additional Review
Considerations
Budget: The
reasonableness of the proposed budget and the requested period of support in
relation to the proposed research may be assessed by the reviewers. Is the
percent effort listed for the PI appropriate for the work proposed? Is each
budget category realistic and justified in terms of the aims and methods?
Period of Support: The
appropriateness of the requested period of support in relation to the proposed
research.
2.C. Sharing Research
Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data may 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 funding
organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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.
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. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an
application. The final version of the data and resource sharing plans negotiated
by both will become a condition of the award of the grant. 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
N/A
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.
If the application is under
consideration for funding, NIH will request "just-in-time" information from the
applicant. For details, applicants may refer to the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH
Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 Also
Section IV.5. Funding
Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the
NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH
Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the
PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Susan Z. Yanovski, M.D.
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 665
Bethesda, MD
20892-5450
Phone:
(301)594-8882
Fax:
(301)480-8300
Email: [email protected]
Chhanda Dutta,
Ph.D.
National Institute on Aging
Gateway
Building, Suite 3C-307
7201 Wisconsin Avenue
Bethesda, MD
20892-9205
Phone:
(301)435-3048
Fax:
(301)402-1784
Email: [email protected]
Janice Phillips, PhD, RN, FAAN
National Institute of Nursing
Research
6701 Democracy Boulevard, Suite
710
Bethesda, MD
20892-4870
Phone:
(301)594-6152
Fax:
(301)480-8260
Email: [email protected]
Mary Frances Picciano, Ph.
D.
Office of Dietary
Supplements
National Institutes of
Health
6100 Executive Blvd., Suite
3B01
Bethesda,
MD 20892-7517
Phone:
(301)435-3608
Fax:
(301)480-1845
Email: [email protected]
2. Peer Review Contacts:
N/A
3. Financial or Grants Management Contacts:
Diana Ly
Grants Management
Branch
National Institute of Diabetes and
Digestive and Kidney Diseases
6707 Democracy
Blvd., Room 708
Bethesda, MD
20892-5456
Phone: 301-594-3197
FAX:
301-594-9523
Email: [email protected]
John Bladen
Grants Management Branch
National Institute on Aging
7201 Wisconsin Avenue, Room
2N212
Bethesda,
MD 20892-9205
Phone:
(301)402-1472
Fax:
(301)402-3672
Email: [email protected]
Tara
Mowery
Grants Management
Branch
National Institute of Nursing
Research
6701 Democracy Blvd., Suite
710
Bethesda,
MD 20892-4870
Phone:
(301)594-5979
Fax:
(301)451-5650
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities
involving live, vertebrate animals must comply with 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.
Human Subjects
Protection:
Federal regulations (45CFR46)
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).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for
all types of clinical trials, including physiologic toxicity and dose-finding
studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and
comparative trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application
seeking $500,000 or more in direct costs in any single year are expected to
include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions on
issues related to institutional policies and local IRB rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into the
determination of scientific merit or the priority score.
Access to Research Data through the Freedom of Information
Act:
The Office of Management and Budget
(OMB) Circular A-110 has been revised to provide access to research data through
the Freedom of Information Act (FOIA) under some circumstances. Data that are
(1) first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency in
support of an action that has the force and effect of law (i.e., a regulation)
may be accessed through FOIA. It is important for applicants to understand the
basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider use
of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of
important research resources including the sharing of model organisms for
biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a cost
threshold in any year and is expected to be included in all applications where
the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and
members of minority groups and their sub-populations must be included in all
NIH-supported clinical research projects unless a clear and compelling
justification is provided indicating that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy continues
to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that
children (i.e., individuals under the age of 21) must be included in all
clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects
should read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection
of Human Subject Participants:
NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH
manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as the
final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting
from 1) currently funded NIH research projects or 2) previously supported NIH
research projects if they are accepted for publication on or after May 2, 2005.
The NIH Public Access Policy applies to all research grant and career
development award mechanisms, cooperative agreements, contracts, Institutional
and Individual Ruth L. Kirschstein National Research Service Awards, as well as
NIH intramural research studies. The Policy applies to peer-reviewed, original
research publications that have been supported in whole or in part with direct
costs from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For
more information about the Policy or the submission process please visit the NIH
Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
Standards for Privacy of Individually
Identifiable Health Information:
The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996
that governs the protection of individually identifiable health information, and
is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and
implementation of the Privacy Rule reside with the researcher and his/her
institution. The OCR Website (http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress monitoring of
grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or
Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.
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 PA 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.
Authority and Regulations:
This program is described in the Catalog of
Federal Domestic Assistance and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and administered under NIH grants
policies and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and
92. All
awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH
Grants Policy Statement. The
NIH Grants Policy Statement can be found
at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant
recipients to provide a smoke-free workplace and discourage the use of all
tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care, health care,
or early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and mental
health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas. The
LRP is an important component of NIH's efforts to recruit and retain the next
generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further information,
please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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