and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/)
Title: Diet Composition and Energy Balance (R21)
Announcement Type
This is a reissue of PA-04-033 which was previously released December 10, 2003.
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-06-174
Catalog of Federal Domestic Assistance Number(s)
93.847, 93.848, 93.853,
93.399, 93.866, 93.273, 93.213, 93.837, and 93.865
Key Dates
Release/Posted
Date: March
2, 2006
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): http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council
Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information
To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: November 2, 2006, unless reissued
(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 the role of diet composition in energy balance, including studies in both animals and humans. Both short and longer-term studies would be encouraged, ranging from basic studies investigating the impact of micro-or macronutrient composition on appetite, metabolism, and energy expenditure through clinical studies evaluating the efficacy of diets differing in micro- or macronutrient composition, absorption, dietary variety, or energy density for weight loss or weight maintenance.
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
Background
Overweight and obesity have increased dramatically in prevalence in the US. More than 60 percent of the US population is overweight (BMI > 25) and 31 percent meet criteria for obesity (BMI > 30). Obesity is particularly prevalent among some minority populations, such as African American, Hispanic, and Native American women. Overweight prevalence is also increasing in children, with more than 15 percent of children and adolescents considered overweight and an additional 15 percent at risk for overweight. Obesity is associated with numerous serious and chronic diseases, including type 2 diabetes, cardiovascular disease, sleep apnea, and certain forms of cancer. The causes of obesity are complex, and involve both genetic and environmental components. Environmental changes over the past two decades have increased sedentary behaviors, decreased physical activity, and increased consumption of more energy dense foods and larger portion sizes. Although an imbalance in energy consumption and expenditure are required to promote inappropriate weight gain, the relative contributions of each to the burgeoning obesity epidemic remain in dispute.
An important gap in knowledge concerns the role of diet composition in energy balance. Diets low in carbohydrates have been purported to enhance weight loss, while those high in carbohydrates (particularly simple sugars and refined grain products) have been cited by some as contributing to weight gain. Some shorter-term studies (up to six months in duration) have reported greater weight loss in those who consumed a low-carbohydrate diet compared with a diet higher in carbohydrate; however, the contribution of reduced caloric consumption to weight loss with such diets has not been adequately studied. Even when carbohydrate level is similar, factors such as glycemic index, nutrient density, fiber content, and dietary variety, have also been proposed to affect energy intake, with potential relevance for enhancing attempts to promote weight loss and prevent inappropriate weight gain. In addition to carbohydrates, further research is needed to elucidate the role of other macronutrients in energy balance (including fats, proteins and ethanol). Some fatty acids (such as conjugated linoleic acid) have been alleged to promote weight loss and/or improve body composition, although studies in humans have been inconsistent. Micronutrients such as calcium have been proposed to play a role in energy balance, either through decreased fat absorption or via other mechanisms, although research in this area is still formative. In addition, the relative impact of calcium from dairy products versus other food or supplement sources also remains in question.
The mechanisms by which diet composition affects energy balance are not well understood, but may include alternations in appetite, nutrient absorption, neuroendocrine and gastrointestinal factors, energy partitioning, physical activity and other components of energy expenditure. Furthermore, the short- and long-term impact of diet composition on factors such as body composition, risk factors for cardiovascular disease, cancer, renal function, psychosocial function, and other health parameters is also not well characterized.
Although there have been numerous animal studies assessing the impact of diet composition on appetite and body weight, these studies have been limited by availability and use of well-defined and standardized diets. Lack of methods in laboratory practice that would permit the assessment of dietary composition and the lack of data comparing commercial preparations from various suppliers may contribute significant variability to studies designed to assess the impact of diet on energy balance. In addition to long-term studies of weight gain in response to standardized diets, short-terms studies with well-characterized diets varying in macro- and micronutrient composition would help to define the effect of diet composition on endocrine and neuronal axes involved in regulation of both food intake and energy partitioning.
Objectives and Scope
This funding opportunity invites research applications investigating the role of diet composition in energy balance, including studies in both animals and humans. Collaborations between basic and clinical researchers, which explore mechanisms underlying differences in response to diet composition, 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 National
Institutes of Health (NIH) Exploratory/Development Research Grant (R21) award
mechanism. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
The R21
awards are to demonstrate feasibility and to obtain preliminary data testing
innovative ideas that represent clear departure from ongoing research
interests. These grants are intended to: 1) provide initial support for new
investigators; 2) allow exploration of possible innovative new directions for
established investigators; and 3) stimulate investigators from other areas to
lend their expertise to research within the scope of this solicitation.
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: http://grants.nih.gov/grants/policy/policy.htm#gps).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less (excluding consortium F&A costs), use the Modular
Budget Component provided in the SF424 (R&R) Application Package and
Instructions Guide (see specifically Section 5.4).
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.
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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
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. For example, you may request $100,000 in the first year and $175,000 in the second 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.
Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
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
N/A
This program does not
require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more
than one application, provided they are scientifically distinct.
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: GrantsInfo@nih.gov.
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. See http://grants1.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(s): 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.
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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and 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 PD/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 NIH Grants Policy Statement 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 and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
3. Anticipated Announcement and Award Dates
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.
Division
of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Blvd., Room 665
Bethesda, MD 20892-5450
Phone:
(301) 594-8882
Fax:
(301) 480-8300
Email: sy29f@nih.gov
John A.
Milner, Ph.D.
Nutritional
Science Research Group
Division
of Cancer Prevention
National
Cancer Institute
6130
Executive Blvd., Suite 3164
Rockville, MD 20892
Phone:
(301) 496-0118
Fax (301)
480-3925
Email: jm524n@nih.gov
Marguerite
Klein
National Center for Complementary and Alternative
Medicine
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Phone:
(301) 402-5860
Fax:
(301) 480-3621
Email: mk443s@nih.gov
Catherine
(Cay) Loria, Ph.D., M.S., M.A.
Division
of Epidemiology and Clinical Applications
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 8150
Bethesda, MD 20892-7934
Phone:
(301) 435-0702
Fax:
(301) 480-1667
Email: cl223r@nih.gov
Chhanda
Dutta, Ph.D.
Geriatrics
and Clinical Gerontology Program
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: cd23z@nih.gov
R. Thomas
Gentry, Ph.D.
Division
of Metabolism and Health Effects
National
Institute on Alcohol Abuse and Alcoholism
6000
Executive Blvd., Suite 302
Bethesda, MD, 20892-7003
Phone:
(301) 443-6009
Fax:
(301) 480-2358
Email: tg69e@nih.gov
Gilman D.
Grave, M.D.
Endocrinology,
Nutrition and Growth Branch
Center
for Research for Mothers and Children
National Institute of Child Health and Human Development
6100
Executive Blvd., Suite 4B-11
Bethesda, MD 20892-7510
Phone:
(301) 496-5593
Fax:
(301) 480-9791
Email: gg37v@nih.gov
Merrill
M. Mitler, Ph.D.
Systems
and Cognitive Neuroscience
National
Institute of Neurological Disorders and Stroke
6001
Executive Blvd., Room 2116
Bethesda, MD 20892
Phone:
(301) 496-9964
Fax:
(301) 402-2060
Email: mm777k@nih.gov
Paul
Coates, Ph.D.
Office of
Dietary Supplements
6100
Executive Blvd., 3 B01
Bethesda, MD 20892-7517
Phone:
(301) 435-2920
Fax:
(301) 480-1845
Email: pc61s@nih.gov
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: dl244e@nih.gov
Debra
Dunne
Grants
Management Branch
National
Cancer Institute
6120
Executive Blvd., Room 243
Bethesda MD 20892
Phone:
(301) 496-3154
Fax:
(301) 496-8601
Email: dd153a@nih.gov
Marc
Milton Pitts, M.B.A.
Grants
Management Branch
National Center for Complementary and Alternative
Medicine
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Phone:
(301)594-9095
Fax:
(301) 480-1552
Email: pittsm@mail.nih.gov
Kieran
Kelley
Grants
Management Branch
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 7170
Bethesda, Maryland 20892-7926
Phone:
(301)-435-0154
Fax:
(301)-480-3310
Email: kk27g@nih.gov
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: jb444y@nih.gov
Judy S.
Fox
Grants
Management Branch
National
Institute on Alcohol Abuse and Alcoholism
6000
Executive Blvd,
Willco Bldg, 504
Bethesda, MD 20892-7003
Phone:
(301) 443-4704
Fax: (301)
443-3891
Email: js182a@nih.gov
Lisa
Moeller
Grants
Management Branch
National Institute of Child Health and Human Development
6100
Executive Blvd., Room 8A17F
Bethesda, MD 20892-7510
Phone:
(301) 496-1305
Fax:
(301) 480-4783
Email: lm236j@nih.gov
Kimberly D. Campbell
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Suite 3249
Bethesda, Maryland 20892-9537
Phone: (301) 496-7809
Fax: (301) 402-0219
Email: kc274k@nih.gov
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://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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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