Update: The following update relating to this announcement has been issued:
November 27, 2009 - See Notice NOT-MH-10-006 NIMH Announces Changes in NIMH Participation, As of January 8, 2010, NIMH will terminate or withdraw its participation from this FOA.
September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.
NOTICE: Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the
application guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four weeks
prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-07-047
Catalog of Federal
Domestic Assistance Number(s) 93.242, 93.853, 93.866, 93.361
Purpose.Insomnia
Disorder affects approximately 10% of adults in the U.S. and results in decreased work and academic performance, increased risk of accidents, increased
health care costs, and increased risk of depression and other mental
disorders. Given the public health significance of this problem, the NIH
State-of-the-Science Conference on Manifestations and Management of
Chronic Insomnia in Adults was held in June, 2005. The resulting
conference statement outlined what is currently known and identified
important future directions for insomnia-related research. The purpose of
this funding opportunity announcement (FOA) is to encourage research that
addresses the research needs outlined in this conference statement.
Recommended areas for future research include genetic and neurobiologic
mechanisms of insomnia, longitudinal studies of incidence and course of
insomnia, improved measures of daytime functioning and quality of life
resulting from insomnia, studies of insomnia in special populations, the
impact of insomnia on the development of other disorders including
depression, drug abuse, and chronic diseases, and the development and
evaluation of treatment approaches and their dissemination. Research that
translates basic science findings into novel clinical approaches is particularly
encouraged.
Mechanism of
Support. This FOA will utilize the R01 grant mechanism,
but applications under the NIH Small Research Grant Program (R03); the NIH
Exploratory/Developmental Research Grant Program (R21); and the NIMH
Clinical Exploratory Grant Program (R34) are also sought. Applicants
for the R03 should respond to PA-06-180,
applicants for the R21 should respond to PA-06-181,
and applicants for the NIMH R34 should respond to PA-06-248.
Funds
Available and Anticipated Number of Awards.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. The total amount awarded and the number of awards will
depend upon the mechanism numbers, quality, duration, and costs of the applications received.
Eligible
Institutions/Organizations.Public/State Controlled Institution of Higher Education; Private
Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status
(Other than Institution of Higher Education); Nonprofit without 501(c)(3)
IRS Status (Other than Institution of Higher Education); Small Business;
For-Profit Organization (Other than Small Business); State Government;
U.S. Territory or Possession; Indian/Native American Tribal Government
(Federally Recognized); Indian/Native American Tribal Government (Other
than Federally Recognized); Indian/Native American Tribally Designated
Organization; Non-domestic (non-U.S.) Entity (Foreign Organization);
Hispanic-serving Institution; Historically Black Colleges and Universities
(HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska
Native and Native Hawaiian Serving Institutions; Regional Organization;
Community-based Organization.
Eligible Project
Directors/Principal Investigators (PDs/PIs).Individuals with the
skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/organization to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for NIH support.
Number of
Applications. Applicants may submit more than one application,
provided each application is scientifically distinct.
Renewals and
Resubmissions. Applications can be renewed
by competing for additional project periods.Applicants may submit a
resubmission application, but such application must include an
Introduction (3 pages maximum) addressing the previous peer review
critique (Summary Statement).
Number of PDs/PIs. More than one PD/PI, or
multiple PDs/PIs, may be designated on the application.
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. Submitting an Application
Electronically 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
The purpose of
this funding opportunity announcement (FOA) is to encourage research in insomnia disorder that is
responsive to the research needs identified in the Conference Statement from
the NIH State-of-the-Science Conference on
Manifestations and Management of Chronic Insomnia in Adults. The
State-of-the-Science (SOS) conference, held June 13-15, 2005, addressed the
following questions: 1) How is chronic insomnia defined, diagnosed, and
classified, and what is known about its etiology?, 2)
What are the prevalence, natural history, incidence, and risk factors for
chronic insomnia?, 3) What are the consequences, morbidities, comorbidities,
and public health burden associated with chronic insomnia?, 4) What treatments are used for the management of chronic insomnia, and
what is the evidence regarding their safety, efficacy, and effectiveness?, and
5) What are important future directions for insomnia-related research. The SOS
conference panel considered: a) results of a
systematic literature review prepared for the Agency for Healthcare Research
and Quality (http://www.ahrq.gov/downloads/pub/evidence/pdf/insomnia/insomnia.pdf), b) presentations by
investigators working in areas relevant to the conference questions (http://consensus.nih.gov/2005/2005InsomniaSOS026Program.pdf), and c) questions and statements
by conference attendees during open discussion periods. Based on this
information, an independent panel of health professionals and public
representatives prepared a State-of-the-Science conference statement (http://consensus.nih.gov/2005/2005InsomniaSOS026PDF.pdf) outlining what is currently known and identifying areas
for future research including genetic and neurobiologic mechanisms of insomnia,
longitudinal studies of the incidence and course of
insomnia, improved measures of daytime functioning and quality of life impacts
from insomnia, studies of insomnia in special populations, the impact of
insomnia on the development of other disorders including depression, drug
abuse, and chronic diseases, and the evaluation of
treatment approaches and their dissemination.
This FOA specifically
encourages basic and translational research proposals that will expand
understanding of the factors contributing to chronic insomnia. Although comparative efficacy of existing treatments are important
questions to pursue, the focus of this FOA is on
understanding the potentially potent and modifiable mechanisms contributing to
insomnia and on developing and evaluating new and innovative treatment approaches based on these mechanisms.
Areas of
research responsive to this FOA include, but are not limited to, the following:
Assessing the diagnostic criteria for
and clinical assessment of chronic insomnia, particularly as these criteria
relate to comorbid disorders, and developing methods
to differentiate symptom overlap from comorbid conditions in diverse
populations;
Evaluating the possible mechanisms
underlying the relationship between insomnia and its comorbid conditions;
Developing, testing, and validating instruments to better assess the impact of
insomnia and related sleep disorders on daytime functioning, subjective
distress, and quality of life;
Conducting genetic research, both
epidemiologic and laboratory research, to understand the genetic predisposition for sleep disruption and the development
of chronic insomnia;
Evaluating in both animal models and
human studies if and how variations in the neurobiological mechanisms
implicated in normal sleep processes (e.g. homeostatic drive, sleep-wake functions, circadian functions) contribute to the
onset and maintenance of chronic insomnia;
Assessing the potential biological and
psychosocial factors that contribute to the hyperarousal observed in chronic
insomnia;
Conducting research that further elucidates the biological, behavioral, and
environmental factors contributing to the precipitation and perpetuation of
insomnia, particularly those factors which could be targeted for prevention and
early intervention strategies;
Conducting longitudinal studies across the lifespan on the incidence and the
natural course and duration of chronic insomnia;
Assessing the short and long term
impacts of insomnia on health, including possible increased risks for
behavioral, emotional, metabolic, and cardiovascular
syndromes, and the possible mechanisms for these risks;
Evaluating the societal impacts of
insomnia, including economic impacts (direct and indirect) and the effects on
sleep partners, families, and social or workplace functioning;
Assessing the effects of insomnia on daytime functioning, including
cognitive, motivational, and emotional effects;
Evaluating the effects of treating
insomnia comorbid with another condition on both the insomnia and on the
comorbid condition;
Developing and evaluating new and innovative interventions for chronic insomnia,
including both pharmacologic and behavioral interventions as well as prevention
and early intervention strategies;
Adapting treatments for insomnia to
special populations (e.g. children, elderly, postmenopausal
women, patients in supportive care environments) and evaluating their efficacy;
Developing and evaluating programs designed to improve the
identification and early intervention of insomnia by health care professionals.
This Funding Opportunity Announcement (FOA) will use
the NIH Research Project Grant (R01) award mechanism. The applicant will be solely responsible for planning,
directing, and executing the proposed project.
Specifically, if you are a U.S. organization and 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).
U.S. applicants requesting more than
$250,000 in annual direct costs and all foreign applicants must complete and
submit budget requests using the Research & Related Budget component found
in the application package for this FOA. See NOT-OD-06-096,
August 23, 2006.
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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
F&A costs requested by consortium
participants are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your institution/organization has
any of the following characteristics:
Public/State Controlled Institution of
Higher Education
Private Institution
of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other
than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status
(Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small
Business)
State Government
U.S. Territory or
Possession
Indian/Native American Tribal Government
(Federally Recognized)
Indian/Native American Tribal Government
(Other than Federally Recognized)
Indian/Native American Tribally Designated
Organization
Historically Black Colleges and
Universities (HBCUs)
Tribally Controlled Colleges and
Universities (TCCUs)
Alaska Native and Native
Hawaiian Serving Institutions
Regional Organization
Community-based Organization
1.B. Eligible Individuals
Any individual(s) with the
skills, knowledge, and resources necessary to carry out the proposed research
as the PD/PI is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be
designated on the application for projects that require a team science
approach that clearly does not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available athttp://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior
to the submission of the application (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor instructions).
The decision of whether to
apply for a single PD/PI or multiple PD/PI grant is the responsibility of the
investigators and applicant organizations and should be determined by the
scientific goals of the project. Applications for multiple PD/PI grants will
require additional information, as outlined in the instructions below. The NIH
review criteria for approach, investigators, and environment have been modified
to accommodate applications involving either a single PD/PI or multiple
PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure
and governance of the PD/PI leadership team as well as the knowledge, skills
and experience of the individual PD/PIs will be factored into the assessment of
the overall scientific merit of the application. Multiple PDs/PIs on a project
share the authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttp://grants.nih.gov/grants/multi_pi.
Applicants
may submit more than one application, provided each application is
scientifically distinct.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
If
your organization does not have a Taxpayer Identification Number (TIN) or
Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN
is necessary for CCR registration.
The
CCR also validates the EIN against Internal Revenue Service records, a step
that will take an additional one to two business days.
Direct
questions regarding Grants.gov registration to: Grants.gov Customer
Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
Direct
questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
The individual(s) designated as
PDs/PIs on the application must also be registered in the NIH eRA
Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and
be assigned the PI role in the eRA Commons prior to the submission of the
application.
Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons
account for both an Authorized
Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have
both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.
When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization. PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.
This registration/affiliation must
be done by the AOR/SO or their designee who is already registered in the
Commons.
Both the PD/PI(s) and AOR/SO need separate accounts in
the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with
an Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than any
DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to the
Federal Government.
Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their organization/institution is
already registered in both Grants.gov and
the Commons. The 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 the 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 for this FOA through Grants.gov/Apply.
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 Frequently Asked Questions Application Guide, Electronic
Submission of Grant Applications.
The SF424 (R&R) application has several
components. Some components are required, others are optional. The forms
package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in 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 or Research & Related Budget,
as appropriate(See Section IV.6., Special Instructions, regarding appropriate
required budget component.)Research
& Related Budget (required for foreign applications)
Optional Components: PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Prepare detailed budgets for all applications
(that is, complete the Research & Related Budget component of the
SF424 (R&R) application forms not the PHS398 Modular Budget
component). SeeNOT-OD-06-096.
Charge back of customs
and import fees is not allowed.
Format: Every effort
should be made to comply with the format specifications, which are based
upon a standard U.S. paper size of 8.5 x 11 within each PDF.
Funds for up to 8%
administrative costs (excluding equipment) may be requested. SeeNOT-OD-01-028, March 29, 2001.
Organizations must
comply with Federal/NIH policies on human subjects, animals, and
biohazards.
Organizations must comply
with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.
Proposed research should provide
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions in other
countries that are not readily available in the United States or that augment
existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one
PD/PI to be designated as the "Contact PI, who will be responsible for
all communication between the PDs/PIs and the NIH, for assembling the
application materials outlined below, and for coordinating progress reports for
the project. The contact PD/PI must meet all eligibility requirements for PD/PI
status in the same way as other PDs/PIs, but has no other special roles or
responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in
item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should
be listed in the Research & Related Senior/Key Person component and
assigned the project role of PD/PI. Please remember that all PDs/PIs must
be registered in the eRA Commons prior to application submission. The
Commons ID of each PD/PI must be included in the Credential field of the
Research & Related Senior/Key Person component. Failure to include
this data field will cause the application to be rejected.
All projects
proposing Multiple PDs/PIs will be required to include a new section describing
the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating
multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI
Leadership Plan (section 14 of the Research Plan Component in the SF424
(R&R) must be included. A rationale for choosing a multiple PD/PI approach
should be described. The governance and organizational structure of the leadership
team and the research project should be described, including communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to
specific components of the project or the individual PDs/PIs should be
delineated in the Leadership Plan. In the event of an award, the requested
allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution,
follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one
institution must be designated as the prime institution and funding for the
other institution(s) must be requested via a subcontract to be administered by
the prime institution. When submitting a detailed budget, the prime institution
should submit its budget using the Research & Related Budget
component. All other institutions should have their individual budgets
attached separately to the Research & Related Subaward Budget Attachment(s)
Form. See Section 4.8 of the SF424 (R&R) Application Guide for further
instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime
institution completes the PHS398 Modular Budget component
only. Information concerning the consortium/subcontract budget is provided
in the budget justification. Separate budgets for each consortium/subcontract
grantee are not required when using the Modular budget format. See Section 5.4
of the Application Guide for further instruction regarding the use of the
PHS398 Modular Budget component.
A letter of intent is not required for the funding
opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through
Grants.gov, any errors have been addressed, and the assembled application has
been created in the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two business days to view the
application image.
If
everything is acceptable, no further action is necessary. The application will
automatically move forward for processing by the Division of Receipt and
Referral, Center for Scientific Review, NIH, after two business days.
Prior
to the submission deadline, the AOR/SO can Reject the assembled application
and submit a changed/corrected application within the two-day viewing window.
This option should be used if the AOR/SO determines that warnings should be
addressed or if information was lost or compromised during transmission. Reminder:
warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two business days if no action is taken. Please remember that
some warnings may not be applicable or may need to be addressed after
application submission.
If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to Reject the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov
system issue.
If
the AOR/SO chooses to Reject the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.
Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.
Upon receipt, applications
will be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note:
Since email can be unreliable, it is the responsibility of the applicant to
check periodically on their application status in the Commons.
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 (3 pages maximum) addressing
the previous critique. Note such an application is considered a
"resubmission" for the SF424 (R&R).
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 or
competing renewal (formerly competing continuation ) 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 or
competing renewal 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
PD/PI Credential (e.g., Agency
Login)
The NIH requires the PD/PI(s)
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.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic
Submission of Grant Applications.
PHS398 Research Plan Component
Sections
Items 2-5 of the PHS398
Research Plan component are limited to 25 pages. While each section of the
Research Plan component needs to be uploaded separately as a PDF attachment,
applicants are encouraged to construct the Research Plan component as a single
document, separating sections into distinct PDF attachments just before
uploading the files. This approach will enable applicants to better monitor
formatting requirements such as page limits. All attachments must be provided
to NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.
All application instructions
outlined in the SF424 (R&R) Application Guide are to be followed,
incorporating "Just-in-Time" information concepts, and with the
following additional requirements:
Special Instructions
for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs
(excluding consortium F&A costs) must be submitted in a modular budget
format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When
submitting a modular budget, the applicant organization will include only the
PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further
instructions regarding the use of the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets.
See NOT-OD-06-096.
Special Instructions
for Applications Requesting $500,000 (direct costs) or More Per Year
Applicants requesting $500,000 or more in direct costs
for any year (excluding consortium F&A costs) must carry out the following
steps:
1) Contact the
IC program staff at least 6 weeks before submitting the application, i.e., as
you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will
accept your application for consideration for award; and,
3) Include the PHS398 Cover Letter component with the
application to identify the staff member and IC who agreed to accept assignment
of the application.
This policy applies to all new applications, competing
renewal (formerly competing continuation ) applications, resubmission
(formerly revised/amended ) applications, and revision (formerly competing
supplemental ) applications. See NOT-OD-02-004,
October 16, 2001.
Appendix Materials
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.
Do not use the Appendix to
circumvent the page limitations of
the Research Plan component. An application that does not observe the
required page limitations may be delayed in the review process.
Note: While each section of
the PHS398 Research Plan component needs to be uploaded separately as a PDF
attachment, applicants are encouraged to construct the Research Plan component
as a single document, separating sections into distinct PDF attachments just
before uploading the files. This approach will enable applicants to monitor better
formatting requirements such as page limits. All attachments must be provided
to NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.
Indicate how the proposed project has specific
relevance to the mission and objectives of the IC and has the potential
for significantly advancing the health sciences in the United States.
Plan for Sharing
Research Data
The precise content of the data-sharing
plan will vary, depending on the data being collected and how the investigator
is planning to share the data. Applicants who are planning to share data may
wish to describe briefly the expected schedule for data sharing, the format of
the final dataset, the documentation to be provided, whether or not any
analytic tools also will be provided, whether or not a data-sharing agreement
will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal Web site, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be
responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
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.
Sharing Research
Resources
NIH policy expects that grant
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statementhttp://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan 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). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria
described below will be considered in the review process.
2. Review and Selection Process
Applications
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:
Undergo a selection process in which only those
applications deemed to have the highest scientific merit, generally the
top half of applications under review, will be discussed and assigned a
priority score.
Receive a written critique.
Receive
a second level of review by the appropriate national advisory council or
board.
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:
Scientific merit of the proposed project as
determined by peer review.
Availability of funds.
Relevance of program priorities.
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.
Significance
Approach
Innovation
Investigator
Environment
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? For applications designating
multiple PDs/PIs, is the leadership approach, including the designated roles
and responsibilities, governance, and organizational structure, consistent with
and justified by the aims of the project and the expertise of each of the
PDs/PIs??
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 or methodologies, tools,
or technologies for this area?
Investigators: Are the PD/PIs and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level(s) of the principal investigator(s) and
other researchers? Do the PD/PIs and investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) in which the
work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment(s), 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 the Human Subjects Sections of
the PHS398 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 the Human Subjects Sections of the PHS398
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 adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R).
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 and
Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions in other
countries that are not readily available in the United States or that augment
existing U.S. resources will be assessed.
Resubmission Applications (formerly revised/amended
applications): Are the responses to comments from the previous
scientific review group adequate? Are the improvements in the resubmission
application appropriate?
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 expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statementhttp://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by 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.
Model Organism Sharing Plan: Reviewersare
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.
3. Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA Commons.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
WilliamRiley, Ph.D. Health and Behavior Research Branch Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Blvd., Room 6226 , MSC 9615
Bethesda, MD 20892
Telephone: (301) 435-0301
FAX: (301) 48 0-2920
Email: [email protected]
MerrillM.Mitler, Ph.D. Division of Extramural Research National Institute of Neurological Disorders and Stroke 6001 Executive Blvd.,
Room 2116 Bethesda, MD 20892-9551 Telephone: (301) 496-9664 Email: [email protected]
AndrewA.Monjan, Ph.D., M.P.H. Chief, Neurobiology of Aging Branch Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 350, MSC 9205 Bethesda, MD 20892-9205 (use 20814 for express
mail) Telephone: (301) 496-9350 Email: [email protected]
Dr. Susan Marden, PhD
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 496-9623
Fax: (301) 480-8260
Email: [email protected]
2. Peer Review Contact(s):
Not Applicable
3. Financial/Grants Management Contact(s):
Rita Sisco Grants Management Branch National Institute of Mental Health
6001 Executive Blvd., Room 6120, MSC 9605 Bethesda, MD 20892 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: [email protected]
MaxineDavis-Vanlue Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd.,
Room 3258 Bethesda, MD 20892 Telephone: (301) 496-9431 FAX: (301) 402-0219 Email: [email protected]
LindaWhipp Grants and Contracts Management Officer National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: [email protected]
DianeE.Drew Grants Management Specialist National Institute of Nursing Research 6701 Democracy Blvd.,
Room 710 Bethesda, MD 20892-4870 Telephone: (301) 594-2807 Email: [email protected]
Human Subjects Protection: Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
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 the 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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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) application; 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.
Standards for
Privacy of Individually Identifiable Health Information: The Department
of Health and Human Services (HHS) 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 HHS
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. For publications listed in
the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles. Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
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 at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. Awards
are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
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/.
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.
