Title:Genetic
and Genomic Analyses of Xenopus (R01)
Announcement Type This is a reissue of PAR-05-166, which was previously released September
20, 2005.
Update: The following update relating to this announcement has been issued:
July 27, 2009 - This PAR has been reissued as (PAR-09-240).
NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four weeks
prior to the grant submission date. See Section IV.
Program Announcement (PA) Number:
PAR-07-144
Catalog of Federal Domestic Assistance
Number(s) 93.865, 93.867, 93.853, 93.173, 93.389, 93.847,
93.848, 93.849, 93.859, 93.121, 93.242
Key Dates
Release/Posted Date: December 12, 2006
Opening Date: November 19, 2007 (Earliest date an application may be submitted
to Grants.gov) Letters of Intent Receipt Date(s):December
19, 2007 NOTE: On time submission requires that applications be successfully submitted
to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). ApplicationSubmission/Receipt
Date(s):January 18, 2008 Peer Review Date(s):May/June 2008 Council Review Date(s):September
2008 Earliest Anticipated Start Date(s):December 2008 Additional Information To Be Available
Date (Activation Date):Not Applicable Expiration Date:
January 19, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Purpose.This Funding Opportunity Announcement (FOA)solicits investigator-initiated applications designed to
exploit the power of Xenopus as a vertebrate model for biomedical research.
Applications are welcome proposing to develop new tools or genetic or genomic resources of high
priority to the Xenopus community that will advance the detection and characterization
of genes, pathways, and phenotypes of interest in development, organogenesis,
and in cell biological processes, such as cell division, signaling and migration.
Mechanism of Support.
This FOA will utilize the NIH Research Project Grant (R01)award mechanism.
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; Other(s): Eligible agencies of the Federal government; Faith-based
or community based organizations
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. At this time, it is not known if competing renewal (formerly
competing continuation ) applications will be accepted and/or if this FOA
will be reissued. Applicants may submit a resubmission application, but
such application must include an Introduction 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
For the past few years, the
international research community has been generating genetic and genomic data
and reagents for the model systems, X. tropicalis and X. laevis . These products
include: 1) cDNA libraries and EST sequences, 2) UniGene clusters, 3) full-insert
cDNA clones and sequences, 4) a genetic map, 5) genomic libraries and genomic
sequences, 6) a physical map, 7) genome sequence, 8) microarrays, and 9) transgenic
and mutant animals (see http://www.nih.gov/science/models/xenopus). These
diverse data and reagents are being generated by investigators from several
different research communities, including geneticists, gene sequencers, gene
mappers, cell biologists, developmental biologists, and bioinformatics experts.
These materials and data can now be used to enhance Xenopus' role as a model
system. This PAR solicits applications from investigators in these different
fields to combine these data, reagents and methodologies to elucidate the
genetic basis of cell biological events, including embryonic development and
organogenesis.
Scope
This Funding Opportunity Announcement (FOA)solicits
applications to utilize the newly generated methodologies and reagents, such
as the clones and sequence information, to identify and characterize genes,
gene families, and gene networks that control developmental and cellular events.
It also solicits applications to generate research tools and to perform pilot
studies. Additionally, it solicits applications to devise and improve techniques
to alter gene expression, and to control the spatial and temporal pattern
of gene expression.
Examples of projects include:
Larger projects from multidisciplinary
teams that are based on extensive preliminary data. These applications could
use the newly available genetic and genomic data and reagents, and/or new
methodologies to characterize and study genes involved in developmental events
and in cellular processes. These projects will be particularly appropriate
for collaborations between investigators with different expertise to analyze
the genomic data to elucidate the genetic bases of cellular and developmental
events.
Smaller projects using existing
techniques to generate research tools, such as genetic and physical maps,
and to mine data; and projects to perform pilot studies such as phenotypic
screens, microarray analyses, and expression cloning designed to produce preliminary
data that would form the basis of future applications.
Smaller projects designed
to develop novel techniques, such as strategies for mutagenesis, conditional
gene expression, or for identifying new genes or mutants, as well as new tools
to mine and analyze sequence data.
Objectives to be addressed in applications submitted
in response to this FOA include, but are not limited to, the following:
Development and/or application of novel methods of mutagenesis (e.g., insertional, site-specific,
conditional knockout vectors or systems).
Development and/or use of techniques supporting more efficient targeting
of induced local lesions in genomes (TILLING).
Development and/or use of technologies for gene inactivation and for gene
expression manipulation including, but not limited to, morpholino oligonucleotides,
new types of antisense technology, techniques for homologous recombination,
techniques for gene trapping, and strategies for directing gene misexpression, or other transgenic methodologies.
Development of high throughput small molecule screens.
Development of new genetic or genomic resources that are of high priority
for the Xenopus community.
Development and/or application of novel screens for mutants. These may be
refinements of phenotypic analyses preparatory to screening, or phenotypic
screens based on observation of alterations in development, morphology or physiology.
Screens focusing on identifying novel developmental genes and pathways.
Interests
of Participating Institutes and Centers
NICHD: Identification, cloning, and characterization
of the genes important in normal development as well as those mutant genes
that cause developmental defects. Elucidation of the cellular, biochemical,
molecular, and genetic mechanisms underlying normal and defective development.
This includes, but is not limited to, the study of general mechanisms of pattern
formation and cell lineage, neural crest development, cell specification,
differentiation, migration, and fate in early development of many organs/systems
such as limb, nervous system, immune system, and heart.
NCRR: The NCRR supports research projects
that broaden the utility of the Xenopus model for cross-cutting biomedical
research that is not encompassed within a single NIH Institute or Center.
Interests include, but are not limited to, development of new methods for
mutagenesis and/or phenotypic characterization that would be of use in research
on a wide range of diseases or organs, particularly if these methods could
be applied to other animal models as well as Xenopus .
NEI: Research on all stages of eye development,
including embryonic patterning, gene regulation, biochemical pathways leading
to normal structural/ functional formation, genotype/phenotype analysis to
characterize genes involved in ocular disorders and diseases, and regeneration
of ocular structures.
NIDCD: Research on the development, normal
function, and diseases of central and peripheral structures related to the
communication sciences of hearing, balance, speech, voice, language, taste
and smell. Of particular interest are the mechanisms underlying neurogenesis,
cell fate, differentiation, cell death, regeneration, axon targeting, and
the formation of neural networks. The development of new research tools, methodologies,
assays, and genetic manipulations to study these various developmental elements
is also encouraged.
NIDCR: All aspects of normal and abnormal
craniofacial development, including genetics, complex origins of craniofacial
disorders, cell lineages and differentiation, cell signaling and gene regulation,
embryonic patterning, imaging, biomimetics, and new technologies for high-throughput
genetic and protein screens.
NIDDK: Research on diabetes, particularly
studies on pancreatic beta cell function and development, obesity and mechanisms
underlying satiety, other endocrine and metabolic diseases, hematologic disorders,
physiology and diseases of the digestive system, liver, kidney, and urinary
tract. Studies aiming to clarify the cellular and molecular events that dictate
tissue and organ formation in all these systems are considered of relevance.
In addition, studies that exploit Xenopus to model physiological processes
such as renal function, fluid and electrolyte balance, are relevant to NIDDK.
These studies could include, but need not be limited to, studies to develop
cell lines from any of the tissues or organs of interest, studies to characterize
normal or abnormal function of tissues or organs of interest, methods to screen
and identify additional mutations in these systems, and studies to define
the molecular mechanisms that dictate cell-specific gene expression in relevant
cell types.
NIGMS: Development of novel methods for
mutagenesis and manipulation of gene expression. Mutagenesis screens to identify
and characterize genes that control fundamental biological mechanisms such
as those that underlie gene regulation, chromosome organization and mechanics,
cell growth and differentiation, pattern formation, sex determination, morphogenesis,
cell cycle control, and behavior. Small molecule screens for phenotypes that
are relevant to those fundamental biological mechanisms.
NIMH: Investigations that examine molecular,
cellular, and biochemical bases of genetic mutations affecting neurogenesis,
biological rhythms, learning, memory, and other cognitive functions and behaviors
of the nervous system. These studies include, but are not limited to, development
of screening methods for such mutations, identification, isolation, mapping,
and functional analyses of the genes underlying mutations.
NINDS: Research on the development, normal
function, and diseases of the nervous system. This research might include
the use of mutants to understand the mechanisms controlling the following
processes: neurogenesis, nervous system patterning, cell lineage, cell migration,
formation of neural circuits, programmed cell death, axon pathfinding and
regeneration, myelination, and motor and sensory function. In addition, the
utility of mutants as models for neurodegenerative diseases for use in translational
research, including therapeutic drug screens, functional neuroanatomy of the
developing and adult nervous system, and use of optical imaging techniques
to visualize neural activity is of particular interest.
The
areas of interest listed above are not presented in order of priority; they are only examples of areas
of research to consider. Applications representing areas of interest to more
than one Institute or Center (IC) will be assigned to multiple ICs for funding consideration. Applicants
are encouraged to propose work in other areas that are related to the objectives
and scope of this FOA.
This 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.
This FOA uses Just-in-Time information concepts. It
also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
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.
At this time, it is not known
if competing renewal (formerly competing continuation ) applications will
be accepted and/or if this FOA will be reissued.
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 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.
There is no special set-aside of funds for applications
submitted in response to this FOA.
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&Acosts 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
Other(s): Eligible agencies of the Federal government; Faith-based
or community based organizations
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 at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH eRA Commons
prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm
for 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:
Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
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). See NOT-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.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: November 19, 2007 (Earliest date an application may be submitted
to Grants.gov) Letters of Intent Receipt Date(s):December 19, 2007 ApplicationSubmission/Receipt
Date(s):January 18, 2008 Peer Review Date(s):May/June 2008 Council Review Date(s):September
2008 Earliest Anticipated Start Date(s):December 2008
3.A.1. Letter of Intent
Prospective applicants are asked
to submit a letter of intent that includes the following information:
Descriptive title of proposed
research.
Name, address, and telephone
number of the PD(s)/PI(s).
Names of other key personnel.
Participating institutions.
Number and title of this funding
opportunity.
Although a letter of intent is
not required, is not binding, and does not enter into the review of a subsequent
application, the information that it contains allows IC staff to estimate
the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Steven L. Klein, Ph.D. Developmental Biology, Genetics
and Teratology Branch National Institute of Child Health
and Human Development 6100 Executive Blvd., Room 4B01 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service; non-USPS service) Telephone: (301) 435-6886 Email: [email protected]
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,
and responsiveness by the assigned IC(s). Incomplete and non-responsive applications
will not be reviewed.
.If
the application is not responsive to the FOA, NIH staff may contact the applicant
to determine whether to return the application to the applicant or submit
it for review in competition with unsolicited applications at the next appropriate
NIH review cycle.
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 addressing the previous critique. Note such an application
is considered a "resubmission" for the SF424 (R&R).
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 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 theNIH 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:
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).
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.
Applicants also are required
to include a plan addressing if, or how, they will exercise their intellectual
property rights while making available to the broader scientific community
patentable research resources. The plan should address the following questions:
Will material transfers be made with no more
restrictive terms than in the Simple Letter MTA or the UBMTA?
Will there be reach-through requirements on
materials transferred?
Should any intellectual property arise that
requires a patent, will the technology remain widely available to the research
community?
Applicants are reminded that
the grantee institution is required to disclose each subject invention to
NIH within two months after the inventor discloses it in writing to grantee
institutional personnel responsible for patent matters. The awarding Institute
reserves the right to monitor awardee activity in this area to ascertain if
patents or patent applications on Xenopus identified through phenotypic screens
and on phenotypic and genotypic data for all Xenopus strains or other patentable
subject matter are adversely affecting the goals of the PA.
The plans for sharing
research data, for sharing research resources, and for addressing intellectual
property rights should be described in a brief section of the application immediately
following the Research Plan.
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:
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, methodologies, tools,
or technologies for this area?
Investigators:Are the PD/PI(s) and other key personnel 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 PD/PI(s) and investigative team bring complementary and integrated
expertise to the project (if applicable)? This FOA encourages, but does not
require, collaborations among PD/PIs in disciplines that contribute to social
neuroscience. Are proposed collaborators sufficient for the project?
Do they individually represent strengths in the subdisciplines essential to
the project? Depending on the basic or translational nature of the project,
these subdisciplines may include, e.g., basic systems neuroscience (animal
or human), social psychology, clinical science.
Environment: Do(es) the scientific environment(s) in which the work
will be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review Criteria
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:
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?
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.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score. The presence of a data sharing
plan will be part of the terms and conditions of the award. The funding organization
will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
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):
Steven L. Klein, Ph.D. Developmental Biology, Genetics and Teratology Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 4B01,MSC 7510 Bethesda, MD 20892-7510 Rockville, MD20852 (for express/courier
service; non-USPS service) Telephone:
(301) 435-6886 Email: [email protected]
2. Peer Review Contact(s):
Richard Panniers, Ph.D. Chief Genes, Genomes and Genetics Integrated Review Group Center for Scientific Review Rockledge 2, Room 2212 6701 Rockledge Drive Bethesda, MD20892-7890 BethesdaMD20817 (for express/courier
service; non-USPS service) Telephone:
(301) 435-1741 Email: [email protected]
3. Financial/Grants Management
Contact(s):
Christopher Robey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Blvd.,
Room 8A17K, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD20852 (for express/courier
service; non-USPS service) Telephone:
(301) 435-6996 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.
