Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
This RFA is developed as an NIH roadmap initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate in roadmap initiatives. The RFA will be administered by the National Institute of General Medical Sciences (NIGMS) on behalf of the NIH.

Title: NIH Director’s Pioneer Award Program (DP1)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 forms and the application instruction 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 should be started at least two weeks in advance of the planned submission. See Section IV.

[Two steps are required for on time submission:

1) The application must be submitted to grants.gov by 8:00 p.m. Eastern Time on the receipt date (see “Key Dates” below)

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.]

The text above, shown in brackets, has been replaced with the following text, in bold, per NOT-RM-06-012.

In order for a submission to be considered on time, the application must be submitted to Grants.gov by 8:00 p.m. Eastern Time on the receipt date (see "Key Dates" below).

Request For Applications (RFA) Number: RFA-RM-06-005

Catalog of Federal Domestic Assistance Number(s)
93.390

Key Dates
Release/Posted Date: November 18, 2005
Opening Date(Earliest date an application may be submitted to Grants.gov): January 15, 2006
Letters of Intent Receipt Date(s): Not applicable.
Application Receipt Date: February 27, 2006, 8:00 p.m. (EST)
Letters of Reference Submission Date: February 27, 2006, 8:00 p.m. (EST)
Peer Review Date(s): May, 2006
Advisory Council to the Director Date(s): September, 2006
Earliest Anticipated Start Date: September 30, 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: February 28, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals

2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

A unique aspect of the NIH Roadmap for Medical Research is the NIH Director's Pioneer Award (NDPA) Program. First announced in Fiscal Year 2004, nine awards were made in September 2004, and 13 awards were made in 2005. The NDPA is designed to support individual scientists of exceptional creativity who propose pioneering approaches to major challenges in biomedical research. The term “pioneering” is used to describe highly innovative approaches that have the potential to produce an unusually high impact, and the term “award” is used to mean a grant for conducting research, rather than a reward for past achievements. Biomedical research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences. The NDPA is meant to support individuals who intend to pursue new research directions that are not already supported by other mechanisms. The program is not intended simply to expand the funding of persons already well supported for a particular project.

Background

The NIH's success depends on the creativity of investigator-initiated research, much of it supported by the R01 grant mechanism. Many scientists who participated in the development of the NIH Roadmap, however, expressed the view that additional means might be necessary to identify scientists with ideas that have the potential for high impact, but may be too novel, span too diverse a range of disciplines, or be at a stage too early to fare well in the traditional peer review process. A group of distinguished outside consultants proposed that NIH implement a completely new program to encourage highly innovative biomedical research with the great potential to lead to significant advances in human health. This program would complement NIH's traditional, investigator-initiated grant programs. Unlike most NIH grant mechanisms, the NDPA is designed not to support projects but rather to support highly creative and pioneering people.

This RFA announces a third NPDA competition for approximately 5-10 new awards of $500,000 in direct costs per year for five years that will be made in Fiscal Year 2006. Awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the NDPA.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the DP1 award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

2. Funds Available

Sufficient funds have been set aside in 2006 to provide 5-10 awards. The awards will be for $500,000 in direct costs each year for five years.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Investigators eligible for the NDPA must be U.S. citizens, non-citizen nationals, or permanent residents who are currently engaged in research. The research proposed need not be in a conventional biomedical or behavioral discipline; if the individual's experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical relevance. If selected, individuals must show evidence of institutional infrastructure support. Nominees and applicants who were not selected for an award in 2004 or 2005 may submit applications this year. Investigators at all career levels are eligible. Those at early to middle stages of their careers, and women and members of groups underrepresented in biomedical research are especially encouraged to apply.

2. Cost Sharing or Matching

Not applicable

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Not applicable

Section IV. Application and Submission Information


Registration and Instructions for Submission via Grants.gov


To download an Application Package and Instructions for completing the SF424 forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that site.

A one-time registration is required for institutions at both:

Investigators should work with their institutional/organizational officials to make sure that institutional officials and investigators are registered in the NIH Commons.

Several additional separate actions are required before an applicant institution can submit an application through Grants.gov. See "Preparing for Electronic Submission" at http://era.nih.gov/ElectronicReceipt/preparing.htm.

Several of the steps of the registration process could take up to two weeks. Therefore, applicants should immediately check with their institution official to determine whether their institution is already registered in both Grants.gov and the Commons.

Please direct questions regarding the Commons registration process to the NIH eRA Commons Help Desk at phone: 301-402-7469 or 866-504-9552 (Toll Free) or 301-451-5939 (TTY) during business hours on M-F from 7AM-8PM, Eastern Time.

1. Request Application Information

Applicants must download the SF424 application forms and instructions for this FOA through the Grants.gov Apply http://www.grants.gov/Apply Web site.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

The application process has been streamlined and is different from that used in 2005. The application submission process requires two separate, but concurrent, steps: submission of the application to Grants.gov (http://www.grants.gov) and submission of supplementary information to the NDPA Secure Web site (http://nihroadmap.nih.gov/pioneer/Supplemental.aspx).

Prepare all applications using the SF424 application forms.

Detailed instructions for submitting materials to Grants.gov and to the NDPA Secure Web site are at http://www.nihroadmap.nih.gov/pioneer/ApplicationInstructions.aspx. In addition, applicants must arrange to have three letters of reference sent to the NDPA Secure Web site http://nihroadmap.nih.gov/pioneer/lettersofreference.aspx.

The application to be submitted to Grants.gov must include:

An abstract of no more than 300 words describing the goals of the project.

An essay of 3-5 pages that addresses the investigator's innovative vision for, and the significance of, the biomedical problem to be addressed, and his/her qualifications to engage in groundbreaking research. The essay should describe the individual's view of the major challenges in biomedical research to which he/she can make seminal contributions. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections within the 3-5 page limit:

A 2-page biographical sketch.

A list of current research support from all sources.

The applicant’s single most significant publication or achievement.

The supplemental information to be submitted to the NDPA Secure Web site must include:

The format for the three letters of reference on behalf of the applicant and instructions for submitting the letters to the NDPA Secure Web site can be found at http://nihroadmap.nih.gov/pioneer/LettersofReferenceFormat.aspx.

Applications may be submitted to Grants.gov (http://www.grants.gov) on or after January 15, 2006 (i.e., the Open Date on Grants.gov) and must be submitted no later than 8:00 P.M. EST, February 27, 2006.

Letters of reference must also be submitted to the NDPA Secure Web site (http://nihroadmap.nih.gov/pioneer/LettersofReference.aspx) between January 15, 2006 and 8:00 P.M. EST, February 27, 2006.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Receipt Dates and Times

Applications must be submitted on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Release/Posted Date: November 18, 2005
Opening Date: January 15, 2006 (Earliest date an application may be submitted to Grants.gov)
Application Receipt Date: February 27, 2006, 5:00 p.m. (EST)
Letters of Reference Submission Date(s): February 27, 2006, 5:00 p.m. (EST)
Peer Review Date(s): May, 2006
Advisory Council to the Director Date(s): September, 2006
Earliest Anticipated Start Date: September 30, 2006
Expiration Date: February 28, 2006

3.A.1. Letter of Intent

Not applicable

3.B. Sending an Application to the NIH

Applications in response to this FOA may only be submitted to Grants.gov through Grants.gov Apply. Applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must also submit supplementary information to the NDPA Secure Web site (http://nihroadmap.nih.gov/pioneer/supplemental.aspx). See section IV.2 above for detailed information regarding submission of supplementary information.

3.C. Application Processing

Applicants are reminded to follow the submission dates cited in this FOA. Applications must be submitted to Grants.gov and supplemental information to the NDPA Secure Web Site on or before the application submission date(s) described above (Section IV.3.A.). Three letters of reference must also be submitted by the date specified above. If an application, supplemental information, or letters of reference are received after that date, it will not be reviewed.

[
There will be acknowledgements of receipt of applications from Grants.gov, the NDPA Secure Web site, and the Commons. Information related to the assignment of an application for review is also in the Commons.]

The text above, shown in brackets, has been replaced with the following text, in bold, per NOT-RM-06-012.

“There will be acknowledgements of receipt of applications from Grants.gov and of the supplementary application information from the NDPA Secure Web site.

Note that it may take several weeks for applications to appear in the NIH Commons. Although Pioneer Award applications are submitted electronically, application receipt and processing has not been automated. As a result, it may take several weeks for applications to be processed and added to the NIH Commons.”

Upon receipt, applications will be evaluated for completeness and eligibility by NIH staff. Incomplete and/or ineligible applications will not be reviewed.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).

6. Other Submission Requirements

Not applicable

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 will be evaluated based on the likelihood that the applicant will pursue a pioneering approach to a problem of relevance to biomedical research, the absence of alternative funding to pursue this direction; and compelling justification for the advantage of evaluation by the NPDA process rather than by the standard peer review process. In particular, reviewers will evaluate:

The scientific problem to be addressed: The biomedical significance/importance of the problem, the likelihood that, if successful, the project will have a significant impact on a biomedical problem, and the innovativeness of the project.

The investigator: Evidence for the investigator’s claim of innovativeness/creativity (innovation density), and the demonstrated ability of the investigator to devote 51% or more effort on NDPA project.

The suitability for NDPA mechanism: Evidence that the proposed project is of sufficient risk/impact to make it more suitable for the NDPA than for the traditional NIH grant mechanism and that it is distinct from other research previously or currently conducted by the investigator.

The following will be considered in making funding decisions:

Sufficient funds have been set aside in 2006 to provide 5-10 awards. The awards will be for $500,000 in direct costs each year for five years. Although there are no stipulations on the research agenda, awardees will be required to submit a report on June 1 of each year describing the activities conducted during the year through the NPDA, to submit a final progress report at the end of the grant period, and to participate in an annual symposium on the NIH campus. This symposium will allow awardees to share their ideas, progress, and experience with each other, the research community, and NIH staff.

Applications that are complete and responsive to the RFA will be evaluated first by NIH staff for completeness and eligibility and then electronically by a multidisciplinary group of outside experts. Those candidates that are identified as the most outstanding will be invited to NIH for interviews in August 2006. Interviews will be conducted by a panel of distinguished outside experts. The Advisory Committee to the Director (ACD), NIH, will conduct the final level of review. The Director, NIH, will make the final selection of awardees based on the evaluations by the outside experts, the recommendations of the ACD, and programmatic considerations. Final selections will be announced, and awards made, by the end of September 2006.

2.A. Additional Review Criteria:

Not applicable

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

Not applicable

3. Anticipated Announcement and Award Dates

Finalists selected for interviews and those applicants not selected for interviews will be notified in June, 2006. Awardees will be notified in August, 2006, and awards will begin September 30, 2006.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the NoA and will be provided to the Principal Investigator and the appropriate institutional official at the time of award:

a. The grant program legislation and program regulation cited in this Notice of Grant Award.

b. The restrictions on the expenditure of federal funds in appropriations acts, to the extent those restrictions are pertinent to the award.

c. 45 CFR Part 74 or 45 CFR Part 92 as applicable.

d. The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period.

(See NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above.)

Awardees are expected to participate in an annual symposium on the NIH campus. This symposium will allow awardees to share their ideas, progress, and experience with each other, the research community, and NIH staff.

Individuals who apply should be aware that they may be contacted at a later time to provide NIH with a limited amount of follow-up information. Because the NDPA is a pilot program, NIH believes that contacting participants is important for evaluating the NDPA program and its outcomes.

3. Reporting

Although there are no stipulations on the research agenda, awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually on June 1 (http://grants.nih.gov/grants/funding/2590/2590.htm), a final progress report at the end of the grant period, and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Detailed instructions for submitting applications to Grants.gov and to the NDPA Secure Web site can be found at http://nihroadmap.nih.gov/pioneer/applicationInstructions.aspx. For more information about the NPDA, see Frequently Asked Questions at http://nihroadmap.nih.gov/pioneer.

Judith H. Greenberg, Ph.D.
Director, Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As25
MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-0943
Fax : 301-480-2228
Email: pioneer@nih.gov

The NIH Director's Pioneer Award is among several initiatives being undertaken as a part of the NIH Roadmap. To learn more about the NIH Roadmap see the NIH Roadmap Website at http://nihroadmap.nih.gov.

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

[Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score. ]

The text above, in brackets, has been deleted from this announcement, per NOT-RM-06-012.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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