Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)

Title: Complementary and Alternative Medicine Career Transition Award (K22)

Announcement Type
New

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

Program Announcement Number: PAR-05-129

Catalog of Federal Domestic Assistance Number(s)
93.213

Key Dates
Release Date: June 23, 2005
Letters of Intent Receipt Date(s): Not required
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 2, 2008 (now September 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Eligible organizations include:

Eligible Principal Investigators include scientists with clinical or research doctorates (including Ph.D., M.D., D.O. D.C., N.D., D.D.S., D.V.M., Sc.D., D.N.S. or equivalent doctoral degrees) who have at least 1 year but no more than 5 years of postdoctoral research training.

In addition, applicants must also be currently

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(s) 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. Address to 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

Nature of the training/research opportunity

This transition award will provide support for up to 1 year at the postdoctoral level and 3 years of support as an independent scientist to an outstanding advanced postdoctoral trainee who has at least 1 and not more than 5 years of postdoctoral research training at time of submission of the application. The purpose of the short term postdoctoral support (up to one year) is to allow the postdoctoral trainee time to complete research, publish results, and search for an independent position, if they have not obtained an independent position at the time of the K22 award. As part of this application, the candidate must propose a CAM research project for his/her independent research position. The candidate's postdoctoral training may be on a CAM research topic or a research topic that will prepare him/her for the proposed CAM research as an independent scientist.

Pertinent background information that establishes the need for the training/research

One of the most challenging transitions in any research career is the transition from postdoctoral trainee to independent scientist. Recent reports have highlighted the need to foster the transition of postdoctoral scientists from mentored environments to independence. For postdoctoral trainees doing research in CAM, this transition has an added challenge because there are still relatively few CAM departments in research institutions where they might seek positions. Therefore, an important goal of this initiative is to improve the chances of outstanding postdoctoral scientists preparing to do CAM research to obtain positions in either CAM and more conventional departments in research institutions, thus benefiting the CAM research field as a whole.

NCCAM is committed to training researchers in CAM so that they are prepared to launch successful independent research careers. Providing support to such trainees is crucial to CAM research to ensure a sufficient number of highly trained researchers in this relatively new research field and to sustain high quality CAM research in the future.

Scientific knowledge to be achieved through research supported by the special program

The mission of NCCAM is to apply rigorous research methods to investigate the efficacy and underlying mechanisms of CAM therapies. NCCAM defines CAM therapies as medical or health-related therapies practiced in the United States but not presently considered an integral part of conventional medicine. For more information please see the NCCAM Five-Year Strategic Plan 2005-2 009 (http://nccam.nih.gov/about/plans/2005/index.htm). As stated in NCCAM's strategic plan, CAM can be divided into four major domains. These domains are mind-body medicine, biologically based practices, manipulative and body-based practices, and energy medicine. Both clinical and basic research is encouraged in all these domains.

In addition, NCCAM periodically reviews its research portfolios and revises its areas of special interest. These areas are posted on the NCCAM website at: http://nccam.nih.gov/research/priorities/index.htm#5. However, research proposals need not be limited to these areas. Therefore, applicants are encouraged to visit this website and consult with the scientific/research contact person listed in this announcement about potential CAM research topics.

Objectives of this research program

The objective of this award is to assist outstanding postdoctoral scientists planning a CAM research career to make the transition from postdoctoral trainee to independent research scientist; and once they obtain an independent position, to have the protected time to develop their research career. The advantage to the applicant is that this award will provide financial support during the postdoctoral phase and additional support for the future independent investigator phase that can be utilized immediately upon obtaining an independent research position. Thus, these outstanding advanced postdoctoral scientists selected for this award, will not only have outstanding research credentials to offer a perspective employer, but also research funds that they can activate immediately upon accepting an independent position. The goal is to improve the likelihood of successfully transitioning postdoctoral scientists planning to do CAM research to independence research careers. A related goal for NCCAM is to increase the probability that the very best new CAM researchers will obtain positions at research-intensive institutions and start foci of high quality CAM research at these sites.

See Section VIII, Other Information – Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the N IH Research Scholar Development Award (K22) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed research project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the “initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

2. Funds Available

The NCCAM K22 award has two phases: a mentored postdoctoral phase (intramural or extramural) of up to 1 year and an independent scientist phase of 3 years. Intramural Postdoctoral Phase: Postdoctoral scientists in the NIH intramural program will be fully supported by the NIH Institute/Center intramural laboratory in which they are doing their research. The total budget for intramural scientists for the postdoctoral phase will be negotiated with the sponsoring intramural laboratory Institute/Center and should be consistent with that offered postdoctoral scientists in similar positions. There will be no extramural grant award associated with intramural postdoctoral phase for this K22 award.

Extramural Postdoctoral Phase: Extramural postdoctoral scientists supported by any one of the mechanisms listed under eligibility requirements will be supported by NCCAM and/or ODS extramural funds. Direct costs are limited to salary, fringe benefits, and a maximum of $25,000 for research-related expenses. Although this is not a National Research Service Award, salary in the postdoctoral phase will be based on NRSA Individual Postdoctoral Fellowship stipends levels. These stipend levels change periodically. The current levels are found at this website: http://grants.nih.gov/training/nrsa.htm#policy. Research expenses may include (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Ancillary Personnel Support including salary for mentors, secretaries and administrative assistants is not allowed.

The postdoctoral candidate (intramural or extramural) is required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program during the postdoctoral phase. This would typically include activities such as completing research, publishing results, and searching for an independent position. If the candidate has already obtained an independent position at the time of the award, the postdoctoral phase may be eliminated.

Independent Investigator Phase: In the independent investigator phase, direct costs are limited to $150,000 per year. They may include salary and fringe benefits; research expenses, such as supplies, equipment and technical personnel; travel to research meetings or training; and statistical services including personnel and computer time. The maximum salary that can be requested from this grant award is $50,000. It is expected that the institution will supplement this salary, if necessary, to bring it to a salary level similar to the level for comparable positions at the institution. Since the grantee is required to devote at least 75 per cent effort to the research proposed in this award during the independent phase, this supplementation may not include additional duties that would interfere with this required percent effort.

Administrative costs will be reimbursed at 8 percent of modified total fiscal costs for both phases of the award.

It is anticipated that the start dates for the first awards will be in July 2006.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

The applicant institution should be the postdoctoral phase institution. All institutions types listed above are eligible for both the postdoctoral and independent phase, with one exception: Eligible agencies of the Federal government, such as the NIH intramural program, are eligible for the postdoctoral phase only.

Foreign institutions are not eligible to apply for this grant.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

An applicant is eligible if he/she meets requirements 1 and 2 and 3 and any one of requirements a to d.

At time of submission, applicants must:

  1. be a US citizen, non-citizen national, or lawful and verifiable permanent US resident with an Alien Registration Card (I-151 or I152); AND
  2. have an earned clinical or research doctorate (including Ph.D., M.D., D.O., N.D., D.C., Sc.D., D.V.M., and D.N.S or equivalent doctoral degree); AND
  3. have between 1 and 5 years of postdoctoral research training at time of application.

Applicants must also be currently supported as a postdoctoral trainee or fellow by any ONE of the following mechanisms:

a. by an NCCAM Institutional NRSA training grant (T32) or an Individual NRSA Postdoctoral fellowship award F32); OR
b. by a T32 or F32 grant award from another NIH Institute or Center; OR
c. by a NIH Individual intramural Research Training Award, such as an IRTA; OR
d. by another prestigious national or international postdoctoral award to individual scientists.

Applicants are strongly encouraged to consult with the scientific/research contact person listed in this announcement if they have questions about eligibility.

Individuals are NOT eligible if they:

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun &Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Applicants should follow the instructions in the PHS 398 application for Individual Research Career Development Awards (CDA) and complete ALL the required sections with the following modifications unless otherwise noted here:

Section C. Letters of Reference: Follow the instructions described in this section of the PHS 398 application. The current postdoctoral mentor should not be one of the 3 required references.

Section D. Administrative Data: Complete ALL sections with the following modifications.

Section F. Career Development Plan: Complete ALL the sections with the following modifications/exceptions.

2.Submission Dates and Times
See Section IV.3.C for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date Not required
Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all five copies of the appendix material must be sent to:

Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 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 continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

For projects proposing clinical trials, guidelines for NCCAM-supported clinical trials should be followed:

http://nccam.nih.gov/research/policies/index.htm

For projects involving biologically active products, the following guidance should be followed:

http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-003.html
http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html

Training in the Responsible Conduct of Research

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regard the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction.  An award cannot be made if an application lacks this component.

Plan for Sharing Research Data
A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the data sharing plan and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria
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 NCCAM on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NCCAM in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research and research training are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Candidate: Based on the postdoctoral candidate's research training background and research accomplishments, what is his/her potential to become a successful independent investigator? In making this judgment consider the overall quality of the candidate's postdoctoral research training experience including expertise gained, productivity, the mentor(s) research qualifications and productivity, and the quality of the postdoctoral research project. Comment on how this experience will prepare the candidate to successfully implement the independent phase project. In addition, consider letters of recommendations from referees, the statement from the postdoctoral mentor (sponsor) and the statement from the institutional training grant director (where applicable), as well as the quality of the research project proposed for the independent phase.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Since the quality of the scientific environment of the independent investigator phase is not known as the time of the application, please comment on the postdoctoral scientific research environment, in terms of promoting success of this candidate.

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:

Training in responsible conduct of research
Appropriateness and adequacy of training in responsible conduct of research.

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from 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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data
A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. 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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the 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.

Requirements and guidance for the independent phase:
Grantees are encouraged to consider independent positions at departments and institutions different from where they conducted their postdoctoral research. Should a grantee wish to activate the independent phase of the grant award at the same department or institution at which they conducted their postdoctoral research, grantees will be asked to include and document compelling justification addressing the decision to remain at the same institution.

To activate the independent phase of this K22 grant award, the grantee must submit to NCCAM a transfer research application, with an updated research and budget plan, using the PHS 398 application form. This transfer application must be signed by the appropriate officials at the hiring institution. The transfer application will be administratively reviewed by NCCAM. Approval, based on the administrative review, will be required before the independent phase can be activated.

Evidence of institutional commitment to the newly independent investigator: To activate the second, independent phase of the grant, individuals must have been offered and accepted a tenure-track, full time assistant professor position (or equivalent) at an institution with a history of rigorous research programs and extensive outside research funding. While an institutional commitment agreement from the independent phase institution is not required when the original application is submitted, such an agreement will be required at the time of activation of the independent phase of the award. This agreement will be similar to the institutional agreement described in the CDA section of the PHS 398 application.

So that the grantee can devote as much time as possible to the development of his/her research career, institutions are expected to confirm that at least 75% of the candidate's time and effort can be devoted to the research proposed in the K22 grant award for the duration of the independent phase of the award. Therefore, NCCAM expects that the institution will release the grantee from most administrative duties. Candidates may engage in limited teaching and clinical duties as part of the 25% maximum of the applicant's effort not covered by this grant award, as long as such teaching and clinical duties are minimal. In addition, the institution is expected to provide the candidate sufficient resources and salary support to launch his/her research career. The start-up package must be similar to that which is typically offered to other new faculty members. NCCAM staff may review start-up packages and other agreements between the institution and grantee prior to activating the second, independent phase of the grant. NCCAM need not activate independent phase funds if the institutional commitment is deemed inadequate.

Institutions may supplement a grantee's salary so that the salary is consistent with salaries of individuals in comparable positions at the institution. However, performing or assuming additional responsibilities that would interfere with the required 75 percent effort on the K22 award is not permitted.

K22 Grant awardees will be expected to submit an R-series grant application to the NIH, or a similar application to a Federal government or private funding agency, by the end of second year of the independent phase.

Postdoctoral fellows with the NCCAM K22 award are free to apply for independent phase positions within NIH's intramural research program (IRP). However, should the fellow accept such a position in the IRP, the independent portion of the K22 grant to the individual will be terminated.

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 grant 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/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually, for both the postdoctoral and independent phase:  Note that the instructions for Research Career Development applications must be followed for this program, http://grants.nih.gov/grants/funding/2590/2590.htm and annual financial statements as required in the NIH Grants Policy Statement.

The Progress Report must include Sections a through f as described in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. Evaluation of your progress will depend on the following:

A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or when an award is relinquished as a recipient changes institutions.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Nancy J. Pearson, PH.D.
DHHS
National Institutes of Health, NCCAM
Democracy II, Suite 401
6707 Democracy Blvd.
Bethesda, MD 20892-5475
Telephone: (301) 594 0519
FAX: (301) 480 3621
Email: pearsonn@mail.nih.gov

2. Peer Review Contacts:

Martin Goldrosen, Ph.D.
DHHS
National Institutes of Health, NCCAM
Democracy II, Suite 401
6707 Democracy Blvd.
Bethesda, MD 20892-5475
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: gt85x@nih.gov

3. Financial or Grants Management Contacts:

George Tucker, MBA
DHHS
National Institutes of Health, NCCAM
Democracy II, Suite 401
6707 Democracy Blvd
Bethesda, MD 20892-5475
Telephone: (301) 594 8853
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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 the scientific merit or the priority score.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 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.

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.

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.

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/.


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NIH Funding Opportunities and Notices


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