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
 National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)

Title: NIAAA Career Transition Award (K22)

Announcement Type
New  

Program Announcement (PA) Number: PAR-06-096

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

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Catalog of Federal Domestic Assistance Number(s)
93.271

Key Dates
Release Date: December 15, 2005
Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s):  http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date:  http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable  
Expiration Date: January 8, 2009 (per PAR-09-059) – Previously: January 8, 2010 (per NOT-OD-07-093) – Originally: January 3, 2010 

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(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. Receipt and 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
 
PURPOSE OF THIS PA

A vital component of the NIAAA mission is to develop the next generation of exceptionally talented new scientists who are committed to conducting basic or clinical research related to the health risks and benefits of alcohol consumption, and the prevention and treatment of alcohol-related problems.   The purpose of the NIAAA Career Transition (K22) Award is to facilitate the transition of postdoctoral fellows and beginning investigators into fully independent faculty positions.  This will be achieved by providing salary and research support for up to three years after candidates receive appointments at academic research institutions.   The program is designed for: 1) advanced postdoctoral fellows at extramural research institutions who are currently supported by an NIAAA-sponsored Ruth L. Kirschstein National Research Service Award (NRSA) for Individual Postdoctoral Fellows (F32) or an NIAAA Institutional Research Training Grant (T32);  2) current Intramural Research Training Awardees (IRTA) or equivalent staff fellows in the NIAAA Division of Intramural Clinical and Biological Research (DICBR).  

Eligible individuals may apply while they are still in a "mentored" postdoctoral position.  Successful applicants will be given up to 18 months to identify an independent faculty position at a sponsoring institution before the award can be activated.   The purpose of the award is to provide core salary and research support while candidates develop their independent research capabilities and begin obtaining preliminary data.   After establishing the research program, the K22 recipient is expected to apply for an investigator-initiated research grant (R01, R03, R21) in a research area relevant to the mission of the NIAAA.

BACKGROUND

One of the most important goals of NIAAA is to ensure the development of highly qualified new investigators in alcohol-related research.  To accomplish this objective, NIAAA sponsors fellowship training and career development programs in a variety of basic and clinical research disciplines, including social, behavioral, biological, and mathematical sciences.  Pre- and postdoctoral support is provided via Ruth L. Kirschstein National Research Service Awards (NRSA).    NRSA awards are made as individual fellowships (F30 and F31 predoctoral fellowships, F32 postdoctoral fellowships) or as institutional programs that support multiple trainees (T32 Institutional Research Training Grants).  

Postdoctoral training can also be obtained in the Division of Intramural Clinical and Biological Research (DICBR) at NIAAA.  Basic and clinical scientists in the intramural laboratories conduct a broad array of alcohol-related research activities including: basic neuroscience investigations conducted at molecular, cellular, systems, and behavioral levels; studies on alcohol metabolism, alcohol-related liver disorders, and structural analysis of membrane proteins; and clinical investigations into the diagnosis, treatment and prevention of alcohol abuse and alcoholism.  Detailed information about intramural investigators and their research programs can be obtained at http://www.niaaa.nih.gov/ResearchInformation/IntramuralResearch/.

For those seeking an academic research career at a university or medical school, the next stage in career development is to obtain a faculty position and launch a research program with independent grant support.   This transition is one of the foremost challenges facing aspiring new investigators.  Many postdoctoral fellows continue to be supported in their mentors’ laboratories for several years after completing their NRSA or IRTA programs.  Finding a faculty position can be a long and difficult process.  For those who do find a position, developing a successful research program is often impeded by teaching and administrative responsibilities.   Lack of experience in writing grant applications may also be a barrier for new investigators.

The NIAAA Career Transition Award is designed to facilitate the transition of postdoctoral fellows as they acquire new faculty positions and secure research independence.   The award is intended for fellows who have completed, or are nearing completion of, their formal mentored training programs.  In general, applicants will have completed at least two, but no more than six years of postdoctoral training at the time of application.  Eligible individuals may apply while they are still in a “mentored” position.  Fellows currently working in the NIAAA intramural program (DICBR) who meet the requirements are eligible to apply. Postdoctoral fellows at extramural institutions who are supported by NIAAA through an Individual NRSA (F32) or an Institutional Research Training Grant (T32) are also eligible.  Applicants for the K22 award should apply via PHS398 application procedures according to standard receipt dates (See Section IV, Application and Submission Information). 

Applications will be evaluated for scientific and technical merit by an appropriate review group convened by NIAAA in accordance with the review criteria outlined in Section V. of this announcement.  Applicants selected for potential funding will receive a letter of intent to commit funds from NIAAA.   Applicants will then have up to 18 months to activate the award.  Activation requires a formal offer of appointment to an independent faculty position.  In addition, the proposed institution must demonstrate a commitment to the candidate’s career development by 1) assuring 75% protected time for research or career-related activities, and 2) providing a supportive environment and adequate facilities to carry out the project.    The K22 award provides the core resources and protected time needed for beginning faculty to develop independent research programs.   It is anticipated that the awardee will use the award to obtain preliminary data that will become the basis for a future research grant application.

Individuals considering the K22 mechanism should also consult Program Announcements for other Career Development Awards (K-awards) to determine which program is most appropriate to their academic background and level of research experience. NIAAA offers a variety of K-awards to support investigators at specific stages of their careers (see http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/PAs/career.htm).   Mentored career awards are designed for individuals who seek further research career development and guidance under the direction of an established Principal Investigator.  Such career awards are for a term of 3 - 5 years.   Mentored awards are also available for established investigators who wish to receive training in another research field.   A listing of the various career development awards and the Institutes that sponsor them can be found at the NIH “K-Kiosk” website (http://grants.nih.gov/training/careerdevelopmentawards.htm).  Prospective applicants are strongly encouraged to contact NIAAA Program Staff to obtain more specific guidance on funding mechanisms and career planning.

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 NIAAA Career Transition (K22) award mechanism.   As an applicant, you will be solely responsible for planning, directing, and executing the proposed project and career development activities. The award will provide support for up to three years after appointment to an academic research position. K22 awards are not renewable.   

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).   The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs for each year and the entire proposed period of support as well as budget justification information.  

2. Funds Available

NIAAA anticipates 2 - 5 new K22 awards per year. The total amount to be awarded under the K22 program and the number of anticipated awards will depend upon the quality, duration, and costs of the applications received, the availability of funds, and program priorities.

ALLOWABLE COSTS

Salary:  The K22 Career Transition Award will provide a salary up to a maximum of 75 percent of the institutional base salary, based on a full-time, 12-month staff appointment. The award requires the candidate to devote a minimum of 75% of full-time professional effort to conducting the research career development plan described in the application; the remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.  If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.  Confirmation of salary is required prior to the issuance of an award.  Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution’s salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.  In no case may PHS funds be used for salary supplementation.  Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the K22 award.  Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution’s salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. 

K22 recipients in the last two years of career award support are encouraged to obtain funding from NIH either as Principal Investigator on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award. Requested budgets for such grants should request appropriate amounts for the salary and associated costs for the career recipient’s effort.  At the time the research grant is awarded, the effort required on the career award may be reduced to no less than 50 percent and replaced by effort from the research award so that the total level of research commitment remains at 75 percent or more for the duration of the career award.   Details of this policy can be found at:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Support:  In addition to salary, the K22 award will provide a maximum of $75,000 per year for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) statistical services, including personnel and computer time; (c) tuition and fees related to career development; and (d) travel to relevant research meetings or for training.   

Ancillary Personnel Support:  Salary for secretarial or administrative assistance is not allowed. 

Facilities and Administrative (F&A) Costs:  These costs, which were formerly called indirect costs, will be reimbursed at 8% of modified total direct costs.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

The candidate for the Career Transition Award must be an outstanding basic science or clinical investigator with demonstrated potential for a highly productive research career.  Candidates for this award must have a research or health-professional doctoral degree or its equivalent.  Such degrees include but are not limited to the Ph.D., M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., as well as a doctoral degree in nursing research or practice.   

In general, candidates will have completed at least two, but no more than six years of postdoctoral training at the time of application.  This includes individuals with postdoctoral research experience in any environment (e.g., academic, industry, and government).  In unusual circumstances, exceptions to the six year limitation may be granted by NIAAA.  Such waivers will be considered on a case by case basis, and must accompany the initial application packet.   Years of clinical training will not count against the six years of relevant research experience  

Eligible individuals include: 1) advanced postdoctoral fellows at extramural research institutions who are currently supported by an NIAAA-sponsored Ruth L. Kirschstein National Research Service Award (NRSA) for Individual Postdoctoral Fellows (F32) or an Institutional Research Training Grant (T32); 2) current Intramural Research Training Awardees (IRTA) or equivalent staff fellows in the NIAAA Division of Intramural Clinical and Biological Research (DICBR).   

Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible.

To activate the award, candidates must obtain a formal offer of appointment to a faculty position at a U.S. academic institution.  Candidates will have up to 18 months to activate the award.  Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research and research career development activities associated with this award. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K22 Award. 

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the NIH Grants Policy Statement.  

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

Applications must be relevant to the mission or to the research priorities of the NIAAA. 

A candidate for an NIH K22 award may not simultaneously submit or have an application pending for any other PHS career development award (e.g., K01, K07, K08, K23), a research project grant (R01), or any PHS or non-Federal award that duplicates any of the provisions of the K22 award. 

Former or current principal investigators on any NIH research project grant or project leaders on sub-projects of program project (P01) or center (P50/P60) grants are not eligible to apply.  K22 recipients are encouraged to apply for independent research grant support during the latter period of this award.  Recipients of a K22 award may hold concurrent research support, and under certain circumstances (see Allowable Costs above) salary support from their career award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

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 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 for preparing research career development award applications in Section III of the PHS 398 instructions.  Applications that exceed the page limitations or the PHS 398 requirements for font size (height or letters), type density (characters per inch), and margins (see PHS 398 directions) will be returned to the applicant. Further details are provided below under Other Submission Requirements.  

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Submission Date:   Not applicable
Application Submission Date(s):  http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date:   http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date:   http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date:   http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity

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 five 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)

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. Incomplete applications will not be accepted.  

The NIH will not accept any application in response to this funding opportunity 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 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 award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing 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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III), the following information must be included in the application.     

FACE PAGE

BUDGET

The pages specifying Detailed Budget for the Initial Budget Period (Form Page 4) and Budget for Entire Proposed Period of Support (Form Page 5) are NOT required for the initial application and should be omitted.  A detailed budget is subsequently required only for the activation of the award at the academic institution of employment.  See specific instructions above for allowable costs.

CANDIDATE

CAREER DEVELOPMENT PLAN (one page maximum)

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction 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 regarding 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.

RESEARCH PLAN

Organize the Research Plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods.  The Research Plan may not exceed 15 pages in length.  Tables and figures, but not the Literature Cited , are included in the 15-page limitation. 

The scope of the proposed work should be sufficient to justify the requested period of support.

The Research Plan should describe the use of a basic, behavioral, or clinical approach to a biomedical question relevant to the mission of the NIAAA.  The Research Plan is expected to follow the typical NIH research grant application organization and structure, and should include, but is not limited to the following:

Although the research proposal is expected to be independently designed and carried out by the candidate, input from the applicant’s postdoctoral mentor or other senior faculty into the review and editing of the research proposal is encouraged as a part of the career development experience.

LETTERS OF REFERENCE

Include with the application three letters of reference from established scientists that address your potential to become a successful independent investigator in basic, behavioral, or clinical research relevant to the mission of NIAAA (see instructions in Section III of PHS 398 application kit).   Letters from former or current mentors are acceptable.  Applications without letters of recommendation will be considered incomplete and will not be accepted.  Late receipt of letters of recommendation (e.g., letters not submitted concomitantly with the application) will not be allowed.

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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process
 
Applications that are complete and responsive to this PAR will be evaluated for scientific and technical merit by an appropriate review group convened by the NIAAA in accordance with the review criteria stated below.

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

Applications will compete for available funds with all other approved career development award applications.  The following will be considered in making funding decisions:

REVIEW CRITERIA

The goals of NIH-supported research career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs.  The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority. 

Candidate:

Career Development Plan:

Research Plan:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the 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 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 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: Although a detailed budget is not required, the appropriateness of the scope of work for the funds that are available through this grant mechanism will be considered.  The applicant should assume that general laboratory equipment items such as spectrophotometer, centrifuges, etc., will be available at the institution. However, highly sophisticated or limited use equipment required for the studies should be identified and funds for the use of such equipment should be considered by the applicant in developing the research plan.  For example, magnetic resonance imaging equipment and fluorescence cell sorters are available for a fee at many institutions, and the cost for their use should be considered by the applicant.  

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 (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr 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 awardee 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

Applicants who have competed successfully for funding will receive a "Letter of Intent to Commit Funds" from the NIAAA.  This letter states the conditional intent of the NIAAA to make a grant award and may be used by the applicant when entering into negotiations for a position with a suitable institution to document potential grant support for the applicant’s research project.  Applicants will then have up to 18 months from the date of the letter to identify a permanent position, preferably tenure track or equivalent, at a research intensive domestic institution (sponsoring grantee institution). 

The sponsoring institution will request that the K22 award be activated by submitting form PHS 398 that includes a detailed budget.  The application must also include a "Statement of Environment and Institutional Commitment" from the institutional official signing the application describing the position and confirming that the applicant has been offered and has accepted a permanent faculty position.  In addition, a statement from the Department Chair or equivalent official must be included which certifies institutional commitment to the 75 percent of full-time professional effort requirement of this award, and describes the resources that will be available for the investigator.  Finally, if the research involves animals/human subjects, certification that the protocols were approved by the appropriate institutional committee of the designated grantee institution must be provided.  These and other relevant information are to be submitted to the NIAAA Grants Management Branch at the address listed on the Letter of Intent to Commit Funds.

These materials will be used by NIAAA staff to assess the appropriateness and soundness of the proposed arrangement.  The institution will be evaluated for its ability to make a significant commitment of resources, time and other factors conducive to the research project and career establishment of the investigator. 

The applicant is expected to relocate to a different research intensive institution when the award is activated.   Arrangements in which a candidate moves from a postdoctoral position to that of an assistant professor at the same institution must be justified convincingly to NIAAA program staff in order to be considered for K22 support.

Subject to NIAAA approval of the application, 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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA 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.

At the time the K22 is awarded to the grantee institution, any current award held or other support provided for the mentored training of the candidate will be terminated.  Candidates receiving support through an NRSA fellowship (F32 or T32) must submit a termination notice to prior to activation of the K22 award.

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 related administrative policies apply to NIH Research Career Award (“K”) programs: 

A.   Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided that these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Special Leave

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.  Only local institutional approval is required if such leave does not exceed 3 months.  For longer periods, prior written approval of the NIH funding institute or center is required.    Details on the process for submission of prior approval requests can be founds in the NIH Grants Policy Statement, Requests for Prior Approval, at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600130.)

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIAAA and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50 percent effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program

Consultation with the applicable NIAAA program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development at a specific institution in a specific research program.  A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, program staff could recommend that the award be terminated.

E. Change of Institution or Termination 

Consultation with the applicable NIH program staff is strongly encouraged when either a change of institution or termination is being considered. 

A change of institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIAAA will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project.   A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIAAA may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report (Form 2590) annually along with financial statements as required in the NIH Grants Policy Statement.  Note that the instructions for Research Career Development applications must be followed for this program (see http://grants.nih.gov/grants/funding/2590/2590.htm).

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 the awardee’s progress will encompass the following:

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

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:

Dennis A. Twombly, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Bethesda, MD  20892-9304
Telephone:  (301) 443-9334
FAX: (301) 443-1650
Email: dtwombly@mail.nih

2. Peer Review Contacts:

Ernestine Vanderveen, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Bethesda, MD 20892-9304
Telephone: (301) 443-2531
FAX:  (301) 443-6099
Email: tvanderv@mail.nih.gov

3. Financial or Grants Management Contacts:

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021
Bethesda, MD  20892-9304
Telephone:  (301) 443-4704
FAX: (301) 443-3891
Email: jfox@mail.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 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 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 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.

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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