NRSA and Stuff Jeff Thurston, NIAMS (thurstoj@mail.nih.gov) Monte Parham, NIAMS (Parhamm@mail.nih.gov) Cynthia Dwyer, NCI (dwyerc@mail.nih.gov)

Ruth L. Kirschstein National Research Service Awards 10/27/2002 Ruth L. Kirschstein National Research Service Awards Jeff Thurston, NIAMS (thurstoj@mail.nih.gov) Introductions When we’ll take questions

Here is a chart of the NIH Institutes and Centers. 10/27/2002 Here is a chart of the NIH Institutes and Centers. indicates a funding IC indicates an IC that doesn’t issue awards Each NIH IC receives a separate appropriation from Congress

10/27/2002 New Name Public Law 107-206, signed August 2, 2002 officially renamed this program the “Ruth L Kirschstein National Research Service Awards” In recognition of her years of dedicated service to NIH & the NIH community, particularly for her years of support for NRSA training

10/27/2002 Overview Purpose of NRSA: To help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s biomedical & behavioral research agenda.

Two Support Mechanisms FY2002 Estimates 10/27/2002 Two Support Mechanisms FY2002 Estimates Individual Fellowships (Fs) $109,053,000, 2866 FTTPs Institutional Training Grants (Ts) $545,437,000, 13,843 FTTPs F=Award to support a particular individual T=Award to an institution to support a training program Each mechanism will be discussed separately

FY 2002 Operating Budget $23,042 Million 10/27/2002 FY 2002 Operating Budget $23,042 Million

History/Timeline Policy Highlights: 10/27/2002 History/Timeline Policy Highlights: Early 1970s: showed end of growth of training budget, culminating with the 1973 decision by the Administration to abolish 1974: Passage of National Research Service Award Act—reauthorized training grant programs, support restored. 4-year phase in/out period of old & new training programs. Predoc stipend = $3,900 1980: Stipend Inc--Predoc = $5,040 (29% increase)

10/27/2002 Timeline (cont.) 1981: Omnibus Reconciliation Act: 1) increased emphasis on training of physicians; 2) abolished payback for prebaccalaureate trainees; 3) amended payback requirements by establishing 12-month legislative allowance & eliminating “alternate service” as an option. 1983: Stipend Inc.: Predoc = $5,292 (5%) 1985: Stipend Inc.: Predoc = $6,552 (24%) 1986: 1) Announced Minority Recruitment Guidelines for Ts. 2) Tax laws changed impacting taxability of stipends 1989: 1) Stipend Increase: Predoc = $8,500; 2) Federal Debt Delinquency Assurance Added. Individual Trainees & Fellows certify

10/27/2002 Timeline (cont.) 1990: Announced Requirement for Responsible Conduct of Research 1991: Stipend Inc: Predoc = $8,800 (4%) 1992: NIH announces availability of short-term positions on T32s 1993: NIH Revitalization Act of 1993: further modified payback requirements: 1) abolished payback for predoctoral trainees appointed after June 10, 1993; 2) allowed 2nd year of postdoc NRSA support to payback 1st year of NRSA Postdoc; 3) no obligation for 3rd year.

10/27/2002 Timeline (cont.) 1994: Stipend Inc.: Predoc = $10,008 (14%). Modified Leave Policy. 1996: 1) NIH implements new tuition reimbursement policy for competing Ts—100% for first $2,000, 60% of that over $2,000. 2) NIH receives deviation for 8% F&A (a.k.a.indirect) costs for Ts. 3) NIH announces modified guidelines for citizenship on Fs—is now time of award, not application.

Timeline (cont.) 1997: 1) Stipend Inc: Predoc = $11,496 (15%). 10/27/2002 Timeline (cont.) 1997: 1) Stipend Inc: Predoc = $11,496 (15%). 2) Increased Institutional Allowance for Fs. 3) Revised NRSA Guidelines published. 1998: 1) Stipend Inc: Predoc = $11,748 (2%) 2) NRSA Guidelines incorporated into NIH Grants Policy Statement 1999: 25% Stipend Inc. Predoc = $14,688 Program has evolved. New policies added. Existing ones modified. Have shown many periods of flat-lined budgets, sporadic stipend increases (not always with increase in $$), yet increased tuition costs requests.

Timeline (cont.) FY2000 1) Stipend Inc: Predoc = $15,060 10/27/2002 Timeline (cont.) FY2000 1) Stipend Inc: Predoc = $15,060 2) Family Health Insurance now allowable 3) Predoc Fs—Inst. Allow. increased from $2,000 to $2,500 4) Predoc Ts--Per Trainee Training Related Expenses increased from $1,500 to $2,000 5) Change in Per Trainee Tuition Formula for both F’s & T’s: Now 100% of the first $3,000 + 60% of costs >$3,000. Changes were effective for all FY2000 awards-competing & non-competing

10/27/2002 Timeline (cont.) FY2001 1) Cost-of-Living Increase for pre and postdoc Stipends. Predoc = $16,500 2) $1,000 Increase in Postdoc Institutional Allowance (to $5,000) 3) $1,000 Increase in Postdoc Trainee Related Expenses (to $3,500/trainee) PD IA = $5,000 PD TRE = $3,500

Timeline (cont.) FY2002 1) Stipend Increase for all levels: 10/27/2002 Timeline (cont.) FY2002 1) Stipend Increase for all levels: Predoc = $18,156, Postdoc begins @ $31,092 2) Increase in Fellowship Institutional Allowance Predoc = $2,750, Postdoc = $5,500 3) Increase in Ts “Trainee Related Expenses” Predoc = $2,200/trainee , Postdoc = $3,850/trainee 4) New race/ethnicity reporting requirements implemented—2 tiered reporting system

Timeline (cont.) FY2002 (continued) 10/27/2002 Timeline (cont.) FY2002 (continued) 5) Part-time training implemented—in cases of disability of pressing family need 6) New lexicon for Field of Training (FOT) introduced 7) Changes in review of Minority Recruitment Requirement (now partially a component within the priority score) 8) Revised 2271 published Spring 2002 Pt Time Training Requires NIH IC Prior Approval Applicant Pool now includes a component on “selection of individuals for appointment to the training grant and that the assessment will include a consideration of the racial & ethnic diversity of the trainee pool.” Mandatory Use of new 2271 for all appointment on/after June 1, 2002. Uses new race/ethnicity & FOT coding. See April 5, 2002 GUIDE Announcement

Timeline (cont.) FY 20002 (Continued) 10/27/2002 Timeline (cont.) FY 20002 (Continued) 9) Revised NIH-wide T32 Program Announcement published 5/16/2002 10) Revised Fellowship Instructions & Forms (416-1 & 416-9) Fall 2002 (PDF-fillable) 11) Revised Termination Notice, Activation Notice & Payback Agreement published Fall 2002 (PDF-fillable)

FY2003 Proposed Budget & Policy Changes 10/27/2002 FY2003 Proposed Budget & Policy Changes Proposed Stipend Increase--Proposing 10% for Predoc & entry level Postdoc. Smaller increases proposed for other Postdoc levels Discussing Increase in Postdoc Institutional Allowance Discussing potential change in tuition formula Discussing potential change in leave policy Any changes will be announced in the NIH Guide Tuition Formula: 100% of the first $8,000 + 65% > $8,000. Would be phased in with competing applications only Leave Policy Changes: Considering establishing NRSA Minimum and aligning policies more with your Institutional Leave Policy

NRSA Policy Overview Policies that apply to both Fellowships and Training Grants

Citizenship Requirements 10/27/2002 Citizenship Requirements Must be Citizen, non-citizen national, or lawfully admitted for permanent residence. Fs: Permanent residency is at the time of award Ts: Permanent residency is at time of appointment Non-citizen national = owes permanent allegiance to US. Generally persons born in outlying US possessions (America Samoa, Swains Island) If lawfully admitted for permanent residency, must be possession of Alien Registration Receipt Card (I-551) or of legal verification of such status.

10/27/2002 Degree Requirements Predoc: Baccalaureate degree & be enrolled in doctoral program leading to Ph.D., comparable research doctoral degree or MD/Ph.D. Postdoc: Ph.D. or M.D. or comparable doctoral degree from an accredited domestic or foreign institution

NRSA Limitations Predoc: 5 years Postdoc: 3 Years 10/27/2002 NRSA Limitations Predoc: 5 years Postdoc: 3 Years Are aggregate limits, including any combination from individual and/or institutional awards

NRSA Limitations Exceptions/Waiver Physicians/Clinicians 10/27/2002 NRSA Limitations Exceptions/Waiver Physicians/Clinicians Interruptions (break in service) Other Waiver requests require IC prior approval. Physician/Clinician: combined degree students or clinician completing postdoc training Interruption: (loss of preceptor, accident, illness, etc) Other: Request is from trainee, with endorsement from PD or sponsor

Stipends Subsistence Allowance to help defray living expenses 10/27/2002 Stipends Subsistence Allowance to help defray living expenses Not a salary, not considered employees of either Government or Institution NIH publishes levels in NIH Guide when increases are approved Grantees may supplement

Stipends (cont.) Predoc 10/27/2002 Stipends (cont.) Predoc One level for all individuals, regardless of years of experience FY02 level = $18,156

Stipends (cont.) Postdoc 10/27/2002 Stipends (cont.) Postdoc Dependent on number of years of relevant experience (0 – 7) For Fs, level set at time of award (not activation) For Ts, level set at time of appointment Once set, no change mid year Subsequent year based on initial level + 1

Stipends (cont.) Years of Relevant Experience/FY02 Level 0 = $31,092 10/27/2002 Stipends (cont.) Years of Relevant Experience/FY02 Level 0 = $31,092 1 = $32,820 2 = $38,712 3 = $40,692 4 = $42,648 5 = $44,616 6 = $46,584 7 = $48,852

10/27/2002 Stipends (cont.) Relevant experience may include research experience (including industrial) teaching assistantship, internship, residency, clinical duties, or other time spent in a health-related field beyond that of qualifying doctoral degree. Relevant experience may include research experience (including industrial) teaching assistantship, internship, residency, clinical duties, or other time spent in a health-related field beyond that of qualifying doctoral degree. Once appropriate stipend level has been determined, fellow must be paid at that level for entire grant year Stipend for each additional year of support is next level in the stipend structure and does not change mid-year.

Stipend Supplementation 10/27/2002 Stipend Supplementation Grantee determines amount according to formally established policies applied to all in similar training status Non-Federal funds Without obligation to trainee/fellow

Compensation Actual employment for services rendered 10/27/2002 Compensation Actual employment for services rendered Examples: teaching assistant, lab assistant In these cases, individual receives a salary and it is not considered stipend supplementation

Can compensation be provided from an NIH grant? 10/27/2002 Can compensation be provided from an NIH grant? Yes, limited part-time basis May not be same research that is part of planned experience Fellowship sponsor or Training Grant Program Director must approve May not interfere with, detract from, nor prolong the approved NRSA training “Limited Part-time” = up to 10 hours per week or 25% Grantee Monitoring of this is important. Since NIH no longer requires itemized budgets (SNAP & eventually Modular Grants), close monitoring at the grantee is vital to avoid an audit disallowance

10/27/2002 Stipend Taxability IRS (not NIH) has domain over interpretation & implementation Rules changed January 1, 1987; however interpretations seem to vary even among IRS offices NIH Grants Policy Statement provide minimal guidance but individuals should really consult local IRS offices

10/27/2002 Employee Benefits Since stipends are not provided as a condition of employment, it is inappropriate and unallowable to charge NRSA grants for employee benefits—FICA, workman’s comp, unemployment insurance etc.

10/27/2002 Leave VACATIONS & HOLIDAYS: Both Pre- and Postdoctoral Fellows & Trainees may receive same vacations and holidays available to individuals in comparable training positions at the grantee or sponsoring institution. Will continue to receive stipends.

10/27/2002 Leave (cont.) SICK LEAVE : May continue to receive stipends for up to 15 calendar days of sick leave per year. PARENTAL LEAVE: May receive stipends for up to 30 calendar days of parental leave per year for the adoption or birth of a child. In case of individual fellowships, use of parental leave requires approval of sponsor.

10/27/2002 Leave (cont.) Upaid Leave: Approval for leave of absence must be requested in advance from awarding component. Fellowship: award will be revised extending term date by number of months of leave. Trainee (T32): terminate & reappoint Stipends may not be reimbursed during leave of absence.

Part-time Training Allowed in unusual and pressing personal circumstances (e.g., medical conditions, disability, child or elder care) NIH prior approval required Program Director/Sponsor must submit written request, countersigned by trainee/fellow & authorized institutional official Must continue to be at least 50%. Less than 50% would require leave-of-absence from NRSA support

INDIVIDUAL FELLOWSHIPS 10/27/2002 INDIVIDUAL FELLOWSHIPS Predoctoral F30: Individual predoctoral NRSA for MD/Ph.D. fellowships F31: Individual predoctoral NRSA for minority students and students with disabilities & other announced initiatives The F30 is an Individual Predoctoral NRSA fellowship for MD/PH.D students This mechanism provides combined medical school and predoctoral Ph.D. support The Purpose is to ensure that an adequate no. of trained physician/scientists will be available The maximum number of years of support is six years Several Institutes issued a joint announcement: NIMH, NIDA, NIAAA, NIEHS. Others have issued stand along announcements—NINDS, NIDCD Research must fall within the mission of the participating Institute(s) The F31 is also a predoctoral NRSA fellowship It provides research training leading to Ph.D. or a combined MD/PH.D and support is available for 5 years. There are several Types: 1) The NRSA Predoctoral Fellowship for Minority Students 2) The NRSA Predoctoral Fellowship Program for Students with Disabilities and 3) Some ICs have issued separate announcements using this mechanism for anyone (not just targeted populations)

Individual Postdoctoral 10/27/2002 Individual Postdoctoral F32: Postdoctoral individual National Research Service Award F33: National Research Service Award for senior fellows The F32 is an Individual Postdoctoral NRSA fellowship It provides postdoctoral research training to individuals in order to broaden scientific background and extend potential for research Support is available on a full-time basis for up to three years Revised F32 Program Announcement (to be) issued Fall 2002 The F33 is an NRSA fellowship for Senior Fellows It provides opportunities for experienced scientists to make major changes in research careers and to acquire new research capabilities The Candidates must have doctoral degree and at least 7 subsequent years of relevant research or professional experience In addition, the Candidate must arrange for acceptance by an institution and sponsor Support may be requested for a period of up to two years The Stipend is determined individually at the time of award and is commensurate with base salary which the individual would have been paid by the institution. May not exceed NRSA stipend limit

Individual NRSA Fellowship Standard Receipt Dates 10/27/2002 Individual NRSA Fellowship Standard Receipt Dates F32: April 5, August 5, December 5 F31: May 1, November 15 Generally 5- 6 month period for review Check PAs for variations

Helpful Hints In Preparing Fellowship Applications 10/27/2002 Helpful Hints In Preparing Fellowship Applications Carefully read the instructions in application kit (416-1, Revised 6/02) and the most recent supplementary program guidelines. Page limitations Research plan Training site Time requested References page Read Instructions Carefully (use 416-1, revised 6/02) and most recent supplementary program guidelines. Note new form pages are available on the NIH web in a PDF-fillable format (similar to what is now available for the 398 & 2590) Stick to the Page Limitations Summary of Research Experience and Doctoral Dissertation are limited to 1 page each The Research proposal should not exceed l0 pages and the Biographical Sketch is limited to 2 pages The Research Plan should be a description of the proposal in the fellows own words – The Reviewers are looking for an understanding and approach to research, clarity, logic, and how the research will accomplish the training goals For the Training Site: If the fellow proposes to train at doctorate or current institution, explain how it would broaden perspective Time Requested: Three years for postdocs is standard. One year is generally not appropriate. May be shortened depending on time already spent training with sponsor and/or prior NRSA support Time proposed should be consistent with training goals in application References: Three references in sealed envelopes submitted with application – 4 preferred One reference from thesis advisor

10/27/2002 Helpful Hints (cont.) Applicant should not be overly or inadequately trained. Sponsor must demonstrate both the capability and commitment to provide the required training. Applicant should not be overly or inadequately trained If the applicant is well on the way to becoming an independent investigator they should submit an R01 If the applicant is inadequately prepared in research area of proposed project, reviewers may question potential for performing research independently The Sponsor must demonstrate the capability and commitment to provide the training The Sponsor and lab must be proficient in the research to be covered in the fellowship and The Sponsor must demonstrate a willingness to provide sufficient time So Selecting sponsor based only on prestige is not sufficient

10/27/2002 Helpful Hints (cont.) Applicant should describe precisely and succinctly the adequacy of the training facilities and environment. Project should have merit as research and as training mechanism. For revised applications, candidate should make sure the changes are significant and clearly identified. The applicant should describe precisely and succinctly the adequacy of training facilities and environment The training program described by sponsor should include not only lab experience but other approaches such as seminars, scientific meetings and courses. There should be significant degree of interaction with other research scientists Lab should be productive as illustrated by quality of publications The project should have merit as research and as training mechanism Description of the project and methodology should be precise and succinct Discuss potential problem areas – possible alternative approaches – how will the results be interpreted For revised applications, candidate should make sure the changes are significant and clearly identified. They should: Analyze the Summary Statement Include an explanation of the significant changes and Document responses to the critique in the Summary Statement

Helpful Hints (cont.) Applicant should seek appropriate advice. 10/27/2002 Helpful Hints (cont.) Applicant should seek appropriate advice. Candidate should prepare application carefully. The Applicant should seek appropriate advice: He should get assistance from the sponsor He may consider presubmission review at the sponsoring organization and May consider contacting NIH staff for advice on application preparation The candidate should prepare application carefully with A clear, concise, scientific writing style using the active voice Remember: editing and proofreading are important-a sloppy application will make a poor impression

Helpful Hints (cont.) Assurances & Certifications 10/27/2002 Helpful Hints (cont.) Assurances & Certifications Individual Fellow (signature on face pg) Sponsoring Institution (Facilities & Commitment pg) Human Subjects : Assurance # & IRB approval date (IRB Approval is now Just-In-Time) Education Requirement (New in FY2001) Animal Subjects--IACUC date now Just-In-Time Assurances & Certifications Required in Application The signature of the applicant on the face page of the application verifies assurances and certification such as: Debarment and Suspension, Delinquent Federal Debt, Drug-Free Workplace The Institutional assurances are made and verified by the signature of official signing for sponsoring institution For Humans – The Sponsoring institution must file a written Assurance of Compliance with the Office for Human Research Protections, DHHS (formerly OPRR). The assurance number must appear on the application. – Also a certification of IRB approval of the proposed activity is required, not at time of application but prior to award. This has been changed recently - see NIH Guide Notice dated May 1, 2000. Beginning with FY2001 awards there is a new education requirement on protection of HS --Like Research grants, a letter will be required prior to award. For Animals – The sponsoring institution must file an Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW), NIH – Also, a certification of Institutional Animal Care and Use Committee approval of the proposed activity is required at time of application. Therefore, the assurance number and IACUC date must appear on the application. Unless IACUC approval is delayed - then put “pending” with approval to be submitted within 60 days of receipt date. This did not change from the previous practice.

Helpful Hints (cont.) Instruction in Responsible Conduct of Research Required as part of all new & competing fellowship applications See NIH F32 Program announcement issued

Review Considerations 10/27/2002 Review Considerations Candidate Sponsor and training environment Research proposal Training potential Candidate Extent and level of previous education including degrees, field, academic performance, mentor and institution Dissertation topics Previous postdoctoral research or clinical experience Evidence of commitment to a career in research Awards and honors, other relevant experience, prof. training and publications Reference letters; considering both the numerical rankings and the text of the letters Sponsor and training environment Reviewers will assess qualifications and appropriateness of sponsor including research expertise and prior experience as a postdoctoral mentor Reviewers will also consider environment of host laboratory and institution Research proposal Proposal should have scientific merit It will be evaluated in light of candidate’s previous training and career development Training potential Reviewers will evaluate proposed training as it relates to preparation for an independent research career Training potential will be considered in light of requested period of support

Eligibility Sponsorship 10/27/2002 Eligibility Sponsorship Before submitting a fellowship application, candidate must identify: A sponsoring institution - private (profit or nonprofit) or public, domestic or foreign; An individual willing to serve as sponsor. The applicant must identify a sponsoring institution and an individual who will serve as a sponsor and will supervise the training and research experience The applicant’s sponsor should be an active investigator in the area of proposed research who will directly supervise candidate’s research The sponsoring institution may be private (profit or nonprofit) or public, domestic or foreign, including NIH intramural programs and other federal laboratories.

10/27/2002 Initiation Of Support Awarding component will notify individual of intention to make an award. The fellowship award will be issued. Fellow must start training within six months of the award issue date. In NIGMS there is a moratorium on activating between October 1 and November 15th. Because of difficulties in funding awards during this time frame. Other ICs are adopting similar policies

Initiation of Support (cont.) 10/27/2002 Initiation of Support (cont.) The day Fellow begins training, Activation Notice and Payback Agreement (only for fellows in first 12 months of NRSA support) must be completed and submitted to awarding component.

10/27/2002 PAYMENT Domestic, non-Federal sponsoring institutions receive an award for stipends, institutional allowance, and tuition and fees (when applicable) Domestic institutions directly pay fellow and disburse all other awarded costs Funds may not be expended until the fellowship is activated Use these additional notes only if audience include Federal or Foreign grantees: Federal: Fellows training at Federal Labs are paid stipends and institutional allowance directly by the awarding component through the Office of Financial Management, NIH Foreign: The stipend is paid by OFM to the fellow and the Institutional allowance to the sponsoring institution

10/27/2002 Stipends PREDOCTORAL: One level regardless of number of years of experience ($18,156) POSTDOCTORAL: Stipend level determined by number of years of relevant postdoctoral experience at time of award.

Institutional Allowance 10/27/2002 Institutional Allowance Domestic & Foreign, Nonprofit institutions: Allowance is intended to defray such expenses as research supplies, equipment, travel to scientific meetings, and health insurance. Family health insurance now allowable (if allowed for all in similar status regardless of source of support) Institutional Allowance: One should consult the NIH program announcement regarding specific level of allowance for predoctoral and postdoctoral support The levels are published in NIH Guide for Grants and Contracts and are also in Appendix 1 of the Guidelines Handout The type of sponsoring institution dictates what allowable costs may be charged to this category and how the funds are administered For Non-Federal Public and Private Nonprofit institutions (Domestic and Foreign): The allowance is intended to defray such expenses for individual fellows as research supplies, equipment, travel to scientific meetings, health insurance, and to otherwise offset administrative costs of graduate training. Family health insurance is now allowable (If allowed for all in similar status regardless of source of support).

Institutional Allowance (cont.) 10/27/2002 Institutional Allowance (cont.) Federal & For-Profit institutions: Allowance is to cover scientific meeting travel, health insurance, and books.

Institutional Allowance (cont.) 10/27/2002 Institutional Allowance (cont.) Individual postdocs (F32): $5,500 – domestic & foreign nonprofit $4,400 - federal & for-profit Includes health insurance Tuition & fees separately reimbursed when applicable

Institutional Allowance (cont.) 10/27/2002 Institutional Allowance (cont.) Individual predocs (F31& F30): $2,750 –exclusive of health insurance and tuition/fees Tuition/fees and health insurance awarded as a separate budget item Individual Predoctoral fellowships (F30 and F31) The IA is $2,500 (exclusive of tuition/fees and health insurance). This was increased in FY 2000. Tuition and fees and health insurance are awarded separately using new formula established in FY 2000. Health insurance Is an allowable cost only if required of all persons in a similar training status regardless of the source of support and as stated previously can now provide for family health insurance under these same conditions. Travel Payment for travel to scientific meetings is appropriate when necessary for the individual’s training Expenditure of Institutional Allowance: Except for fellows at Federal training sites, sponsoring institution authorizes expenditure of the institutional allowance on behalf of the fellow

10/27/2002 Tuition and Fees POSTDOCS: Tuition limited for specific courses required by the training program. Health insurance is not included. Reimbursement: 100% up to $3,000 + 60% of costs above $3,000 – no escalation in future years For Postdocs tuition and fees are limited to those for specific courses required by training program and must receive prior approval from the awarding component The reimbursement formula which was effective FY 2000 is: 100% up to $3,000+60% of costs above $3,000 with no escalation in future years. For purposes of calculating this budget item, health insurance is not included since it is still awarded as part of institutional allowance

Tuition and Fees (cont.) 10/27/2002 Tuition and Fees (cont.) PREDOCS: Tuition reimbursement varies -specific programmatic guidelines should be consulted. When tuition/fees and health insurance awarded as a separate cost, reimbursement: 100% up to $3,000 + 60% of costs above $3,000 – no escalation in future years.

10/27/2002 Reporting Procedures Forms are now available in PDF-fillable format on web: http://grants.nih.gov/grants/forms.htm ACTIVATION NOTICE (FORM PHS 416-5): Immediately upon initiation of training, fellow completes and returns this form to the NIH awarding component. Activation Notice: (Form PHS 416-5) – You can see Appendix 3 of Guidelines for a Sample Immediately upon initiation of training, individual completes and signs Activation Notice, obtains signature of sponsoring institution officials, and forwards notice with Payback Agreement (postdoc in first 12 months of NRSA support) to the NIH awarding component This form should be enclosed with all competing awards Domestic Non-Profit: Activation Notice Required in initial year only Foreign and Federal: Form must be submitted every year Form may be submitted up to 30 days in advance; However, funds may not be released until individual has actually started training

Activation Notice Helpful Hints Activation Date (Date Fellow Entered on Duty) must be > “Issue Date” on the Award Activation Date must be < “Latest Activation Date” listed on the award If more time is needed to activate, contact awarding IC to extend Latest Activation Date

Reporting Procedures (cont.) 10/27/2002 Reporting Procedures (cont.) PAYBACK AGREEMENT (FORM PHS 6031): Must be signed by each person who is to receive an individual postdoctoral fellowship that covers their initial 12 months of NRSA postdoc support. TERMINATION NOTICE (FORM PHS 416-7): For individual fellowships, this form is required upon completion of support. Payback Agreement (Form PHS 6031) See Appendix 5 of Guidelines for sample Payback Agreement must be signed by each person who is to receive an individual postdoctoral fellowship that covers their initial 12 months of NRSA postdoc support. Termination Notice (Form PHS 416-7) See Appendix 6 of Guidelines (Handout) The Termination Notice (along with Activation Notice and Fellowship Award) is the basis for establishing amount of payback obligations For individual fellowships, a Termination Notice is sent to fellow by awarding component prior to scheduled termination date For early terminations, Term Notice issued upon receipt of notification to the awarding component. Stipend should be prorated appropriately. Institutional Allowance may be adjusted as well if period of support < 6 months. Contact IC Following Termination, no funds may be drawn down. Invention Reporting: Not required for fellows or trainees Forms can be obtained at website previously given

Termination Notice Helpful Hints Dates in Item 6 must match totals in Item 7 List each year of support separately in Item 7 (must match levels on NGA) Item 7 must reflect only the NRSA stipend. Do not include any supplementation from other sources Item 10-vital particularly for postdocs that may have a payback obligation

10/27/2002 CHANGES IN PROJECT A transfer of the award to another institution or a change in sponsors requires the approval of the NIH awarding component. Should consult with NIH ASAP. Any proposed change in the individual’s area of research training must be approved by the awarding component. Change in sponsor Considerations for change in Sponsor: Is new sponsor qualified Will project change? If so, does training continue to be the originally approved area of research Change in institutions 1. Relinquishing Statement or Term Notice with all $$ information/Application from new institution – like research T7 2. If transfer occurs before end of current award year, the initial institute may be requested to continue to pay stipend until end of current year or it may be handled like a research grant T7 with award actions transferring the funds between the two institutions. See more of the later option these days. Disposition of Institutional Allowance negotiable between two sponsoring institutions If there is a project change, it must be approved in writing by the awarding component to assure that the training continues to be an area that falls within the scientific area of the original peer reviewed application or it may have to undergo re-review.

PROGRESS REPORTS, FINANCIAL STATUS REPORTS 10/27/2002 PROGRESS REPORTS, FINANCIAL STATUS REPORTS PROGRESS REPORTS: Progress reports are submitted annually when continued support is committed. For individual awards, a final progress report is required as part of the Termination Notice. A separate final progress report is not required. Financial Status Report: A Financial Status Report is not required for individual fellowship awards.

Institutional NRSAs (a.k.a.) Training Grants 10/27/2002 Institutional NRSAs (a.k.a.) Training Grants Purpose To develop or enhance research training opportunities for individuals, selected by the institution who are training for careers in specified areas Most or all of the information covered can be found in the NRSA Guidelines and/or the Application kits 398 & 2590. At the back of each kit there is a separate section for Institutional Training grants including special form pages.

Eligibility Application submitted by Institution (not individual). 10/27/2002 Eligibility Application submitted by Institution (not individual). Domestic, non-profit public or private institutions Research training must fall within the mission of the NIH awarding components

10/27/2002 Eligibility (cont.) Applicants must have: 1) strong research program in the proposed area(s); and, 2) requisite staff & facilities to carry out proposed program Program Director will be responsible for 1) overall direction, management, & administration of the training program; and 2) selection & appointment of NRSA eligible trainees

10/27/2002 Eligibility (cont.) Trainees must have opportunity to carry out supervised biomedical or behavioral research with the goal of developing or extending their research skills and knowledge

10/27/2002 Eligibility (cont.) Programs can consist of Predoc, Postdoc, or combination Short-term: solely (T35) or in combination with pre & post T32 Prebaccalaureate MARC USTAR—NIGMS COR--NIMH Some ICs allow only all pre or all post. Other ICs allow mix. Specific program announcements and/or IC staff should be contacted. T35: Used to promote Health Professionals into Research

Review for T’s 2 Level review like R01s 1) Peer Review--Study Section 10/27/2002 Review for T’s 2 Level review like R01s 1) Peer Review--Study Section 2) IC Council The following information is provided from the NRSA portion of the NIH Grants Policy Statement and the Instructions in the 398 Application kit. The NIH T32 Program Announcement and/or specific IC Program Announcements should also be consulted. Questions concerning review should be directed to the NIH program official or the SRA.

Review Criteria Past training record of program & preceptors 10/27/2002 Review Criteria Past training record of program & preceptors Objectives, design & direction of program Caliber of preceptors Quality of training environment for NRSA trainees and relationship of NRSA program to the broader training program. Institutional environment and commitment The 398 Application kit provides specific data that must be submitted; e.g., participating faculty--training grant support, other support, current & past trainees, trainee applicant pool data, trainee publications Some NIH Institutes provide additional guidance with respect to “suggested table formats” for organizing the data. You are encouraged to contact the potential NIH IC for additional guidance. Review Criteria itemized in recent T32 PA—5/16/2002 Quality & Size of Applicant Pool. This is the basis for the recommended number of trainee slots

Review Criteria (continued) 10/27/2002 Review Criteria (continued) Quality of applicant pool, selection process for appointment to training grant. This now includes a consideration of the racial/ethnic diversity of the trainee pool If postdoc, record of retaining postdoc health professionals for at least 2 yrs When appropriate, the concomitant research training of health professionals w/basic science postdocs or linkages with basic science departments Will be coupled with the Minority Recruitment & Retention efforts. But this means that minority recruitment will have some bearing on the priority score now.

Minority Recruitment & Retention 10/27/2002 Minority Recruitment & Retention Recruitment & Retention of underrepresented minorities All competing must include recruitment & retention plan Competing continuations must also include report on outcomes of recruitment & retention during awarded period Noncompeting progress reports (T-5s) must also include info on recruitment & retention T32 PA includes specifics for what should be included in the report

Responsible Conduct of Research 10/27/2002 Responsible Conduct of Research Required for all NRSA trainees All competing grants must include description of formal & informal activities NIH suggests: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding use of animal and/or human subjects, data management, data sharing and institutional and individual responsibilities. Requirement since 1990 Required for NRSA, “encouraged” for all students in the program NIH “suggests” but has no specific requirements Specifics should be geared to training program. No additional “education” requirement is necessary for anyone involved in a training grant (PD, participating faculty and/or trainees).

Additional Notes for Both Requirements 10/27/2002 Additional Notes for Both Requirements Plans evaluated by the IRG In general, will not impact the overall priority score (except minority recruitment as it affects applicant pool) Are discussed after score has been assigned Information presented to IC staff as administrative notes in the summary statement Councils will consider these areas in their recommendations 2 Official Ratings--Acceptable & Unacceptable “Unacceptable” ratings = no funding “Marginally Acceptable” ratings = perhaps restrictions, fewer years

Animal & Human Subjects 10/27/2002 Animal & Human Subjects Can indicate “Indefinite” on face pg In many cases, trainees will be participating in individual projects already reviewed These grants (and their review/approval dates) should be identified in application Grantee responsible for assuring proper approval is received prior to a trainee participating in any project involving either vertebrate animals and/or human subjects

Receipt Dates See T32 Program Announcement 10/27/2002 Receipt Dates See T32 Program Announcement January 10, May 10, Sept. 10 Varies among ICs--Many use only 1 or 2 dates Applicants should contact specific ICs for guidance Progress Report Receipt Dates Vary For T-5s, may not the same as R01s (2 months before start date). If an early receipt is required, face page notifications are mailed early with specific instructions

Period of Support/Appointments 10/27/2002 Period of Support/Appointments Trainees are considered full-time participants in the training program 9 - 12-month appointments Less than 9 months not allowed unless completing a planned training program. Appointment may begin anytime during the budget period Appointment may not exceed 12 months from a single budget period Initial < 9 months OK if promise to immediately reappoint

“Overlapping” Appointment 10/27/2002 “Overlapping” Appointment An appointment period may overlap budget periods Year 9 Year 10 7/1/2001 – 6/30/2002 7/1/2002 – 6/30/2003 Reminder that stipend level must correspond to the level provided from the support year. So if Year 10 includes a stipend increase, you’ll have trainees at 2 different levels. You can supplement to bring them in line but what is charged to the grant must reflect the level provided in that particular award year. Appointment Period 1/1/2002 – 12/31/2002 Stipend & Tuition $$ (6-months reported as unliquidated obligation)

Costs: Stipends Subsistence Allowance Not condition of employment 10/27/2002 Costs: Stipends Subsistence Allowance Not condition of employment Predocs--all one level For postdocs, level set at time of appointment. Grantee institution determines level. This is double checked by NIH staff by reviewing the educational info provided on 2271 Must use the stipend level(s) in effect for the particular grant year

Costs: Tuition & Fees Grantees request full needs 10/27/2002 Costs: Tuition & Fees Grantees request full needs Health Insurance OK as fee if required of all trainees (Family HI allowable) Formula used for award calculation only Per trainee basis: 100% of first $3,000, 60% of that >$3,000 No escalation in future years Grantees reimburse as needed Tuition formula since FY96 Include all in-state, out-of-state mixes Health Insurance OK as fee if required of all trainees in similar status, regardless of funding source--consistent treatment Family HI now allowable Future years flat-lined Reimbursement not necessarily limited to formula (unless specifically restricted). Actual needs may vary greatly from that submitted in application

10/27/2002 Costs: Trainee Travel Usually per/trainee formula based, Varies among ICs Scientific Mtgs OK Not travel from residence to institution Training experiences away from institution OK but require IC approval Spend a minute on this last point since it’s one I’ve provided advice on a lot this year. Each situation differs and that is why each should be reviewed separately. Consider: support of mentor & program director; distance away from “home” institution--plans for the trainee to continue to benefit from the other “training activities” provided at the home institution. This may be a particular issue for a early predoc, but not so much for a postdoc. Special “skills” that may be acquired as a result of this away experience

Costs: Training Related Expenses (TRE) 10/27/2002 Costs: Training Related Expenses (TRE) Formula based: $2,200/pre, $3,850/post Formula is Per Trainee Can be used for: Staff salaries, Consultant Costs, Equipment, Research Supplies, Staff travel, and Other Expenses directly related to the training program First time this cost category has seen any increase since the 1980s.

10/27/2002 Costs: F & A 8% rate Base = TDC less tuition & fees

Rebudgeting No prior approval (unless otherwise restricted) for: 10/27/2002 Rebudgeting No prior approval (unless otherwise restricted) for: Stipends: Into Tuition & Fees only Tuition: Into Stipends only Trainee Travel: Anywhere TRE: Anywhere Prior approval required to rebudget stipends and/or tuition into travel or TRE Caution on Moving Stipends into Tuition. May indicate inability to fill full compliment of trainees. May have negative impact on next review. Caution on Moving Tuition into Stipends: May be restricted. May require prior approval If in doubt, contact awarding IC

Statement of Appointment Form (PHS 2271) 10/27/2002 Statement of Appointment Form (PHS 2271) Revised version available 4/2002 Available in PDF-fillable format on web: http://grants.nih.gov/grants/forms.htm Includes new ethnicity/race breakouts & Field of Training coding Mandatory use of new form as of appointments beginning on/after 6/1/2002 Must mandate use of new version to be in compliance with OMB requirements for collecting race/ethnicity data See 4/5/2002 GUIDE Notice

Statement of Appointment Form (PHS 2271) 10/27/2002 Statement of Appointment Form (PHS 2271) Due on or before the start of appointment period No stipend or other allowance may be paid until submitted Delinquent forms may result in disallowance Computer facsimiles OK Reemphasize need for timely forms. Delinquent forms may also mean no award Send forms in throughout the year. Do not hold until all trainees have been appointed. But all forms pertaining to same trainee (2271, payback, citizenship) must be submitted together Next revision available for use around November 2001

2271s-Helpful Hints Read instructions carefully & check for accuracy before mailing Complete all required sections Make sure you are appointing trainees to the correct grant year—check appointment start date & compare to budget period on NGA For New-complete all sections For Reappointment, skip the shaded areas unless changed Citizenship--Proof of permanent residency must be submitted with 2271

2271s-Helpful Hints (cont.) Trouble spots Incomplete Data--particularly degrees & prior NRSA support (Item 5) Permanent Address (Item 9): Address NIH can use later (not a school address) Period of Support (Item 13) and Stipend Dollars (Item 18) must match. If period of support is 10 months, stipend must also reflect 10 months

2271s-Helpful Hints (cont.) Item 18 must reflect NRSA T32 portion only Do not include amount supplemented by Institution from other sources For Postdoc Trainees: Initial stipend level must be based on number of years of relevant experience (listed in Item 14-Education)

Electronic 2271 Now “X-TRAIN” 10/27/2002 Electronic 2271 Now “X-TRAIN” Electronic submission of 2271 data available through “X-TRAIN”, an application in the NIH Commons X-TRAIN is currently in limited deployment Will eventually be open to all Commons-registered institutions. Commons registration expected to re-open in FY2003 Electronic Termination Notices also being developed as part of X-Train. However it requires another layer of sophistication because of the need for a BO signature

Watch NIH GUIDE for announcement on opening up Commons Registration 10/27/2002 New Commons Interface Watch NIH GUIDE for announcement on opening up Commons Registration Right now U PA & CHOP are Commons Registered Would need to register both your Institution & PD before using X-TRAIN One of the features of the new Commons will be “Delegation”. A PD will be able to designate one or more individuals with the authority to do data entry.

Payback Agreement (PHS 6031) 10/27/2002 Payback Agreement (PHS 6031) Required only for postdocs, entering their first 12-months of postdoctoral NRSA support Available in PDF-fillable format on web: http://grants.nih.gov/grants/forms.htm No longer required of predocs--rules changed in 1993

Termination Notice (PHS 416-7) 10/27/2002 Termination Notice (PHS 416-7) Required at time an appointment is ending Reflects total support period & NIH amount only If there was a hiatus of support, report only current period Do not include support already reported on a prior Term Notice Available in PDF-fillable format on web: http://grants.nih.gov/grants/forms.htm Required at the time an appointment is ending (if there is to be no reappointment) Even if just a break of a month or 2, you must terminate and then reappoint Include only NIH stipends—do not include amounts you may have “supplemented” Electronic Submission of Term Notice being developed in X-Train

Termination Notice Helpful Hints Completeness—Read instructions, fill in all items Items 6 & 7--Dates & money must match what was reported on 2271s. Item 7--Stipends reflect only amount charged to grant. Do not include any supplementation from other sources If final year of support is being terminated early, need to submit an amended 2271 or include a note on Termination Notice indicating early termination

Termination Notice Helpful Hints (cont) Item 8--Summary of training, may use an attachment Item 10--Mailing Address--important particularly for postdocs Item 12--Trainee Signature--May be submitted indicating “Trainee Unavailable for signature” but only after good faith effort to secure Item 14-Business Official must verify $$

10/27/2002 Form 1099 For tax purposes, stipends paid to trainees may be reported annually using the Form 1099—Statement of Miscellaneous Income (not a W-2) Generated by Institutional Business Office Note grantees are not required to report stipend income on a 1099. However, it does serve as a handy reminder for the trainee about their potential tax obligation.

Financial Status Report (SF 269) 10/27/2002 Financial Status Report (SF 269) Required annually within 90 days of budget end date Unliquidated obligations can be used to report any stipends and tuition charges for “overlapping” appointments. Automatic Carryover of an unobligated balance is not generally allowed but awards should be footnoted either way Generally unused TRE and/or Trainee Travel must be reported as part of the unobligated balance HG & AI have granted this authority to Ts

10/27/2002 Payback Legislation requires some NRSA recipients to “pay back” the Federal Government through service Rules changed dramatically in 1993

Payback (cont.) Predocs 10/27/2002 Payback (cont.) Predocs Eliminated payback for any predoc appointed on or after June 10, 1993 Any predoc receiving support prior to June 10, 1993 would still have an obligation

Payback (cont.) Postdocs 10/27/2002 Payback (cont.) Postdocs Obligation exists for first 12 months of postdoc NRSA support The 13th and subsequent months of postdoc NRSA support can “payback” the postdoc obligation Postdoc NRSA cannot be used to payback predoc obligation If postdoc is supported for 2 or more years, no obligation

Acceptable Payback Service 10/27/2002 Acceptable Payback Service Health-related biomedical or behavioral research Health-related teaching Direct administration or review of health-related research Any combination of these activities

Acceptable Payback Service 10/27/2002 Acceptable Payback Service Definition of Health-related has broadened Range of activities related to the description, diagnosis, prevention or treatment of disease From the most basic biomedical/behavioral research to applied clinical research Also includes agriculture, environmental sciences, biotechnology & bioengineering

Acceptable Payback Service 10/27/2002 Acceptable Payback Service Activities must average > 20 hours per week < 20 hours per week is allowable in cases of disability or other pressing personal circumstances < 20 hour/week activity will be prorated Exceptions are rare & require prior approval

Payback Reporting Requirements 10/27/2002 Payback Reporting Requirements Annual Payback Activities Certification (APAC) [PHS Form 6031-1] Mailed annually on the anniversary of termination of support Report reflects activities performed during last 12 months Service must begin within 2 years of termination

APAC Helpful Hints Form is a retrospective reporting—what the individual has done over the last 12 months Signatures—of recipient & supervisor--#1 missing item Block 4, Description—Need details Monitoring Payback at NIH is being consolidated. Contact NRSA Payback Service Center, 301-594-1835

Financial Payback Can be voluntary or involuntary 10/27/2002 Financial Payback Can be voluntary or involuntary Amount owed is total stipend received (plus interest when applicable)

Waiver Rare & Requires NIH Director approval 10/27/2002 Waiver Rare & Requires NIH Director approval Permanent or Total Disability Substantial hardship & against equity Cancelled upon death

10/27/2002 Information Sites NIH Extramural Training and Research Career Development Programs: http://grants.nih.gov/training/ NIH T32 Announcement, NIH Guide, 5/16/02: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html The first site provides a wealth of information on Training, Fellowships and even K awards T32 PA being revised. Check Guide for latest version

Information Sites (cont.) 10/27/2002 Information Sites (cont.) NIH NRSAs for Individual Postdoctoral Fellows (F32), NIH Guide, 6/1/00: http://grants.nih.gov/grants/guide/pa-files/PA-00-104.html NRSA T32 Frequently Asked Questions (FAQs): http://grants.nih.gov/training/faq_training.htm NRSA Fellowship FAQs: http://grants.nih.gov/training/faq_fellowships.htm F32 Should be revised in Fall 2002

Information Sites (cont.) 10/27/2002 Information Sites (cont.) NIH Grants Policy Statement (Revised 3/2001) http://grants.nih.gov/grants/policy/nihgps/

10/27/2002 Questions????