NLM SENIOR INDIVIDUAL BIOMEDICAL INFORMATICS FELLOWSHIPS (F38)

RELEASE DATE:  April 18, 2003

PA NUMBER: PAR-03-109 (This PAR has been suspended, see NOT-LM-05-014)
                      (Scientific review contact change, see NOT-LM-05-013)
                      (Peer Review contact change, see NOT-LM-05-007)
                      (Correction to eligibility requirements, see NOT-LM-05-004 
and see change NOT-LM-04-005)

This program announcement supersedes PA-92-90

EXPIRATION DATE:  November 30, 2005

National Library of Medicine (NLM)
 (http://www.nlm.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.879 NLM Medical 
Library Assistance 
 
THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose 
o Training Objectives
o Mechanism of Support 
o Eligibility Requirements
o Eligible Sponsoring Institutions
o Allowable Costs
o Stipend Supplementation, Compensation, and Other Income
o Tax Liability
o Payback Requirements
o Leave Policies
o Trainee Terms of Appointment
o Part-Time Training
o Other Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Other Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

NLM senior fellowships in biomedical informatics provide support for 
the training of experienced health professionals in informatics. 
Training may be for informatics research or for the application of 
informatics to any area of biomedicine, including, among others, 
clinical medicine, basic biomedical research, education, or. 
administration. 

These fellowships are intended for experienced scientists, physicians, 
and other professionals who wish to make major changes in the direction 
of their careers or who wish to broaden their scientific background by 
acquiring new capabilities in informatics research and development.  
These awards will enable professionally independent individuals with at 
least ten years of post-graduate experience to take time from their 
regular professional responsibilities for the purpose of receiving 
training in informatics.  This award can be used in conjunction with 
a sabbatical experience. The fellowship is not designed for post-
doctoral level investigators prior to independence or for pre-doctoral 
training per se. 

The majority of candidates for this award will have a research or 
health-professional doctorate, and post-doctoral clinical or research 
experience at the time of application. The requirement for a doctoral 
degree may be waived for candidates in the following professional 
fields: engineering, computer science, library and information 
sciences. Applicants without a doctoral degree should contact the 
Program Officer named at the end of this announcement for information 
regarding eligibility. 

RESEARCH OBJECTIVES

Fellowship training is intended to help meet the growing national need 
for professionals able to do research in informatics or to apply the 
power of computation to the myriad domains of biomedicine. Thus, this 
fellowship is suitable for training in informatics specializations 
ranging from clinical informatics to the informatics of molecular 
biology and other large research datasets.  Applications that focus on 
building new skills or extending the applicant's existing expertise are 
particularly desirable.  

Upon completion of training, fellows should be able to conduct basic or 
applied research at the intersection of biology and medicine with 
computer and cognitive sciences, and are expected to be familiar with 
the use and potential of modern information technology.  Fellows in 
informatics will achieve this goal through an individually tailored 
program of formal coursework and research experience, associated with a 
project.  

Although a canonical set of basic courses for informatics training has 
not yet evolved, there is general agreement that the field is 
interdisciplinary, and includes, among others, components of computer 
science, information science, cognitive science, and knowledge of one 
or more domains of biomedicine.  The program of coursework should 
develop or augment the trainee's basic competency in each of these 
areas.  This fellowship may lead to a degree, although it is not a 
requirement.  Whether or not the training is to be used for credit or 
certification in an educational program is up to the applicant, the 
fellowship sponsor, and the organization involved.  The curriculum for 
applied research training may be different from that needed for basic 
research training, but should provide sufficient theoretical foundation 
in the area of application.

An opportunity to carry out supervised research and/or applications 
development in informatics is essential to achieve the primary 
objective of developing or extending knowledge and skills.  The 
fellowship must provide hands-on experience obtained via a defined 
project.  Projects may be in basic informatics research areas or 
address an informatics application.  An applied informatics project 
does not require the form or concepts of a research project, and need 
not be hypothesis-driven, but the proposal should provide sufficient 
detail to permit reviewers to judge importance of the problem, 
feasibility of the approach, and the post-training utility of the 
informatics techniques required.

MECHANISM OF SUPPORT 

This program announcement for Senior Individual Biomedical Informatics 
Fellowships uses the F38 funding mechanism.  For NLM, these awards are 
authorized by the Medical Library Assistance Act and are not a part of 
the National Research Service Awards Program (NRSA) of the Public 
Health Service.  However, the policies and requirements of the NLM 
program are similar in most respects to NRSA awards.  Applicants with 
fewer than ten years of professional experience are encouraged to 
investigate their eligibility for the Individual Informatics fellowship 
(F37).  The project period may be for one to two years, and awards are 
not renewable.

ELIGIBLE INSTITUTIONS  

Only domestic non-Federal organizations, public or private, such as 
Medical, Dental or Nursing schools or other institutions of higher 
education, may accept an award on behalf of an applicant.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

By the date of appointment, applicants must have at least ten full 
years of relevant research or other professional experience beyond the 
qualifying degree.  Relevant postdoctoral experience may include 
research experience (including industrial), teaching, internship, 
residency, clinical duties, or other time spent in full-time studies in 
a health-related field following the date of the qualifying doctoral 
degree.  All candidates must be willing to spend a minimum of 50 
percent of full-time professional effort conducting research and 
research career development during the entire award period.

Candidates for the F38, under some circumstances, may have been 
principal investigators (PIs) on NIH research or career development 
awards, provided the research experience proposed in this application 
is in a fundamentally new field of study or there has been a 
significant hiatus in their research career because of family or other 
personal obligations. Current PIs on NIH career awards are not 
eligible.  A candidate for the F38 award may not have pending nor 
concurrently apply for any other type of NIH career development award.  
F38 recipients are encouraged to apply for independent research grant 
support during the period of this award. 

Postdoctoral Trainees
Postdoctoral trainees must have received a Ph.D., M.D. or comparable 
doctoral degree from an accredited domestic or foreign institution.  
Eligible doctoral degrees include, but are not limited to, the 
following:  D.D.S., D.M.D., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., 
Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. Documentation by an 
authorized official of the degree-granting institution certifying all 
degree requirements have been met prior to appointment is acceptable.  

Professional degrees
The NLM recognizes that graduates of training programs in professions 
that do not customarily require a doctoral degree (e.g., library 
science and nursing) can make important contributions to Informatics.  
The NLM also encourages applications on behalf of individuals without 
doctoral degrees, but who have significant professional training and 
experience in closely related cognate fields.  Nurses, health science 
librarians, researchers, educators, administrators, and other health 
professionals are eligible, as are computer scientists and engineers 
who wish to focus on the health domain.  

Applications on behalf of women and other groups underrepresented in 
biomedical informatics are strongly encouraged.

Citizenship
By the time of award, individuals must be citizens or non-citizen 
nationals of the United States, or must have been lawfully admitted to 
the United States for permanent residence (i.e., possess a currently 
valid Alien Registration Receipt Card I-551, or other legal 
verification of such status).  Non-citizen nationals are generally 
persons born in outlying possessions of the United States (e.g., 
American Samoa and Swains Island). Individuals on temporary or student 
visas are not eligible. 

SPECIAL REQUIREMENTS

Before submitting a fellowship application, the applicant must identify 
a sponsoring institution and an individual who will serve as a sponsor 
(also called mentor or supervisor) and will supervise the training and 
research experience. 

To apply for support, an institution must submit an application on 
behalf of the individual seeking the fellowship.  Applications on 
behalf of prospective fellows may be submitted by domestic non-profit 
organizations, public or private, such as universities, colleges, 
hospitals, laboratories, units of State or local government, and 
eligible agencies of the Federal government. Applicants proposing 
training at their doctorate institution or at the institution where 
they have been training for more than a year must document the 
opportunities for new training experiences designed to broaden their 
scientific background.  

Each fellow must have a mentor who provides guidance and oversight for 
the training program. The mentor should be expert in an area of 
informatics or information science that is pertinent to the proposed 
program, and should be an active investigator in the area of the 
proposed research who will directly supervise the candidate's research. 
The sponsor must document the availability of staff, research support, 
and facilities for high-quality research training.  The mentor may be 
at the applicant's home institution or at another institution.  If the 
latter, the plan for supervision and interaction must be described.  

SPECIAL FELLOWSHIP AT THE LISTER HILL NATIONAL CENTER FOR BIOMEDICAL 
COMMUNICATIONS (LHCNBC) 

Co-Mentorship Program is available to NLM Individual Informatics 
Fellows with project interests that coincide with research and 
development ongoing at the NLM.  In this program plan option, the 
Fellow spends the academic year at the home (sponsoring) institution, 
and the three summer months of each fellowship year on site at the 
LHNBC in Bethesda doing a relevant research project under the 
supervision of an NLM staff scientist.

Applications from underrepresented minorities (African Americans, 
Alaskan Native, Hispanic Americans, Native Americans and Pacific 
Islanders) and persons with disabilities are encouraged to apply as 
applicants and as mentors.

ALLOWABLE COSTS

Stipends

Stipends for NLM Senior Fellows are determined individually at the time 
of award.  The amount of the stipend shall be based on the documented 
salary or remuneration paid to the candidate from the home institution 
at the time of award, and shall be based on the normal full-time 12-
month staff appointment at the home institution.  However, in no case 
shall the NIH contribution to the stipend during the fellowship exceed 
the current legislated maximum salary; in Fiscal Year 2002, the maximum 
salary provided by a Federal grant is $166,700.  For Fellows on 
sabbatical, the level of the stipend award will take into account 
concurrent sabbatical salary support provided by the home institution 
and any other supplementation.

Training awards provide stipends to fellows to help defray living 
expenses during the research training experience. The awards are not 
provided as a condition of employment with either the Federal 
government or the sponsoring institution.  For fellows sponsored by 
domestic non-federal institutions, the stipend will be paid through the 
sponsoring institution. For fellows sponsored by Federal institutions, 
the monthly stipend payment will be deposited in the fellow's U.S. bank 
account or paid directly to the fellow by U. S. Department of Treasury 
check. No departure from the established stipend schedule may be 
negotiated between the institution and the fellow. 

Tuition and Fees  
NLM will award 100% of the combined costs of tuition, fees, and health 
insurance up to $3,000 and 60 percent of the combined costs above 
$3,000.  The tuition formula is used for award calculation purposes 
only.  Actual costs may be higher.  Costs associated with tuition and 
fees are allowable only if they are required for specific courses in 
support of the research training experience supported by the 
fellowship.  A full description of the tuition policy is contained 
within the NRSA Policy Guidelines on the NIH website at 
http://grants.nih.gov/training/nrsa.htm  

Trainee Travel 
Travel for attendance at scientific meetings that are important to the 
individual's training is an allowable trainee expense. The base formula 
for travel allows up to $1,000 per year per trainee.  In their proposed 
budgets, applicants for NLM fellowships should request additional 
trainee travel funds for a meeting each year, to be held at the 
National Library of Medicine in Bethesda or at another site.  The 
purpose of these meetings will be to exchange information among all NLM 
trainees, including those at NLM institutional training program sites, 
institutional program directors, NLM program staff, and other selected 
participants. 

Support for travel by NLM fellows to a research training experience 
away from the primary institution is also permitted. Such experiences 
are acceptable as a complement to the course work, expertise, and 
experiences available at the parent institution.  Letters requesting 
such training may be submitted to the NLM at any time during the award 
period, and should explain the type of opportunities for training 
available, how these opportunities differ from those offered at the 
parent institution, and the relationship of the proposed experience to 
the trainee's career stage and goals.  The LHNCBC co-mentorship program 
described above is an example of such a program.

Awards for training at a foreign site may include a single economy or 
coach round-trip travel fare.  No allowance is provided for dependents.  
U.S. flag air carriers must be used to the maximum extent possible when 
commercial air transportation is available for travel between the 
United States and a foreign country or between foreign countries.  
Funds are not provided to cover the cost of travel between the fellow's 
place of residence and a domestic training institution. However, in 
cases of extreme need or hardship, a one-way travel allowance may be 
authorized by the sponsoring institution. Such travel must be paid from 
the Institutional Allowance. 

Health Insurance
In order to adjust policies to facilitate the recruitment of women and 
individuals from disadvantaged backgrounds as required by Section 487 
of the Public Health Service Act (as amended), NLM will allow costs 
associated with family health insurance for trainees who have families 
and are eligible for family health insurance coverage at the sponsoring 
institution.  Self-only health insurance will continue to be an 
allowable cost for trainees without families.  Institutions may include 
the cost of family health insurance for trainees who are eligible for 
this coverage in the calculation of the combined cost of tuition, fees, 
and health insurance.  

Institutional Costs  
NLM provides an institutional allowance of $6000 per year per trainee 
to defray the costs of other research training expenses, including 
consultant costs, equipment, and research supplies.   This allowance is 
intended to cover training-related expenses for the individual trainee 
and is not available until the fellow officially activates the award. 
NIH will provide an institutional allowance of up to $3,000 for fellows 
sponsored by Federal laboratories for expenses associated with travel 
to scientific meetings, health insurance, and books. Funds for fellows 
at Federal laboratories will be disbursed from the NIH awarding 
institute.

The institution may request additional funds when the training of a 
fellow involves extraordinary costs for travel to field sites remote 
from the sponsoring institution or for accommodations for fellows who 
are disabled, as defined by the Americans With Disabilities Act. The 
funds requested for costs of this nature must be reasonable in 
relationship to the total dollars awarded under the fellowship and must 
be directly related to the approved research training experience. Such 
additional funds shall be provided only in exceptional circumstances 
that are fully justified and explained by the sponsoring institution.  
Consultation with NLM program staff in advance of such requests is 
advised.
  
Facilities and Administrative (F&A, indirect) costs are not allowed on 
individual fellowship awards.

Salary for mentors, secretarial, and administrative assistance, etc., 
is not allowed.

STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME

An institution is permitted to provide funds to a fellow in addition to 
the stipend paid by the NIH.  Such additional amounts may be in the 
form of augmented stipends (supplementation) or compensation. 

The grantee institution may provide supplementation or additional 
support to offset the cost of living on the condition that such 
supplementation does not require any additional effort from the 
trainee.  Federal funds may not be used for supplementation unless 
specifically authorized under the terms of both the program from which 
such supplemental funds are to be received and the program whose funds 
are to be supplemented.  Under no circumstances may Department of 
Health and Human Services (DHHS) funds be used for supplementation.  

An institution may also provide additional compensation to a trainee in 
the form of compensation (as salary and/or tuition remission) for 
services such as teaching, research, or clinical care.  A trainee may 
receive compensation for services as a research assistant or in some 
other position on a Federal research grant, including a DHHS research 
grant. However, compensated services should occur on a limited, part-
time basis apart from the normal research training activities. In 
addition, compensation may not be paid from a research grant supporting 
research that is part of the research training experience.  Under no 
circumstances may the conditions of stipend supplementation or 
additional compensation interfere with, detract from, or prolong the 
trainee's approved training program.  

Additionally, compensation must be in accordance with institutional 
policies applied consistently to both federally and non-federally 
supported activities and supported by acceptable accounting records 
determined by the employer-employee relationship agreement. 

Educational Loans or G.I. Bill. An individual may make use of Federal 
educational loan funds and assistance under the Veterans Readjustment 
Benefits Act (G.I. Bill). Such funds are not considered supplementation 
or compensation. 

Concurrent Awards. An NLM fellowship may not be held concurrently with 
another Federally sponsored fellowship or similar award that provides a 
stipend or otherwise duplicates provisions of the NLM award.

TAX LIABILITY  

Section 117 of the Internal Revenue Code applies to the tax treatment 
of all scholarships and fellowships.  Under that section, non-degree 
candidates are required to report as gross income any monies paid on 
their behalf for stipends, or any course tuition and fees required for 
attendance.  Degree candidates may exclude from gross income (for tax 
purposes) any amount used for tuition and related expenses such as 
fees, books, supplies, and equipment required for courses of 
instruction at a qualified educational organization. The taxability of 
stipends, however, in no way alters the relationship between NIH 
trainees and institutions.  NLM fellowship stipends are not considered 
salaries.  In addition, trainees supported under these fellowships are 
not considered to be in an employee-employer relationship with the NIH 
or the awardee institution. It is therefore, inappropriate and 
unallowable for institutions to charge costs associated with employment 
(such as FICA, workman's compensation, or unemployment insurance) to 
the fellowship award.  It must be emphasized that the interpretation 
and implementation of the tax laws are the domain of the Internal 
Revenue Service (IRS) and the courts.  The NIH takes no position on the 
status of a particular taxpayer, and it does not have the authority to 
dispense tax advice.  Individuals should consult their local IRS office 
about the applicability of the law to their situation and for 
information on their tax obligations.

PAYBACK REQUIREMENTS

Because the NLM senior individual informatics fellowships (F38) are not 
subject to NRSA policies, there are no service payback requirements.

LEAVE POLICIES

In general, fellows may receive stipends during the normal periods of 
vacation and holidays observed by individuals in comparable training 
positions at the sponsoring institution. For the purpose of these 
awards, however, the period between the spring and fall semesters is 
considered to be an active time of research and research training and 
is not considered to be a vacation or holiday.  Fellows may receive 
stipends for up to 15 calendar days of sick leave per year.  Sick leave 
may be used for the medical conditions related to pregnancy and 
childbirth.  Fellows may also receive stipends for up to 30 calendar 
days of parental leave per year for the adoption or the birth of a 
child when those in comparable training positions at the grantee 
institution have access to paid leave for this purpose and the use of 
parental leave is approved by the program director.

A period of terminal leave is not permitted and payment may not be made 
from fellowship funds for leave not taken. Fellows requiring periods of 
time away from their research training experience longer than specified 
here must seek approval from the NLM program staff for an unpaid leave 
of absence.  

TRAINEE TERMS OF APPOINTMENT

Full-time Fellows
Funded training periods may be for one to two years, and customarily 
require a full-time commitment.  That is, trainees are typically 
required to pursue their research training on a full-time basis, 
devoting at least 40 hours per week to the program.  Within the 40 
hours per week training period, research trainees in clinical areas 
must devote their time to the proposed research training and must 
confine clinical duties to those that are an integral part of the 
research training experience. If the fellowship is proposed at less 
than full time, stipends will be adjusted appropriately. The minimum 
effort permitted is 50 percent of full-time.

Part-time Fellows
Fellows are typically expected to make a full-time commitment to their 
training program.  However, under unusual and pressing personal or 
professional circumstances, part-time training may be appropriate.  
Part-time training program at a level of 50 to 99 percent effort will 
be considered on an ad hoc basis with sufficient justification of need.  
If part-time training is requested, the application clearly justify the 
level of effort proposed, and clearly demonstrate how the research and 
program of study will be accomplished with respect to other duties and 
responsibilities.  A fellow will not be permitted to engage in NLM-
supported research training for less than 50 percent effort.  
Individuals desiring to reduce their commitment to less than 50 percent 
effort must take a leave-of-absence from NLM fellowship support.  The 
fellowship notice of award will be reissued and the stipend will be 
pro-rated during the period of any approved part-time training.  
Stipend levels for part-time trainees will be appropriately pro-rated 
according to their level of effort.

Other Appointment Terms
No individual trainee may receive more than 4 years of aggregate NLM 
support at the predoctoral level or 3 years of support at the 
postdoctoral level, including any combination of support from 
institutional training grants and individual fellowship awards. 

Any extension of the total duration of trainee support at either the 
predoctoral or postdoctoral level requires approval by NIH.  Requests 
for extension must be made in writing by the trainee, endorsed by the 
sponsor and the appropriate institutional official, and addressed to 
the NLM Program Officer. The request must include a sound justification 
for an extension of the limits on the period of support.

General information about NIH support of fellowships, including those 
awarded by the NLM, can be found at 
http://grants.nih.gov/training/extramural.htm.  Please note that the 
"Service Payback" provisions do not apply:  NLM's Individual 
Informatics Fellowships require no payback.  Information about current 
NIH stipend levels and other support may be found in NATIONAL RESEARCH 
SERVICE AWARD (NRSA) STIPEND INCREASE AND OTHER BUDGETARY CHANGES 
EFFECTIVE FOR FISCAL YEAR 2002 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html. 

OTHER SPECIAL REQUIREMENTS

Certification and Reporting Procedures. No application will be accepted 
without the applicant signing the certification block on the face page 
of the application.  Individuals admitted to the United States as 
Permanent Residents must submit notarized evidence of legal admission 
prior to the award.  When support ends, the fellow must submit a 
Termination Notice (PHS 416-7) to the NIH.  Forms may be found on the 
NIH Website at http://grants.nih.gov/grants/forms.htm. 

Inventions and Publications. Fellowships made primarily for educational 
purposes are exempted from the PHS invention requirements.  F38 awards 
will not contain any provision giving PHS rights to inventions made by 
the awardee. 

Data Sharing.  It is the policy of the DHHS that the results and 
accomplishments of all funded activities should be made available to 
the public.  This policy also applies to individuals supported by 
individual NRSA postdoctoral fellowships.  The sponsoring institution 
should place no restrictions on the publication of results in a timely 
manner. 

Copyrights. Except as otherwise provided in the terms and conditions of 
the award, the recipient is free to arrange for copyright without 
approval when publications, data, or other copyrightable works are 
developed in the course of work under a PHS grant-supported project or 
activity. Any such copyrighted or copyrightable works shall be subject 
to a royalty-free, nonexclusive, and irrevocable license to the 
Government to reproduce, publish, or otherwise use them, and to 
authorize others to do so for Federal Government purposes. 

WHERE TO SEND INQUIRIES

Inquiries from potential applicants concerning this PA are encouraged.  
Inquiries about NLM Fellowships may fall into three areas, 
programmatic, peer review, and financial or grants management issues, 
and should be directed to the following individuals accordingly.

o Direct your questions about scientific/research issues to: (Contact changed, see NOT-LM-05-013)

Dr. Charles Friedman
6705 Rockledge Drive, Suite 301 
Bethesda , MD 20892-7968 
Telephone: (301) 594-4882
FAX: (301) 402-2952
Email: Friedmc1@mail.nih.gov

o Direct your questions about peer review issues to: (Contact changed, see NOT-LM-05-007)

Dr. Arthur Petrosian 
Scientific Review Administrator 6705 Rockledge Drive, Suite 301, MSC 7968 Bethesda, MD 20892-7968 Bethesda, MD 20817 (for courier/express service) Telephone: (301) 594-4933 FAX: (301) 402-2952 Email: petrosia@mail.nih.gov o Direct your questions about financial or grants management matters to: Dwight Mowery Extramural Programs National Library of Medicine Rockledge 1, Suite 301, 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 496-4221 FAX: (301) 402-0421 SUBMITTING AN APPLICATION Individuals must submit the application form PHS Individual National Research Service Award (PHS 416-1, rev. 6/02). APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF REFERENCE MAY BE RETURNED OR DELAYED IN REVIEW. Applications are available at: http://grants.nih.gov/grants/funding/416/phs416.htm Complete Item 3 on the face page of the application indicating that the application is in response to this announcement and print F38 NLM SENIOR INDIVIDUAL INFORMATICS FELLOWSHIP. If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application. Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident block on the Face Page of the PHS 416-1 application, and also write in the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS, and all other required materials) and two (2) exact, clear, single- sided photocopies of the signed application, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED. Concurrent Applications An individual may not have more than one individual NRSA fellowship or comparable application pending review or award at the NIH or other DHHS agencies at the same time. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR 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. Application Receipt Dates and Review Schedule Fellowship applications undergo a review process that takes between 5 and 8 months. The receipt dates and the three annual review cycles are as follows: Application Receipt Dates: Apr 5 Aug 5 Dec 5 Initial Review Dates: Jun/Jul Oct/Nov Feb/Mar Secondary Review Dates: Aug/Sep Dec/Jan Apr/May Range of Likely Start Dates: Sep 1-Dec 1 Jan 1-Mar 1 May 1-Jul 1 PEER REVIEW PROCESS Applications will be reviewed for scientific and technical merit by the NLM Biomedical Library and Informatics Review Committee (BLIRC) in accordance with standard NIH peer review procedures. In general, the merit review criteria customarily employed by the NIH for fellowship applications will be followed. Additional information may be found at http://grants.nih.gov/training/nrsa.htm. After the initial merit review, the NLM program official will forward to each applicant a written critique and summary of the review of the application prepared by the Scientific Review Administrator. After scientific-technical review, staff within the NLM will provide a second-level review to evaluate relevance to the mission and scope of NLM. Following the second-level review, the NLM program official will notify each applicant of the final disposition of the application. Any questions on BLIRC recommendations and funding possibilities should be directed to the NLM program official, not the Scientific Review Administrator. REVIEW CRITERIA Candidate: An assessment of the candidate's previous academic and research performance and the potential to become an important contributor to biomedical, behavioral, or clinical science. Sponsor and Training Environment: An assessment of the quality of the training environment and the qualifications of the sponsor as a mentor for the proposed research training experience. Research Proposal: The merit of the scientific proposal and its relationship to the candidate's career plans. Training Potential: An assessment of the value of the proposed fellowship experience as it relates to the candidate's needs in preparation for a career as an independent researcher. Additional Review Criteria In addition to the above criteria, applications will also be reviewed with respect to the following: Protections. The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. Inclusion. 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) Budget. The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Training In The Responsible Conduct Of Research. Applications must include a description of a program to provide instruction in scientific integrity and the responsible conduct of research. (See the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992.) OTHER REVIEW CRITERIA All applications must include in the proposed research plan an outline and description of the project including specific hypotheses, objectives, and milestones as appropriate. Applications with an applied rather than research focus must include a specific section labeled Milestones following the Research Plan. Milestones should be well described, quantifiable, and scientifically justified. A discussion of the milestones relative to the progress of the project, as well as the implications of successful completion of the milestones for further investigation or implementation, should be included. The milestone section should be indicated in the Table of Contents. The clarity and completeness of the application with regard to specific goals and feasibility of milestones is critical. The presentation of milestones that are not sufficiently scientifically rigorous to be valid for assessing progress will reflect upon the scientific judgment of the applicant in this application. Applications for the LHNCBC co-mentorship program must clearly describe the plan for shared mentorship as well as supervision of the proposed project(s), and must include a letter of commitment from the proposed NLM mentor and the Director of the LHNCBC. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data if applicable AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NLM. The following factors will be considered when making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities Activation No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5) has been submitted to the NIH. An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Terms And Conditions Of Support Fellowships must be administered in accordance with the current NRSA Policy Guidelines for Individual Awards and Institutional Grants (see the NIH Website at http://grants.nih.gov/training/nrsa.htm), the current NIH Grants Policy Statement (see the NIH Website at http://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the award notice. Certification and Reporting Procedures No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. Forms may also be found on the NIH Website at http://grants.nih.gov/grants/forms.htm. Inventions and Publications Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F38 awards will not contain any provision giving PHS rights to inventions made by the awardee. REQUIRED FEDERAL CITATIONS 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 MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 - Amended, October 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 that is available at 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice- files/NOT-OD-00-039.html. PUBLIC 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 public 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 PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 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, Medical Library Assistance, 93.879. Awards are made under the authority of the Public Health Service Act, Section 472 (42 USC 286b-3) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 61 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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.


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