NIDDK MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01)

RELEASE DATE:  February 19, 2002

PA NUMBER:  PAR-02-065 (This PA is being replaced by, PAR-05-066)

EXPIRATION DATE:  February 1, 2005

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
 
THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) 
invites applications for Mentored Research Scientist Development Awards (K01) 
from basic scientists interested in pursuing research careers in the areas of 
diabetes, endocrinology, metabolic disorders, digestive diseases, nutrition, 
obesity, and kidney, urologic, and hematologic disorders.  The intent of 
these K01 awards is to provide support for the critical transition period 
between postdoctoral training and independent R01 funding for those non-
clinical investigators whose careers are vital for the future excellence of 
the NIDDK research endeavor. Candidates must justify the need for a three, 
four, or five year period of mentored research experience and provide a 
convincing case that the proposed period of support will substantially 
enhance his/her career as an independent investigator.

RESEARCH OBJECTIVES

The goal of the NIDDK K01 program is to ensure a future cadre of well-trained
Ph.D. scientists competitive for regular research project (R01) grant 
support. The intent is to provide a final mentored period of support to 
facilitate the transition of the candidate to independence and to allow 
him/her to accumulate the data and expertise needed to apply for an initial 
R01 grant.

Key elements for the award, in addition to the candidate, include:

Environment:  The applicant institution must have a well-established research 
career development program and qualified basic research faculty to serve as 
mentors. The institution must be able to demonstrate a commitment to the 
development of the candidate as a productive, independent investigator and be 
willing to allow the protected time needed by the applicant.  The candidate, 
mentor, and institution must be able to describe a multi-disciplinary career 
development program that will maximize the use of relevant research and 
educational resources.

Program: The award provides three, four, or five consecutive 12-month 
appointments.  At least 75 percent of the recipient"s full-time professional 
effort must be devoted to the program, although 100% effort may be requested. 
The remainder of the applicant"s time should be devoted to other research-
related and/or teaching pursuits consistent with the objectives of the award.  
The candidate must develop knowledge in the basic sciences and research 
skills relevant to his/her career goals.  The candidate may find it 
appropriate to include relevant didactic and laboratory or field 
research experiences.

Mentor(s):  The candidate must receive appropriate mentoring throughout the 
3-5 year program.  Where feasible, women and minority mentors should be 
involved as role models.

MECHANISM OF SUPPORT

This PA will use the NIH Mentored Research Scientist Development
Award (K01) (http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html) 
mechanism.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project. The applicant institution must 
demonstrate its commitment to you and your goals for career development.  
Awards are not renewable. The project period may be three, four, or five 
years, although it is anticipated that the majority of awards issued will be 
for three years.

This PA uses just-in-time concepts.  Modular budgeting is not used.  Follow 
the instructions for non-modular research grant applications.

Allowable Costs: 

1.  Salary: The NIDDK will provide salary and fringe benefits for the K01 
award recipient.  Salary is limited to $75,000, fringe benefits are in 
addition to this.  The total salary requested must be based on a full-time, 
12-month staff appointment and must be consistent both with the established 
salary structure at your institution and with salaries actually provided by 
the institution from its own funds to other staff members of equivalent 
qualifications, rank, and responsibilities in the department concerned.  If 
full-time, 12-month salaries are not currently paid to comparable staff 
members, the salary proposed must be appropriately related to the existing 
salary structure.  Confirmation of salary is required prior to an award 
being issued.

Your institution may supplement the salary you receive from the K01 award, up 
to a level consistent with the institution"s salary scale.  Supplementation 
may not be from Federal funds unless specifically authorized by the Federal 
program from which such funds are derived. In no case may PHS funds be used 
for salary supplementation.  Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the 
purpose of the K01 award. 

2.  Research Development Support: The NIDDK will provide up to $25,000 per 
year for the following expenses:  (a) tuition, fees, and books related to 
career development, (b) research expenses, such as supplies, equipment, and 
technical personnel, (c) travel to research meetings or training, and (d) 
statistical services, including personnel and computer time.

3.  Ancillary Personnel Support: Salary for mentors, secretarial and
administrative assistance, etc., is not allowed.

4.  Indirect costs: Indirect costs will be reimbursed at 8 percent of 
modified total direct costs, or at the actual indirect cost rate, whichever 
is less.

Additional Information for K awardees

Other Income: You may not keep fees resulting from professional consultation 
or other comparable activities required by the research and research-related 
activities of this award. Such fees must be assigned to the grantee 
institution for disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with the 
NIH policy on supplementation of career award salaries and to provide fringe 
benefits in proportion to such supplementation.  Such salary supplementation 
and fringe benefit payments must be within the established policies of the 
grantee institution.

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks
should be made payable to the Department of Health and Human Services, NIH 
and forwarded to the Director, Division of Financial Management, NIH, 
Bethesda, Maryland 20892.  Checks must identify the relevant award account 
and reason for the payment.

You may retain royalties and fees for activities such as scholarly writing, 
service on advisory groups, or honoraria from other institutions for lectures 
or seminars, provided these activities remain incidental and provided that 
the retention of such pay is consistent with the policies and practices of 
your institution.

Special Leave: Leave to another institution, including a foreign laboratory, 
may be permitted if directly related to the purpose of the award.  Only 
local, institutional approval is required if such leave does not exceed 3 
months.  For longer periods, prior written approval of the NIH funding 
component is required.  To obtain prior approval, you must submit a letter to 
the NIDDK describing the plan, countersigned by your department head and the 
appropriate institutional official.  A copy of a letter or other evidence 
from the institution where the leave is to be taken must be submitted to 
assure that satisfactory arrangements have been made.  Support from the 
career award will continue during such leave.

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

Leave without award support may not exceed 12 months.  Such leave requires 
the prior written approval of the NIDDK and will be granted only in unusual 
situations.  Support from other sources is permissible during the period of 
leave.  Such leave does not reduce the total number of months of program 
support for which an individual is eligible.  Parental leave will be granted 
consistent with the policies of the NIH and the grantee institution.

Termination or Change of Institution: When a grantee institution plans to
terminate an award, the NIDDK must be notified in writing at the earliest
possible time so that appropriate instructions can be given for termination.  
The Director of the NIH may discontinue an award upon determination that the
purpose or terms of the award are not being fulfilled.  In the event an award 
is terminated, the Director of the NIH shall notify the grantee institution 
and career award recipient in writing of this determination, the reasons for 
this action, the effective date, and the right to appeal the decision.

If you plan to relocate, you must submit to the NIDDK in advance of the move, 
a written request for transfer, countersigned by the appropriate 
institutional business office, describing the reasons for the change and 
including the new sponsor"s name and biosketch.  You must establish in this 
request that the specific aims of the research program to be conducted at the 
new institution are within the scope of the original peer reviewed research 
program. Additionally, your new sponsor must have the appropriate research 
expertise to supervise your program and sufficient research support to ensure 
continuation of the research program to the end of the award.  NIDDK program 
staff will review this request and may require a review by an initial review 
group and/or the NIDDK National Advisory Council.  Upon approval of the 
request, the new institution, on your behalf, must submit a new career award 
application far enough in advance of the requested effective date to permit 
review.  The period of support requested in the new application must be no 
more that the time remaining within the existing award period. 

When you plan to replace a mentor, the institution must submit a letter from 
the proposed mentor and K01 awardee documenting the need for substitution, 
the new mentor"s qualifications for supervising the program, and the level of 
support for the your continued career development.  The letter must also 
document that the specific aims of the research program will remain within 
the scope of the original peer reviewed research program.  NIDDK program 
staff will evaluate the request and will notify your institution of the 
results of the evaluation. 

A final progress report, invention statement, and Financial Status Report are
required upon either termination of an award or relinquishment of an award in 
a change of institution situation.

If you have questions about any of these issues, please contact the 
appropriate NIDDK staff person listed under "INQUIRIES."

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution has any of the following 
characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

Applicants must have a research or a health-related professional doctorate,
usually a Ph.D. degree, and have completed at least two, but usually not more 
than five, years of postdoctoral research training prior to submitting a K01 
application.  Postdoctoral work should have been in an area clearly relevant 
to the mission of the NIDDK.  Applicants may not have been principal 
investigators on peer-reviewed research project grants (R01s), or their 
equivalent, from the NIH or other Federal or non-Federal sources.

The research proposed must be related to the areas of diabetes, metabolic
disorders, cystic fibrosis, endocrinology, digestive diseases, liver 
diseases, nutrition, obesity, and kidney, urologic, or hematologic disorders.  
You are strongly encouraged to consult with the program staff listed under 
INQUIRIES to determine if you and your proposed research are appropriate for 
this award.

You must identify one or more mentors with extensive research experience, and 
you must be willing to spend a minimum of 75 percent of your full-time 
professional effort conducting research and research career development 
activities for the period of the award.

Only U.S. citizens or noncitizen nationals, or an individual lawfully 
admitted for permanent residence who possesses an Alien Registration Receipt 
Card (I-151 or I-551), or some other verification of legal admission as a 
permanent resident, are eligible for the K01.  Noncitizen nationals, although 
not U.S. citizens, owe permanent allegiance to the U.S.  They are usually 
born in lands that are not states but are under U.S. sovereignty, 
jurisdiction, or administration.  Individuals on temporary or student visas 
are not eligible. 

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research and peer review issues to 
one of the following individuals, based on your area of scientific interest:

James Hyde, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 609 MSC 5460
Bethesda, MD  20892-5460
Telephone:  (301) 594-7692
Email:  jh486z@nih.gov

Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 667, MSC 5450
Bethesda, MD  20892-5450
Telephone:  (301) 594-8876
Email:  jp53s@nih.gov

Terry Rogers Bishop, Ph.D.
Division of Kidney, Urologic, and Hematologic Disorders
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 619, MSC 5458
Bethesda, MD  20892-5458
Telephone:  (301) 594-7717
Email:  tb232j@nih.gov
 
o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D.
Review Branch, Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy  Blvd, Room 752, MSC 5452
Bethesda, MD  20892-5452
Telephone:  (301) 594-8897
Email:  fc15y@nih.gov

o Direct your questions about financial or grants management matters to:

Donna Huggins
Grants Management Office
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 711, MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301) 549-8848
Email:  dh48v@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  You must follow the additional instructions for Research Career 
Awards within the 398 instructions and forms. For further assistance contact 
GrantsInfo, Telephone (301) 435-0714, Email:  GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked

Applications (new and revised) must include at least three sealed letters of 
reference attached to the face page of the original application.  
Applications submitted without the required number of reference letters will 
be considered incomplete and will be returned without review.

APPLICATION PROCESSING: Applications must be received by, or mailed on or 
before, the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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 an application must include an Introduction addressing the 
previous critique.

The application must contain the following information:

Candidate

o  Describe your commitment to a career in an area of biomedical or 
behavioral research of importance to the NIDDK,

o  Document your potential to develop into a successful independent 
investigator.  Usually this is evident from your publications, prior research 
interests and experience, and your letters of recommendation.

o  Describe your immediate and long-term career objectives, explaining how 
the K01 award will help you achieve them.

o Confirm that you will devote at least 75 percent effort to research career 
development activities.  Your mentor or department chair must agree that this 
amount of your time will be protected.

o Letters of recommendation.  Three sealed letters of recommendation 
addressing your potential for a research career must be included as part of 
the application.

Career Development Plan

o Describe your career development plans, incorporating consideration of your 
goals and prior experience.  A systematic plan to obtain the necessary basic 
biomedical or behavioral science background and research experience to launch 
an independent research career must be proposed.  The career development plan 
must be tailored to your needs and to your goal of becoming an 
independent researcher.

o You must justify the need for a three, four, or five year period of 
mentored research experience and must be able to provide a convincing case 
that the proposed period of support will substantially enhance your career 
and/or will allow you to pursuit of a novel or promising approach to a 
particular research problem. We anticipate that most applicants, since they 
have already completed two or more years of postdoctoral fellowship training, 
will not need more than three years of support from this K01 award.

Training in the Responsible Conduct of Research

o You must describe your plans to receive instruction in the responsible 
conduct of research. These plans must detail the proposed subject matter, 
format, frequency, and duration of instruction.  No award will be made if an 
application lacks this component.

Research Plan

o Describe your research plan and the use of a basic or clinical approach to 
a biomedical or behavioral problem.  The research plan must be described as 
outlined in form PHS 398 including sections on the Statement of Hypothesis 
and Specific Aims, Background, Significance, and Rational, Preliminary 
Studies and Any Results, and Research Design and Methods. You should consult 
with your mentor(s) regarding the development of these sections.

Candidates for this award will have had previous research experience
as postdoctoral fellows.  A sound research plan that is consistent with your
career development plan and your level of research development is a key  
element of the application.

Mentor"s Statement

o The application must include a statement from your mentor including 
information on his/her research qualifications and previous experience as a 
research supervisor.  The application must also include information to 
describe your mentor"s research support relevant to your research plan and 
the nature and extent of supervision that he/she will provide during the 
period of the award.  Your primary mentor must agree to provide annual 
evaluations of your progress for the duration of the award.

o Similar information must be provided by each co-mentor.  When more than one 
mentor is proposed, the respective areas of expertise and responsibility of 
each should be described.

Environment and Institutional Commitment

o Your institution must have a strong, well-established research program 
related to your area of interest, including a high-quality research 
environment with staff capable of productive collaboration with you.  The 
institution also must provide a statement to document the level of commitment 
to your development into a productive, independent investigator during the 
period of the award.  This must include an indication of support for your 
proposed level of effort (at least 75 percent), commitment to the necessary 
release time from other duties (e.g. teaching), as well as the availability 
of support and supervision during the award period.

Budget

o Budget information must be provided according to the instructions in the 
PHS 398, including information on your mentor(s)" pending and current 
research support as stipulated.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened by the NIDDK in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for 
scientific and technical merit.  

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

o Receive a written critique
o Receive a second level review by the NIDDK National Advisory Council

REVIEW CRITERIA
 
The following review criteria will be applied:

Candidate

o Quality of your research and academic record, 

o Potential to develop as an independent researcher, and

o Commitment to an independent research career.

Career Development Plan

o Appropriateness of your career development plan when considered in the 
context of your prior research and academic experience and your stated 
career goals,

o Appropriateness of the content, the phasing, and the proposed duration of 
your career development plan for achieving scientific independence,

o Likelihood that your career development plan will contribute substantially 
to your scientific development and help you achieve scientific independence, 

o Clarity of the goals and scope of the plan and the need for the proposed
research experience.

Training in the Responsible Conduct of Research

o Quality of the proposed training in the responsible conduct of research.

Research Plan 

o Appropriateness of the research plan to your stage of research development 
and as a vehicle for developing the research skills described in your career 
development plan,

o Scientific and technical merit of the research question, design, and
methodology, judged in the context of your prior training and experience,

o Relevance of the proposed research to your career objectives and to the 
mission of the NIDDK, and

o Adequacy of the plans to include both genders, minorities, and children and
their subgroups as appropriate for the scientific goals of the research when 
human subjects are used.  Plans for the recruitment and retention of subjects 
will also be evaluated, when applicable.

Mentor/Co-mentors

o Appropriateness of your mentor"(s)" research qualifications in the area of 
research proposed,

o Quality and extent of your mentor"(s)" proposed role(s) in providing you 
with guidance and advice,

o Previous experience in fostering the development of researchers, 

o History of research productivity and support, and

o Adequacy of support for the proposed research project.

Institutional Environment and Commitment

o Evidence that your institution is committed to your scientific development 
and assurance that your institution intends for you to be an integral part of 
its research program,

o Adequacy of research facilities and training opportunities,

o Quality and relevance of the environment for your scientific and 
professional development, and

o Your institution"s commitment to an appropriate mix of research, 
teaching, and administrative responsibilities for you.

Budget

o The requested budget must be appropriate in relation to your career 
development goals and research aims and plans.

AWARD CRITERIA

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

o Quality of the proposed applications as determined by peer review
o Availability of funds
o Program priority

REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "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 are 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

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants an Contracts, June 5, 
2000 (Revised August 25, 2000), and is available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned 
without review.

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.

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.

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

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 No. 93.847, 93.848, 93.849 and is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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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