EXPLORATORY CENTERS (P20) FOR INTERDISCIPLINARY RESEARCH
 
RELEASE DATE:  September 30, 2003
 
RFA Number:  RFA-RM-04-004 (formerly RFA-RR-04-002, see NOT-RM-05-006 and NOT-OD-04-008)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
 (http://www.nih.gov) 
 
This RFA is developed as a roadmap initiative.  All NIH Institutes and 
Centers participate in roadmap initiatives.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.389
 
LETTER OF INTENT RECEIPT DATE:  January 30, 2004
APPLICATION RECEIPT DATE:  February 24, 2004
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

In addition to the biological sciences, biomedical research encompasses 
a large number of scientific disciplines, including the behavioral, 
quantitative, engineering and computer sciences.  Distinct disciplinary 
perspectives represent significant sources of strength to the overall 
research enterprise because each discipline has its own intellectual 
history, experimental and analytic approaches, and theoretical context 
that produce a unique way of thinking about a problem.  Nevertheless, 
as scientific capabilities move forward, increasingly complex questions 
arise, and these often require the convergence of perspectives from 
multiple disciplines.  Over the years, the Institutes and Centers (ICs) 
of the National Institutes of Health (NIH) have developed many 
initiatives, mechanisms and programs to support multidisciplinary 
research--that is, research that brings together researchers from 
different disciplines to focus on a circumscribed problem.

It is becoming apparent that, in some cases, the collaborative nature 
of disciplines that characterizes multidisciplinary research is not 
sufficiently sustained to address, in a comprehensive and effective 
way, challenging problems in biomedical and behavioral research.  
Rather, interdisciplinary research, which integrates several 
disciplinary approaches in a more sustained and systematic fashion, may 
be required to tackle these more complex problems.  Integrating 
different disciplines in this way holds the promise of opening up 
currently unimagined scientific avenues of inquiry, and in the process, 
may form whole new disciplines.  Historical examples include the 
development of genomics, which was formed from genetics, molecular 
biology, analytical chemistry, and informatics.  Another example in 
which multiple disciplines have, in a less directed way, blended and 
evolved into a new discipline is neuroscience.  Thirty years ago, 
students of the brain might have identified themselves as anatomists, 
physiologists, or psychobiologists, but today they would consider 
themselves neuroscientists.
  
Combining particular aspects of different disciplines to develop 
entirely new ways to approach biomedical and behavioral research 
problems is daunting in many ways.  In recognition of the difficulty of 
establishing interdisciplinary research efforts, this Request for 
Applications (RFA) solicits applications for P20 planning grants that 
will support planning activities for groups of researchers to develop 
interdisciplinary research strategies to solve significant biomedical 
and/or behavioral research problems.  Activities supported will include 
study design and, perhaps, pilot research to demonstrate the approach 
to be pursued.  Whatever the approach, it must integrate aspects of 
multiple disciplines, which will be specified by the applicants.     
Planning activities are intended to lay the foundation and prepare 
investigators for submitting a subsequent application for more 
substantial and longer duration support through an Interdisciplinary 
Research Consortium.  In recognition of the need to bring several 
disciplines together as equal partners, this RFA allows the research 
team to submit separate, but related applications that will be reviewed 
as a unit.

RESEARCH OBJECTIVES
 
This RFA invites applications for planning grants using the P20 
(exploratory center) mechanism that will focus on developing new 
approaches to solving significant and complex biomedical problems, 
particularly those that have been resistant to more traditional 
approaches.  These new approaches must hold the promise of leading to 
new research approaches to improving human health.

These planning grants are expected to identify a biomedically relevant 
problem, evaluate why previous approaches have not worked, justify why 
the proposed interdisciplinary approach will work, identify the 
planning approach, and propose a timeline.  The planning approach could 
include holding workshops or conducting feasibility studies, but these 
are only examples of possible planning approaches.
    
It is expected that the outcome of these planning centers will 
demonstrate that the proposed interdisciplinary approach is likely to 
be successful.  Success is defined as combining aspects of individual 
disciplines to provide a new approach to solving a problem that is 
likely to yield insights that could not have been achieved by an 
isolated laboratory or using a multi-disciplinary approach.  The 
planning grant should request three years of funding.

In most cases, it is expected that the proposed centers will have 
leaders from more than one discipline.  In order to recognize the 
intellectual input from scientists from more than one discipline and 
potentially from separate institutions, this RFA will allow 
contributing scientists to submit separate, but related, applications 
that address the same research problem. In addition to describing the 
research to be accomplished, these linked applications must address the 
nature of the collaboration.  Whether applicants choose to submit one 
or multiple linked P20 applications, the development of interactions 
across disciplines must be specifically addressed.  This innovative 
approach should allow each of the intellectual leaders to achieve 
appropriate credit for their contribution to this interdisciplinary 
project.  This RFA also allows applications from single principal 
investigators who propose an interdisciplinary approach.  

MECHANISM OF SUPPORT
 
This RFA will use NIH P20 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  The anticipated award 
date is September 2004.  

This RFA uses just-in-time concepts.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE
 
The participating ICs intend to commit approximately $9 million in FY 
2004 to fund roughly fifteen new planning grants in response to this 
RFA. An applicant must request a project period of three years and a 
budget for direct costs of up to $400,000 per year.  The F&A costs 
(often called indirect costs) for any subcontracts will not count 
toward this $400,000 cap.  For linked applications, the total direct 
costs for all of the grants is limited to $400,000; that is, the 
$400,000 maximum budget will need to be distributed across the 
multiple, linked applications.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size also will vary. Although the financial plans 
of the IC(s) provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) 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 Foreign institutions are not eligible to apply

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

SPECIAL REQUIREMENTS

This RFA demonstrates the interest of NIH in supporting 
interdisciplinary research efforts as new pathways of discovery, but 
support by NIH is not sufficient for such research to prosper.  More 
important is the commitment by research institutions to foster and 
accommodate interdisciplinary research.  

Therefore, applicant organizations must describe their plans to 
facilitate interdisciplinary research as it relates to the P20 planning 
grant.  Among the issues that should be addressed are:  1) how the 
institution will distribute credit for direct (and indirect) costs to 
reflect the contributions of different components, 2) how the 
institution will recognize the contributions of the research team 
beyond the Principal Investigator, and 3) how the institution attends 
to the careers of "interstitial" team members who play important roles 
in interdisciplinary research, but who are not tenure track or 
eligible/appropriate to be principal investigators on research grants.  
Applicant institutions are encouraged to describe how interdisciplinary 
research will be facilitated beyond these three issues. 
 
This description of institutional commitment should be included as a 
letter from an appropriate representative of the applicant institution.  
It is likely that the appropriate institutional representative will 
have authority beyond a single department.
  
WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Greg Farber, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, Room 960
Bethesda, MD  20892-4874
Telephone:  (301) 435-0778
FAX:  (301) 480-3659
Email: gf48a@nih.gov

Michael F. Huerta, Ph.D.
Associate Director, Scientific Technology and Research
National Institute of Mental Health
6001 Executive Blvd., Room 7202
Bethesda, MD 20892-9645
Telephone:  (301) 443-3563
FAX: (301) 443-4822
Email: mh38f@nih.gov 

o Direct your questions about peer review issues to:

Sheryl Brining, Ph.D.
Director, Office of Review
National Center for Research Resources
6701 Democracy Blvd, Rm 1074 
Bethesda MD 20892-4868
Telephone:  (301) 435-0809
FAX:  (301) 480-3660
Email: sb44k@nih.gov

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

Mary Niemiec
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd, Rm 1046
Bethesda, MD  20892-4874
Telephone:  (301) 435-0842
FAX:  (301) 480-3777
Email: mn20z@nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Name, address, and telephone number of collaborating Principal 
Investigators if a linked application is submitted.
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Greg Farber, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, Room 960
Bethesda, MD  20892-4874
Telephone:  (301) 435-0778
FAX:  301-480-3659
Email: gf48a@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR ALL APPLICATIONS

Required information, in addition to that requested in the PHS 398 Form 
Instructions, is listed below.

1) Timeline

A specific section labeled Timeline must be included following the 
Research Design and Methods section.  The timeline should show the 
planned actions over the three-year period of the award.  The timeline 
section must be contained within the 25-page limit.

2) Meeting

All awardees should plan to attend a meeting in the Washington, DC area 
in the second year of the award.  Awardees will be expected to present 
their results at the meeting and will help NIH staff plan for future 
programs to support interdisciplinary research at NIH.  The budget 
should contain support for travel for the project leaders for this 
meeting.

3) Management Plan

A plan should be presented for how the team will collaborate and how 
the efforts of the individual investigators will be coordinated.  This 
concise management plan should be presented in a separate section 
following the Research Design and Methods section and must be contained 
within the 25-page limit.

4) Institutional Barriers to Interdisciplinary Research

The items mentioned in the Special Requirements section should be 
addressed in a letter from the appropriate institutional official.  
This letter should follow the Management Plan in the application.

5) Budget

The modular budget format should not be used.

SPECIFIC INSTRUCTIONS FOR SEPARATE APPLICATIONS FROM RESEARCH A TEAM 
(LINKED APPLICATIONS)

It is important that applicants who wish to submit linked applications 
announce their intentions clearly and early.  Linked applications must 
mention the linkage in 4 separate areas of the application:  the letter 
of intent, the cover letter included with the application, the title of 
the proposal, and in the abstract.

1) Letter of Intent

Linked applications should be clearly identified in letters of intent. 
Each Principal Investigator for the linked proposals should send a 
separate letter as detailed above.  In the letter, the name and 
institution of the other members of the team should be identified 
clearly.

2) Cover Letter

To aid the Division of Receipt and Referral in making appropriate 
assignments, it is essential that the other members of a linked group 
be identified in the cover letter of the application.  The cover letter 
should mention that this is a linked application and give the title(s), 
PI name(s), and originating institution(s) of application(s) that are 
linked.  

3) Title

Linked applications must have identical titles followed by the phrase 
(number of number).  An appropriate title would be "Plans for 
Interdisciplinary Studies of Obesity (1 of 2)".

4) Abstract

The fact that this is a linked application should be specified in the 
abstract of the application.  The names and institutions of the other 
"linked" Principal Investigators should be in the abstract.

5) Budget

Linked applications can request, at most, $400,000 in total direct 
costs for ALL awards (e.g., if two applications are linked, and if one 
requests $250,000, the other linked application could only request up 
to $150,000).  The modular budget format should not be used.

6) Research Plan and Common Text

The PHS 398 form instructs applicants to divide the Research Plan 
section of the application into four parts (A-D) to answer the 
following questions:

A) What do you intend to do? 
B) Why is the work important? 
C) What has already been done? 
D) How are you going to do the work? 

For linked applications, it is expected that sections A, and B will be 
the same in each linked application.  Section C may or may not have 
common text between linked applications.  Section D should be different 
for each of the components of a linked application.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
five copies of the appendix material must be sent to:

Office of Review 
National Center For Research Resources
6701 Democracy Boulevard, 10th floor
Bethesda, MD 20892-4874
Bethesda, MD 20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes from the previous unfounded version 
of the application.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the (IC).  Incomplete and/or nonresponsive 
applications will not be reviewed.  

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NCRR in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate National Advisory 
Council or Board.
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
bio-medical and behavioral systems, improve the control of disease, and 
enhance health.  In the written comments, reviewers will be asked to 
discuss the following aspects of the application in order to judge the 
likelihood that the proposed research will have a substantial impact on 
the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.  The application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

SIGNIFICANCE: Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Do the applicants acknowledge potential problem areas and 
consider alternative tactics? Are the appropriate disciplines 
adequately represented and well integrated to approach this complex 
research question?

INNOVATION: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?

INVESTIGATORS: Are the investigators appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigators and other researchers 
(if any)?

ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?  

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

1) Is the proposed approach interdisciplinary? Are the appropriate 
disciplines included to provide a unified approach to the problem?

2) Does the proposed interdisciplinary approach have the potential to 
significantly change the way research on this topic is pursued? 

3) Is there a plan in place to ensure that the collaboration runs 
smoothly?  Does the management plan ensure that there will be 
sufficient coordination and collaboration among the members of the 
research team?

4) Will the proposed timeline allow the research team and NIH program 
staff to assess the impact of the anticipated interdisciplinary 
approach to solving a biomedical problem by the end of the award?

5) Will this interdisciplinary approach accomplish more than what would 
be accomplished by individuals working separately on the same problem, 
i.e. is the whole greater than the sum of the parts?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy 
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL CONSIDERATIONS 

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  January 30, 2004
Application Receipt Date:  February 24, 2004
Peer Review Date:  July 2004
Council Review:  September 2004
Earliest Anticipated Start Date:  September 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants.   (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 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: 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.

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

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 RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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