COLLABORATIVE RESEARCH IN STEM CELL BIOLOGY 

RELEASE DATE:  July 22, 2004

PA NUMBER:  PAS-04-130

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
A replacement R21 (PAS-06-264) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: November 2, 2006 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.853 (NINDS) 

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
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 Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 
 
This Program Announcement with Set-Aside fosters co-operation between 
investigators and joint research projects to understand how fate choices are 
made by stem and precursor cells in the nervous system, and to design, 
refine, and improve upon the use of stem cells for diagnostic or therapeutic 
applications for neurological disorders.  The National Institute of 
Neurological Disorders and Stroke (NINDS) is interested in supporting 
research that combines the unique and complementary expertise of laboratories 
from the United States and abroad, applying different disciplines, 
techniques, model systems or tissues. We anticipate that such research will 
ultimately lead to innovative approaches for the prevention, management and 
treatment of disorders of the nervous system, and encourage collaborations 
from disparate scientific areas and disciplines, including those not 
traditionally supported by the NINDS.  It is essential, however, that the 
proposed activities be within the mission of the NINDS.

RESEARCH OBJECTIVES

Background

Among the most important biomedical questions are how complex tissues and 
organs such as the nervous system develop from small founder populations of 
stem cells, how organs are maintained and sometimes regenerate during adult 
life, and how age and disease affect this capacity.  Central to answering all 
these questions is a profound understanding of the biology and behavior of 
stem cells. In regenerative medicine for example, the ultimate goal is to 
replace, repair and regenerate cells, tissues and organs in order to restore 
biological function that has been halted or compromised by injury or disease. 
Achieving this goal may require harnessing the activities of exogenous and 
endogenous stem and progenitor cells, perhaps in combination with 
biomolecules and biomaterials, and integrating them into host tissue while 
avoiding host rejection, tumorigenesis or other adverse events. 
Cell-replacement strategies are of particular interest for diseases of the 
central nervous system (CNS), because, unlike many other tissues, the mature 
mammalian brain and spinal cord have a limited capacity for self-repair.  
Stem cell research offers potential for treating a host of congenital, 
developmental or degenerative neurological diseases for which there are no 
cures or treatments. In recent studies, stem cells from many different 
sources have been reported to generate cells with neuronal or glial 
properties, raising expectations that they could be used to replace lost 
neurons and glia, repair defective circuits, and restore neurological 
function. In addition to cell and tissue therapy, the ability to selectively 
produce differentiated cell types from pluripotent stem cells would be of 
great clinical importance in investigating the effects of drugs and 
environmental factors on cell function in the human nervous system. 
There are, however, serious barriers to progress in realizing the potential 
of stem cells in regenerative medicine. There are currently few markers, 
antibodies or probes with which to distinguish specific classes of stem or 
progenitor cells, to follow their differentiation, or to facilitate their 
isolation.  Similarly, there is little characterization of the niches within 
the host nervous system that allow regeneration, including the cell types and 
molecular cues that are responsible for tissue organization.  While methods 
exist to allow lineage tracing in animal models, there are no well-defined 
non-invasive methods and reagents with which to study the survival, 
migration, fate and function of stem cells and their progeny in the living 
animal or human.  This limitation makes it difficult to investigate how stem 
or progenitor cells might behave differently in healthy and diseased states 
in vivo.  The flexibility or plasticity of stem cells, coupled with their 
ability to self-renew, raises the specter of unintended side effects such as 
the formation of tumors or maladaptive neural circuits.  Little is currently 
known about the frequency or circumstances under which these events occur, or 
how they could be controlled. We also need to explore avenues to avoid host 
rejection of grafted cells. Finally, coaxing cells to form functional tissue 
may require physical support, such as a three dimensional scaffold, in 
conjunction with chemical and mechanical signals, provided at appropriate 
times and places, to establish the intricate structures that characterize 
native tissue.  While there is some promising work using artificial matrices, 
there is a pressing need to expand this research with new types and designs 
of biomaterials.  Success may require an approach that combines 
bioengineering, stem cell biology and expertise in extracellular matrices.
It is clear that no single investigator, laboratory or institution has the 
resources to tackle these complex questions.  The solution lies in developing 
synergy between the various scientific disciplines and investigators with 
very different expertise and resources.  Great opportunities are possible as 
researchers combine rapidly improving technology, expertise, tools, model 
systems, resources such as transgenic animals and specific disease models, 
and assessment tools.
  
Many of the challenges to progress in stem cell biology were first identified 
by investigators at several workshops and meetings held by NINDS to review 
the current state of stem cell biology and to determine critical needs. This 
initiative is responsive to recommendations made by the working groups of 
stem cell experts to the NIH Stem Cell Task Force, by panelists at a recent 
NINDS-NIMH workshop on International Networking in Stem Cell Research: 
Targeting Neural Repair and Development, and by participants of the Brain 
Tumor Progress Review Group. 
 
Objectives and Scope

Applications must demonstrate that the success of the proposed research 
requires the full collaboration between two or more independent groups 
contributing unique yet complementary expertise or resources. The following 
examples illustrate areas of research where synergy between different 
disciplines is of high interest; other innovative projects are also 
encouraged. These examples of research approaches are not meant to be all-
inclusive or restrictive. Plans for data and/or reagent sharing and 
promulgation of results will be integral to the applications.  

o Harnessing immune mechanisms to develop tolerance and overcome rejection 
for use of allogenic cells in the nervous system.

o Defining the transcriptome and proteome of different stem cells and their 
microenvironment or niche within the host brain and spinal cord.

o Defining co-regulated elements, so-called “hub genes” in stem cell 
differentiation toward neuronal or glial phenotypes. 

o Evaluating chemical libraries to identify small molecules for stem cell 
proliferation or neural differentiation.

o Developing cell-based tools for drug discovery, or sensors for the 
detection and identification of chemical and biological agents that are 
important for clinical diagnostics for neurological disorders. 
 
o Developing non-invasive methods and agents with which to visualize or track 
stem cells in vivo.

o Exploring the relationship between stem cells and brain tumors, and 
identifying factors influencing tumor risk in stem cell therapies.

o Investigating the use of stem cells as vehicles to deliver targeted 
therapeutics to sites in the nervous system.

MECHANISM(S) OF SUPPORT 

This PAS will use the NIH Exploratory/Developmental Grant (R21) and the 
Research Project Grant (R01) award mechanisms.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  The proposed project period during which the research will be 
conducted should adequately reflect the time required to accomplish the 
stated goals and should be no more than 5 years for R01 grants.  The R21 
grants are one-time awards to support innovative, high impact research 
projects that would either 1) generate pilot data to assess the feasibility 
of a novel avenue of investigation, 2) involve high risk experiments that 
could lead to a breakthrough in a particular field, or 3) demonstrate the 
feasibility of new technologies that could have major impact in a specific 
area.  Support for the R21 grants is limited to two years with a cumulative 
maximum of $275,000 direct costs requested for both years.  This program is 
appropriate both for new investigators seeking to establish independent 
research careers and for established investigators wishing to explore new 
areas of neuroscience or develop novel technologies.  For further information 
on the R21 mechanism, including Institute-specific information, see 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html

This PAS uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  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 NINDS has set aside a total of $3 million dollars to support this 
initiative. The amount and timing of awards paid from set aside funds will 
depend on the overall scientific merit of the applications and the 
availability of funds throughout the duration of this solicitation (3 years). 
Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration of 
each award will also vary. Although the financial plans of the NINDS provides 
support for this program, awards pursuant to this PAS 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 Domestic or foreign institutions/organizations

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.  

SPECIAL REQUIREMENTS 

Upon initiation of the program, the NINDS will sponsor an annual meeting to 
encourage the exchange of information among investigators who participate in 
this program.  In the preparation of the budget for the grant application, 
applicants should REQUEST ADDITIONAL TRAVEL FUNDS for one meeting each year 
to be held in Bethesda, Maryland.  For R21 applications, the total budget, 
including this request for additional travel, should stay within the two 
year, $275,000 limit for this mechanism.  Applicants should also include a 
statement in the applications indicating their willingness to participate in 
such meetings.  Applicants are also strongly encouraged to include plans for 
data and/or reagent sharing and promulgation of results.  

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PAS and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Arlene Y. Chiu, Ph.D.
Program Director, 
Repair and Plasticity Program
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2207, MSC 9525
Bethesda, MD  20892-9525
Telephone:  (301) 496-1447
FAX: (301) 480-1080
Email:  chiua@ninds.nih.gov

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

Gavin Wilkom
Grants Management Specialist
Grants Management Branch, DER 
National Institute of Neurological Disorders and Stroke
Neuroscience Center, 6001 Executive Blvd. Room 3250, MSC 9537
Bethesda MD, 20892
Telephone: (301) 496-7480
FAX: 301-402-0219
Email: gw62m@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 D&B number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The D&B number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 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.

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 checked.

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.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member who has agreed to 
accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the NINDS will accept your         
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the IC staff 
member who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

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)

APPLICATION PROCESSING: Applications must be 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 PAS 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 unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PAS will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
convened 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 Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council 
or board  

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application's overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

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? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

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?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator 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?  

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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See 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 REVIEW CONSIDERATIONS  

Sharing Research Data: Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research are expected to include a data 
sharing plan in their application. The reasonableness of the data sharing 
plan or the rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing plan 
into the determination of scientific merit or priority score. 

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

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities 

An additional consideration will be the demonstration that the proposed 
research requires the full collaboration of two or more independent groups 
contributing unique and non-overlapping expertise and resources.

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).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing.  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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. 

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).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople. 

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 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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