UBIQUITIN AND UBIQUITIN-LIKE MODIFICATIONS REGULATING DISEASE PROCESSES 

RELEASE DATE:  July 1, 2003

PA NUMBER: PA-03-145

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. Accordingly, this funding opportunity 
expires on the date indicated below. Replacement R01 (PA-06-167) and R21 (PA-06-168) 
funding opportunity announcements have been issued for the submission date 
of June 1, 2006 and submission dates thereafter. 

See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and 
AIDS-related R03 and R21 Applications.

EXPIRATION DATE:  March 2, 2006

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Institutes of Aging (NIA)
 (http://www.nia.nih.gov)
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.847, 93.848, 93.849, 
93.866, and 93.396

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 Diseases (NIDDK), 
the National Institute of Aging (NIA), and the National Cancer Institute 
(NCI) invite investigator-initiated research projects (R01 and R21) focused 
on elucidating the various roles of ubiquitin and ubiquitin-like 
modifications in the development, normal physiology and/or disease 
progression in cells, organs, and tissues of interest to NIDDK, NCI, and NIA.  
The NIDDK supports research pertaining to diabetes, endocrine and metabolic 
diseases; nutritional disorders, obesity and digestive diseases; and kidney, 
urologic and hematologic diseases.  The NIA supports research pertaining to 
the basic biology of aging and age-associated diseases in various models 
including, but not limited to, tissue culture models and other cell-based 
paradigms, and tissues such as heart, muscle, brain and prostate.  The 
Division of Cancer Biology of the NCI supports basic research projects 
covering a broad spectrum of topics directed at understanding the biological 
basis of cancer. 

RESEARCH OBJECTIVES

Background

Ubiquitin, a highly conserved 76 amino acid polypeptide, was the first 
protein shown to be covalently attached to other proteins.  Through a multi-
enzyme cascade, polyubiquitin chains are added to a variety of different 
proteins that are then ultimately degraded by the 26S proteasome.  

Recent mining of the human and mouse genomes, use of yeast genetics, and 
detailed analyses of several biochemical pathways, have resulted in the 
identification of many new roles for ubiquitin conjugation.  Searches of the 
available genomes suggest that many ubiquitin ligases and deconjugating 
enzymes are also present in eukaryotes.  Mono-ubiquitination has now been 
shown to be involved in the regulation of wide variety of important cellular 
processes including receptor internalization and down-regulation, gene 
transcription, and virus budding.  Furthermore, several ubiquitin-like 
modifications (e.g. Sumoylation, Neddylation, and ISGylation) have been 
recently identified. The known functions of ubiquitin and ubiquitin-like 
modifications are already quite diverse, and their biological role is 
expanding beyond the original notion that these modifications simply mark 
proteins for destruction. 

Ubiquitin and ubiquitin-like modifications are increasingly recognized as key 
regulatory events in many basic cell biology processes that impact the 
development of cancer, such as regulation of the cell cycle, protein 
trafficking, and cell survival versus cell death decisions.  Ubiquitin and 
ubiquitin-like modifications and the processes activated by these 
modifications are also increasingly being investigated as potential cancer 
therapeutics.    

On March 24th and 25th, 2003 the NIDDK sponsored a meeting entitled "Ubiquitin 
and Ubiquitin-like modifications in Health and Disease".  The meeting 
highlighted some of the most recent advances in our understanding of how 
ubiquitination and similar modifications affect the regulation of metabolism 
and gene transcription, protein sorting and intracellular trafficking, as 
well as proteasomal degradation.  

The goal of current research is to try and understand the many rules 
governing signaling by ubiquitin and ubiquitin-like modifications, so that we 
can better understand the clinical implications of defects in this abundant, 
complex, and highly regulated protein modification machinery.

Objectives and Scope

This program announcement (PA) is intended to stimulate novel and productive
research focused on the involvement of ubiquitin and ubiquitin-like 
modifications in normal physiology and in disease processes of interest to 
the NIDDK, NIA, and NCI.  Areas of interest for NIDDK include research on 
cell types of the kidney, pancreas, liver, gastrointestinal tract, and blood; 
diseases such as diabetes, obesity, and other metabolic and nutritional 
disorders; as well as hematologic, urologic and kidney diseases.  Areas of 
interest for NIA include research on a variety of cellular, tissue and animal 
models of aging. Areas of interest for NCI include the identification of 
genes, proteins, and signaling networks responsible for the cancer phenotype; 
investigation of aberrantly modified processes that promote cell 
proliferation or inhibit cell death; and the exploration of molecular events 
that determine tumor cell survival and progression.   

Examples that illustrate possible areas of research are presented below.  
They are intended only to provide a broad direction for research and should 
be considered illustrative and not restrictive.  Some potential topics 
include, but are not limited to:

o Investigation of the role of ubiquitin ligases in attenuation of receptor 
signals initiated by growth factors, cytokines and hormones binding in cells 
of the liver, pancreas, kidney, intestine, bladder, prostate, or blood

o Exploring how Cbl and other ubiquitin ligases are involved in immune 
responses and how alterations in the system can lead to defects in immuno-
regulation and development of type I diabetes, intestinal inflammation or 
cholestatic liver disease

o Study of ubiquitin mediated proteosome degradation in insulin resistance 
and sensitivity of beta cells to autoimmune destruction

o Characterizing the role of ubiquitin and ubiquitin-like modifications in 
the regulation of cellular metabolism and gene transcription by the 
adipocyte, hepatocyte, or pancreatic beta cell

o Research on ubiquitin modifications and protein degradation associated with 
cachexia

o Elucidating the physiological relevance of ubiquitin-like modifications 
such as sumoylation or neddylation of ion channels and transporters

o Investigation of the role of ubiquitin modifications in diseases caused by 
misfolded or misprocessed proteins, such as cystic fibrosis, nephrogenic 
diabetes insipidus, and alpha-1-antitrypsin deficiency

o Investigation of the role of ubiquitin and ubquitin-like modifications in 
the oncogenesis of preneoplastic lesions leading to gastrointestinal and 
hepatic cancers

o Elucidation of the involvement of ubiquitin-like modifications in the 
regulation of hepatitis C replication

o Research on ubiquitin modifications and protein degradation associated with
the process of aging 

o Investigation of the role of ubiquitin in age-related protein diseases

MECHANISM(S) OF SUPPORT 

This PA will use the NIH investigator-initiated research project grant (R01) 
and the Exploratory/Development Research grant (R21) award mechanisms.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project. The total requested project period for an 
application submitted in response to this PA may not exceed 5 years for the 
R01 mechanism, and 2 years for the R21 mechanism.  R21 grants will not be 
renewable; continuation of projects developed under this program will be 
through the R01 grant program.

The R21 awards are to demonstrate feasibility and to obtain preliminary data 
testing innovative ideas that represent a clear departure from ongoing 
research interests. These grants are intended to: 1) allow exploration of 
possible innovative new directions for established investigators; and 2) 
stimulate investigators from other areas to lend their expertise to research 
within the scope of this solicitation. Applicants for the R21 may request a 
project period of up to two years with a combined budget for direct costs of 
up to $275,000 for the two-year period.  For example, you may request 
$100,000 in the first year and $175,000 in the second year.  The request 
should be tailored to the needs of your project.  Normally, no more than 
$200,000 can be requested in a single year.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format (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. 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.
  
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

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.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA 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:

Carol Renfrew Haft, Ph.D.
Program Director
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 605
Bethesda, MD  20892-5460
Telephone:  (301) 594-7689
FAX:  (301) 480-3503 
E-mail:  cr84g@nih.gov

Christopher Mullins, Ph.D.
Program Director
Division of Kidney, Urology and Hematology 
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 637
Bethesda, MD  20892-5460
Telephone:  (301) 451-4902
FAX:  (301) 480-3510 
E-mail:  cm@419z@nih.gov

Jose Serrano, M.D., Ph.D.
Program Director
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 657
Bethesda, MD  20892-5460
Telephone:  (301) 594-8871
FAX:  (301) 480-8300 
E-mail:  js362q@nih.gov

Felipe Sierra, Ph. D.
Program Director
Biology of Aging Program
National Institute on Aging
Gateway Building, Room 2C231
Bethesda, MD 20892
Tel:  (301) 496-6402
FAX:  (301) 402-0010
E-mail:  fs78n@nih.gov

Mary Perry, Ph. D.
Program Director
Division of Cancer Biology 
National Cancer Institute
EPN 5018
Bethesda, MD 20892-7396
Tel:  (301) 496-7028
FAX:  (301) 402-1037
E-mail:  mp372j@nih.gov

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

Denise Payne
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 733 
Bethesda, MD  20892-5456
Telephone:  (301) 594-8845
FAX:  (301) 480-3504
E-mail:  dp43@nih.gov

Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room 2N212
Bethesda, MD 20892
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
E-mail:  lw17m@nih.gov

Aida Vasquez
Grants Management Specialist
Division of Cancer Biology
National Cancer Institute
6120 Executive Blvd., Suite 243
Bethesda, MD 20892
Telephone:  (301) 496-2736
FAX:  (301) 496-8601
E-mail:  av47p@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.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The program announcement title and number must be typed on line 2 of the face 
page of the application form and the YES box marked.  Also indicate if the 
application in an R01 or R21. 

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 R21 APPLICATIONS

All application instructions outlined in the PHS 398 application kit are to be 
followed, with the following requirements for R21 applications:  

1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, 
with direct costs requested in $25,000 modules, up to a combined budget for 
direct costs of up to $275,000 for the two year period.

2. Preliminary data for the actual studies proposed in the R21 application are 
not required.  However, the PI should demonstrate that he/she has the 
appropriate expertise and resources on hand to perform the proposed 
experiments.  If not evidenced by publications, this may require inclusion of 
preliminary data to demonstrate facility in the methodologies proposed.

3. Sections a-d of the Research Plan of the R21 application may not exceed 15 
pages, including tables and figures.  

4. R21 appendix materials should be limited, as is consistent with the 
exploratory nature of the R21 mechanism, and should not be used to circumvent 
the page limit for the research plan. Copies of appendix material will only be 
provided to the assigned reviewers of the application and will not be 
reproduced for wider distribution. The following materials may be included in 
the appendix:

o Up to 5 publications, including manuscripts (submitted or accepted for 
publication), abstracts, patents, or other printed materials directly relevant 
to the project. These may be stapled as sets.

o Surveys, questionnaires, data collection instruments, and clinical 
protocols.  These may also be stapled as sets.

o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within the 
15 page limit of items a-d of the research plan.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular 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 within one of NIH 
institutes or centers 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 IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC 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 PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.  

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 PA 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 Receive a written critique
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 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 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? 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?

SPECIAL R21 REVIEW CRITERIA: The R21 exploratory/developmental grant is a 
mechanism for supporting novel scientific ideas or new model systems, as well 
as for supporting the development of tools and technologies that have the 
potential to significantly advance our knowledge or the status of health-
related research.  Because the research plan is limited to 15 pages, an R21 
grant application need not have background material or preliminary 
information as one might normally expect in an R01 application.  Appropriate 
justification for the proposed work can be provided through literature 
citations, data from other sources, or, when available, from investigator-
generated data.  Preliminary data are not required for these R21 
applications.  
  
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

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 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 CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data. Do 
investigators state their willingness to submit data to a public database in 
a timely fashion or make the information available to the community at large 
in another way?  Do the investigators agree to share reagents such as knock-
out mice, cell populations, plasmids and antibodies?  The plans proposed for 
sharing and data release will be reviewed for adequacy by reviewers as well 
as NIDDK, NIA or NCI staff prior to award and will be considered as a 
criterion for award.  

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

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm .  

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines 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:  tc 
"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 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 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. 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)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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