NON-INVASIVE METHODS FOR DIAGNOSIS AND PROGRESSION OF DIABETES, KIDNEY, 
UROLOGICAL, HEMATOLOGICAL AND DIGESTIVE DISEASES

RELEASE DATE:  April 7, 2004

PA NUMBER:  PA-04-088

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-06-143) and R21 (PA-06-142) 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:  After March 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 Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov)

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

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 Special Requirements
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  

This program announcement is a call for the application of imaging and other 
non- or minimally-invasive technologies to detect, characterize, diagnose, 
identify persons with predisposition to, or monitor treatment of diseases of 
interest to the National Institute of Diabetes and Digestive and Kidney 
Diseases.  Also needed are new, robust surrogate markers for clinical trial 
endpoints, and new ways to characterize normal and pathological tissues in 
vivo.  Diseases of interest include type 1 and 2 diabetes, obesity, and 
kidney, liver, urologic, hematologic, digestive, endocrine and metabolic 
diseases and their complications.  Applicable techniques include molecular 
imaging and functional imaging approaches, imaging methods with high spatial, 
chemical or time resolution, and new spectroscopic or sensor array 
technologies for monitoring metabolic or physiological events.

RESEARCH OBJECTIVES

New non- or minimally-invasive methods offer considerable opportunity, 
particularly in human investigation, to evaluate normal biological processes 
and diseases in intact living organisms.  This is well illustrated by the 
wide-spread application of imaging techniques to clinical medical diagnosis 
in the areas of heart disease and cancer, and the promise of functional 
magnetic resonance imaging (MRI) for learning about the organization of the 
brain.  Despite this progress, most biological processes and diseases of 
interest to NIDDK remain difficult to evaluate in intact living animals or 
people, without resort to invasive techniques.  It is necessary to take 
advantage of the large range of emerging non-invasive technologies to improve 
our ability to diagnose and characterize disease activity, identify people 
with predisposition to preventable diseases or disease complications, and 
monitor response to therapy.  This is especially important for chronic 
diseases such as diabetes and its complications, kidney disease, hepatitis, 
digestive diseases, anemia of chronic disease or inborn errors of metabolism, 
where patients must be evaluated repeatedly over time.  

Special note must be made of the need for novel, non-invasive measurements 
that can improve the ability to design and conduct efficient clinical 
intervention and prevention trials for NIDDK-specific diseases.  A clinical 
trial may need to enroll a large number of patients, and follow them for 
several years when the study is designed to monitor clinical endpoints, such 
as disease onset, progression through its well-defined clinically observable 
stages, or development of debilitating complications of a chronic disease.  
This can be prohibitively expensive for chronic or rare diseases, and 
severely limits the number of such trials that the NIDDK can undertake, and 
therefore the translation of new therapies into real benefit for the public 
health.  NIDDK places a priority on the development of non- or minimally-
invasive measurements that faithfully report on the onset or progression of 
disease and can serve as surrogate markers for clinical endpoints. 

Examples where non-invasive methods, such as imaging, are needed include 
identification of pre-malignant tissue, such as in Barrett’s esophagus or 
colon dysplasia; assessment of the extent of renal fibrosis in progressive 
kidney diseases; improved methods of quantifying kidney and cyst growth in 
polycystic kidney disease; metabolic characterization of adipocytes and other 
tissues in diabetes and obesity;  defining the extent and rate of progression 
of fibrosis and steatosis of the liver;  non-invasive measurement of portal 
hypertension;  quantification of the mass of biliary epithelial cells and the 
fraction affected by active inflammation in primary biliary cirrhosis; 
quantification of active inflammation of the bowel in IBD; quantification of 
the mass and function of pancreatic beta cells in type 1 and type 2 diabetes; 
metabolic evaluation of transplanted organs or tissues; methods to identify 
patients at risk for development of diabetic complications of the nervous 
system and kidney; evaluation of body iron levels; and non-invasive 
measurement of plasma glucose, lipids, urea, ions, insulin, and other 
hormones.

New strategies are needed to measure metabolic and physiologic events in 
order to drive basic research forward.  Our understanding of the molecular 
events associated with normal function and disease (gene transcription, 
protein modification, folding and trafficking, signaling, etc.) is far 
greater than our ability to monitor these events and their metabolic sequelae 
in the cell or living tissues.  We need new tools to help obtain a functional 
picture of the vast array of molecular events that interact to produce the 
healthy or diseased state.  These might include new ways to measure flux 
through enzymatic pathways in tissues, to measure the unique functions of 
specialized cells in vivo, to monitor the activity of short-lived, small 
molecule signals, to explore the physical environment of intracellular 
compartments, or to assess nerve activation in an organ.  As such new 
technologies emerge, investigators are encouraged to apply them to the 
understanding of the tissues and diseases of interest to NIDDK.

In many cases, the application of imaging and other non-invasive measurements 
to diseases of interest to NIDDK requires specialized biological information, 
such as the identification of unique cell markers to be used as targets for 
molecular imaging studies.  In other cases, detailed studies of in vitro 
model systems or isolated cells and tissues must be completed before it is 
apparent whether a new imaging or sensing modality can be applied to the in 
vivo state.  Finally, many extant technologies will require modified software 
or hardware before they can be applied to the disease or tissue of interest 
to NIDDK. 

This initiative is meant to encompass the goals described above.  However, it 
is not the intent of this initiative to support the development of novel 
imaging or sensing technologies that may have general applications, such as 
imaging devices or computational methods.  Such basic technique or device 
development is not within the scope of NIDDK’s mission. 

Multi-disciplinary teams are strongly encouraged, consisting of investigators 
experienced in the use of non-invasive measurements and those experts in the 
diseases and tissues of interest to the NIDDK.  Formation of partnerships 
between public or academic institutions and private organizations interested 
in developing proprietary technologies is encouraged.  Applicants responding 
to this initiative might take advantage of existing resources, such as tissue 
repositories from previous or current NIH funded clinical studies, or NIDDK-
funded research consortia and Centers.  

Areas of interest for this initiative could include the following:

o Discovery of novel cell targets that can be exploited for molecular imaging 
studies(e.g., unique surface markers or metabolic pathways) using gene 
arrays, proteomics, or high throughput small molecule screens;

o Application of non-invasive mechanical or biological sensors to diseases of 
interest to NIDDK and tissues (such as the measurement of portal pressure);

o Application of existing imaging techniques to the diagnosis, progression, 
or understanding the pathophysiology of diseases of interest to the NIDDK, 
such as by development of indicator materials for direct measurement of 
entities that presently are difficult to detect; 

o New functional imaging applications, such as ways to measure transplanted 
tissue engraftment, angiogenesis, cell or organ function;

o Application to NIDDK specific diseases of novel noninvasive or minimally 
invasive detection methods currently used in non-biological fields 
(nanosensors, T-rays);

o Pilot and feasibility studies to validate non-invasive detection methods in 
human diseases or animal models of interest to NIDDK;

o Ancillary pilot and feasibility studies of non-invasive detection methods 
in NIDDK sponsored clinical research studies.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  For the R21, the applicant 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, the applicant may request $100,000 in the 
first year and $175,000 in the second year.  The request should be tailored 
to the needs of the project.  Normally no more than $200,000 may be requested 
in any single year. The direct cost cap excludes the F&A costs on 
subcontracts for consortia.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 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 budget format.  Otherwise, follow the instructions 
for non-modular budget 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.  

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
o Faith-based or community-based 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 

Funding will be dependent on the receipt of applications of high 
scientific merit and on the availability of funds for this purpose.  This PA 
will remain active through the March 1, 2007 receipt date.

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:

Maren R. Laughlin, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6101
Bethesda, MD  20892-5460
Telephone:  (301) 594-8802
FAX:  (301) 480-3503
Email: ml33q@nih.gov 

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

Millissa Lee
Grants Management Branch, Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 721
Bethesda, MD  20892
Telephone:  (301) 594-0417
FAX:  (301) 480-3504
Email: ml306e@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applicants should complete the face 
page item 2,  Response to Specific Program Announcement , by entering the 
number of this initiative.  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 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
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 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 the total 
direct costs limit of $275,000 for the combined two years (no more than 
$200,000 in any given year).  Indirect costs on consortia subcontracts are 
excluded from the direct costs cap.

2. Although preliminary data are not required for an R21 application, they 
may be included.

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 primary reviewers of the application and  will not be 
reproduced for wider distribution.  The following materials may be included 
in the appendix:

o Up to five publications, including manuscripts (accepted for 
publication), abstracts, patents, or other printed materials directly 
relevant to the project.  

o Surveys, questionnaires, data collection instruments, and clinical 
protocols.

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 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 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 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 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 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?  

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).
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 

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

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: Starting with the October 1, 2003 receipt date, 
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. 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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

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.

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