INDUSTRY-ACADEMIC PARTNERSHIPS FOR DEVELOPMENT OF BIOMEDICAL IMAGING SYSTEMS 
AND METHODS THAT ARE CANCER SPECIFIC (R21)

RELEASE DATE:  July 29, 2003

PA NUMBER:  PAR-03-157

EXPIRATION DATE:  November 18, 2004, unless reissued.

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.394, 93.395, 93.396

LETTER OF INTENT RECEIPT DATES:  October 22, 2003; October 20, 2004

APPLICATION RECEIPT DATES:  November 19, 2003; November 17, 2004

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations

PURPOSE OF THIS PAR  

The intent of this initiative is to encourage industry-academic partnerships 
by making "seed" grants available for the pursuit of collaborative in vivo 
imaging research projects directed at cancer. Support for the exchange of 
scientists between industry and academia can be requested under this 
initiative. 

The goals of this initiative are to

o Provide grants to help establish and/or expand industry-academic 
partnerships for development of biomedical imaging systems and methods that 
are cancer specific whether or not preliminary data or a history of prior 
collaborations have been established;
o Support partnerships and pilot projects that may result in 
commercialization of imaging technologies;
o Target partnerships that address high-risk/high-gain research and 
development of new approaches for early cancer detection, diagnosis, image-
guided interventions, and assessment of drug therapy.

RESEARCH OBJECTIVES

Recent advances in biomedical imaging, and molecular imaging in particular, 
are having a significant impact on cancer detection, diagnosis, image-guided 
intervention, and assessment of drug therapy for cancer. These imaging 
advances apply to both pre-clinical and clinical investigations. Emerging 
imaging technologies and methods are increasingly complex in terms of 
development, optimization, and the validation needed for regulatory approvals 
and broad dissemination. New developments in medical imaging often need to be 
integrated into operational systems on commercial imaging platforms. There is 
therefore a need to support multi-disciplinary academic and industrial 
research teams for the development of imaging technologies, system 
integration, standardization of interfaces for component technologies, 
delivery of imaging systems and methods, and validation of these emerging 
imaging methods for small animal and human investigations.

Industrial involvement is essential for these innovations to reach full 
maturation and availability to patients. However, there are often significant 
barriers to forming academic-industry collaborations or partnerships 
necessary for final development and delivery to occur. From the academic 
perspective, the institutional reward systems for promotion and tenure and 
the NIH peer review process do not, in general, provide motivation for 
academic investigators to partner with industry. Academic promotion criteria 
are tied to original publications, rather than commercial success, and peer 
review of applications for NIH grants is heavily influenced by innovation 
rather than maturation of an imaging technology and related standards for its 
assessment. Academic investigators tend to focus on basic discovery or early 
development of prototype imaging systems and methods. Their primary interest 
is in publishing their work as opposed to promoting its commercial maturation 
and dissemination. From the industry perspective, the economic return from 
diagnostic procedures is orders of magnitude less than that from therapeutic 
products. Industry cannot carry too many high-risk projects in their 
portfolio given the competitive pressures companies face. Diagnostic imaging 
device and contrast agent companies are therefore very cautious about 
investing in research and development of many new imaging devices or agents 
until the commercial potential is relatively clear. This risk-averse approach 
comes at a time when there is actually a wealth of ideas available for the 
imaging industry to choose from. 

Despite the factors described above that tend to work against academic-
industry collaborations, both academic and industrial investigators have 
expressed interest in working together when incentives exist. One such 
incentive is government investment. Endorsement by NIH peer-review carries 
significant weight for both parties. Small "seed" grants from NIH can help to 
overcome academic and/or commercial reluctance to pursue the development and 
dissemination of innovative technologies and methods. Federal support can 
encourage the development of productive new partnerships among academic and 
industry scientists.

This Program Announcement is to help establish and foster industry-academic 
partnerships. One of the goals is to support projects that would not be 
undertaken by industry in the absence of external support. Another goal is to 
stimulate commercialization of new imaging technologies. 

Examples of the types of partnerships and research projects that might be 
funded under this initiative are listed below. Scope may include development 
and clinical evaluation of imaging technologies that improve early cancer 
detection, screening, diagnosis, image-guided intervention, treatment, or 
assessment of response to therapy. 

o Development and optimization of imaging systems or component technologies, 
related interfaces, or new contrast agents for cancer.
o Development of multi-modality imaging systems and technologies, including 
those for molecular imaging.
o Development and optimization of new image acquisition techniques, image 
processing and CAD algorithms, or related informatics that can be 
incorporated into one or more commercial imaging systems. Development of open 
source software tools and common software platforms are encouraged.
o Development and validation of imaging methods or component technologies 
that appear to have limited applicability and therefore limited market 
potential, such as "orphan" technologies for either small animal or clinical 
imaging.
o Pre-clinical or clinical evaluations of new and emerging imaging 
methodologies for small animal or human cancer investigations, including 
image guided intervention and assessment of drug therapies.

Applications for support of the following will be eligible: 

o An extended visit of industrial scientists or research engineers to an 
academic institution to catalyze and conduct collaborative research and bring 
industry's resources, perspective and skills to the academic setting. 
Industry will be required to provide release time from regular duties and 
continued salary support as in-kind support. Support may be requested for up 
to three industry scientists and may include travel and on-site residency 
support for up to a total of 6 months each per year. 
o An extended visit of faculty, postdoctoral or medical fellows, residents, 
and faculty-supervised graduate students to industry to conduct and translate 
fundamental discoveries to the industrial setting and/or provide clinical 
perspectives as required for pre-clinical or clinical investigations. 
Academic institutions will be required to provide release time from faculty 
duties where appropriate. Support may be requested for up to three academic 
scientists and may include travel and on site residency support for up to a 
total of 6 months each per year. 
o Conduct of joint, collaborative research projects by industrial and 
academic investigators either at the academic or industrial sites. This might 
include, for example, support for a clinical fellow or junior faculty member 
to plan and conduct a clinical trial of a new imaging device, agent or 
method, support for a post-doctoral fellow or junior faculty member to devote 
laboratory time to a project with commercial potential, or support for the 
development of pilot projects that may lead to enhanced collaborative 
research activities, shared research infrastructure, and/or future research 
projects.

The Program Announcements listed below are potential funding mechanisms for 
continued support of the projects funded under this initiative: 

NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (R21/R33) 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-124.html 
NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (SBIR/STTR) 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-125.html
BIOENGINEERING RESEARCH GRANTS (BRG)
http://grants.nih.gov//grants/guide/pa-files/PA-02-011.html
QUICK-TRIALS FOR NOVEL CANCER THERAPIES 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-005.html

MECHANISM OF SUPPORT 

This PAR will use the NIH exploratory/developmental (R21) grants award 
mechanism.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  The total project period for 
an R21 application submitted in response to this PAR may not exceed 2 years 
and $150,000 total direct costs including third party indirect costs per 
year. 

This PAR 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.  

ELIGIBLE INSTITUTIONS 

You may submit applications 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.   

SPECIAL REQUIREMENTS 

The Principal Investigator (PI) can be from industry or academia. If the PI 
is from industry, there must be a co-PI identified from academia, and a clear 
statement of intent from both industry and academia partners about the 
collaboration. If the PI is from academia, there must be a co-PI identified 
from industry, and a clear statement of intent from both the academic and 
industry partners about the collaboration.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Guoying Liu, Ph.D.
Biomedical Imaging Program 
National Cancer Institute 
6130 Executive Plaza, Suite 6000 
Bethesda MD   20892-7412 
Rockville MD  20852 (for express/courier service)  
Telephone:  (301) 496 9531 
FAX:  (301) 480 3507 
Email:  [email protected]

Laurence P. Clarke Ph.D.
Branch Chief, Imaging Technology Development Branch
Biomedical Imaging Program 
National Cancer Institute 
6130 Executive Plaza, Suite 6000 
Bethesda MD   20892-7412 
Rockville MD  20852 (for express/courier service)  
Telephone:  (301) 435 9190
Email: [email protected] 

o Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  [email protected]

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

Brian E. Martin
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd, EPS 243
Bethesda MD  20892-7148
Rockville MD  20852 (for express/courier service)
Telephone:  (301) 846 1016
FAX:  (301) 846 1014
Email: [email protected]

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PAR 

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

Guoying Liu, Ph.D.
Biomedical Imaging Program 
National Cancer Institute 
6130 Executive Plaza, Suite 6000 
Bethesda MD   20892-7412 
Rockville MD  20852 (for express/courier service)  
Telephone:  (301) 496 9531 
FAX:  (301) 480 3507 
Email:  [email protected]

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) 710-0267, 
Email: [email protected].

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted by the dates listed on the first page of this 
program announcement.

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 PREPARING AN EXPLORATORY/DEVELOPMENTAL (R21) AWARD 
APPLICATION FOR INDUSTRY-ACADEMIC PARTNERSHIPS:

The application must present specific aims that are scientifically 
appropriate for establishing a new or expanding an existing partnership. The 
instructions for the PHS 398 application suggest that the investigators state 
hypotheses to be tested under Specific Aims. Since the goal of this PAR is to 
support new or existing collaborations between industry and academia for the 
development of in vivo imaging systems and methods for cancer, hypothesis 
testing may be less applicable than engineering, problem-solving or design-
driven methods.  No preliminary and/or pilot data and no prior partnerships 
are required for the R21 partnership application.  However, scientifically 
sound preliminary data or information relevant to the proposed collaboration 
should be included to aid review, if available. 

The application should provide a rationale for the proposed partnerships and 
the feasibility of the proposed collaborative research.  Applicants are 
encouraged to include detailed information about the proposed partnerships 
and project(s) for adequate peer review evaluation.  

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  
This change in practice is effective immediately.  
This policy is similar to and consistent with the policy for applications 
addressed to Centers for Scientific Review as published in the NIH Guide 
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before the 
receipt dates listed on the first page.  The CSR will not accept any 
application in response to this PAR 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

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCI.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the PAR will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the Division of Extramural Activities of the NCI in accordance 
with the review criteria stated below.  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 National Cancer Advisory Board.

REVIEW CRITERIA

The NIH review criteria have been adapted to ensure that the partnership 
application is evaluated appropriately. The score should reflect the overall 
impact that the award could have on strengthening industry-academic 
collaborations in the area of in vivo imaging as related to cancer. 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 or dissemination of technologies that by its nature 
is not innovative but is essential to move a field forward.

A Partnership application may propose design-directed, problem-solving, 
developmental, discovery-driven, or hypothesis-driven research involving 
large or small businesses, academia, national laboratories, or other public 
and private entities. The review criteria include:

SIGNIFICANCE: Do the proposed partnership and research projects address a 
problem(s) of importance to cancer? If the specific aims of the application 
are achieved, how will scientific knowledge be advanced? What will be the 
effect of these projects on the concepts or methods that drive the field of 
biomedical imaging?

APPROACH: Are the conceptual framework for the proposed partnership, the 
design, methods, and analyses of the research project(s) adequately 
developed, well integrated, and appropriate to the aims of the project? Does 
the applicant acknowledge potential problem areas and consider alternative 
tactics? 

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

INVESTIGATOR: Are the industry and academic investigators 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 projects 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:

o Does the proposed partnership positively affect the research goals? 
o Are the proposed collaboration and projects likely to result in a transfer 
of new knowledge between academia and industry that may lead to the more 
timely commercial development and delivery of in vivo imaging technologies? 
o Does the proposed partnership utilize the unique skills from industry and 
academia that are complementary? 
o Is there evidence that the partners from academia and industry can work 
together effectively, with an understanding that preliminary data or prior 
research collaborations are not required? 
o Will the proposed collaborative arrangements facilitate fruitful 
participation and exchange of scientists between partners? 

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 

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 PAR 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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  October 22, 2003; October 20, 2004
Application Receipt Date:  November 19, 2003; November 17, 2004
Peer Review Date:  March 2004; March 2005
Council Review:  June 2004; June 2005
Earliest Anticipated Start Date:  July 2004; July 2005

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).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" for additional information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

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.  A 
continuing education program in the protection of human participants in 
research is available online at: http://cme.nci.nih.gov/

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 PAR 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 
PAR 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 authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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

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