INTEGRATION OF HETEROGENEOUS DATA SOURCES (SBIR/STTR)

RELEASE DATE:  October 14, 2004 

PA NUMBER: PA-05-003 (This PA has been reissued,  see PA-06-010 and PA-06-011)
                     (Contact change for NLM, see NOT-LM-05-006) 
                     (see PA-03-001)

EXPIRATION DATE: October 21, 2005

Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATION: 
National Center for Research Resources (NCRR)  
 (http://www.ncrr.nih.gov)
National Institute of Mental Health (NIMH)  
 (http://www.nimh.nih.gov) 
National Cancer Institute (NCI)  
 (http://www.nci.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)  
 (http://www.nhlbi.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib.nih.gov)
National Library of Medicine (NLM)
 (http://www.nlm.nih.gov) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.389, 93.242, 
93.396, 93.839, 93.286 and 93.879

APPLICATION RECEIPT DATE(S): Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines (April 1, August 1, December 1)

THIS PA CONTAINS THE FOLLOWING INFORMATION 

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Project Period and Amount of Award
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Receipt and Review Schedule 
o  Required Federal Citations

NOTICE: This program announcement (PA) must be read in conjunction with 
the current Omnibus Solicitation of the National Institutes of Health, 
Centers for Disease Control and Prevention, and Food and Drug 
Administration for Small Business Innovation Research (SBIR) and Small 
Business Technology Transfer (STTR) Grant Applications. The 
solicitation (see 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word]) 
contains information about the SBIR and STTR programs, regulations 
governing the programs, and instructional information for submission. 
All of the instructions within the current SBIR/STTR Omnibus 
Solicitation apply.

PURPOSE OF THIS PA  

This PA is a reissue of PA-03-001. The purpose of this PA is to 
encourage small businesses to develop innovative software for 
addressing the integration of distributed cross-disciplinary data 
sources into coherent knowledge bases for biomedical research. 
Federating such data sources requires solving a large number of 
technical, scientific, financial, social and legal issues, and new 
tools are needed for aiding in almost every aspect of this problem. 
Applications are expected to describe at least one biomedical research 
problem that will benefit from the proposed tool or tool set, as well 
as to describe how the approach will scale when applied to additional 
data sources and/or to other biomedical problems. A clear description 
should be provided of how the impact of these tools on biomedical 
research will be measured. Finally, a reasonable mechanism for 
maintenance and expansion of the software as well as integration with 
existing solutions should be carefully outlined. 

RESEARCH OBJECTIVES 

Industry has over the past five years shown increased interest in 
information technology's (IT) promise to aid in the assembling of a 
corporation's knowledge that is typically distributed across 
individuals and vast numbers of unconnected documents and databases 
into a coherent, accessible entity known as a knowledge base. Although 
much of the promise remains unfulfilled, some technologies resulting 
from initial efforts appear to be moving from the research stage to 
mainstream production (e.g. IBM's Discovery Link). 

Like a corporation, the biomedical research community is greatly 
hindered by its inability to easily access knowledge that may have 
already been painstakingly acquired. Existing approaches and tools from 
corporate knowledge base efforts should be employed wherever they can 
to improve this situation. However, the biomedical research community 
is more diverse than a typical corporation in almost every aspect, from 
document and data types to philosophies of data sharing. Accordingly, 
new tools and processes for knowledge integration must be developed 
that facilitate cooperative approaches to solving biomedical research 
problems that span a broad array of subdisciplines. These tools and 
processes must be designed with openness, flexibility and extreme 
scalability if they are to address the diverse needs of this community 
with regard to knowledge integration, and if they are to be able to 
grow and adapt with the rapidly changing developments in this field 
that are expected to come. 

Awards made under this PA will support software and system development 
that address one or more aspects of the components necessary for 
integrating knowledge across data sources that reside at multiple 
laboratories and institutions and that encompass disparate data types 
from multiple subdisciplines. Tools for visualization and summarization 
of results from such systems may also be supported, as well as tools 
for managing data security, data integrity, query efficiency, and data 
ownership. 

MECHANISM(S) OF SUPPORT 

This PA uses the SBIR and STTR mechanisms, which are set-aside 
programs. As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project. Future unsolicited, 
competing- continuation applications based on this project will compete 
with all SBIR/STTR applications and will be reviewed according to the 
customary peer review procedures.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. Specifically, if you are submitting an application budget of 
$100,000 total costs (direct, F&A and fee) or less, use the modular 
format and instructions as described in the current SBIR/STTR Omnibus 
Solicitation.  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_2003/NIHGPS_Part2.htm#
matching_or_cost_sharing.

Applications may be submitted for support as Phase I STTR (R41) or 
Phase I SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) 
grants; or the SBIR/STTR FAST-TRACK option as described in the 
SBIR/STTR Omnibus Solicitation.  Phase II applications in response to 
this PA will only be accepted as competing continuations of previously 
funded NIH Phase I SBIR/STTR awards.  The Phase II application must be 
a logical extension of the Phase I research but not necessarily a Phase 
I project supported in response to this PA.  

PROJECT PERIOD AND AMOUNT OF AWARD
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines 
of funding support and project duration periods for SBIR and STTR Phase 
I and Phase II awards.   SBIR Phase I awards normally may not exceed 
$100,000 total costs for a period normally not to exceed 6 months; STTR 
Phase I awards normally may not exceed $100,000 total for a period of 1 
year; and SBIR and STTR Phase II awards normally may not exceed 
$750,000 total costs for a period normally not to exceed 2 years.  
Because the duration and cost of research to develop knowledge 
integration tools are likely to exceed that routinely awarded, well-
justified applications with higher budgets and longer time periods will 
be considered.

ELIGIBLE INSTITUTIONS 

Eligibility requirements are described in the SBIR/STTR Omnibus 
Solicitation.  Only small business concerns are eligible to submit 
applications. A small business concern is one that, on the date of 
award for both Phase I and Phase II agreements, meets ALL of the 
criteria as described in the SBIR/STTR Omnibus Solicitation.

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.  On an 
SBIR application, the principal investigator must have his/her primary 
employment (more than 50%) with the small business at the time of award 
and for the duration of the project. The PI on an STTR application may 
be employed with the small business concern or the participating non-
profit research institution as long as s/he has a formal appointment 
with or commitment to the applicant small business concern, which is 
characterized by an official relationship between the small business 
concern and that individual.

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 A. Bean, Ph.D. 
National Center for Research Resources (NCRR) 
6701 Democracy Boulevard, Room 972 
Bethesda, Maryland 20982 
Telephone: (301) 435-0755 
FAX: (301) 480-3659 
Email: cabean@mail.nih.gov

Margaret Grabb, Ph.D. 
National Institute of Mental Health (NIMH) 
6001 Executive Blvd, Rm 7201 (MSC 9645) 
Bethesda, MD 20892 
Telephone: (301) 443-3563 
FAX:(301) 443-1731 
Email: mgrabb@mail.nih.gov

Jennifer Couch, Ph.D. 
National Cancer Institute (NCI) 
SBMAB, DCB 
Bethesda, MD 20892 
Telephone: (301) 435-5226 
FAX: (301) 480-2854 
Email: couchj@mail.nih.gov

Jane Ye, Ph.D. 
National Heart, Lung, and Blood Institute (NHLBI) 
Rockledge II, Room 9148 
6701 Rockledge Drive, MSC 7940 
Bethesda, MD 20892 
Telephone: (301) 435-0513 
FAX: (301) 480-1335 
Email: yej@nhlbi.nih.gov

Grace C.Y. Peng, Ph.D. 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
6707 Democracy Blvd, Suite 200, MSC 5469 
Bethesda, MD 20892 
Telephone: (301) 451-4778 
FAX:(301) 480-4973 
Email: penggr@mail.nih.gov

Dr. Hua-Chuan Sim (Contact changed, see NOT-LM-05-006)
6705 Rockledge Drive
Suite 301, MSC 7968
Bethesda, MD 20892-7968
Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 496-4253
FAX: (301) 402-2952
Email: simh@mail.nih.gov

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

Holly Atherton 
Office of Grants Management National Center for Research Resources 
6701 Democracy Boulevard 
Bethesda, Maryland 20982 
Telephone: (301) 435-0844 
FAX: (301) 480-3777 
Email: ha5i@nih.gov

Brian Albertini 
Division of Extramural Activities 
National Institute of Mental Health 
6001 Executive Boulevard, Room 6134, MSC 9605 
Bethesda, MD  20892-9605 
Telephone:  (301) 443-0004 
FAX:  (301) 443-6885 
Email:  albertib2@mail.nih.gov

Shane Woodward 
Grants Administration Branch National Cancer Institute Executive Plaza 
South, Room 243 
Bethesda, MD 20892-7150 
Telephone: (301) 496-8649 
FAX: (301) 496-8601 
Email: Shane_Woodward@nih.gov

Edward (Gene) McGeehan 
Grants Management 
National Heart, Lung, and Blood Institute (NHLBI) 
6701 Rockledge Drive, Room 7044 
Bethesda, MD 20892 
Telephone: (301) 435-0148 
FAX: (301) 480-3659 
Email: McGeehaE@nhlbi.nih.gov

Karen Shields 
Office of Grants Management 
National Institute of Biomedical Imaging 
and Bioengineering 
6707 Democracy Blvd, Suite 900 
Bethesda, MD 20892-5469 
Telephone: (301) 451-4791 
FAX: (301) 480-4974 
Email: shieldsk@mail.nih.gov

Dwight Mowery 
Chief Grants Management Officer 
Division of Extramural Programs 
National Library of Medicine 
Telephone: (301) 496-4222 
FAX: (301) 402-0421 
Email: moweryd@mail.nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR 
Phase I, Phase II and Fast-Track applications (new and revised.)  
Effective October 1, 2003, applications must have a 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.dnb.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.  Prepare your 
application in accordance with the SBIR/STTR Omnibus Solicitation and 
the PHS 398. Helpful information for advice and preparation of the 
application can be obtained at: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH 
will return applications that are not submitted on the 5/2001 version 
of the PHS 398.  For further assistance contact GrantsInfo, Telephone: 
(301) 435-0714, Email: GrantsInfo@nih.gov. 

The title and number of this PA must be typed on line 2 of the face 
page of the application.
 
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 (FOR USPS EXPRESS or REGULAR MAIL)
Bethesda, MD  20817 (FOR EXPRESS/COURIER NON-USPS SERVICE)

APPLICATION PROCESSING:  Applications must be received by or mailed on 
or before the receipt dates described on the first page of this program 
announcement. 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 that are complete 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 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

ALL SBIR/STTR APPLICATIONS

1. Significance:  Does the proposed project have commercial potential 
to lead to a marketable product or process? Does this study address an 
important problem? What may be the anticipated commercial and societal 
benefits of the proposed activity? If the aims of the application are 
achieved, how will scientific knowledge be advanced? Does the proposal 
lead to enabling technologies (e.g., instrumentation, software) for 
further discoveries? Will the technology have a competitive advantage 
over existing/alternate technologies that can meet the market needs? 

2. Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Is the proposed plan a sound approach for 
establishing technical and commercial feasibility? Does the applicant 
acknowledge potential problem areas and consider alternative 
strategies? Are the milestones and evaluation procedures appropriate? 

3. Innovation:  Does the project challenge existing paradigms or employ 
novel technologies, approaches or methodologies? Are the aims original 
and innovative? 

4. Investigators: Is the Principal Investigator capable of coordinating 
and managing the proposed SBIR/STTR? Is the work proposed appropriate 
to the experience level of the Principal Investigator and other 
researchers, including consultants and subcontractors (if any)? Are the 
relationships of the key personnel to the small business and to other 
institutions appropriate for the work proposed? 

5. Environment:  Is there sufficient access to resources (e.g., 
equipment, facilities)? Does the scientific and technological 
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? 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be applied to ALL applications 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 
additional information and 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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See additional information and 
Inclusion Criteria in the sections on Federal Citations, below).
Human Subjects: 

1. Protection of Human Subjects from Research Risks - for all studies 
involving human subjects. See instructions and "Guidance for Preparing 
the Human Subjects Research Section." If an exemption is claimed, is it 
appropriate for the work proposed? If no exemption is claimed, are the 
applicant's responses to the six required points appropriate? Are human 
subjects placed at risk by the proposed study? If so, are the risks 
reasonable in relation to the anticipated benefits to the subjects and 
others? Are the risks reasonable in relation to the importance of the 
knowledge that reasonably may be expected to be gained? Are the plans 
proposed for the protection of human subjects adequate? 

2. Inclusion of Women Plan - for clinical research only.  Does the 
applicant propose a plan for the inclusion of both genders that will 
provide their appropriate representation? Does the applicant provide 
appropriate justification when representation is limited or absent? 
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants? 

3. Inclusion of Minorities Plan - for clinical research only.  Does the 
applicant propose a plan for the inclusion of minorities that will 
provide their appropriate representation? Does the applicant provide 
appropriate justification when representation is limited or absent? 
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants? 

4. Inclusion of Children Plan- for all studies involving human 
subjects.  Does the applicant describe an acceptable plan in which the 
representation of children of all ages (under the age of 21) is 
scientifically appropriate and recruitment/retention is addressed 
realistically? If not, does the applicant provide an appropriate 
justification for their exclusion? 

5. Data and Safety Monitoring Plan – for clinical trials only.  Does 
the applicant describe a Data and Safety Monitoring Plan that defines 
the general structure of the monitoring entity and mechanisms for 
reporting Adverse Events to the NIH and the IRB? 

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the required five items described under 
Vertebrate Animals (section f of the Research Plan instructions) will 
be assessed. 

BIOHAZARDS:  Is the use of materials or procedures that are potentially 
hazardous to research personnel and/or the environment proposed? Is the 
proposed protection adequate? 

ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be 
considered by reviewers but will not be included in the determination 
of scientific merit.

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

BUDGET:  The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI 
appropriate for the work proposed? On applications requesting up to 
$100,000 total costs, is the overall budget realistic and justified in 
terms of the aims and methods proposed? On applications requesting over 
$100,000 in total costs, is each budget category realistic and 
justified in terms of the aims and methods? 

PERIOD OF SUPPORT: The appropriateness of the requested period of 
support in relation to the proposed research.

PHASE II APPLICATIONS: In addition to the above review criteria:
1. How well did the applicant demonstrate progress toward meeting the 
Phase I objectives, demonstrating feasibility, and providing a solid 
foundation for the proposed Phase II activity? 

2. Did the applicant submit a concise Commercialization Plan that 
adequately addresses the seven areas described in the Research Plan 
item J? 

3. Does the project carry a high degree of commercial potential, as 
described in the Commercialization Plan? 

AMENDED APPLICATIONS

In addition to the above criteria, the following criteria will be 
applied to revised applications.

1. Are the responses to comments from the previous SRG review adequate?

2. Are the improvements in the revised application appropriate?

PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA

For Phase I/Phase II Fast Track applications, the following criteria 
also will be applied:

1. Does the Phase I application specify clear, appropriate, measurable 
goals (milestones) that should be achieved prior to initiating Phase 
II? 

2. Did the applicant submit a concise Commercialization Plan that 
adequately addresses the seven areas described in the Research Plan, 
item J? 

3. To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private 
sector or non-SBIR/ STTR funding sources that would enhance the 
likelihood for commercialization?

4. Does the project carry a high degree of commercial potential, as 
described in the Commercialization Plan?

Phase I and Phase II Fast-Track applications that satisfy all of the 
review criteria will receive a single rating. Failure to provide clear, 
measurable goals may be sufficient reason for the scientific review 
group to exclude the Phase II application from Fast-Track review.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended SBIR and STTR 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

For FAST-TRACK applications, the Phase II portion may not be funded 
until a Phase I final report and other documents necessary for 
continuation have been received and assessed by program staff that the 
Phase I milestones have been successfully achieved.

RECEIPT AND REVIEW SCHEDULE  
See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 

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

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects. You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: 
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  

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

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

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

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