NLM RESOURCE GRANT IN BIOMEDICAL INFORMATICS/BIOINFORMATICS (P41)

RELEASE DATE:  August 13, 2004

PA NUMBER:  PAR-04-142 - June 11, 2008  - This PAR has been reissued as (RFA-LM-08-001).

(This PA has been suspended until further notice, see NOT-LM-05-001)   
                       (See, NOT-LM-04-010 for clarification of scope.)

EXPIRATION DATE:  February 7, 2005 
Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Library of Medicine (NLM) 
 (http://www.nlm.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.879 Medical Library 
Assistance

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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The purpose of this program announcement is to reissue and update the 
National Library of Medicine’s grant program for support of the development, 
maintenance and dissemination of databases or software tools that are unique, 
of major importance to an important research domain, and sufficiently mature 
to have a broad, describable community of users. These tools and resources 
should advance research or practice in the biomedical sciences, clinical 
medicine or health services research. To quality for support, biomedical 
informatics resources – software, algorithms, knowledge resources – must be 
of proven value to a large community of users. The NLM Biomedical Informatics 
Resource grant supports ongoing research, development and maintenance of the 
tool or resource, user training and services, and wide dissemination of the 
tool or resource.      

RESEARCH OBJECTIVES

NLM defines biomedical informatics as the intersection of basic informational 
and computing sciences with an application domain in biomedicine, as 
discussed in the work of the American College of Medical Informatics 
referenced below.  The term biomedical informatics encompasses the closely-
aligned field of bioinformatics, which can be defined as the intersection of 
basic informational and computer sciences with an application domain in 
biological/biochemical sciences. NLM’s research funding centers on 
understanding data, information and knowledge – their nature, forms and uses 
– in the domains of health and basic biological sciences. In clinical 
medicine, health services administration, education and basic biomedical 
sciences, there are information needs and problems that transcend 
organizational, regional and national boundaries. Biomedical informatics 
resources – software, algorithms and knowledge resources – that are of proven 
value to a large community of users, should be improved, sustained and widely 
shared. The kinds of tools and resources appropriate for support by NLM’s 
Biomedical Informatics Resource grant program include: 

o Software for information and knowledge processing, including natural 
language processing, information extraction, integration of data from 
heterogeneous sources or domains, event detection, feature recognition;
o Tools for analyzing and/or storing very large datasets, including genomic 
and proteomic data; data supporting clinical trials; and other data used in 
clinical or health services research;
o Systems for knowledge representation, including vocabularies, ontologies, 
simulations and virtual reality;
o Algorithms for linking clinical and genomic information to benefit health 
care;
o Technology-based tools for clinical decision support, error reduction, 
outcomes analysis, and the delivery of usable, useful information at the 
point of care;
o Effective human-machine interfaces,  retrieval tools and intelligent agents 
for health and scientific information;
o Unique collections of data, information or knowledge that support learning, 
decision making, research and administration at national /international 
levels;
o Tools and resources that foster translation of research findings into 
health care practice.

NLM’s Biomedical Informatics Resource Grant can not be used to support 
research and development intended as proof of concept, to ascertain 
feasibility, or to underwrite the initial development of a tool or resource. 
NLM offers several kinds of informatics research grants. Applicants who wish 
to undertake biomedical informatics research, to develop and test novel 
information technologies, or to perform feasibility or proof-of-concept 
studies, should use one of NLM’s other research grant mechanisms.

NLM’s Biomedical Informatics Resource grants are not intended to support 
research projects that utilize a tool or database being supported through 
this resource grant program. Such projects should seek funding through 
customary NIH research grant mechanisms. These grants are not intended to 
support tools and resources that duplicate activities of the National Library 
of Medicine.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH P41 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project. The applicant may request a project period of up to 4 years. These 
grants may renewed by submission of a competing continuation application. 

The budget request should be tailored to the needs of the project. Applicants 
who wish to request$500,000 or more in direct costs per year must obtain 
permission in advance from NLM’s Extramural Programs Division. Applications 
received without proof of this advance permission will be returned without 
review.   

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_2003/NIHGPS_Part2.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 Foreign institutions are not eligible to apply--however, domestic 
applications with foreign components are permitted.

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 
 
NLM’s Biomedical Informatics Resource grants provide funds to support an 
operations center whose functions include: (1) maintenance of scalable, 
appropriate infrastructure to support local and distant users; (2) support 
services and/or collaboration with users and stakeholders; (3) research and 
development to improve the longevity, effectiveness and value of the 
resource; (4) user training; and (5) dissemination of information about the 
resource.  Applicants must provide plans for each of these areas. 

1.  Maintenance of the resource: A unique, widely-used resource requires 
expertise, equipment and a plan to keep up with the pace of technological 
change and evolving approaches to information handling. Such maintenance is a 
principal purpose of NLM’s Biomedical Informatics Resource grant, and 
evidence of plans to assure continued usefulness and sustainability are a 
major component of the application for support.

2. Service: Assisting the biomedical investigators and clinicians who use or 
want to use a tool or database is a fundamental activity of a biomedical 
informatics resource center. Providing access to the resource's technology  
should include techniques for helping users obtain, install and use a tool or 
database, and offering consultation and technical assistance. 

3. Technological Research and Development: A biomedical informatics resource 
requires continuing development of its features and components to sustain 
value for the user community, and to meet changing needs of health care and 
biomedical research. Such research and development may involve modification 
or even reconceptualization of databases and software. Informatics research 
and development to improve a biomedical informatics resource is most 
effective when it responds to perceived, unfulfilled needs of those who use 
it. 

4. Training: This includes educational programs designed to inform the user 
community about the features of a tool or database, demonstrating new 
features as they are developed, and attracting new users to the community. 
Training may encompass many techniques, including short courses, workshops, 
and individual training of visiting scientists and students. Applicants 
should include some training approaches that involve in-person, hands-on 
training.

5. Dissemination: This activity involves informing the scientific community 
about the resource and its potential for science by publishing articles or 
books, conducting conferences, distributing software products, or 
transferring technologies to industry where they will be distributed widely. 
In biomedical informatics resource centers that are developing software, 
emphasis should be placed on producing portable software. Open source 
software is strongly encouraged as is cooperation with complementary 
resources. Biomedical informatics resource centers that are providing 
databases should have techniques for supporting localization of the resource, 
and open access policies. Requests to charge for access must be approved in 
advance by NLM staff.
 
Applicants for this grant are strongly encouraged to establish an advisory 
committee for the resource. Members of this committee should be knowledgeable 
about the resource's technology and its value to the user community. The 
committee should have members that represent the geographical regions served, 
and the types of users served.  The chair of the Advisory committee should 
have knowledge of the resource's value, but should not be a member of the 
resource center’s staff or the major external user of the resource. The 
Advisory Committee should provide guidance to the principal investigator on 
all aspects of the 5 areas discussed above, including future directions, 
growth, marketing, guidelines for the resource's use, and sustainability 
plans. The Advisory Committee should meet at least annually. Funds should be 
budgeted to support yearly meetings of the committee.  Proposed members of 
the Advisory Committee should not be contacted in advance of the application.

Applicants should plan for one progress visit each year, to discuss and 
coordinate plans and activities with NLM. 

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 three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Dr. Valerie Florance
Deputy Director
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive  
Bethesda, MD  20892
Telephone:  (301) 594-4882
FAX:  301-402-2952
Email: floranv@mail.nih.gov

o Direct your questions about peer review issues to:  

Dr. Hua-Chuan Sim
Scientific Review Administrator
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive  
Bethesda, MD  20892
Telephone:  (301) 496-4253
FAX:  301-402-2952
Email: simh@mail.nih.gov

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

Dwight Mowery
Grants Management Officer
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive  
Bethesda, MD  20892
Telephone:  (301) 496-4221
FAX:  301-402-2952
Email: moweryd@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The D&B number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The D&B number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

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

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

Applicants requesting $500,000 or more 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 PAR will be assigned on the basis of 
established PHS referral guidelines.  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 NLM in accordance with the 
review criteria stated below.  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 Board of Regents of the National 
Library of Medicine.   

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:

A Biomedical Informatics Resource grants is not a research grant, thus the 
traditional NIH criteria describe above are used, but modified to suit the 
purposes of the grant program. In a well-developed Biomedical Informatics 
Resource grant application, the following criteria are of high importance:

o Significance: Convincing evidence that the resource is unique and of 
substantial value to biomedical research or practice
o Approach: Provisions are made for insightful, timely development, sound 
maintenance, quality assurance, and project evaluation
o Innovation: The plans for improvement of the resource incorporate new 
techniques and technologies
o Investigator: An appropriate and sufficient array of expertise is 
available for planning, training and service 
o Environment: The technological infrastructure is adequate to meet 
current needs and scalable to meet future needs. 
o Users: Evidence of a broad, describable existing community of users.
     
In addition, reviewers will expect to see an evaluation plan that documents 
(1) sustained use by the community of users for which a resource is intended, 
(2) increasing number of new users, (3) examples of advances in research or 
practice that can be traced to the resource. 

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data

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

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

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

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

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

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

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

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.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.

REFERENCES:   

1. Charles P. Friedman, Russ B. Altman, Isaac S. Kohane, Kathleen A. 
McCormick, Perry L. Miller, Judy G. Ozbolt, Edward H. Shortliffe, Gary D. 
Stormo, M. Cleat Szczepaniak, David Tuck, and Jeffrey Williamson Training the 
Next Generation of Informaticians: The Impact of "BISTI" and Bioinformatics—A 
Report from the American College of Medical Informatics  J. Am. Med. Inform. 
Assoc. 2004;11(3):167-172.


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