MECHANISMS OF HIV-RELATED PULMONARY COMPLICATIONS  

RELEASE DATE:  July 8, 2004
 
RFA Number:  RFA-HL-04-031

EXPIRATION DATE:  March 17, 2005

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.838

LETTER OF INTENT RECEIPT DATE:  February 17, 2005 
APPLICATION RECEIPT DATE:       March 16, 2005

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
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 Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this Request for Applications (RFA) is to encourage innovative 
research on the roles of co-infections, immune factors and genetic 
predisposition in the pathogenesis of HIV-related pulmonary diseases.  The use 
of high throughput technologies, collaborations between bench and clinical 
investigators with mathematical modelers and research involving human tissues or 
biological samples, is encouraged.  The ultimate goal is to provide a rational 
basis for prevention and therapy for the pulmonary complications caused by HIV 
and its related factors.  

RESEARCH OBJECTIVES

Due to early diagnosis, highly active antiviral therapy (HAART), and better 
supportive care for HIV-infected patients, survival time is being prolonged and 
pulmonary complications have become more important contributors to morbidity and 
mortality in these patients.  

Respiratory complications are a prominent feature of HIV infection and its 
treatment, but the pathogenesis of these disorders is unclear.  Alterations of 
pulmonary immune cells and the expression of inflammatory mediators caused by 
the presence of HIV in the lung may contribute.  Now that HIV is emerging as a 
chronic disease, complications such as accelerated pulmonary emphysema, the 
bronchitis/bronchiolitis observed in HIV infected patients, HIV-associated 
pulmonary hypertension and interstitial infiltrates associated with HIV 
infection, as well as sarcoidosis-like manifestations in the lungs seen during 
immune reconstitution are increasingly important.

Research on the pathogenesis of these complications is important to understanding 
HIV in the lung and also presents opportunities to examine HIV-associated lung 
diseases as models of lung diseases such as emphysema and pulmonary hypertension.  
Pulmonary diffusion defects suggestive of emphysema have been observed in 
populations of HIV-infected patients by several groups of clinical investigators.   
It is thought that HIV-associated emphysema may be related to increased 
recruitment of inflammatory cells to the lung and nutritional deficiencies, as 
well as to cigarette smoking.  The cells found in the lung and the local cytokine 
environment differs between HIV+ smokers and nonsmokers.  Fewer CD4+ and CD8+ 
cells are found in BAL fluid from HIV+ cigarette smokers than in BAL fluid from 
HIV+ non-smokers.  The smokers produce less TNF-alpha and IL-1beta.   The 
incidence of HIV-related pulmonary hypertension has been recognized in the last 
few years with increasing frequency.  It is estimated to occur in 1/200 HIV-
infected patients, a rate 10,000 times higher than the 1/2,000,000 rate of 
histologically identical primary pulmonary hypertension observed in the general 
population.  The recent finding that human herpes virus eight (HHV8), the same 
virus that causes Kaposi’s sarcoma, is associated with primary pulmonary 
hypertension has increased interest in the role of viral agents in the 
pathogenesis of primary pulmonary hypertension.  The etiology of HIV-related 
pulmonary hypertension is unknown and different factors could induce a remodeling 
of pulmonary vasculature leading to elevation of vascular resistance.  Current 
theories on the pathogenesis focus on abnormalities of endothelial and smooth 
muscle cells of the pulmonary vasculature. 

As a result of HAART many HIV-infected patients exhibit varying degrees of 
improved immune function.  This has given rise to new pulmonary manifestations of 
HIV disease caused by immune reconstitution, e.g., sarcoidosis-like lesions in the 
lungs of patients who have been on multidrug treatment for HIV.  Usually, CD8+ 
cells are predominant in HIV-associated lymphocytic infiltrates, but the sarcoid-
like granulomas appear to be composed primarily of CD4+ cells.  The mechanisms 
responsible for this pulmonary manifestation HIV and its relationship to 
sarcoidosis have just begun to be examined.  Multicentric Castleman’s disease, a 
severe type of lymphatic hyperplasia, has also been observed to occur with immune 
reconstitution.  Castleman’s disease is associated with HHV-8, the cause of 
Kaposi’s sarcoma. Castleman’s may be due to immune reconstitution producing an 
exaggerated response to the HHV-8 virus.  Little is known about it.

Potential areas of investigation might include but would not be limited to the 
following:

o  Investigate dysregulation of inflammatory responses and reduced local lung 
defenses associated with emphysema in the presence of HIV infection. 
   
o  Explore possible roles of abnormal cytokine production, activation of ?1-
adrenoreceptors, chronic hypoxia, HHV8 and genetic factors in the pathogenesis of 
HIV-related pulmonary hypertension. 

o  Determine the role of immune reconstitution in the etiology of HIV-associated 
lung complications, for example sarcoidosis.

The following URLs may be useful to applicants:

NHLBI shared microarray facilities 
(http://www.nhlbi.nih.gov/resources/medres/microarray.htm)

AIDS information
http://aidsinfo.nih.gov/Guidelines/Default.aspx?MenuItem=Guidelines

Programs for Genomic Applications (PGA) which include resources for animal 
modeling and phenotyping, clinical and physiological studies, databases and 
software tools, bioinformatics, expression profiling, mutagenesis, proteomics, 
SNP’s and genotypes, comparative sequence analysis, educational programs, 
biomedical topics, and biochemical pathways 
(http://www.nhlbi.nih.gov/resources/pga/)

NHLBI Proteomics Initiative 
(http://www.nhlbi.nih.gov/resources/medres/proteomics/index_contacts.htm).

The Centers for Fetal Monkey Gene Transfer for Heart, Lung, and Blood Diseases at 
the California National Primate Research Center 
(http://www.cfmgt.ucdavis.edu/).

MECHANISM OF SUPPORT
 
This RFA will use the R01 (investigator-initiated research project grant) award 
mechanism.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  This RFA is a one-time 
solicitation.  Future unsolicited, competing-continuation applications based on 
this project will compete with all investigator-initiated applications and will be 
reviewed according to the customary peer review procedures.  The anticipated award 
date is September 29, 2005.  

Applications that are not funded in the competition described in this RFA may be 
resubmitted as NEW investigator-initiated R01 applications using the standard 
receipt dates for NEW applications described in the instructions to the PHS 398 
application.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting format. 
All budgets submitted in response to this RFA should be modular.
(see http://grants.nih.gov/grants/funding/modular/modular.htm).

This program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE  

The NHLBI intends to commit approximately $2,500,000 in FY 2005 to fund up to 8 
new grants in response to this RFA. An applicant may request a project period of 
up to 5 years and a budget for direct costs of up to $275,000. Since the total 
costs for a subcontract or consortium are included in the direct cost request, one 
additional module of $25,000 above the $275,000 cap may be requested for the 
facilities and administrative costs associated with third party agreements. A 
module requested for this purpose must be clearly identified in the budget 
justification section of the application, and will be restricted for this purpose 
only at the time of award. 

Because the nature and scope of the proposed research will vary from application 
to application, it is anticipated that the size and duration of each award will 
also vary. Although the financial plans of the IC(s) provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of funds 
and the receipt of a sufficient number of meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the following 
characteristics: 
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, and 
laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry out 
the proposed research is invited to work with their institution to develop an 
application for support.  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are always encouraged to apply for 
NIH programs.
 
SPECIAL REQUIREMENTS

Work on normal lungs may be used for comparison purposes, but to be responsive to 
the RFA the proposed research projects must focus on the pathogenesis of lung or 
lung vasculature/right heart complications of HIV and HIV-related opportunistic 
infections.  Research on human cells and tissue is encouraged.  Large clinical or 
population based studies are not within the scope of this RFA. 

We encourage applicants to use high through-put genomic and proteomic techniques, 
when appropriate. If these techniques are used the applicants must demonstrate 
that investigators who have sufficient mathematical, modeling, statistical, and 
bioinformatics structural expertise to analyze the large amounts of data produced 
are committed to the project.  In addition, the applicants will be expected to 
clearly outline their approaches to collecting, organizing, analyzing, and sharing 
the data obtained.  To the extent possible, genomic and proteomic data from these 
studies (e.g., gene sets, protein sets) need to be made available quickly in a 
usable form, via a public website, to a wide range of researchers. The applicants 
must indicate their willingness to rapidly release such data.

Each application submitted for this RFA must be a complete, independent entity and 
not depend on any other application submitted in response to this RFA.

Grantee's Meetings

Upon initiation of the program, the NHLBI will sponsor meetings to encourage 
exchange of information among investigators who participate in this program.  In 
their budgets, applicants should include funds for annual one-day grantees' 
meetings, most likely in Bethesda, Maryland.  Applicants should also include a 
statement in their applications indicating their willingness to participate in 
these meetings.  The first such meeting likely will take place about 12 months 
after the award is issued.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

Hannah H. Peavy, M.D.
Leader, AIDS/TB Scientific Research Group
Lung Biology and Disease Program 
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10018, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0222
FAX:  (301)480-3557
Email:  peavyh@nih.gov

o Direct your questions about peer review issues to:

Valerie Prenger, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD  20892-7924 (20817 for express/courier service)
Telephone:  (301) 435-0270
FAX:  (301) 480-0730
Email: prengerv@nhlbi.nih.gov

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

Robert Pike
Grants Management Officer
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7144, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email: piker@nhlbi.nih.gov

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 RFA 

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, information that it contains allows 
IC 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 Dr. Valerie Prenger at the 
address listed under WHERE TO SEND INQUIRIES.

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 DUNS number can be 
obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of 
the face page of the PHS 398 form. The PHS 398 document 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.

SUPPLEMENTARY INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be 
followed, with these exceptions:

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 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. For this announcement the modular ceiling has been increased, as 
previously noted, to $275,000. 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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
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, plus all 
collated sets of appendix material must be sent to Dr. Valerie Prenger at the 
address listed under where to send inquires.

APPLICATION PROCESSING: Applications must be received on or before the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review. 

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.
 
The Center for Scientific Review (CSR) will not accept any application in response 
to this RFA that is essentially the same as one currently pending initial review, 
unless the applicant withdraws the pending application.  However, when a 
previously unfunded application, originally submitted as an investigator-initiated 
application, is to be submitted in response to an RFA, it is to be prepared as a 
NEW application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text must not 
be marked to indicate the changes from the previous unfunded version of the 
application.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness to special requirements of the RFA by the NHLBI.  Incomplete and/or 
non-responsive applications will be returned to the applicant without further 
consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by the 
NHLBI in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:

o Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will be 
discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Heart, Lung, and Blood Advisory 
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.  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. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

SIGNIFICANCE: Does this study address an important problem? If the aims of the 
application are achieved, how will scientific knowledge be advanced? What will be 
the effect of these studies on the concepts or methods that drive this field?

APPROACH: Are the conceptual framework, design, methods, and analyses adequately 
developed, well-integrated, and appropriate to the aims of the project? Does the 
applicant acknowledge potential problem areas and consider alternative tactics?

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

INVESTIGATOR: Is the investigator appropriately trained and well suited to carry 
out this work? Is the work proposed appropriate to the experience level of the 
principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items 
will be considered in the determination of scientific merit and the priority 
score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects 
and protections from research risk relating to their participation in the proposed 
research will be assessed. (See criteria included in the section on Federal 
Citations, below).
 
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 Inclusion 
Criteria in the sections on Federal Citations, below).

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

ADDITIONAL REVIEW CONSIDERATIONS 

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  February 17, 2005
Application Receipt Date:  March 16, 2005
Peer Review Date:  June/July 2005
Council Review:  September 2005
Earliest Anticipated Start Date:  September 29, 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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

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

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   It 
is the responsibility of the applicant to provide, in the project description and 
elsewhere in the application as appropriate, the official NIH identifier(s) for 
the hESC line(s) to be used in the proposed research.  Applications that do not 
provide this information will be returned without review.

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

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

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

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 RFA 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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