PAR-04-140: NIBIB RESEARCH SUPPLEMENTS TO PROMOTE CLINICAL RESIDENT RESEARCH EXPERIENCES

NIBIB RESEARCH SUPPLEMENTS TO PROMOTE CLINICAL RESIDENT RESEARCH EXPERIENCES

RELEASE DATE: August 12, 2004

PA NUMBER: PAR-04-140 (Reissued as PAR-06-531)
(Clinical fellows now eligible for support,
see NOT-EB-05-009)(Program extended, see NOT-EB-05-006)

EXPIRATION DATE: February 22, 2006, unless reissued.

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.286

LETTER OF INTENT RECEIPT DATES: September 21, 2004 and January 17, 2005 (See revised dates, NOT-EB-05-006)
APPLICATION RECEIPT DATES: October 21, 2004 and February 14, 2005 (See revised dates, NOT-EB-05-006)

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Receive Supplement Funding
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 PAR

The purpose of this Program Announcement is to provide a 1-2 year period of
research experience for physicians in a residency program through supplements
to existing NIBIB grant awards. The program targets applicants who have
demonstrated the potential for productive research in an area of interest to
the candidate and of relevance to the mission of the NIBIB.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks
to improve human health by supporting research and training aimed at
developing imaging, engineering, and bioinformatics tools with broad medical
utility in the diagnosis, treatment, and prevention of disease. To this end,
the institute will fund the research and/or training of creative and
insightful clinicians to work in interdisciplinary research teams.
Furthermore, cognizant of the importance of translating research findings to
health benefits, NIBIB considers facilitation of the translation of
discoveries from the laboratory to the clinical setting a cornerstone of its
mission. This PAR aims specifically to enhance the fundamental knowledge and
research skills of clinical residents interested in research careers in areas
related to the mission of the NIBIB.

PROGRAM OBJECTIVES

The intent of this initiative is to attract outstanding clinicians into
research careers related to the mission of the NIBIB. This initiative is not
intended to support clinical residency training. The NIBIB anticipates that
by providing research opportunities for these individuals during their
residency, the number entering and remaining in NIBIB-focused research
careers will increase. It is expected that individuals selected for this
research experience will continue in research and subsequently apply for
career development awards and/or research project grants.

MECHANISM OF SUPPORT

This PAR will use the NIH competitive supplement award mechanism. The
supplement may be awarded to any of the following active NIBIB research
project grant mechanisms: R01, R37, P01, P41, P50 (For additional details see
the “SPECIAL REQUIREMENTS” section). The PI is solely responsible for
planning, directing, and executing the proposed project.

The proposed research experience must be related to the ongoing research of
the parent grant and have the potential to contribute significantly to the
research career development of the candidate. As part of this research
experience, the candidate and the PI must describe a plan by which the
candidate will have the opportunity to interact with other individuals on the
parent grant, to contribute intellectually to the research, and to enhance
her/his research skills and knowledge regarding the particular area of
biomedical science. Furthermore, the PI must demonstrate an understanding
that the purpose of the award is to enhance the research capability of the
clinical resident and that the research experience is intended to provide
opportunities for development as a productive research investigator, and
demonstrate willingness to provide appropriate mentorship. Supplement awards
will be consistent with the goal of strengthening the existing research
program and with the overall programmatic balance and priorities of the
NIBIB. A supplement award does not preclude the institution's use of funds
from other sources to supplement the award.

Each parent grant may support up to two clinical residents. A separate
supplemental application is required for each resident. Support under the
supplement program is not transferable to another individual or transportable
to another institution.

This program has been designed to attract individuals into research careers
and is not intended to provide an alternative or additional means of
supporting individuals who already receive support from a research grant or a
research training grant or any other DHHS funding mechanism. Individuals who
are supported by a National Research Service Award (NRSA) Institutional
research training grant or NRSA Individual Fellowship may not be transferred
to supplemental support prior to the completion of their appointed period of
training. Individuals may not be transferred to a supplement to increase the
availability of funds to the parent grant for other uses.

This PAR 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). The budget format
of the supplemental application must be the same as that of the parent grant.
Specifically, if the parent grant has direct costs in each year of $250,000
or less, use the modular budget format for the supplement. 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 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 institutions/organizations
o Foreign institutions are not eligible to apply

INDIVIDUALS ELIGIBLE TO RECEIVE SUPPLEMENT FUNDING

Principal Investigators: Principal Investigators (PIs) holding an active
R01, R37, P01, P41, or P50 from the NIBIB may apply for this program.

Any individual who meets the criteria described below is invited to work with
his/her institution and an identified mentor (PI holding an active R01, R37,
P01, P41, or P50 from the NIBIB) 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.

Candidate Eligibility: A candidate must have a health professional degree
(M.D. or the equivalent) and be enrolled in an accredited clinical residency-
training program in the United States. Candidates need not be citizens or
permanent residents of the U.S. Individuals who received medical degrees at
foreign sites, but are currently enrolled in an accredited U.S. residency-
training program are eligible. Individuals who have already completed their
residency training are not eligible; they should contact Dr. Meredith Temple-
O’Connor listed under “WHERE TO SEND INQUIRIES,” for other training/research
opportunities.

SPECIAL REQUIREMENTS

The candidate must work with a mentor for the research experience who is the
PI on an active NIBIB grant. Co-mentoring is encouraged for
interdisciplinary projects.

The duration of the supplement should be at least one year to provide the
candidate with a meaningful research experience, and to prepare him/her for
further research experiences.

Supplements can be requested only for active NIBIB grants that have a minimum
of one year of support remaining. Submit a supplemental application only for
a period within the current period of support. (A supplement may not extend
beyond the parent award period.)
A maximum of two clinical residents (i.e., two supplements) will be allowed
on any given parent grant award.

Ideally, candidates may take time off from residency training to participate
in this program on a full-time basis. However, candidates must be willing
and able to dedicate at least 75% of their professional time to the research
project.

Up to $100,000 direct costs per year may be requested. Of that amount,
residents may request funds for research costs and travel up to $25,000
direct costs per year of support. A maximum of $2000 per year can be
allocated for travel. Salary and fringe benefits for the candidate should be
consistent with the institution’s salary structure for the residency-training
program. No funds may be requested to supplement the salaries of the PI or
other personnel, or to purchase equipment.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Meredith D. Temple-O’Connor, Ph.D.
Acting Director, Division of Interdisciplinary Training
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institutes of Health/Dept. of Health and Human Services
6707 Democracy Boulevard, Democracy II, Suite 200, MSC 5477
Bethesda, MD 20892
Telephone: (301) 451-4792
FAX: (301) 480-4973
Email: templem@mail.nih.gov

o Direct your questions about peer-review issues to:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Voice: (301) 496-8633
Fax: (301) 480-0675
Email: GeorgeD@nih.gov

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

Florence Turska
Grants Management Specialist
Grants Management Branch
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Blvd., Suite 900, MSC 5469
Bethesda, MD 20892
Telephone: (301) 496-9314
FAX: (301) 480-4974
Email: ft7p@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 PAR

A letter of intent is not required, is not binding, and does not enter into
the review of a subsequent application. However, the information 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, and should be sent to

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.

SUPPLEMENTARY INSTRUCTIONS

The request for a supplemental award must include the following:

1. The supplemental application must have the same Principal
Investigator/Program Director as the currently funded (parent) grant.

2. Supplements can be requested only for active NIBIB grants that have a
minimum of one year of support remaining. Submit a supplemental application
only for a period within the current period of support. (A supplement may not
extend beyond the parent award period.)

3. A proposed budget related to the percent effort (where appropriate) for
the research experience of the candidate during the first and future years.
The budget format (modular or non-modular) must be the same as that of the
parent grant.

4. The supplemental application must include an Introduction of not longer
than one page.

5. Completed biographical sketch pages (for the candidate and updated for the
mentor(s)), resources page (updated), and checklist page (updated). The
biographical sketch of the candidate should include evidence of scientific
achievement and/or interest.

6. Research and Career Plans: The description of the research and career
plans must not exceed 10 pages. This section must be prepared by the
candidate and the PI of the parent grant and must include:

(a) A statement by the candidate outlining his/her overall career plans and a
timeline for the research and career development experiences proposed in this
supplement;

(b) A statement by the PI of the parent grant (i.e., the mentor) addressing
the eligibility of the candidate for support under this program, detailing
any current or previous PHS research grant support the candidate has
received, and outlining how mentoring will be provided to help expand and
foster the research capabilities of the candidate.

(c) A description of the specific aims of the original project, and how the
research proposed under this supplement relates to the specific research
goals and objectives of the parent grant. The review committee will not
receive a copy of the parent grant.

(d) A description of the candidate’s proposed research project including
research design and methods section.

If the candidate’s proposed project uses vertebrate animals and/or human
subjects, the application must address the points of Section E (human
subjects research, including inclusion of women, minorities, and children in
the study population) and/or Section F (vertebrate animals) of the PHS 398
application instructions.

7. A letter of support from the director of the residency program or
department chair specifically stating that the candidate will be able to
devote time at the requested effort (at least 75%) to his/her research
experience.

8. If any of the research is to be conducted at a site other than the grantee
institution, an appropriately signed letter from the institution where the
research is to be conducted must be submitted. The request must be signed by
the candidate, the PI, and the appropriate institutional business official.

9. Appendix material: Up to 5 publications, manuscripts (accepted for
publication), abstracts, patents, or other printed materials directly
relevant to this project may be included.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: The budget
format of the supplemental application must be the same as that of the parent
grant. If the parent application requested up to $250,000 per year in direct
costs, the budget for the supplement 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.

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 and all
copies of the appendix material must be sent to

APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this PAR. 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 PAR 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 by the NIBIB. Incomplete applications will not be reviewed.

If the application is not responsive to the PAR, NIH staff may contact the
applicant to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
appropriate NIH review cycle.

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 NIBIB in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:

As part of the initial merit review, all applications will:

o Undergo a selection process in which all applications will be discussed and
assigned a priority score
o Receive a written critique
o Receive a second level review by the National Institute of Biomedical
Imaging and Bioengineering staff.

REVIEW CRITERIA

The goal of this PAR is to provide research experiences for physicians in a
residency program through supplements to existing NIBIB grant awards. The
NIBIB seeks to enhance the research experiences of creative and insightful
clinicians in order to help facilitate the translation of research findings
to health benefits. This PAR aims specifically to enhance the fundamental
knowledge and research skills of clinical residents interested in research
careers in areas related to the mission of the NIBIB. In the written
comments, reviewers will be asked to evaluate the application 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.

Candidate

o Quality of the candidate's proposed research;

o Quality of the candidate’s academic and clinical record;

o Potential to develop as an independent researcher;

o Commitment to a research career; and

o Appropriateness of the candidate’s career development plan

Research Plan

o Scientific and technical merit of the research question, design and
methodology;

o Relevance of the proposed research to the parent grant

Mentor/Co-Mentor

o Quality and extent of mentor(s) proposed role in providing guidance and
advice to the candidate;

o Previous experience in fostering the development of researchers;

Environment and Institutional Commitment

o Applicant institution's commitment to an appropriate balance of research
and clinical responsibilities including the level of effort proposed by the
candidate. (A minimum of 75% effort is required.)

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.

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

RECEIPT AND REVIEW SCHEDULE (See revised dates, NOT-EB-05-006)

Letter of Intent Receipt Dates: September 21, 2004 and January 17, 2005
Application Receipt Dates: October 21, 2004 and February 14, 2005
Peer Review Date: Feb-March 2005 and May-June 2005
Council Review: May 2005 and October 2005
Earliest Anticipated Start Date: July 1, 2005 and December 1, 2005

AWARD CRITERIA

The following will be considered in making funding decisions:

o Merit of the proposed research and training experience 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.

Effective October 1, 2004, applicants are required to submit sharing plan for
model organisms, see NIH GUIDE May 7 issue
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.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 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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