NIAID ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY SCIENTISTS

RELEASE DATE:  July 10, 2003

RFA:  AI-03-045
 
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

LETTER OF INTENT RECEIPT DATE: January 16, 2004

APPLICATION RECEIPT DATE: February 19, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the RFA
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 Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Allergy and Infectious Diseases (NIAID), National 
Institutes of Health (NIH), invites applications from underrepresented 
minority investigators who are in the early stages of their scientific careers 
(assistant professor or junior level faculty) to establish basic or clinical 
research programs in the areas of allergy, immunology, transplantation, 
microbiology, and infectious diseases, including AIDS. 

This Request for Applications reflects NIAID's continued commitment to the 
development of a cadre of talented underrepresented minority scientists.  Full 
participation and engagement of the junior investigator must be accomplished 
throughout the research process. While the previous RFA (AI-94-027 - 
http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-94-027.html) supported 
research in the area of AIDS only, the present RFA includes all the scientific 
areas encompassed in the scientific mission of the NIAID.  

RESEARCH OBJECTIVES

The NIAID is committed to increasing the number of underrepresented minority 
investigators in all fields encompassed by its scientific mission.  
Historically, the NIAID has supported a variety of programs for 
underrepresented minorities in biomedical research, encompassing high school 
through postdoctoral training. Although these programs have demonstrated 
success in specific areas, only a few underrepresented minority investigators 
have become well established in biomedical research.  

The goals of the present RFA are: (1) to increase the number of 
underrepresented minority investigators capable of performing independent 
competitive research in the areas encompassed by the NIAID's scientific 
mission, and (2) to enhance the long-term research skills and potential of 
these individuals.

A list of research areas that are considered relevant for this RFA follows. 
This list is not all-inclusive, and prospective applicants are encouraged to 
discuss program relevance issues with the program staff cited under INQUIRIES. 
The scope of acceptable areas of research includes basic and clinical 
research. The following are examples of research within the scope of this 
program announcement:

o Immune-Mediated Diseases- Basic Immunology, immune tolerance, 
transplantation, asthma and allergic diseases, autoimmune diseases, 
genetically-determined immunodeficiencies, immunologic basis of human 
vaccines, and infectious etiologies of chronic immune-mediated diseases.

o Acquired Immunodeficiency Syndrome (AIDS)- Epidemiology, pathogenesis, 
treatment, HIV vaccines, and non-vaccine prevention strategies.

o Emerging Infectious Diseases and Global Health- Microbiology and vector 
biology, diagnosis and detection, treatment, drug and insecticide resistance, 
and global health.

o Bio-Defense Research- programs to investigate pathogen biology, host 
response, microbial genomic sequencing, and proteomics; programs to identify 
potential vaccines, diagnostics, and immunotherapy targets; initiatives to 
evaluate biodefense therapies and diagnostics

o Vaccines- Vaccine discovery, design and development, pathogens associated 
with emerging and re-emerging global health problems, overcoming obstacles to 
vaccines for pathogens of high public health importance, and newly identified 
areas of vaccine need.  
Specific research questions of the highest priority are contained in the 
current NIAID Strategic Plan.  The plan is available on-line at 
http://www.niaid.nih.gov/strategicplan2000/default.htm.  Please contact 
program staff listed under INQUIRIES for additional information.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) award. The total requested project period for an application 
submitted in response to this RFA may not exceed four years for an R01.  The 
applicant 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.

Applications that are not funded in the competition described in this RFA may 
be resubmitted as NEW investigator-initiated 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 
(see http://grants.nih.gov/grants/funding/modular/modular.htm. Specifically, 
if the investigator is submitting an application with direct costs in each 
year of $250,000 or less, us the modular format.  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 NIAID intends to commit approximately $1M in FY 2004 to fund 3 to 5 new 
and/or competitive continuation grants in response to this RFA. An applicant 
may request a project period of up to four (4) years and a budget for direct 
costs of up to $250,000 per year. 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 NIAID 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

The applicant may submit (an) application(s) if their 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   Domestic 
o   Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Underrepresented minority investigators who are identified as such by their 
own domestic private or public institutions are encouraged to submit 
applications. Underrepresented minority refers to racial and ethnic minority 
groups that usually include African Americans, Hispanics, Native Americans, 
Alaska Natives, Hawaiian Islanders, Asian and Pacific Islanders. Applicants 
should be at the assistant professor level of their careers. Applicant 
institutions must have sufficient research infrastructure and a core of 
investigators already conducting basic, behavioral, clinical or 
epidemiological biomedical research.  Foreign institutions are ineligible for 
this program.

Participants in NIH programs for underrepresented minorities, such as the 
Research Supplements for Underrepresented Minorities (RSUM), Minority 
Biomedical Research Support (MBRS), Minority Access to Research Careers 
(MARC), and Research Centers in Minority Institutions (RCMI) are encouraged to 
apply.  Scientists who have previously been Principal Investigators on NIH 
grants (R01 grants or equivalent) or similar awards from other funding 
agencies or organizations are not eligible for this award. Underrepresented 
minority scientists supported under a previous RFA AI-94-027 funded by NIAID 
are not eligible to apply. NIAID staff listed under INQUIRIES should be 
consulted for details concerning eligibility requirements.  

SPECIAL REQUIREMENTS

Applicants are required to have available a recognized expert in the area of 
proposed research for guidance and consultation. It is expected that this 
expert will assist the applicant in the design and conduct of his/her 
research. It is not necessary that the expert be at the same institution as 
the applicant, but he/she should be within a reasonable proximity to be 
available for guidance and consultation.

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study. An 
UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is 
available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. 
The full policy including terms and conditions of award is available 
at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

WHERE TO SEND INQUIRIES

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

o Direct questions about scientific/research issues to:

Milton J. Hernández, Ph.D. 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2133, MSC-7610
6700B Rockledge Drive
Bethesda, MD  20892-7610
Bethesda, MD 20817-7610 (for express/courier service)
Telephone:(301) 496-8697
FAX:  (301) 496-8729
Email: mh35c@nih.gov

Paula S. Strickland, Ph.D., MPH
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2139, MSC-7610
6700B Rockledge Drive
Bethesda, MD  20892-7610
Bethesda, MD 20817-7610 (for express/courier service)
Telephone:(301) 435-8563
FAX:  (301) 402-0369
Email: ps30f@nih.gov

Opendra Sharma, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room Number 4136, MSC-7620
6700B Rockledge Drive
Bethesda, MD  20892-7620
Bethesda, MD 20817-7620 (for express/courier service)
Telephone:(301) 496-8378
FAX:  (301) 402-3211
Email: os4g@nih.gov

Lawrence J. Prograis, M.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room Number 5134, MSC-7640
6700B Rockledge Drive
Bethesda, MD  20892-7640
Bethesda, MD 20817-7640 (for express/courier service)
Telephone:(301) 496-1886
FAX:  (301) 402-2571
Email: lp13r@nih.gov

Robert L. Quackenbush, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room Number 6050, MSC-7630
6610 Rockledge Drive
Bethesda, MD  20892-7630
Bethesda, MD 20817-7630 (for express/courier service)
Telephone:(301) 402-0443
FAX:  (301) 480-3617
Email: rq1i@nih.gov

o Direct questions about peer review issues to:

Gary S. Madonna, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2149, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service)
Telephone:(301) 496-3528
FAX:  (301) 402-2638
Email: gm12w@nih.gov

o Direct questions about financial or grant management matters to:

Barbara Huffman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2132, MSC-7610
6700B Rockledge Drive
Bethesda, MD  20892-7610
Bethesda, MD 20817-7610 (for express/courier service)
Telephone:  (301) 496-3821
FAX:  (301) 496-8729
Email:  bh23q@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, the 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:

Gary S. Madonna, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2149, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service)
Telephone:(301) 496-3528
FAX:  (301) 402-2638
Email: gm12w@nih.gov

SUBMITTING AN APPLICATION

In October of 2003, there will be a one-day PRE-APPLICATION MEETING in the 
Washington, DC metropolitan area to provide potential applicants with 
background information and to answer questions.  Applicants are encouraged to 
attend this meeting before submitting an application. Information about the 
meeting date, agenda, and a summary of the meeting results will be made 
available via the NIAID Internet site at http://www.niaid.nih.gov. For 
additional information about the Pre-Application Meeting call the NIAID Office 
of Special Populations and Research Training at 301 496-8697.

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

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

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 exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Gary S. Madonna, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2149, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by 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.

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.  While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIAID.

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

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Allergy and 
Infectious Diseases Council
   
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work 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 application 
will also be reviewed with respect to the following: 

The applicant's plans and the availability of a recognized expert in the area 
of the proposed research for council and advice as attested to by a letter of 
agreement.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

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

ADDITIONAL CONSIDERATIONS

DATA SHARING:  The adequacy of the proposed plan to share data.

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:    January 16, 2004
Application Receipt Date:         February 19, 2004
Peer Review Date:                 May, 2004
Council Review:                   June, 2004
Earliest Anticipated Start Date:  August, 2004

AWARD CRITERIA

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

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

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and 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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

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

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects. 
 This policy announcement is 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.

RECOMBINANT DNA AND HUMAN GENE TRANSFER RESEARCH:  The National Institutes of 
Health Guidelines for Research Involving Recombinant DNA Molecules (NIH 
Guidelines) apply to NIH-funded and non-NIH-funded gene transfer projects that 
are conducted at or sponsored by an institution that receives NIH support for 
recombinant DNA research. As defined by the NIH Guidelines, recombinant DNA 
molecules are either: (1) molecules which are constructed outside living cells 
by joining natural or synthetic DNA segments to DNA molecules that can 
replicate in a living cell; or (2) DNA molecules that result from the 
replication of those described in (1). The NIH Guidelines set forth principles 
and standards for safe and ethical conduct of recombinant DNA research and 
apply to both basic and clinical research studies. Specific guidance for the 
conduct of human gene transfer studies appears in the appendix of the document 
(Appendix M.) The NIH Guidelines should be carefully reviewed to ensure 
compliance with all other requirements for the conduct of projects involving 
recombinant DNA research and human gene transfer. Failure to comply with the 
NIH Guidelines may result in suspension, limitation, or termination of NIH 
funds for recombinant DNA research at the organization or a requirement for 
NIH prior approval of any or all recombinant DNA projects at the organization. 
A copy of the NIH Guidelines is posted at the following URL: 
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html and may be obtained 
from the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 
750, Bethesda, MD 20892, 301-496-9838.

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

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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

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

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 
2010," a PHS-led national activity for setting priority areas. This 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 Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research. Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes general 
information about the grant application and review process; information on the 
terms and conditions that apply to NIH Grants and cooperative agreements; and 
a listing of pertinent offices and officials at the NIH.  All awards are 
subject to the terms and conditions, cost principles, and other considerations 
described in the NIH Grants Policy Statement.

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) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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