BIODEFENSE AND EMERGING INFECTIOUS DISEASE RESEARCH OPPORTUNITIES
 
RELEASE DATE:  March 19, 2003

PA NUMBER:  PA-03-080 (see replacement PA-04-119) 
                      (see correction NOT-AI-03-040)
                      (see NOT-AI-03-031, NOT-AI-03-034 and NOT-AI-04-016)

EXPIRATION DATE: March 2, 2006

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

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

This program announcement (PA) replaces notice NOT-AI-02-023, BIODEFENSE AND 
EMERGING INFECTIOUS DISEASES RESEARCH OPPORTUNITIES, published in the NIH Guide 
on May 17, 2002.

This PA is intended to encourage the submission of investigator-initiated 
research grant applications in biodefense and select emerging infectious 
diseases. The goal is to expedite research leading to the diagnosis, prevention 
and treatment of diseases caused by potential bioterrorism agents.

RESEARCH OBJECTIVES

In response to growing concerns about the use of biological agents in acts of 
terrorism, NIAID has expanded its biodefense research program.  The ultimate 
goal of that expansion is to develop effective diagnostics, vaccines and 
therapeutics to protect the public in the event of a biological attack or the 
sudden emergence of select rare or eradicated diseases. 

NIAID has developed a list of high priority agents to help focus accelerated 
research efforts.  The NIAID Category A, B and C Priority Pathogens are listed 
at http://www.niaid.nih.gov/biodefense/bandc_priority.htm.  This PA 
addresses the need for more basic and applied research on those pathogens, 
their toxic products, and the body's immune defenses against them.

Details of the scientific priorities addressed through this PA are available at: 
http://www.niaid.nih.gov/biodefense/rfalplat.htm. A list of contacts for 
individual subject areas is also provided.  Research priorities and contact 
persons may change periodically as NIAID goals evolve; investigators are 
therefore strongly encouraged to review that information prior to submission.

Research projects appropriate for this PA include, but are not limited to, the 
following general areas:

o Pathogen Biology 
o Bacterial Toxins
o Immune Response
o Microbial Immune Evasion and Enhancement
o Animal Models of Infection and Immunity
o Epidemiology and Natural History of Infection
o Discovery of Vaccines, Therapeutics, Adjuvants, Diagnostics and Vector 
Control Products for Biodefense

Applications should specifically address NIAID Category A, B and C Priority 
Pathogens, the diseases caused by them, and/or relevant host immune responses.  
Proposals focusing on other microbes will be considered only when those 
organisms are established models of infection by category A, B and C agents.  

In some cases, immunological mechanisms relevant to biodefense are broadly 
applicable for many pathogens and may be most efficiently studied using model 
systems.  Immunological research that is not directed specifically at NIAID 
Category A, B and C Priority Pathogens or their products is responsive to this 
announcement if it addresses a practical approach to inducing, controlling or 
improving the effectiveness of innate or adaptive immune responses to infection 
by those pathogens or vaccines to prevent them. Applications may also address 
basic immunological mechanisms when understanding those mechanisms is necessary 
for the development of protective approaches for biodefense.  Applicants not 
specifically addressing NIAID Category A, B and C Priority Pathogens or their 
products should justify how the proposed research is applicable to immune 
responses against the listed agents

MECHANISM(S) OF SUPPORT

This PA will use NIH individual research project grant (R01), and/or program 
project grant (P01), and/or Exploratory/Developmental Research Project Grant 
(R21).  The total requested project period for an application submitted in 
response to this PA may not exceed five years for an R01 or a P01, and two 
years for an R21.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project. 

NIAID uses R21 grants to provide short-duration support for preliminary studies 
of a highly speculative nature, which are expected to yield, within this time 
frame, sufficient information upon which to base a well-planned and rigorous 
series of further investigations.  Applicants for R21 awards may request up to 
$200,000 direct costs annually.  

Program project grants support broadly based, multidisciplinary research 
programs that have a well-defined, central research focus or objective. An 
important feature is that the interrelationships of the individual 
scientifically meritorious projects will result in a greater contribution to 
the overall program goals than if each project were pursued individually. The 
program project grant consists of a minimum of three interrelated individual 
research projects that contribute to the program objective. This type of award 
also can provide support for certain common resources termed cores. Such 
resources should be utilized by two or more projects within the award. The 
total project period for P01 grants may not exceed five years.

Applicants for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; 
this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

This PA uses just-in-time concepts. It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format. Otherwise follow the instructions for 
non-modular 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_2001/part_i_1.htm. 

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the following 
characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government 
o Domestic or foreign
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 

CLINICAL STUDIES AND TRIALS: 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.

SELECT AGENTS: All applicant organizations, domestic and foreign, must comply 
with Select Agent regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines 
for Research Involving Recombinant DNA Molecules 
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). Applicants must 
document their ability and willingness to comply.

WHERE TO SEND INQUIRIES

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

o Direct your general questions about scientific/research issues to:

Samuel S. Perdue, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4115, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-5083
FAX: (301) 402-2508
Email: [email protected] 

o Direct your questions about issues related to P01 peer review to:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
Scientific Review Program, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-435-8537
FAX: 301-402-2638
e-mail: [email protected] 

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

Lesia Norwod
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-7146
FAX: 480-3780
Email: [email protected] 

SUBMITTING AN APPLICATION

Applications for P01, R01, and R21 grants 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) 710-0267, Email: [email protected].

For purposes of identification and processing, item 2a on the face page of 
the application must be marked "YES" and the PA number (see first page of this 
announcement) and the words " BIODEFENSE AND EMERGING INFECTIOUS DISEASE 
RESEARCH OPPORTUNITIES" must be entered on the face page.

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

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

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your application 
for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff member and 
IC who agreed to accept assignment of the application. 

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised version 
of these grant application types. Additional information on this policy is 
available in the NIH Guide for Grants and Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

P01, R01, R21 APPLICATIONS: See the following paragraphs for information 
specific to the preparation and submission of P01, R01, and R21 applications.

PROGRAM PROJECT (P01) APPLICATIONS: Applicants for P01 grants must follow 
special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW 
at:  http://www.niaid.nih.gov/ncn/grants/multibron.htm.

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 same time, submit two additional exact copies of the P01 grant 
application and all five sets of any appendix material to:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
Scientific Review Program, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone: 301-435-8537
FAX: 301-402-2638
e-mail: [email protected] 

RESEARCH PROJECT (R01) APPLICATIONS

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT R01 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.

Submit a signed, typewritten original of the application, including the 
checklist, and five signed photocopies and all appendices 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)

SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS: 

To apply, please follow NIH guidelines for submission of an R21 application as 
listed below: 

1) The description (abstract) must include a brief explanation of the proposed 
activity, and how it is consistent with the exploratory/development nature of 
the R21 mechanism as described in this notice. 

2) Although preliminary data are neither expected nor required for an R21 
application, they may be included. 

3) Sections a-d of the Research Plan may not exceed 10 pages, including tables 
and figures. 

4) Appendix materials should be limited, as is consistent with the exploratory 
nature of the R21 mechanism, and should not be used to circumvent the page 
limit for the research plan. Copies of appendix material will only be provided 
to the primary reviewers of the application and will not be reproduced for 
wider distribution. The following materials may be included in the appendix: 

o Up to five publications, including manuscripts (submitted or accepted for 
publication), abstracts, patents, or other printed materials directly relevant 
to the project. These may be stapled as sets. 

o Surveys, questionnaires, data collection instruments, and clinical protocols. 
These may be stapled as sets. 

o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within the 
10-page limit of items a-d of the research plan. 

Include five collated sets of all appendix material, in the same package with 
the application, following all copies of the application. Identify each item 
with the name of the principal investigator. 

SENDING AN R21 APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies and all 
appendices in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application. The CSR will not accept any 
application that is essentially the same as one already reviewed. This does not 
preclude the submission of a substantial revision of an application already 
reviewed, but such application must include an Introduction addressing the 
previous critique.  

Concurrent submission of an R01 and a Component Project of a Multi-project 
Application:  Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application.  If, following review, both the 
multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have the 
option to withdraw from the multi-project grant.  This is an NIH policy intended 
to preserve the scientific integrity of a multi-project grant, which may be 
seriously compromised if a strong component project(s) is removed from the 
program.  Investigators wishing to participate in a multi-project grant must be 
aware of this policy before making a commitment to the Principal Investigator 
and awarding institution.

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

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines. An appropriate scientific review group convened in 
accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit. 

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

o 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 NIAID advisory council.

REVIEW CRITERIA

The general review criteria for P01 grant applications are presented in the 
NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" 
at http://www.niaid.nih.gov/ncn/grants/multibron.htm.

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 
your 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

For review of R01 and R21 grant applications, the scientific review group will 
address and consider each of these criteria in assigning your application's 
overall score, weighting them as appropriate for each application. Your 
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, you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

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

(2) APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Do you acknowledge potential problem areas and consider alternative 
tactics?

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

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

(5) ENVIRONMENT: Does the scientific environment in which your 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 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, if appropriate.
 
BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND 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. 
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://grants.nih.gov/grants/stem_cells.htm 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 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.

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

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

AUTHORITY AND REGULATIONS

This program is described in the 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.

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