FOOD ALLERGY RESEARCH CONSORTIUM AND STATISTICAL CENTER

RELEASE DATE:  August 24, 2004

RFA Number:  RFA-AI-04-034

Update: The following update relating to this announcement has been issued:

July 7, 2009 - This RFA has been reissued as (RFA-AI-09-039).

EXPIRATION DATE: December 17, 2004

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 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:  November 16, 2004
APPLICATION RECEIPT DATE:  December 16, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Institute of Allergy and Infectious Diseases (NIAID) invites 
applications from single institutions or consortia of institutions to 
establish the Food Allergy Research Consortium, a collaborative research 
program designed to develop new approaches to treat and prevent food allergy. 
Applications are also invited to establish a Statistical and Clinical 
Coordinating Center (SACCC) to support the clinical research projects 
undertaken by the Consortium.  The goals of the program are to: (1) develop 
immune intervention strategies for preventing and treating food allergy; (2) 
identify the mechanisms of development, loss and re-emergence of oral 
tolerance; (3) determine the molecular and functional characteristics of food 
allergens; and (4) determine the role of the gastrointestinal (GI) tract in 
development and loss of oral tolerance.

RESEARCH OBJECTIVES

Background

Food allergy is an immunologic disease responsible for substantial morbidity 
and mortality. Food allergy occurs in 6 – 8% of children and 2% of adults, and 
prevalence is increasing. Severe food allergic reaction may cause anaphylaxis 
and death. In the United States, approximately 30,000 anaphylactic episodes 
and 150 deaths per year are due to food allergy. Six foods (milk, egg, 
peanuts, tree nuts, fish, shellfish) cause 90% of all allergic reactions to 
foods, and peanuts and tree nuts are the most common food allergens causing 
anaphylaxis. Food allergic disorders encompass IgE-mediated immediate 
hypersensitivity and cell-mediated hypersensitivity. Both immune mechanisms 
contribute to the gastrointestinal (GI), cutaneous, respiratory and systemic 
symptoms associated with food allergy.

The GI tract is responsible for digestion and absorption of nutrients 
essential for survival of the organism, and GI mucosal immunity provides 
critical functions that support distinctions between nutrients and pathogens. 
Oral tolerance describes the immunosuppressive mechanism that prevents 
individuals from developing an allergic response to foods. Failure to develop 
or maintain oral tolerance precedes food allergy in children and adults. 
Delayed maturation of GI mucosal immunity and oral tolerance in newborns is 
linked to the high incidence of food allergy in children under 3 years of age. 
Several common childhood food allergies (cow’s milk and egg) are frequently 
transient, whereas other allergies (peanut) often persist throughout 
adulthood. 

Limitations of and lack of consensus on methods for diagnosis and management 
of food allergy hinder development of best clinical practices. Diagnosis is 
confirmed by the double-blind, placebo-controlled food challenge, a test with 
inherent risk of severe reactions. The most effective strategy to prevent an 
allergic episode is strict food avoidance. Compliance with strict food 
avoidance is complicated by the ubiquitous presence of certain foods, such as 
peanut, soy, milk, and egg, in processed foods, poor food labeling practices 
and cross-contamination of food products during processing. Recent advances in 
food allergy research suggest that new, focused research directions will 
advance our understanding of the pathophysiology of food allergy and translate 
these findings into new options for identification and treatment of 
susceptible individuals. 

In June 2003, the NIAID convened an Expert Panel on Food Allergy Research to 
evaluate the current state of IgE-mediated food allergy and to make 
recommendations for targeted basic science and clinical research. The Expert 
Panel concluded that the field of food allergy research is poised to make 
significant advances in the prevention and treatment of food allergies and 
anaphylactic reactions to foods and recommended new initiatives to eliminate 
critical gaps in understanding GI physiology, immunology and the mechanism of 
oral tolerance; the pathophysiology of food allergy and food allergy-
associated anaphylaxis and the molecular characteristics of food allergens.  
The panel also recommended targeted research to define the natural history of 
childhood and adult-onset food allergy, including the importance of 
understanding spontaneous reestablishment of tolerance following development 
of allergy; and to develop new immune-based therapies to prevent and treat 
food allergy. The summary of this meeting is posted at 
http://www.niaid.nih.gov/dait/pdf/11-20-03FAreport1.pdf.

Objective and Scope

The objectives of this research program are to: explore the pathobiology 
underlying the development and loss of oral tolerance and the development and 
reversal of food allergies; translate these findings into new immune-based 
approaches to prevent and treat food allergy; and explore the molecular and 
functional characteristics of food allergens. Close interaction between basic 
scientists and clinical investigators should promote utilization of patient 
materials in research and accelerate the translation of basic research 
advances to clinical application. 

Food Allergy Research Consortium 
 
To be deemed responsive, applications must contain at least two projects 
organized around a central hypothesis:
 
o  One project, termed “immune intervention project,” must focus on an immune 
intervention in either human food allergic subjects, an animal model of food 
allergy, or both. The project must test the intervention selected in either:  
(a) a clinical trial; (b) a pre-clinical study with strong likelihood of 
leading to a clinical trial; or (c) both a pre-clinical study and a clinical 
trial. The intervention may include mechanistic and/or biomarker studies. 
Additional details are found in “Supplementary Instructions.”
o  The second project, termed “immune mechanisms in observational study,” must 
study immune mechanisms in food allergic subjects during an observational 
study without interventions. This project must utilize clinical samples from 
food allergic individuals. One example is to utilize specimens and clinical 
data from food-allergic subjects in a longitudinal study and also evaluate 
immune parameters accompanying the development and reversal of food allergy. 
The study may include biomarker studies. Additional details are found in 
“Supplementary Instructions.”
o  If additional projects are proposed, each one must also be organized around 
the same central hypothesis.

This program is milestone-based and funding beyond the first year will be 
contingent upon satisfactory progress in meeting negotiated milestones (see 
“SPECIAL REQUIREMENTS” and “COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF 
AWARD” for additional information on this requirement). 

For the purposes of this RFA, pre-clinical studies are defined as research 
projects testing immune intervention strategies to prevent or treat food 
allergy using animal models such as, but not limited to, inbred and 
genetically-modified mice, pigs and non-human primates. For the NIH definition 
of clinical research and clinical trials, see 
http://grants.nih.gov/grants/funding/phs398/instructions2/p3_definitions.htm.

Studies involving genetically-modified foods will not be supported under this 
RFA.

Research areas considered responsive to this RFA include, but are not limited 
to, the following:

o  Delineation of the unique properties of the gastrointestinal tract that 
promote oral tolerance and the failure of tolerance, including the role of 
innate immunity, the Th1/Th2 microenvironments, and regulatory T cells in the 
pathogenesis of food allergy;
o  Analysis of the molecular and functional characteristics of food allergens 
and the role that food processing may have in the development of antigenicity 
and in the severity of food allergic reactions;
o  Investigation of the natural history of food allergy, including analysis of 
the immunologic parameters underlying development and reversal of food allergy 
and the acquisition of new food sensitivities; and
o  Testing or development of new immunologic approaches to prevent and treat 
food allergy with either clinical trials, preclinical studies that have the 
potential to lead to new clinical trials, or both preclinical studies and 
clinical trials.

Statistical and Clinical Coordinating Center (SACCC)
 
The SACCC will provide coordination, assistance, centralized data management, 
and analytical support for all human studies within the first and second 
projects of the Food Allergy Research Consortium, that is, for all clinical 
trials and for all immune mechanisms in observational studies involving food 
allergic patients funded under this RFA. SACCC responsibilities include 
statistical design, data collection and analysis, and logistical support for 
the Consortium Steering Committee and the NIAID Data and Safety Monitoring 
Board (DSMB).  Specifically, the SACCC will provide assistance in the 
following areas: 

o  Clinical Trial Design, Implementation and Management:  Develop and 
implement plans for the statistical design, analysis and management of 
clinical trials, including monitoring clinical sites, implementing Standard 
Operating Procedures, and training of site clinical, technical and data 
management staff.
o  Protocol Development:  Assist in developing clinical protocols, protocol 
modifications, case report forms, consent forms and Manual of Operations.
o  Regulatory Requirements:  Assist in the preparation of Investigational New 
Drug (IND) applications to the Food and Drug Administration, as well as 
interim and annual reports; track IND applications; and provide data to IND 
sponsors (NIAID, pharmaceutical company or other entity).
o  Computerized Data and Communication Systems:  Establish and manage a secure 
and confidential computerized system to collect study data; provide quality 
assurance for and report on study data; establish electronic communication 
linkages between clinical sites and the SACCC; and provide a computerized 
system for clinical site registration and for the receipt, follow-up, report 
and disposition of adverse events.     
o  Distribution of Study Medications:  Receive, package and deliver study 
medications to  clinical sites, and maintain an inventory and tracking system 
for all study medications.
o  Prepare reports and analyses to be used for presentations and publications.
o  Consortium Steering Committee and NIAID DSMB:  Provide logistical support 
for meetings and teleconferences of the Consortium Steering Committee and the 
NIAID DSMB including budgeted support for travel, lodging, meeting venues and 
teleconferences as required by the Consortium, as specified in the 
“Cooperative Agreement Terms and Conditions of Award”.
o  The Principal Investigator of the SACCC shall be a member of the Steering 
Committee.

MECHANISM OF SUPPORT

This RFA will use the NIH single project (U01) and NIH multi-project 
cooperative agreement (U19), "assistance" mechanisms, rather than 
"acquisition" mechanisms. 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. The anticipated award date is July, 2005.  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.

The NIH U01 and U19 are cooperative agreement award mechanisms in which the 
Principal Investigator retains the primary responsibility and dominant role 
for planning, directing, and executing the proposed project, with NIH staff 
being substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."

The total project period for applications submitted in response to this RFA 
may not exceed five years.

This RFA uses just-in-time concepts. It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if 
the investigator is submitting an application with direct costs in each year 
of $250,000 or less, use the modular budget format. Otherwise follow the 
instructions for non-modular budget research grant applications. This program 
does not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm. 

Applicants for U19 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.

FUNDS AVAILABLE

The NIAID intends to commit approximately $3.6 million in FY 2005 to fund two 
to three new U19 grants for the Food Allergy Research Consortium, and $0.9 
million in FY 2005 to fund one new U01 grant for the Statistical and Clinical 
Coordinating Center. An applicant may request a project period of up to five 
years. 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.  At this time, the NIAID has not determined whether or how this 
solicitation will be continued beyond the present RFA. 

ELIGIBLE INSTITUTIONS

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

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

Foreign Organizations:

Several special provisions apply to applications submitted by foreign 
organizations: 
o  Funds for alterations or renovations cannot be requested.
o  Charge back of customs and import fees is not allowed.
o  Format: every effort should be made to comply with the format 
specifications, which are based
upon a standard U.S. paper size of 8.5" x 11”.
o  Funds for up to 8% administrative costs can be requested, 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
o  Organizations must comply with federal/NIH policies on human subjects, 
animals and biohazards.  
o  Organizations must comply with federal/NIH biosafety and biosecurity 
regulations.
o  Proposed research should provide a unique research opportunity, not 
available in the U.S.

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

1.  Meetings – Food Allergy Research Consortium and Statistical and Clinical 
Coordinating Center

The Steering Committee will serve as the main governing body for the 
Consortium and will consist of the following voting members:  the Principal 
Investigators, two additional scientists from each awardee appointed by the 
Principal Investigator, the Director of the SACCC, and the NIAID Scientific 
Coordinator. The Committee shall meet twice each year in the Bethesda, MD 
area. At the first meeting of the Steering Committee, a Chair will be selected 
from among the non-Federal members.

All Steering Committee members of the Food Allergy Research Consortium and the 
Statistical and Clinical Coordinating Center must agree to participate in the 
meetings and teleconferences of the Steering Committee and other subcommittees 
to be established by the Steering Committee. Each awardee agrees to work 
collaboratively with the Consortium, its Steering Committee and the SACCC, 
abide by the policies, procedures, recommendations and decisions of the 
Steering Committee, and participate in all Steering Committee activities. 

Additional details of the Steering Committee are found in “Cooperative 
Agreement Terms and Conditions of Award,” item 4, Collaborative 
Responsibilities.

Applications for a SACCC should budget for travel and lodging for all non-
government Steering Committee members, to attend two Steering Committee 
meetings per year, and also budget for arranging teleconferences of the 
Steering Committee and other subcommittees to be established by the Steering 
Committee.

2.  Milestones - Food Allergy Research Consortium 

This program is milestone-based and funding beyond the first year will be 
contingent upon satisfactory progress in meeting milestones. These milestones 
should be in the form of concrete accomplishments whose attainment represents 
significant advancement toward the overall goals of each project. The 
milestones in the initial application will serve as examples for purposes of 
review of the scientific merit. Final milestones will be negotiated between 
the awardee and the NIAID. 

3.  Statistical and Clinical Coordinating Center
 
The Principal Investigator of the SACCC may not serve as a U19 Principal 
Investigator or as a Project Leader for a U19 project funded under this RFA. 

Applications for the SACCC should include in their budget request support for 
travel and lodging of all members of the Steering Committee to attend the 
Committee meetings in Bethesda, MD, to be held as specified in the 
“Cooperative Agreement Terms and Conditions of Award” section. In addition, 
the budget should include support for arranging teleconferences of the 
Steering Committee and other subcommittees to be established by the Steering 
Committee, and for meetings and teleconferences of the Data and Safety 
Monitoring Board (DSMB). It is anticipated that the DSMB will consist of five 
to seven members, who will have one meeting per year in Bethesda, MD and one 
meeting per year by teleconference. Additional details on the DSMB are 
provided under “Cooperative Agreement Terms and Conditions of Award,” item 4. 
Collaborative Responsibilities.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD 

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator as well as the 
institutional official at the time of award.

These special Terms of Award are in addition to, and not in lieu of, otherwise 
applicable OMB administrative guidelines, HHS Grant Administration Regulations 
at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.

The administrative and funding instruments used for this program are the 
single project (U01) and multi-project (U19) cooperative agreements, 
"assistance", rather than "acquisition" mechanisms, in which substantial NIH 
scientific and/or programmatic involvement with the awardees is anticipated 
during the performance of the activity. Under the cooperative agreement, the 
NIH purpose is to support and/or stimulate the recipient's activity by 
involvement in and otherwise working jointly with the award recipient in a 
partner role, but it is not to assume direction, prime responsibility, or a 
dominant role in the activity. Consistent with this concept, the dominant role 
and prime responsibility for the activity resides with the awardees for the 
project as a whole, although specific tasks and activities in carrying out the 
research will be shared among the awardees and the NIAID Scientific 
Coordinator.

1. Monitoring Clinical Studies

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.

This award provides support for one or more NIH-defined clinical trials. The 
NIH Policy for research supported as an NIH Clinical Trial, “NIH Guidelines on 
the Inclusion of Women and Minorities as Subjects in Clinical Research”, was 
updated October 9, 2001 (URL listed below under REQUIRED FEDERAL CITATIONS). A 
description of plans to conduct analyses, as appropriate, by sex/gender and/or 
racial/ethnic groups must be included in clinical trial protocols and the 
results of the subset analyses must be reported to NIH in Progress Reports, 
Competitive Renewal Applications, and in the required Final Progress Report, 
as stated in the Guidelines.
 
2. Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the research 
objectives, approaches and details of the projects within the guidelines of 
the RFA and for performing the scientific activity. Specifically, awardees 
have primary responsibility as described below.

Consortium Principal Investigators and the Director of the SACCC, as voting 
members of the Steering Committee, shall be responsible for establishing and 
following the policies of the committee and for the development and review of 
milestones of progress. Principal Investigators will be expected to 
participate in two Steering Committee meetings each year, in the Bethesda 
vicinity or by teleconference. Meetings will be organized by the Chair of the 
Steering Committee.

3. NIAID Staff Responsibilities 

An NIAID Program Official will be responsible for the normal program 
stewardship, including monitoring program progress, approving changes and 
concurring in proceeding into study implementation stage. Release of each 
yearly funding increment for U19s will be based on a review of progress 
towards achieving the previously agreed upon milestones, and for the SACCC, 
evaluation will be based on achieving effective support of clinical trials and 
the DSMB. The Government, via the NIAID Program Official, will have access to 
data generated under this Cooperative Agreement and may periodically review 
the data and progress reports.  NIAID staff may use information obtained from 
the data for the preparation of internal reports on the activities of the 
study.  However, awardees will retain custody of and have primary rights to 
all data developed under these awards, subject to Government rights of access 
consistent with HHS, PHS, and NIH policies. 
 
The NIAID Scientific Coordinator will have substantial scientific/programmatic 
involvement during the conduct of this activity through technical assistance, 
advice and coordination above and beyond normal program stewardship for 
grants. This includes providing guidance and support in the development, 
assembly, and submission of all required regulatory documents, e.g., those 
regarding the use of investigational drugs, to the Food and Drug 
Administration. As a member of the Steering Committee, the NIAID Scientific 
Coordinator will serve as a resource for protocol design and development and 
provide scientific/programmatic support during the accomplishment of the 
research by participating in the design of the activities, advising in the 
selection of sources or resources (e.g., determining where a particular 
reagent can be found), advising in management and technical performance, or 
participating in the preparation of publications. The NIAID Scientific 
Coordinator will be a voting member of the Steering Committee and participate 
in all Steering Committee activities, including, but not limited to, 
conference calls, subcommittees and special committees. 

An NIAID Medical Officer will monitor the clinical trials and serve as the 
Medical Monitor. Should a pharmaceutical or biotechnology company sponsoring a 
clinical trial choose to name its own Medical Monitor, then the NIAID Medical 
Officer will work with the company-assigned Medical Monitor.

4. Collaborative Responsibilities

Steering Committee 

The Steering Committee will serve as the main governing body for the 
Consortium and will consist of the following voting members:  the Principal 
Investigators of each funded U19 application, two additional members appointed 
by the Principal Investigators of each funded U19 application, the Director of 
the SACCC, and the NIAID Scientific Coordinator.  The Committee shall meet 
twice each year in the Bethesda, MD area. At the first meeting of the Steering 
Committee, a Chair will be selected from among the non-Federal members. All 
members of the Steering Committee must agree to participate in all Steering 
Committee meetings and teleconferences.
 
The Steering Committee will be responsible for:  (1) reviewing and 
prioritizing the research projects to be undertaken by the Consortium; (2) 
making recommendations on funding of Consortium research projects; (3) 
reviewing and determining project milestones; (4) establishing appropriate 
methods/measures to assess progress and the attainment of milestones; (5) 
evaluating progress of Consortium research projects, recommending 
modifications in research goals and milestones, and, when appropriate, 
curtailing projects for lack of progress; and (6) coordinating all activities 
of the Consortium.  The Steering Committee may also recommend that the 
clinical, pre-clinical, mechanistic and biomarker studies proposed by the 
awardees require modification, coordination/consolidation with other projects, 
or will not be carried out by the Consortium. Therefore, the specific projects 
proposed in applications may not necessarily be those that are implemented by 
the Consortium. 
  
The Steering Committee will establish priorities and set milestones for the 
Consortium within 6 months of the award. Review of milestones shall be linked 
to the annual funding cycle and submission of the annual progress report. The 
NIAID Scientific Coordinator will monitor accomplishment of milestones and 
work with the Steering Committee to redirect, replace and/or curtail research 
projects that do not meet negotiated milestones during the funding period. Any 
re-budgeting that will result in a change of scope of the individual projects 
undertaken by the Consortium must be approved by the Grants Management 
Specialist in consultation with the NIAID Program Official. 

Each awardee agrees to work collaboratively with the Consortium, its Steering 
Committee and the SACCC, abide by the policies, procedures, recommendations 
and decisions of the Steering Committee, and participate in all Steering 
Committee activities. 
 
Data and Safety Monitoring Board 

The NIAID will appoint five to seven individuals to an independent Data and 
Safety Monitoring Board (DSMB) to advise the Institute on issues pertaining to 
appropriateness of clinical protocols and the conduct and safety of clinical 
research and clinical trials. Information is also provided to the Principal 
Investigator, Co-Investigators and the Steering Committee. The DSMB will meet 
at least twice a year, by teleconference or in the Bethesda, MD vicinity.  The 
SACCC will be responsible for organizing DSMB meetings and teleconferences. 

5. Arbitration:

Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award), between award recipients and the NIAID may be brought to 
arbitration. An arbitration panel will be composed of three members – one 
chosen by the awardee, a second member selected by the NIAID, and the third 
member selected by the two prior selected members. This special arbitration 
procedure in no way affects the awardee's right to appeal an adverse action 
that is otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

These special Terms of Award are in addition to and not in lieu of otherwise 
applicable OMB administrative guidelines, HHS Grant Administration Regulations 
at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.

WHERE TO SEND INQUIRIES

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

o Direct questions about scientific/research issues to:

Marshall Plaut, M.D. 
Division of Allergy, Immunology, and Transplantation 
National Institute of Allergy and Infectious Diseases 
Room Number 3093, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601 
Telephone: 301.-435-4425  
FAX: 301-402-0175 
Email: mp27s@nih.gov

o Direct questions about peer review issues to: 

Geetha Bansal
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3145, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-1464
FAX: (301) 402-2638
Email: gb183z@nih.gov

o Direct questions about financial or grants management matters to:

Michael Fato
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2247, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-2690
FAX: (301) 480-3780
Email: mf59e@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 NIAID 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:

Geetha Bansal
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3145, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-1464
FAX: (301) 402-2638
Email: gb183z@nih.gov

SUBMITTING AN APPLICATION

Applicants for U19 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.

Applications for U01 grants use the same format as R01 applications.

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 
document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

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:

Geetha Bansal
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3145, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
BETHESDA, MD 20817 (for express mail or courier service)

Applications that are not received as a single package on or before the 
December 16, 2004 or that do not conform to the instructions contained in PHS 
398 (rev. 5/01) Application Kit (for the U19 application: as modified in, and 
superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR 
MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to 
the applicant.

It is highly recommended that the appropriate NIAID program contact be 
consulted before submitting the letter of intent and during the early stages 
of preparation of the application. (See program contact under INQUIRIES).

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA:

Applicants for U19 cooperative agreements must follow special application 
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR 
MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under 
INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.

This brochure presents specific instructions for sections of the PHS 398 (rev. 
5/01) application form that should be completed differently than usual. For 
all other items in the application, follow the usual instructions in the PHS 
398.

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 NIH will not accept any application in response to this RFA that is 
essentially the same as one currently pending initial review, unless the 
applicant withdraws the pending application. However, when a previously 
unfunded application, originally submitted as an investigator-initiated 
application, is to be submitted in response to an RFA, it is to be prepared as 
a NEW application. That is the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text must 
not be marked to indicate the changes from the previous unfunded version of 
the application. While the investigator may still benefit from the previous 
review, the RFA application is not to state explicitly how.

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.

SUPPLEMENTARY INSTRUCTIONS

Food Allergy Research Consortium Applications (U19)

Research Plan for Immune Intervention Project

o  Each application must contain a project that is either a clinical trial of 
a food allergy therapy, a pre-clinical study with strong potential to lead to 
a food allergy therapy, or both a pre-clinical study and a clinical trial.
o  Clinical Trials:  Applications proposing a clinical trial must include: the 
scientific rationale for the therapeutic intervention; confirmation of the 
ability to acquire the drug and the timetable for drug availability; study 
design including statistical analyses; target population; primary and 
secondary outcomes; and, if applicable, associated mechanistic and/or 
biomarker studies. 
o  Pre-clinical Studies:  Applications proposing a pre-clinical study should 
include not only a full description of such a study, but also, in the 
experimental design section, a brief synopsis describing a proposed phase I 
clinical trial that would follow successful completion of the pre-clinical 
study. The synopsis should include a brief description of the same elements 
described above for clinical trials.
o  Pre-clinical Studies plus Clinical Trials:  Applications proposing a pre-
clinical study may also propose an actual phase I clinical trial. If both a 
pre-clinical study and a phase I clinical trial are proposed, then not only 
full details of the pre-clinical study, but also full details of the trial, 
not just a synopsis, are required.

Research Plan for Immune Mechanisms in Observational Study Project  

The Immune Mechanisms Project must include the scientific rationale for the 
study; study design including statistical analysis; target population; 
retention of the population for the duration of the study; primary and 
secondary outcomes; conceptual framework for selecting and designing the 
mechanistic studies and, if applicable, biomarker studies.

Milestones 

Each U19 project must propose annual milestones that form the basis of 
progress evaluation by the Steering Committee. These milestones should be in 
the form of concrete accomplishments whose attainment represents significant 
advancement toward the overall goals of each project. The milestones in the 
initial application will serve as examples for purposes of review of the 
scientific merit. As stated in the “Cooperative Agreement Terms and Conditions 
of Award,” the final milestones are negotiated with the Steering Committee and 
may be different from the milestones in the initial application.

Statistical and Clinical Coordinating Center Applications (U01)

Applications for the Statistical and Clinical Coordinating Center should 
include the following:

o A plan for statistical design and analyses of clinical trials and 
observational studies which should include a summary of overall strategy and 
approaches to overcoming anticipated obstacles for the type of clinical trials 
and observational studies that may be undertaken by the Food Allergy Research 
Consortium; 
o A plan for management of clinical trials and observational studies that 
includes: 
      -     clinical site monitoring;
      -     collection, storage, and reporting of data;
      -     a system for adverse event reporting;  
      -     assistance in development, implementation, and modification of 
clinical protocols, including preparation of Manual of Operations;
      -     assistance in the preparation and tracking of Investigational New 
Drug applications; and 
      -     preparation of reports and analyses for review and publication.
o Provision of statistical, technical and logistical support to the Steering 
Committee and the NIAID DSMB.

Budget – Statistical and Clinical Coordinating Center

For the purpose of budget development and project planning, applicants should 
assume that, at any one time, there will be protocols at some stage of 
development (from early protocol design and development, through post-
treatment data analysis), involving no more than three Phase I clinical 
trials, three Phase II clinical trials and three immune mechanisms 
observational studies 

Steering Committee

The voting membership of the Steering Committee will include the Principal 
Investigator of each U19 and two additional members appointed by the Principal 
Investigator for each funded application, the Director of the SACCC, and the 
NIAID Scientific Coordinator. The NIAID Program Official, if different from 
the NIAID Scientific Coordinator, may attend the Steering Committee meetings, 
as a non-voting participant.  The NIAID Scientific Coordinator has one vote. 
The chairmanship of the Steering Committee will be determined at the first 
meeting. The Steering Committee will convene at least twice a year. One 
meeting will be in the Bethesda, MD vicinity; the second meeting may be in the 
Bethesda vicinity or by a teleconference.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAID.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration or review.

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

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

REVIEW CRITERIA 

Review Criteria for the U19 Food Allergy Research Consortium

The general review criteria for U19 multi-project cooperative agreement 
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. 

Review Criteria for the U01 Statistical and Clinical Coordinating Center

These include standard NIH criteria:

o Significance
o Approach
o Innovation
o Investigator
o Environment
   
In the written comments, reviewers will be asked to evaluate the application 
in order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review group 
will address and consider each of these criteria in assigning the 
application’s overall score, weighting them as appropriate for each 
application. The application does not need to be strong in all categories to 
be judged likely to have major scientific impact and thus deserve a high 
priority score. For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to move a 
field forward.
 
SIGNIFICANCE: Does this study address an important problem? If the aims of the 
application are achieved, how will scientific knowledge be advanced? What will 
be the effect of these studies on the concepts or methods that drive this 
field?
 
APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?
 
INNOVATION: Does the project employ novel concepts, approaches or methods? Are 
the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?
 
INVESTIGATOR: Is the investigator appropriately trained and well-suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?
 
ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?

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

Additional review criteria for the Statistical and Clinical Coordinating 
Center include:

1. Qualifications and experience of the Director of the Center and the staff 
to manage clinical trials and clinical observational studies.
      - documentation of training, expertise, relevant experience, 
leadership/management skills 
2. Ability to provide statistical leadership in the design and analysis of 
clinical trials. 
3. Quality of the management plan for supporting the conduct clinical trials, 
including:   
      - site monitoring and the collection, storage and reporting of data
      - experience assisting with regulatory activities, including 
Investigational New Drug applications
      - a system for adverse event reporting
      - preparation of reports and analyses for review and publication.
4. Ability to provide statistical, technical and logistical support to the 
Steering Committee and to the DSMB. 
5. Appropriateness of the staffing plan.

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

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

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

ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct costs 
in any year of the proposed research are expected to include a data-sharing 
plan in their application. The reasonableness of the data-sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data-sharing plan into the 
determination of scientific merit or priority score. (See instructions and URL 
to policy in the Federal Citations, below.)

BUDGET: The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research. However, reviewers will not 
factor budget considerations into the determination of scientific merit or 
priority score.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: November 16, 2004
Application Receipt Date: December 16, 2004
Peer Review Date: April, 2005
Council Review: June, 2005   
Earliest Anticipated Start Date:  July, 2005

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 Programmatic 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 Safety and Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

All investigators proposing clinical research should read the 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. 

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.

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). 

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.


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