IMMUNOTHERAPY FOR ADDICTION TREATMENT: SBIR/STTR INITIATIVE
RELEASE DATE: December 30, 2002
RFA NUMBER: DA-03-015
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
LETTER OF INTENT RECEIPT DATE: March 24, 2003
APPLICATION RECEIPT DATE: April 23, 2003
THIS REQUEST FOR APPLICATIONS (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 Where to Send Inquiries
? Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
NOTICE: This Request for Application (RFA) must be read in conjunction with
the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH,
CENTERS FOR DISEASE CONTROL AND PREVENTION, AND FOOD AND DRUG ADMINISTRATION
FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) GRANT APPLICATIONS
(see https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf).
The solicitation contains information about the SBIR and STTR programs,
regulations governing the programs, and instructional information for
submission. Applicants are required to use the PHS398 forms for all SBIR and
STTR submissions. Helpful information for advice and preparation of the
application can be obtained at:
https://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf.
All of the instructions within the OMNIBUS SBIR/STTR SOLICITATION apply with
the following exceptions:
o Special receipt dates
o Initial review convened by the (insert IC) Division of Extramural
Activities
o Additional review considerations
The title and number of this RFA must be typed on line 2 of the face page of
the application.
PURPOSE OF THIS RFA
This RFA encourages small businesses, or small businesses in collaboration
with research institutions, to develop effective methods for the large-scale
production and clinical testing of monoclonal antibodies or vaccines as
therapeutic agents for drug or nicotine addiction and/or overdose. Because
the RFA is focused on the advanced phase development of these therapies,
applicants should already have access to a new molecular entity (NME), either
for active or passive immunization, which is in the advanced stages of
preclinical development and is ready to begin the process for translation
into clinical trials (large scale GMP production of the entity, toxicity
testing, formulation development, stability testing and clinical evaluation).
The small business should be conversant with the requirements for the
Investigational New Drug (IND) filing of such an entity and should have
access to a clinical site. The clinical site could be a part of the small
business, the research institution involved in the project, or a
subcontractor site.
RESEARCH OBJECTIVES
Background
There has been a great deal of research in the past ten years on the
production of monoclonal antibodies and vaccines for the treatment of drug
and nicotine abuse. Monoclonal antibodies have been reported as possible
treatment agents through passive immunization for PCP, methamphetamine, MDMA,
and cocaine overdose and may also serve to minimize abuse and prevent
relapse. New vaccines are being developed as therapies for drug or nicotine
cessation and relapse prevention. However, the transition of a new molecular
entity, or NME (a term which is applied by the Food and Drug Administration
to both new pharmaceutical and immunological agents) from the preclinical
phase to the clinical phase of development requires large-scale production of
the NME and toxicity testing. The requirements are described in the most
recent FDA Guidance for Industry documents for vaccines and monoclonal
antibodies (http://www.fda.gov/cber/gdlns/cmcvacc.pdf and
http://www.fda.gov/cber/gdlns/mab032901.pdf) and constitute a major
commitment of resources.
Recent advances in the production methods for monoclonal antibodies and
vaccines have led to the discovery and preclinical development of new
entities intended for the treatment of drug overdose and relapse prevention
and cocaine and nicotine addiction. Although preclinical research on new
therapies for active or passive immunization for substance abuse disorders
has been reported in the literature, the need exists for the advanced phase
development and validation of technologies for the bulk scale production of
new monoclonal antibodies or vaccines in quantities large enough for clinical
trials, and for the design and implementation of clinical trials using
immunotherapy for treatment of substance abuse disorders.
Major difficulties in the large-scale production of these types of NMEs arise
from contaminants such as animal proteins and viruses, culture media
constituents, and purification problems. Alternative methods to antibody and
immunoconjugate production, which minimize these problems or avoid them
altogether, would provide faster and more efficient manufacture of the NME
and involve less toxicity testing and therefore less time and expense to
obtain a marketable product.
Current procedures such as the development of antibodies in bioreactors are
costly and time-consuming, with potential for contamination and purification
problems. New developments in proteomics should facilitate a more rapid and
efficient production method. The testing of these products in human clinical
trials will establish the proof-of-concept that active immunization is an
effective way of preventing or controlling drug or nicotine addiction and/or
relapse and that passive immunization will prevent the adverse health effects
of drug overdoses caused by cocaine, methamphetamine, PCP, or MDMA abuse in
emergency room overdose situations.
Objectives and Scope
The goal of this RFA is to facilitate the development of a monoclonal
antibody or vaccine for a drug overdose and treatment indication, or drug or
nicotine addiction treatment indication, respectively.
New technologies are emerging for the large-scale and cost-effective
production of monoclonals and vaccines, and it is reasonable to consider that
these advances could be applied to their development. The objective of this
RFA is to provide the support necessary to successfully transition a NME for
immunotherapy for drug or nicotine abuse from the preclinical to the clinical
phase, through utilization of improved technology approaches, and to support
the clinical safety and efficacy testing of the NME.
Because the program is designed to provide support to bridge the critical
translation of the NME from the laboratory into the clinic, this RFA is
suitable for applicants who already have access to an NME for immunotherapy
that has been adequately characterized in animal models, and is ready for
clinical development.
MECHANISMS OF SUPPORT
This RFA uses the SBIR (R43,R44) and STTR (R41,R42) mechanisms, which are
set-aside programs. As an applicant, you will be solely responsible for
planning, directing, and executing the proposed project. Future competing
continuation applications based on this project will compete with all
SBIR/STTR applications and will be reviewed according to the customary peer
review procedures. The anticipated award date is (insert month, date, year).
Applications may be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the
SBIR/STTR FAST-TRACK option as described in the OMNIBUS SBIR/STTR
SOLICITATION. Phase II applications in response to this RFA will only be
accepted as competing continuations of previously funded NIH Phase I
SBIR/STTR awards. The Phase II application must be a logical extension of
the Phase I research but not necessarily a Phase I project supported in
response to this RFA.
Fast Track applications will benefit from expedited evaluation of progress
following the Phase I feasibility study for transition to Phase II funding
for expanded developmental work.
PROJECT PERIOD AND AMOUNT OF AWARD
The OMNIBUS SBIR/STTR SOLICITATION indicates the statutory guidelines of
funding support and project duration periods for SBIR and STTR Phase I and
Phase II awards. Because the duration and cost of research for the
development of a new immunotherapeutic agent (large-scale production under
Good Manufacturing Practices (GMP), toxicity testing needed to support
initial human safety testing, and costs associated with the implementation
and execution of safety and efficacy trials) is likely to exceed that
routinely awarded for SBIR/STTR grants. However, a well-justified application
under this RFA will be considered with a Phase I project period of up to 2
years and a budget not to exceed $1,000,000 ($500,000 per year), and a Phase
II project period of up to 3 years and a budget not to exceed $2,000,000
(approximately $700,000 per year). Total costs include direct costs, F&A, and
a fixed fee.
FUNDS AVAILABLE
The NIDA intends to commit approximately $1,000,000 in FY 2003 to fund 2 new
grants in response to this RFA under the SBIR/STTR set-aside funding
mechanism. Because the nature and scope of the research proposed may vary,
it is anticipated that the size of each award will also vary. Although the
financial plans of NIDA 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
Eligibility requirements are described in the OMNIBUS SBIR/STTR SOLICITATION.
Only small business concerns are eligible to submit applications. A small
business concern is one that, on the date of award for both Phase I and Phase
II agreements, meets ALL of the criteria as described in the SBIR/STTR
OMNIBUS SOLICITATION.
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. On an SBIR application, the principal
investigator must have his/her primary employment (more than 50%) with the
small business at the time of award and for the duration of the project. The
PI on an STTR application may be employed with the small business concern or
the participating non-profit research institution as long as s/he has a
formal appointment with or commitment to the applicant small business
concern, which is characterized by an official relationship between the small
business concern and that individual.
Consultant and Contractual Costs
Because the resources required for the successful development of an
immunotherapeutic agent are highly specialized, the total amount of
consultant costs and contractual costs requested by applicants may exceed the
statutory guidelines. Requests in excess of the guidelines must be fully
justified.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues.
o Direct your questions about scientific/research issues to:
Jamie Biswas, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-8096
FAX: (301) 443-9649
Email: jb168r@nih.gov
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
o Direct your questions about financial or grants management issues to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: GF6S@NIH.GOV
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent by that
includes the following information:
? Descriptive title of the proposed research
? Name, address, and telephone number of the Principal Investigator
? Names of other key personnel
? Participating institutions
? Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
affect the review of a subsequent application, the information that it
contains allows NIDA 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 addressed to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd, Room 3158, MSC 9547
Bethesda, MD 20892-9551
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
SUBMITTING AN APPLICATION
The PHS 398 research grant application (rev. 5/2001) must be used for all
Phase I, Phase II and Fast-Track applications (new and revised.)
Instructions and forms are available at
https://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare your
application in accordance with the SBIR/STTR Omnibus Solicitation and Chapter
VI of the PHS 398. The NIH will return applications that are not submitted on
the 5/2001 version of the PHS 398. For further assistance contact
GrantsInfo, Telephone: (301) 710-0267, 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:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
RECEIPT OF APPLICATIONS. Applications must be received by the receipt date
listed on the first page of this announcement.
The Center for Scientific Research (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. 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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIDA. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration. If the
application is not responsive to the RFA, CSR staff may contact the applicant
to determine whether to return the application to the applicant or submit it
to compete with other applications submitted in response to the next
available receipt date of the OMNIBUS SOLICITATION. 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 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 Those that receive a priority score will undergo a second-level review by
the appropriate national advisory council or board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of 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 Milestones and Proof of Principle
o Innovation
o Investigator
o Environment
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.
Review criteria are described in the NIH Omnibus Solicitation and available
on the web at the following URL address:
https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
SIGNIFICANCE: Will the product arising from this research address a clinical
need in the targeted patient population?
APPROACH: Does the applicant have access to the new molecular entity (NME)?
Does the applicant have access to a clinical site for clinical trials? Has
the applicant or applicant organization provided a Data and Safety Monitoring
Plan for the clinical studies?
INNOVATION: Will the production of the proposed monoclonal antibody or
vaccine utilize an innovative method, or methods, which will allow for the
reasonably cost effective and efficient large scale production of the
immunotherapeutic agent? Is the product expected to improve the treatment of
substance abuse and its consequences?
INVESTIGATOR: Is the PI knowledgeable in FDA requirements for
Investigational New Drug (IND) filing? Does the applicant have experience in
the development and clinical testing of immunotherapies?
ENVIRONMENT: Has the site experience in producing entities under Good
Manufacturing Practices (GMP)? Is the facility set up for the large scale
GMP manufacture, purifications, and formulation of a therapeutic entity?
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: 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 included in the
section on Federal Citations, below)
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: March 24, 2003
Application Receipt Date: April 23, 2003
Peer Review Date: June/July/August 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
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
Phase II applications will be selected for funding based on the following:
o Quality of the proposed project as determined by peer review
o Assessment of Phase I progress
o Determination that the Phase I goals were achieved
o The project's potential for commercial success
o Availability of funds
Fast Track Phase II applications may be funded following submission of:
o The Phase I progress report
o Other documents necessary for continuation
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phases 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: https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://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
https://grants.nih.gov/grants/funding/children/children.htm.
HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG
ABUSE: Researchers funded by NIDA who are conducting research in community
outreach settings, clinical, hospital settings, or clinical laboratories and
have ongoing contact with clients at risk for HIV infection, are strongly
encouraged to provide HIV risk reduction education and counseling. HIV
counseling should include offering HIV testing available on-site or by
referral to other HIV testing services. Persons at risk for HIV infection
including injecting drug users, crack cocaine users, and sexually active drug
users and their sexual partners. For more information see
https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on
Drug Abuse recognizes the importance of research involving the administration
of drugs to human subjects and has developed guidelines relevant to such
research. Potential applicants are encouraged to obtain and review these
recommendations of Council before submitting an application that will
administer compounds to human subjects. The guidelines are available on
NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained
by calling (301) 443-2755.
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
https://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 https://grants.nih.gov/grants/stem_cells.htm and at
https://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
https://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.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.279 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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 described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
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.