GENE THERAPY APPROACHES FOR DIABETES AND ITS COMPLICATIONS
Release Date: August 30, 2000
RFA: DK-01-006
National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov/
National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov/
National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov/
Letter of Intent Receipt Date: October 16, 2000
Application Receipt Date: November 16, 2000
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT
MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.
PURPOSE
The National Institute of Diabetes and Digestive and Kidney Diseases, the
National Institute of Allergy and Infectious Diseases, and the National
Heart, Lung and Blood Institute are soliciting applications to develop
gene therapy approaches for the treatment of diabetes and/or its
complications. Gene therapy is a promising technology to introduce
exogenous genes into somatic cells that will alter the cell’s properties.
On November 8 and 9, 1999, the NIDDK and NIAID along with other
Institutes sponsored a meeting entitled, Gene Therapy Approaches for
Diabetes and Its Complications, to discuss possible approaches for using
gene therapy to treat either diabetes or its complications. One of the
recommendations from the meeting was to support additional studies to
develop novel approaches using gene therapy for the treatment of diabetes
and its complications.
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 Request for
Applications (RFA), Gene Therapy Approaches for Diabetes and Its
Complications, is related to the priority areas of Diabetes and Chronic
Disabling Conditions. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign for-profit and
nonprofit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local governments,
and eligible agencies of the Federal government. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply
as principal investigators.
This program enables investigators to explore the feasibility of a
concept related to gene therapy of diabetes and generate sufficient data
to pursue it through other funding mechanisms. The pilot and feasibility
studies are intended to: (1) provide initial support for new
investigators; (2) allow exploration of possible innovative new leads or
new directions for established investigators in gene therapy and (3)
stimulate investigators from other areas to lend their expertise to
research in this area. Pilot and feasibility grants are not intended to
support or supplement ongoing funded research of an established
investigator.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH)
exploratory/developmental grant (R21) award mechanism. Responsibility
for the planning, direction, and execution of the proposed project will
be solely that of the applicant. An applicant may request a project
period of up to 2 years and a budget for direct costs of up to $100,000
per year.
This RFA is a one-time solicitation. These grants are not renewable;
continuation of projects developed under this program will be through the
regular research grant program and will compete with all investigator-
initiated applications and be reviewed according to the customary peer
review procedures. The anticipated award date is July 1, 2001.
FUNDS AVAILABLE
The NIDDK, NIAID, and NHLBI intend to commit a total of approximately
$2,000,000 ($1,000,000 from the Balanced Budget Act of 1997 and
$1,000,000 from the NIDDK appropriation) in FY 2001 to fund 12 to 15 new
grants in response to this RFA. Although the financial plans of the
NIDDK, NIAID, and NHLBI 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 applications of outstanding scientific and
technical merit. At this time, it is not known if this RFA will be
reissued.
RESEARCH OBJECTIVES
Background
Over the last ten years, gene therapy techniques have been developed for
introducing genes into somatic cells that alter the properties of these
cells. Recently, several successful reports suggest that gene therapy
may be an appropriate treatment for certain conditions. There are many
approaches to interfering with the development of type 1 diabetes and to
treating the complications resulting from both type 1 and type 2 diabetes
that would appear to be amenable to gene therapy technology. The purpose
of this RFA is to encourage development of gene therapy approaches for
type 1 diabetes and its complications and to test these in appropriate
animal models or small pilot studies.
On November 8 and 9, 1999, the NIDDK, NIAID, NHLBI, NCRR, JDFI and ADA
sponsored a meeting entitled, Gene Therapy Approaches for Diabetes and
Its Complications, to discuss some possible approaches for using gene
therapy to treat either diabetes or its complications. The Summary and
Recommendations from that conference can be found on the NIDDK Web page
at http://www.niddk.nih.gov/fund/divisions/DEM/DEMintro.htm. One of the
recommendations from that meeting was to support the development of
additional approaches using gene therapy for the treatment of diabetes
and its complications. Since these are preliminary studies to explore
the appropriate use of this new technology and to demonstrate its
feasibility, the NIDDK is using the exploratory/developmental grant
mechanism. These grants can be used to demonstrate the feasibility of an
approach and to develop preliminary data for a future regular research
grant submission. This mechanism allows investigators to test new
approaches where there are limited preliminary data but a strong
rationale and a reasonable expectation of feasibility.
Type 1 diabetes results from the immune destruction of the beta cells in
the pancreas. Therefore, methods that interfere with the development of
autoimmunity or the immuno-destructive process would prevent the
development of type 1 diabetes. There seems to be sufficient
understanding of type 1 diabetes immune mediated beta-cell killing to
devise gene therapy approaches that interrupt the inflammatory process.
It may also be possible to interfere directly with the apoptotic pathways
within the beta cell that result in its death. This use of gene therapy
will not correct a defective genetic makeup but rather will interrupt the
progression of disease pathogenesis.
Fundamental research could focus on induction of immunologic tolerance.
For example, DNA-based vaccine approaches should be explored as a method
of providing expression of autoantigens to induce tolerance. Preclinical
work has already tested the hypothesis that the genetic manipulation to
express autoantigens will reduce beta-cell self reactivity. This approach
would be applicable to prevention of type 1 diabetes.
Gene therapy can be applied as an intervention for type 1 diabetes.
Research utilizing T cell homing technologies to deliver immune
suppressive cytokines or other factors at the site of the inflammation is
a very exciting prospect. This is an important area of research that may
yield therapeutic modalities that would interfere with progressive
inflammatory diseases, including beta-cell killing in type 1 diabetes.
It would seem that the antigen or epitope specificity of the immune
system with respect to the use of either antibodies, T cells or both has
not been fully explored for disease protection and inhibition of
progressive autoimmunity diseases. The gene therapy technology would
involve both ex vivo and in vivo approaches.
Another potential approach to prevent the development of diabetes is to
prevent apoptosis of the beta-cell by targeting protective genes into the
pancreas in vivo. These could include tissue-specific expression of
immune suppressive cytokines and apoptotic genes. These techniques could
also be employed to protect transplanted pancreatic beta-cells or
transplanted islets from autoimmune destruction, allograft rejection or
both. Ongoing research at the preclinical level suggests that islets
expressing certain ligands or immune suppressive cytokines have an
improved survival. This is a novel and hitherto uncharted area of
research that deserves further exploration.
Recently, a novel approach of generating beta cells in vivo has been
tested in an animal model. The introduction of the transcription factor,
PDX1, into hepatocytes resulted in the transdifferentiation of
hepatocytes to beta-cells (Nature Medicine 6:568-572, 2000). The
exploration of this and other transdifferentiation strategies may also
yield novel ways to treat type 1 diabetes.
Long-term complications of diabetes include nephropathy, retinopathy,
neuropathy, accelerated cardiovascular disease, impaired wound healing,
altered gastrointestinal and bladder function, and periodontal disease.
Since glucose management remains a difficult problem, complications from
diabetes continue to be a high priority area for development of novel
treatments. Gene therapy approaches seem promising in the selected areas
of micro and macro vascular disease, neuropathy and wound healing.
Several of these studies are progressing to phase I clinical trials. One
approach expressed the growth factor, VEGF, locally to grow new blood
vessels for the treatment of vascular disease. Another approach used the
introduction of the growth factor, PDGF, into diabetic ulcers to
accelerate wound healing. These and other gene therapy approaches to
treat these conditions need to be explored.
Scope and Objectives
Applications should focus on the development of gene therapy approaches
for the treatment of type 1 diabetes and its complications. Although
delivery of insulin by gene therapy is one possible method to treat
diabetes, this approach is complicated by the requirement for rapid and
tight regulation of insulin secretion to glucose levels. Such studies may
be premature with our current technology. Relevant topics listed below
are examples and should not be construed as required or limiting.
o To investigate gene therapy strategies to induce tolerance to beta-cell
antigens
o To investigate novel strategies such as T-cell homing to deliver
immunosuppressive genes
o To investigate altering cytokine gene expression in order to suppress
the inflammatory process
o To develop vectors that are targeted to the pancreatic beta-cell to
deliver genes that interfere with its immunodestruction
o To investigate the expression of protective genes in beta-cells to
prevent immunodestruction
o To explore the use of altered expression of other genes in the glucose
metabolic pathway for their therapeutic potential to complement the
effects of insulin
o To investigate expressing genes involved in mouse and human beta-cell
differentiation to determine their role in transdifferentiation of cell
types such as hepatocytes and pancreatic duct cells
o To develop strategies to prevent and/or delay the onset of
complications such as the targeted expression of growth factors
o To investigate the expression of genes that may regulate wound healing
o To investigate the expression of genes to prevent and/or delay the
onset of peripheral vascular diseases
o To develop gene therapy approaches to alter the expression of the
receptors for Advanced Glycated Endproducts
o To develop gene therapy methodologies to effectively treat various
complications and validate them in relevant animal models
o To develop carefully designed pilot clinical gene therapy studies for
diabetic complications.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 biomedical
and behavioral research projects involving human subjects, unless a clear
and compelling rationale and justification are 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 research involving human subjects should read
the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," published in the NIH Guide for Grants and
Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and
to conduct and report analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS.
It is the policy of NIH 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 was published in
the NIH Guide for Grants and Contracts, March 6, 1998, and is available
at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.
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. Reviewers are cautioned that their
anonymity may be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, by October 16, 2000, a letter
of intent that includes a descriptive title of the proposed research; the
name, address, and telephone number of the Principal Investigator; the
identities of other key personnel and participating institutions; and the
number and title of the RFA in response to which the application may be
submitted.
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 NIDDK staff to estimate the potential review workload
and plan the review.
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8885
FAX: (301) 480-3505
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301-710-0267, email: GrantsInfo@nih.gov.
The modular grant concept establishes specific modules in which direct
costs may be requested as well as a maximum level for requested budgets.
Only limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants,
reviewers, and Institute staff. The research grant application form PHS
398 (rev. 4/98) is to be used in applying for these grants, with the
modifications noted below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules,
up to a total direct cost request of $100,000 per year. The total direct
costs must be requested in accordance with the program guidelines and the
modifications made to the standard PHS 398 application instructions
described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $100,000) and Total Costs
[Modular Total Direct plus Facilities and Administrative (F&A) costs] for
the initial budget period. Items 8a and 8b should be completed
indicating the Direct and Total Costs for the entire proposed period of
support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form
Page 4 of the PHS 398. It is not required and will not be accepted with
the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not
required and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget
Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm
for sample pages.) At the top of the page, enter the total direct costs
requested for each year. This is not a Form page.
o Under Personnel, list all project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the NIH
appropriation language salary cap and the NIH policy for graduate student
compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded
to the nearest $1,000. List the individuals/organizations with whom
consortium or contractual arrangements have been made, the percent effort
of key personnel, and the role on the project. Indicate whether the
collaborating institution is foreign or domestic. The total cost for a
consortium/contractual arrangement is included in the overall requested
modular direct cost amount. The Letter of Intent should include
information on establishing a consortium.
Provide an additional narrative budget justification for any variation in
the number of modules requested.
o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used
by reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required
for all key personnel, following the instructions below. No more than
three pages may be used for each person. A sample biographical sketch may
be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations.
o CHECKLIST: This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be
applied in the calculation of the F&A costs for the initial budget period
and all future budget years.
o The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
The RFA label available in the PHS 398 (rev. 4/98) application form must
be affixed to the bottom of the face page of the application. 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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
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 time of submission, two additional copies of the application must be
sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Applications must be received by the application receipt date listed in
the heading of the RFA. If an application is received after that date,
it will be returned to the applicant without review. Supplemental
documents containing significant revision or additions will not be
accepted, unless applicants are notified by the Scientific Review
Administrator.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially
the same as one already reviewed. This does not preclude the submission
of substantial revisions of applications previously reviewed, but such
applications must include an introduction addressing the previous
critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDDK, NIAID, and NHLBI. Incomplete
applications will be returned to the applicant.
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 NIDDK in accordance with the review criteria
stated below. As part of the initial merit review, all applications will
receive a written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally the
top half of the applications under review, will be discussed, assigned a
priority score, and receive a second level review by the National
Diabetes and Digestive and Kidney Diseases Advisory Council, the National
Allergy and Infectious Diseases Advisory Council and the National Heart,
Lung, and Blood Advisory Council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals. Each of these criteria will be addressed and considered in
assigning the overall score, weighting them as appropriate for each
application. Note that 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.
(1) 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?
(2) 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?
(3) 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?
(4) 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)?
(5) 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?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o Adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also
be evaluated.
o The reasonableness of the proposed budget and duration to the proposed
research.
o The adequacy of the proposed protection of humans, animals, or the
environment, to the extent that they may be adversely affected by the
project proposed in the application.
o Availability of special opportunities for furthering research programs
through the use of unusual talent resources, populations, or
environmental conditions in other countries which are not readily
available in the United States or which provide augmentation of existing
U.S. resources.
Schedule
Letter of Intent Receipt Date: October 16, 2000
Application Receipt Date: November 16, 2000
Peer Review Date: February/March 2001
Council Review: May 30-31, 2001
Earliest Anticipated Start Date: July 1, 2001
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit as determined by peer review;
o Innovation;
o First time NIH awardee;
o Availability of funds;
o Programmatic priorities.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify
any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Catherine McKeon, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 6103 MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-8810
FAX: (301) 480-3503
E-mail: Catherine_McKeon@nih.gov
Elaine Collier, MD
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 5135 MSC 7640
Bethesda, MD 20892-7640
Telephone: (301) 496-7104
FAX: (301) 402-2571
E-mail: ec5x@nih.gov
Sonia I. Skarlatos, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10186, MSC7940
Bethesda, Maryland 20892-7940
Telephone: (301) 435-0545
FAX: (301) 480-2849
E-mail: skarlats@nhlbi.nih.gov
Direct inquiries regarding fiscal matters to:
Denise Payne
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 626 MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8845
FAX: (301) 480-3504
E-mail: PayneD@extra.niddk.nih.gov
Mary Ledford
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Dr., Room 2249, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-6446
FAX: (301) 493-0597
E-mail: ml28g@nih.gov
Jane Davis
Division of Extramural Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7174, MSC 7926
Bethesda, Maryland 20892-7926
Telephone: (301) 435-0166
FAX: (301) 480-3310
E-mail: davisj@nhlbi.nih.gov
AUTHORITY AND REGULATIONS
These programs are described in the Catalog of Federal Domestic
Assistance No. 93.847, 93.855, and 93.837. Awards are under
authorization of the Public Health Service Act, Title IV, Part A (Public
Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) 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 PHS strongly encourages all grant and contract recipients to provide
a smoke-free workplace and promote the non-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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