COLLABORATIONS FOR ADVANCED STRATEGIES IN COMPLICATIONS OF HIV INFECTION
Release Date: January 28, 2000
PA NUMBER: PA-00-048
National Institute of Allergy and Infectious Diseases
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Mental Health
Receipt Date: May 8, 2000
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID), the
National Institute on Drug Abuse (NIDA), the National Institute on Alcohol
Abuse and Alcoholism (NIAAA), National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) and National Institute of Mental Health (NIMH) invite
applicants to expand the clinical knowledge of the complications of HIV by
expediting the translation of promising innovative preclinical findings into
clinical research applications. NIAID, NIDA, NIAAA, NIDDK and NIMH are
interested in supporting focused collaborative research between preclinical
and clinical scientists to test, refine, and improve diagnostic, pathogenic,
or therapeutic concepts. It anticipates such research will lead to innovative
approaches for the prevention and management of complications causing
significant morbidity or mortality in HIV infected persons, including the
recently recognized metabolic complications, coincident pathogens such as
hepatitis C virus, and the opportunistic pathogens. This type of
collaborative research would be dedicated to the expedited development and use
of advanced preclinical findings into clinical applications and would be
designed to: elucidate pathogenic mechanisms involved in metabolic
dysregulation or in the human host-pathogen relationship in HIV-associated
complications, develop strategies to prevent or treat complications of HIV or
HIV therapy, or develop approaches to measure treatment response. The NIDA
will support research on metabolic disorders in drug users with HIV infection.
The NIAAA is interested in supporting research as it relates to alcohol
consumption as a cofactor in HIV infection. The NIMH will support research on
the neurobiological/neuropsychiatric complications of HIV infection and
associated therapies.
The program encourages investigators to engage in interdisciplinary and
collaborative research that focuses on clinical as well as basic studies and
fosters collaborations among scientists with different expertise, abilities,
and talents. Among the disciplines and expertise that may be appropriate for
this research program are clinical investigation, immunology, microbiology,
virology, endocrinology, pharmacology, molecular and cell biology, genetics,
biostatistics, neuropathology/neuropsychiatry, and diagnostic radiology. The
collaborations should focus on a common hypothesis with all component projects
contributing scientifically to the central theme. The collaborative projects
may include shared resources as long as the interdependence and multi
disciplinary nature of the individual components is demonstrated.
Applications that include collaborations with the private sector (e.g.,
pharmaceutical, chemical, or biotechnological companies) are strongly
encouraged.
Research projects that propose the development of new and advanced
technologies for the development of targeted therapies, diagnostic tests, or
tests for the monitoring of clinical response may also be within the areas of
programmatic emphasis described in PAR-98-073, "Small Business Innovation
Research Advanced Technology: NIAID (SBIR-AT-NIAID)" published in the NIH
Guide May 22, 1998 and updated on August 16, 1999 or PAS-00-006,
"Bioengineering Research Partnerships" Published in NIH Guide October 15,
1999.
Research projects that principally encompass preclinical laboratory research
are not within the area of interest of this PA, but may be within the areas of
programmatic emphasis described in PA-99-124,"Innovative Drug Discovery
Research in AIDS Opportunistic Infections," published in the NIH Guide, July
9, 1999.
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 Program Announcement (PA),
Collaborations for Advanced Strategies in Complications of HIV Infection , is
related to one or more of the priority areas including HIV Infection and
Substance Abuse. Potential applicants may obtain a copy of "Healthy People
2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit 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.
Applicants must propose a multi disciplinary program, comprising basic and
clinical science studies to be performed at one or more institutions.
Investigators are encouraged to establish appropriate collaborations to meet
the objectives of this PA. Collaborative groups may consist of either two or
three research projects consisting of basic science and clinical studies, with
a common theme. Interactions between basic and clinical scientists are
expected to strengthen the research, enhance the transfer of fundamental
research findings to the clinical setting, and identify new research
directions. A coordinated multidisciplinary effort exploring focused
questions can facilitate rapid advancements and lead to innovative approaches
for identification and optimal treatment of high risk individuals. Such
approaches may have a more than average risk-to-benefit ratio, but are likely
to have greater potential for effective, long-term therapeutic returns. Plans
for the transfer of findings from basic to clinical studies should be
described. Applications not proposing both basic and clinical research
studies will not be considered responsive to this solicitation.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) research project
grant (R01) award mechanism. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant. The
total project period for an application submitted in response to this PA may
not exceed 5 years.
This PA has one annual receipt date. Future unsolicited competing continuation
or revised applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures. The anticipated award date is December 2000.
The funding decision will be influenced by the scientific merit of the
individual applications, the degree of collaboration among the investigators,
the approaches taken to meet the objectives of the PA, and the programmatic
balance and needs of National Institute of Allergy and Infectious Diseases
(NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the National Institute on Alcohol Abuse and Alcoholism (NIAAA),
National Institute of Drug Abuse (NIDA) and National Institute of Mental
Health (NIMH). Although applicants are required to submit collaborative
applications, the NIAID, NIDDK, NIDA or NIMH may choose to fund individual
R01s outside the collaborative arrangement owing to their special scientific
merit and programmatic needs and balance.
RESEARCH OBJECTIVES
Background:
The introduction of potent antiretroviral regimens has resulted in marked
reductions in the incidence of opportunistic infections and dramatic declines
in mortality for persons with HIV in the United States [Surveillance for
AIDS-Defining Opportunistic Illnesses, 1992-1997. MMWR. April 16, 1999/
48(SS-2), 1-22].
The beneficial effects of potent antiretroviral regimens are tempered by newly
recognized metabolic complications. Patients treated with anti-retrovirals
are presenting with a myriad of metabolic complications representing
alterations in lipid and glucose metabolism. Clinicians are noting increasing
cases of hyperlipemia, hyperglycemia, hyperinsulinemia and altered body
habitus. The most commonly reported body habitus changes are loss of fat of
the face and extremities, increase in abdominal fat, dorsocervical fat
deposition and lipomas. Many of these metabolic complications are well known
risk factors for cardiovascular disease in the general population. There have
been reported cases of heart attack and angina among patients receiving highly
active antiviral therapy treatment suggesting that premature atherosclerosis
may be occurring. Clinical studies have been designed to estimate the
prevalence and incidence of the complications, risk factors and to define the
syndromes. The pathogenesis and long-term consequences of these complications
are unknown. In addition, the neuropathological/neuropsychiatric
complications associated with anti-retroviral therapy have not been
extensively studied. The significant dysregulation of glucose and lipid
metabolism that accompany HAART therapy could contribute to CNS vascular
disease that results in serious neurologic functional deficits.
Expectations of longer survival of HIV-infected persons raise concerns about
the long-term sequelae of other chronic infections, such as hepatitis C virus
(HCV). The natural history of HCV infection in persons co-infected with HIV
is poorly understood, as are the mechanisms of pathogenesis and protective
immunity. Ideal methods for detecting HCV infection, assessing HCV disease
status and monitoring disease progression are not available. Of particular
concern are the interactions between HIV and HCV, including the impact of HIV
on HCV disease progression and the impact of HCV on HIV disease progression.
HCV-induced liver disease, the complications of HIV and its therapies, and the
overlapping toxicities of available HCV and HIV therapies impair the abilities
to provide the best available treatments for HIV and HCV infections.
While increasing attention needs to be focused on these newly recognized
health threats, efforts must be maintained to enhance the prevention and
management of the traditional opportunistic infections in persons with AIDS.
Critical areas of research include better knowledge of the HIV-associated
immune defects that render infected persons unable to prevent or overcome
diseases caused by these organisms, the extent and duration of immune function
restoration by highly effective antiretroviral regimens, immunomodulatory
strategies to prevent and or treat infection, and the development of new OI
therapies that can overcome drug resistance.
Proposed Research
Appropriate topics for investigation may include, but are not limited to, the
following:
METABOLIC COMPLICATIONS
Elucidation of mechanisms and molecular sites of lipid and glucose
dysregulation
Determination of the significance of histological and biochemical changes in
fat cells in body regions affected by abnormal fat distribution
Development and testing of new methods for quantifying regional fat
Determination of the extent and the significance of cellular metabolic changes
caused by HIV-infection or specific antiretroviral therapy
Determination of the interactions of alcohol-induced metabolic complications
and the metabolic complications of HIV disease and its treatment including
triglyceridemia, lipodystrophy, glucose dysregulation and cardiovascular
disease
Determination among drug users with HIV infection the clinical manifestations
and underlying mechanisms of metabolic complications or the interactions
between drugs of abuse and therapeutic agents used in the treatment of
metabolic disorders.
Evaluation of therapeutic strategies and preliminary clinical testing, with
modifications as necessary based on clinical research findings
Study of vascular complications in the CNS as a result of HAART therapy that
contribute to neurologic and neuropsychiatric deficits
HEPATITIS C COINFECTION
Elucidation of viral and host factors contributing to HCV pathogenesis and
disease progression in HIV-infected persons
Elucidation of the contribution of alcohol and drug use to HCV pathogenesis
and disease progression in HIV-infected persons
Development of methods for improved detection of HCV infection and monitoring
of disease progression and response to treatment in HIV-infected persons
Evaluation of innovative therapeutic strategies for treatment of HCV in HIV-
infected persons
OPPORTUNISTIC INFECTIONS
Elucidation of immune responses to the infection occurring in HIV-infected
individuals, and identification of features of immune dysregulation
Clinical evaluation of methods for early detection of infection and
quantitative assessment of response to therapy in inaccessible infections
(e.g., quantitative PCR, surrogate markers)
Evaluation of innovative therapeutic strategies (e.g., immune-based therapies,
gene-based approaches, novel antimicrobials) and preliminary clinical testing,
with modifications as necessary based on clinical research findings
Determination of the role of chronic alcohol abuse -induced immune modulation
(induction of Th2 cytokine responses) in progression of opportunistic
infections, particularly tuberculosis
Study of chronic opportunistic infections in the brain that impact on neuronal
function.
SPECIAL REQUIREMENTS
Terms and Conditions of Award
The NIH has responsibility to ensure the safety of participants in studies
that it supports. Terms and conditions addressing NIH review of clinical
protocols, reporting requirements, time-sensitive notifications to the Food
and Drug Administration, and requirements for Data, Safety, and Monitoring
Boards may be incorporated into the Notice of Grant Award and provided to the
Principal Investigator as well as the institutional official at the time of
award. These terms and conditions are a reiteration of and in addition to,
and not in lieu of, otherwise applicable OMB administrative guidelines, HHS
grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 is
applicable when State and local Governments are eligible to apply], and other
HHS, PHS, and NIH grant administration policies.
B. Federally Mandated Regulatory Requirements
The research project must be in compliance with all Federal regulations and
NIH policies that apply to the conduct of research involving human subjects.
These include, but are not limited to, Title 21 CFR 50, 56, 312, and Title 45
CFR 46. The research project must be able to demonstrate that: (1) each
institution conducting clinical trials has a current, approved Assurance
Number on file with the NIH Office for Protection from Research Risks (OPRR),
(2) each protocol and informed consent is approved by the responsible
Institutional Review Board (IRB) prior to subject entry, (3) each investigator
has supplied a completed (including curriculum vitae) FDA 1572 to the Division
of AIDS for each protocol conducted at each site, and (4) each subject (or
legal representative) gives written informed consent prior to entry on study.
C. Patent Coverage
Because the development and availability of innovative, effective strategies
for the clinical management of complications of HIV is the principal goal of
this PA, and because active involvement by the private sector is facilitated
by the existence of adequate patent coverage, it is essential that applicants
provide plans to ensure such coverage.
Since several institutions may be involved in this collaborative research,
complex patent situations may arise. Each applicant must therefore provide a
detailed description of (1) the approach to be used for obtaining patent
coverage and for licensing where appropriate, in particular where the
invention may involve investigators from more than one institution, and (2)
the procedures to be followed for the resolution of legal problems that
potentially may develop. Attention is drawn to the reporting requirements of
35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions
were also published in the NIH Guide for Grants and Contracts, Vol. 19, No.
23, June 22, 1990. Note that non-profit organizations (including
universities) and small business firms retain the rights to any patent
resulting from Government contracts, grants or Cooperative Agreements.
It is also noted that a Presidential memorandum of February 18, 1983 extended
to all business concerns, regardless of size, the first option to the
ownership of rights to inventions as provided in P.L. 96-517. As a result of
this memorandum, the relationships among industrial organizations and other
participants are simplified, since all members can now be full partners in the
research and in any inventions resulting therefrom. The specific patenting
arrangements among the institutions may vary, and could include joint patent
ownership, exclusive licensing arrangements, etc. Applicants are encouraged
to develop an arrangement that is most suitable for their own particular
circumstances.
The patent agreement among the collaborating institutions, signed and dated by
the organizational officials authorized to enter into patent arrangements for
each investigator and institution, must be delivered to Dr. Barbara Laughon
prior to an award at the address listed under INQUIRIES. A copy of the
proposed patent agreement may be submitted with the application with Appendix
materials. If the collaborators wish to place all inventions and discoveries
resulting from these studies within the public domain, a letter to that effect
must be submitted to Dr. Laughon in lieu of the patent agreement prior to
award. The letter must be co-signed by the Principal Investigator, each
investigator, and each of the business officials representing the respective
institutions.
Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR
Parts 6 and 8 require that NIH be informed of inventions and licensing
occurring under NIH funded research. Invention and licensing reports must be
submitted to the Division of Extramural Invention and Technology Resources,
Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 3188, Bethesda,
MD 20892.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided 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
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994 available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children 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. This document is available at the
following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
For purposes of this PA, children are classified as individuals under the age
of 18. Investigators may obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff also may provide additional
relevant information concerning the policy.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the stated deadline. Application kits 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, or at the
following URL address: http://grants.nih.gov/grants/funding/phs398/phs398.html
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the application
must obtain agreement from the IC staff that the IC will accept the
application for consideration for award. Finally, the applicant must identify,
in a cover letter sent with the application, the staff member and Institute or
Center who agreed to accept assignment of the application. This policy
requires an applicant to obtain agreement for acceptance of both any such
application and any such subsequent amendment. Refer to the NIH Guide for
Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research. If so,
a letter of agreement from either the GCRC program director or Principal
Investigator could be included with the application. Applicants from an
institution receiving government funds under Center for AIDS Research (CFAR),
AIDS Clinical Trial Unit (ACTU), AIDS Vaccines Trials Network (VTN),
Prevention Trials Network (PTN), and Terry Beirn Community Programs for
Clinical Research on AIDS (CPCRA) programs, should describe how these programs
are integrated with the proposed studies, if applicable, and should ensure
that no scientific and budget overlap exists with the proposed project.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies and five copies of Appendix material 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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established NIH referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. 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 applications under review, will be discussed, assigned a
priority score, and receive 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
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 method?
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 also will be reviewed with respect to the following:
o The 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 also will be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o 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.
AWARD CRITERIA
Applications will compete for available funds with all other approved
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding NIAID programmatic issues to:
Barbara Laughon, Ph.D.
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases
6700 B Rockledge Drive, Room 5108, MSC 7624
Bethesda, MD 20892-7624
Telephone: (301) 402-2304
FAX: (301) 402-3171
Email: BL17U@nih.gov
Direct inquiries regarding NIAID programmatic issues specific to hepatitis C
virus to:
Leslye D. Johnson, Ph.D.
Chief, Enteric and Hepatic Diseases Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 3109, MSC 7630
Bethesda, MD 20892-7630
Telephone: (301) 496-7051
FAX: (301) 402-1456
Email: lj7m@nih.gov
Direct inquiries regarding NIDA programmatic issues to:
Jag H. Khalsa, Ph.D.
Health Scientist Administrator
Center on AIDS & Other Medical
Consequences of Drug Abuse (CAMCODA)
National Institute on Drug Abuse, NIH
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone: 301-443-1801 (443-2159 direct)
Fax: 301-443-4100
Email: jk98p@nih.gov
Direct inquiries regarding NIAAA programmatic issues to:
Thomas F. Kresina, PhD
Chief, Biomedical Research Branch
Institute AIDS Coordinator
National Institute on Alcohol Abuse & Alcoholism
Room 402, 6000 Executive Blvd
Bethesda, MD 20892-7003
Telephone: 301-443-6537
Fax: 301-594-0673
Email: tk13v@nih.gov
Direct inquiries regarding NIDDK programmatic issues to:
Philip F. Smith, Ph.D.
Senior Advisor
Neuroendocrinology and Endocrinology of Obesity Research
Division of Diabetes, Endocrinology, and Metabolic Diseases
NIDDK
Natcher Building, Room 5AN-12C
45 CENTER DR MSC 6600
BETHESDA MD 20892-6600
Telephone: (301) 594-8816
Fax: (301) 480-3503
Email: ps56z@nih.gov
Direct inquiries regarding NIMH programmatic issues to:
Dianne Rausch, Ph.D
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Blvd, Room 6209, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7281
FAX: (301) 443-9719
Email: dr89b@nih.gov
Direct inquiries regarding fiscal matters to:
Laura Eisenman
Division of Extramural Activities
NIAID
6700-B Rockledge Drive, Room 2120, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-5541
FAX: (301) 402-2638
Email: le55d@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.856 MID, 93.855 IA. Awards are made under authorization of the Public
Health Service Act Sections 301 and 406 of (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 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, and 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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