The final receipt date for applications submitted in response to this Program
Announcement will be October 1, 2004 unless reissued.
THE ROLE OF ANTIOXIDANTS IN THE PREVENTION OF DIABETIC COMPLICATIONS
Release Date: June 27, 2001
PA NUMBER: PA-01-112
National Institute of Diabetes and Digestive and Kidney Diseases
National Eye Institute
National Heart, Lung and Blood Institute
National Institute on Aging
National Institute of Neurological Disorders and Stroke
Office of Dietary Supplements
THIS PA 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 PA.
PURPOSE
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
the National Eye Institute (NEI), the National Heart, Lung and Blood
Institute (NHLBI), the National Institute on Aging (NIA), the National
Institute of Neurological Disorders and Stroke (NINDS) and the Office of
Dietary Supplements (ODS) seek basic and clinical research applications to
study the use of vitamin E and other antioxidants in the prevention or
amelioration of diabetic complications.
Prevention and treatment of long-term micro- and macrovascular complications
remain critical problems in the management of type 1 or type 2 diabetes
mellitus. A growing body of in vitro and in vivo research indicates that
hyperglycemia leads to increased oxidative stress and endothelial
dysfunction. In addition, numerous studies have suggested that patients with
diabetes appear to have decreased antioxidant defense capability, measured as
lower levels of specific antioxidants, such as ascorbic acid (vitamin C) or
vitamin E, or reduced activities of antioxidant enzymes, such as catalase,
superoxide dismutase or glutathione peroxidase.
This Program Announcement solicits applications to 1) determine the efficacy
of vitamin E or other antioxidants in preventing, delaying or ameliorating
the micro- or macrovascular complications of diabetes, and 2) provide insight
into the mechanism(s) by which antioxidants might prevent or influence the
development of diabetic vascular disease.
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
ed national activity for setting priority areas. This Program Announcement
PA), The Role of Antioxidants in the Prevention of Diabetic Complications, 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/.
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.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) research project
grant (R01) and the Exploratory/Development Research Grant (R21) award
mechanisms. Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. The total project
period for an R01 application submitted in response to this PA may not exceed
5 years.
The R21 awards are to demonstrate feasibility and to obtain preliminary data
testing innovative ideas that represent clear departure from ongoing research
interests. These grants are intended to 1) provide initial support for new
investigators, 2) allow exploration of possible innovative new directions for
established investigators, and 3) stimulate investigators from other areas to
lend their expertise to research within the scope of this solicitation.
Applicants for the R21 must limit their requests to $125,000 direct costs per
year and are limited to two years. These R21 grants will not be renewable,
continuation of projects developed under this program will be through the
regular research grant (R01) program.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grants can be
found at http://grants.nih.gov/grants/funding/modular/modular.htm.
RESEARCH OBJECTIVES
Background
Prevention and treatment of long-term micro- and macrovascular complications
remain a critical problem in the management of type 1 or type 2 diabetes
mellitus. In the United States, diabetes is the leading cause of new
blindness in working-age adults, of new cases of end stage renal disease and
of non-traumatic lower leg amputations. In addition, cardiovascular
complications are now the leading cause of diabetes-related morbidity and
mortality, particularly among women and the elderly. In adult patients with
diabetes, the risk of cardiovascular disease (CVD) is three to five fold
greater than in the general population.
A growing body of in vitro and in vivo research indicates that hyperglycemia
leads to increased oxidative stress and endothelial dysfunction. Evidence of
oxidative damage has been demonstrated in arterial samples obtained from
animal models of experimental diabetes and from human diabetic subjects. It
has been recognized that oxidation of glucose can generate oxygen free
radicals and excess reactive oxygen species such as superoxides. These
molecules can promote lipid peroxidation, leading to excessive oxidative
burden in patients with diabetes. Oxidative stress can also influence the
expression of multiple genes in vascular cells, including signaling molecules
such as PKC, NFkB and ERK, overexpression of these genes may lead to
endothelial dysfunction and, ultimately, to micro- and macrovascular disease.
Molecules in the arterial wall can also be modified by glycation, which
usually is associated with oxidation. The formation of advanced glycation
end-products (AGEs) can occur on proteins, lipids and nucleic acids. AGEs
can lead to increased production of oxygen free radicals and may, therefore,
play a role in the development of microvascular disease and atheroscerosis
Numerous studies have also suggested that patients with diabetes appear to
have decreased antioxidant defense capability, measured as lower levels of
specific antioxidants, such as ascorbic acid (vitamin C) or vitamin E, or
reduced activities of antioxidant enzymes, such as catalase, superoxide
dismutase or glutathione peroxidase.
In diabetic animals, many, but not all, studies support the use of
antioxidant supplementation in reducing various parameters of oxidative
stress and in slowing or preventing the development of microvascular
complications. Studies in humans have also been promising. Recently,
particular interest has focused on the use of vitamin E for the prevention of
microvascular complications. Several studies of vitamin E supplementation in
diabetic individuals have demonstrated a decrease in biochemical markers of
oxidative stress. One small, short-term study of vitamin E supplementation in
patients with diabetes showed improvement in some surrogate markers for
retinopathy and nephropathy.
A limiting feature of the published studies is that the preparation and dose
of vitamin E used has been widely variable. In addition, little data is
available regarding potential toxicity of high doses of vitamin E, nor is
there data on potential interactions of vitamin E with other nutrients or
other antioxidants. Furthermore, interest in mounting a large clinical trial
to study the efficacy of vitamin E in preventing diabetic vascular disease
has been tempered by the recent negative results of several large,
randomized, prospective trials of vitamin E in the prevention of
cardiovascular disease and cancer. These large trials were undertaken based
on the results of animal studies and a wealth of epidemiologic data
suggesting that increased antioxidant consumption is associated with
protection from cancer and atherosclerosis. The reason for the discrepancy
between the epidemiologic and intervention data is not clear.
Nevertheless, given the enormous public health cost of diabetes, the prospect
of being able to use a relatively low-cost vitamin supplement to lower the
risk of diabetic complications merits further study. The ODS, the NIDDK, the
NHLBI, the NEI, the National Cancer Institute (NCI) and the Juvenile Diabetes
Research Foundation International (JDRF) sponsored a workshop on Vitamin E
and Diabetic Complications in October 2000. Participants highlighted a number
of critical gaps in knowledge, which merit further investigation. This
Program Announcement seeks to address some of these important issues.
Objectives and Scope
This Program Announcement solicits basic or clinical applications to 1)
determine the efficacy and safety of vitamin E or other antioxidants in
preventing, delaying or ameliorating the micro- or macrovascular
complications of diabetes, and 2) provide insight into the mechanism(s) by
which antioxidants might prevent or influence the development of diabetic
vascular disease. Epidemiologic or descriptive studies which assess diet or
nutritional supplementation, or which simply measure blood levels of
oxidants/antioxidants in patients with diabetes will not be considered
responsive to this solicitation.
Appropriate topics for investigation under this PA would include but are not
limited to:
o Preclinical studies to determine the mechanism(s) by which antioxidant(s)
prevent or influence the development of diabetic vascular disease, including
neurovascular and cerebrovascular disease,
o Studies to define interactions between oxidative pathways and free radical
formation and the signaling pathways by which insulin, glucose and other
factors affect the endothelium,
o Studies to investigate genetic factors that may affect susceptibility to
oxidative damage and response to anti-oxidant therapies in people with
diabetes,
o Studies to define similarities and differences in the mechanisms by which
oxidative stress and anti-oxidant therapies affect microvascular and
macrovascular disease in diabetes,
o Phase II studies to assess metabolism and tissue distribution, determine
kinetics, and establish optimal dosing regimens for vitamin E or other
antioxidants in patients with diabetes and/or diabetic complications,
o Studies to establish valid surrogate markers or clinical endpoints of
diabetic complications that could be used in phase III trials of
antioxidants,
o Studies to determine clinically meaningful, state-of-the art measures of
oxidant/antioxidant status of patients with diabetes,
o Small trials to compare antioxidants to establish which one(s) is most
likely to be efficacious in diabetic complications, or to define specific
subpopulations who are most likely to benefit from antioxidant intervention,
o Studies to develop new strategies to inhibit oxidation/glycoxidation and
examine the effect of these strategies on microvascular or cardiovascular
disease.
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 also may 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.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) at http://grants.nih.gov/grants/funding/phs398/phs398.html and will be
accepted at the standard application deadlines
(http://grants.nih.gov/grants/dates.htm) as indicated in the application kit.
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
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
The Research Plan for R21 applications cannot exceed 15 pages and appendix
material will not be accepted. Further details regarding the purpose and
format of R21 applications can be found by reading the NINDS guidelines
describing the R21 program
(http://www.ninds.nih.gov/funding/r21guidelines.htm). All R21 applications
submitted in response to this Program Announcement should follow the NINDS
guidelines, regardless of Institute assignment. Applicants may also contact
one of the Program Officials listed under Inquiries for further
information. If there is other important information it should be included
in the PA.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
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 $250,000 per year for an R01 and up to
$125,000 per year for an R21. Applications that request more than $250,000
direct costs in any year must follow the traditional PHS 398 application
instructions. 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 $250,000) 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 all 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.
Include the Letter of Intent to establish 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 Program Announcement 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 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 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 PHS 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 will also 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 will also 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
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Barbara Linder, M.D, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive
And Kidney Diseases
6707 Democracy Boulevard, Rm. 699 MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-0021
FAX: (301) 480-3503
E-mail: bl99n@nih.gov
Peter Dudley, Ph.D.
Vision Research Program
National Eye Institute
Executive Plaza South, Rm. 350
Bethesda, MD 20892
Telephone: (301) 496-0484
FAX: (301) 402-0528
E-mail: pd8n@nih.gov
Momtaz Wassef, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10186
Bethesda, MD 20892-7956
Telephone: (301) 435-0550
FAX: (301) 480-2848
E-mail: mw47d@nih.gov
David B. Finkelstein, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue,
Suite 2C231, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-6402
FAX: (301) 402-0010
Email: df18s@nih.gov
Paul Nichols, Ph.D.
National Institute of Neurological
Disorders and Stroke
Neuroscience Center, Room2118
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-9964
FAX: (301) 401-2060
E-mail: pn13w@nih.gov
Rebecca B. Costello, Ph.D.
Office of Dietary Supplements
Office of Disease Prevention
Building 31, 1B29
Bethesda, MD 20892
Telephone: (301) 435-2920
FAX: 301-480-1845
Email: bc135d@nih.gov
Direct inquiries regarding fiscal matters to:
Charlette Kenley
Division of Extramural Activities
Grants Management Branch
National Institute of Diabetes and Digestive
And Kidney Diseases
6707 Democracy Boulevard
Rm. 640 MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8847
FAX: (301) 480-3504
E-mail: ck128k@nih.gov
Margie Baritz
Division of Extramural Activities
National Eye Institute
Executive Plaza South, Rm. 350
Bethesda, MD 20892-6600
Telephone: (301) 496-5884
FAX: (301) 496-9997
E-mail: mb41k@nih.gov
Owen Bobbitt
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 7156
Bethesda, MD 20892-7926
Telephone: (301) 435-0177
FAX: (301)480-3310
E-mail: ob5i@nih.gov
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: lw17m@nih.gov
Denise Chatman
Grants Management Branch
National Institute of Neurological
Disorders and Stroke
Neuroscience Center, Room 3290
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-9231
FAX: (301) 402-0129
E-mail: dc55g@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.847, 93.867, 93.121, 93.866, and 93.853. 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 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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