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 301/435-0714, 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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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