SBIR/STTR STUDY AND CONTROL OF MICROBIAL BIOFILMS

Release Date:  April 21, 1999

PA NUMBER:  PA-99-084

P.T.

National Heart, Lung, and Blood Institute
National Institute of Dental and Craniofacial Research
National Institute of Allergy and Infectious Diseases
National Institute on Deafness and Other Communication Disorders
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of General Medical Sciences
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
Office of Research on Women's Health

Application Receipt Dates:

Applications will be accepted for SBIR proposals three times a year with the
following deadlines:  December 15; April 15; August 15.

Applications will be accepted for STTR proposals three times a year with the
following deadlines:  December 1; April 1; August 1.

PURPOSE

The National Heart, Lung, and Blood Institute (NHLBI), National Institute of
Dental and Craniofacial Research (NIDCR), National Institute of Allergy and
Infectious Diseases (NIAID), National Institute on Deafness and Other
Communication Disorders (NIDCD), National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS), National Institute of General
Medical Sciences (NIGMS), National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), National Institute of Child Health and Human
Development (NICHD), National Institute of Neurological Disorders and Stroke
(NINDS), National Institute of Nursing Research (NINR), and Office of Research
on Women's Health (ORWH) invite research grant applications to conduct studies
on microbial biofilms leading to improved strategies and technologies to
diagnose, prevent and treat biofilm-associated infectious diseases.

This program announcement must be read in conjunction with the "Omnibus
Solicitation of the Public Health Service for Small Business Innovation
Research Grant Applications (PHS 99-2)," and the "Omnibus Solicitation of the
National Institutes of Health for Small Business Technology Transfer Grant
Applications (PHS 99-3)."  All of the instructions within the Omnibus
Solicitations apply.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Program Announcement, SBIR/STTR
Study and Control of Microbial Biofilms, is related to the priority areas of
oral health, immunization and infectious diseases, unintentional injuries,
diabetes and chronic disabling conditions, special population objectives, and
heart disease and stroke. Potential applicants may obtain a copy of "Healthy
People 2000" at http://www.crisny.org/health/us/health7.html

ELIGIBILITY REQUIREMENTS

Eligibility requirements for SBIR and STTR are described in the Omnibus
Solicitation of the NIH for SBIR/STTR grant applications.

MECHANISM OF SUPPORT

A.  FAST-TRACK APPLICATIONS.  Applications may be submitted for the FAST-TRACK
review option.  Information on the FAST-TRACK process may be found at:
http://www.nih.gov/grants/funding/sbir.htm

B.  INDIVIDUAL PHASE I APPLICATIONS.  Phase I applications in response to this
PA will be funded as Phase I SBIR Grants (R43) or STTR Grants (R41).
Responsibility for the planning, direction, and execution of the proposed
research will be solely that of the applicant.  Applications for Phase I
grants should be prepared following the directions for Phase I SBIR/STTR
applications as described in the NIH Omnibus Solicitation.  The NIH Omnibus
SBIR Solicitation is available on the Internet at:
http://www.nih.gov/grants/funding/sbir1/toc.htm

The National Institutes of Health (NIH) is employing features of the Modular
Grant Application and Award procedures under its Small Business Innovation
Research (SBIR) program. These features are explained in more detail below
under "APPLICATION PROCEDURES."

The NIH OMNIBUS STTR Solicitation is available at:
http://www.nih.gov/grants/funding/sttr1/toc.htm

A limited number of hard copies of the NIH Omnibus SBIR and STTR Solicitations
are available from:

PHS SBIR/STTR Solicitation Office
13685 Baltimore Avenue
Laurel, MD  20707-5096
Telephone:  (301) 206-9385
FAX:  (301) 206-9722
Email:  a[email protected]

C.  INDIVIDUAL PHASE II APPLICATIONS

Phase II applications in response to this PA will be awarded as Phase II SBIR
Grants (R44) or STTR Grants (R42). Phase II applications in response to this
PA will only be accepted as competing continuations of previously funded NIH
Phase I SBIR/STTR awards.  The Phase II application must be a logical
extension of Phase I research in the area of microbial biofilms.

Applications for Phase II awards should be prepared following the instructions
for NIH Phase II SBIR/STTR applications.  The Phase II SBIR instructions and
application may be found on the Internet at:
http://www.nih.gov/grants/funding/sbir2/index.htm

The Phase II STTR instructions and application may be found on the Internet
at: http://www.nih.gov/grants/funding/sttr2/index.html

Applications over $500,000.  Although the Phase II application has no official
budgetary limit, applications requesting in excess of $500,000 dollars direct
costs in any single year of the grant period require prior approval before
submission.  Applicants who plan to submit a Phase II SBIR/STTR application
requesting $500,000 or more in any year are advised that it is important that
they contact program staff listed under INQUIRIES as they begin to develop
plans.  Applications requesting more than $500,000 received without prior
staff contact may be delayed in the review process or returned to the
applicant without review (NIH GUIDE, Volume 22, Number 45, December 17, 1993).

RESEARCH OBJECTIVES

Background

A biofilm is an accumulation of microorganisms (bacteria, fungi, and/or
protozoa, with associated bacteriophages and other viruses) embedded in a
polysaccharide matrix and adherent to a solid biologic or non-biologic
surface. Biofilms are medically important, accounting for over 80 percent of
microbial infections in the body.  Examples include infections of the: oral
soft tissues, teeth and dental implants; middle ear; gastrointestinal tract;
urogenital tract; airway/lung tissue, eye; urinary tract prostheses;
peritoneal membrane and peritoneal dialysis catheters, indwelling catheters
for hemodialysis and for chronic administration of chemotherapeutic agents
(Hickman catheters); cardiac implants such as pacemakers, prosthetic heart
valves, ventricular assist devices, and synthetic vascular grafts and stents;
prostheses, internal fixation devices, and percutaneous sutures; and tracheal
and ventilator tubing.

Several recent symposia and workshops sponsored by the American Society for
Microbiology and the NIH have emphasized the unique features of bacteria and
fungi growing as a biofilm rather than in free-floating, planktonic forms.  In
particular the microorganisms tend to be far more resistant to antimicrobial
agents and to be particularly difficult for the host immune system to render
an appropriate response.

The need for increased development of technologies for the study and control
of microbial biofilms is based on many factors:

- Biofilms are remarkably difficult to treat with antimicrobials.  The reasons
for this are not clear.  Antimicrobials may be readily inactivated or fail to
penetrate into the biofilm.  In addition, bacteria within biofilms have
increased (up to 1000-fold higher) resistance to antimicrobial compounds, even
though these same bacteria are sensitive to these agents if grown under
planktonic conditions.

- Biofilms increase the opportunity for gene transfer between/among bacteria. 
This is important since bacteria resistant to antimicrobials or chemical
biocides can transfer the genes for resistance to neighboring susceptible
bacteria.  Gene transfer can convert a previous avirulent commensal organism
into a highly virulent pathogen.

- Certain species of bacteria communicate with each other within the biofilm. 
As their density increases, the organisms secrete low molecular weight
molecules that signal when the population has reached a critical threshold. 
This process, called quorum sensing, is responsible for the expression of
virulence factors.

For example, Pseudomonas aeruginosa produces destructive proteinases when the
number of these bacteria reach a high enough density in the airway biofilms of
cystic fibrosis patients.

- Bacteria express new, and sometimes more virulent phenotypes when growing
within a biofilm.  Such phenotypes may not have been detected in the past
because the organisms were grown on rich nutrient media under planktonic
conditions.  The growth conditions are quite different particularly in the
depths of biofilms, where nutrients and oxygen are usually limited, and waste
products from neighbors can be toxic.  In short, bacteria found at the bottom
of the biofilm look and act different than species located at the surface.

- Bacteria embedded within biofilms are resistant to both immunological and
non-specific defense mechanisms of the body.  Contact with a solid surface
triggers the expression of a panel of bacterial enzymes which catalyze the
formation of sticky polysaccharides that promote colonization and protection. 
The structure of biofilms is such that immune responses may be directed only
at those antigens found on the outer surface of the biofilm, and antibodies
and other serum or salivary proteins often fail to penetrate into the biofilm. 
In addition, phagocytes are unable to effectively engulf a bacterium growing
within a complex polysaccharide matrix attached to a solid surface.  This
causes the phagocyte to release large amounts of pro-inflammatory enzymes and
cytokines, leading to inflammation and destruction of nearby tissues.

The field of biofilm research has traditionally been hindered by an inability
to study the biofilm in non-destructive, three dimensional ways.  In addition,
it has been difficult or impossible to assess gene expression and metabolism
of the microbe at the single cell level within a biofilm.  However, as a
result of advances in laser technology, digital imaging, scanning electron
microscopy, and new fluorescent probes, researchers can now build a three
dimensional model of biofilms and identify the location in the biofilm where
specific genes are being expressed.

Summary

This broad-based initiative on microbial biofilms is designed to support
development of technologies and strategies for the prevention and treatment of
microbial biofilm-associated diseases, and for advanced studies of microbial
biofilms.  In addition, this initiative is intended to capitalize on
contemporary research in immunology, microbiology, bio-engineering and
computer technology that might synergize with current biofilm research. 
Another potential aim of this initiative is to link clinical experts, such as
nurses, physicians, respiratory therapists, and orthopedic technicians, with
bioengineers and basic scientists to better identify the clinical problems
associated with microbial biofilm-associated infection.

Research Objectives and Scope

Since microbial biofilms are a major problem affecting diverse organs and
organ systems, several components of the NIH have joined in this Program
Announcement.  Therefore,  examples of relevant research topics, which are
listed below, may reflect interests of specific Institutes within the NIH.
Importantly, the list should not be construed as complete or restrictive. 
Applicants are encouraged to propose other topics that address the development
of systems and technologies to advance the understanding of the formation of
biofilms; to study their role in disease; and to develop the means to control
them.

o  Development of improved imaging of biofilms in situ;

o  Development of improved clinically relevant in vitro and in vivo models of
biofilms under specific in vivo conditions such as flow rate, nutrient
content, and temperature;

o  Development of better probes (genetic, metabolic, and immunological) for
real-time analysis;

o  Development of systems for improved studies of quorum sensing/signaling
molecules;

o  Development of systems for the study of biofilm-specific gene expression;
and the exchange of genetic material within biofilms;

o  Technologies for studies of organic contaminants on substrata, and their
influence on biofilm structure;

o  Development of novel approaches to control pathogenic bacteria by, for
example, devising strategies to favor growth of non-pathogenic microorganisms
in biofilm communities;

o  Technologies and materials relevant to the interactions of biofilms with
host tissues and artificial implants;

o Development of materials and technologies to prevent pathogenic bacteria
development for long term chronic users of devices; such as total hip
replacements beyond ten years and home care use of tracheostomy tubes for
mechanical ventilation;

o  Development or use of novel agents, materials, or coatings for preventing
or treating infections related to cardiovascular and pulmonary devices, and
musculoskeletal prostheses (artificial joints), internal fixation devices,
percutaneous sutures, and engineered tissues;

o  Technologies for studies of pathogenic mechanisms of microbes growing in
biofilms; and the mechanisms of resistance of biofilms to antimicrobial
agents;

o  Systems to enhance the sensitivity of biofilms to antimicrobial agents;

o  Techniques or assays for studies of host immune responses, both innate and
adaptive to biofilms;

o  Improved techniques for the study of the potential role of biofilms and
host response in the development of systemic inflammatory response syndrome,
septic shock, acute respiratory distress syndrome, and multiple organ
dysfunction syndrome in injured, disabled or critically ill patients, or in
model systems reflecting these clinical conditions;

o  Improved techniques for the studies of infectious lung disease in cystic
fibrosis;

o  Development of treatments or products to inhibit the potential of
diagnostic procedures such as bronchoalveolar lavage and bronchoscopy to
disturb local biofilm flora and inoculate distant locations;

o  Development of mathematical models and computer simulations of biofilms;
and

o  Development of the methodology for the prevention and control of biofilms
from catheters, water unit lines, and other clinically important solid
surfaces.

The focus of this Program Announcement is technology development.  Support
will not be provided for mechanistic studies of basic questions.  Although
testing of biological samples or procedures in whole organisms in the course
of validating the technology is appropriate.

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 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, and is available at the following URL:
https://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 (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:
http://www.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 this policy.

APPLICATION PROCEDURES

OMNIBUS SOLICITATIONS for both the SBIR and STTR programs are available
electronically through the NIH, Office of Extramural Research "Small Business
Funding Opportunities" web site at http://www.nih.gov/grants/funding/sbir.htm. 
Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR
Solicitation Office, phone (301) 206-9385; FAX (301) 206-9722; Email
[email protected].  Helpful information for preparation of the application can be
obtained: https://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf

Applications are to be submitted on the grant application form PHS 6246-1
(1/98) (SBIR) and PHS 6246-3 (STTR) (1/98) located in the back pages of the
OMNIBUS SOLICITATIONS, and will be accepted at the application deadlines.  The
title and number of this PA must be typed in Line 2 on the face page of the
application.

Applications will be accepted for SBIR proposals three times a year with the
following deadlines: December 15; April 15; August 15.

Applications will be accepted for STTR proposals three times a year with the
following deadlines: December 1; April 1; August 1.

The OMNIBUS SOLICITATIONS give the general guidelines for levels of support
and period of time for SBIR and STTR Phase I and II awards. (See NIH Guide,
February 12, 1998:
http://www.nih.gov/grants/guide/notice-files/not98-014.html).  Because the
length of time and cost of research may exceed that normally awarded for
SBIR/STTR grants, larger budgets with longer periods of time may be requested
if required to complete the proposed research.

MODULAR GRANT APPLICATION AND AWARD

The National Institutes of Health (NIH) is employing features of the Modular
Grant Application and Award procedures under its Small Business Innovation
Research (SBIR) program. See the  "Modular Grant Application and Award"
section of the OMNIBUS SOLICITATION, which can be found at
http://www.nih.gov/grants/funding/sbir1/modular.htm.

SBIR Phase I grant applications requesting up to $100,000 total costs (direct
costs, indirect costs, and fixed fee) will request direct costs in a budget
narrative format rather than being compiled from detailed and separate
categories.

Applications requesting up to $100,000 total costs (direct costs, indirect
costs, and fixed fee) will request budgets using "Budget Justification" (form
page 4 of PHS 6246-1) ONLY.  Present the total amount requested for direct
costs on line 7a of the Face Page of PHS 6246-1. Information, in narrative
form, is to be provided on "Budget Justification" (form page 4) for Personnel,
Fixed Fee, and, when applicable, for Consultant Costs and Contractual Costs.
No other budget information is to be submitted. Do not submit "Budget for
Phase I Direct Costs Only" (form page 3 of PHS 6246-1). It is to be used as a
"worksheet" only.  Pages should be renumbered as necessary.

Applications requesting in excess of $100,000 total costs (direct costs,
indirect costs, and fixed fee) do not fall within the Modular Grant
Application and Award procedures.  Applications requesting in excess of
$100,000 should use "Budget for Phase I Direct Costs Only" (form page 3 of PHS
6246-1), and justify this request using "Budget Justification" (form page 4).

FAST-TRACK OPTION

The "Fast-Track" procedures are designed to expedite the decision and award of
SBIR Phase II funding for scientifically meritorious applications for projects
that have a high potential for commercialization. In order to apply for the
FAST-TRACK option, applications for both Phase I and Phase II must be
submitted together according to the instructions for Fast-Track applications
as described in the OMNIBUS SOLICITATIONS
(https://grants.nih.gov/grants/funding/sbirsttr1/6method.htm#6g).

SBIR applications are eligible for the Fast-Track review process upon meeting
the following criteria:

The small business concern must submit a concise Product Development Plan
(limited to ten pages) as a Product Development Plan Appendix to the Phase II
application addressing each of the following areas:

a. Company information, including size; specialization area(s); products with
significant sales; and history of previous federal and non-federal funding,
regulatory experience, and subsequent commercialization.

b. Value of SBIR project, including lay description of key technology
objectives, current competition, and advantages compared to competing products
or services.

c. Commercialization plans, milestones, target dates, market analyses of
market size, and estimated market share after first year sales and after five
years.

d. Patent status or other protection of project intellectual property.

The Product Development Plan appendix should be labeled clearly.

Fast-Track SBIR applications for both Phase I and Phase II must be submitted
together for concurrent initial peer review and evaluation. In order to
identify the application as such, the words "Fast-Track" must be shown in item
2 on the face page of the Phase I application.

The Phase I application must specify clear, measurable goals (milestones) that
should be achieved prior to initiating Phase II.  Failure to provide clear,
measurable goals may be sufficient reason for the scientific peer review group
to exclude the Phase II application from Fast-Track review.

Applicants are ENCOURAGED to seek commitment(s) of funds and/or resources from
an investor or partner organization for commercialization of the product(s) or
service(s) resulting from the SBIR grant.

For all applications submit a signed, typewritten original of the application,
including a cover letter, the checklist and two 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

Review Procedures

Application will be assigned on the basis of established NIH referral
guidelines.  When the subject of an application is of interest to more than
one Institute, dual assignments will be made.  Upon receipt, applications will
be reviewed for completeness by the Center for Scientific Review (CSR). 
Incomplete applications will be returned to the applicant without further
consideration.

Applications that are complete will be evaluated for scientific and technical
merit by study sections of the CSR.  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

Review criteria are described in the NIH Omnibus Solicitation and are as
follows:

1.  The soundness and technical merit of the proposed research. (Preliminary
data are not required for Phase I proposals.

2.  The qualifications of the proposed principal investigator, supporting
staff, and consultants.

3.  The scientific, technical, or technological innovation of the proposed
research.

4.  The potential of the proposed research for commercial application or
societal impact.

5.  The appropriateness of the budget requested.

6.  The adequacy and suitability of the facilities and research environment.

7.  Where applicable, the adequacy of assurances detailing the proposed means
for (a) safeguarding human or animal subjects and/or (b) protecting against or
minimizing any adverse effect on the environment.

For Fast-Track,  Phase I applications should specify clear, measurable goals
(milestones) that should be achieved prior to initiating Phase II. Failure to
provide clear, measurable goals may be sufficient reason for the study section
to judge the application non-competitive.

The initial review group will also examine: the appropriateness of the
proposed project budget and duration; the adequacy of plans to include both
genders and minorities and their subgroups as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.  In addition,  reviewers will be instructed to
address the adequacy of plans for including children as appropriate for the
scientific goals of the research, or justification for exclusion (see section
on NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN 
RESEARCH INVOLVING HUMAN SUBJECTS).

AWARD CRITERIA

Applications will compete for available funds with all other approved SBIR and
STTR applications.  Funding decisions for Phase I will be based on quality of
the proposed project as determined by peer review, availability of funds, and
program priority.

Fast-Track Phase II applications may be funded following submission of the
Phase I progress report and other documents necessary for continuation.  Phase
II applications will be selected for funding based on the quality of the
proposed project, the determination that Phase I goals were achieved, the
project's potential for commercial success, and the availability of funds.

INQUIRIES

Written, email, and telephone inquiries concerning this program announcement
are strongly encouraged. NIH staff welcome the opportunity to clarify any
issues regarding the application procedures or provide guidance to applicants
regarding specific aspects of their proposals.

Direct inquiries regarding programmatic issues to:

Joyce A. Reese, DDS, MPH
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-32K
Bethesda, MD 20892-6402
Telephone:  (301) 594-2088
FAX:  (301) 480-8318
Email:  [email protected]

Stephen P. Heyse, M.D., M.P.H.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A32
Bethesda, MD  20892
Telephone:  (301) 496-7728
FAX:  (301) 402-2508
Email:  [email protected]

Lynn E. Luethke, Ph.D. (formerly Lynn E. Huerta)
National Institute on Deafness and Other Communication Disorders/NIH
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251
Email:  [email protected]

James S. Panagis, M.D., M.P.H.
Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37K, MSC 4500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  [email protected]

Scott D. Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49J, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5560
FAX:  (301) 480-2802
Email:  [email protected]

Susan Banks-Schlegel, Ph.D.
Airway Biology and Disease Program
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10018, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email:  [email protected]

Lawrence Agodoa, M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS13B, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  [email protected]

Eugene G. Hayunga, Ph.D.
Office of Research on Women's Health
National Institutes of Health
Building 1, Room 201
Bethesda, MD  20892
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  [email protected]

Louis A. Quatrano, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03
Rockville, MD  20852
Telephone:  (301) 402-2242
Email:  [email protected]

Hilary D. Sigmon Ph.D., RN
Division of Extramural Activities
National Institute of Nursing Research
45 Center Drive, Room 3AN12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5970
FAX:  (301) 480-8260
Email:  [email protected]

Dr. William Heetderks
Division of Stroke, Trauma, and Neurodegenerative Disorders
National Institute for Neurological Disorders and Stroke
Federal Building, Room 8A13
Bethesda, MD  20892-9155
Telephone:  (301) 496-1447
FAX:  (301) 402-1501
Email:  [email protected]

Direct inquiries regarding grants management issues to:

Daniel Milstead
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44A, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  [email protected]

Robert Tarwater
Grants Management Branch
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4A29
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  [email protected]

Sharon Hunt
Division of Extramural Affairs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  [email protected]

Vicki Maurer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37H, MSC 4500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3504
FAX:  (301) 480-5450
Email:  [email protected]

Toni Holland
Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, Room 2AN-50B, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5132
FAX:  (301) 480-3423
Email:  [email protected]

Marie Willett
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge 2, Room 7156
Bethesda, MD  20892-7156
Telephone:  (301) 435-0144
FAX:  (301) 480-3310
Email:  [email protected]

Trude Hilliard
Division of Extramural Affairs
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AN-44B
Bethesda, MD  20892-6600
Telephone:  (301) 594 8859
FAX:  (301) 480 3504
Email:  [email protected]

Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17G
Rockville, MD  20852
Telephone:  (301) 496-1304
Email:  [email protected]

Jeff Carow
Division of Extramural Activities
National Institute of Nursing Research
45 Center Drive, Room 3AN12, MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email: [email protected]

Ms. Brenda Kibler
Grants Management Specialist
National Institute for Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.121 (NIDR), 93.856 (NIAID), and No. 93.173 (NIDCD), and No. 93.846 (NIAMS),
No. 93.859 (NIGMS), No. 93.838 (NHLBI), and No. 93.849 (NIDDK).  Awards are made
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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 
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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)