and Human Services (HHS)
EXPIRED
BIOENGINEERING NANOTECHNOLOGY INITIATIVE (supercedes PA-00-018)
RELEASE DATE: July 2, 2002 (This PA has been reissued as PA-06-008 and PA-06-009)
(Scientific program contact change for NLM, see NOT-LM-05-006)
(Program extension, see NOT-HG-05-005)
(see also PA-00-018)
PA NUMBER: PA-02-125
EXPIRATION DATE: June 3, 2005, unless reissued. (See NOT-HG-05-005)
National Human Genome Research Institute (NHGRI)
(http://www.nhgri.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov/)
National Library of Medicine (NLM)
(http://www.nlm.nih.gov/)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement (PA), issued as an initiative of the trans-NIH
Bioengineering Consortium (BECON), invites grant applications for Small
Business Innovation Research (SBIR) projects on nanotechnologies useful to
biomedicine. Nanotechnology is defined as the creation of functional
materials, devices and systems through control of matter at the scale of 1 to
100 nanometers, and the exploitation of novel properties and phenomena at the
same scale. Nanotechnology is emerging as a field critical for enabling
essential breakthroughs that may have tremendous potential for affecting
biomedicine. Moreover, nanotechnologies developed in the next several years
may well form the foundation of significant commercial platforms.
In recognition of the nascence of this area, the duration and amounts of
individual grants awarded under this PA may be greater than those routinely
allowed under the SBIR program. Few small businesses possess the highly
specialized resources needed for nanoengineering. Therefore, this PA
encourages team approaches to research in the belief that a synergistic blend
of expertise and resources may be needed to allow for strong partnerships
between the small businesses and other entities in Phase I. Applications are
encouraged from teams of investigators from commercial, academic and other
sectors of the research community. Partners to the small businesses may play
important roles in these projects and may receive appropriate support for
their efforts. In addition to requiring collaboration from various sectors,
it is expected that this initiative will require expertise from a variety of
disciplines, including engineering, chemistry, physics, material science,
engineering, and biology.
This PA must be read in conjunction with the current Omnibus Solicitation of
the Public Health Service (Omnibus Solicitation) for Phase I SBIR Grant
Applications available at http://grants.nih.gov/grants/funding/sbir.htm
RESEARCH OBJECTIVES
Background
Nearly half a century ago, the finest minds in physics disagreed as to whether
it would ever be possible to manipulate individual atoms and electrons.
Today, the amount of nanoscale science and engineering is exploding because of
the availability of new investigative tools. These new analytical tools are
capable of probing the nanometer world and will make it possible to
characterize chemical and mechanical properties of cells, discover novel
phenomena and processes, and provide science with a wide range of tools,
materials, devices, and systems with unique characteristics. For example,
complementing optical traps and tweezers, nanoscale carbon tubes are ideal
probe tips for scanning microscopy, and could be used to better understand the
structure of biomolecules. Carbon nanotubes with bioactive tips could be used
to serve as chemically-selective grips for particular, individual molecules.
This capability could be used, in turn, to manipulate and observe directly
interactions between individual molecules (e.g., proteins) and to detect
different biological agents and pathogens thus revolutionizing the use of
probe microscopy in chemistry and biology. Indeed, by using diverse tools and
concepts such as scanning probe manipulators, nanolithography, and self-
assembling molecular properties, it should be possible to arrange individual
atoms and molecules in space with great precision, leading to the fabrication
of truly smart biosensors.
On the other hand, complex biological systems provide models from which to
design components that can be brought together to form three-dimensional
nanostructured systems. For example, the properties of DNA to undergo highly
controlled and hierarchical assembly makes it ideal for applications in
nanotechnology such as molecular sieves, or scaffolds for the assembly of
molecular electronic components. Likewise, eukaryotic rotary motors based on
ATPase could be employed as generic engines driving other nanodevices for
purposes such as highly directed delivery of drugs or other agents.
Eventually, by coupling advances in the knowledge of living systems with the
unique capabilities imparted by nanostructures and materials, it may be
possible to detect and intervene in disease states using biologically inspired
solutions. Integration of biocompatible materials with fluidics, optics,
mechanical and electronic components, all at micro- to nano- scale, will
enable development of implantable noninvasive sensing systems for the
detection and prevention of disease at the earliest stages of its development.
Controlled release delivery systems will make possible delivery of both
conventional and new, nanostructured drugs at targeted specific sites in the
body, while nanoscale chemical and topographical details on the surface of
implantable materials will mediate their reaction with the body.
Nanotechnology promises scientific and commercial opportunities that are
virtually unimaginable at this time.
Research Topics
BECON has identified a number of priority areas for nanoscience and
nanotechnology research support at NIH. This list is not exhaustive, nor are
the topics mutually exclusive. Their presentation here exemplifies important
scientific areas in which research at the nanoscale has the potential to make
enormous contributions to solving biomedical problems.
o Nanomaterials (enabling): nano materials science for interfacing with
living tissues, passive delivery of pharmaceuticals, tissue engineering
scaffolds, contrast and biological agents, and medical devices.
o Nanoimaging: real-time subcellular imaging of structure, function,
properties and metabolism.
o Cell biology: nano-scale research on cellular processes, including
biophysics of molecular assemblies, membranes, organelles, and
macromolecules.
o Molecular and cellular sensing/signaling: technologies to detect
biological signals and single molecules within and outside cells.
o Nanomotors: understanding structure/function and self-assembly; primary
and secondary power supply.
o Prosthetics: mechanical, chemical, and cellular implant nano-technologies
to achieve functional replacement tissue architectures.
o Nanobioprocessor: implantable nano scale processors that can integrate
with biological pathways and modify biological processes.
o Nanosystem design and application: fundamental principles and tools to
measure and image the biological processes of health and disease; and methods
to assemble nanosystems.
Examples of general research topics that would be considered responsive to
this PA are listed below. This is not meant to be an exhaustive, exclusive or
delimiting set of topics, rather these merely represent illustrations of
projects that would be considered relevant to this PA.
o Nanoplumbing components such as valves, microfluidic channels, and motors
(e.g., to be used as pumps)
o Development and improvement of techniques based on new principles for
probing biological properties and phenomena not well understood at the
nanometer scale and for characterizing nanoscale materials
o Development of fluorescent probes at the nanometer scale for monitoring
biochemical processes on the surface and inside a cell in health and disease
o Creation of "smart" nanostructured biocompatible materials. Approaches may
include self-assembling techniques and supramolecular chemistry for building
up functional nanostructures and for modifying and patterning material surface
texture
o Development of nanofabricated barriers to prevent rejection of implantable
materials
o Development of nanoparticles and nanospheres that enable controlled
released of therapeutic agents, antibodies, genes and vaccines into targeted
cells
o Development of sensor technologies for detection and analysis of
biologically relevant molecular and physical targets in samples from blood,
saliva and other body fluids, or for use in the research laboratory (purified
samples), clinical specimens and in the living body.
MECHANISM OF SUPPORT - PHASE I
Phase I applications in response to this PA will be funded as Phase I SBIR
Grants (R43). As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project.
Project Period and Amount of Award
Because the duration and cost of research to develop nanotechnologies are
likely to exceed that routinely awarded for SBIR grants, well-justified Phase
I applications under this PA will be considered with a project period up to
two years and a budget not to exceed a total cost of $400,000 (i.e., an
average of $200,000 per year).
Consultant and contractual costs
Because the resources required for nanoengineering are relatively scarce,
highly specialized, and multidisciplinary, the total amount of consultant
costs and contractual costs requested by applicants may exceed the statutory
guidelines. Requests in excess of the guidelines must be fully justified.
MECHANISM OF SUPPORT - PHASE II
Phase II applications in response to this PA will be awarded as Phase II SBIR
grants (R44) with modifications as described below. Phase II applications in
response to this PA will only be accepted as competing continuations of
previously funded NIH Phase I SBIR awards. The previously funded Phase I
award need not have been awarded under this PA but the Phase II proposal must
be a logical extension of the Phase I research. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project.
Project Period and Amount of Award
Because the duration and cost of research to develop nanotechnologies is
likely to exceed that routinely awarded for SBIR grants, well-justified Phase
II applications under this PA will be considered with a project period up to
three years and a budget not to exceed a total cost of $1,200,000 (i.e., an
average of $400,000 for each of three years).
Consultant and Contractual Costs
Because the resources required for nanoengineering are relatively scarce,
highly specialized, and multidisciplinary, the total amount of consultant
costs and contractual costs requested by applicants may exceed the statutory
guidelines. Requests in excess of the guidelines must be fully justified.
ELIGIBLE INSTITUTIONS
Eligibility requirements for Phase I and Phase II grants are found at
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
NCI Ed Monachino, Ph.D.; National Cancer Institute; Building 31, Room 10A49,
MSC 2580, Bethesda, MD 20892-2580; Telephone: (301) 496-1550; FAX: (301)
496-7807; Email: [email protected]
NEI Richard S. Fisher, Ph.D.; National Eye Institute; Executive Plaza South,
Suite 350; 6120 Executive Boulevard, MSC 7164; Bethesda, MD 20892-7164;
Telephone: (301) 451-2020; FAX: (301) 402-0528; Email: [email protected]
NHLBI NHLBI - John T. Watson, Ph.D.; National Heart, Lung, and Blood
Institute; 6701 Rockledge Drive, Room 9166; Bethesda, MD 20892-7940;
Telephone: (301) 435-0555; FAX: (301) 480-7971; Email: [email protected]
NHGRI - Jeffery A. Schloss, Ph.D.; Division of Extramural Research; National
Human Genome Research Institute; Building 31, Room B2B07, MSC 2033; Bethesda,
MD 20892-2033; Telephone: (301) 496-7531; FAX: (301) 480-2770; Email:
[email protected]
NIA Winifred K. Rossi, M.A.; Geriatrics and Clinical Gerontology; National
Institute on Aging; Gateway Building, Suite 3E327, MSC 9205; Bethesda, MD
20892-9205; Telephone: (301) 496-3836; FAX: (301) 402-1784; Email: Email:
[email protected]
NIAAA -Michael Eckardt, Ph.D.; Office of Scientific Affairs; Institute on
Alcohol Abuse and Alcoholism; Suite 409; 6000 Executive Blvd.; Bethesda, MD
20892-7003; Telephone: (301) 443-6107; Fax: (301) 443-6077; Email:
[email protected]
NIAID Maria Y. Giovanni, Ph.D.; Division of Microbiology and Infectious
Disease; National Institute of Allergy and Infectious Diseases; 6700-B
Rockledge Dr. MSC 7630; Bethesda, MD 20892-7630; Telephone: (301) 496-1884;
FAX: (301) 480-4528; Email: [email protected]
NIAMS - James S. Panagis, M.D., M.P.H.; Orthopaedics Program; National
Institute of Arthritis and Musculoskeletal and Skin Diseases; Bethesda, MD
20892-6500; Telephone: (301) 594-5055; Email: [email protected]
NIBIB Joan T. Harmon, Ph.D.; Division of Bioengineering; National Institute
of Biomedical Imaging and Bioengineering; 6707 Democracy Boulevard, Room 956;
Bethesda, MD 20892-5469; Telephone: (301) 451-4776; FAX: (301) 480-4973;
Email: [email protected]
NIDCD - Lynn E. Luethke, Ph.D.; National Institute on Deafness and Other
Communication Disorders; 6120 Executive Boulevard, MSC 7180; Bethesda, MD
20892-7180; Telephone: (301) 402-3458; FAX: (301) 402-6251; Email:
[email protected]
NIDCR - Eleni Kousvelari, D.D.S., D.Sc.; Cellular and Molecular Biology,
Physiology and Biotechnology Branch; National Institute of Dental and
Craniofacial Research; Natcher Building, Room 4AN 18A, MSC 6402; Bethesda, MD
20892-6402; Telephone: (301) 594-2427; FAX: (301) 480-8318; Email:
[email protected]
NIDDK - Thomas Eggerman, Ph.D.; Division of Diabetes, Endocrinology, and
Metabolic Diseases; National Institute of Diabetes and Digestive and Kidney
Diseases; 6706 Democracy Blvd., Room 697, MSC 5460, Bethesda, MD, 20895-5460,
Telephone: (301) 594-8813; FAX: (301) 480-3503; Email:
[email protected]
NIDA - Thomas G. Aigner, Ph.D.; Division of Basic Research; National Institute
on Drug Abuse; 6001 Executive Boulevard, Room 4282, MSC 9555; Bethesda, MD
20892-9555; Telephone: (301) 443-6975; FAX: (301) 594-6043; Email:
[email protected]
NIEHS - Dr. Claudia Thompson; Division of Extramural Research and Training;
National Institute of Environmental Health Sciences; PO Box 12233, Mail Drop
EC-23; Research Triangle Park, NC 27709; Telephone: (919) 541-4638; FAX:
(919) 541-5064; Email: [email protected]
NIGMS Catherine Lewis, Ph.D.; Bldg. 45, Rm 2AS-13K; 45 Center Dr.; Bethesda,
MD 20892-6200; Telephone: 301-594-0828; FAX: (301) 480-2004; Email:
[email protected]
NIMH Margaret Grabb, Ph.D.; Division of Neuroscience and Basic Behavioral
Science; National Institute of Mental Health; 6001 Executive Boulevard, Room
7202, MSC 9645; Bethesda, MD 20892-9645; Telephone: (301) 443-3563; FAX:
(301) 443-1731; Email: [email protected]
NINR - Hilary Sigmon, Ph.D.; Cardiopulmonary Health & Critical Care; National
Institute of Nursing Research; Building 45, Room 3AN12; 45 Center Drive;
Bethesda, Maryland 20892-6300; Telephone: (301) 594-5970; FAX: (301) 480-
8260; Email: [email protected]
NLM - Dr. Hua-Chuan Sim, 6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD 20892-7968, Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 496-4253, FAX: (301) 402-2952, Email: [email protected]
o Direct your questions about financial or grants management matters to:
NCI - Bill Wells; Grants Administration Branch; National Cancer Institute;
6120 Executive Boulevard, Room 243, MSC 7150; Bethesda, MD 20892-7150;
Telephone: (301) 496-7800; FAX: (301) 496-8601; Email:
[email protected]
NEI William Darby, Grants Management Officer; National Eye Institute; 6120
Executive Boulevard, Suite 350, MSC 7164; Bethesda, MD 20892-7164; Telephone:
(301) 451-2020; FAX: (301) 402-0528; Email: [email protected]
NHLBI - Jane Davis; National Heart, Lung, and Blood Institute; 6701 Rockledge
Drive, Room 7174; Bethesda, MD 20892; Telephone: (301) 435-0166; FAX: (301)
480-3310; Email: [email protected]
NHGRI - Jean Cahill; Grants Management Office; National Human Genome Research
Institute; Building 31, Room B2B34; 31 Center Drive, MSC 2030; Bethesda, MD
20892-2030; Telephone: (301) 402-0733; FAX: (301) 402-1951; Email:
[email protected]
NIA - Linda Whipp; Grants and Contracts Management Officer; National
Institute on Aging; Gateway Building, Suite 2N212; Bethesda, MD 20892;
Telephone: (301) 496-1472; FAX: (301) 402-3672; Email: [email protected]
NIAAA - Judy Simons; Grants Management Officer; National Institute on Alcohol
Abuse and Alcoholism; 6000 Executive Blvd., Suite 504; Bethesda, MD 20892-
7003; Telephone: (301) 443-4704; Fax: (301) 443-3891; Email:
[email protected]
NIAID Lesia Norwood; Division of Extramural Activities; National Institute
of Allergy and Infectious Diseases; Room 3221, MSC-7614; 6700-B Rockledge
Drive; Bethesda, MD 20892-7614; Telephone: (301) 402-6581; FAX: (301) 480-
3780; Email: [email protected]
NIAMS Melinda Nelson; Grants Management Branch; National Institute of
Arthritis and Musculoskeletal and Skin Diseases; Bethesda, MD 20892-6500;
Telephone: (301) 594-3535; Email: [email protected]
NIBIB - Ms. Annette Hanopole; Grants Management Officer; National Institute
of Biomedical Imaging and Bioengineering; 6707 Democracy Boulevard; Bethesda,
MD 20892-5469; Telephone: 301-451-4789; Fax: 301-480-4973; Email:
[email protected]
NIDCD - Sharon Hunt; Grants Management Branch; National Institute on Deafness
and Other Communication Disorders; 6120 Executive Boulevard, Room 400-C, MSC
7180; Bethesda, MD 20892-7180; Telephone: (301) 402-0909; FAX: (301) 402-
1758; Email: [email protected]
NIDCR - Kevin Crist; Division of Extramural Research; National Institute of
Dental and Craniofacial Research; Natcher Building, Room 4AS 55; Bethesda, MD
20892-6402; Telephone: (301) 594-4800; FAX: (301) 480-8301; Email:
[email protected]
NIDDK - Kathleen J. Shino, MBA; Grants Management Branch; National Institutes
of Diabetes and Digestive and Kidney Diseases; 6707 Democracy Blvd., Room
708; Bethesda, MD 20892; Telephone: (301) 594-8869; FAX: (301) 594-9523;
Email: [email protected]
NIDA - Gary Fleming, J.D., M.A.; Grants Management Branch; National Institute
on Drug Abuse; 6001 Executive Boulevard, Room 3131, MSC 9541; Bethesda, MD
20892-9541; Telephone: (301) 443-6710; FAX: (301) 594-6847; Email:
[email protected]
NIEHS Dorothy Duke; Division of Extramural Research and Training; National
Institute of Environmental Health Sciences; P.O. Box 12233, Mail Drop EC-22;
Research Triangle Park, NC 27709; Telephone: (919) 541-1373; FAX: (919)
541-2860; Email: [email protected]
NIGMS - Grace Tuanmu; Grants Management, CBB; National Institute of General
Medical Sciences; 45 Center Drive MSC 6200; Room 2AN.32E; Bethesda, Md.
20892-6200; Telephone: (301) 594 5520; FAX: (301) 480 2554; Email
[email protected]
NIMH - Kathy Hancock; Grants Management Branch; National Institute of Child
Health and Human Development; 6100 Executive Boulevard, Room 8A17M; Bethesda,
MD 20892-7510; Telephone: (301) 496-5482; FAX: (301) 402-0915; Email:
[email protected]
NINR Cynthia McDermott; Office of Grants and Contracts Management; National
Institute of Nursing Research; Building 45, Room 3AN12; 45 Center Drive;
Bethesda, Maryland 20892-6300; Telephone: 301-594-6869; FAX: 301-480-8260;
Email: [email protected]
NLM J. Christopher Robey, M.A; Division of Extramural Programs; National
Library of Medicine; Rockledge One, Suite 301; 6705 Rockledge Drive;
Bethesda, MD 20817 (For courier delivery service use: 20817); Telephone:
(301) 594-4937; FAX: (301) 402-0421; Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. Suggest cite specific Small Business Section. For further
assistance contact GrantsInfo, Telephone (301) 710-0267, Email:
[email protected].
For purposes of identification and processing, the title and number of this
PA must be shown in item 2 on the face page of the application (i.e.,
"BIOENGINEERING NANOTECHNOLOGY INITIATIVE," PA-02-125)
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SENDING AN APPLICATION TO THE NIH: 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)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council
or board
REVIEW CRITERIA
Review criteria are described in the Omnibus Solicitation
(http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm).
The Phase I application 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.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a
clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy 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 is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
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.
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. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
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.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.394 (NCI); 93.387 (NEI); 93.233, 93.837,
93.838, 93.839 (NHLBI); 93.172 (NHGRI); 93.866 (NIA); 93.271 (NIAAA); 93.856
(NIAID); 93.846 (NIAMS); 93.286, 93.287 (NIBIB); 93.173 (NIDCD); 93.121
(NIDCR); 93.849, 93.848 and 93.847 (NIDDK); 93.279 (NIDA); 93.114 (NIEHS);
93.821, 93.859, 93.862 (NIGMS); 93.242 (NIMH); 93.361 (NINR); 93.879 (NLM)
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. 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
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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