NANOSCIENCE AND NANOTECHNOLOGY IN BIOLOGY AND MEDICINE

RELEASE DATE:  December 12, 2002  

PA NUMBER:  PAR-03-045

Update: The following update relating to this announcement has been issued: 

- December 27, 2006 - This PAR has been reissued as PAR-07-270 for submission of 
R01 applications, and PAR-07-271 for R21, which now uses the electronic SF424 (R&R)
 application for February 5, 2007 submission dates and beyond.
-July 12, 2006 - This PA has been reissued as PAR-06-475 for submission of R21 applications as of July 10, 2006.

EXPIRATION DATE:  This Program Announcement expires on August 19, 2006, 
unless reissued. 

APPLICATION RECEIPT DATE:  February 18 and August 18 

National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
National Human Genome Research Institute (NHGRI)
 (http://www.genome.gov/)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib1.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.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 Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.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), is aimed at enhancing 
nanoscience and nanotechnology research approaches that have the 
potential to make valuable contributions to biology and medicine. 

Nanoscience and nanotechnology refer to research at the atomic, 
molecular or macromolecular levels, at the length scale of 
approximately 1 - 100 nanometers.  The purpose of this initiative is to 
stimulate cross-cutting, integrative research in these fields of 
science and technology. In particular, this initiative invites research 
on: i) the creation and use of structures, devices and systems that 
have novel properties and functions because of their small size, that 
may be used to achieve a fundamental understanding of biological 
processes and /or contribute to disease detection, therapy, or 
prevention; ii) conception and fabrication of devices, that will 
effectively detect and analyze nanoscale entities of relevance to 
biomedicine; and iii) the study of biological systems at the nanoscale 
for the explicit purpose of using that information to develop 
nanotechnologies and nanostructured materials that will in turn benefit 
biology and medicine. 

It is anticipated that the research projects that will be most 
responsive to this PA will require interdisciplinary collaborations 
among investigators with expertise in a range of disciplines, including 
but not limited to engineering, physics, chemistry, cellular and 
molecular biology, materials and computer science. Applications 
submitted in response to this PA may propose hypothesis-driven, 
discovery-driven, developmental, or design-directed research.

RESEARCH OBJECTIVES

Background

A revolution has begun in science, engineering and technology, based on 
the ability to characterize, manipulate and organize matter 
systematically at the nanometer scale. Nanotechnology is beginning to 
provide the ability to work at this level -- to control nanoscale 
structures, using them as building blocks to construct larger material 
components, systems and architectures to form supramolecular structures 
with fundamentally new molecular organization. Within these larger 
scale assemblies, the control and construction of substructures and 
components remains at the nanometer scale. Nanotechnology offers 
opportunities for the creation and utilization of materials, devices 
and systems by building from the level of atoms and molecules.  The key 
resultant opportunity is the exploitation of novel and improved 
properties that emerge at the nanoscale.  Nanotechnology is expected to 
play an important role in scientific disciplines such as physics, 
material science, biology, medicine, engineering and computer 
simulation.  

Based on measurements on phenomena and processes at the nanoscale, new 
experimental, theoretical and simulation tools have been developed. 
These advances provide fresh opportunities for scientific and 
technological developments in nanostructured materials, nanodevices and 
systems that can benefit biology and medicine. To date, by merging 
biological and synthetic materials, scientists have been able to make 
hybrid structures, such as a nanoscale motor, by attaching a metal rod 
to an ATPase protein complex; assemble nanostructured fibrous scaffolds 
reminiscent of extracellular matrix that can be used to mimic 
properties of bone; and construct nanotubes based on self-assembly of 
unique cyclic peptides for novel antibiotics. Nanostructures such as 
those based on functional polymers and dendrimers, or semiconductor 
nanocrystals, are already having a significant impact on nanotechnology 
research. Dendritic polymers provide access to well controlled 
functional building blocks that may be used for a broad spectrum of 
applications, ranging from unimolecular devices or nanoreactors to 
complex sensors and targeted drug delivery.  Fluorescent quantum dots 
(QDs), about 2 to 7 nm in diameter, provide highly sensitive probes 
that can be used to explore biomolecules, organelles, cells, and 
tissues at the nanoscale. 

Nature's nanomachines, such as motors, pumps, and valves, have inspired 
the design and development of engineered devices.  These nanomachines 
catalyze chemical reactions, transduce information, and transport 
material within and out of the cell.  Recently, the first steps have 
been taken to employ these machines in capacities outside of their 
natural environment; they have been implemented in systems constructed 
to improve our understanding of basic biology and physiology.  
Importantly, these nanomachines may also be useful in driving other 
nanodevices for purposes such as directed delivery of drugs or other 
agents. 

During the last few years, scientists have developed the technology for 
rapidly mapping the genetic and functional information in DNA molecules 
and their products, including the detection of mutations and 
measurement of expression levels.  However, with the completion of the 
human genome, as well as other mammalian and bacteria genomes, new 
types of arrays and methodologies will be required to interpret and use 
the genomic information efficiently and inexpensively. Work on new 
types of chemical arrays should expand to parallel processing of 
biological information, and to analysis of proteins and other 
biomolecules. Nanotechnology has the potential to replace tedious, 
insensitive, and expensive analytical processes. New research aimed at 
the development of new analytical tools that can probe and manipulate 
single molecules at the nanometer scale is emerging. For example, 
scientists are working to develop a nanopore-based DNA sequencing 
device, in which the active components are the size of a DNA molecule. 
These devices can already distinguish between DNA molecules that differ 
from each other by a single base pair, based on the electrical signals 
produced as the DNA interacts with a pore inserted into a membrane. A 
similar concept may be useful for the analysis of other biological 
molecules.

Physical tools for measurement and manipulation of individual molecules 
have also been developed.  Laser-based optical traps allow the capture 
and measurement of forces on individual biomolecules as they interact 
with their substrates or binding partners.  Atomic force microscopes 
permit the measurement of molecular forces as well as imaging of the 
surface topology of individual molecules in the range of 1-10nm, thus 
producing new insight into protein structure and function.  The 
application of specialized spectroscopic techniques, such as 
Fluorescence Resonance Energy Transfer (FRET) allow distances to be 
measured at the nanometer scale, thereby enabling inter- and 
intramolecular structural changes and interactions to be tracked on 
individual molecules.  The utilization of such tools make accessible 
for the first time not only novel measurements, but also the capacity 
to derive information from individual molecules rather than ensemble 
averages.  Novel studies of biological variability at the molecular 
level and of time-dependent phenomena in asynchronous populations of 
molecules are thus coming within reach.  

Realizing the enormous promise of nanotechnology in the different areas 
of biomedical research the BECON/NIH convened a symposium on 
"Nanoscience and Nanotechnology: Shaping Biomedical Research" on June 
25-26, 2000 in Bethesda. The goals and objectives of the Symposium were 
to:

o Develop a better understanding of nanotechnology as it pertains to 
biological and medical applications;
o Communicate recent developments and identify challenges and 
opportunities;
o Develop strategies for integrating nanoscience and nanotechnology 
with medical research and treatment; 
o Discuss the vision and future of this interdisciplinary area; 
o Ensure that NIH can facilitate nanoscience and nanotechnology 
research that will benefit biomedical science; and
o Make recommendations to NIH on areas of future investment.

These goals and objectives were primarily addressed and accomplished 
through breakout panel discussions, which were in turn stimulated by 
visionary and thought-provoking plenary presentations.  In part this PA 
is based on the recommendations made by the participants in that 
symposium. 

Scope

The intent of this PA is to stimulate nanoscience and nanotechnology 
research that will contribute to future advancements in biology and 
medicine. 

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 development of spectroscopic tools (e.g., scanning probe methods, 
quantum dot probes, NSOM, force spectroscopy) and computational methods 
for nanoscale research on cellular processes for structure analysis and 
for the extraction of quantitative information from biological 
nanoscale materials and machines;
 
o research on fundamental principles for nanosystem design, integration 
and application to develop tools to measure and image biological 
processes in health and disease;

o design of artificial nanostructures that could be used within the 
cell as replacements for defective naturally-occurring nanostructures 
or to serve other therapeutic purposes not found in normal cells;

o studies on the integration of active biological molecules such as 
molecular motors and membrane pumps with engineered systems to create 
"living" machines for use in the study of biology, disease diagnosis, 
or therapy; 

o development of new methods for high-throughput cell or molecular 
sorting or sensing using nanotechnology-based particles or tools;

o development of novel synthetic methods for generation of functional 
biomimetic nanostructures characterized by precisely defined 
architectures for use in the study of biology, disease diagnosis, or 
therapy;

o design of nano-sensors suitable for transducing chemical information 
from molecular regions within and surrounding individual cells, 
including monitoring in situ biochemical processes and therapeutic 
action of pharmaceutical agents within single cells, as well as 
monitoring a cell's environment and its response to that environment;  

o development of nanopatterned substrates on programmable surfaces for 
the capture, maintenance, and expansion of therapeutically useful 
cells, and to improve understanding of the role of mechanical forces in 
cell signaling processes;

o development of nanoparticles that enable controlled release of 
therapeutic agents, antibodies, genes and vaccines into targeted cells;

o development of nano-technologies to achieve functional replacement of 
tissue architectures;   

o use of nanoscience and nanotechnology approaches for controlling 
interfaces between prosthetic and extracorporeal devices and tissues. 

Applicants are strongly advised to contact IC scientific program staff 
to discuss the relevance of their proposed work to the institute's 
mission before preparing a detailed research application.  NIH 
institute contacts and specific focus areas are available at: 
http://www.becon.nih.gov/nano_contacts.htm.  

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 (investigator-initiated research project 
grant) and the R21 (exploratory/developmental research grant) award 
mechanisms. As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.  
This PA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.

The R01 mechanism is recommended for applications that propose basic 
and applied nanoscience and nanotechnology research and for which 
preliminary data exists.   

The R21 mechanism is appropriate for proposals that have little 
preliminary data and have the potential for truly groundbreaking 
impact. Investigators with expertise in fields other than biology and 
medicine who wish to explore nanoscience and nanotechnology approaches 
to address biological or medical research questions are encouraged to 
apply. An R21 applicant may request a project period of up to 3 years 
and a budget for direct costs of up to $125,000 per year. An R21 
application should not exceed 15 pages for the Research Plan. 
Applicants are encouraged to contact program staff for information 
about choosing the appropriate grant mechanism. 

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

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.

NIH BECON scientific and financial contacts listed at the following Web 
site should be contacted for answers to questions about scientific or 
financial issues:
http://www.becon.nih.gov/nano_contacts.htm.  

Inquiries regarding general programmatic issues should be directed to:

Eleni Kousvelari, DDS, D.Sc.,
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45 Room 4AN-18A
Bethesda, MD  20892
Telephone:  (301) 594-2427
FAX:  (301) 480-8318
Email:  Kousvelari@de45.nidr.nih.gov

Jeff Schloss, Ph. D.
National Human Genome Research Institute
31Center Drive, Room B2B07
Bethesda, MD  
Telephone:  (301) 435-5538
FAX:  (301) 480-2770
Email:  schlossj@exchange.nih.gov

Inquiries concerning review issues should be directed to:

Jean D. Sipe, Ph.D.
Scientific Review Administrator
NIH - Center for Scientific Review
Rockledge II, Room 4106, Mail Stop 7814
6701 Rockledge Drive,  
Bethesda, MD 20892-7814 (US Mail),
20817 (courier services such as FedEx, UPS)
Telephone: (301) 435-1743
FAX: (301) 480-2644
Email: sipej@csr.nih.gov

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.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted twice a year on February 18 and 
August 18. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: (include if 
appropriate) Applications requesting up to $250,000 per year in direct 
costs must be submitted in a modular grant format.  The modular grant 
format simplifies the preparation of the budget in these applications 
by limiting the level of budgetary detail.  Applicants request direct 
costs in $25,000 modules.  Section C of the research grant application 
instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER 
YEAR:  Applications requesting $500,000 or more in direct costs for any 
year must include a cover letter identifying the NIH staff member 
within one of NIH institutes or centers who has agreed to accept 
assignment of the application.  A list of scientific program contacts 
for participating IC's is available on the Internet at  
http://www.becon.nih.gov/nano_contacts.htm.  
Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before the submittal 
deadline  (February 18 and August 18), i.e., as you are developing 
plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff 
member and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended 
or revised version of these grant application types. Additional 
information on this policy is available in the NIH Guide for Grants and 
Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

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 the receipt 
date listed on the first page.  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

Upon receipt, applications will be reviewed for completeness by CSR 
staff. Applications that are complete will be evaluated for scientific 
and technical merit by an appropriate peer review group convened in 
accordance with standard NIH peer review procedures. 
(http://www.csr.nih.gov/refrev.htm) 
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

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 your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.  Application 
submitted in response to this PA may propose hypothesis-driven, 
discovery-driven, developmental, or design-directed research.

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  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?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

OTHER REVIEW CRITERIA: 

R01 and R21 applications: Are engineering, scientific and clinical 
strategies and methods adequately developed, integrated and appropriate 
to the specific aims?  Are the research milestones and timetable 
adequate?  Is assessment of technological progress adequate with 
respect to specifications and evaluation procedures?  Is the plan for 
dissemination (commercialization, publication, etc.) of results 
adequate? Will the proposed approaches or concepts solve current 
scientific or technical problems in novel ways?

R01 applications only: Does the project address a basic or applied 
nanoscience and/or nanotechnology issue? Does the research team include 
investigators with the required expertise in physical and biomedical 
sciences and engineering? How will the proposed research benefit 
biology and medicine? 

R21 applications only: Does this project have the potential for 
groundbreaking impact?   If successful, will this project achieve at 
least one of the following goals: 1) generate pilot data to effectively 
assess the feasibility of a novel avenue of investigation; 2) involve 
high risk nanoscience and nanotechnology experiments that could lead to 
a breakthrough in biology and medicine; or 3) demonstrate the 
feasibility of new nanotechnologies that could have major impact in a 
specific area of biology and/or medicine?

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 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 
components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 Nos. No., 93.821, 93.847, 93.848, 93.849, 
93.286, 93.287, 93.173, 93.121, 93.394, 93.866, 93.113, 93.114, 93.853, 
93.867).
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 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 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
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