COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR HEART, LUNG, BLOOD, 
AND SLEEP DISORDERS    

RELEASE DATE:  December 01, 2003

PA NUMBER:  PA-04-028 (This PA has been expired, see NOT-HL-06-117)
                      (Clarification of submission requirements, see NOT-HL-05-124)

EXPIRATION DATE:  February 1, 2006

IMPORTANT CHANGE: The opportunity to apply for an NHLBI SBIR and STTR Phase II 
Competing Renewal is available from the PHS 2006-2 SBIR/STTR Omnibus Solicitation. 
(See Program Descriptions and Research Topics (PDF or MS Word)). Interested 
applicants must apply using the electronic application package from the parent 
SBIR (PA-06-120) or STTR (PA-06-121) Funding Opportunity Announcements (FOAs).  
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837, 93.838, 93.839 

APPLICATION RECEIPT DATE(S):   Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines 
[April 1, August 1, December 1]

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Project Period and Amount of Award
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements  
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

NOTICE: This program announcement (PA) must be read in conjunction with the 
current Omnibus Solicitation of the National Institutes of Health, Centers for 
Disease Control and Prevention, and Food and Drug Administration for Small 
Business Innovation Research (SBIR) and Small Business Technology Transfer 
(STTR) Grant Applications. The solicitation (see 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) contains information 
about the SBIR program, regulations governing the program, and information for 
submission. All of the instructions within the current SBIR Omnibus 
Solicitation apply. 

PURPOSE OF THE PA 
 
The purpose of this Program Announcement (PA) is to solicit from NHLBI-
supported SBIR Phase II awardees, competing continuation applications that 
propose to continue the process of assessing and improving devices or 
conducting preclinical studies of products or devices that ultimately require: 
1) clinical evaluation, 2) approval by a Federal regulatory agency, and 3) 
continuing refinements to durable medical equipment (DME) designs such as cost 
reduction, testing for safety, durability, and reliability, and meeting or 
establishing standards.  Such products include, but are not limited to 
biological products, devices, drugs, vaccines, medical implants, etc. related 
to the mission of the NHLBI. Only SBIR Phase II awardees are eligible to 
submit a competing continuation application.  The previously funded Phase II 
SBIR grant need not have been submitted in response to a particular 
solicitation, as long as the research is appropriate to the purpose of this 
solicitation. Since the Phase II competing continuation grant is a new funding 
mechanism and is contingent on the fiscal and programmatic interests and 
priorities of the NHLBI, eligible applicants are strongly encouraged to 
contact their NHLBI Program official prior to submission. 

RESEARCH OBJECTIVES

Background

The Small Business Innovation Research (SBIR) program was initiated as a 
means for government agencies to use small businesses to stimulate 
technological innovation and to help agencies meet their research and 
development (R&D) needs. An additional provision of these programs is the 
expected commercialization of the research.  Certain types of research 
require clinical evaluation and federal regulatory approvals before Phase III 
of the small business research pathway can be realized.  A recipient of NIH 
SBIR Phase I and Phase II awards normally receives a total of no more than 
$850 thousand.  If the intended commercialized product is a medical device, 
drug or biologic, the $850 thousand often represents a small fraction of the 
funds necessary to complete the studies required for approval and licensing 
by the Food and Drug Administration (FDA) or other federal agencies.  The 
Phase II competing continuation support will allow small businesses to 
address clinical issues, and other important issues relevant to regulatory 
approvals by agencies such as the FDA.

The SBIR Phase II competing continuation would represent a continuation of 
support for research and development of such previous work funded by the 
original Phase II grant.  It is expected that promising results from a 
previous SBIR Phase I and Phase II grant will indicate the merit of further 
research and development.  Clinical investigations and Federal regulatory 
approvals will ultimately be required to realize the potential of the product 
being researched and developed.

Activities supported by a competing continuation of a Phase II SBIR 
grant are meant to enable small businesses to complete the necessary 
preclinical R&D needed for pre-investigational new drug (IND), or 
investigational device exemption (IDE) filing, or other processes needed to 
meet the requirements and expectations of Federal regulatory agencies prior 
to clinical evaluation for safety, toxicity and effectiveness.  A competing 
continuation Phase II award may not be used to conduct early stage research 
(e.g., identifying targets for drugs, identification of new and more 
effective compounds or potential diagnostic markers, initial device/software 
development, optimizing device functionality or initial assay testing, etc.). 

Examples of Research Topics

Examples of research that would be considered responsive to this announcement 
are listed below for illustrative purposes and are not exclusive of other 
appropriate activities.

o  Preclinical studies, including pharmacology and toxicology, beyond those 
conducted under the Phase I (R43) and initial Phase II (R44) grants.    

o  Completion of studies as required by the Food and Drug Administration 
(FDA) for Investigational New Drug (IND) or Radioactive Drug Research 
Committee (RDRC) application.  

o  Assessment of devices with regard to performance standards related to the 
FDA approval process.

o  Safety and effectiveness studies of novel medical devices and tissue 
engineered products. 

o  Biocompatibility studies of surface materials of putative medical 
implants.

o  Evaluation of novel imaging approaches for diagnostic purposes.

o  Clinical studies in support of New Drug Application approval by the FDA.

o  Clinical studies in support of Pre-Market Approval for biomarkers/medical 
devices by the FDA.
      
MECHANISM(S) OF SUPPORT 

This PA uses the SBIR Phase II (R44) mechanism. As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project. 

An NHLBI SBIR Phase II competing continuation application must be in response 
to this PA, and the application will be accepted only as a competing 
continuation of a previously funded NHLBI Phase II SBIR (R44) grant.  The 
previously funded NHLBI Phase II grant need not have been submitted in 
response to any particular solicitation, but the application for the competing 
continuation must propose research and development that represents a logical 
extension of the previously supported Phase II research as described in this 
announcement.  

This PA uses just-in-time concepts.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 

PROJECT PERIOD AND AMOUNT OF AWARD

For this PA, budgets up to $1,000,000 total costs per year and time periods 
up to 3 years may be requested for Phase II. Total costs include direct 
costs, F&A, and fee/profit in accordance with the current SBIR guidelines.  
(see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) The competing 
continuation grant cannot be renewed.

ELIGIBLE INSTITUTIONS 

Eligibility requirements are described in the SBIR/STTR Omnibus 
Solicitation.  Only small business concerns are eligible to submit 
applications.  A small business concern is one that, on the date of award for 
both Phase I and Phase II agreements, meets ALL of the criteria as described 
in the SBIR/STTR Omnibus Solicitation. The competing continuation application 
must be a continuation of a previously funded NHLBI Phase II (R44) grant 
focusing on research and development of a product or products ultimately 
requiring clinical testing and Federal regulatory approval.

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.  On an SBIR application, the principal 
investigator must have his/her primary employment (more than 50%) with the 
small business at the time of award and for the duration of the project. 

SPECIAL REQUIREMENTS

An applicant must provide evidence that they have contacted the Food and Drug 
Administration (FDA) for guidance concerning the development of a drug, 
biologic, or medical device.  Such evidence should include FDA correspondence 
regarding an investigational new drug (IND) application, investigational 
device exemption (IDE), or pre-market notification (510k) for the applicant’s 
product development and the status of their project in a timeline related to 
Federal regulatory approval processes. 

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 two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Heart

Suzanne Goldberg, R.N., M.S.N.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9174 (MSC 7940)
Bethesda, MD 20892-7940 (20817 for Courier)
Telephone: (301)435-0532 
Fax: (301)480-1336
Email: goldbergsh@mail.nih.gov

Rosalie A. Dunn, Ph. D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9196 (MSC 7940)
Bethesda, MD 20892-7940 (20817 for Courier)
Telephone: (301) 435-0505
Fax:  (301) 480-1454
Email:  dunn@nhlbi.nih.gov

Lung/Sleep

Mrs. Ann Rothgeb
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10114 (MSC 7952)
Bethesda, MD 20892-7952 (20817 for Courier)
Telephone:  (301) 435-0202
FAX:  (301) 480-3557 
Email:  ar31t@nih.gov

Blood

Phyllis Mitchell, M.S.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10163(MSC 7950)
Bethesda, MD 20892-7950 (20817 for Courier)
Telephone: (301) 435-0481
Fax: (301) 480-1060
Email:  mitchelp@nhlbi.nih.gov

Liana Harvath,Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10170 (MSC 7950)
Bethesda, MD  20892-7950 (20817 for Courier)
Telephone:  (301) 435-0063
FAX:  (301) 480-0868
Email: HarvathL@nhlbi.nih.gov

Epidemiology and Clinical Applications

Paula T. Einhorn, M.D., M.S.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8001 (MSC 7936)
Bethesda, MD  20892-7936 (20817 for Courier)
Telephone:  (301) 435-0563
FAX:  (301)480-1669
Email: einhornp@nhlbi.nih.gov

o Direct your questions about financial or grants management matters to:

Shelia Ortiz
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7171
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
Fax: (301) 480-3310
Email:  ortizs@nhlbi.nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR Phase II 
applications (new and revised.)  Effective October 1, 2003, applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number 
as the Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html.  

Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation 
and the PHS 398. Helpful information for advice and preparation of the 
application can be obtained at: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will 
return applications that are not submitted on the 5/2001 version of the PHS 
398.  For further assistance contact GrantsInfo, Telephone: (301) 435-0714, 
Email: GrantsInfo@nih.gov. 

The title and number of this PA must be typed on line 2 of the face page of 
the application.

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 (for USPS Express or Regular Mail)
Bethesda, MD  20817 (for Express/courier non-USPS service)

Applications must be received by or mailed on or before the receipt dates 
described on the first page of this program announcement. 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 unfunded version of an application 
already reviewed, but such application must include an Introduction addressing 
the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
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 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 written critique
o Receive a second level review by an appropriate advisory council or board.  

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

ALL SBIR APPLICATIONS
  
1.   Significance:  Does the proposed project have commercial potential to 
lead to a marketable product or process? Does this study address an important 
problem? What may be the anticipated commercial and societal benefits of the 
proposed activity? If the aims of the application are achieved, how will 
scientific knowledge be advanced? Does the proposal lead to enabling 
technologies (e.g., instrumentation, software) for further discoveries? Will 
the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs? 

2.   Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Is the proposed plan a sound approach for establishing technical and 
commercial feasibility? Does the applicant acknowledge potential problem 
areas and consider alternative strategies? Are the milestones and evaluation 
procedures appropriate? 

3.   Innovation:  Does the project challenge existing paradigms or employ 
novel technologies, approaches or methodologies? Are the aims original and 
innovative? 

4.   Investigators: Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR? Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subcontractors (if any)? Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed? 

5.   Environment:  Is there sufficient access to resources (e.g., equipment, 
facilities)? Does the scientific and technological environment in which the 
work will be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific environment 
or employ useful collaborative arrangements?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be applied to ALL applications in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See additional information and 
criteria included in the section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 additional information and Inclusion Criteria in the sections 
on Federal Citations, below).

Human Subjects: 
1.   Protection of Human Subjects from Research Risks - for all studies 
involving human subjects. See instructions and "Guidance for Preparing the 
Human Subjects Research Section.” If an exemption is claimed, is it 
appropriate for the work proposed? If no exemption is claimed, are the 
applicant's responses to the six required points appropriate? Are human 
subjects placed at risk by the proposed study? If so, are the risks 
reasonable in relation to the anticipated benefits to the subjects and 
others? Are the risks reasonable in relation to the importance of the 
knowledge that reasonably may be expected to be gained? Are the plans 
proposed for the protection of human subjects adequate? 

2.   Inclusion of Women Plan - for clinical research only.  Does the 
applicant propose a plan for the inclusion of both genders that will provide 
their appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

3.   Inclusion of Minorities Plan - for clinical research only.  Does the 
applicant propose a plan for the inclusion of minorities that will provide 
their appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

4.   Inclusion of Children Plan - for all studies involving human subjects.  
Does the applicant describe an acceptable plan in which the representation of 
children of all ages (under the age of 21) is scientifically appropriate and 
recruitment/retention is addressed realistically? If not, does the applicant 
provide an appropriate justification for their exclusion? 

5.   Data and Safety Monitoring Plan – for clinical trials only.  Does the 
applicant describe a Data and Safety Monitoring Plan that defines the general 
structure of the monitoring entity and mechanisms for reporting Adverse 
Events to the NIH and the IRB? 

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the required five items described under Vertebrate 
Animals (section f of the Research Plan instructions) will be assessed. 

BIOHAZARDS:  Is the use of materials or procedures that are potentially 
hazardous to research personnel and/or the environment proposed? Is the 
proposed protection adequate? 

ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be 
considered by reviewers but will not be included in the determination of 
scientific merit.

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research must include a data sharing plan 
in their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
     
BUDGET:  The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI appropriate for 
the work proposed? On applications requesting up to $100,000 total costs, is 
the overall budget realistic and justified in terms of the aims and methods 
proposed? On applications requesting over $100,000 in total costs, is each 
budget category realistic and justified in terms of the aims and methods? 
   
PERIOD OF SUPPORT:  The appropriateness of the requested period of 
support in relation to the proposed research.

TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS 

In addition to the above review criteria, the following items will be applied 
to ALL Type 2 Competing Continuation Phase II applications in the 
determination of scientific merit and the priority score: 
o  Does the activity as proposed address issues related to Federal regulatory 
approval processes?
o  What will be the effect of these studies on the concepts or methods that 
drive this field?

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

RECEIPT AND REVIEW SCHEDULE  

See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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 "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://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

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

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