SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID)

RELEASE DATE:  July 19, 2004    

PA NUMBER:  PA-04-127 (This PA has been reissued, see PA-06-134 
                       and PA-06-135)

EXPIRATION DATE:  February 2, 2006

Department of Health and Human Services (DHHS) 

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

COMPONENT OF PARTICIPATING ORGANIZATION
National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

APPLICATION RECEIPT DATES
Applications submitted in response to this program announcement will be 
accepted at the standard SBIR and STTR application deadlines 
(http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm)

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o Purpose of the PA
o Research Objectives
o Mechanisms 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule 
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 [PDF] or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains 
information about the SBIR and STTR programs, regulations governing the 
programs, and instructional information for submission. All of the 
instructions within the current SBIR/STTR Omnibus Solicitation apply with the 
exceptions of total costs and award periods.

PURPOSE OF THE PA

This PA invites grant applications for SBIR advanced technology projects that 
require a longer award period and greater award amount than those routinely 
allowed under the SBIR program.  For this PA, "advanced technology" is 
defined as a product or service that will require approval of the Food and 
Drug Administration (FDA) and is in one of the following three research 
areas.

o Development of vaccines, biologics, drugs and prevention strategies for 
infectious and immunologic diseases, allergy, and transplantation.

o Development of vaccine, biologic and drug delivery systems.

o Development of assays and therapeutic monitoring systems for clinical and 
vaccine trials and for improved diagnosis of infectious, allergic, and 
immunologic diseases.

The NIAID Small Business High Priority Areas of Interest are listed at 
http://www.niaid.nih.gov/ncn/sbir/sbirareas.htm.

This PA replaces PA-01-052 (http://grants.nih.gov/grants/guide/pa-files/PA-01-052.html) 
and the Notice addendum NOT-AI-03-049 to PA-01-052 
(http://grants.nih.gov/grants/guide/notice-files/NOT-AI-03-049.html). 

RESEARCH OBJECTIVES 

The SBIR program was initiated as a means for government agencies to use 
small businesses to stimulate technological innovation and help agencies meet 
their research and development (R&D) needs.  An additional provision of the 
SBIR program is the expected commercialization of the research.  Many NIAID 
supported small business projects require clinical evaluation and FDA 
approval.  To be successful, these types of projects often require longer 
periods for Phase I and Phase II and higher award amounts than those 
routinely awarded under the SBIR program. Despite the cost and the length of 
time required to move such products from the laboratory to the patient, these 
are precisely the products with potential to contribute significantly to the 
economy of the nation and to the improvement of public health.  The intent of 
the NIAID SBIR-AT-NIAID PA is to support such R&D.

MECHANISMS OF SUPPORT

This PA uses the SBIR mechanism which is a set-aside program. Neither STTR 
applications nor SBIR Fast-Track applications will be accepted in response to 
this PA. As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project. Future unsolicited, competing 
continuation applications based on this project will compete with all SBIR 
applications and will be reviewed according to the customary peer review 
procedures.

This PA uses just-in-time concepts. It also uses the modular budgeting 
format. Specifically, if you are submitting an application budget of $100,000 
total costs (direct, F&A and fee) or less, use the modular format and 
instructions as described in the current SBIR/STTR Omnibus Solicitation. 
Otherwise follow the instructions for non-modular budget research grant 
applications.  This PA encourages but does not require cost sharing as 
defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#matching_or_cost_sharing.

PROJECT PERIOD AND AMOUNT OF AWARD

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards. For this PA, budgets up to $300,000 total costs per year and 
time periods up to 2 years for Phase I may be requested.  Budgets up to $1 
million 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 a profit/fee.  

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 grants, meets ALL of the criteria as described in the SBIR/STTR Omnibus 
Solicitation.

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

As stated under PURPOSE, the only projects eligible for this PA are those 
that propose research leading to a product or service that will require 
approval of the FDA and that propose research in one of the following three 
areas.  

o Development of vaccines, biologics, drugs and prevention strategies for 
infectious and immunologic diseases, allergy, and transplantation.

o Development of vaccine, biologic and drug delivery systems.

o Development of assays and therapeutic monitoring systems for clinical and 
vaccine trials and for improved diagnosis of infectious, allergic, and 
immunologic diseases.

Only applicants who have received a Phase I SBIR award are eligible to apply 
for a competing continuation SBIR-AT-NIAID Phase II award.  The Phase I SBIR 
award required for eligibility need not be an SBIR-AT-NIAID award.

When human clinical studies or trials are a component of the research 
proposed, NIAID policy requires that studies be monitored commensurate with 
the degree of potential risk to study subjects and the complexity of the 
study.  Terms and Conditions of Award will be included with awards.  An 
updated NIAID policy was published in the NIH Guide on July 8, 2002 and is 
available at:  http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.
The full policy, including terms and conditions of award, is 
available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

A mandatory milestone for projects involving humans is the approval of the 
final clinical protocol by NIAID prior to the accrual of subjects into the 
trial.  Applications that contain or comprise a clinical trial should also 
include a budget item for preparation of a clinical protocol.  Protocol 
development must be consistent with Federal and NIAID specific regulations 
governing the conduct of human subjects research 
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).  Potential applicants are 
encouraged to contact appropriate NIAID program staff concerning this policy.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries fall into two areas:  
scientific/research and financial or grants management issues.  

o Direct your questions about scientific/research issues to:

Gregory Milman, Ph.D.  
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2153, MSC-7610
6700-B Rockledge Drive
Bethesda, MD 20892-7610 (US Mail) 
Rockville, MD 20817-7610 (Delivery Services) 
Telephone (301) 496-8666
Fax: (301) 402-0369 
Email: gm16s@nih.gov 

Applicants are also directed to a list of research areas and program staff 
for each area at 
http://grants.nih.gov/grants/funding/sbirsttr1/2005-2_SBIR-STTR-topics.pdf#page=25.

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

Ms. Pamela Fleming
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2119, MSC 7614
6700-B Rockledge Drive 
Bethesda, MD 20892-7614 
Bethesda, (MD 20817-7614 for express/courier service)
Telephone: (301) 402-6580 
FAX: (301) 480-3780 
Email: pf49e@nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR Phase 
I, Phase II and Fast-Track 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)

APPLICATION PROCESSING:  Applications must be received by or mailed on or 
before the receipt dates described on the first page of this program 
announcement. The NIH 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 NIH 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 that are complete 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 national advisory council 
or board.

REVIEW CRITERIA

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

o Significance
o Approach
o Innovation
o Investigator
o Environment

ALL SBIR/STTR 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). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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 $500,000 or more 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. 
(http://grants.nih.gov/grants/policy/data_sharing)

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.

PHASE II APPLICATIONS In addition to the above review criteria:

1. How well did the applicant demonstrate progress toward meeting the Phase I 
objectives, demonstrating feasibility, and providing a solid foundation for 
the proposed Phase II activity? 

2. Did the applicant submit a concise Commercialization Plan that adequately 
addresses the seven areas described in the Research Plan item J? 

3. Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan? 

AMENDED APPLICATIONS

In addition to the above criteria, the following criteria will be applied to 
revised applications.

1. Are the responses to comments from the previous SRG review adequate? 
2. Are the improvements in the revised application appropriate? 

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended SBIR 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 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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.htm).
  
SHARING RESEARCH DATA:  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. 

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).
  
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/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research 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)(cite appropriate 
authorizations) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 
and 92 (cite relevant regulations). 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.


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