HIV VACCINE RESEARCH AND DESIGN PROGRAM

RELEASE DATE:  April 3, 2003 
PA NUMBER:  PAR-03-094 (See amendment, NOT-AI-05-033)
                       (see addenda NOT-AI-04-004, NOT-AI-03-038)

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Replacement P01 (PAR-06-285) funding 
opportunity announcement has been issued for the 
submission date of June 1, 2006 and submission dates thereafter.

EXPIRATION DATE: November 15, 2005, unless reissued.

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

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

APPLICATION RECEIPT DATE: November 13, 2003, November 15, 2004, November 14, 
2005

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 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

PURPOSE OF THIS PA 

The National Institute of Allergy and Infectious Diseases (NIAID) of the 
National Institutes of Health (NIH) invites applications for research aimed 
at obtaining a safe and efficacious vaccine against HIV or AIDS.  NIAID 
supports the progressive stages of AIDS vaccine research and development from 
basic research through iterative product development, and clinical trials.  
NIAID supports AIDS prophylactic vaccine research and development via three 
solicited grant programs.  The Innovation Grant Program for AIDS Vaccine 
Research supports high risk/high impact early stage concept evaluation for 
projects with limited preliminary data. The HIV Vaccine Research and Design 
(HIVRAD) Program supports a multi-project HIV vaccine design and development 
research application.  The Integrated Preclinical/Clinical AIDS Vaccine 
Development (IPCAVD) Program, also a multi-project Program, supports 
iterative product development and later stage vaccine optimization and must 
include limited human studies.

NIH Support of Research on this Topic
Applications submitted in response to Program Announcements are assigned 
according to established PHS referral guidelines.  When the subject of an 
application is of interest to more than one component of NIH, dual 
assignments are made.

RESEARCH OBJECTIVES

Background

Vaccine research requires contributions from multiple fields including 
immunology, virology, molecular biology, viral disease pathogenesis, and 
animal modeling.  The HIVRAD program supports multidisciplinary AIDS vaccine-
related studies.  As summarized in PURPOSE above, HIVRAD is designed to 
accept projects too advanced for the exploratory Innovation Grant Program, 
but not yet sufficiently advanced for the product/clinically-oriented IPCAVD 
program.

Research Objectives and Scope

The overall objective of the HIVRAD program and this program announcement is 
to advance vaccine concepts further towards the development of an AIDS 
vaccine.  To that end, applicants may target any area of AIDS vaccine 
research.  These areas include, but are not limited to: development of viral 
and bacterial vector systems, development of improved animal model systems to 
address vaccine efficacy, and studies of immune responses from existing 
vaccine cohort samples. Other areas may include studies of HIV immunogen 
structure as it relates to improving immunogenicity, or approaches to 
increase the immunogenicity of HIV antigens.  Extensive modeling of vaccine 
concepts in non-human primates may also be included. The safety evaluation of 
immunogens in infected animals may be included if these studies directly 
support the development of a prophylactic vaccine.  Applicants are required 
to delineate in their application discrete goals with measurable milestones 
and include criteria that can be used in deciding when to proceed to the next 
phase of vaccine development. Clinical studies involving humans and/or 
vaccine research focused solely on therapeutic applications would not be 
considered appropriate for this PA.  For information on programs that support 
therapeutic vaccine development, please contact program staff.  

MECHANISM OF SUPPORT

This PA will use the NIH program project grant (P01) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  Program project grants support broadly 
based, multidisciplinary research programs that have a well-defined, central 
research focus or objective.  An important feature is that the 
interrelationships of the individual scientifically meritorious projects will 
result in a greater contribution to the overall program goals than if each 
project were pursued individually.  The program project grant consists of a 
minimum of three interrelated individual research projects that contribute to 
the program objective.  This type of award also can provide support for 
certain common resources termed cores.  Such resources should be utilized by 
two or more projects within the award.  An exception to standard policy has 
been granted for this program announcement such that fundable applications 
may have at least two (2) projects and one  (1) core. The total project 
period for P01 grants may not exceed five years.  At this time, the NIAID is 
administratively limiting the duration of P01 grants to four years; this 
administrative limitation may change in the future.  In addition, P01 grant 
applications submitted in response to this PA may not request in excess of 
$750,000 first-year total (direct and FFacilities and Administrative (F&A) 
costs.

Applicants for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

ELIGIBLE INSTITUTIONS 

The applicant may submit (an) application(s) if the 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 
o Faith-based or community-based organizations 

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.

SPECIAL REQUIREMENTS

Milestones

Based on comments from the peer reviewers, the Program Officer may wish to 
revise the milestones included in the application through negotiation with 
the applicant.  The finalized milestones will be included in the Terms of 
Award.  The achievement of the milestones will be the focus of discussion at 
the annual site visit review (as described below).

Annual Meetings

All awardees are required to host, for the Program Officer and NIAID Program 
Staff, an annual site visit.  The PI and all co-PIs shall attend this 
meeting.  An update and summary of results generated from each project shall 
be presented by the PI, co-PI and/or all pertinent staff.  These 
presentations shall include summaries of all goals or milestones achieved 
during the review period and a description of all problems encountered that 
may have an impact on the achievement of future goals and/or milestones.

Patent Coverage

Since applications may involve several institutions, including the private 
sector, complex patent issues may arise.  To avoid delays in the 
implementation of new vaccines for HIV-related intellectual property issues, 
each multi-project group is required to provide a plan as part of the 
application that details: (1) the approach for obtaining patent coverage and 
licensing, where appropriate, (2) a statement demonstrating acceptance of the 
approach signed by all parties, and (3) the procedures to be followed for the 
resolution of legal problems that may potentially develop.

When 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. 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.

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 letter of intent identifying the NIAID staff member who has agreed 
to accept assignment of the application. 

Specifically, applicants requesting more than $500,000 must carry out the 
following steps:

1) Contact the NIAID program staff person listed in this PA at least 6 weeks 
before submitting the application, i.e., as applicant is developing plan for 
the study. 

2) Obtain agreement from the NIAID contact that the IC will accept the 
application for review and potential consideration for award, and

3) Identify in the letter of intent, the NIAID staff member contacted, a 
proposed first year budget with the number of Projects, PIs and Institution 
for each project, specific aims for each project, and a projected budget for 
the proposed funding period. 

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. 

WHERE TO SEND INQUIRIES

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

o Direct questions about scientific/research issues to:

Dr. Michael Pensiero
Division of AIDS 
National Institute of Allergy and Infectious Diseases 
Room Number 4109, MSC-7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628 
Telephone: (301) 435-3749 
FAX: (301) 402-3684 
Email: mp338m@nih.gov 

o Direct questions about peer review issues to:

Dr. Dianne Tingley
Division of Extramural Affairs 
National Institute of Allergy and Infectious Diseases 
Room Number 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-2550
FAX: (301) 402-2638 
Email: dt15g@nih.gov 

o Direct questions about financial or grants management matters to:

Victoria P. Connors 
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases 
Room Number 2121, MSC-7614 
6700-B Rockledge Drive
Bethesda, MD 20892-7614 
Telephone: (301) 402-6579  
FAX: (301) 480-3780 
Email: vp14v@nih.gov 

SUBMITTING AN APPLICATION

Applicants for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.  This brochure presents 
specific instructions for sections of the PHS 398 (rev. 5/01) application 
form that should be completed differently than usual.  For all other 
instructions for sections of the PHS follow the usual instructions in the PHS 
398.

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 on or before the receipt dates noted at the 
heading of this Program Announcement.

Applications that are not received as a single package on the receipt date or 
that do not conform to the instructions contained in PHS 398 (rev. 5/01) 
Application Kit (as modified in, and superseded by, the NIAID BROCHURE 
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be 
judged non-responsive and will be returned to the applicant. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three 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)

At the time of submission, two additional exact copies of the grant 
application and all five sets of any appendix material must be sent:

Dr. Dianne Tingley
Chief, AIDS Preclinical Research Review Branch 
Division of Extramural Affairs 
National Institute of Allergy and Infectious Diseases 
Room Number 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-2550
FAX: (301) 402-2638 
Email: dt15g@nih.gov 

APPLICATION PROCESSING: The application must be received by the 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.

Concurrent submission of an R01 and a Component Project of a Multi-project 
Application: Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application. If, following review, both the 
multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have 
the option to withdraw from the multi-project grant.  This is an NIH policy 
intended to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is removed from 
the program.  Investigators wishing to participate in a multi-project grant 
must be aware of this policy before making a commitment to the Principal 
Investigator and awarding institution.

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

Upon receipt, applications will be reviewed for completeness by the NIH 
Center for Scientific Review and for responsiveness to the goals of this PA 
by NIAID staff. Incomplete or non-responsive applications will be returned to 
the applicant without further consideration. Applications that are complete 
and responsive to this PA will be evaluated for scientific and technical 
merit by an appropriate peer review group convened by the NIAID. As part of 
the initial merit review, all applications will: 

P01 applications that are complete and responsive to this PA will be 
evaluated for scientific and technical merit by an appropriate peer review 
group convened by the NIAID.

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 National Advisory Allergy and 
Infectious Diseases Council

REVIEW CRITERIA

The general review criteria for P01 grant applications are presented in the 
NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm.

ADDITIONAL REVIEW CRITERIA: In addition, the following review criteria items 
will be considered 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 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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.

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

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

The NIAID gives special consideration for funding, including award of grants 
beyond the established NIAID percentile and priority score paylines, to 
scientifically meritorious applications in response to Program Announcements.

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.

MONITORING PLAN AND DATA AND SAFETY 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.  This policy announcement is 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.

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 Catalogue 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. 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 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 NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.  All awards are subject to the terms and conditions, cost 
principles, and other considerations described in the NIH Grants Policy 
Statement. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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