and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19) |
Activity Code |
U19 Research Program Cooperative Agreements |
Announcement Type |
Reissue of PAR-10-161 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-13-042 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855, 93.856 |
Funding Opportunity Purpose |
The goal of the IPCAVD Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) is to facilitate the translation of sufficiently advanced, innovative and promising vaccine candidates into early clinical testing. The IPCAVD program is designed to enable a multi-disciplinary team of investigators to complete all steps necessary from down-selection of a vaccine candidate through CGMP manufacture/testing/product release and into clinical trials. A preclinical research application alone is not sufficient for this announcement. Awards will provide the critical resources to allow the advancement of vaccine concepts to clinical trials within the first 5 years of the award. The reduced support for two additional years will support ongoing stability studies, updating regulatory submissions and further optimization as informed from the clinical studies. However, this funding opportunity will not provide funds for conducting the clinical studies; applicants are encouraged to collaborate with NIAID-supported clinical trial networks or to develop other relationships to support the clinical studies. A clinical development plan describing means to initiate a clinical study during the first 5 years of award is a requirement of this FOA. |
Posted Date |
December 14, 2012 |
Letter of Intent Due Date(s) |
February 15, 2013 ; February 14, 2014; February 13, 2015 |
Application Due Date(s) |
March 15, 2013; March 14, 2014; March 13, 2015 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
July, 2013; July, 2014; July, 2015 |
Advisory Council Review |
October, 2013; October, 2014; October, 2015 |
Earliest Start Date |
December, 2013; December, 2014; December, 2015 |
Expiration Date |
(Now Expired January 16, 2014 per NOT-AI-14-030), Originally March 14, 2015 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The development of a safe and effective prophylactic vaccine against HIV/AIDS is one of the highest priorities of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). To date numerous experimental prophylactic HIV vaccines have been tested in phase I clinical trials, some of which were supported through NIAID s Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD). Only three large-scale HIV vaccine efficacy trials have been completed to date. Two of these trials provided no evidence of efficacy, despite the fact that the vaccines induced an immune response in many trial participants. Recently, vaccines tested in a third trial, in Thailand (RV144), demonstrated modest efficacy at preventing HIV infection. These results, together with promising Non-Human Primate (NHP) vaccine efficacy studies, provide some evidence that a HIV vaccine may be within reach. Therefore, one of the goals of the NIAID is to support studies to confirm and extend the results of RV144. Another major goal of the NIAID, is to continue the advancement of promising and innovative HIV vaccine platforms, unrelated to those used in RV144, for evaluation in early clinical trials. This IPCAVD is designed to support both of the NIAID goals through the translation of innovative HIV vaccines of various types to the point of testing in human clinical trials.
The objective of the IPCAVD program is to facilitate the translation of advanced, innovative, and promising vaccine platforms for the development of prophylactic HIV vaccines towards clinical research studies by providing the support necessary for achieving this goal. Applicants are expected to articulate what scientific question(s) or concepts are being addressed in their applications. This 7 year FOA will provide the critical resources necessary for achieving the goal of advancing vaccine concepts into clinical studies within the first 5 years of the award; the latter 2 years of funding will provide resources to allow for ongoing stability studies, updating regulatory submissions and further vector optimization as informed by clinical testing. Specifically the IPCAVD award will provide support for: (1) all stages of vaccine platform research and development through facilitation of Non-Human Primate (NHP) proof-of concept studies and down-selection of the final lead candidate; (2) all product development stages including processes development, CGMP manufacturing and formulation: and (3) support for all IND-enabling studies and regulatory submissions. Unlike previous IPCAVD FOAs, funds will not be provided for the performance of clinical trials. However, a clinical development plan including a plan or a clinical trial within the first 5 years of the funding period is a requirement. It is anticipated that in the last 2 years of the 7-year award the applicants will perform ongoing stability program studies, continue product characterization, and update regulatory submission that would allow the product to remain in compliance for future clinical trials
Research Projects: The multi-project (U19) application must propose a minimum of two projects and one of the projects must perform product manufacture as described below. The Program will support the funding of a multidisciplinary consortium of experts in animal models, molecular biology, immunology, and manufacturing. Specific activities in the application may include basic HIV vaccine research, preclinical testing and vaccine optimization, product development and CGMP manufacturing; and parallel NHP efficacy studies. In addition, each individual research project must include a clear delineation of goals with measurable milestones, and a timeline for the attainment of each goal and milestone.
Product Manufacturing Project (required): Product development will be required for generating materials for a clinical study to address the specific questions with the proposed vaccine platform. The Product Manufacturing Project should contain a Product Development Plan describing the clinical materials to be generated for the clinical studies.
Applications consisting of preclinical research alone will not be considered appropriate for this announcement and will not be reviewed.
Administrative Core (required): Each application must include an administrative core headed by the contact PD/PI. An administrative core is a resource to the multi-project grant, providing overall management, coordination, and supervision of the Program. The administrative core administers the plan provided in the application to address the short- and long-term management of the program. The Administrative Core should specifically address communications, group meetings and teleconferences, presentation and publication of data, resource and model sharing and transmission of information and reagents, awareness of development progress and outcomes of other projects within the program, and the identification and resolution of problems. The communication plan should address the interrelationship between the projects and cores. Provide an organizational chart for the U19 program including the name, institution, scientific discipline of the Program Director/Prinicipal Investigatorand all key personnel. Include a discussion of lines of authority and plans for coordination of projects and cores and the collaboration for the clinical trial.
Scientific Core(s) (optional): A scientific core is a resource to the multi-project grant and inclusion of Scientific Cores is at the discretion of the applicant. Scientific Cores must support at least two of the proposed research projects. The application must indicate the specific projects to be served by the Scientific Core(s).
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the PHS 398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIAID anticipates that approximately $4 million total costs will be available in FY2014 to fund 1-3 new or renewal awards in response to this FOA. |
Award Budget |
As a guideline, the approximate range of funding in direct cost for similar awards has been $1.5 to $2.5 million per year for the first 5 years; years 6 and 7 will be funded at significantly reduced levels commensurate with the reduced scope of work compared to the first 5 years. Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
The total project period for an application submitted in response to this FOA may not exceed seven years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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 support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Eleazar Cohen, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3129, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
FEDEX zip code: 20817
Phone: (301) 435-3564
Fax: (301) 480-2408
Email: [email protected]
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:
Eleazar Cohen, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3129, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FEDEX zip code: 20817
Phone: (301) 435-3564
Fax: (301) 480-2408
Email: [email protected]
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed. with the following pages limits for the research strategy of each component.
Supplemental Instruction for the Preparation of Multi-Project Applications
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.
The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme. All applications must be submitted on Form PHS 398. The multi-project grant application should be assembled and paginated as one complete document in the following order:
Essential elements of the multi-project U19 include:
Lack of synergy and interaction among the Research Projects and Scientific Cores will adversely affect the impact score of a U19 application, even if the Scientific and Technical merit of individual projects is high.
Complete this page as instructed in the Application Guide. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.
Description: Using Page 2 of Form 398; provide a succinct but accurate description (abstract) of the overall multi-project application addressing the major, common theme of the program. Do not exceed the space provided.
Project/Performance Sites: List the performance sites where the research will be conducted.
Senior/Key
Personnel: Under "Key Personnel", list the
PD(s)/PI(s) of the multi-project application, followed by the Research Projects
and Core Leaders of the component research projects and cores, and other key
personnel and then other significant contributors.
Do not use Form Page 3 of the PHS 398; a more comprehensive
table of contents is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed project by
project and core by core; prepare a detailed Table of Contents that will enable
reviewers to readily locate specific information pertinent to the overall
application as well as to each component research project and core. A page
reference should be included for the budget for each project and each core.
Further, each research project should be identified by number (e.g. Project 1),
title, and responsible Project Leader, and each Core should be identified by
letter (e.g. Core A), title, and responsible Core Leader. The page location of
a COMPOSITE BUDGET should be indicated in the "Table of Contents."
Do not use Form Page 4 of PHS Form 398. Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)
SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support
Component |
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
Year 6 |
Year 7 |
All Years |
|
Project 1. Research |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
50,000 |
25,000 |
752,040 |
|
Project 2. Research |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
50,000 |
25,000 |
752,040 |
|
Project 3. Manuf |
100,000 |
300,000 |
500,000 |
500,000 |
400,000 |
200,000 |
100,000 |
2,100,000 |
|
Core A. Admin |
50,000 |
52,000 |
54,080 |
56,243 |
58,493 |
100,000 |
100,000 |
470,816 |
|
Core B. Labs |
25,000 |
50,000 |
52,000 |
54,080 |
56,243 |
100,000 |
100,000 |
437,323 |
|
Totals |
425,000 |
662,000 |
876,480 |
891,539 |
807,200 |
500,000 |
350,000 |
4,512,219 |
Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below). Also, use a second Form Page 5 to reflect the additional budget years requested for 2 additional years.
Biographical sketches of all professional personnel for all
components should be placed at the end of the application with the PD(s)/PI(s)
first, followed by those of other key personnel in alphabetical order.
Do not complete. Essential information is to be presented in the individual research project and core sections of the application.
Specific Aims
List in priority order, the broad, long-range overall objectives and goals of the proposed Program. Concisely and realistically describe the hypothesis or hypotheses to be tested.
Overall Research Strategy
This narrative section summarizes the overall research plan for the multi-project application. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.
The Program Overview of the multi-project application MUST include:
Multiple PD/PI Leadership Plan (required if applicable)
Applications designating multiple PDs/PIs for the overall Program must include a new section, entitled Multiple PD/PI Leadership Plan , as part of the Program Overview. This Plan must describe: a rationale for choosing a multiple PD/PI approach; the governance and organizational structure of the leadership team and the research projects and cores; communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts; the administrative, technical, and scientific roles and responsibilities for the PDs/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should also be delineated. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Please note: A separate leadership plan is not required within individual project(s) and core(s) that designate multiple Project/Core Leaders.
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:
One Checklist, placed at the end of the application, is to
be submitted for the entire application.
Appendix
Materials
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide. with the following modifications:
For each project or core in the multi-project application, 3 publications plus other approved material are allowed.
Please note thatwhile individual Research Projects and Cores can contain appendix material, only ONE appendix may be submitted for the entire U19 application.
The application must propose a minimum of two projects, and one of the projects must perform product manufacturing.
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.
For each individual Research Project, include:
Cover page (see special instructions, below)
Description & Key personnel (PHS 398 Form Page 2)
Table of Contents (PHS 398 Form Page 3)
Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications
Research Plan
Resources
The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):
If Yes: Exemption number, -or- IRB Approval Date (e.g., 12/13/2006, or "Pending"), and Federal wide Assurance (FWA) number
If Yes: IACUC Approval Date (e.g., 11/17/2006, or Pending) and Animal welfare assurance number
From: (mmddyy - e.g., 07/01/2007)-To: (mmddyy - e.g., 06/30/2112)
Description: Provide a Description (abstract) of the research proposed in the individual research project according to the instructions on Form Page 2 of PHS Form 398. In addition, the abstract should contain a brief description of how the individual research project will contribute towards attainment of the multi-project Program objectives.
Project/Performance Sites: List the performance sites where the research will be conducted.
Key Personnel: Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398. ). Also, use a second Form Page 5 to reflect the additional budget years for 6 and 7 requested.
Introduction
For Resubmission or Revision Projects within a Resubmission or Revision Application Only.
See specific instructions in 2.7 Resubmission Applications and 2.8 Revision Applications of the PHS 398 Application Instructions on the content of the Introduction. New applications and projects should not include an Introduction.
Specific Aims
List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically, describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects or cores.
Research Strategy
Use this section to describe how the proposed research will contribute to meeting the program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.
Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in the order of Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new projects and progress reports for renewal and revision projects as part of a renewal or revision application must be included as part of the approach section.
The required Product Manufacturing Project must include a Product Development Plan. This should include: (1) a description of the conceptual framework, design, and iterative evaluation of the vaccine concept, (2) a description of the proposed vaccine candidate and its stage of development, (3) data resulting from research conducted to date with respect to the potential for the proposed vaccine candidate to elicit the desired responses, (4) a clear delineation of the proposed product development activities to be undertaken, (5) a discussion of potential limitations/obstacles in achieving project objectives, and proposed alternative methods to deal with anticipated limitations/obstacles, and (6) proposed steps for the maintenance of quality oversight throughout the implementation and operation of the project. In addition, the applicant should include a thorough description of the infrastructure, facilities, and resources for both production of the vaccine under Current Good Manufacturing Practices (CGMP) conditions and performance of IND-enabling preclinical animal studies under Good Laboratory Practices (GLP), 21 CFR Part 58. An audit of the proposed manufacturing facility before initiation of CGMP activities will be conducted to assess quality systems and facility design.
As part of the requirement for each individual Research Project,the application must include Milestone and Timelines. This will include a clear delineation of goals with measurable milestones, including detailed quantitative and qualitative criteria for go/no go decision-making, and a timeline for the attainment of each goal and milestone.
Select Agent Research (if applicable)
As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used in the project. Describe the procedures that will be used to monitor possession, use, and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:
Provide information on resources available for the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.
For each individual Core, include:
Cover page (see special instructions, below)
Description & Key personnel (PHS 398 Form Page 2)
Table of Contents (PHS 398 Form Page 3)
Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications
Research Plan
Resources Format Page
The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):
If Yes, Exemption Number, -or-IRB Approval Date (e.g., 5/14/06, or Pending), and Federal wide Assurance (FWA) number
If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending), and Animal welfare assurance number
From: (mmddyy, e.g., 07/01/2007)-To: (mmddyy, e.g., 06/30/2012)
The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.
Description: Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the objectives.
Project/Performance Sites: List the performance sites where the core activities and services will be conducted.
Key Personnel: Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.
Each application must include an administrative core headed by the contact PD/PI.
Prepare a Table of Contents for the core using page 3 of Form PHS 398.
Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.
Administrative Core should include funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses.
Scientific Core(s) should include the apportionment of budget that will be required to support each component of the research projects .
Specific Aims
List in priority order, the broad, long-range objectives, and goals of the proposed core. Concisely and realistically, describe the hypothesis or hypotheses to be tested. In addition, state the core s relationship to the multi-project program goals and how it relates to the research projects or other cores in the application.
Research Strategy: Administrative Core (required)
An administrative core is a resource to the multi-project grant, providing overall management, coordination, and supervision of the Program. As part of the administrative core, provide a plan that includes a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; prioritization of fiscal, budgets and other resources, their allocation, and management.
It is strongly recommended that a 3-4 member External Advisory Committee (EAC), consisting of independent experts in the areas of research that the project addresses, be identified soon after award. EAC members will be required to attend annual meetings, sponsored by the grantee, to review the progress of all projects and cores and provide guidance for the future direction of the U19, to the PI and Program Staff. Applicants must NOT include names of proposed EAC members in their applications.
Research Strategy: Scientific Core(s) (optional)
A scientific core may be proposed if it supports the multi-project grant as a whole and must directly support at least two of the proposed research projects. The application must indicate which specific projects the Scientific Core(s) will support. This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants.
Select Agent Research (if applicable)
As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used with respect to the core. Describe the procedures that will be used to monitor possession, use, and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:
Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS 398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS 398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH
Grants Policy Statement.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact - Overall
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Program proposed).
Overall Impact Individual Research Projects
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria - Individual Research Projects
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Review Criteria Cores
Reviewers will consider each of the review criteria below in determination of the scientific merit of the Core as applicable and give a separate score for each Core.
Administrative Core:
Scientific Cores (if applicable):
Additional Review Criteria - Overall, Projects and Cores
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Milestones
Are the proposed Milestones well-defined with quantifiable measures that are appropriate for assessing the success of the individual projects and overall Program application? Do the Milestones have specific criteria that will enable clear decisions about their attainment? Do the milestones support the goal of advancing vaccine concepts into clinical studies within the first five years of the award? Does the application describe a collaboration to support and conduct clinical trials?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human Subjects Protection and
Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council l. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and other HHS, PHS,
and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism, (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The Program Director(s)/Principal Investigator(s) will have the primary responsibility for: defining the research objectives, approaches, and details of the projects within the guidelines of the FOA and for performing the scientific activities.
Annual Site Visit Review: Each awardee is required to coordinate an annual site visit. The site visit will provide a progress report and allow discussion of the future year plans. The site visit will be attended by the PD/PI, all co-Investigators, the External Advisory Committee (see below under Collaborative Responsibilities) members, the NIAID/DAIDS Project Scientist (see below) and NIAID Program Official (see below). An update and summary of the results generated on each project shall be presented by the PD/PI, Co- Investigators, and/or pertinent staff. These presentations should include summaries of all goals or milestones (refer to Other Submission Requirements section of the FOA) and a description of all problems encountered that may have an impact on the achievement of future goals and milestones.
No later than the third year of the award the Program Officials with assistance from the NIAID Project Scientist will assess the accomplishment of the milestones as a measure of progress, the immunologic parameters of the vaccine candidate as an efficacious prophylactic HIV/AIDS vaccine, and whether the feasibility of manufacture as reported will allow, with high probability, initiation of a clinical study within the duration of the grant. The assessment will be based on the first two annual reports and any additional information that the PD/PI elects to submit (Refer to Section Year Three Assessment above and Reporting below for specifics on the year three review process).
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIH Project Scientist will have substantial involvement that is above and beyond the normal stewardship role in awards as described below.
The NIAID Project Scientist will provide technical assistance, advice, and coordination, and interact with the PD/PI on a regular basis to monitor study progress, regulatory compliance, adherence to clinical protocol, and quality assurance in order to ensure the production of high-quality, unbiased results. Monitoring may include: (1) regular communication with the PD/PI and staff, (2) periodic site visits for discussions with awardees research teams, and (3) observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as, (4) attendance at and participation in annual site visit meetings and/or External Advisory Committee meetings. The NIAID retains as an option, periodic review of progress. NIAID retains the right to independently monitor any clinical trial to ensure adherence to regulatory requirements. Such review and monitoring may be conducted through organizations contracted by and acting on behalf of NIAID.
The NIAID Project Scientist will serve as a resource with respect to concurrent NIAID research and research support activities that may be relevant to the IPCAVD project, to facilitate compatibility, avoid unnecessary duplication, and potentially forge collaborations that may enhance the quality and breadth of the study.
The NIAID Project Scientist will provide substantial assistance in design and coordination of preclinical research activities and clinical testing for awardees, including: (1) advice on the planning, management, and technical performance of the investigators, (2) access to and use of reagents and assays, and other resources available through NIAID contractors and grantees, including the independent non-clinical evaluation of the candidate vaccine , (3) technical advice and assistance for meeting Food and Drug Administration requirements for investigational drugs, (4) serving as the point of contact between the PD/PI and NIAID for initiating the NIAID review process of all clinical protocols (per the NIAID Clinical Terms and Conditions of Award), (5) providing guidance (e.g., submission of the required documentation etc.) for the NIAID clinical protocol review process, and (6) providing guidance and oversight throughout the clinical trial to ensure that the awardee is in full compliance with all human subjects research as delineated in the NIAID Clinical Terms and Conditions of Award.
At the mid-point of the cooperative agreement (No later than the third year), the NIAID Project Scientist, will assess the accomplishment of the milestones as a measure of progress, the immunologic parameters of the vaccine candidate as an efficacious prophylactic HIV/AIDS vaccine, and whether the feasibility of manufacture as reported will allow, with high probability, initiation of a clinical study within the duration of the grant. The assessment will be based on the first two annual reports and any additional information that the PI elects to submit a point no later than the third year of the award assessment period (Refer to Section Mid-Point Progress Report above and Reporting below for specifics on the mid-point review process). Based on comments from the peer reviewers, the NIAID Project Scientist may wish to revise the milestones included in the application through negotiation with the awardee. The revised milestones will be included in the Terms of Award.
Funding for years 6 and 7 of the cooperative agreement will be contingent on the successful completion of the negotiated milestones delineated in the Terms of Award and the feasibility of clinical testing within the funding period. If the NIAID Project Scientist and Program Official find that progress is sufficient and a clinical trial is feasible, years 6 and 7 will be required. Funding for the final 2 years of the grant will be at a significantly reduced amount as compared to the first 5 years of funding. The decision to release funds for initiation of the Project Development Project will be contingent upon the successful completion of a DAIDS-contracted GMP audit of the manufacturing facility.
Additionally, an NIAID Program Official or NIAID Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibilities include:
In addition to the interactions defined above, awardees and the NIAID Project Scientist shall share responsibility for the organization of an External Advisory Committee (EAC). The composition and membership of the EAC shall be determined by consensus between the POD/PI and the NIAID Project Scientist. The EAC will consist of a minimum of 3 members not directly affiliated with the research being conducted by the awardee. The EAC, together with the PD/PI, will be responsible for determining progress of the PD/PI/co-investigators during the annual site visit. Each EAC member will have one vote. Awardees will be required to accept and implement policies approved by the External Advisory Committee. The NIAID Project Scientists and Program Officials will participate as non-voting members of the EAC.
Federally Mandated Regulatory Requirements for Clinical Research:
Each institution participating in clinical research is required to meet DHHS regulations for the protection of human subjects. At a minimum, this includes:
Methods for assuring that each institution at which Program investigators are conducting clinical studies has registered with the Office of Human Research Protections (OHRP; http://www.hhs.gov/ohrp) and has a Federal wide Assurance; that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to participant entry; that active protocols are reviewed at least annually by the IRB, and that amendments are approved by the IRB.
Methods for assuring or documenting that each participant, or participant’s parent/legal guardian, gives fully informed consent to participation in a research protocol prior to the initiation of the intervention.
Intellectual Property:
The successful development of tools for the evaluation of a prophylactic HIV/AIDS vaccine will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet this critical public health need. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:
The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for applicant to perform the project;
Before, during, and subsequent to the award, the U.S. Government is not required to obtain for awardee any proprietary rights, including intellectual property rights, or any materials needed by awardee to perform the project;
Awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified at 35 U.S.C. Sect. 202 (Bayh-Dole Act). In addition, awardees are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goal of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit.
Publications:
The PD(s)/PI(s) will be responsible for the timely submission to the NIAID of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in whole or in part under this Cooperative Agreement. The PD(s)/PI(s) are requested to provide manuscripts to the NIAID Program staff at the time of acceptance by a Journal so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Research Project and Core Leaders and will require appropriate acknowledgement of NIAID support. Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and report to the NIAID or other mechanisms consistent with laws, regulations, and NIH policies.
Program Generated Data, Software and Other Resources:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the EAC, one NIH designee, and a third designee with expertise in the relevant area that is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Michael Pensiero, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 5136, MSC-7628
6700B Rockledge Drive
Bethesda, MD 20892-7628
Bethesda, MD 20817 (for express mail)
Telephone: 301-435-3749
Fax: 301-402-3684
Email: [email protected]
Eleazar Cohen, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3129, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FEDEX zip code: 20817
Telephone: 301- 435-3564
Fax: 301-480-2408
Email: [email protected]
Lauren Early
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 2229, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614 (20817 express)
Telephone: 301-496-7075
Fax: 301-480-3780
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 Part 52 and 45 CFR Parts 74 and 92.
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