RBL Construction RFA Scientific Review Program

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RBL Construction RFAScientific Review Program

• John Bogdan, Ph.D.
• JBogdan_at_niaid.nih.gov
• 301-402-7372
• Peter R. Jackson, Ph.D.
• PJackson_at_niaid.nih.gov
• 301-496-8426

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RBL Construction RFAScientific Review Program

• This presentation discusses aspects of
  application preparation, submission, receipt and
  review.
• Exhaustive coverage of these areas cannot be
  achieved today.
• Applicant interactions with appropriate NIAID
  staff are encouraged.
• Critical documents are the RFA (with specific,
  overriding requirements), the Standard Form (SF)
  424 and 424C for the UC6 application, and the
  associated DHHS and NIH policy documents
  referenced therein.

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Important Date

• Receipt, NOT mailing date
• Letter of Intent (LOI) - November 29, 2004
• LOI is not required, not binding, does not enter
  into application review
• Allows staff to estimate review workload / plan
  the review
• Descriptive title
• PI Name, address, e-mail address, telephone
  number
• Names of key personnel
• Participating institutions
• Number and title of this RFA
• It is highly recommended to consult appropriate
  NIAID staff
• before submitting the LOI and during the early
  stages of preparation
• of an application.
• .

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• Letter of Intent
• TO John Bogdan, Ph.D.
• Division of Extramural Activities
• National Institute of Allergy and Infectious
  Diseases
• Room 3258, MSC-7616 6700-B Rockledge Drive
• Bethesda, MD 20892-7616 (20817 - express mail /
  courier service)
• Telephone [phone]
• FAX [phone] Email jb753c_at_nih.gov

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APPLICATION RECEIPT - December 29, 2004

• 1. One signed, typewritten original 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)
• 2. In addition, at the time of submission send
  two additional exact copies of the application
  and all six sets of any appendix material in one
  package to
• John Bogdan, PhD
• Division of Extramural Activities
• National Institute of Allergy and Infectious
  Diseases
• Room Number, MSC-7616
• 6700-B Rockledge Drive
• Bethesda, MD 20892-7616
• BETHESDA, MD 20817 (for express mail or courier
  service)
• Applications must be received on or before
  December 29, 2004.
• Applications that are not received as a single
  package on the receipt date will be judged
  non-responsive and will be returned to the
  applicant.

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Grant Mechanism

• UC6 - NIH Construction Cooperative Agreement
• Cooperative agreement (UC6), - "assistance"
  rather than an "acquisition" mechanism.
• Principal Investigator retains primary
  responsibility and dominant role for planning,
  directing, and executing the proposed project
• Substantial NIH scientific and/or programmatic
  involvement with the awardee is anticipated
  during the performance of the activity. NIH staff
  are substantially involved as a partner with the
  Principal Investigator, as described under the
  section "Cooperative Agreement Terms and
  Conditions of Award.

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Application Preparation

• Standard Form (SF) 424 and 424C
• http//forms.cit.nih.gov/adobe/grants/SF424.PDF
  and http//forms.cit.nih.gov/adobe/grants/SF424C.P
  DF

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Some important RFA sections

• 1. Special Requirements pp. 4-9 Elements of
  the application and process you need to consider
  as you plan your application.
• 2. Cooperative Agreement terms and conditions of
  award pp. 9-11 Awardee rights, NIAID
  responsibilities Collaborations Arbitration
• 3. Supplementary Instructions- pp 13-18 Nuts
  and bolts of putting together an application 12
  parts!
• Note Emphasis weights 65 Facility 35
  Strategic Plan for the use of the facility. These
  emphasis areas flow to the review criteria as
  well.
• 4. Review and Award Criteria pp. 19-20

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WHAT HAPPENS TO YOUR APPLICATION?

• Copies to CSR CSR will
• Check for completeness Code applicant /
  application information in IMPAC II
• Scan the applications but not the appendices
  Prepare CDs for reviewers.
• Assign the application to NIAID for review
  Notify the PI
• Copies to NIAID - The SRA will
• Conduct a complete check for format, completeness
• Request information from PIs. For example
  additional Appendices, missing material,
  information about pending awards etc. Generally
  up to 2 pages of new
• information can be accepted prior to review.
• Read all applications / appendices
• Develop Conflict of Interest (COI) lists people
  / places
• Identify required reviewer expertise, number of
  reviewers
• Recruit reviewers, clear COI, assign reviews,
  provide review materials
• Plan, manage pre-review teleconference(s) with
  reviewers and NIAID staff
• Plan, manage the review meeting
• Report results of the review meeting
• Post Review Applicants interact with Program
  staff, not Review staff

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• Reviewer Expertise - tentative
• BSL 2/3 Laboratory Architecture, Engineering,
  Construction, Commissioning
• Research Scientists- Appropriate basic /
  clinical
• Veterinarians- Research support, animal
  appropriate
• Regulatory Biosafety, GLP etc.
• Public Health
• Community relations
• Environmental issues
• Security
• Other- as needed to meet application content

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REVIEW CRITERIA Description of Planned Facility
and Design Plan Justification 65 weight

• 1. Adequacy, feasibility and technical merit of
  the chosen site and the plans for design,
  construction and commissioning of the
  biocontainment facility. This includes the plans
  for specialized facilities such as vivarium
  (including non-human primate facilities),
  aerobiology, GLP, and other components of the
  RBL.

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REVIEW CRITERIA Description of Planned Facility
and Design Plan Justification (continued )

• 2. Adequacy, appropriateness, and suitability of
  the approaches and methods for ensuring safety,
  security and biohazard control at the proposed
  biocontainment facilities. This includes plans
  for maintaining containment, waste management,
  compliance with select agent regulations, and
  safety/security operations plans.

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REVIEW CRITERIA Description of Planned Facility
and Design Plan Justification (continued)

• 3. Adequacy and feasibility of the plans for the
  applicant to construct a high-level containment
  facility in a timely manner including the
  reasonableness of the proposed time-course and
  sequence for the construction.

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REVIEW CRITERIADescription of Planned Facility
and Design Plan Justification (continued)

• 4. The reasonableness of the proposed budget and
  the requested period of support in relation to
  the proposed design plan, including
  constructability and cost effectiveness.

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REVIEW CRITERIA Project Strategic Plan - 35
weight

• 1. Adequacy, feasibility and merit of the
  proposed administrative and organizational
  structure, administrative arrangements,
  operations plans, financial resources and
  commitments from institutions within the region
  to meet the objectives of the project. Adequacy
  and suitability of the position, training,
  capabilities and experience of the Principal
  Investigator and other proposed key personnel for
  the management and administration of the design,
  construction, and certification of the proposed
  facility (this does not include evaluation of
  future personnel who will be required to operate
  and maintain the facility).

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REVIEW CRITERIAProject Strategic Plan
(continued)

• 2. Scientific / technical merit of the local and
  regional scientific environment with respect to
  the number and quality of biomedical research
  investigators and their anticipated need for the
  facility.
• The impact of the proposed construction on
  existing and future NIAID supported, research
  training and /or research support activities.
• Appropriateness of the plans to make the RBL and
  its resources available to investigators and
  institutions throughout the region to meet
  current and future local, regional and national
  needs for facilities to support NIAID funded
  biodefense and emerging infectious diseases
  research and to function as a regional resource
  and as part of a national response in the event
  of a biodefense emergency.
• NOTE SPECIFIC RESEARCH PROJECTS ARE NOT PEER
  REVIEWED IN THE REVIEW OF A CONSTRUCTION PROGRAM.

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REVIEW CRITERIAProject Strategic Plan
(continued)

• 3. Adequacy and merit of the proposed community
  relations plan, including an evaluation of the
  current status and plans for educating and
  informing the community

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Additional Criteria

• Protection of Human Subjects from Research Risks
• Inclusion of Women, Minorities and Children in
  Research
• Care and Use of Vertebrate Animals in Research
• Sharing Research Data
• Appropriate Federal Citations are referenced in
  the RFA
• Since in a construction grant application
  specific research projects and protocols are NOT
  evaluated, not all the aspects of these criteria
  will apply.

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Scoring

• Reviewers assign a Scientific and Technical Merit
  score of 1.0 to 5.0 to each application.
• Successful applicants score as close to 1.0 as
  possible.
• However, Awards are based on
• Scientific and Technical Merit
• Ability to support the desired scope of work
• Programmatic priorities
• Regional distribution of meritorious applications

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HINTS

• You need us we need you. Before you Act, Ask!
• Consult appropriate NIAID program, review or
  grants management staff early and often.
• Follow the RFA especially the RFA-specific
  requirements.
• Follow FORM 424 / FORM 424C instructions.
• Write clearly Seek the advice of others
• Visit http//www.ncrr.nih.gov/resinfra/RFIPpres
  2004.asp
• The National Center for Research Resources
  (NCRR) July 2004 Research Facilities Improvement
  Program Power Point Presentations. This
  includes DO / DONT advice from C06 applicants
  and reviewers.
• Two caveats
• a. The NCRR Research Facility Program is
  smaller in scope and
• different in purpose from the NIAID RBL
  Program.
• b. The NIAID RBL RFA requirements take
  precedence in your application.