# Presentation: 704471

## RBL Construction RFAScientific Review Program

- John Bogdan, Ph.D.
- _[JBogdan@niaid.nih.gov](mailto:JBogdan@niaid.nih.gov)_
- 301-402-7372
- Peter R. Jackson, Ph.D.
-  _[PJackson@niaid.nih.gov](mailto:PJackson@niaid.nih.gov)_
- 301-496-8426

## RBL Construction RFAScientific 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.

## 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.**
- .

## 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: (301) 402-7372 
FAX: (301) 402-2638 Email: jb753c@nih.gov 

- 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: (301) 402-7372
- FAX: (301) 402-2638 Email: _[jb753c@nih.gov](mailto:jb753c@nih.gov)_

## 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.

## 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“. **
**	**
**	**

## Application Preparation

**Standard Form (SF) 424 and 424C**
- _[http://forms.cit.nih.gov/adobe/grants/SF424.PDF](http://forms.cit.nih.gov/adobe/grants/SF424.PDF)__ and __[http://forms.cit.nih.gov/adobe/grants/SF424C.PDF](http://forms.cit.nih.gov/adobe/grants/SF424C.PDF)_

## 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**

## 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**

## 	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

- 	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

## 	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.

## 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.

**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.

**REVIEW CRITERIA**** *****Description 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.

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

## 
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).

- 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)._

** ****REVIEW CRITERIA *****Project Strategic Plan***** - 35 % weight**

## 

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.

- 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**.

**REVIEW CRITERIA*****Project 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

- 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

**REVIEW CRITERIA*****Project Strategic Plan (continued)***

## 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.

## 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

## 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/RFIPpres2004.asp](http://www.ncrr.nih.gov/resinfra/RFIPpres2004.asp)_
- 		The National Center for Research Resources (NCRR) July 2004 	Research Facilities Improvement Program Power Point Presentations.  	This includes DO / DON’T 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.