SAMPLE TASK ORDER 0002 - PRMRP.docx

Attachment 2 SAMPLE Task Order Statement of Work Fiscal Year 2021 Peer Reviewed Medical Research Program (PRMRP)

Overview: The Contractor shall provide complete scientific peer review for the FY21 PRMRP. This includes all aspects of the contract performance work statement.

Funding: The anticipated FY21 Congressional appropriation is $370,000,000 for 38 or more Congressionally-directed topics. Funding will be provided for:

Mechanisms & Anticipated Number of Submissions:

(# of proposals)

Anticipated Timeline (subject to change): The FY21 milestone calendar will be provided by the Government upon request by the contractor. The contractor shall coordinate with the respective program manager to finalize milestone dates. If a discrepancy in dates cannot be resolved, then it is up for COR approval.

Support requested:

· Peer review of pre-applications for the IIRA, TTDA, and ExPAN

· Peer review of full applications for all award mechanisms

The dates below are estimates:

Cycle 1 (DA) PA release: end January/early February 2021 Pre-application receipt (LOI): late March /early April 2021 Full application receipt: mid-April 2021 Verification ends: mid-April 2021 Compliance completed: late April 2021 Online peer review completed: June/July 2021 Programmatic Review: September 2021

Cycle 2 (IIRA, TTDA, ExPAN) PA release: end January/early February 2021 Pre-application receipt (pre-proposal): late March 2021 Pre-application compliance completed: late March 2021 Pre-application screening completed by Scientific / Peer Review Contractor: late April 2021 Pre-application screening completed by Programmatic Review Contractor: mid May 2021 Full application receipt: mid-late July 2021 Verification ends: late July 2021 Compliance completed: late July/early August 2021 Peer review completed: September 2021 Programmatic Review: mid- late November 2021

Cycle 3 (FPA) PA release: end January/early February 2021 Pre-application receipt (preproposal): late March 2021 Pre-application compliance completed: late March 2021 Pre-application screening completed by Programmatic Review Contractor: April 2021 Full application receipt: mid-July 2021 Verification ends: mid-July 2021 Compliance completed: mid-July 2021 Peer review completed: September 2021 Programmatic Review: mid- late November 2021

Cycle 4 (CTA) PA release: early-mid February 2021 Pre-application receipt (pre-proposal): late March 2021 Pre-application compliance completed: late March 2021 Pre-application screening completed by Programmatic Review Contractor: April 2021 Full application receipt: mid/end July 2021 Verification ends: mid/end July 2021 Compliance completed: mid/end July 2021 Peer review completed: September 2021 Programmatic Review: mid- late November 2021

Pre-application Reviewer Requirements:

· IIRA,TTDA, ExPAN Pre-application Reviewer Requirements:

· Online peer review panels (PRP) for IIRA pre-applications with 3 scientist reviewers (no consumers).

· Online PRP for TTDA pre-applications with 3 scientist reviewers (no consumers).

· Online PRP for ExPAN pre-applications with 3 scientist reviewers (no consumers).

Full application Reviewer Requirements:

· DA applications require scientist and consumer reviewers for full application review (3 scientists, 1 consumer)

· CTA and ExPAN FL4 applications require scientist and consumer reviewers for full application review (3 scientists, 1 consumer)

· FPA applications require scientist and consumer reviewers for the overall project and each research project review (2 scientists, 1 consumer)

· IIRA, TTDA, ExPAN Funding Levels 1-3 require scientist and consumer reviewers for full application review (2 scientists, 1 consumer).

· At least 25% of the scientists on each panel must be new to PRMRP.

· Consumer reviewers cannot have served more than three (3) years on any PRMRP panel.

· The TTDA applications should have a technology transfer specialist (advanced development-like).

· The ExPAN applications for funding level 3 should have a technology transfer specialist (advanced development-like).

· The CTA and ExPAN Funding Level 4 applications will require a biostatistician, clinicians, and a technology transfer specialist (FDA knowledge/expertise desired, not necessarily university tech transfer experience).

Peer Review Modality:

· TTDA/IIRA/ExPAN funding levels 1-3 full applications – Combine mechanisms for peer review but review all award mechanisms as a group (don’t bounce around between mechanisms). Combine topic areas on a panel if there is significant overlap in the subject matter of the applications. On site review for topic areas with medium and large receipt (approximately 20 applications or more). Videoconference review for panels with small receipt (approximately less than 20 applications). Expedited review to be utilized.

· Statisticians will be needed for some, but not all, FPA applications. Peer review will score and provide narrative reviews for each of the individual projects, in addition to an overall score for the application. Summary statements will present scores, project description, and critique for the overall project, and for each individual project.

· Technical Execution Plan and Pricing are requested for online PRP for IIRA, TTDA, and ExPAN pre-applications (3 reviewers each).

· Technical Execution Plan and Pricing are requested for online PRP for Discovery Award full applications.

· Technical Execution Plan and Pricing are requested for both in-person peer review panels and video/telephonic peer review panels to enable cost comparisons for IIRA, TTDA, ExPAN, CTA, and FPA full applications. Final modality will be conveyed to the contractor and specified in the task order award.

· Four (4) Technical Execution Plans and pricing are requested.

FY21 DRAFT PRMRP Topic Areas Below are the Draft Topic Areas for FY21, and potentially will change in the final Congressional conference report. Number of applications and reviewers assigned may range from small to large depending on receipt in a given topic area. Thus, reviewer load is flexible; however, assignments below the lower threshold should be discussed with the PM before being finalized.

· Arthritis

· Burn Pit Exposure

· Cardiomyopathy

· Congenital Heart Disease

· Constrictive Bronchiolitis

· Diabetes

· Eating Disorders

· Emerging Viral Diseases

· Epidermolysis Bullosa

· Familial Hypercholesterolemia

· Fibrous Dysplasia

· Focal Segmental Glomerulosclerosis

· Food Allergies

· Fragile X

· Frontotemporal Degeneration

· Hemorrhage Control

· Hepatitis B

· Hydrocephalus

· Hypertension

· Inflammatory Bowel Diseases

· Malaria

· Metals Toxicology

· Mitochondrial Disease

· Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

· Myotonic Dystrophy

· Nutrition Optimization

· Pathogen-Inactivated Blood Products

· Peripheral Neuropathy

· Plant-based Vaccines

· Platelet Like Cell Production

· Polycystic Kidney Disease

· Pressure Ulcers

· Respiratory Health

· Rheumatoid Arthritis

· Sleep Disorders and Restriction

· Suicide Prevention

· Sustained Release Drug Delivery

· Trauma

· Women's Heart Disease