Attachment_1_FY16_PRMRP_Peer_Review_PWS.docx

Task Order Statement of Work FY16 Peer Reviewed Medical Research Program (PRMRP)

Overview: The Contractor shall provide complete scientific peer review for the FY16 PRMRP. This includes all aspects of the contract performance work statement.

Funding: The current FY16 Congressional appropriation is anticipated to be $250,000,000. Funding will be provided for:

Mechanisms & Anticipated Number of Submissions:

PROGRAM ANNOUNCEMENTS

(# of proposals)

Anticipated Timeline (subject to change): See tentative dates below for each cycle.

Cycle 1 (DA) – online panel reviews PA release: February 2016 Pre-application deadline (LOI): April 2016 Application deadline: late April 2016 Peer review: June - August 2016 Programmatic Review: October to November 2016

Cycle 2 (IIRA, TTDA) – Onsite panel reviews PA release: late January 2016 Pre-Application deadline (preproposal): mid March 2016 Peer Review of IIRA and TTDA preproposals (online, scores only, no summary statement): Results due mid May 2016 Lists of invite/not invite: late April/early June 2016 Application deadline: late July 2016 Peer Review: September 2016 Programmatic Review: late November/early December 2016

Cycle 3 (CTA) – Onsite panel reviews PA release: late January 2016 Pre-Application deadline (preproposal): mid March 2016 Lists of invite/not invite: late April 2016 Application deadline: late July 2016 Peer Review: September 2016 Programmatic Review: late November/early December 2016

Cycle 4 (FPA) – Video teleconference and teleconference panel reviews PA release: late January 2016 Pre-Application deadline (preproposal): mid March 2016 Lists of invite/not invite: late April 2016 Application deadline: late July 2016 Peer Review: September 2016 Programmatic Review: late November/early December 2016

Reviewer Requirements:

Pre-applications:

· Online peer review panel of IIRA pre-applications requires 3 scientist reviewers (no consumers).

· Online peer review panel of TTDA pre-applications requires 3 scientist reviewers (no consumers).

Full applications:

· All mechanisms require scientist and consumer reviewers for full application review (2 scientists, 1 consumer).

· The CTA panels will require a biostatistician, clinicians, technology transfer specialist (FDA knowledge/expertise desired, not necessarily university tech transfer experience), and a bioethicist (IRB expert preferred).

· The FPA panels may require a statistician, depending on whether clinical trials are included in the applications on the panel. Each FPA application will be reviewed by a minimum of two scientists and a consumer – more scientist reviewers should be assigned as needed depending on the subject matter expertise needed for the individual projects described.

Additional Requirements/Notes:

· Historically there were 41 topic areas in the PRMRP for FY15, listed below. Congress changes the number of, and focus areas each fiscal year. Number of applications and reviewers assigned may range from small to large depending on receipt in a given topic area.

· IIRA/TTDA pre-app screening – Combine TTDA and IIRA preproposals on same online review panels by topic area. Request peer review comments be delivered in raw form, but may be delivered after final score report.

· TTDA/IIRA full applications – Combine mechanisms for peer review.

· The CTA applications will be split by general topic area and reviewed in panels of appropriate sizes (small panels OK). Focused Program Award numbers/estimates are very tentative. FPA is to be limited to the following topic areas: acupuncture, advanced prosthetics, burn pit exposure, cardiovascular heart disease, congenital heart disease, focal segmental glomerulosclerosis, healthcare-acquired infection reduction, hepatitis B, hydrocephalus, integrative medicine, metals toxicology, mitochondrial disease, nanomaterials for bone regeneration, osteoarthritis, pathogen-inactivated dried plasma, pulmonary fibrosis, psychotropic medications, respiratory health, sleep disorders, vascular malformations, and women’s heart disease. Statisticians will be needed for some, but not all, applications.

BROAD AGENCY ANNOUNCEMENT

It is also anticipated that that several proposals shall be received through the USAMRMC Broad Agency Announcement. Estimated number of reviews for each (all scientific reviewers):

Historical FY15 PRMRP Topic Areas (for planning purposes)

Historical FY15 PRMRP Topic Areas

Acupuncture

Acute Lung Injury

Advanced Prosthetics (new for FY15)

Arthritis

Burn Pit Exposure (new for FY15)

Cardiovascular Heart Disease (new for FY15)

Chronic Migraine and Post-Traumatic Headache

Congenital Heart Disease

Dengue

Diabetes

DNA Vaccine Technology for Post-Exposure Prophylaxis

Dystonia

Focal Segmental Glomerulosclerosis (new for FY15)

Food Allergies

Fragile X Syndrome

Healthcare-Acquired Infection Reduction (new for FY15)

Hepatitis B (new for FY15)

Hereditary Angioedema

Hydrocephalus (new for FY15)

Inflammatory Bowel Disease

Integrative Medicine (new for FY15)

Interstitial Cystitis

Lupus

Malaria

Metals Toxicology (new for FY15)

Mitochondrial Disease (new for FY15)

Nanomaterials for Bone Regeneration (new for FY15)

Osteoarthritis (new for FY15)

Pancreatitis

Pathogen-Inactivated Dried Plasma (new for FY15)

Polycystic Kidney Disease

Post-Traumatic Osteoarthritis

Psychotropic Medications

Pulmonary Fibrosis (new for FY15)

Respiratory Health

Rheumatoid Arthritis

Scleroderma

Sleep Disorders (new for FY15)

Tinnitus

Vascular Malformations (new for FY15)

Women’s Heart Disease (new for FY15)