BAA PAPHA Amendment.doc

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED DEVELOPMENT OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

Broad Agency Announcement Number:

BAA-BARDA-09-34

Amendment Number:

Two (2)

Amendment Posting Date:

April 09, 2009

Issued By:

Biomedical Advanced Research and Development Authority (BARDA)

330 Independence Ave., SW, Room G640

Washington, D.C. 20201

Point of Contact:

Primary: Glynis Fisher, Contract Officer glynis.fisher@hhs.gov

Alternate: Jeannett Jackman, Contract Specialist jeannett.jackman@hhs.gov

SUMMARY OF CHANGES

A. PURPOSE: The purpose of this Amendment is to revise Page 3, paragraph four (4) of the Introduction to include the definition of ‘Advanced Research and Development’ and BARDA’s duty to coordinate proposals with other HHS entities as follows (changes highlighted in bold):

The Pandemic and All Hazard Preparedness Act (PAHPA; http://www.hhs.gov/aspr/opsp/pahpa/index.html) directs BARDA to promote (i) innovations in technologies that may assist MCM advanced research and development, (ii) research and development of tools, devices, and technologies, and (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies. PAPHA defines Advanced Research and Developments as follows:

(A) IN GENERAL.—The term ‘advanced research and development’ means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—

(i) are conducted after basic research and preclinical development of the product; and

(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act.

(B) ACTIVITIES INCLUDED.—The term under subparagraph (A) includes—

(i) testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act for a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license;

(ii) design and development of tests or models, including animal models, for such testing;

(iii) activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity;

(iv) activities to improve the shelf-life of the product or technologies for administering the product; and

(v) such other activities as are part of the advanced stages of testing, refinement, improvement, or preparation of the product for such use and as are specified by the Secretary.

The PAPHA also directs BARDA to coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services. As such, BARDA reserves the right to coordinate proposals submitted under this BAA with other Department of Health and Services organizations engaged in basis research and pre-clinical development activities. Proposal in clinical development after submission of an IND but prior to entrance into Phase II testing (between TRL-6 and TRL-7) will be coordinated with the National Institutes of Health for potential funding by either agency according to mission needs of each agency.

(2) The date specified for receipt of white papers and proposals remains unchanged. Except as provided herein, all terms and conditions of the Broad Agency Announcement remain unchanged.