The purpose of this program is to coordinate the acceleration of countermeasure and product advanced research and development by-(A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies, relevant industries, academia, and other persons, with respect

credit:

to such advanced research and development; (B) promoting countermeasure and product advanced research and development; (C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act and under section 351 of the Public Health Service Act; and (D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and development.

The Public Health Service Act at 42 U.S.C.

247d-6a defines a qualified countermeasure as "…a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to - (i) diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or (ii) diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph".

Fiscal Year 2009: No Current Data Available Fiscal Year 2010: It is anticipated that 20 applications will be received and 12 awards will be issued in fiscal year 2010. Fiscal Year 2011: No Current Data Available

Uses and Use Restrictions

Support international in-country advanced development and industrialization of human pandemic influenza vaccine.

Support activities related to the mitigation of the global shortage of influenza vaccines through awards and sub-awards to developing countries with the potential and capacity to manufacture various influenza vaccines.

Basic research (e.g.

scientific or medical experiments) is not allowable.

100% of funds are for discretionary activities.

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Eligibility Requirements

Applicant Eligibility

All types of entities are eligible, including highly qualified foreign nationals outside the United States either alone or in collaboration with American participants when such transactions may inure to the benefit of the American people.

Applicants should review the individual funding opportunity announcements issued under this CFDA program.

Beneficiary Eligibility

All individuals including at-risk individuals such as children, pregnant women, elderly, and others at-risk who may be given special priority.

Credentials/Documentation

Applicants should review the individual funding opportunity announcements issued under this CFDA program for any credentials or certifications that must be submitted prior to or simultaneous with submission of an application package. OMB Circular No. A-87 applies to this program.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

OMB Circular No. A-102 applies to this program. OMB Circular No. A-110 applies to this program. Grant applications and required forms for this program can be obtained through Grants.gov - FIND, http://www.grants.gov/. Applicants should visit Grants.gov - FIND for the funding opportunity announcement and Grants.gov - APPLY to download application materials to complete and submit their applications in accordance with the funding opportunity announcement (FOA).

Award Procedures

Applications that successfully proceed through initial screening (as outlined in the funding opportunity announcement) will be objectively reviewed based upon the review criteria specified in the FOA. Applications selected for funding will be processed and the applicant notified in writing through the issuance of a Notice of Award from the Office of the Assistant Secretary for Preparedness and Response.

Deadlines

Sep 30, 2010: Applicable deadlines and due dates are specified in each funding opportunity announcement.

Authorization

Public Health Service Act, Title III, Section 319L, as amended by Pandemic and All-Hazards Preparedness Act of 2006, Public Law 109-417; Consolidated Appropriations Act, 2010, Division D-Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010.

Range of Approval/Disapproval Time

From 90 to 120 days.

Appeals

Not Applicable.

Renewals

Not Applicable.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.

Length and Time Phasing of Assistance

Project periods are limited up to 60 months. Budget periods are limited up to 12 months. See the following for information on how assistance is awarded/released: Awardee is issued a Notice of Award, a legal document that informs the awardee that a grant award has been made. Awardee may draw down funds in advance of the incursion of an expenditure (up to three days) from the Payment Management System.

Post Assistance Requirements

Reports

Program reports are not applicable.

Recipients must report cash transaction data via the Payment Management System (PMS) using the cash transaction data elements captured on the Federal Financial Report (FFR), Standard Form (SF) 425.

Recipients will utilize the "Transactions" section of SF425 in lieu of the SF272.

The FFR SF425 cash Transaction Report is due 30 days after the end of each calendar quarter.

Grantees are required to submit semi-annual Program Progress Reports as well as final Program Progress Reports.

Report formats and submission requirements are outlined in the funding opportunity announcement.

ASPR requires cumulative financial reporting through consecutive funding periods on the SF269 FSR long form.

The FFR SF425 was designed to replace the Financial Status Report SF269 and the Federal Cash Transactions Report SF272 with one comprehensive financial reporting form.

Until HHS fully migrates to the SF425 FFR, recipients are still required to submit the SF269 Financial Status Report (FSR) semi-annually within 30 days after the first 6 month period and within 90 days of the budget period end date.

Grantees are required to submit final Financial Status Reports (SF-269).

Performance monitoring of awardees is completed by BARDA program staff.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133.

Records

Records must be kept available for 3 years after submission of the final expenditure report.

Financial Information

Account Identification

75-0140-0-1-551.

Obigations

(Project Grants (Cooperative Agreements)) FY 09 $15,000,000; FY 10 est $16,000,000; FY 11 est $16,000,000

Range and Average of Financial Assistance

$250,000 to $2,000,000.

Regulations, Guidelines, and Literature

Public Law 109-417, 45 CFR 92, 45 CFR 74, 45 CFR 46, 2 CFR, HHS Grants Policy Statement found at http://www.hhs.gov/asrt/og/grantinformation/hhsgps107.pdf

Information Contacts

Regional or Local Office

None.

Headquarters Office

Michael L. Perdue, Biomedical Advanced Research and Development Authority, 330 Independence Ave SW, Room G-640, Washington, District of Columbia 20201 Email: Michael.Perdue@hhs.gov Phone: (202) 260-0966.

Criteria for Selecting Proposals

Discretionary awards are subject to objective review. Reviewers will individually evaluate and score applications based upon the review criteria specified in the funding opportunity announcement. Scored applications will be ordinally ranked. The highest ranked applications will receive priority consideration for award within available funding.