Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development

 

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 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”.

General information about this opportunity
Last Known Status
Active
Program Number
93.360
Federal Agency/Office
Agency: Department of Health and Human Services
Office: Office of the Secretary
Type(s) of Assistance Offered
Cooperative Agreements (Discretionary Grants); Project Grants (Discretionary)
Program Accomplishments
Not Applicable.
Authorization
Public Health Service Act, Title III, Section 319L; Consolidated Appropriations Act, 2010, Division D—Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010.
Who is eligible to apply/benefit from this assistance?
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. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Pre-Application Procedure
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 Procedure
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards 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 Procedure
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.
Approval/Disapproval Decision Time
From 90 to 120 days.
Appeals
Not Applicable.
Renewals
Not Applicable.
How are proposals selected?
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.
How may assistance be used?
Support international in-country and domestic 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.
What are the requirements after being awarded this opportunity?
Reporting
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.
Auditing
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503.
Records
Records must be kept available for 3 years after submission of the final expenditure report.
Other 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.
Who do I contact about this opportunity?
Regional or Local Office
None.
Headquarters Office
Rick A. Bright 330 Independence Ave SW, Room G-640, Washington, District of Columbia 20201, Washington, District of Columbia 20201 Email: Rick.Bright@hhs.gov Phone: 202-260-8535
Website Address
https://www.medicalcountermeasures.gov/
Financial Information
Account Identification
75-0140-0-1-551.
Obligations
(Project Grants (Cooperative Agreements)) FY 14 $15,455,000; FY 15 est $16,440,000; and FY 16 Estimate Not Available
Range and Average of Financial Assistance
$250,000 to $15,000,000.
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
Examples of Funded Projects
Fiscal Year 2014: No Current Data Available Fiscal Year 2015: No Current Data Available Fiscal Year 2016: No Current Data Available

 



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