2011-23464. Office of the Assistant Secretary for Preparedness and Response; Delegation of Authorities

Notice is hereby given that I have delegated to the Assistant Secretary for Preparedness and Response (ASPR) the authorities vested in the Secretary of Health and Human Services under Sections 319F-2(c) and 319L of the Public Health Service (PHS) Act, as amended, with the exception of those reserved to the Secretary, as they pertain to the functions assigned to the Office of the ASPR. The Secretary reserves the authority under:

1. Section 319F-2(c)(2)(B)(ii) to determine which countermeasures are necessary to protect public health;

2. Section 319F-2(c)(4) to call for development of countermeasures;

3. Section 319F-2(c)(6)(a) to make recommendation to the President;

4. Section 319F-2(c)(2)(C) and (6)(C) to submit notices to Congress;

5. Section 319F-2(c)(7)(C)(i)(II) to promulgate regulations;

6. Section 319L(c)(3) to appoint the Director of BARDA;

7. Section 319L(c)(7)(B) to hire special consultants; and

8. Section 319L(c)(7)(C) to hire a limited number of highly qualified individuals.

Functions and authorities under section 319F-2(c) may be re-delegated. Functions and authorities necessary to implement section 319L of the PHS Act shall be re-delegated to the Biomedical Advanced Research and Development Authority Director. Additionally, the ASPR is permitted to re-delegate authorities and functions under 319L otherwise, such as to the Acquisitions Management, Contracts and Grants Director (AMCG), as needed. These authorities shall be exercised under the Department's policy on regulations and the existing delegation of authority to approve and issue regulations.

The ASPR will implement the Other Transactions authorities under Section 319L(c) in accordance with statutory limitations and memorandum between AMCG and the Office of the Grants & Acquisition Policy and Accountability, dated June 16, 2010.

The authority granted herein under Section 319F-2(c)(7)(C)(iii)(IV) shall be exercised subject to advance concurrence by and consultation with the Office of the Assistant Secretary for Financial Resources.

I hereby affirm and ratify any actions taken by the Assistant Secretary for Preparedness and Response, or your subordinates, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation.

This delegation is effective upon date of signature.

Dated: September 7, 2011.

Kathleen Sebelius,

Secretary, Department of Health and Human Services.