[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Page 62068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25851]



[[Page 62068]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Delegation of Authorities

    Notice is hereby given that I have delegated to the Administrator, 
Centers for Medicare & Medicaid Services (CMS), and the Commissioner, 
Food and Drug Administration (FDA), with authority to re-delegate, the 
authorities vested in the Secretary of the Department of Health and 
Human Services under Section 6004 of the Patient Protection and 
Affordable Care Act, Public Law 111-148, which adds Section 1128H [42 
U.S.C. 1320a-7i] to the Social Security Act.
    I hereby delegate to CMS the authority vested in the Secretary to 
issue guidance and take other appropriate actions, to the extent that 
Section 1128H [42 U.S.C. 1320a-7i] relates to Titles XVIII (Medicare), 
XIX (Medicaid), or XXI (State Children's Health Insurance Program) of 
the Social Security Act.
    I hereby delegate to FDA all other authority vested in the 
Secretary under Section 1128H [42 U.S.C. 1320a-7i]. This shall include, 
but is not limited to, issuing guidance and taking other appropriate 
action to the extent that Section 1128H [42 U.S.C. 1320a-7i] relates to 
Section 503 of the Federal Food, Drug, and Cosmetic Act; identifying 
the information to be collected as allowed by Sections 1128H(a)(1)(B) 
[42 U.S.C. 1320a-7i(a)(1)(B)] and 1128H(a)(2)(B) [42 U.S.C. 1320a-
7i(a)(2)(B)]; and generally, with respect to the information to be 
submitted under Section 1128H(a) [42 U.S.C. 1320a-7i(a)], issuing 
guidance and taking other appropriate action to identify the 
information to be submitted and the manner of submission, and 
overseeing and making arrangements for the collection, maintenance, and 
availability of such information.
    This delegation shall be exercised in accordance with the 
Department's applicable policies, procedures, and guidelines.
    I hereby affirm and ratify any actions taken by the Administrator, 
CMS, the Commissioner, FDA, or other CMS and FDA officials, which 
involve the exercise of these authorities prior to the effective date 
of this delegation.
    This delegation of authorities is effective upon date of signature.

    Authority:  44 U.S.C. 3101.

    Dated: September 30, 2011.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2011-25851 Filed 10-5-11; 8:45 am]
BILLING CODE 4150-03-P