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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Statement of Organization, Functions, and Delegations of Authority

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 77 FR 43837--43841, dated July 26, 2012) is amended to reflect the reorganization of the Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention.

Section C-B, Organization and Functions, is hereby amended as follows:

Delete in its entirety the title and functional statements for the Program Services Branch (CGCB), and Applied Science Evaluation Branch (CGCC), within the Division of State and Local Readiness (CGC), and insert the following:

Program Services Branch (CGCB). (1) Provides consultation and technical assistance to state, territorial, tribal and local health departments in management and operation of activities to support public health preparedness, response and recovery including the infrastructure and systems necessary to manage and use deployed Division of Strategic National Stockpile (DSNS) assets; (2) facilitates partnerships between public health preparedness programs at federal, state, and local levels to ensure their consistency, sharing promising practices, and integration; (3) collaborates with and supports other divisions in OPHPR and other national centers across CDC to ensure high quality technical assistance is available to the grantees on preparedness capabilities; (4) supervises federal field staff providing technical assistance to state and local public health preparedness programs; (5) provides oversight to partnership organization cooperative agreements and maintains a strong working relationship with national partners; (6) monitors activities of cooperative agreements and grants of partners and state, local, tribal and territorial organizations to assure program objectives and key performance

indicators are achieved including reviews of Cities Readiness Initiative response plans; (7) provides assistance to state and local governments and public health agencies in engaging communities of major metropolitan areas to prepare for effective responses to large scale public health events; (8) provides health communications guidance and products before, during, and after an event to assist state/local public health departments in developing risk communicating strategies and messages; and (9) collaborates with the DSNS Response and Logistics Branches during exercises or upon a federal deployment of DSNS assets.

Applied Science and Evaluation Branch (CGCC). (1) Assesses the effectiveness of the Public Health Emergency Preparedness (PHEP) Cooperative Agreement;

(2) provide analytic support and evaluation expertise to the Division of State and Local Readiness and the Office of Public Health Preparedness and Response; (3) conducts, integrates, translates, and leverages interdisciplinary preparedness science; (4) fosters innovation and efficiency in evaluation and research through collaboration with healthcare and health security partners; and (5) develops evidence based recommendations to improve the quality of decision-making on preparedness, response and recovery activities.

Delete in its entirety the title and functional statements for the Office of the Director (CGE1), within the Division of Strategic National Stockpile (CGE), and insert the following:

Office of the Director (CGE1). (1) Conducts the executive planning and management of the division; (2) plans strategies and methods for educating the public health and emergency response communities about the Strategic National Stockpile (SNS) and its effective use; (3) represents the DSNS in state, local, and federally sponsored exercises to test community response to a catastrophic health event; (4) directs and monitors a comprehensive strategy for managing and executing the critical systems in operating a successful commercial good manufacturing practice compliance program; (5) provides medical, pharmaceutical, and scientific oversight of the SNS formulary; (6) partners with other governmental agencies, public health organizations, and commercial entities with interest and involvement in DSNS activities and information; (7) coordinates the Stockpile Configuration Management Board that is responsible for reviewing, reconciling, and adjusting SNS package and kit design and contents to maintain consistency with medical, scientific, resource, and end user requirements; (8) provides leadership, guidance, and technical integration of preparedness planning across the public health, healthcare, and emergency management sectors; (9) provides status of DSNS assets and deployment strategies to inform development and refinement of SNS guidance and communications to PHEP awardees; (10) serves as the point of contact for federal agencies, non-governmental organizations, and partners for initiatives and issues relating to the contents, management, deployment and use of DSNS assets; (11) develops and implements innovative strategies and solutions to reduce the burden of medical countermeasure distribution and dispensing from state and local public health agencies; (12) collaborates with Division of State and Local Readiness (DSLR) to promote and encourage PHEP awardees to pilot and implement private-public partnerships and initiatives to enhance medical countermeasure distribution and dispensing capabilities; (13) provides guidance to prepare healthcare systems partners for medical surge events and supply chain awareness, access, to public sector pathways; and (14) develops and leverages systems to manage, track and report the disposition of deployed SNS assets.

Delete in its entirety the title and functional statements for the Program Preparedness Branch (CGEC).

After item (12) of the functional statement for the Response Branch (CGEE), add the following: (13) supports response capabilities with state and local medical countermeasure receipt, distribution and dispensing training courses and exercise; and (14) coordinate staff training in support of the SNS response capabilities.

After item (8) of the functional statement for the Operations Branch (CGFB), Division of Select Agents and Toxins (CGF), add the following: and (9) performs inspections of foreign select agent laboratories in accordance with National Institutes of Health/National Institute of Allergy and Infectious Diseases agreements.

Delete item (2) of the functional statement for the Program Services Branch (CGFD), and insert the following: (2) processes permit applications to import etiological agents, hosts, and vectors of human disease (not limited to select agents) into the United States from international sources.

Dated: August 16, 2012. Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention.