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Statement of Organization, Functions, and Delegations of Authority

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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 75 FR 59277-59278, dated September 25, 2010) is amended to reflect the reorganization of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Office of Infectious Diseases, Centers for Disease Control and Prevention.

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

Delete in its entirety the function statements for the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (CJV) and the Office of the Director (CJV1) and insert the following:

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (CJV). The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) maximizes public health and safety nationally and internationally through the elimination, prevention, and control of disease, disability, and death caused by Human Immunodeficiency Virus Infection/Acquired Immunodeficiency Syndrome (HIV/AIDS), non-HIV retroviruses, viral hepatitis, other sexually transmitted diseases (STDs), and tuberculosis (TB). In carrying out its mission, NCHHSTP: (1) Builds capacity and enhances public health infrastructure for preventing and treating HIV/AIDS, viral hepatitis, STDs, and TB; (2) coordinates activities and programs across CDC and with other Department of Health and Human Services Operational Divisions in order to maximize the public health impact of HIV/AIDS, viral hepatitis, STDs, and TB interventions; (3) conducts surveillance and research to determine the distribution, determinants, and burden of HIV/AIDS, viral hepatitis, STDs, and TB; (4) conducts program evaluation to improve programs and activities relating to the prevention of HIV/AIDS, viral hepatitis, STDs, and TB, and determine their impact; (5) provides reference laboratory and clinical diagnostic services for HIV/AIDS, viral hepatitis, STDs, and TB to relevant stakeholders; (6) promotes collaboration and service integration among HIV/AIDS, viral hepatitis, STDs, and TB programs; (7) engages external partners to develop and implement effective HIV/AIDS, viral hepatitis, STDs, and TB policies, research, and programs; (8) engages partners, to promote health equity and reduce health disparities among those affected by HIV/AIDS, viral hepatitis, STDs, and TB; (9) provides technical assistance and training in the diagnosis, treatment, and prevention of HIV/AIDS, viral hepatitis, STDs, and TB; (10) conducts public health communication activities to disseminate research findings and increase awareness of HIV/AIDS, viral hepatitis, STDs, and TB; (11) conducts operational, behavioral, and biomedical research to improve the distribution, diagnosis, prevention, and control of HIV/AIDS, viral hepatitis, STDs, and TB; (12) provides scientific leadership regarding public health ethics and protection of human subjects linked to HIV/AIDS, viral hepatitis, STDs, and TB; (13) translates research findings into public health practice and policy for HIV/AIDS, viral hepatitis, STDs, and TB prevention; (14) plans, coordinates, and guides programs and activities with external partners, federal agencies, and other organizations related to HIV/AIDS, viral hepatitis, STDs, and TB prevention, care, and treatment; (15) leads and participates in the development, implementation, and evaluation of policies and guidelines related to HIV/AIDS, viral hepatitis, STDs, and TB; (16) provides scientific leadership regarding screening, treatment, immunization, and other prevention interventions relevant to HIV/AIDS, viral hepatitis, STDs, and TB; (17) assures all public health decisions are based on the highest quality scientific data, openly and objectively derived; (18) provides leadership to assist international partners in establishing and maintaining, HIV/AIDS, viral hepatitis, STDs, and TB screening, treatment, Start Printed Page 62555immunization, and other prevention and control programs; (19) ensures that programmatic and scientific activities are aligned with, and in support of, CDC's overall mission, goals, and strategic imperatives; (20) allocates and tracks CDC resources and contributes to the development of CDC's short-, medium- and long-term strategic plans for preventing the spread of HIV/AIDS, viral hepatitis, STDs, and TB; (21) collaborates with other federal agencies, domestic and international governmental and non-governmental organizations to advance CDC and NCHHSTP health protection goals; and (22) coordinates oversight of the NCHHSTP Federal Advisory Committees.

Office of the Director (CVJ1). (1) Provides leadership and guidance on the development of goals and objectives, policies, program planning and development, and program management and operations of the activities of NCHHSTP and manages, directs, coordinates, and evaluates the center's activities; (2) plans and coordinates the annual program planning process; (3) coordinates with Office of the Director (OD), Centers/Institute/Offices (CIOs), and divisions in determining and interpreting operating policy and in ensuring their respective management input for specific program activity plans; (4) facilitates CIOser linkages between HIV, non-HIV retroviruses, STDs, viral hepatitis, and TB, surveillance activities and prevention programs at all levels, and facilitates collaboration, integration, and multi-disciplinary approaches to enhance the effectiveness of HIV, STD, viral hepatitis, and TB prevention programs; (5) facilitates collaboration among, and integration of, science and prevention programs throughout NCHHSTP and enhances the coordination and integration of HIV, STD, viral hepatitis, and TB prevention services for individuals and populations at increased risk for more than one of these infections; (6) coordinates the integration of CDC funding of state and local health departments for HIV, STD, viral hepatitis, and TB prevention; (7) maximizes center-wide collaboration to promote and support Program Collaboration and Service Integration (PCSI) in state and local HIV/AIDS, viral hepatitis, STD and TB programs to increase efficiencies and provide comprehensive evidence based prevention services to impacted populations; (8) develops partnership objectives and strategies for advancing center priorities (e.g., on cross-cutting functions PCSI, reducing health disparities, etc.) and leverages OD resources to address these objectives and strategies; (9) coordinates and tracks health equity science and program activities within the center; (10) coordinates and tracks science and program activities that concern or address social determinants of health within NCHHSTP and other programs; (11) collaborates with the CDC OD and other CDC components on health equity activities, and works with the CDC OD to monitor progress in meeting Executive Orders related to improving minority health; (12) develops partnerships with other federal agencies and nongovernmental organizations working on similarly-affected populations; (13) supports research, surveillance, education, training, and program development to achieve health equity and reduce health disparities; (14) sponsors workgroups, meetings, and conferences related to health equity; (15) promotes a diverse public health workforce through internships, fellowships, training programs, and other activities; (16) ensures process consistency for laboratory related functions within NCHHSTP and across the CIOs; (17) facilitates cross-center decision-making regarding laboratory activities; (18) monitors the performance of funded extramural research projects in the areas of HIV/AIDS, viral hepatitis, STD and TB; (19) collaborates with other federal agencies to advance prevention through healthcare; (20) coordinates and supports cross-cutting strategic initiatives in support of NCHHSTP divisions and partners; and (21) works across the agency to advance prevention priorities.

After the functional statement for the Office of the Director (CVJ1), insert the following:

Office of the Associate Director for Science (CVJ12). (1) Ensures process consistency for science across the CIOs; (2) facilitates cross-center decision-making regarding science; (3) facilitates communication regarding scientific and programmatic services across the Office of Infectious Diseases (OID); (4) conducts necessary regulatory and ethical reviews for activities involving human participants, including determining whether an activity includes research, includes human subjects, is exempt or requires Institutional Review Board approval, and whether an exception is needed to the Public Health Service HIV policy; (5) reviews funded activities for application of human research regulations; (6) reviews, approves, and tracks research protocols, clinical investigations, and the Food and Drug Administration regulated response activities intended for submission to CDC Human Research Protections Office; and (7) coordinates and tracks Office of Management and Budget clearance under the Paperwork Reduction Act.

Informatics Office (CVJ13). (1) Manages all information technology (IT) project costs, schedules, performances, and risks; (2) provides expertise in leading application development techniques in information science and technology to effect the best use of resources; (3) performs technical evaluation and integrated baseline reviews of all information systems' products and services prior to procurement to ensure software purchases align with NCHHSTP strategy; (4) provides access to quality data in support of programmatic data analysis; (5) coordinates all enterprise-wide IT security policies and procedures with key agency offices; (6) ensures operations are in accordance with CDC Capital Planning and Investment Control guidelines; (7) ensures adherence to CDC enterprise architecture guidelines and standards; (8) consults with users to determine IT needs and to develop strategic and action plans; and (9) participates in the evolution, identification, development, or adoption of appropriate informatics standards.

Extramural Research Program Office (CVTJJ14). (1) Serves as the focal point for the OID for implementing policies and guidelines for the conduct of the peer review of infectious disease extramural research grant proposals and subsequent grant administration; (2) coordinates and conducts in-depth external peer review and secondary program relevance review of extramural research applications by use of consultant expert panels; (3) makes recommendations to the appropriate infectious disease center director on award selections and staff members serve as the program officials in conjunction with CDC grants management and policy officials to implement and monitor the scientific, technical, and administrative aspects of awards; (4) facilitates scientific collaborations between external and internal investigators; (5) disseminates and evaluates extramural research progress, findings, and impact; and (6) coordinates and executes objective review, including the special emphasis panel (SEP) process for funding of CDC infectious disease non-research grants and cooperative agreements.

Office of Management and Program Support (CVJ15). (1) Helps implement and enforce management and operations policies and guidelines developed by Start Printed Page 62556federal agencies, DHHS, and Staff Service Offices (SSO); (2) plans, develops, implements, and provides oversight and quality control for center-wide policies, procedures, and practices for administrative management and acquisition and assistance mechanisms, including contracts, memoranda of agreement, and cooperative agreements; (3) provides management and coordination of NCHHSTP-occupied space and facilities; (4) supplies technical guidance and expertise regarding occupancy and facilities management to emergency situations; (5) provides oversight and management of the distribution, accountability, and maintenance of CDC property and equipment; (6) provides oversight, quality control, and management of NCHHSTP records; (7) serves as lead and primary contact and liaison with relevant SSO on all matters pertaining to the center's procurement needs, policies, and activities; (8) develops, reviews, and implements policies, methods and procedures for NCHHSTP non-research extramural assistance programs; (9) interprets general policy directives, proposed legislation, and appropriation language for implications on management and execution of center's programs; (10) provides consultation and technical assistance to NCHHSTP program officials in the planning, implementation, and administration of assistance programs; (11) develops and implements objective review processes, including use of SEP process for competitive application cycles; (12) oversees the formulation of the NCHHSTP budget and responds to inquiries related to the budget; (13) provides technical information services to facilitate dissemination of relevant public health information and facilitates collaboration with national health activities, CDC components, other agencies and organizations, and foreign governments on international health activities; (14) provides oversight for the programmatic coordination of HIV, STD, viral hepatitis, and TB activities between NCHHSTP and other CIOs; develops recommendations to the CDC Director as the lead CIO for these programs for the distribution of HIV, STD, viral hepatitis, and TB funds CDC-wide; (15) provides guidance and coordination to divisions on cross-divisional negotiated agreements; (16) facilitates state and local cross-divisional issues identification and solutions; (17) in coordination with the Office of Program Planning and Policy Coordination, responds to Congress as needed; (18) serves as NCHHSTP liaison to relevant SSOs for all matters related to financial management; (19) serves as focal point for emergency operations and deployment; (20) manages and coordinates workforce development and succession planning activities within NCHHSTP in collaboration with internal and external partners, and coordinates the recruitment, assignment, technical supervision, and career development of staff with emphasis on developing and supporting diversity initiatives and equal opportunity goals; (21) facilitates the assignment of field staff in accordance with CDC and NCHHSTP priorities and objectives and reassesses the role of NCHHSTP field staff assignees to state and local health jurisdictions; and (22) provides center-wide training to supervisors, managers and team leaders.

Office of Program Planning and Policy Coordination (CVJ16). (1) Identifies program priorities through strategic planning and other processes as appropriate; (2) oversees the development of the center's performance plan and performance reports to ensure accountability and improve programs and activities; (3) coordinates with the center director and management officer the formulation of the NCHHSTP budget; (4) liaises with the CDC SSOs on Congressional, legislative, and other inquiries; (5) maintains liaison with Congress on matters including appropriations, legislative bill tracking, and legislative requests, testimony for hearings, congressional inquiries, etc.; (6) develops policy- and program-related materials, and talking points; (7) oversees the preparation and routing of controlled correspondence; (8) maintains liaison with key CDC offices and individuals working on public health policies and legislative issues; (9) serves as liaison to governmental and nongovernmental partners on policy-related issues; (10) oversees priority issues management and proactive and reactive strategic media efforts; (11) conducts environmental analysis in response to short-term issues to be shared with leadership and program managers; (12) works with the Health Communication Science Office to coordinate communication strategy and manage short-term issues; (13) formulates strategic media objectives for advancing program priorities and addressing identified long-range issues; and oversees the implementation of strategic media plans through several functional areas; (14) develops and implements all proactive media outreach and reactive media responses for the center; (15) provides media training and technical assistance, as appropriate; and (16) serves as liaison to key offices for obtaining CDC and HHS media clearance on products/activities.

Health Communication Science Office (CVJ17). (1) Serves as the principal advisor to NCHHSTP on communication and marketing science, research and practice; (2) provides oversight to ensure the quality and science of health communication and marketing campaigns and products created by NCHHSTP and its divisions; (3) serves as NCHHSTP clearance office for health communication campaigns and products; develops and manages clearance systems; (4) provides strategic planning and coordination for NCHHSTP communication and marketing programs in collaboration with OD and division-level staff; (5) collaborates with NCHHSTP policy and media relations staff to ensure consistent and timely translation of center-specific health information; (6) executes communication activities to support strategic goals and objectives of the NCHHSTP OD and activities to support division-level programs; (7) coordinates and provides center input on communication activities; (8) coordinates CDC and NCHHSTP brand management; (9) provides oversight and consultation on partnership development and partner/stakeholder communication; (10) develops and manages partner relationships in collaboration with NCHHSTP divisions and CDC CIOs; (11) coordinates partnership strategies across NCHHSTP divisions; (12) manages communication infrastructure for NCHHSTP partnerships; (13) oversees management, policy guidance, and governance of NCHHSTP digital channels and Web sites per HHS and CDC policy for the use of communication technologies; (14) provides coordination and conducts activities to support NCHHSTP's presence on networked media, such as social and mobile media; and (15) collects/analyzes user data/metrics from communication channels and technologies to assess system performance, usability, accessibility, and usefulness.

Delete items (15) and (16) of the functional statement for the Office of the Director (CVJB 1), Division of HIV/AIDS, Prevention-Intervention Support (CVJB), and insert the following: (15) Collaborates with other branches, divisions, and CIOs to synthesize HIV prevention research findings and translate them into prevention practice; and (16) collaborates, as appropriate, with other divisions and offices of NCHHSTP, and with other CIOs throughout CDC in carrying out these activities.Start Printed Page 62557

Delete item (1) of the functional statement for the Prevention Program Branch (CVJBC), and insert the following: (1) In collaboration with state and local public health and non-governmental national/regional and local partners, CIOs, and other federal agencies, develops and implements programs, policies, and activities that enable and mobilize affiliates and communities to become involved with, and support, local and statewide strategic community planning that improves HIV prevention programs and activities.

Delete in its entirety the title and function statement for the Program Evaluation Research Branch (CVJBD), and insert the following:

Program Evaluation Branch (CVJBD). (1) Evaluates the effectiveness and impact of HIV prevention interventions, strategies, policies, and programs as practiced or implemented by CDC-funded public health agencies and organizations at the national/regional and state/local levels; (2) collaborates within DHAP, with HIV prevention program grantees, and with other national partners to systematically collect, process, and use HIV prevention program data for program planning and improvement; (3) collaborates in the conduct of evaluation research activities and economic evaluations of HIV prevention activities; (4) seeks to advance the methodology of HIV prevention evaluation through CDC evaluation activities and with the field of program evaluation more broadly; and (5) collaborates with other branches as they develop, test, and disseminate models for quality assurance of programs and services.

Delete in its entirety the title and function statement for the Technical Information and Communications Branch (CVJBG), and insert the following:

Prevention Communications Branch (CVJBG). (1) Implements science and evidence based HIV/AIDS communication programs and approaches that target opinion leaders, stakeholders, persons at risk for and living with HIV/AIDS and the general public; (2) systematically translates and disseminates science based messages through multiple communication channels; (3) effectively implements agenda setting and mobilization efforts; and (4) implements efficient internal communication approaches targeting DHAP staff.

Delete items (3) and (10) of the functional statement for the Office of the Director (CVJC 1), Division of HIV/AIDS, Prevention-Surveillance and Epidemiology (CVJC) and insert the following: (3) Provides leadership in developing research in epidemiology, surveillance, and other scientific aspects of HIV/AIDS prevention, and in coordinating activities between the division and other NCHHSTP divisions, CIOs, and national-level prevention partners who influence HIV/AIDS prevention programs involved in HIV/AIDS investigations and research; and (10) collaborates, as appropriate, with other divisions and offices of NCHHSTP, and with other CIOs throughout CDC.

After item (10) of the functional statement for the Office of the Director (CVJD1), Division of Sexually Transmitted Disease Prevention (CVJD), add the following: and (11) manages the Tuskegee Participants Health Benefits Program.

After the functional statement for the Statistics and Data Management Branch (CVJDH), add the following:

Field Services Branch (CVJDJ). (1) In collaboration with the Program and Training Branch assigns Public Health Advisors to state and local health departments; (2) provides state and local health departments technical assistance with the development and implementation of strategies for addressing the STD burden; (3) provides state and local health departments assistance with developing, implementing and evaluating core public health activities to reduce the incidence, strengthen public, private clinical and community-based partnerships; and (4) promotes and enhances capacity-building within state and local health departments through consultation, demonstration and technical expertise.

Delete in their entirety the functional statements for the Division of Tuberculosis and Elimination (CVJE), and Office of Director (CVJE1), and insert the following:

Division of Tuberculosis Elimination (CVJE). The Division of Tuberculosis Elimination (DTBE) promotes health and quality of life by preventing, controlling, and eventually eliminating TB from the United States (U.S.), and by collaborating with other countries and international partners in controlling TB worldwide. In carrying out its mission, the division conducts the following activities under each focus area: (1) Administers and promotes a national program for the prevention, control, and elimination of TB; (2) supports a nationwide framework for surveillance of TB and evaluation of national TB prevention and control program performance; (3) provides programmatic consultation, technical assistance, and outbreak response assistance to international, state, and local TB programs; (4) co-chairs and coordinates administrative support for the Federal TB Task Force, and supports and collaborates with the National Tuberculosis Controllers Association and the Tuberculosis Education and Training Network to promote effective national communications and coordinated feedback on urgent policy and program performance issues; (5) supports development of TB patient education materials and interventions, capacity development, and access to medical consultation; (6) provides national and supranational reference laboratory function for identification, drug susceptibility testing of Mycobacterium tuberculosis; (7) fosters patient-centered measures, including directly-observed therapy, to promote adherence with long-term treatment for improvements in well-being and interruption in community transmission of M tuberculosis; (8) promotes targeted testing of idemiologically-defined at-risk populations and treatment of persons with latent TB; (9) conducts epidemiologic, laboratory, behavioral, health systems, and clinical research; (10) supports patient and provider research to identify barriers and facilitators to TB services; (11) supports multicenter consortia for epidemiologic, laboratory, diagnostics, clinical, and vaccine development research; (12) develops and applies mathematical TB transmission models to forecast future incidence and prevalence trends; (13) provides leadership and formulates national and global policies and guidelines; (14) provides technical supervision and training to federal assignees working in international, state, and local TB control programs; (15) develops training and educational materials, and provides technical assistance on communications and training needs; (16) participates in the development of policies and guidelines for TB prevention and control within populations at high risk, such as persons infected with HIV or racial and ethnic minorities; (17) provides programmatic consultation, technical assistance, and outbreak response assistance to other countries by collaborating with national and international partners; (18) supports technical activities and operational research to reduce TB in foreign-born populations; (19) provides leadership and technical support to the global health initiatives for the prevention and control of TB and drug-resistant TB; (20) provides leadership and technical support to the World Health Organization (WHO)-hosted Stop TB Start Printed Page 62558Partnership for implementation of the Global Plan to Stop TB and Millennium Development Goals; (21) monitors progress and trends towards TB elimination; (22) monitors progress towards CDC, Healthy People 2010, and the Government Performance Results Act goals; (23) provides progress reports to, and solicits advice from, the Advisory Council for the Elimination of Tuberculosis (ACET); and (24) facilitates partnerships with affected communities, nongovernmental, professional, and global organizations.

Office of the Director (CVJE1). (1) Provides leadership and guidance in program planning and management, policy formulation, and development of training, surveillance, and research programs in TB; (2) directs and evaluates the operations of the division; (3) establishes contact with, and promotes TB activities of, other national and international organizations which have an important role to play in achieving TB elimination; (4) coordinates administrative and logistical support services for the division; (5) provides consultation and assistance in writing reports for presentation at local, regional, national, and international scientific meetings and for publication in scientific journals; (6) coordinates and tracks materials for purposes of clearance and approval for publications and presentations; (7) presents findings at national and international scientific meetings; (8) presents division overview at the ACET meetings; (9) collaborates and coordinates division activities with other components of NCHHSTP and CDC; (10) provides technical support to ACET; (11) provides administrative and technical support for the Stop TB USA (previously the National Coalition for the Elimination of Tuberculosis) and the Federal TB Task Force; and (12) provides leadership and technical expertise to the global Stop TB partnership.

Delete in its entirety the functional statement for the Communications, Education, and Behavioral Studies Branch (CVJEB), and insert the following:

(1) Provides technical assistance to health departments and other health care providers in assessing and meeting their TB training, education, and communication needs; (2) provides technical expertise to assess the impact of training and education activities by health departments; (3) provides technical assistance to health departments and other TB health care providers regarding behavioral studies research and intervention development; (4) collaborates with the WHO, the World Bank, the International Union Against Tuberculosis and Lung Diseases (IUATLD), United States Agency for International Development (USAID), and others, in assessing and meeting TB training, education, and communication needs in other countries; (5) provides consultation and assistance in coordinating TB training, education, behavioral studies and interventions, and communication activities carried out by other CDC programs, Regional Training and Medical Consultation Centers, and Stop TB USA members, and develops, markets, and maintains electronic mailing lists for persons with TB-related education, training, and communication responsibilities; (6) develops, plans, and coordinates agendas necessary to conduct TB conferences and workshops sponsored by the division; (7) provides DTBE coordination and oversight and technical information for CDC INFO; (8) organizes and maintains scientific and non-scientific information resources related to TB; (9) conducts formative research and evaluation on approaches to patient, provider, and public education, and conducts research on individual and social factors affecting health-care seeking behavior and treatment outcomes related to TB; (10) based on research findings, develops behavioral interventions targeted to health care providers, persons with or at risk for TB, and other high-risk populations; (11) provides consultation to national and international organizations on behavioral research needs and study designs; on the technical transfer of behavioral research findings into TB program practice and TB training and educational strategies; and provides consultation, technical assistance, and coordination to other branches within the division regarding development and implementation of behavioral interventions and training for branch specific activities such as Report of Verified Case of Tuberculosis, Aggregate Reports for Program Evaluation, and surveillance activities; (12) presents findings at national and scientific meetings and develops, disseminates, and evaluates training and educational materials and courses providing TB information to the scientific and public health communities, as well as the general population; (13) conducts training and education needs assessments; identifies resources available for health department TB control officers and senior managers, TB nurse consultants, TB training and education directors and for senior staff carrying out TB activities in other programs or facilities serving persons at high risk for TB; and develops, conducts, and coordinates training courses on TB for state and big city TB program managers and nurse consultants; (14) based on needs assessments, develops and conducts or coordinates training courses and materials for staff who train and/or supervise front-line TB program staff (15) provides oversight in the planning, coordination, and maintenance of the division's Internet and Intranet Web sites; (16) conducts and/or coordinates communications programs designed to build public support and sustain public interest and commitment to the elimination of TB; (17) conducts communications research and identifies communications resources available for health department TB control officers and senior managers, TB nurse consultants, and for senior staff carrying out TB activities in other programs or facilities serving persons at high risk for TB; (18) coordinates graphic support to the division and senior field staff; (19) provides coordination and oversight for division responses and relations with the media and public and serves as point of contact for telephonic, written, and electronic (e-mail) requests for information from the media and public; (20) develops, coordinates, and staffs the divisions exhibit booth at conferences/meetings; (21) provides oversight and coordination for TB related voice and Web-based TB information, training, and education resources; (22) maintains inventory of TB training opportunities and coordinates with employees and supervisors for training necessary to carry out their duties; and (23) presents communications issues to ACET and at national and international scientific meetings.

Delete in its entirety the title and function statement for the Clinical and Health Systems Research Branch (CVJEE), and insert the following:

Clinical Research Branch (CVJEE). (1) Assesses the need for and conducts studies of new or existing drugs and regimens used in the prevention and treatment of TB, including dosage, duration, pharmacokinetics and toxicity; (2) supports the TB Trials Consortium in the conduct of studies of new treatments for active TB and latent TB infection; (3) supports coordinated and standardized data management for branch research, and serves as the Data and Coordinating Center for the TB Trials Consortium, collaborating as needed with both internal and external partners; (4) collaborates with private and public institutions in the area of vaccine development; (5) provides clinical support and oversight for the Start Printed Page 62559distribution of investigational drugs for the treatment and prevention of TB by CIOs/Scientific Resources/Drug Service; (6) assesses the need for and conducts clinical and field trials of more specific and rapid tests to diagnose active TB and latent TB infection and to identify drug-resistant TB in collaboration with the Laboratory Branch; (7) collaborates with and provides consultation and technical assistance to national and international organizations on the design and conduct of clinical trials and research needs; (8) conducts, participates in, and collaborates with other DTBE units in research on clinical, epidemiologic, immunologic and genetic aspects of TB prevention and control; (9) collaborates in contact investigation research with other branches and local programmatic areas; (10) conducts multidisciplinary studies (including the analysis of behavioral, economic, and epidemiologic factors) of health care systems to assess the cost, effectiveness, and impact of public health policies, programs, and practices on TB outcomes to further the goal of TB elimination in the U.S., and targets these studies toward various populations at high risk for TB, including persons from high TB prevalent countries, homeless persons, HIV-infected persons, residents of correctional facilities, substance abusers, and health care workers; (11) provides consultation and training to local, state, national, and international organizations, and to TB program field staff, on design and conduct of clinical trials, TB therapeutics and diagnostics, health care systems research needs, decision and economic analyses, evaluation techniques, qualitative research methods, and research on TB transmission; (12) has responsibility for divisional engagement in preparing for and participating in trials of new TB vaccines; (13) reports study results to public health practitioners through direct communication, articles in scientific journals and CDC publications, and oral and poster presentations at national and international scientific meetings; (14) provides input into statements and guidelines issued by the CDC, the ACET, and professional organizations; and (15) presents research issues and findings to ACET and at national and international scientific meetings.

Delete items (2), (3), (4), and (6) of the functional statement for the International Research and Programs Branch (CVJEI1D), and insert the following: (2) Coordinates the assessment of immigration and its impact on TB patterns in the U.S. and assists with the evaluation of overseas TB screening procedures for immigrants and refugees; (3) conducts and coordinates operational research and demonstration projects to improve both the overseas screening for TB of immigrants and refugees and the domestic follow-up of those entering with suspected TB (in collaboration with other CIOs); (4) promotes the improved recognition and management of TB among the foreign-born through epidemiological analyses of national TB surveillance data and special studies on the U.S./Mexico border and in countries contributing to foreign-born TB cases in the U.S.; (6) collaborates with the nation of Botswana, WHO, the World Bank, IUATLD, USAID, and others, to conduct investigations into the diagnosis, management, and prevention of TB in persons with and without HIV infection.

Delete in its entirety the title and function statement for the Mycobacteriology Laboratory Branch (CVJEJ), and insert the following:

Laboratory Branch (CVJEJ). (1) Serves as the national reference laboratory in support of the mission of DTBE, fulfilling public health function in leadership, clinical and consultative service, and research; (2) provides laboratory support for epidemic investigations, surveillance activities, and special studies of TB, in collaboration of other branches; (3) administers contracts to provide Mycobacterium tuberculosis genotyping, maintains a national database of genotypes, and conducts operational research to implement genotyping; (4) develops and evaluates new methods to subtype M tuberculosis for epidemiologic studies; (5) serves as primary CDC focus for diagnostic laboratory services for TB; (6) administers grants and cooperative agreements with states and others to upgrade laboratory activities and provide special services; (7) provides reference diagnostic services, consultation, technical assistance, and training to state, federal, and municipal public health laboratories; (8) provides laboratory support, reference services, assessment, consultation, and training for CDC's international TB activities; (9) develops, evaluates, or improves conventional and molecular methods for the detection, classification, identification, characterization, and susceptibility testing of M tuberculosis; (10) conducts studies to define the role of bacterial virulence factors, host factors, and pathogenic and immunologic mechanisms in disease processes and protective immunity in mycobacteria, and develops, evaluates, and improves immunologic methods for the diagnosis and prevention of TB; (11) develops tissue culture and animal models of TB and conducts studies on chemotherapy, immunotherapy, pathogenesis, pathology, and vaccines for TB; (12) prepares manuscripts for publication in scientific journals; (13) presents findings at national and international scientific meetings; (14) supervises and trains fellows in temporary or multi-year educationally-based programs in endeavors related to the mission of the branch; and (15) presents laboratory issues to ACET and at national and international scientific meetings.

Start Signature

Dated: September 27, 2010.

William P. Nichols,

Chief Operating Officer, Centers for Disease Control and Prevention.

End Signature End Preamble

[FR Doc. 2010-25427 Filed 10-8-10; 8:45 am]

BILLING CODE 4160-18-M