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 67 FR 42268-71, dated June 21, 2002) is amended to restructure the Epidemiology and Surveillance Division, National Immunization Program.

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

Delete the functional statement for the Epidemiology and Surveillance Division (CJ3), and insert the following:

(1) Directs all Program activities regarding epidemiology, national surveillance, research and technical consultation for pertussis, diphtheria, tetanus, polio, measles, mumps, rubella, varicella, smallpox, and the vaccines, and toxoids to prevent these diseases, has the lead responsibility for immunization safety, and takes an active role in the development of immunization policy and vaccine recommendations in the United States; (2) collaborates with other CDC CIOs in epidemiologic studies and surveillance activities for influenza and pneumococcal disease; (3) provides medical and epidemiologic expertise and collaborates with other NIP Divisions and CDC CIOs in developing strategies to enhance immunization coverage of adults; (4) directs national surveillance of diphtheria, pertussis, tetanus, polio, Haemophilus influenzae type b (in collaboration with other CDC CIOs), measles, mumps, rubella, congenital rubella, varicella, complications arising from these diseases, and adverse events following vaccination; (5) monitors vaccine safety, and conducts scientific research to evaluate the safety of all currently available and new vaccines; (6) develops strategies for designated national and international vaccine-preventable disease control programs and/or disease elimination activities; (7) provides epidemic aid in collaboration with other CDC CIOs, during outbreaks of vaccine-preventable diseases and consultation to State and local health departments and to foreign countries on these diseases and their prevention; (8) provides consultation and assistance to public health professionals on vaccine-preventable diseases, vaccines, and biological products; (9) directs epidemiologic research to evaluate the efficacy, safety, and cost effectiveness of vaccines, and to study aspects of vaccine-preventable diseases relevant to immunization practice; (10) provides scientific and administrative support for the Advisory Committee on Immunization Practices in the development of vaccine policies and recommendations.

Delete the titles and functional statements for the Vaccine Safety and Development Activity (CJ3-2), Adult Vaccine-Preventable Diseases Branch (CJ33), and Child Vaccine-Preventable Diseases Branch (CJ34), and insert the following:

Bacterial Vaccine Preventable Disease Branch (CJ35). (1) Conducts epidemiologic research and provides medical expertise on bacterial vaccines and vaccine-preventable disease, including diphtheria, pertussis, Haemophilus influenzae type b, tetanus, anthrax, and pneumococcal disease; (2) provides consultation on the use of vaccines and toxoids recommended to prevent these diseases; (3) provides consultation and support to State and local health departments in the investigation of epidemics and other problems associated with bacterial vaccine-preventable diseases, and recommends appropriate control measures; (4) conducts national surveillance and prepares and distributes surveillance information for diphtheria, pertussis, and tetanus; (5) in collaboration with other CDC CIOs, conducts surveillance and investigates outbreaks of Haemophilus influenzae type b disease and pneumococcal disease; (6) analyzes and prepares information and statements for the Advisory Committee on Immunization Practices and other advisory committees on diphtheria, pertussis, and tetanus, and in collaboration with other CDC CIOs, Haemophilus influenzae type b, anthrax, and pneumococcal disease; (7) evaluates the effectiveness of activities to prevent bacterial vaccine-preventable diseases; (8) conducts epidemiologic studies to determine efficacy and safety of vaccines and toxoids recommended to prevent bacterial vaccine-preventable diseases; (9) prepares and reviews articles based on study findings for publication in professional journals, and makes presentations at professional conferences; (10) provides scientific support to other CDC CIOs in the development of effective communications and techniques to prevent bacterial vaccine-preventable diseases; (11) collaborates with the WHO, the Pan American Health Organization, as well as other national and international agencies on investigating bacterial vaccine-preventable disease outbreaks, conducting surveillance and epidemiologic research, and developing strategies for the prevention and elimination of bacterial vaccine-preventable diseases.

Viral Vaccine Preventable Diseases Branch (CJ36). (1) Conducts epidemiologic research and provides medical expertise on viral vaccine-preventable diseases, including measles, mumps, rubella, polio, varicella, influenza, and smallpox; (2) provides consultation on the use of vaccines recommended to prevent these diseases; (3) provides consultation and support to State and local health departments in the investigation of epidemics and other problems associated with viral vaccine-preventable diseases, and recommends appropriate control measures; (4) conducts national surveillance and prepares and distributes surveillance information for measles, mumps, rubella, polio, and varicella; (5) in collaboration with other NIP Divisions and CDC CIOs, performs surveillance and other emergency response activities for viral vaccine-preventable diseases (e.g., surveillance for suspected smallpox cases); (6) analyzes and prepares information and statements for the Advisory Committee on Immunization Practices and other advisory committees on measles, mumps, rubella, polio, and varicella, and in collaboration with other CDC CIOs, influenza, rotavirus, and smallpox disease; (7) evaluates the effectiveness of activities to prevent viral vaccine-preventable diseases; (8) conducts epidemiologic studies to determine efficacy and safety of vaccines recommended to prevent viral vaccine-preventable diseases; (9) prepares and reviews articles based on study findings for publication in professional journals, and makes presentations at professional conferences; (10) provides scientific support to other CDC CIOs in the development of effective communications and techniques to prevent viral vaccine-preventable diseases; (11) collaborates with the WHO, the Pan American Health Organization, as well as other national and international agencies on investigating viral vaccine-preventable disease outbreaks, conducting surveillance and epidemiologic research, and developing strategies for the prevention and elimination of viral vaccine-preventable diseases.

Immunization Safety Branch (CJ37). (1) Coordinates a national surveillance program for monitoring vaccine safety, in collaboration with the Food and Drug Administration (FDA); (2) collects, analyzes, and evaluates data to determine the safety of designated vaccines; (3) prepares and distributes surveillance information pertaining to the monitoring of adverse events following immunization; (4) conduct ad-hoc studies and investigations pertaining to adverse events following immunization; (5) coordinates studies using large linked data bases to evaluate the potential causal relationship of vaccination with specific health outcomes; (6) collaborates with other CDC CIOs, the FDA, the National Institute of Allergy and Infectious Diseases, the Health Resources and Services Administration, the Department of Defense, and the National Vaccine Program Office in development and execution of a coordinated national plan to improve immunization safety; (7) assists the National Vaccine Injury Compensation Program in analyzing data from cases seeking compensation; (8) provides consultation to State and local health departments pertaining to monitoring and reporting of adverse events following immunization; (9) prepares articles based on findings of studies for publication in professional journals and presentation at professional conferences; (10) collaborates with partners to develop new and combined vaccines that can be integrated into national and international immunization programs; (11) participates in trials of new and combined vaccines; (12) participates in international as well as domestic vaccine safety research activities; and (13) conducts research and evaluates alternative approaches for administering vaccines to enhance safety.