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Code · REGISTER · 2006-12-14 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

1,673 words·~8 min read·/register/2006/12/14/06-9668·

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BILLING CODE 4163-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-05AJ] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection—New—Division of Tuberculosis Elimination (DTBE), National Center for HIV, STD, and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description As part of the national TB elimination strategy, the American Thoracic Society and CDC have published recommendations for targeted testing for TB and treatment for latent TB infection (LTBI). However, between October 2000 and September 2004, the CDC received reports of 50 patients with severe adverse events associated with the use of the two or three-month regimen of rifampin and pyrazinamide
(RZ)for the treatment of LTBI; 12 (24%) patients died (Morbidity and Mortality Weekly Report 2003;52[31]:735-9). A severe adverse event is defined as hospitalization or death of a person receiving treatment for LTBI. On the basis of these data, the American Thoracic Society and CDC recommended that RZ should generally not be offered for treatment of persons with LTBI, regardless of HIV status. Rifampin and pyrazinamide should continue to be administered in multidrug regimens for the treatment of persons with active TB disease. Reports of severe adverse events related to RZ and other older LTBI regimens have prompted a need for this three year project—a national surveillance system of such events. The objective of the project is to determine the annual number and temporal trends of severe adverse events (hospitalization or death) associated with any treatment for LTBI in the United States. Surveillance of such events will provide data to support periodic evaluation of guidelines for treatment of persons with LTBI and revision, as needed. This project will set up a passive reporting system for severe adverse events (death or hospitalization) to therapy for LTBI. The system will rely on medical chart review of already existing data by TB control staff. Potential respondents are any of the 60 reporting areas for the national TB surveillance system (the 50 states, the District of Columbia, New York City, Puerto Rico, and 8 jurisdictions in the Pacific and Caribbean). Data will be collected using the data collection form for adverse events associated with LTBI treatment (AELT). Based on previous reporting, CDC anticipates receiving an average of 3 responses per year from the 60 reporting areas. The AELT form is completed for each reported hospitalization or death related to treatment of LTBI and contains demographic, clinical, and laboratory information. CDC will analyze and periodically publish reports summarizing national LTBI treatment adverse events statistics and also will conduct special analyses for publication in peer-reviewed scientific journals to further describe and interpret these data. The Food and Drug Administration
(FDA)collects data on adverse events related to drugs through the FDA MedWatch Program. CDC is planning to collaborate with FDA in developing the national surveillance system for adverse events associated with treatment for LTBI. Reporting will be conducted through telephone, e-mail, or during CDC site visits. The only cost to respondents is their time to gather medical records to complete the form. Estimate of Annualized Burden Hours Type of respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Physicians 3 1 3 9 Nurses 3 1 4 12 Medical Clerk 3 1 1 3 Total 24 Dated: December 8, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21269 Filed 12-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-0128] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Congenital Syphilis
(CS)Case Investigation and Report Form (CDC73.126)—OMB No. 0920-0128—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC proposes to continue data collection for congenital syphilis case investigations under the “Congenital Syphilis
(CS)Case Investigation and Report Form” (CDC73.126, REV 10-2003). This form is currently approved under OMB No. 0920-0128, and is due to expire on 12/31/2006. This request is for a 3-year extension of OMB approval. Reducing congenital syphilis is a national objective in the DHHS Report entitled Healthy People 2010 (Vol. I and II). Objective 25-9 of this document states the goal: “Reduce congenital syphilis to 1 new case per 100,000 live births”. In order to meet this national objective, an effective surveillance system for congenital syphilis must be continued to monitor current levels of disease and progress towards the year 2010 objective. This data will also be used to develop intervention strategies and to evaluate ongoing control efforts. Respondent burden is approximately 15 minutes per response for those who provide data electronically and 30 minutes per response for those who provide data via hard copy. The estimated annual number of cases expected to be reported using the current case definition is approximately 500. There are no costs to the respondents other than their time. The total estimated annual burden hours are 160. Estimated Annualized Burden Hours Respondents Number of respondents Average number of responses per respondent Average burden per response (in hours) Total burden (in hours) Clerical and hospital staff of state and local health department STD project areas 50 (electronic data) 8 15/60 100 15 (hardcopy data) 8 30/60 60 Dated: December 7, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21273 Filed 12-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Public Law 92-463) of October 6, 1972, that the Mine Safety and Health Research Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 30, 2008. For information, contact Jeffrey Kohler, Ph.D., Executive Secretary, Mine Safety and Health Research Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, 626 Cochrans Mill Road, Mailstop P05, Pittsburgh, Pennsylvania 15236, telephone 412/386-5301 or fax 404/386-5300. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: December 8, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-21264 Filed 12-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Decision To Evaluate a Petition To Designate a Class of Employees at Dow Chemical Company, Madison, IL, To Be Included in the Special Exposure Cohort AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Department of Health and Human Services
(HHS)gives notice as required by 42 CFR § 83.12(e) of a decision to evaluate a petition to designate a class of employees at Dow Chemical Company, Madison, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: *Facility:* Dow Chemical Company. *Location:* Madison, Illinois. *Job Titles and/or Job Duties:* All Atomic Weapons Employer employees who were monitored, or should have been monitored, for exposure to ionizing radiation while working for a number of work days aggregating at least 250 work days, either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. *Period of Employment:* January 1, 1957 through December 21, 1960. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 513-533-6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to *OCAS@CDC.GOV.* Dated: December 7, 2006. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 06-9668 Filed 12-13-06; 8:45 am]
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  • Pub. L. 92-463
  • 42 CFR 83.12(e)
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Pub. L.Pub. L. 92-463
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