[Federal Register Volume 63, Number 12 (Tuesday, January 20, 1998)] [Notices] [Pages 2982-2984] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-1206] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [INFO-98-08] 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) and the Agency for Toxic Substances and Disease Registry (ATSDR) 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 the CDC/ATSDR Reports Clearance Officer on (404) 639-7090. 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 for other forms of information technology. Send comments to Wilma Johnson, CDC/ ATSDR Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice. Proposed Projects 1. Model Performance Evaluation Program for Retroviral and AIDS- Related Testing--(0920-0274)--Extension--Public Health Practice Program Office (PHPPO). The CDC Model Performance Evaluation Program (MPEP) currently assesses the performance of laboratories that test for human immunodeficiency virus type 1 (HIV-1) antibody, human T-lymphotropic virus types I and II (HTLV-I/II) antibody, perform CD4 T-cell testing or T-lymphocyte immunophenotyping (TLI) by flow cytometry or alternate methods, perform HIV-1 ribonucleic acid (RNA) determinations (viral load), and test for HIV-1 p24 antigen through the use of mailed sample panels. The CDC MPEP is proposing to use annual data collection documents to gain updated information on the characteristics of testing laboratories and their testing practices. Two data collection instruments, or survey questionnaires, will be used. The first data collection instrument will be concerned with laboratories that perform HIV-1 antibody (Ab) testing, HTLV-I/II Ab testing, HIV-1 viral RNA determinations, and HIV-1 p24 antigen (Ag) testing. Laboratories enrolled in the MPEP will be mailed a survey questionnaire and be asked to complete the sections pertinent to their laboratory's testing. The survey instrument will collect demographic information related to laboratory type, primary purpose for testing, types of specimens tested, minimum education requirements of testing personnel, laboratory director, and laboratory [[Page 2983]] supervisor, and training required of testing personnel. The demographic section will be followed by more specific sections related directly to HIV-1 Ab testing, HTLV-I/II Ab testing, HIV-1 RNA, and HIV-1 p24 Ag testing. Included in the latter sections will be questions related to the types of tests performed, the algorithm of testing, how test results are interpreted, how results are reported, how specimens may be rejected for testing, if some testing is referred to other laboratories, and what quality control and quality assurance procedures are conducted by the laboratory. Similarly, the TLI survey questionnaire will also collect demographic information about each laboratory, as well as, the type(s) of flow cytometer used, educational and training requirements of testing personnel, the types of monoclonal antibodies used in testing, how specimens are received, prepared, and stored, how test results are recorded and reported to the test requestor, and what quality control and quality assurance procedures are practiced. Information collected through the use of these instruments will enable CDC to determine if laboratories are conforming to published recommendations and guidelines, whether education and training requirements of testing personnel are conforming to current legislative requirements, and whether problems in testing can be identified through the collection of information. Information collected through the survey instruments will then be compared statistically with the performance evaluation results reported by the enrolled laboratories to determine if characteristics of laboratories that perform well can be distinguished from laboratories not performing as well. Upon enrolling in the MPEP, participants are assigned an MPEP number used to report testing results and survey questionnaire responses allowing the individual responses of each laboratory participant to be treated in confidence. When participants respond to the surveys by sending CDC completed questionnaires, the collected information is developed into aggregate reports. A copy of the completed report is provided to each participating laboratory. Other than their time, there will be no cost to the respondents. ---------------------------------------------------------------------------------------------------------------- No. of Average burden/ Respondents Number of respondents/ response (in Total burden respondents response hrs) (in hrs) ---------------------------------------------------------------------------------------------------------------- MPEP Enrollment Form............................ 100 1 0.1 10 Retroviral Survey............................... 1,000 1 0.5 500 TLI Survey...................................... 350 1 0.5 175 --------------------------------------------------------------- Total....................................... 685 ---------------------------------------------------------------------------------------------------------------- 2. Prostate and Colorectal Cancer Screening in the Managed Care Environment--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). Prostate and colorectal cancer are among the leading causes of cancer deaths in the U.S. Prostate cancer screening has increased rapidly during the past few years; however, little is known about actual rates of screening, or the proportion of men screened who present with symptoms or who are at high risk for prostate cancer. Evidence suggests that colorectal cancer screening can save lives and efforts are under way to increase participation in screening. However, little information is available to monitor screening rates. It is also unknown how well self-reported prostate and colorectal cancer screening rates, which are often used in population surveys, compare to actual screening rates. Therefore, the Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention and Health Promotion, Division of Cancer Prevention and Control, intends to conduct a survey of prostate and colorectal cancer screening test utilization. As an increasing number of people are served by managed care organizations where they may receive cancer screening tests, the proposed study population are members of managed care organizations. A sample of members (men aged 40 years and older and women 50 years and older) of 3 managed care organizations will be interviewed over the telephone, and the medical charts of the participants will be abstracted. The information collected will include demographic information, prostate and colorectal cancer screening tests received within the past 5 years, and the reasons and outcomes of the tests. The total cost estimate is: $400,000. ---------------------------------------------------------------------------------------------------------------- No. of Average burden Respondents No. of responses/ of response (in Total burden respondents respondent hrs) (in hrs) ---------------------------------------------------------------------------------------------------------------- Members of Prepaid Health Plans............. 2200 1 0.25 550 ---------------------------------------------------------------------------------------------------------------- 3. Substance Specific Applied Research Program (AMHPS) [King/Drew Lead Study in-Person Interview, Lead and Hypertension Screening Questionnaire/Risk Factor Questionnaire]--(0923-0015)--EXTENSION--The Agency for Toxic Substances and Disease Registry (ATSDR) is mandated pursuant to the 1980 Comprehensive Environmental Response Compensation and Liability Act (CERCLA), and its 1986 Amendments, The Superfund Amendments and Reauthorization Act (SARA), to prevent or mitigate adverse human health effects and diminished quality of life resulting from the exposure to hazardous substances into the environment. Disadvantaged minorities in large urban areas have higher than national blood lead levels. Some of these groups also suffer from disproportionately high rates of hypertension. Previous data shows a relationship between higher blood lead levels and higher blood pressure, even at the lowest lead exposure. To facilitate this effort, this study examines the relationship between lead exposure history in inner city minorities and blood pressure, using a group at special risk for elevated blood pressure, pregnant women. Elevated blood lead [[Page 2984]] and elevated blood pressure are two problems that disproportionately affect minority groups. Establishing a link between blood pressure and lead exposure, especially utilizing two new biomarkers of lead exposure, bone lead and serum lead, can provide a new tool for dealing with elevated blood pressure nationwide. This request is for a 3-year extension. Two previously approved questionnaires will continue to be used to collect socioeconomic data, and data pertaining to risk factors for elevated blood pressure and lead exposure. A new questionnaire assessing social stress (Scale of Chronic Social Role Stressors) and a 16 item, four response choice scale will be added to better control for social stress factors affecting blood pressure. There is no cost to respondents. ---------------------------------------------------------------------------------------------------------------- No. of No. of Avg. burden Type of respondent respondents responses/ per response Total burden per year respondent (in hrs) (in hrs) ---------------------------------------------------------------------------------------------------------------- Screening Questionnaire......................... 880 1 .5 440 Social Role Stressors........................... 880 1 .08 70 Risk Questionnaire.............................. 330 2 .75 495 --------------------------------------------------------------- Total....................................... .............. .............. .............. 1005 ---------------------------------------------------------------------------------------------------------------- Dated: January 13, 1998. Wilma G. Johnson, Acting Associate Director for Policy Planning and Evaluation, Centers for Disease Control and Prevention (CDC). [FR Doc. 98-1206 Filed 1-16-98; 8:45 am] BILLING CODE 4163-18-P