[Federal Register Volume 62, Number 13 (Tuesday, January 21, 1997)] [Notices] [Pages 3044-3047] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-1340] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [INFO-97-01] 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 the CDC 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 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. AIDS Prevention and Surveillance Project Reports, (0920-0208)-- Extension--CDC funds cooperative agreements for 65 HIV Prevention Projects (50 states, 6 cities, 7 territories, Washington, D.C., and Puerto Rico). The cooperative agreements support counseling, testing, referral, and partner notification programs conducted by official public health agencies of states, territories, and localities (project areas). HIV counseling and testing in STD clinics, Women's Health Centers, Drug Treatment Centers, and other health agencies has been described as a primary prevention strategy of the national HIV Prevention Program. These project areas have increased HIV counseling and testing activities to specifically reach more minorities and women of child bearing age. CDC is responsible for monitoring and evaluating HIV prevention activities conducted under the cooperative agreement. Counseling and testing programs are a major component of the HIV Prevention Program. Without data to measure the impact of counseling and testing programs, priorities cannot be assessed and redirected to prevent further spread of the virus in the general population. CDC needs information from all project areas on the number of at-risk persons tested and the number positive for HIV. The HIV Counseling and Testing Report Form provides a simple yet complete means to collect this information. We are requesting a three year extension for this study. The estimated cost to the respondents is $10,320 per year. [[Page 3045]] ---------------------------------------------------------------------------------------------------------------- No. of Average burden/ Respondents No. of responses/ response (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Manual Form Project Areas....................... 21 4 2 168 Scan Form Project Areas......................... 44 4 0.25 44 --------------- Total....................................... .............. .............. .............. 212 ---------------------------------------------------------------------------------------------------------------- 2. Multi-Center Cohort Study to Assess the Risk and Consequences of Hepatitis C Virus Transmission from Mother to Infant (0920-0344)-- Extension--The purpose of the study is to determine the incidence of vertical hepatitis C virus (HCV) transmission, to assess risk factors for vertical HCV transmission, to assess the clinical course of disease among infants with HCV infection, and to assess diagnostic methods for detecting HCV infection in infants. Respondents for the study will be anti-HCV positive mothers. There is no cost to the respondents. They will be remunerated for travel costs; provided well-child visits and free vaccinations for infants enrolled in the study; and, provided anti-HCV testing to all family members free of charge. The total response burden for the study, over a 3 year period, is as follows: ---------------------------------------------------------------------------------------------------------------- No. of Avg. burden/ Respondents Form name No. of responses/ response (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Individual Mothers........... Form A........... 300 1 0.25 75 Mothers...................... Form B........... 1200 1 0.25 300 Mothers...................... Form C........... 300 1 0.10 30 Mothers...................... Form D........... 300 1 0.25 75 Family members............... Form E........... 700 1 0.25 175 Mothers...................... Form F........... 300 1 0.25 75 Mothers...................... Form G........... 300 8 0.10 240 --------------- Total.................... ................. .............. .............. .............. * 970 ---------------------------------------------------------------------------------------------------------------- * The annualized response burden is estimated to be 970 hours/3 years=323 hours. (Target enrollment in the study is 300; the target population will be drawn from those who complete Form B. Family members will complete Form E.) 3. Continuing Medical Education (CME) Activity Registration Form-- (0923-0013)--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. As stated in CERCLA, the Administrator of ATSDR is charged to ``assemble, develop as necessary, and distribute to the states, and upon request to medical colleges, physicians, and other health professionals, appropriate educational materials (including short courses) on this topic''. The development and use of activity registration forms for documenting participation in these activities at these meetings is an integral part of this process. This attendance documentation process is required by the Accreditation Council for Continuing Medical Education (ACCME), the body that authorizes agencies and institutions to award nationally recognized continuing medical education (CME) credit. As a condition of relicensure, physicians in 40 states are required to participate in CME courses. Individual physicians in these states are required to submit the number of hours of CME credit to state boards of professional registration at the time of relicensure. Failure by the physician to provide this information in a timely fashion will result in suspension of professional licensure. This request is for a 3-year extension of the current OMB approval of uniform CME activity registration forms--one machine entry form and the other manually entered--to serve as the initial step in the development of an attendance documentation system. Other than their time, there will be no cost to the respondents. ---------------------------------------------------------------------------------------------------------------- No. of Average burden/ Respondents No. of responses/ response (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Manual Entry Registration Form.................. 2,000 1 0.066 132 Scantron Registration form...................... 3,000 1 0.083 250 --------------- Total....................................... .............. .............. .............. 382 ---------------------------------------------------------------------------------------------------------------- 4. National Surveillance System for Hospital Health Care workers (NASH)--New--CDC has developed surveillance system that focuses on surveillance of exposures and infections among hospital-based health care workers (HCWs). This system, modeled after the National Nosocomial Infections Surveillance (NNIS) system for patient infections, includes standardized methodology for various occupational health issues (OMB 0920-0012). The Hospital Infections Program, National Center for Infectious Diseases (NCID) has developed this system in [[Page 3046]] collaboration with the Hepatitis Branch, Division of Viral and Rickettsial Diseases, NCID; the Division of Tuberculosis (TB) Elimination, National Center for HIV, STD, and TB Prevention; the National Immunization Program (NIP), and the National Institute for Occupational Safety and Health (NIOSH). The NASH system consists of modules for collection of data about various occupational issues. Baseline information about each HCW such as demographics, immune-status for vaccine-preventable diseases, and TB status is collected when the HCW is enrolled in the system. Results of routine tuberculin skin test (TST) are collected and entered in the system every time a TST is placed and read. In the event that an HCW is exposed to blood/bloodborne pathogen, to a vaccine-preventable disease, or to a TB infectious patient/HCW, epidemiologic data will be collected about the exposure. For HCWs exposed to a bloodborne pathogen (i.e. HIV, HCV, or HBC), follow-up data will be collected during the follow- up visits. Once a year, the hospitals will perform a survey to assess the level of underreporting of needlesticks (HCW survey) and will complete a hospital survey to provide denominator data. Data will be sent entered into the software and diskettes will be sent to CDC. No identifiers of the HCW will be sent to CDC. This system is protected by the Assurance of Confidentiality (308d). Data collected in this surveillance system will assist hospitals, HCWs, HCW organizations, and public health agencies. This system will allow CDC to monitor national trends, to identify newly emerging hazards for HCWs, to assess the risk of occupational infection, and to evaluate preventive measures, including engineering controls, work practices, protective equipment, and postexposure prophylaxis to prevent occupationally acquired infections. Hospitals who volunteer to participate in this system will benefit by receiving technical support and standardized methodologies, including software, for conducting surveillance activities on occupational health. This system has been developed and piloted in large teaching hospitals. Prior to implementation in a nationwide network of hospitals, an expansion of this pilot project to include more medium/ small size hospitals is essential for further refinement of protocols and software. The first pilot project ran from October 1994 to September 1996 (RFP-200-94-0834(p)) and included four hospitals; the second pilot started in October 1996 (RFP-200-96-0524(P)) and includes five hospitals. Fifteen hospitals are expected to participate in this proposed project, including the five currently participating. Once the expanded pilot project is completed, the system will be made available to all short-term care hospitals in the United States who wish to voluntarily participate in this project. The total estimated maximum cost to respondents is $201,840 ($15 an hour for hospital personnel who will collect/input the data). ---------------------------------------------------------------------------------------------------------------- No. of Avg. burden/ Respondents No. of responses/ response (in Total burden respondents respondents hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Baseline Information (form)..................... 22,500 1 0.3333 7,500 TST Result Form................................. 22,500 1 0.1666 3,750 Exposure Form................................... 1,500 1 0.416 625 Follow-up Form.................................. 750 1 0.25 188 Exposure to vaccine-prv. dis Summary Form....... 120 1 0.333 40 HCW Form........................................ 240 1 0.333 80 Exposure to TB Form............................. 45 1 0.50 23 HCW Survey...................................... 7,500 1 0.166 1,250 --------------- Total......................................... .............. .............. .............. 13,456 ---------------------------------------------------------------------------------------------------------------- *The same 15 hospitals will be completing the 8 separate forms listed above. The number of respondents includes x number of employees time each of 15 hospitals. 5. Information Collection Procedures for Requesting Public Health Assessments--(0923-0002)--Extension--The Agency for Toxic Substances and Disease Registry is announcing the request for a 3-year extension of the OMB approval for the Information Collection Procedures for Requesting Public Health Assessments. ATSDR is authorized to accept and respond to petitions from the public that request public health assessments of sites where there is a threat of exposure to hazardous substances (42 USC 9604(i)(6)(B)). The Agency conducts public health assessments of releases or facilities for which individuals provide information that people have been exposed to a hazardous substance, and for which the source of such exposure is a release, as defined under CERCLA. The general administrative procedures for conducting public health assessments, including the information that must be submitted with each request, is described at 42 CFR 90.3, 90.4, and 90.5. Procedures for responding to petitions, decision criteria, and methodology for determining priorities may be found at 57 FR 37382-89. ATSDR anticipates approximately 36 requests will be received each year. This estimate is based on the number of requests received since the enabling legislation was enacted and the expressions of interest (via telephone, letter, etc.) from members of the public, attorneys, and industry representatives. There is no cost to the respondents other than their time. ---------------------------------------------------------------------------------------------------------------- No. of Avg. burden Respondent No. of responses response (in Total burden respondents respondents hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- General Public.................................. 3 1 .50 18 ------------------------------------------------- [[Page 3047]] Total....................................... .............. .............. .............. 18 ---------------------------------------------------------------------------------------------------------------- Dated: January 14, 1997. Wilma G. Johnson, Acting Associate Director for Policy Planning and Evaluation, Centers for Disease Control and Prevention (CDC). [FR Doc. 97-1340 Filed 1-17-97; 8:45 am] BILLING CODE 4163-18-P