Agency information collection activities: Proposed collection; comment request,
[Federal Register: August 12, 1998 (Volume 63, Number 155)]
[Notices]
[Page 43184-43186]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au98-69]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[INFO-98-25]
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 at (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 or other forms of information technology. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice. Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
Proposed Projects
-
A National Registry for Surveillance of Non-Occupational Exposures to Human Immunodeficiency Virus and Post-Exposure Antiretroviral Therapy--New--The National Center for HIV, STD, and TB Prevention, Division of HIV/AIDS Prevention, Surveillance, and Epidemiology proposes to develop and implement a surveillance registry in the United States which will provide data for analysis and technical reports on the frequency and types of nonoccupational exposures to HIV, offers and acceptance rates of antiretroviral therapy to attempt interruption of transmission and clinical course and outcomes of persons with documented HIV exposure.
Studies of antiretroviral agents for preventing HIV infection in health care workers and from pregnant women to their infants have shown antiretroviral therapy to be efficacious. As a result of these findings, the Public Health Service has recommended the use of antiretroviral drugs to reduce HIV transmission among those exposed in the work place and from HIV-infected women to their infants. These findings may not be directly relevant to nonoccupational settings. Hence, further studies are needed before concluding that use of antiretroviral agents following nonoccupational exposures is clearly effective in preventing HIV infection. The surveillance system will provide data to address those issues.
The surveillance system will be a voluntary and anonymous system in which all health care providers will be encouraged to report by phone, fax, mail, or website 24 hours a day about all persons to whom they have offered antiretroviral therapy after a nonoccupational exposure to HIV. Data will be collected using an assigned unique registry number. During the initial contact, patient consent will be ascertained, data will be collected on the characteristics of the exposure event, knowledge of HIV status of the source patient, and treatment decision of the provider for patients whose HIV exposure has been documented. Follow-up information will be requested at 4-6 weeks, 6 months, and 12 months post prescription of post exposure therapy. Estimated cost to respondents and government is $200,000.00 a year.
[[Page 43185]]
Number of Average burden
Respondents
Number of responses per per response Total burden respondents respondent (in hrs)
(in hrs)
Health Care Providers...........................
100
5
.30
150
Total....................................... .............. .............. ..............
150
-
A National Registry for Surveillance of Non-Occupational Exposures to Human Immunodeficiency Virus and Post-Exposure Antiretroviral Therapy--New--National Center for HIV, STD, and TB Prevention--To ensure the elimination of tuberculosis in the United States, key program activities such as finding tuberculosis infections in recent contacts of cases and in other persons likely to be infected, and providing preventive therapy, must be monitored. The Division of Tuberculosis Elimination (DTBE), is implementing two revised program management reports for annual submission: Aggregate report of follow-up for contacts of tuberculosis, and Aggregate report of screening and preventive therapy for tuberculosis infection. The respondents for these reports are the 68 state and local tuberculosis control programs receiving federal cooperative agreement funding through (DTBE). The revised reports phase out two twice-yearly program management reports in the Tuberculosis Statistics and Program Evaluation Activity (OMB 0920-0026): Contact Follow-up (CDC 72.16) and Completion of Preventive Therapy (CDC 72.21). The revised reports, which are being submitted for an OMB approval outside of OMB 0920-0026, have several improvements over the old reports for the respondents and for DTBE, such as the emphasis on preventive therapy outcomes, the focus on high-priority target populations vulnerable to tuberculosis, and programmed electronic report generation and submission through the Tuberculosis Information Management System. The old reports, CDC 72.16 and CDC 72.21, which have been submitted at least in some form by the respondents since 1961, are tabulated by hand.
Three program management reports in the previous series already have been phased out. They are Bacteriologic Conversion of Sputum (CDC 72.14), Case Register (CDC 72.15), and Drug Therapy (CDC 72.20). These three reports have been superseded by integrated reporting in Tuberculosis Statistics and Program Evaluation Activity (OMB 0920- 0026). The discontinuation of these reports has resulted in an estimated reduction in the annual response burden of 159 hours. The cost to the respondent is $6,324.
Number of Average burden
Report
Number of responses per per response Total burden respondents respondent (in hrs.) (in hrs.)
Aggregate report of follow-up for contacts of
tuberculosis...................................
68
1
2.5
170 Aggregate report of screening and preventive
therapy for TB infection.......................
68
1
2.5
170
Total....................................... .............. .............. ..............
340
-
Provider Survey of Partner Notification and Partner Management Practices following Diagnosis of a Sexually-Transmitted Disease (0920- 0431)--Extension--The National Center for HIV, STD, and TB prevention, Division of STD Prevention, CDC is proposing to conduct a national survey of physician's partner management practices following the diagnosis of a sexually-transmitted disease. Partner notification, a technique for controlling the spread of sexually-transmitted diseases is one of the five key elements of a long standing public health strategy to control sexually-transmitted infections in the US. At present, there is very little knowledge about partner notification practices outside public health settings despite the fact that most STD cases are seen in private health care settings. No descriptive data currently exist that allow the Centers for Disease Control and Prevention to characterize partner notification practices among the broad range of clinical practice settings where STDs are diagnosed, including acute or urgent care, emergency room, or primary and ambulatory care clinics. The existing literature contains descriptive studies of partner notification in public health clinics, but no baseline data exist as to the practices of different physician specialties across different practice settings.
The CDC proposes to fill that gap through a national sample survey of 7300 office managers and physicians who treat patients with STDs in a wide variety of clinical settings; a 70% completion rate is anticipated (n=5110 surveys). This survey will provide the baseline data necessary to characterize infection control practices, especially partner notification practices, for syphilis, gonorrhea, HIV, and chlamydia and the contextual factors that influence those practices. Findings from the proposed national survey of office managers and physicians will assist CDC to better focus STD control and partner notification program efforts and to allocate program resources appropriately. Without this information, CDC will have little information about STD treatment, reporting, and partner management services provided by physicians practicing in the US. With changes underway in the manner in which medical care is delivered and the move toward managed care, clinical functions typically provided in the public health sector will now be required of private medical providers. At present, CDC does not have sufficient information to guide future STD control efforts in the private medical sector.
Data collection will involve a mail survey of practicing physicians. The questionnaire mailing will be followed by a reminder postcard after one week, a second mailing to non-respondents at three weeks, telephone follow-up with non-respondents at five weeks, and a final certified mailing of the survey to non-respondents at eight weeks. A study specific computerized tracking and reporting system will monitor all phases of the study. Receipt of the completed questionnaire or a refusal will be logged
[[Page 43186]]
into this computerized control system to ensure that respondents who return the survey are not contacted with reminders.
The current OMB approval for this collection covers the pilot only and expires on October 31, 1998. The pilot will vary the respondent payment to equal subsections of the sample using amounts of $0, $15, and $25. The re-submission of the full information collection package will include a report from the pilot including a detailed report of the response rates overall and break down by use of the various response rates.
Estimated cost to respondents and government based on an average pay rate of $25/hour, the estimated total cost burden for office managers to answer Section 1 is $10,650. Based on an average pay rate of $70/hour, the estimated cost burden for physicians is $94,640. Thus the total cost burden for the data collection effort is estimated to be $105,290.
Number of Average burden/
Respondents
Sections
Number of responses/ response (in Total burden respondents respondent
hrs.)
(in hrs.)
Office Managers.................
1
7300
1
.08
584 Physicians......................
2-4
5110
3
.03
460 Physicians......................
5-10
5110
6
.20
6132
Total....................... .............. .............. .............. ..............
7176
Dated: August 4, 1998. Charles W. Gollmar, Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention (CDC).
[FR Doc. 98-21581Filed8-11-98; 8:45 am]
BILLING CODE CODE 4163-18-P
