[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Notices]
[Pages 44461-44463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-98-25]


Proposed Data Collections Submitted for Public Comment and 
Recommendations: Correction

    On August 12, 1998, the Centers for Disease Control and Prevention 
published: A National Registry for Surveillance of Non-Occupational 
Exposures to Human Immunodeficiency Virus and Post-Exposure 
Antiretrovial Therapy in section 2 was incorrect.
    On page 43185 in the first column the title for section 2 is 
corrected to read Aggregate report of follow-up for contacts of 
tuberculosis, and Aggregate report of screening and preventive therapy 
for tuberculosis infection: two revised tuberculosis programs.
    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.

[[Page 44462]]

    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

    1. 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.

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                                                                            Number of     Average               
                                                               Number of    responses    burden per     Total   
                         Respondents                          respondents      per        response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Health Care Providers.......................................          100            5          .30          150
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........          150
----------------------------------------------------------------------------------------------------------------

    2. Aggregate report of follow-up for contacts of tuberculosis, and 
Aggregate report of screening and prevention therapy for tuberculosis 
infection: two revised tuberculosis program management reports--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 and 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.

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                                                                            Number of     Average               
                                                               Number of    responses    burden per     Total   
                           Report                             respondents      per        response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
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
                                                             ---------------------------------------------------

[[Page 44463]]

                                                                                                                
    Total...................................................  ...........  ...........  ...........          340
----------------------------------------------------------------------------------------------------------------

    3. 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 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.

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                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
             Respondents                     Sections         respondents   responses/    response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Office Mangers......................  Section 1.............         7300            1          .08          584
Physicians..........................  Sections 2-4..........         5110            3          .03          460
Physicians..........................  Sections 5-10.........         5110            6          .20         6132
                                                                                                                
      Total.........................  ......................  ...........  ...........  ...........         7176
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Charles W. Gollmar,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 98-22260 Filed 8-18-98; 8:45 am]
BILLING CODE 4163-18-M