[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)
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Health Care Providers....................................... 100 5 .30 150
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Total................................................. ........... ........... ........... 150
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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)
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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
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[[Page 44463]]
Total................................................... ........... ........... ........... 340
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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)
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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
