Proposed Data Collections Submitted for Public Comment and Recommendations

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

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.

[[Page 43185]]

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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

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Total....................................... .............. .............. .............. 150

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2. 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.

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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

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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

[[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.

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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

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Total....................... .............. .............. .............. .............. 7176

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Dated: August 4, 1998.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 98-21581 Filed 8-11-98; 8:45 am]

BILLING CODE CODE 4163-18-P