Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[INFO-98-08]

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) and the Agency for Toxic Substances and Disease

Registry (ATSDR) 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/ATSDR

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/

ATSDR 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. Model Performance Evaluation Program for Retroviral and AIDS-

Related Testing--(0920-0274)--Extension--Public Health Practice Program

Office (PHPPO). The CDC Model Performance Evaluation Program (MPEP)

currently assesses the performance of laboratories that test for human

immunodeficiency virus type 1 (HIV-1) antibody, human T-lymphotropic

virus types I and II (HTLV-I/II) antibody, perform CD4 T-cell testing

or T-lymphocyte immunophenotyping (TLI) by flow cytometry or alternate

methods, perform HIV-1 ribonucleic acid (RNA) determinations (viral

load), and test for HIV-1 p24 antigen through the use of mailed sample

panels. The CDC MPEP is proposing to use annual data collection

documents to gain updated information on the characteristics of testing

laboratories and their testing practices. Two data collection

instruments, or survey questionnaires, will be used. The first data

collection instrument will be concerned with laboratories that perform

HIV-1 antibody (Ab) testing, HTLV-I/II Ab testing, HIV-1 viral RNA

determinations, and HIV-1 p24 antigen (Ag) testing. Laboratories

enrolled in the MPEP will be mailed a survey questionnaire and be asked

to complete the sections pertinent to their laboratory's testing. The

survey instrument will collect demographic information related to

laboratory type, primary purpose for testing, types of specimens

tested, minimum education requirements of testing personnel, laboratory

director, and laboratory

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supervisor, and training required of testing personnel. The demographic

section will be followed by more specific sections related directly to

HIV-1 Ab testing, HTLV-I/II Ab testing, HIV-1 RNA, and HIV-1 p24 Ag

testing. Included in the latter sections will be questions related to

the types of tests performed, the algorithm of testing, how test

results are interpreted, how results are reported, how specimens may be

rejected for testing, if some testing is referred to other

laboratories, and what quality control and quality assurance procedures

are conducted by the laboratory. Similarly, the TLI survey

questionnaire will also collect demographic information about each

laboratory, as well as, the type(s) of flow cytometer used, educational

and training requirements of testing personnel, the types of monoclonal

antibodies used in testing, how specimens are received, prepared, and

stored, how test results are recorded and reported to the test

requestor, and what quality control and quality assurance procedures

are practiced. Information collected through the use of these

instruments will enable CDC to determine if laboratories are conforming

to published recommendations and guidelines, whether education and

training requirements of testing personnel are conforming to current

legislative requirements, and whether problems in testing can be

identified through the collection of information. Information collected

through the survey instruments will then be compared statistically with

the performance evaluation results reported by the enrolled

laboratories to determine if characteristics of laboratories that

perform well can be distinguished from laboratories not performing as

well. Upon enrolling in the MPEP, participants are assigned an MPEP

number used to report testing results and survey questionnaire

responses allowing the individual responses of each laboratory

participant to be treated in confidence. When participants respond to

the surveys by sending CDC completed questionnaires, the collected

information is developed into aggregate reports. A copy of the

completed report is provided to each participating laboratory. Other

than their time, there will be no cost to the respondents.

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No. of Average burden/

Respondents Number of respondents/ response (in Total burden

respondents response hrs) (in hrs)

----------------------------------------------------------------------------------------------------------------

MPEP Enrollment Form............................ 100 1 0.1 10

Retroviral Survey............................... 1,000 1 0.5 500

TLI Survey...................................... 350 1 0.5 175

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Total....................................... 685

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2. Prostate and Colorectal Cancer Screening in the Managed Care

Environment--New--National Center for Chronic Disease Prevention and

Health Promotion (NCCDPHP). Prostate and colorectal cancer are among

the leading causes of cancer deaths in the U.S. Prostate cancer

screening has increased rapidly during the past few years; however,

little is known about actual rates of screening, or the proportion of

men screened who present with symptoms or who are at high risk for

prostate cancer. Evidence suggests that colorectal cancer screening can

save lives and efforts are under way to increase participation in

screening. However, little information is available to monitor

screening rates. It is also unknown how well self-reported prostate and

colorectal cancer screening rates, which are often used in population

surveys, compare to actual screening rates. Therefore, the Centers for

Disease Control and Prevention (CDC), National Center for Chronic

Disease Prevention and Health Promotion, Division of Cancer Prevention

and Control, intends to conduct a survey of prostate and colorectal

cancer screening test utilization. As an increasing number of people

are served by managed care organizations where they may receive cancer

screening tests, the proposed study population are members of managed

care organizations.

A sample of members (men aged 40 years and older and women 50 years

and older) of 3 managed care organizations will be interviewed over the

telephone, and the medical charts of the participants will be

abstracted. The information collected will include demographic

information, prostate and colorectal cancer screening tests received

within the past 5 years, and the reasons and outcomes of the tests. The

total cost estimate is: $400,000.

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No. of Average burden

Respondents No. of responses/ of response (in Total burden

respondents respondent hrs) (in hrs)

----------------------------------------------------------------------------------------------------------------

Members of Prepaid Health Plans............. 2200 1 0.25 550

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3. Substance Specific Applied Research Program (AMHPS) [King/Drew

Lead Study in-Person Interview, Lead and Hypertension Screening

Questionnaire/Risk Factor Questionnaire]--(0923-0015)--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.

Disadvantaged minorities in large urban areas have higher than national

blood lead levels. Some of these groups also suffer from

disproportionately high rates of hypertension. Previous data shows a

relationship between higher blood lead levels and higher blood

pressure, even at the lowest lead exposure. To facilitate this effort,

this study examines the relationship between lead exposure history in

inner city minorities and blood pressure, using a group at special risk

for elevated blood pressure, pregnant women. Elevated blood lead

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and elevated blood pressure are two problems that disproportionately

affect minority groups. Establishing a link between blood pressure and

lead exposure, especially utilizing two new biomarkers of lead

exposure, bone lead and serum lead, can provide a new tool for dealing

with elevated blood pressure nationwide.

This request is for a 3-year extension. Two previously approved

questionnaires will continue to be used to collect socioeconomic data,

and data pertaining to risk factors for elevated blood pressure and

lead exposure. A new questionnaire assessing social stress (Scale of

Chronic Social Role Stressors) and a 16 item, four response choice

scale will be added to better control for social stress factors

affecting blood pressure. There is no cost to respondents.

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No. of No. of Avg. burden

Type of respondent respondents responses/ per response Total burden

per year respondent (in hrs) (in hrs)

----------------------------------------------------------------------------------------------------------------

Screening Questionnaire......................... 880 1 .5 440

Social Role Stressors........................... 880 1 .08 70

Risk Questionnaire.............................. 330 2 .75 495

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Total....................................... .............. .............. .............. 1005

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Dated: January 13, 1998.

Wilma G. Johnson,

Acting Associate Director for Policy Planning and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 98-1206 Filed 1-16-98; 8:45 am]

BILLING CODE 4163-18-P