Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[INFO-96-26]

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 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

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on respondents, including through the use of automated collection

techniques for other forms of information technology. Send comments to

Wilma Johnson, CDC 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. List of Ingredients Added to Tobacco in the Manufacture of

Smokeless Tobacco Products--(0920-0338)--Extension--Oral use of

smokeless tobacco represents a significant health risk which can cause

cancer and a number of noncancerous oral conditions, and can lead to

nicotine addiction and dependence. Furthermore, smokeless tobacco use

is not a safe substitute for cigarette smoking. The Centers for Disease

Control and Prevention's (CDC) Office on Smoking and Health (OSH) has

been delegated the authority for implementing major components of the

Department of Health and Human Services' (HHS) tobacco and health

program, including collection of tobacco ingredients information. HHS's

overall goal is to reduce death and disability resulting from cigarette

smoking and other forms of tobacco use through programs of information,

education and research.

The Comprehensive Smokeless Tobacco Health Education Act of 1986

(15 U.S.C. 4401 et seq., Pub.L. 99-252) requires each person who

manufactures, packages, or imports smokeless tobacco products to

provide the Secretary of HHS with a list of ingredients added to

tobacco in the manufacture of smokeless tobacco products. HHS is

authorized to undertake research, and to report to the Congress (as

deemed appropriate), on the health effects of the ingredients. The

total cost to respondents is estimated at $22,000.

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No. of Average burden/

Respondents No. of responses/ response (in Total burden

respondents respondent hrs.) (in hrs.)

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Tobacco manufacturers........................... 11 1 26 286

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Total..................................... .............. .............. .............. 286

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2. Survey of diagnostic and management practices for group A

streptococcal pharyngitis--New--Appropriate diagnosis and management of

streptococcal pharyngitis is important to prevent severe nonsuppurative

complications such as rheumatic fever. In addition, early treatment

will prevent suppurative complications and decrease spread of infection

to close contacts. To achieve optimal sensitivity, the American Academy

of Pediatrics recommends that throat cultures be performed, or that if

an antigen detection test is done, that a negative test be backed-up by

culture. Despite these recommendations, many clinicians diagnose

streptococcal pharyngitis based on clinical findings or on the results

of an antigen detection test alone. One factor that has been shown to

be associated with the use of culture for diagnosis, is whether the

physician cultures for group A streptococci in the office.

Recent changes in the medical care system and in Federal

regulations may have affected the availability and use of throat

cultures in office settings. Managed care organizations are unlikely to

reimburse clinicians for performing two diagnostic tests and, in a

capitated system, any use of diagnostic testing would reduce a

physician's profit. Moreover, recently implemented CLIA regulations of

office laboratories may have decreased the use of office culture as

physicians find it easier not to test than to comply with these

regulations.

Surveying physician diagnostic and management practices for group A

streptococcal pharyngitis will help identify current practices and the

factors that have affected the use of diagnostic testing, especially

throat culture. These results can be used to develop interventions to

promote appropriate diagnostic methods, leading to improved accuracy of

diagnosis, and prevention of morbidity.

This proposed two year study, will collect data from practicing

pediatricians and family physicians on the characteristics of their

practice, their approach to diagnosis of pharyngitis including the use

of laboratory testing, the testing methods that are used in their

office laboratory, recent changes that they have made in testing, and

reasons for those changes. This survey will build on results of a

survey that was conducted in 1991 before the implementation of CLIA

regulations and the expansion of managed care. The survey will be

carried out during the winter of 1996-97, in the Chicago metropolitan

area by the Chairman of the American Academy of Pediatrics Section on

Infectious Diseases, who also is an expert on streptococcal infections.

Data will be entered and analyzed by this investigator in collaboration

with CDC and the HCFA Region V office in Chicago. The total cost to

respondents is estimated at $33,350.

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No. of Avg. burden/

Respondents No. of responses/ response (in Total burden

respondents respondent hrs.) (in hrs.)

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Pediatricians and Family Physicians with primary

care practices................................. 2000 1 0.333 667

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Total..................................... .............. .............. .............. 677

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3. Sentinel Surveillance for Chronic Liver Disease--New-- A

questionnaire has been designed to collect information for the Sentinel

Surveillance for Chronic Liver Disease project. The purpose of the

project is to determine the incidence and period prevalence of

physician-diagnosed chronic liver disease in a defined geographic area,

the contribution of chronic viral hepatitis to the burden of disease,

and the influence of etiologic agents(s) and other factors on

mortality, and to monitor the incidence of and mortality from chronic

lever disease over time. The information gathered will be analyzed, in

conjunction with data collected from other sources, to address these

questions. The results of the project will assist the Hepatitis Branch,

Division of Viral and Rickettsial Diseases, National

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Center for Infectious Diseases in accomplishing the part of its mission

related to preparing recommendations for the prevention and control of

all types of viral hepatitis and their sequellae. In order to focus

prevention efforts and resource allocation, a representative view of

the overall burden of chronic liver disease, its natural history, and

the relative contribution of viral hepatitis is needed. The total cost

to respondents is estimated at $600.

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No. of Average burden/

Respondents No. of responses/ response (in Total burden

respondents respondent hrs.) (in hrs.)

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All consenting adults with physician- diagnosed

chronic liver disease residing in catchment

area........................................... 120 1 0.50 60

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Total..................................... .............. .............. .............. 60

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Dated: September 12, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning and Evaluation Centers

for Disease Control and Prevention (CDC).

[FR Doc. 96-23863 Filed 9-17 -96; 8:45 am]

BILLING CODE 4163-18-P