[Federal Register Volume 61, Number 182 (Wednesday, September 18, 1996)]
[Notices]
[Pages 49145-49147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23863]


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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

[[Page 49146]]

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
                                                 ---------------------------------------------------------------
      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.)  
----------------------------------------------------------------------------------------------------------------
Pediatricians and Family Physicians with primary                                                                
 care practices.................................            2000               1           0.333             667
                                                 ---------------------------------------------------------------
      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

[[Page 49147]]

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.)  
----------------------------------------------------------------------------------------------------------------
All consenting adults with physician- diagnosed                                                                 
 chronic liver disease residing in catchment                                                                    
 area...........................................             120               1            0.50              60
                                                 ---------------------------------------------------------------
      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