[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
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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