[Federal Register Volume 67, Number 150 (Monday, August 5, 2002)]
[Notices]
[Pages 50679-50680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Extended Lung Cancer 
Incidence Follow-Up for the Mayo Lung Project Participants

SUMMARY: 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 National Cancer Institute 
(NCI), the National Institutes of Health (NIH) will publish periodic 
summaries of proposed projects to be submitted to the Office of 
Management and Budget (OMB) for review and approval.
    Collection: Title: Extended Lung Cancer Incidence Follow-Up for the 
Mayo Lung Project Participants.
    Type of Information Collection Request: EXTENSION, OMB No. 0925-
0496, expiration date 10-31-2002.
    Need and Use of Information Collection: The Mayo Lung Project (MLP) 
was an NCI-funded randomized controlled trial (RCT) of lung cancer 
screening conducted among 9,211 male smokers from 1971 to 1983. No 
reduction in lung cancer mortality was observed in the MLP with an 
intense regimen of x-ray and sputum cytology screening. Recent analysis 
of updated mortality and case survival data (through 1996) suggests 
that lesions with little-to-no clinical relevance (over-diagnosis may 
have been detected through screening in the MLP intervention arm. Over-
diagnosis leads to unnecessary medical interventions, including 
diagnostic and treatment procedures that carry with them varying 
degrees of risk. Consequently, over-diagnosis can result in 
considerable harm, including premature death, that would not have 
occurred in the absence of screening. The persistence, after screening 
ends, of an excess of lung cancer cases in the intervention arm is the 
strongest evidence in support of over-diagnosis, but this information 
cannot be adequately obtained with available MLP data. Therefore, we 
propose to re-contact the MLP participants and/or their next-of-kin to 
determine the participants who were diagnosed with lung cancer after 
the formal end of the Project. These data will allow the NCI to either 
more-convincingly state or perhaps refute the

[[Page 50680]]

possibility of over-diagnosis in lung cancer screening, and may be used 
to guide future research agendas and lung cancer screening policies.
    Frequency of response: Once.
    Affected public: Individuals.
    Type of respondents: MLP participants or their next-of-kin. The 
annual reporting burden is as follows:
    Maximum number of respondents: 6,223;
    Estimated number of Responses per Respondent: 1.
    Average Burden Hours Per Response: 0.25;
    Estimated Maximum Total Annual Burden Hours Requested: 1,556. The 
annualized cost to respondents is estimated at zero. There are no 
Capital Costs to report. There are no Operating or Maintenance Costs to 
report.
    Request for comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) Minimize the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

FOR FURTHER INFORMATION:  To request more information on the proposed 
project or to obtain a copy of the data collection plans and 
instruments, contact: Dr. Pamela Marcus, Epidemiologist, Biometry 
Research Group, Division of Cancer Prevention, National Cancer 
Institute, Suite 3131 EPN, 6130 Executive Blvd, Bethesda, MD 20892-
7354; or call non-toll free 301-496-7468; or email [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: July 29, 2002.
Reesa L. Nichols,
NCI Project Clearance Liaison.
[FR Doc. 02-19727 Filed 8-2-02; 8:45 am]
BILLING CODE 4140-01-M