[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Notices]
[Pages 21404-21405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10582]


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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 
Center 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.

Proposed Collection

    Title: Extended Lung Cancer Incidence Follow-Up for the Mayo Lung 
Project Participants. Type of Information Collection Request: NEW. Need 
and Use of Information Collection: The Mayo Lung Project (MLP) was an 
NCI-funded randomized collection 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, which 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 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: 9200; Estimated number of 
Responses per Respondent: 1. Average Burden Hours Per Response: 0.25; 
Estimated Maximum Total Annual Burden Hours Requested: 2300. 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 CONTACT: 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 344 EPN, 6130 Executive Blvd, Bethesda, MD 20892-7354; 
or call non-tool 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 on 
or before June 29, 2001.

    Dated: April 20, 2001.
Reesa L. Nichols,
NCI Project Clearance Liaison.
[FR Doc. 01-10582 Filed 4-27-01; 8:45 am]
BILLING CODE 4140-01-M