[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Notices]
[Page 46642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Extended Lung Cancer 
Incidence Follow-Up for the Mayo Lung Project Participants

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request to review and approve the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on April 
30, 2001, page 21404, Volume 66, No. 83 and allowed 60 days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment. The National 
Institutes of Health may not conduct or sponsor, and the respondent is 
not required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.
    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 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 update 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: Estimated Number of Respondents: 6,223; Estimated Number of 
Responses per Respondent: 1. Average Burden Hours Per Response: 0.25; 
Estimated Total Annual Burden Hours Requested: 1,556. The annualized 
cost to respondents is estimated at $27,230. 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) 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) 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) Ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) Ways to 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. 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-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 30 days 
of the date of this publication.

    Dated: August 27, 2001.
Reesa L. Nichols,
NCI Project Clearance Liaison.
[FR Doc. 01-22352 Filed 9-5-01; 8:45 am]
BILLING CODE 4140-01-M