[Federal Register Volume 67, Number 200 (Wednesday, October 16, 2002)]
[Notices]
[Pages 63934-63935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26213]


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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 for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on August 
5, 2002, page 50679-50680 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: 
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

[[Page 63935]]

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 cyotology 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 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 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 colletion 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 20530, 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 3131 EPN, 6130 
Executive Blvd, Bethesda, MD 20892-7354; or call non-toll free 301-496-
7468; or e-mail [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: October 7, 2002.
Reesa L. Nichols,
NCI Project Clearance Liaison.
[FR Doc. 02-26213 Filed 10-15-02; 8:45 am]
BILLING CODE 4140-01-M