[Federal Register Volume 73, Number 41 (Friday, February 29, 2008)]
[Notices]
[Pages 11122-11123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Cancer Care for 
Uninsured Individuals: A Feasibility Study (NCI)

    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 December 
21, 2007 (Vol. 72, No. 245, p. 72741 and allowed 60-days for public 
comment. One public comment was received that questioned why the study 
was not funded by University of Alabama (UAB) funds. A response was 
made on February 8, 2008, that indicated that UAB was funding this 
study. 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: Cancer Care For Uninsured Individuals: 
A Feasibility Study. Type of Information Collection Request: New. Need 
and Use of Information Collection: The purpose of this information 
collection is to assess the feasibility of obtaining health insurance 
information for participants of the Prostate, Lung, Colon and Ovarian 
(PLCO) Cancer Screening Trial participants from health care providers 
and self reports. The ultimate objective is to compare the health care 
utilization of insured and uninsured PLCO participants. The PLCO data 
provides a unique opportunity to study health care seeking behavior 
after an abnormal cancer screening test and the effect of lack of 
health insurance. Participants who had positive cancer screening tests 
were referred to their doctors for follow-up care. No additional care 
was provided by the trial. The study collected detailed information on 
tests received for diagnosis, clinical presentation of disease, and 
cancer treatment. Since the PLCO original data collection had not 
recorded the health insurance of participants at the time of their 
screening, it is necessary to collect it retrospectively. This 
feasibility study will request information from 50 physicians and 150 
participants. The aims are to determine the:
    (1) Total number of physicians to be contacted to obtain insurance 
information on all PLCO participants who had a positive cancer 
screening test;
    (2) Percentage of physicians willing and able to provide insurance 
information;
    (3) Percentage of participants with and without insurance;
    (4) Number of participants for whom insurance status can be only 
determined by self report;
    (5) Percentage of PLCO participants who accept to respond to the 
survey;
    (6) Percentage of individuals who are willing to provide 
information on insurance status; and,
    (7) Potential proportion of PLCO participants without health 
insurance.
    These results will be used to design a study to examine the health 
care behavior of insured and uninsured PLCO participants. This is 
relevant to understand the results of the PLCO Cancer Screening Trial 
and other screening trials currently being conducted in the U.S. The 
success of these trials is conditional on participants' access to care 
following a recommendation for follow-up. Uninsured individuals may be 
more likely to join these trials than insured ones in order to get free 
preventive care. They may also be more likely to not seek, or delay 
seeking, care after an abnormal screening test even though they are 
encouraged to get care and they may be highly motivated to receive the 
best care possible. It is relevant for other decision makers to 
understand whether uninsured persons are receiving appropriate care 
after abnormal screening results. The efforts to control cancer disease 
and the loss of life associated with it are concentrated on population 
wide screening. These endeavors may be compromised if a significant 
proportion of the population does not get appropriate follow-up after 
screening or does not get the care known to be effective for their 
disease. Frequency of Response: One time. Affected Public: Individuals 
and households; businesses or other for-profit. Type of Respondents: 
Individuals older than 55 who participated in the PLCO Screening trial 
and physicians who provided care for them. The annual reporting burden 
is shown in the following table.

[[Page 11123]]



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                                          Number of     Frequency of     Average  burden hours      Annual hour
         Type of respondents             respondents      response            per response            burden
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PLCO participants....................             150               1  5 minutes                            12.5
                                                                       (0.083)..................
Physicians office staff..............              50               1  20 minutes                           16.7
                                                                       (0.333)..................
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    Totals...........................             200  ..............  .........................            29.2
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    The annualized cost to respondents is estimated at: $487.50. 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.
    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 Attention: NIH Desk Officer, Office of Management and 
Budget, at [email protected] or by fax to 202-395-6974. To 
request more information on the proposed project or to obtain a copy of 
the data collection plans and instruments, contact: Dr. Maria Pisu, 
Division of Preventive Medicine, University of Alabama at Birmingham, 
MT 628, 1530 3rd Avenue South, Birmingham, AL 35294-4410, or call non-
toll-free number (205) 975-7366 or e-mail your request, including your 
address to: [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: February 20, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-3836 Filed 2-28-08; 8:45 am]
BILLING CODE 4140-01-P