[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72741-72742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24872]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Cancer Care for Uninsured 
Individuals: A Feasibility Study (NCI)

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) of 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: 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 conduct a pilot study 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

[[Page 72742]]

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. Individuals randomized to the intervention 
arm of the trial received screening for the PLCO cancers. Individuals 
with positive findings were referred to their doctors for follow-up 
care, but no additional care was provided by the trial. The PLCO study 
then 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:
    (1) The total number of physicians to be contacted to obtain 
insurance information on all PLCO participants who had a positive 
cancer screening test;
    (2) The percentage of physicians willing and able to provide 
insurance information;
    (3) The percentage of respondents' patients with and without 
insurance, and possibly distribution of patients by insurance type;
    (4) The number of participants for whom the insurance status can be 
only determined by self report;
    (5) The percentage of PLCO participants who are willing to respond 
to the survey;
    (6) The percentage of individuals who are willing to provide 
information on insurance status and type; and,
    (7) The potential proportion of PLCO participants without health 
insurance at the time of screening.
    The results of this feasibility study will be used to design of a 
larger study to examine the health care behavior of insured and 
uninsured PLPCO 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 or 
households; Businesses or other for-profit. Type of Respondents: Men 
and women 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.

----------------------------------------------------------------------------------------------------------------
                                           Number of     Frequency of   Average burden hours per    Annual hour
          Type of respondents             respondents      response             response              burden
----------------------------------------------------------------------------------------------------------------
PLCO participants.....................             150               1  5 minutes (0.08)........            12.5
Physicians office staff...............              50               1  20 minutes (0.33).......            16.7
                                       -------------------------------------------------------------------------
    Totals............................             200  ..............  ........................            29.2
----------------------------------------------------------------------------------------------------------------

    The annualized cost to respondents is estimated at: $488. 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 are invited on 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.

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. 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 60-days 
of the date of this publication.

    Dated: December 11, 2007.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-24872 Filed 12-20-07; 8:45 am]
BILLING CODE 4140-01-P