[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14400-14401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-11-11DD]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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 Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Carol E. Walker, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to <a href="/cdn-cgi/l/email-protection#402f2d22002324236e272f36"><span class="__cf_email__" data-cfemail="d0bfbdb290b3b4b3feb7bfa6">[email protected]</span></a>.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.
    Proposed Project: Raising Public Awareness for Deep Vein 
Thrombosis/Pulmonary Embolism--NEW--National Center on Birth Defects 
and Developmental Disabilities (NCBDDD), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    The Division of Blood Disorders, located within the National Center 
on Birth Defects and Developmental Disabilities, implements health 
promotion and wellness programs designed to prevent secondary 
conditions in people with bleeding and clotting disorders.
    There are few public health problems as serious as deep vein 
thrombosis (DVT) and pulmonary embolism (PE), yet these conditions 
receive little attention. DVT/PE is an under diagnosed, serious, 
preventable medical condition that occurs when a blood clot forms in a 
deep vein. These clots usually develop in the lower leg, thigh, or 
pelvis, but they can also occur in the arm. In more than one third of 
people affected by DVT, clots can travel to the lungs and cause PE, a 
potentially fatal condition.
    The precise number of people affected by DVT/PE is unknown, but 
estimates range from 300,000 to 600,000 annually in the United States. 
DVT/PE is associated with substantial morbidity and mortality: One 
third of people with DVT/PE will have a recurrence within 10 years and 
one third of people die within 1 month of diagnosis. Among people who 
have had a DVT, one third will have long-term complications (post-
thrombotic syndrome), such as swelling, pain, discoloration, and 
scaling in the affected limb. In some cases, the symptoms can be so 
severe that a person can become disabled. More troubling, sudden death 
is the first symptom in

[[Page 14401]]

about one quarter of people who have a PE.
    The Division of Blood Disorders submitted questions to the 2007 
HealthStyles survey to determine the public's knowledge of DVT, its 
common symptoms, and risk factors. Although over 60% of respondents 
identified pain and swelling as symptoms, 60% did not identify 
tenderness (often the first sign of DVT) as a symptom. Only 38% of 
respondents knew that a DVT was a blood clot in a vein, and most could 
not identify common risk factors for DVT such as sitting for a long 
period of time (e.g., during air travel); having a leg or foot injury; 
having a family member who has had a DVT; taking birth control pills; 
or getting older; and certain groups could not identify risk factors 
that specifically applied to their risk. The results of this survey 
demonstrates the need for greater awareness of DVT, and its risk 
factors and the data show that there are many opportunities to develop 
audience specific messages that are age specific and culturally 
appropriate.
    Much of the morbidity and mortality associated with DVT/PE could be 
prevented with early and accurate diagnosis and management. DVT/PE is 
preventable. It is important for people to be able to recognize the 
signs and symptoms and know when to seek care and available treatment. 
Individuals, families, and their support communities can reduce their 
risk by understanding DVT/PE and its risk factors. DVT/PE affects 
people of all races and ages. Many of the acquired risks such as 
obesity, advanced age, air travel, chronic diseases, cancer, and 
hospitalization are increasing in the United States, and we can expect 
to see increasing numbers of people affected by DVT/PE.
    The CDC's Division of Blood Disorders will conduct focus groups to 
develop messaging concepts that will be used in a public awareness 
campaign to build knowledge and awareness of DVT/PE, increase 
recognition of the symptoms and risk factors for DVT/PE, and empower 
people to take action.
    The project will address these objectives in two stages: In the 
first stage the Contractor selected will conduct eight (8) formative 
focus groups with nine (9) participants in each focus group to explore 
consumer knowledge, attitudes, and beliefs (KABs) toward DVT. It is 
estimated that 144 respondents will have to be screened in order to 
recruit 72 focus group participants. Message concepts will be developed 
from insights emerging from this exploratory research phase. The 
Contractor will conduct eight (8) focus groups with nine (9) 
participants in each focus group during the second stage to test the 
message concepts and identify possible ways to present the messages. It 
is estimated that 144 respondents will have to be screened in order to 
recruit 72 focus group participants. The informed consent will take 
approximately 6 minutes to complete, for a total burden of 7 hours.
    The Contractor selected will work with CDC to identify and recruit 
focus group participants. Formative research participants will include 
adults (aged 25-64) who have been hospitalized in the last year and 
seniors (aged 65-80). Message testing participants will include adults 
(aged 25-64) who have been hospitalized in the last year and seniors 
(aged 65-80). Participants will be recruited to participate in one of 
sixteen in-person focus groups that will be conducted in the following 
cities:
    <bullet> Atlanta, Baltimore, Pittsburgh, and Tampa (formative 
research task), and
    <bullet> Atlanta, Baltimore, Pittsburgh, and Tampa (message testing 
task)
    There are no costs to the respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of        Number        burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Seniors (65-80)...............  Formative                    144               1            5/60              12
Adults (25-64) recently          research stage:
 hospitalized.                   Participant
                                 Screener and
                                 Recruitment
                                 Script.
Seniors (65-80)...............  Message testing              144               1            9/60              22
Adults (25-64) recently          stage: Re-
 hospitalized.                   screener.
Seniors (65-80)...............  Formative                     72               1             1.5             108
Adults (25-64) recently          Research stage:
 hospitalized.                   Moderator's
                                 Guide.
Seniors (65-80)...............  Formative                     72               1            6/60               7
Adults (25-64) recently          Research stage:
 hospitalized.                   Informed
                                 Consent.
Seniors (65-80)...............  Message testing               72               1             1.5             108
Adults (25-64) recently          stage:
 hospitalized.                   Moderator's
                                 Guide.
Seniors (65-80)...............  Message testing               72               1            6/60               7
Adults (25-64) recently          stage: Informed
 hospitalized.                   Consent.
    Total.....................  ................  ..............  ..............  ..............             264
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    Dated: March 10, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2011-6107 Filed 3-15-11; 8:45 am]
BILLING CODE 4163-18-P


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