[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 [email protected].
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:
Atlanta, Baltimore, Pittsburgh, and Tampa (formative
research task), and
Atlanta, Baltimore, Pittsburgh, and Tampa (message testing
task)
There are no costs to the respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
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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]
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