[Federal Register Volume 76, Number 114 (Tuesday, June 14, 2011)]
[Notices]
[Pages 34705-34706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14422]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-11-11DD]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Focus Group Study for Raising Public Awareness of 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 underdiagnosed, 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 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 
demonstrate 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.

[[Page 34706]]

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. 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.
    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).
    It is estimated that a total of 144 respondents will have to be 
screened in order to recruit 36 focus group participants for each year. 
There are no costs to the respondents other than their time. The 
estimated annualized burden hours are 125.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of        Number        burden per
         Type of respondent                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Seniors (65-80)....................  Participant Screener.......             144               1            5/60
Adults (25-64) recently
 hospitalized
Seniors (65-80)....................  Participant Re-screener....              36               1            9/60
Adults (25-64) recently
 hospitalized
Seniors (65-80)....................  Moderator's Guide:                       36               1             1.5
                                      Formative Research Focus
                                      Groups.
Adults (25-64) recently
 hospitalized
Seniors (65-80)....................  Moderator's Guide: Message               36               1             1.5
                                      Testing Focus Groups.
Adults (25-64) recently
 hospitalized
Seniors (65-80)....................  Informed Consent Form......              36               1            6/60
Adults (25-64) recently
 hospitalized
----------------------------------------------------------------------------------------------------------------


    Dated: June 3, 2011.
Daniel L. Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-14422 Filed 6-13-11; 8:45 am]
BILLING CODE 4163-18-P