[Federal Register Volume 81, Number 20 (Monday, February 1, 2016)]
[Notices]
[Pages 5126-5127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01720]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-16CO]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Developing a Self-Management Tool for Individuals with Systemic 
Lupus Erythematosus--New--National Center for Chronic Disease 
Preventions and Health Promotion (NCCDPHP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    Systemic Lupus Erythematosus (SLE) is an autoimmune disease in 
which the immune system produces antibodies to cells within the body 
leading to widespread inflammation and tissue damage. SLE has a variety 
of clinical manifestations and can affect joints, skin, the brain, 
lungs, kidneys, and blood vessels.
    Effective SLE management depends not only upon clinical 
interventions, but also on self-management-- those things done on a 
day-to-day basis to manage SLE. SLE self-management requires gaining 
essential knowledge, skills, and confidence to manage the condition.
    CDC previously launched a two-year project called ``Filling a Gap: 
Creating Educational Program, Tools, or Materials to Enhance Self-
Management in Systemic Lupus Erythematosus'' to identify and address 
the needs of lupus patients in practicing effective self-management. 
The purpose of this project is to develop a SLE self-management tool to 
improve the ability of people living with lupus to manage their 
condition.
    The proposed information collection will assess a prototype CDC SLE 
self-management tool that is in development to ensure that the tool is 
usable and useful to members of the target audience. The tool is 
expected to be comprised of multiple SLE self-management resources that 
may include, but are not limited to: Education resources about fatigue 
management, pain management, healthy diet, and exercise; symptom 
trackers; medication trackers; appointment calendars; resources about 
communication with family, friends, and co-workers about SLE; and 
strategies for coping with depression and anxiety.
    CDC plans to make the tool available in an electronic format (web-
based or a native mobile application) and will

[[Page 5127]]

consider making it available as a printed resource, depending on the 
feedback obtained during the testing process.
    The information collection will also gauge the needs of the target 
audience(s), tool format and delivery method(s), and the tool's 
clarity, relevance, salience and appeal. A series of focus groups with 
women with a diagnosis of SLE, and one-on-one telephone interviews with 
men with a diagnosis of SLE will be conducted to assess the tool. The 
same discussion guide will be used for all information collections.
    The estimated burden per response for participating in a focus 
group discussion is two hours. The estimated burden per response for a 
discussion conducted via telephone interview is 45 minutes. Respondent 
burden also includes two hours for reviewing the prototype CDC SLE 
Self-management Tool in advance of the focus group meeting or telephone 
interview.
    OMB approval is requested for one year. Participation is voluntary 
and there are no costs to respondents other than their time.
    The total estimated burden hours are 646.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents   responses  per   response  (in
                                                                                     respondent        hrs.)
----------------------------------------------------------------------------------------------------------------
Women with SLE diagnosis...........  Screener for Women.........             192               1           10/60
                                     Prototype CDC SLE Self-                 128               1               2
                                      management Tool.
                                     Discussion Guide for Use in             128               1               2
                                      Focus Groups with Women or
                                      Interviews with Men.
Men with SLE diagnosis.............  Screener for Men...........              40               1           10/60
                                     Prototype CDC SLE Self-                  20               2               2
                                      management Tool.
                                     Discussion Guide for Use in              20               1           45/60
                                      Focus Groups with Women or
                                      Interviews with Men.
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-01720 Filed 1-29-16; 8:45 am]
 BILLING CODE 4163-18-P