[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Pages 69679-69680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16CO; Docket No. CDC-2015-0099]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment for Developing a 
Self-Management Tool for Individuals with Systemic Lupus Erythematosus 
(SLE), to assess the value of a tool aimed to enhance the ability of 
persons with SLE to effectively manage their condition.

DATES: Written comments must be received on or before January 11, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0099 by any of the following methods:
    Federal eRulemaking Portal: Regulation.gov. Follow the instructions 
for submitting comments.
    Mail: Leroy A. Richardson, Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below. 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; (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; and (e) estimates of capital or start-up costs and costs of 
operation, maintenance, and purchase of services to provide 
information. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; to develop, acquire, install and 
utilize technology and systems for the purpose of collecting, 
validating and verifying information, processing and maintaining 
information, and disclosing and providing information; to train 
personnel and to be able to respond to a collection of information, to 
search data sources, to complete and review the collection of 
information; and to transmit or otherwise disclose the information.

Proposed Project

    Developing a Self-Management Tool for Individuals with Systemic 
Lupus Erythematosus (SLE)--New--National Center for Chronic Disease 
Prevention 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

[[Page 69680]]

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 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 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 collection. The 
estimated burden per response for participating in a focus group 
discussion is 2 hours. The estimated burden per response for a 
discussion conducted via telephone interview is 45 minutes. Respondent 
burden also includes 2 hours for reviewing the draft 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.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs.)
                                                                    respondent         hrs.)
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Women with SLE diagnosis......  Screener........             192               1           10/60              32
                                Review of the                128               1               2             256
                                 CDC SLE Self-
                                 Management Tool.
                                Discussion Guide             128               1               2             256
Men with SLE diagnosis........  Screener........              40               1           10/60               7
                                Review of the                 20               2               2              40
                                 CDC SLE Self-
                                 Management Tool.
                                Discussion Guide              20               1           45/60              15
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             606
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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. 2015-28472 Filed 11-9-15; 8:45 am]
 BILLING CODE 4163-18-P