[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
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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]
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