[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44128-44129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-FY-15AWA; Docket No. CDC-2015-0055]
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 on a proposed
information collection entitled ``Screening and Counseling of Male EVD
Survivors to reduce Risk of Sexually Transmitting Ebola Virus''. This
activity will collect information on participants' laboratory results
and sexual activity prior to and during participation in the screening
program.
DATES: Written comments must be received on or before September 22,
2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0055 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
Screening and Counseling of Male EVD Survivors to reduce Risk of
Sexually Transmitting Ebola Virus--New--Center for Global Health (CGH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Much progress has been made in the year since the CDC first
responded to the Ebola outbreak in West Africa, but the agency's
efforts must continue until there are zero new cases of Ebola virus
disease (EVD). In order to reach the international goal of zero new EVD
cases in 2015, the agency must intensify its efforts to identify and
prevent every potential route of human disease transmission and to
understand the most current community barriers to reaching that final
goal.
The ``Screening and Counseling of Male EVD Survivors to reduce Risk
of Sexually Transmitting Ebola Virus'' information collection will help
inform male Ebola infection survivors >=15 years of age of Ebola virus
detected in their semen through voluntary laboratory testing performed
in each country. Participants for the semen testing program will be
recruited by trained study staff from Ebola treatment units and
survivor registries in Sierra Leone. Participants will be followed up
at study sites in government hospitals.
Specimens will be tested for Ebola Virus ribonucleic acid (RNA) by
reverse transcription polymerase chain reaction test (RT-PCR). Semen
specimens will be collected and tested every two weeks until two
consecutive negative RT-PCR results are obtained.
Participants will be asked follow-up questions until their semen
specimens test negative twice consecutively. They will receive tokens
of appreciation for their participation at the initial visit and again
at every subsequent follow-up visit and a supply of condoms. A trained
study data manager will collect test results for all participants in a
laboratory results form. Results and analyses are needed to update
relevant counseling messages and recommendations from the Sierra Leone
Ministry of Health, World Health Organization, and CDC.
This program will provide the information that is critical to the
development of public health measures, such as recommendations about
sexual activity and approaches to evaluation of survivors to determine
whether they can safely resume sexual activity. These
[[Page 44129]]
approaches in turn are expected to reduce the risk of Ebola resurgence
and mitigate stigma for thousands of survivors. The information is
likewise critical to reducing the risk that Ebola would be introduced
in a location that has not previously been affected.
CGH requests a three-year OMB approval for this information
collection request. The total burden hours for each semen testing
program are 1,664 hours incurred by 1,000 participants. There are no
other costs to the respondents other than their time.
Estimated Annualized Burden Hours
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Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
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Male Ebola Survivors >=15 Baseline 1,000 1 20/30 667
years old. Questionnaire.
Male Ebola Survivors >=15 Follow-up 1,000 8 10/60 1,334
years old. Questionnaire.
Male Ebola Survivors >=15 Consent Form.... 1,000 1 2/30 67
years old.
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Total..................... ................ .............. .............. .............. 2,067
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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. 2015-18147 Filed 7-23-15; 8:45 am]
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