80 FR 51273 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 163 (August 24, 2015)

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 in Guinea''. This activity will collect information on participants' laboratory results and sexual activity prior to and during participation in the screening program.

[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51273-51274]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-FY-15BBV; Docket No. CDC-2015-0066]


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 in 
Guinea''. 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 October 23, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0066 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

[[Page 51274]]

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 Projects

    Screening and Counseling of Male EVD Survivors to reduce Risk of 
Sexually Transmitting Ebola Virus in Guinea--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.
    ``Screening and Counseling of Male EVD Survivors to reduce Risk of 
Sexually Transmitting Ebola Virus in Guinea'' will inform male Ebola 
infection survivors >=15 years of age of Ebola virus detected in their 
semen through voluntary laboratory testing performed in Guinea. 
Participants for the semen testing program will be recruited by trained 
study staff from Ebola treatment units (ETUs) and survivor registries 
in Guinea. 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 Guinea 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 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 approval for this information collection. 
Each semen-testing program time burden is 2,067 hours which is 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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                                                                                      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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Male Ebola Survivors >=15       Baseline                   1,000               1           20/60             334
 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            2/60              34
 years old.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,702
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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. 2015-20812 Filed 8-21-15; 8:45 am]
BILLING CODE 4163-18-P