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)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 163 (August 24, 2015)
| Page Range | 51273-51274 | |
| FR Document | 2015-20812 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hrs.) respondent hrs.) ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices 51273
Prevention (DVP)/NCIPC in establishing enforcement official and a school events in which there was a school-
an ongoing SAVD in the United States official who are knowledgeable about associated violent death in the U.S.
with the goal of tracking and monitoring the case in question. Researchers will The surveillance system will continue
the extent of this problem on an ongoing request information on both the victim to contribute to the understanding of
basis. The SAVD surveillance system and alleged offender(s)—including fatal violence associated with schools,
remains the only systematic effort to demographic data, their academic and guide further research in the area, and
document school-associated violent criminal records, and their relationship
deaths on a national basis. Data from the help direct ongoing and future
to one another. They will also collect prevention programs. Data collected
SAVD surveillance system are intended data on the time and location of the
to contribute to the understanding of through the surveillance system will be
death; the circumstances, motive, and reviewed and used by CDC, the DOE,
fatal violence associated with schools, method of the fatal injury; and the
guide further research in the area, and the US Department of Justice, and other
security and violence prevention outside agencies and organizations.
help direct ongoing and future
activities in the school and community
prevention programs. OMB approval is requested for three
The data collection methodology where the death occurred, before and
after the fatal injury event. Additionally, years for a revision of the currently
involves investigators reviewing public approved information collection. The
records and published press reports CDC will obtain law enforcement
reports on each case. only cost to respondents will be time
concerning each SAVD. For each spent on the telephone responding to
identified case, investigators will The study population will include the
the survey.
interview an investigating law victims and offenders from all identified
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total burden
Number of burden per
Type of respondent Form name responses per hours
respondents response
respondent (in hrs.)
(in hrs.)
Law Enforcement Officer ................... Law Enforcement Interview Tool ..... 35 1 65/60 38
School Official ................................... School Official Interview Tool .......... 35 1 65/60 38
Total ........................................... .......................................................... ........................ ........................ ........................ 76
Leroy A. Richardson, Act of 1995. This notice invites FOR FURTHER INFORMATION CONTACT: To
Chief, Information Collection Review Office, comment on a proposed information request more information on the
Office of Scientific Integrity, Office of the collection entitled ‘‘Screening and proposed project or to obtain a copy of
Associate Director for Science, Office of the Counseling of Male EVD Survivors to the information collection plan and
Director,Centers for Disease Control and Reduce Risk of Sexually Transmitting instruments, contact the Information
Prevention.
Ebola Virus in Guinea’’. This activity Collection Review Office, Centers for
[FR Doc. 2015–20813 Filed 8–21–15; 8:45 am] will collect information on participants’ Disease Control and Prevention, 1600
BILLING CODE 4163–18–P laboratory results and sexual activity Clifton Road NE., MS–D74, Atlanta,
prior to and during participation in the Georgia 30329; phone: 404–639–7570;
screening program. Email: omb@cdc.gov.
DEPARTMENT OF HEALTH AND
DATES: Written comments must be
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Under the
received on or before October 23, 2015. Paperwork Reduction Act of 1995 (PRA)
Centers for Disease Control and ADDRESSES: You may submit comments, (44 U.S.C. 3501–3520), Federal agencies
Prevention identified by Docket No. CDC–2015– must obtain approval from the Office of
0066 by any of the following methods: Management and Budget (OMB) for each
[60Day–FY–15BBV; Docket No. CDC–2015– • Federal eRulemaking Portal: collection of information they conduct
0066] Regulation.gov. Follow the instructions or sponsor. In addition, the PRA also
Proposed Data Collection Submitted for submitting comments. requires Federal agencies to provide a
• Mail: Leroy A. Richardson,
for Public Comment and 60-day notice in the Federal Register
Information Collection Review Office,
Recommendations concerning each proposed collection of
Centers for Disease Control and
information, including each new
AGENCY: Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–
proposed collection, each proposed
Prevention (CDC), Department of Health D74, Atlanta, Georgia 30329.
Instructions: All submissions received extension of existing collection of
and Human Services (HHS).
must include the agency name and information, and each reinstatement of
ACTION: Notice with comment period.
Docket Number. All relevant comments previously approved information
SUMMARY: The Centers for Disease received will be posted without change collection before submitting the
Control and Prevention (CDC), as part of to Regulations.gov, including any collection to OMB for approval. To
its continuing efforts to reduce public personal information provided. For comply with this requirement, we are
publishing this notice of a proposed
tkelley on DSK3SPTVN1PROD with NOTICES
burden and maximize the utility of access to the docket to read background
government information, invites the documents or comments received, go to data collection as described below.
general public and other Federal Regulations.gov. Comments are invited on: (a) Whether
agencies to take this opportunity to Please note: All public comment should be the proposed collection of information
comment on proposed and/or submitted through the Federal eRulemaking is necessary for the proper performance
continuing information collections, as portal (Regulations.gov) or by U.S. mail to the of the functions of the agency, including
required by the Paperwork Reduction address listed above. whether the information shall have
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![51274 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
practical utility; (b) the accuracy of the Guinea—New—Center for Global Health until two consecutive negative RT–PCR
agency’s estimate of the burden of the (CGH), Centers for Disease Control and results are obtained.
proposed collection of information; (c) Prevention (CDC). Participants will be asked follow-up
ways to enhance the quality, utility, and questions until their semen specimens
Background and Brief Description
clarity of the information to be test negative twice consecutively. They
collected; (d) ways to minimize the Much progress has been made in the will receive tokens of appreciation for
burden of the collection of information year since the CDC first responded to their participation at the initial visit and
on respondents, including through the the Ebola outbreak in West Africa, but again at every subsequent follow-up
use of automated collection techniques the agency’s efforts must continue until visit and a supply of condoms.
or other forms of information there are zero new cases of Ebola virus A trained study data manager will
technology; and (e) estimates of capital disease (EVD). In order to reach the collect test results for all participants in
or start-up costs and costs of operation, international goal of zero new EVD a laboratory results form. Results and
maintenance, and purchase of services cases in 2015, the agency must intensify analyses are needed to update relevant
to provide information. Burden means its efforts to identify and prevent every counseling messages and
the total time, effort, or financial potential route of human disease recommendations from the Guinea
resources expended by persons to transmission and to understand the Ministry of Health, World Health
generate, maintain, retain, disclose or most current community barriers to Organization, and CDC.
provide information to or for a Federal reaching that final goal. This program will provide the
agency. This includes the time needed ‘‘Screening and Counseling of Male information that is critical to the
to review instructions; to develop, EVD Survivors to reduce Risk of development of public health measures,
acquire, install and utilize technology Sexually Transmitting Ebola Virus in such as recommendations about sexual
and systems for the purpose of Guinea’’ will inform male Ebola activity and approaches to evaluation of
collecting, validating and verifying infection survivors ≥15 years of age of survivors to determine whether they can
information, processing and Ebola virus detected in their semen safely resume sexual activity. These
maintaining information, and disclosing through voluntary laboratory testing approaches in turn are expected to
and providing information; to train performed in Guinea. Participants for reduce the risk of Ebola resurgence and
personnel and to be able to respond to the semen testing program will be mitigate stigma for thousands of
a collection of information, to search recruited by trained study staff from survivors. The information is likewise
data sources, to complete and review Ebola treatment units (ETUs) and critical to reducing the risk that Ebola
the collection of information; and to survivor registries in Guinea. would be introduced in a location that
transmit or otherwise disclose the Participants will be followed up at has not previously been affected.
information. study sites in government hospitals. CGH requests a three-year approval
Specimens will be tested for Ebola for this information collection. Each
Proposed Projects
Virus ribonucleic acid (RNA) by reverse semen-testing program time burden is
Screening and Counseling of Male transcription polymerase chain reaction 2,067 hours which is incurred by 1,000
EVD Survivors to reduce Risk of test (RT–PCR). Semen specimens will be participants. There are no other costs to
Sexually Transmitting Ebola Virus in collected and tested every two weeks the respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hrs.)
respondent (in hrs.)
Male Ebola Survivors ≥15 years old Baseline Questionnaire .................... 1,000 1 20/60 334
Male Ebola Survivors ≥15 years old Follow-up Questionnaire .................. 1,000 8 10/60 1,334
Male Ebola Survivors ≥15 years old Consent Form .................................. 1,000 1 2/60 34
Total ........................................... ........................................................... ........................ ........................ ........................ 1,702
Leroy A. Richardson, DEPARTMENT OF HEALTH AND published to obtain comments from the
Chief, Information Collection Review Office, HUMAN SERVICES public and affected agencies.
Office of Scientific Integrity, Office of the Written comments and suggestions
Associate Director for Science, Office of the Centers for Disease Control and
from the public and affected agencies
Director, Centers for Disease Control and Prevention
concerning the proposed collection of
Prevention.
[30Day–15–15AMG] information are encouraged. Your
[FR Doc. 2015–20812 Filed 8–21–15; 8:45 am]
comments should address any of the
BILLING CODE 4163–18–P Agency Forms Undergoing Paperwork following: (a) Evaluate whether the
Reduction Act Review proposed collection of information is
The Centers for Disease Control and necessary for the proper performance of
tkelley on DSK3SPTVN1PROD with NOTICES
Prevention (CDC) has submitted the the functions of the agency, including
following information collection request whether the information will have
to the Office of Management and Budget practical utility; (b) Evaluate the
(OMB) for review and approval in accuracy of the agencies estimate of the
accordance with the Paperwork burden of the proposed collection of
Reduction Act of 1995. The notice for information, including the validity of
the proposed information collection is the methodology and assumptions used;
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Document Created: 2015-12-15 10:54:53
Document Modified: 2015-12-15 10:54:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before October 23, 2015. | |
| 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] | |
| FR Citation | 80 FR 51273 |
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