80 FR 44128 - 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 142 (July 24, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 142 (July 24, 2015)
| Page Range | 44128-44129 | |
| FR Document | 2015-18147 |
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)] [Notices] [Pages 44128-44129] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18147] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- 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. --------------------------------------------------------------------------------- Total..................... ................ .............. .............. .............. 2,067 ---------------------------------------------------------------------------------------------------------------- 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] BILLING CODE 4163-18-P
![44128 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
By order of the Board of Governors of the Please note: All public comment should be the collection of information; and to
Federal Reserve System, July 20, 2015. submitted through the Federal eRulemaking transmit or otherwise disclose the
Robert deV. Frierson, portal (Regulations.gov) or by U.S. mail to the information.
address listed above.
Secretary of the Board.
Proposed Project
[FR Doc. 2015–18124 Filed 7–23–15; 8:45 am] FOR FURTHER INFORMATION CONTACT: To
BILLING CODE 6210–01–P request more information on the Screening and Counseling of Male
proposed project or to obtain a copy of EVD Survivors to reduce Risk of
the information collection plan and Sexually Transmitting Ebola Virus—
instruments, contact the Information New—Center for Global Health (CGH),
DEPARTMENT OF HEALTH AND Centers for Disease Control and
HUMAN SERVICES Collection Review Office, Centers for
Disease Control and Prevention, 1600 Prevention (CDC).
Centers for Disease Control and Clifton Road NE., MS–D74, Atlanta, Background and Brief Description
Prevention Georgia 30329; phone: 404–639–7570; Much progress has been made in the
[60-Day–FY–15AWA; Docket No. CDC–
Email: omb@cdc.gov. year since the CDC first responded to
2015–0055] SUPPLEMENTARY INFORMATION: Under the the Ebola outbreak in West Africa, but
Paperwork Reduction Act of 1995 (PRA) the agency’s efforts must continue until
Proposed Data Collection Submitted (44 U.S.C. 3501–3520), Federal agencies there are zero new cases of Ebola virus
for Public Comment and must obtain approval from the Office of disease (EVD). In order to reach the
Recommendations Management and Budget (OMB) for each international goal of zero new EVD
collection of information they conduct cases in 2015, the agency must intensify
AGENCY: Centers for Disease Control and
or sponsor. In addition, the PRA also its efforts to identify and prevent every
Prevention (CDC), Department of Health
requires Federal agencies to provide a potential route of human disease
and Human Services (HHS).
60-day notice in the Federal Register transmission and to understand the
ACTION: Notice with comment period. concerning each proposed collection of most current community barriers to
SUMMARY: The Centers for Disease information, including each new reaching that final goal.
Control and Prevention (CDC), as part of proposed collection, each proposed The ‘‘Screening and Counseling of
its continuing efforts to reduce public extension of existing collection of Male EVD Survivors to reduce Risk of
burden and maximize the utility of information, and each reinstatement of Sexually Transmitting Ebola Virus’’
government information, invites the previously approved information information collection will help inform
general public and other Federal collection before submitting the male Ebola infection survivors ≥15 years
agencies to take this opportunity to collection to OMB for approval. To of age of Ebola virus detected in their
comment on proposed and/or comply with this requirement, we are semen through voluntary laboratory
continuing information collections, as publishing this notice of a proposed testing performed in each country.
required by the Paperwork Reduction data collection as described below. Participants for the semen testing
Act of 1995. This notice invites Comments are invited on: (a) Whether program will be recruited by trained
comment on a proposed information the proposed collection of information study staff from Ebola treatment units
collection entitled ‘‘Screening and is necessary for the proper performance and survivor registries in Sierra Leone.
Counseling of Male EVD Survivors to of the functions of the agency, including Participants will be followed up at
reduce Risk of Sexually Transmitting whether the information shall have study sites in government hospitals.
Ebola Virus’’. This activity will collect practical utility; (b) the accuracy of the Specimens will be tested for Ebola
information on participants’ laboratory agency’s estimate of the burden of the Virus ribonucleic acid (RNA) by reverse
results and sexual activity prior to and proposed collection of information; (c) transcription polymerase chain reaction
during participation in the screening ways to enhance the quality, utility, and test (RT–PCR). Semen specimens will be
program. clarity of the information to be collected and tested every two weeks
collected; (d) ways to minimize the until two consecutive negative RT–PCR
DATES: Written comments must be burden of the collection of information results are obtained.
received on or before September 22, on respondents, including through the Participants will be asked follow-up
2015. use of automated collection techniques questions until their semen specimens
ADDRESSES: You may submit comments, or other forms of information test negative twice consecutively. They
identified by Docket No. CDC–2015– technology; and (e) estimates of capital will receive tokens of appreciation for
0055 by any of the following methods: or start-up costs and costs of operation, their participation at the initial visit and
• Federal eRulemaking Portal: maintenance, and purchase of services again at every subsequent follow-up
Regulation.gov. Follow the instructions to provide information. Burden means visit and a supply of condoms. A
for submitting comments. the total time, effort, or financial trained study data manager will collect
• Mail: Leroy A. Richardson, resources expended by persons to test results for all participants in a
Information Collection Review Office, generate, maintain, retain, disclose or laboratory results form. Results and
Centers for Disease Control and provide information to or for a Federal analyses are needed to update relevant
Prevention, 1600 Clifton Road NE., MS– agency. This includes the time needed counseling messages and
D74, Atlanta, Georgia 30329. to review instructions; to develop, recommendations from the Sierra Leone
Instructions: All submissions received acquire, install and utilize technology Ministry of Health, World Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
must include the agency name and and systems for the purpose of Organization, and CDC.
Docket Number. All relevant comments collecting, validating and verifying This program will provide the
received will be posted without change information, processing and information that is critical to the
to Regulations.gov, including any maintaining information, and disclosing development of public health measures,
personal information provided. For and providing information; to train such as recommendations about sexual
access to the docket to read background personnel and to be able to respond to activity and approaches to evaluation of
documents or comments received, go to a collection of information, to search survivors to determine whether they can
Regulations.gov. data sources, to complete and review safely resume sexual activity. These
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![Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44129
approaches in turn are expected to would be introduced in a location that semen testing program are 1,664 hours
reduce the risk of Ebola resurgence and has not previously been affected. incurred by 1,000 participants. There
mitigate stigma for thousands of CGH requests a three-year OMB are no other costs to the respondents
survivors. The information is likewise approval for this information collection other than their time.
critical to reducing the risk that Ebola request. The total burden hours for each
ESTIMATED ANNUALIZED BURDEN HOURS
Number of re- Avg. burden
Number of re- Total burden
Type of respondents Form name sponses per per response
spondents (in hrs.)
respondent (in hrs.)
Male Ebola Survivors ≥15 years Baseline Questionnaire ......................... 1,000 1 20/30 667
old.
Male Ebola Survivors ≥15 years Follow-up Questionnaire ........................ 1,000 8 10/60 1,334
old.
Male Ebola Survivors ≥15 years Consent Form ........................................ 1,000 1 2/30 67
old.
Total ...................................... ................................................................ ........................ ........................ ........................ 2,067
Leroy A. Richardson, the collection of information on those broadly due to differences in
Chief, Information Collection Review Office, who are to respond, including through definitions, inconsistencies in
Office of Scientific Integrity, Office of the the use of appropriate automated, classifying cause of death on death
Associate Director for Science, Office of the electronic, mechanical, or other certificates, variable ages and types of
Director, Centers for Disease Control and technological collection techniques or study populations, and differing case
Prevention. other forms of information technology, ascertainment methodologies. Because
[FR Doc. 2015–18147 Filed 7–23–15; 8:45 am] e.g., permitting electronic submission of complete information has not been
BILLING CODE 4163–18–P responses; and (e) Assess information collected on the incidences, causes, and
collection costs. risk factors, lack of evidence fuels
To request additional information on disagreements about the best prevention
DEPARTMENT OF HEALTH AND the proposed project or to obtain a copy approaches.
HUMAN SERVICES of the information collection plan and
instruments, call (404) 639–7570 or SDY Registry
Centers for Disease Control and send an email to omb@cdc.gov. Written To address this knowledge gap, the
Prevention comments and/or suggestions regarding Centers for Disease Control and
the items contained in this notice Prevention (CDC), in collaboration with
[30Day–15–15CT]
should be directed to the Attention: the National Heart, Lung, and Blood
Agency Forms Undergoing Paperwork CDC Desk Officer, Office of Management Institute (NHLBI) and the National
Reduction Act Review and Budget, Washington, DC 20503 or Institute of Neurological Disorders and
by fax to (202) 395–5806. Written Stroke (NINDS) at the National
The Centers for Disease Control and comments should be received within 30 Institutes of Health (NIH) have
Prevention (CDC) has submitted the days of this notice. implemented the Sudden Death in the
following information collection request Young (SDY) Registry (DP14–1403) to
to the Office of Management and Budget Proposed Project
provide technical assistance to improve
(OMB) for review and approval in Sudden Death in the Young the current work of existing Child Death
accordance with the Paperwork Registry—New—National Center for Review (CDR) programs. The SDY
Reduction Act of 1995. The notice for Chronic Disease Prevention and Health Registry is an expansion of the CDC’s
the proposed information collection is Promotion (NCCDPHP), Centers for Sudden Unexpected Infant Death (SUID)
published to obtain comments from the Disease Control and Prevention (CDC). Case Registry (currently DP12–1202),
public and affected agencies. Background and Brief Description which provides technical assistance to
Written comments and suggestions state grantees so they can monitor
from the public and affected agencies Sudden Death in the Young (SDY) sudden unexpected deaths in children
concerning the proposed collection of Every year, infants, children and up to age one in their state.
information are encouraged. Your adolescents die suddenly and By building on CDC’s successful SUID
comments should address any of the unexpectedly from previously Case Registry, the SDY Registry also
following: (a) Evaluate whether the undiagnosed conditions. Sudden Death provides technical assistance to grantees
proposed collection of information is in the Young (SDY) is defined as any so they can improve their state’s
necessary for the proper performance of death of an infant, child, or young adult information on infant and child deaths.
the functions of the agency, including (up to the age mandated by each state), This includes two additions to their
whether the information will have investigated by the medical examiner or usual CDR program: (1) Entering new
asabaliauskas on DSK5VPTVN1PROD with NOTICES
practical utility; (b) Evaluate the coroner office, except homicides, SDY information from sources already
accuracy of the agencies estimate of the suicides, overdoses, poisonings, or other available at CDR reviews, (2) conducting
burden of the proposed collection of external injury deaths, for example from an advanced clinical review of a sub-set
information, including the validity of fire or as a passenger in a motor vehicle of SDY cases to allow for a more
the methodology and assumptions used; accident. technical and medical review of
(c) Enhance the quality, utility, and SDY deaths are not routinely or information already compiled. The
clarity of the information to be systematically reported, so estimates of intended result will be complete and
collected; (d) Minimize the burden of the annual incidence of SDY vary timely grantee-based infant and child
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Document Created: 2018-02-23 09:24:55
Document Modified: 2018-02-23 09:24:55
| 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 September 22, 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 44128 |
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