81 FR 18853 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 63 (April 1, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 63 (April 1, 2016)
| Page Range | 18853-18855 | |
| FR Document | 2016-07424 |
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)] [Notices] [Pages 18853-18855] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07424] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-15BFV] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written [[Page 18854]] comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395- 5806. Written comments should be received within 30 days of this notice. Proposed Project A Study of Viral Persistence in Ebola Virus Disease (EVD) Survivors--Existing Information Collection Without an OMB Control Number--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 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). As the CDC's 2014 Ebola virus response maintains 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. Persistence of Ebola Virus (EBOV) in Body Fluids of EVD Survivors in Sierra Leone is the first systematic examination of the post- recovery persistence of EBOV and the risks of transmission from a cohort of convalescent Ebola survivors during close or intimate contact. It is important to fully understand how long the virus stays active in body fluids other than blood in order to target and refine public health interventions to arrest the ongoing spread of disease. The research study is comprised of three modules based on the body fluids to be studied: A pilot module of adult males (semen) and two full modules: Module A of adult men and women repeating collections and questionnaires every two weeks (semen, vaginal secretions, and saliva, tears, sweat, urine, rectal swab), and Module B of lactating adult women repeating collections and questionnaires every three days (sweat and breast milk). Participants for each module will be recruited by trained study staff from Ebola treatment units (ETUs) and survivor registries. Participants will be followed up at study sites in government hospitals. Specimens will be tested for EBOV ribonucleic acid (RNA) by reverse transcription polymerase chain reaction test (RT-PCR) in Sierra Leone at the CDC laboratory facility in Bo. All positive RT-PCR samples will be sent to CDC Atlanta for virus isolation. Each body fluid will be collected until two negative RT-PCR results are obtained. Participants will be followed until all their studied body fluids are negative. They will receive tokens of appreciation for their participation at the initial visit and again at every subsequent follow-up visit [e.g., 120,000 Leones (approximately $28 US dollars) and a supply of condoms]. For Module A, men and women will be recruited in equal numbers for this study until more information on gender effects of viral persistence is available. 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. The study will provide the most current information that is critical to the development of public health measures, such as recommendations about sexual activity, breastfeeding, and other routine activities 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. The total burden hours requested for the research study in Sierra Leone is 2,474 hours incurred by 530 participants. There are no costs to the respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response respondents respondent (hours) ---------------------------------------------------------------------------------------------------------------- Data Manager.......................... Intake Form............. 1 550 20/60 Pilot participants.................... Survivor Questionnaire.. 100 1 30/60 Pilot participants.................... Survivor Follow-up 100 5 15/60 Questionnaire. Pilot participants.................... 3 & 6 Month Follow up 100 2 15/60 Questionnaire. Main study male participants.......... Survivor Questionnaire.. 120 1 30/60 Main study male participants.......... Survivor Follow-up 120 12 15/60 Questionnaire. Main study male participants.......... 3 & 6 Month Follow up 120 2 15/60 Questionnaire. Main study female participants........ Survivor Questionnaire.. 120 1 30/60 Main study female participants........ Survivor Follow-up 120 4 15/60 Questionnaire. Main study female participants........ 3 & 6 Month Follow up 120 2 15/60 Questionnaire. Data Manager.......................... Laboratory Results Form. 1 4,250 10/60 ---------------------------------------------------------------------------------------------------------------- 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. 2016-07424 Filed 3-31-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18853
FOR FURTHER INFORMATION CONTACT: Gary Proposal to renew the following OMB Number: 3064–0114.
A. Kuiper or Manuel E. Cabeza, at the currently-approved collections of Affected Public: Insured branches of
FDIC address above. information: foreign banks.
SUPPLEMENTARY INFORMATION: 1. Title: Foreign Banks. Estimated Burden:
Number of Responses Hours per Burden hours
respondents per year response
Reporting Burden
Moving a Branch ...................................................................................... 1 1 8 8
Consent to Operate .................................................................................. 1 1 8 8
Conduct Activities ..................................................................................... 1 1 8 8
Pledge of Assets Documents ................................................................... 10 4 .25 10
Reports ..................................................................................................... 10 4 2 80
Recordkeeping Burden .................................................................................... 10 1 120 1,200
Estimated Total Annual Burden: FEDERAL DEPOSIT INSURANCE DEPARTMENT OF HEALTH AND
1,314 hours. CORPORATION HUMAN SERVICES
General Description: The Foreign
Notice to All Interested Parties of the Centers for Disease Control and
Banks information collection, 3064–
Termination of the Receivership of Prevention
0114, consist of: Applications to move
10447, the Farmers Bank of
an insured state-licensed branch of a Lynchburg; Lynchburg, Tennessee [30Day–15–15BFV]
foreign bank; applications to operate as
such noninsured state-licensed branch NOTICE IS HEREBY GIVEN that the Agency Forms Undergoing Paperwork
of a foreign bank; applications from an Federal Deposit Insurance Corporation Reduction Act Review
insured state-licensed branch of a (‘‘FDIC’’) as Receiver for The Farmers The Centers for Disease Control and
foreign bank to conduct activities that Bank of Lynchburg, Lynchburg, Prevention (CDC) has submitted the
are not permissible for a federally- Tennessee (‘‘the Receiver’’) intends to following information collection request
licensed branch; internal recordkeeping terminate its receivership for said to the Office of Management and Budget
by such branches; and reporting and institution. The FDIC was appointed (OMB) for review and approval in
recordkeeping requirements relating to receiver of The Farmers Bank of accordance with the Paperwork
such a branch’s pledge of assets to the Lynchburg on June 15, 2012. The Reduction Act of 1995. The notice for
FDIC. liquidation of the receivership assets the proposed information collection is
has been completed. To the extent published to obtain comments from the
Request for Comment permitted by available funds and in public and affected agencies.
accordance with law, the Receiver will Written comments and suggestions
Comments are invited on: (a) Whether
be making a final dividend payment to from the public and affected agencies
the collection of information is
proven creditors. concerning the proposed collection of
necessary for the proper performance of
the FDIC’s functions, including whether Based upon the foregoing, the information are encouraged. Your
the information has practical utility; (b) Receiver has determined that the comments should address any of the
continued existence of the receivership following: (a) Evaluate whether the
the accuracy of the estimates of the
will serve no useful purpose. proposed collection of information is
burden of the information collection,
Consequently, notice is given that the necessary for the proper performance of
including the validity of the receivership shall be terminated, to be the functions of the agency, including
methodology and assumptions used; (c) effective no sooner than thirty days after whether the information will have
ways to enhance the quality, utility, and the date of this Notice. If any person practical utility; (b) Evaluate the
clarity of the information to be wishes to comment concerning the accuracy of the agencies estimate of the
collected; and (d) ways to minimize the termination of the receivership, such burden of the proposed collection of
burden of the information collection on comment must be made in writing and information, including the validity of
respondents, including through the use sent within thirty days of the date of the methodology and assumptions used;
of automated collection techniques or this Notice to: Federal Deposit (c) Enhance the quality, utility, and
other forms of information technology. Insurance Corporation, Division of clarity of the information to be
All comments will become a matter of Resolutions and Receiverships, collected; (d) Minimize the burden of
public record. Attention: Receivership Oversight the collection of information on those
Dated at Washington, DC, this 29th day of Department 32.1, 1601 Bryan Street, who are to respond, including through
March, 2016. Dallas, TX 75201. the use of appropriate automated,
No comments concerning the electronic, mechanical, or other
Federal Deposit Insurance Corporation.
termination of this receivership will be technological collection techniques or
Robert E. Feldman, other forms of information technology,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
considered which are not sent within
Executive Secretary. this time frame. e.g., permitting electronic submission of
[FR Doc. 2016–07403 Filed 3–31–16; 8:45 am] responses; and (e) Assess information
Dated: March 29, 2016.
BILLING CODE 6714–01–P collection costs.
Federal Deposit Insurance Corporation. To request additional information on
Robert E. Feldman, the proposed project or to obtain a copy
Executive Secretary. of the information collection plan and
[FR Doc. 2016–07402 Filed 3–31–16; 8:45 am] instruments, call (404) 639–7570 or
BILLING CODE 6714–01–P send an email to omb@cdc.gov. Written
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![18854 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
comments and/or suggestions regarding transmission from a cohort of for their participation at the initial visit
the items contained in this notice convalescent Ebola survivors during and again at every subsequent follow-up
should be directed to the Attention: close or intimate contact. It is important visit [e.g., 120,000 Leones
CDC Desk Officer, Office of Management to fully understand how long the virus (approximately $28 US dollars) and a
and Budget, Washington, DC 20503 or stays active in body fluids other than supply of condoms]. For Module A, men
by fax to (202) 395–5806. Written blood in order to target and refine and women will be recruited in equal
comments should be received within 30 public health interventions to arrest the numbers for this study until more
days of this notice. ongoing spread of disease. information on gender effects of viral
The research study is comprised of persistence is available. A trained study
Proposed Project three modules based on the body fluids data manager will collect test results for
A Study of Viral Persistence in Ebola to be studied: A pilot module of adult all participants in a laboratory results
Virus Disease (EVD) Survivors—Existing males (semen) and two full modules: form.
Information Collection Without an OMB Module A of adult men and women
Results and analyses are needed to
Control Number—National Center for repeating collections and questionnaires
every two weeks (semen, vaginal update relevant counseling messages
Emerging and Zoonotic Infectious
secretions, and saliva, tears, sweat, and recommendations from the Sierra
Diseases (NCEZID), Centers for Disease
urine, rectal swab), and Module B of Leone Ministry of Health, World Health
Control and Prevention (CDC).
lactating adult women repeating Organization, and CDC. The study will
Background and Brief Description collections and questionnaires every provide the most current information
Much progress has been made in the three days (sweat and breast milk). that is critical to the development of
year since the CDC first responded to Participants for each module will be public health measures, such as
the Ebola outbreak in West Africa, but recruited by trained study staff from recommendations about sexual activity,
the agency’s efforts must continue until Ebola treatment units (ETUs) and breastfeeding, and other routine
there are zero new cases of Ebola virus survivor registries. Participants will be activities and approaches to evaluation
disease (EVD). As the CDC’s 2014 Ebola followed up at study sites in of survivors to determine whether they
virus response maintains the government hospitals. can safely resume sexual activity. These
international goal of zero new EVD Specimens will be tested for EBOV approaches in turn are expected to
cases in 2015, the agency must intensify ribonucleic acid (RNA) by reverse reduce the risk of Ebola resurgence and
its efforts to identify and prevent every transcription polymerase chain reaction mitigate stigma for thousands of
potential route of human disease test (RT–PCR) in Sierra Leone at the survivors. The information is likewise
transmission and to understand the CDC laboratory facility in Bo. All critical to reducing the risk that Ebola
most current community barriers to positive RT–PCR samples will be sent to would be introduced in a location that
reaching that final goal. CDC Atlanta for virus isolation. Each has not previously been affected.
Persistence of Ebola Virus (EBOV) in body fluid will be collected until two The total burden hours requested for
Body Fluids of EVD Survivors in Sierra negative RT–PCR results are obtained. the research study in Sierra Leone is
Leone is the first systematic Participants will be followed until all 2,474 hours incurred by 530
examination of the post-recovery their studied body fluids are negative. participants. There are no costs to the
persistence of EBOV and the risks of They will receive tokens of appreciation respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (hours)
Data Manager ................................................. Intake Form .................................................... 1 550 20/60
Pilot participants .............................................. Survivor Questionnaire ................................... 100 1 30/60
Pilot participants .............................................. Survivor Follow-up Questionnaire .................. 100 5 15/60
Pilot participants .............................................. 3 & 6 Month Follow up Questionnaire ........... 100 2 15/60
Main study male participants .......................... Survivor Questionnaire ................................... 120 1 30/60
Main study male participants .......................... Survivor Follow-up Questionnaire .................. 120 12 15/60
Main study male participants .......................... 3 & 6 Month Follow up Questionnaire ........... 120 2 15/60
Main study female participants ....................... Survivor Questionnaire ................................... 120 1 30/60
Main study female participants ....................... Survivor Follow-up Questionnaire .................. 120 4 15/60
Main study female participants ....................... 3 & 6 Month Follow up Questionnaire ........... 120 2 15/60
Data Manager ................................................. Laboratory Results Form ............................... 1 4,250 10/60
Leroy A. Richardson,
Chief, Information Collection Review Office,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–07424 Filed 3–31–16; 8:45 am]
BILLING CODE 4163–18–P
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![Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18855
DEPARTMENT OF HEALTH AND Prevention (CDC), an Operating Division ACTION: Notice.
HUMAN SERVICES (OPDIV) of the Department of Health
and Human Services (HHS) has SUMMARY: The Centers for Medicare &
Centers for Disease Control and prepared a Final EA to assess the Medicaid Services (CMS) is announcing
Prevention potential impacts associated with the an opportunity for the public to
undertaking of proposed improvements comment on CMS’ intention to collect
Notice of Availability of the Final on the HHS/CDC Fort Collins Campus
Environmental Assessment (Final EA) information from the public. Under the
(CDC Fort Collins Campus) located on Paperwork Reduction Act of 1995 (the
and a Finding of No Significant Impact the Colorado State University (CSU)
(FONSI) for HHS/CDC Fort Collins PRA), federal agencies are require; to
Foothills Campus in Fort Collins, publish notice in the Federal Register
Campus Proposed Improvements Colorado. The Final EA analyzed the
concerning each proposed collection of
AGENCY: Centers for Disease Control and effects of the Build Alternative
information (including each proposed
Prevention, Department of Health and (Proposed Action) and the No Build
extension or reinstatement of an existing
Human Services (HHS). Alternative. The Build Alternative
collection of information) and to allow
ACTION: Notice of Availability of Final consists of improvements to the CDC
Fort Collins Campus which entails the 60 days for public comment on the
Environmental Assessment and a proposed action. Interested persons are
Finding of No Significant Impact construction of a new approximately
5,600 gsf building which will house invited to send comments regarding our
(FONSI) for HHS/CDC Fort Collins burden estimates or any other aspect of
Campus Proposed Improvements. laboratory support freezer space and
communal space, upgrades to existing this collection of information, including
SUMMARY: The Centers for Disease parking areas and additional any of the following subjects: (1) The
Control and Prevention (CDC), within infrastructure improvements. The No necessity and utility of the proposed
the Department of Health and Human Build Alternative represents the information collection for the proper
Services (HHS), is issuing this notice to continued operation of the existing performance of the agency’s functions;
advise the public that HHS/CDC has facilities at the CDC Fort Collins (2) the accuracy of the estimated
prepared and approved on March 22, Campus without any new construction burden; (3) ways to enhance the quality,
2016, a Finding of No Significant Impact or infrastructure upgrades. utility, and clarity of the information to
(FONSI) based on the Final The Final EA evaluated the potential be collected; and (4) the use of
Environmental Assessment for proposed impacts to socioeconomics and automated collection techniques or
improvements on the HHS/CDC Fort environmental justice, land use, zoning, other forms of information technology to
Collins Campus. HHS/CDC prepared the public policy, community facilities and minimize the information collection
Final EA in accordance with the services, transportation, air quality, burden.
National Environmental Policy Act of noise, cultural resources, urban design
1969 (NEPA), as amended (42 U.S.C. and visual resources, natural resources, DATES:Comments must be received by
4321 et seq.), the Council on utility service, hazardous materials, May 31, 2016.
Environmental Quality (CEQ) greenhouse gases and sustainability, and ADDRESSES: When commenting, please
implementing regulations (40 CFR parts construction. HHS/CDC assessed the
1500–1508) and the HHS General reference the document identifier or
potential impacts of the Build OMB control number. To be assured
Administration Manual (GAM) Part 30 Alternative in the Final EA and as a
Environmental Procedures, dated consideration, comments and
result issued a FONSI indicating that recommendations must be submitted in
February 25, 2000. HHS/CDC has the proposed action will not have a
determined that the proposed action any one of the following ways:
significant impact on the environment.
would not have a significant impact on 1. Electronically. You may send your
the human or natural environment and Dated: March 28, 2016.
comments electronically to http://
therefore, the preparation of an Sandra Cashman,
www.regulations.gov. Follow the
Environmental Impact Statement is not Executive Secretary, Centers for Disease instructions for ‘‘Comment or
required. Control and Prevention.
Submission’’ or ‘‘More Search Options’’
DATES: The FONSI and Final EA are [FR Doc. 2016–07368 Filed 3–31–16; 8:45 am]
to find the information collection
available as of the publication date of BILLING CODE 4163–18–P
document(s) that are accepting
this notice. comments.
ADDRESSES: Copies of the FONSI and
DEPARTMENT OF HEALTH AND 2. By Regular Mail. You may mail
Final EA are available at the following
HUMAN SERVICES written comments to the following
locations:
address: CMS, Office of Strategic
• Old Town Library, 201 Peterson Centers for Medicare & Medicaid Operations and Regulatory Affairs,
Street, Fort Collins, Colorado 80524. Services
• Harmony Library, 4616 South Division of Regulations Development,
Shields, Fort Collins, Colorado 80526. Attention: Document Identifier/OMB
Copies of the FONSI and/or Final EA [Document Identifier: CMS–10545, CMS– Control Number l, Room C4–26–05,
can also be requested from: Robert 10309, CMS–855(A, B, I) and CMS–10468] 7500 Security Boulevard, Baltimore,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Lawson, Centers for Disease Control and Maryland 21244–1850.
Agency Information Collection
Prevention, Asset Management Services To obtain copies of a supporting
Activities: Proposed Collection;
Office, MS K80, 1600 Clifton Road, statement and any related forms for the
Comment Request
Atlanta, GA 30329, 770–488–2447. proposed collection(s) summarized in
SUPPLEMENTARY INFORMATION: The AGENCY: Centers for Medicare & this notice, you may make your request
Centers for Disease Control and Medicaid Services, HHS. using one of following:
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Document Created: 2016-04-06 00:08:01
Document Modified: 2016-04-06 00:08:01
| 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 | |
| FR Citation | 81 FR 18853 |
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