81 FR 19608 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 65 (April 5, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 65 (April 5, 2016)
| Page Range | 19608-19609 | |
| FR Document | 2016-07803 |
[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)] [Notices] [Pages 19608-19609] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07803] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-15BFV] 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 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 [[Page 19609]] 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 1,836 hours. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average No. of No. of burden per Type of respondent Form name respondents responses per response 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 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. 2016-07803 Filed 4-4-16; 8:45 am] BILLING CODE 4163-18-P
![19608 Federal Register / Vol. 81, No. 65 / Tuesday, April 5, 2016 / Notices
published materials, research, and date, comprehensive database, NPIN The respondent population includes
trends among the four diseases. plans each year to add up to 400 newly Registered Nurses, Social and
The NPIN Resources and Services identified organizations and to verify Community Service Managers, Health
Database contains entries on those organizations currently described Educators, Social and Human Service
approximately 9,000 organizations and in the NPIN Resources and Services Assistants working within NPIN
is the most comprehensive listing of Database each year. Organizations with member organizations that provide HIV/
HIV/AIDS, viral hepatitis, STD, and TB access to the Internet will be given the AIDS, viral hepatitis, STD, and TB
resources and services available option to complete and submit an prevention, education, testing, and
throughout the country. The American healthcare services.
electronic version of the questionnaire
public can also access the NPIN
by visiting the NPIN Web site. Methods This data collection uses no
Resources and Services database
through the NPIN Web site. More than to be used to collect the information inferential statistical methods. The data
1,000,000 unique visitors and more than include online, telephone and email collected is in textual or anecdotal
3,000,000 page views are recorded survey questionnaires to collect format and will be used for information
annually. information from representatives of the purposes.
To accomplish CDC’s goal of organizations that provide covered There are no costs to respondents
continuing efforts to maintain an up-to- services. other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Form name Type of respondents responses per
respondents response (in (in hours)
respondent hours)
Initial Questionnaire Telephone Registered nurses, Social and com- 400 1 15/60 100
Script. munity service managers, and
Health educators.
Telephone Verification ...................... Registered nurses, Social and com- 6,100 1 10/60 1,017
munity service managers, and
Health educators Social and
human service assistants.
Email Verification .............................. Registered nurses, Health edu- 3,000 1 12/60 600
cators, and Social and human
service assistants, social and
community service managers.
Total ........................................... ........................................................... ........................ ........................ ........................ 1,700
Leroy A. Richardson, Written comments and suggestions send an email to omb@cdc.gov. Written
Chief, Information Collection Review Office, from the public and affected agencies comments and/or suggestions regarding
Office of Scientific Integrity, Office of the concerning the proposed collection of the items contained in this notice
Associate Director for Science, Office of the information are encouraged. Your should be directed to the Attention:
Director, Centers for Disease Control and comments should address any of the CDC Desk Officer, Office of Management
Prevention. following: (a) Evaluate whether the and Budget, Washington, DC 20503 or
[FR Doc. 2016–07707 Filed 4–4–16; 8:45 am] proposed collection of information is by fax to (202) 395–5806. Written
BILLING CODE 4163–18–P necessary for the proper performance of comments should be received within 30
the functions of the agency, including days of this notice.
whether the information will have
DEPARTMENT OF HEALTH AND practical utility; (b) Evaluate the Proposed Project
HUMAN SERVICES accuracy of the agencies estimate of the A Study of Viral Persistence in Ebola
burden of the proposed collection of Virus Disease
Centers for Disease Control and information, including the validity of (EVD) Survivors—Existing
Prevention the methodology and assumptions used; Information Collection Without an OMB
(c) Enhance the quality, utility, and Control Number—National Center for
[30Day–16–15BFV] clarity of the information to be Emerging and Zoonotic Infectious
collected; (d) Minimize the burden of Diseases (NCEZID), Centers for Disease
Agency Forms Undergoing Paperwork the collection of information on those Control and Prevention (CDC).
Reduction Act Review who are to respond, including through
Background and Brief Description
the use of appropriate automated,
The Centers for Disease Control and electronic, mechanical, or other Much progress has been made in the
Prevention (CDC) has submitted the year since the CDC first responded to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
technological collection techniques or
following information collection request other forms of information technology, the Ebola outbreak in West Africa, but
to the Office of Management and Budget e.g., permitting electronic submission of the agency’s efforts must continue until
(OMB) for review and approval in responses; and (e) Assess information there are zero new cases of Ebola virus
accordance with the Paperwork collection costs. disease (EVD). As the CDC’s 2014 Ebola
Reduction Act of 1995. The notice for To request additional information on virus response maintains the
the proposed information collection is the proposed project or to obtain a copy international goal of zero new EVD
published to obtain comments from the of the information collection plan and cases in 2015, the agency must intensify
public and affected agencies. instruments, call (404) 639–7570 or its efforts to identify and prevent every
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![Federal Register / Vol. 81, No. 65 / Tuesday, April 5, 2016 / Notices 19609
potential route of human disease collections and questionnaires every persistence is available. A trained study
transmission and to understand the three days (sweat and breast milk). data manager will collect test results for
most current community barriers to Participants for each module will be all participants in a laboratory results
reaching that final goal. recruited by trained study staff from form.
Persistence of Ebola Virus (EBOV) in Ebola treatment units (ETUs) and Results and analyses are needed to
Body Fluids of EVD Survivors in Sierra survivor registries. Participants will be update relevant counseling messages
Leone is the first systematic followed up at study sites in and recommendations from the Sierra
examination of the post-recovery government hospitals. Leone Ministry of Health, World Health
Specimens will be tested for EBOV Organization, and CDC. The study will
persistence of EBOV and the risks of
ribonucleic acid (RNA) by reverse provide the most current information
transmission from a cohort of
transcription polymerase chain reaction that is critical to the development of
convalescent Ebola survivors during
test (RT–PCR) in Sierra Leone at the public health measures, such as
close or intimate contact. It is important
CDC laboratory facility in Bo. All recommendations about sexual activity,
to fully understand how long the virus
positive RT–PCR samples will be sent to breastfeeding, and other routine
stays active in body fluids other than CDC Atlanta for virus isolation. Each activities and approaches to evaluation
blood in order to target and refine body fluid will be collected until two of survivors to determine whether they
public health interventions to arrest the negative RT–PCR results are obtained. can safely resume sexual activity. These
ongoing spread of disease. Participants will be followed until all approaches in turn are expected to
The research study is comprised of their studied body fluids are negative. reduce the risk of Ebola resurgence and
three modules based on the body fluids They will receive tokens of appreciation mitigate stigma for thousands of
to be studied: A pilot module of adult for their participation at the initial visit survivors. The information is likewise
males (semen) and two full modules: and again at every subsequent follow-up critical to reducing the risk that Ebola
Module A of adult men and women visit [e.g., 120,000 Leones would be introduced in a location that
repeating collections and questionnaires (approximately $28 US dollars) and a has not previously been affected.
every two weeks (semen, vaginal supply of condoms]. For Module A, men The total burden hours requested for
secretions, and saliva, tears, sweat, and women will be recruited in equal the research study in Sierra Leone is
urine, rectal swab), and Module B of numbers for this study until more 1,836 hours. There are no costs to
lactating adult women repeating information on gender effects of viral respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
No. of Average
No. of responses burden per
Type of respondent Form name respondents per 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 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, The meeting will be closed to the Place: National Institutes of Health, 6701
Chief, Information Collection Review Office, public in accordance with the Rockledge Drive, Room 7178, Bethesda, MD
Office of Scientific Integrity, Office of the 20892 (Virtual Meeting).
provisions set forth in sections
Associate Director for Science, Office of the Contact Person: William J. Johnson, Ph.D.,
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Scientific Review Officer, Office of Scientific
Director, Centers for Disease Control and
Prevention.
as amended. The grant applications and Review/DERA, National Heart, Lung, and
the discussions could disclose Blood Institute, 6701 Rockledge Drive, Room
[FR Doc. 2016–07803 Filed 4–4–16; 8:45 am]
confidential trade secrets or commercial 7178, Bethesda, MD 20892–7924, 301–435–
BILLING CODE 4163–18–P 0725, johnsonwj@nhlbi.nih.gov.
property such as patentable material,
and personal information concerning (Catalogue of Federal Domestic Assistance
individuals associated with the grant Program Nos. 93.233, National Center for
DEPARTMENT OF HEALTH AND Sleep Disorders Research; 93.837, Heart and
HUMAN SERVICES applications, the disclosure of which Vascular Diseases Research; 93.838, Lung
would constitute a clearly unwarranted Diseases Research; 93.839, Blood Diseases
asabaliauskas on DSK3SPTVN1PROD with NOTICES
National Institutes of Health invasion of personal privacy. and Resources Research, National Institutes
Name of Committee: National Heart, Lung, of Health, HHS)
National Heart, Lung, and Blood
and Blood Institute Special Emphasis Panel, Dated: March 30, 2016.
Institute; Notice of Closed Meeting
R13 Conference Grant Application Review. Anna Snouffer,
Pursuant to section 10(d) of the Date: April 28, 2016. Deputy Director, Office of Federal Advisory
Federal Advisory Committee Act, as Time: 9:00 a.m. to 6:00 p.m. Committee Policy.
amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant [FR Doc. 2016–07677 Filed 4–4–16; 8:45 am]
hereby given of the following meeting. applications. BILLING CODE 4140–01–P
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Document Created: 2018-02-07 13:53:20
Document Modified: 2018-02-07 13:53:20
| 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 19608 |
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