Agency Forms Undergoing Paperwork Reduction Act Review, 19608-19609 [2016-07803]

Download as PDF 19608 Federal Register / Vol. 81, No. 65 / Tuesday, April 5, 2016 / Notices published materials, research, and trends among the four diseases. The NPIN Resources and Services Database contains entries on approximately 9,000 organizations and is the most comprehensive listing of HIV/AIDS, viral hepatitis, STD, and TB resources and services available throughout the country. The American public can also access the NPIN Resources and Services database through the NPIN Web site. More than 1,000,000 unique visitors and more than 3,000,000 page views are recorded annually. To accomplish CDC’s goal of continuing efforts to maintain an up-to- date, comprehensive database, NPIN plans each year to add up to 400 newly identified organizations and to verify those organizations currently described in the NPIN Resources and Services Database each year. Organizations with access to the Internet will be given the option to complete and submit an electronic version of the questionnaire by visiting the NPIN Web site. Methods to be used to collect the information include online, telephone and email survey questionnaires to collect information from representatives of the organizations that provide covered services. The respondent population includes Registered Nurses, Social and Community Service Managers, Health Educators, Social and Human Service Assistants working within NPIN member organizations that provide HIV/ AIDS, viral hepatitis, STD, and TB prevention, education, testing, and healthcare services. This data collection uses no inferential statistical methods. The data collected is in textual or anecdotal format and will be used for information purposes. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Form name Initial Questionnaire Script. Telephone Telephone Verification ...................... Email Verification .............................. Total ........................................... Registered nurses, Social and community service managers, and Health educators. Registered nurses, Social and community service managers, and Health educators Social and human service assistants. Registered nurses, Health educators, and Social and human service assistants, social and community service managers. ........................................................... 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. 2016–07707 Filed 4–4–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–16–15BFV] asabaliauskas on DSK3SPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 Number of respondents Type of respondents 17:18 Apr 04, 2016 Jkt 238001 Frm 00060 Fmt 4703 Average burden per response (in hours) Total burden (in hours) 400 1 15/60 100 6,100 1 10/60 1,017 3,000 1 12/60 600 ........................ ........................ ........................ 1,700 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 PO 00000 Number of responses per respondent Sfmt 4703 send an email to omb@cdc.gov. 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 E:\FR\FM\05APN1.SGM 05APN1 19609 Federal Register / Vol. 81, No. 65 / Tuesday, April 5, 2016 / Notices 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 No. of respondents Type of respondent Form name Data manager ................................................. Pilot participants .............................................. Pilot participants .............................................. Pilot participants .............................................. Main study male participants .......................... Main study male participants .......................... Main study male participants .......................... Main study female participants ....................... Main study female participants ....................... Main study female participants ....................... Data manager ................................................. Intake Form .................................................... Survivor Questionnaire ................................... Survivor Follow-up Questionnaire .................. 3 & 6 Month Follow up Questionnaire ........... Survivor Questionnaire ................................... Survivor Follow-up Questionnaire .................. 3 & 6 Month Follow Questionnaire ................ Survivor Questionnaire ................................... Survivor Follow-up Questionnaire .................. 3 & 6 Month Follow up Questionnaire ........... Laboratory Results Form ............................... 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 asabaliauskas on DSK3SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. VerDate Sep<11>2014 17:18 Apr 04, 2016 Jkt 238001 The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, R13 Conference Grant Application Review. Date: April 28, 2016. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 No. of responses per respondent 1 100 100 100 120 120 120 120 120 120 1 Average burden per response (hours) 550 1 5 2 1 12 2 1 4 2 4,250 20/60 30/60 15/60 15/60 30/60 15/60 15/60 30/60 15/60 15/60 10/60 Place: National Institutes of Health, 6701 Rockledge Drive, Room 7178, Bethesda, MD 20892 (Virtual Meeting). Contact Person: William J. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD 20892–7924, 301–435– 0725, johnsonwj@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: March 30, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2016–07677 Filed 4–4–16; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Notices]
[Pages 19608-19609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 omb@cdc.gov. 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

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