81 FR 44865 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 132 (July 11, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 132 (July 11, 2016)
| Page Range | 44865-44866 | |
| FR Document | 2016-16297 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Notices] [Pages 44865-44866] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16297] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-16ARP] 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 Zika Virus Persistence in Body Fluids of Patients with Zika Virus Infection in Puerto Rico (ZIPER Study)--New--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Zika virus (ZIKV) is a mosquito-borne flavivirus that has recently emerged in the Americas. Previously, outbreaks had occurred in Asia and islands in the South Pacific. In addition to mosquito-to-human transmission, ZIKV infections have been documented through sexual transmission, blood transfusion, laboratory exposure, intrauterine transmission resulting in congenital infection, and intrapartum transmission from a viremic mother to her newborn. Along with serum, ZIKV RNA has been detected in semen, urine, breast milk, and amniotic fluid. ZIKV IgM antibodies are generally first detectable at 4 to 8 days after onset of illness and likely persist for weeks to months; however, the duration of persistence of anti-ZIKV IgM antibodies is unknown as well as the timing from infection to the development of IgG antibodies. The prevalence of ZIKV RNA in various body fluids among patients with acute ZIKV infection and the length of time that ZIKV RNA might persist in these body fluids is not well understood, nor the frequency with which it is infectious. Characterizing these parameters has implications both for diagnosis of ZIKV infection using specimens other than blood than may be more convenient to collect, as well as for potential human-to-human transmission. The Zika PERsistence (ZIPER) study will help inform the presence and duration of ZIKV shedding in several body fluids among RT-PCR- positive ZIKV cases from Puerto Rico. It will also provide information regarding the duration of detection of anti-ZIKV IgM antibodies and the time for development of IgG antibodies among the same population. In addition, this protocol will determine the prevalence of anti-ZIKV IgM and IgG, and virus shedding in body fluids among household contacts of ZIKV cases. We propose to investigate the persistence (shedding) of ZIKV in different body fluids and its relation to [[Page 44866]] immune response to provide a basis for development of non-blood-based diagnostic tools, and target and refine public health interventions to arrest ongoing spread of infection. To do so, we will conduct a prospective cohort study of individuals with reverse transcription- polymerase chain reaction (RT-PCR) positive ZIKV infection and a cross- sectional study of their household contacts. Results and analyses will be used to update relevant counseling messages and recommendations from the CDC. There are no costs to the respondents other than their time. The total estimated annual burden hours are 374. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Public Health Personnel............ Shedding Questionnaire 200 8 10/60 (Symptomatics). Shedding Questionnaire 400 1 10/60 (Cross-Sectional Asymptomatics). General Public..................... Shedding Eligibility Form.. 1,000 1 2/60 Contact Information Form... 200 1 2/60 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Health Scientist, Acting 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. 2016-16297 Filed 7-8-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44865
expressions of interest no later than Information Needed: Expressions of should be directed to the Attention:
August 25, 2016. interest should outline the CDC Desk Officer, Office of Management
ADDRESSES: Expressions of interest may organization’s ability to meet the and Budget, Washington, DC 20503 or
be directed electronically to Bryan preferred qualifications mentioned by fax to (202) 395–5806. Written
Beamer at zmy4@cdc.gov or mailed to above and be no more than four pages comments should be received within 30
National Institute for Occupational in length. days of this notice.
Safety and Health, Division of Applied Dated: July 5, 2016. Proposed Project
Research and Technology, 1090 Frank Hearl,
Tusculum Avenue, MS C–27, Zika Virus Persistence in Body Fluids
Chief of Staff, National Institute for of Patients with Zika Virus Infection in
Cincinnati, OH 45226. Attention: Bryan Occupational Safety and Health, Centers for
Beamer. Disease Control and Prevention.
Puerto Rico (ZIPER Study)—New—
FOR FURTHER INFORMATION CONTACT:
National Center for Emerging and
[FR Doc. 2016–16267 Filed 7–8–16; 8:45 am]
Questions may be directed to Bryan Zoonotic Infectious Diseases (NCEZID),
BILLING CODE 4163–19–P
Beamer, National Institute for Centers for Disease Control and
Occupational Safety and Health, Prevention (CDC).
Division of Applied Research and DEPARTMENT OF HEALTH AND Background and Brief Description
Technology, 1090 Tusculum Ave., MS HUMAN SERVICES Zika virus (ZIKV) is a mosquito-borne
C–27, Cincinnati, OH 45226. Email: flavivirus that has recently emerged in
zmy4@cdc.gov. Centers for Disease Control and
the Americas. Previously, outbreaks had
SUPPLEMENTARY INFORMATION: NIOSH Prevention
occurred in Asia and islands in the
has developed the Buy Quiet Web Tool [30Day–16–16ARP] South Pacific. In addition to mosquito-
and the Database of Noise Levels for to-human transmission, ZIKV infections
Machinery and Power Tools with the Agency Forms Undergoing Paperwork have been documented through sexual
goal of reducing noise-induced hearing Reduction Act Review transmission, blood transfusion,
loss among the nation’s workers by laboratory exposure, intrauterine
The Centers for Disease Control and
providing information and tools to transmission resulting in congenital
Prevention (CDC) has submitted the
facilitate, document, and track the infection, and intrapartum transmission
following information collection request
progress of Buy Quiet programs. NIOSH from a viremic mother to her newborn.
to the Office of Management and Budget
is looking for one organization to host Along with serum, ZIKV RNA has been
(OMB) for review and approval in
and maintain either one or both of the detected in semen, urine, breast milk,
accordance with the Paperwork
Buy Quiet Web Tool and the interactive and amniotic fluid. ZIKV IgM antibodies
Reduction Act of 1995. The notice for
Database of Noise Levels for Machinery are generally first detectable at 4 to 8
the proposed information collection is
and Power Tools. The grantee days after onset of illness and likely
published to obtain comments from the
organization would ideally possess the persist for weeks to months; however,
public and affected agencies.
following qualifications: Written comments and suggestions the duration of persistence of anti-ZIKV
• Ability to promote the web tools IgM antibodies is unknown as well as
from the public and affected agencies
with national reach; the timing from infection to the
• access to subject matter experts in concerning the proposed collection of
information are encouraged. Your development of IgG antibodies. The
information technologies related to
comments should address any of the prevalence of ZIKV RNA in various
Web-based database development and
following: (a) Evaluate whether the body fluids among patients with acute
maintenance;
• access to subject matter experts in proposed collection of information is ZIKV infection and the length of time
occupational noise mitigation; necessary for the proper performance of that ZIKV RNA might persist in these
• access to appropriate information the functions of the agency, including body fluids is not well understood, nor
technology hardware and software; whether the information will have the frequency with which it is
• ability to solicit, accept, vet and practical utility; (b) Evaluate the infectious. Characterizing these
maintain noise level data from accuracy of the agencies estimate of the parameters has implications both for
manufacturers for the Database of Noise burden of the proposed collection of diagnosis of ZIKV infection using
Levels for Machinery and Power Tools; information, including the validity of specimens other than blood than may be
• ability to solicit and maintain Buy the methodology and assumptions used; more convenient to collect, as well as
Quiet program data for a variety of (c) Enhance the quality, utility, and for potential human-to-human
companies; and clarity of the information to be transmission.
• ability to host and maintain the web collected; (d) Minimize the burden of The Zika PERsistence (ZIPER) study
tools for a minimum period of 3 years the collection of information on those will help inform the presence and
from the date the tools are made who are to respond, including through duration of ZIKV shedding in several
available to the general public. the use of appropriate automated, body fluids among RT–PCR-positive
Furthermore, the organization is to electronic, mechanical, or other ZIKV cases from Puerto Rico. It will also
make these tools available to the general technological collection techniques or provide information regarding the
public within 12 months of signing the other forms of information technology, duration of detection of anti-ZIKV IgM
license agreement. e.g., permitting electronic submission of antibodies and the time for development
Links to the NIOSH Buy Quiet Web responses; and (e) Assess information of IgG antibodies among the same
site and the current NIOSH Power Tools collection costs. population. In addition, this protocol
sradovich on DSK3GDR082PROD with NOTICES
Database can be found here: To request additional information on will determine the prevalence of anti-
• http://www.cdc.gov/niosh/topics/ the proposed project or to obtain a copy ZIKV IgM and IgG, and virus shedding
buyquiet/default.html—Buy Quiet of the information collection plan and in body fluids among household
Web site instruments, call (404) 639–7570 or contacts of ZIKV cases.
• http://wwwn.cdc.gov/niosh-sound- send an email to omb@cdc.gov. Written We propose to investigate the
vibration/—NIOSH Power Tools comments and/or suggestions regarding persistence (shedding) of ZIKV in
Database the items contained in this notice different body fluids and its relation to
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![44866 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
immune response to provide a basis for study of individuals with reverse messages and recommendations from
development of non-blood-based transcription-polymerase chain reaction the CDC.
diagnostic tools, and target and refine (RT–PCR) positive ZIKV infection and a There are no costs to the respondents
public health interventions to arrest cross-sectional study of their household other than their time. The total
ongoing spread of infection. To do so, contacts. Results and analyses will be estimated annual burden hours are 374.
we will conduct a prospective cohort used to update relevant counseling
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Public Health Personnel ......... Shedding Questionnaire (Symptomatics) ............................... 200 8 10/60
Shedding Questionnaire (Cross-Sectional Asymptomatics) .. 400 1 10/60
General Public ........................ Shedding Eligibility Form ........................................................ 1,000 1 2/60
Contact Information Form ...................................................... 200 1 2/60
Jeffrey M. Zirger, the use of appropriate automated, This study will fill gaps in the
Health Scientist, Acting Chief, Information electronic, mechanical, or other scientific knowledge base for Zika virus
Collection Review Office, Office of Scientific technological collection techniques or regarding the persistence and
Integrity, Office of the Associate Director for other forms of information technology, transmissibility of Zika virus in body
Science, Office of the Director, Centers for e.g., permitting electronic submission of fluids, and determine the frequency and
Disease Control and Prevention. responses; and (e) Assess information duration of Zika virus shedding in
[FR Doc. 2016–16297 Filed 7–8–16; 8:45 am] collection costs. semen and urine of infected men.
BILLING CODE 4163–18–P
To request additional information on Minimal health information and
the proposed project or to obtain a copy specimens from consenting men with
of the information collection plan and recent Zika virus infection will be
DEPARTMENT OF HEALTH AND collected once every two weeks for up
HUMAN SERVICES instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written to 6 months post onset of symptoms (or
comments and/or suggestions regarding up to 12 collections). Specimens will be
Centers for Disease Control and tested for Zika RNA by reverse
Prevention the items contained in this notice
should be directed to the Attention: transcriptase polymerase chain reaction
[30Day–16–16ASR] CDC Desk Officer, Office of Management assay (RT–PCR) at CDC; those testing
and Budget, Washington, DC 20503 or positive may be further evaluated by
Agency Forms Undergoing Paperwork by fax to (202) 395–5806. Written virus isolation techniques. Zika virus
Reduction Act Review comments should be received within 30 disease is a nationally notifiable
days of this notice. condition, and participants will be
The Centers for Disease Control and recruited through contact with CDC
Prevention (CDC) has submitted the Proposed Project personnel. Urine and semen specimens
following information collection request will be self-collected using home
to the Office of Management and Budget Persistence of Zika Virus in Semen
collection kits, a short questionnaire
(OMB) for review and approval in and Urine of Adult Men in the United
will be self-administered, and
accordance with the Paperwork States with Confirmed Zika Virus
participants will be compensated for
Reduction Act of 1995. The notice for Infection—New—National Center for their time. Results of testing will be
the proposed information collection is Emerging and Zoonotic Infectious provided to participants at the
published to obtain comments from the Diseases (NCEZID), Centers for Disease conclusion of testing. The results of this
public and affected agencies. Control and Prevention (CDC). study are expected to have immediate
Written comments and suggestions Background and Brief Description implications for public health
from the public and affected agencies recommendations and disease
concerning the proposed collection of Zika virus is an arthropod-borne prevention.
information are encouraged. Your flavivirus that has recently emerged in This is a prospective, descriptive
comments should address any of the the Americas. Maternal infection has cohort study. The prospective nature of
following: (a) Evaluate whether the been linked to congenital microcephaly, the proposed cohort study allows for
proposed collection of information is fetal loss, and other adverse determining the persistence of shedding
necessary for the proper performance of reproductive health outcomes. Although Zika virus in semen and urine through
the functions of the agency, including spread primarily by mosquitoes, recent serial specimen collection from
whether the information will have reports have highlighted the potential individuals with confirmed Zika virus.
practical utility; (b) Evaluate the for sexual transmission of Zika virus The results of this study will be of
accuracy of the agencies estimate of the through the semen of infected men. great relevance to provide evidence-
burden of the proposed collection of Detection of viral RNA in semen 62 days based information to circumvent Zika
sradovich on DSK3GDR082PROD with NOTICES
information, including the validity of after illness onset has been reported; virus transmission. They will inform the
the methodology and assumptions used; however the frequency and duration of development of recommendations used
(c) Enhance the quality, utility, and virus shedding is largely unknown. in the current epidemic setting, as well
clarity of the information to be Information on these parameters is as in future Zika virus situations.
collected; (d) Minimize the burden of needed urgently to better inform public Results and analysis will be used to
the collection of information on those health recommendations, particularly update and refine relevant counseling
who are to respond, including through for couples contemplating pregnancy. messages and recommendations.
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Document Created: 2016-07-09 00:21:20
Document Modified: 2016-07-09 00:21:20
| 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 44865 |
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