81 FR 44866 - 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 | 44866-44867 | |
| FR Document | 2016-16298 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Notices] [Pages 44866-44867] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16298] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-16ASR] 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 Persistence of Zika Virus in Semen and Urine of Adult Men in the United States with Confirmed Zika Virus Infection--New--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Zika virus is an arthropod-borne flavivirus that has recently emerged in the Americas. Maternal infection has been linked to congenital microcephaly, fetal loss, and other adverse reproductive health outcomes. Although spread primarily by mosquitoes, recent reports have highlighted the potential for sexual transmission of Zika virus through the semen of infected men. Detection of viral RNA in semen 62 days after illness onset has been reported; however the frequency and duration of virus shedding is largely unknown. Information on these parameters is needed urgently to better inform public health recommendations, particularly for couples contemplating pregnancy. This study will fill gaps in the scientific knowledge base for Zika virus regarding the persistence and transmissibility of Zika virus in body fluids, and determine the frequency and duration of Zika virus shedding in semen and urine of infected men. Minimal health information and specimens from consenting men with recent Zika virus infection will be collected once every two weeks for up to 6 months post onset of symptoms (or up to 12 collections). Specimens will be tested for Zika RNA by reverse transcriptase polymerase chain reaction assay (RT-PCR) at CDC; those testing positive may be further evaluated by virus isolation techniques. Zika virus disease is a nationally notifiable condition, and participants will be recruited through contact with CDC personnel. Urine and semen specimens will be self-collected using home collection kits, a short questionnaire will be self-administered, and participants will be compensated for their time. Results of testing will be provided to participants at the conclusion of testing. The results of this study are expected to have immediate implications for public health recommendations and disease prevention. This is a prospective, descriptive cohort study. The prospective nature of the proposed cohort study allows for determining the persistence of shedding Zika virus in semen and urine through serial specimen collection from individuals with confirmed Zika virus. The results of this study will be of great relevance to provide evidence-based information to circumvent Zika virus transmission. They will inform the development of recommendations used in the current epidemic setting, as well as in future Zika virus situations. Results and analysis will be used to update and refine relevant counseling messages and recommendations. [[Page 44867]] Potential products include scientific abstracts and manuscripts, presentations, and guidance documents. There are no costs to the respondents other than their time. The total estimated annual burden hours are 134. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- General Public..................... Introductory Survey........ 250 1 20/60 Follow-up survey........... 250 12 1/60 ---------------------------------------------------------------------------------------------------------------- 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. 2016-16298 Filed 7-8-16; 8:45 am] BILLING CODE 4163-18-P
![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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![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44867
Potential products include scientific There are no costs to the respondents
abstracts and manuscripts, other than their time. The total
presentations, and guidance documents. estimated annual burden hours are 134.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
General Public ........................ Introductory Survey ................................................................ 250 1 20/60
Follow-up survey .................................................................... 250 12 1/60
Jeffrey M. Zirger, ADDRESSES: When commenting on the the following proposed collection(s) of
Health Scientist, Acting Chief, Information proposed information collections, information for public comment:
Collection Review Office, Office of Scientific please reference the document identifier
Integrity, Office of the Associate Director for
1. Type of Information Collection
or OMB control number. To be assured Request: Revision of a currently
Science, Office of the Director, Centers for consideration, comments and
Disease Control and Prevention. approved collection; Title of
recommendations must be received by
[FR Doc. 2016–16298 Filed 7–8–16; 8:45 am] Information Collection: Medicaid Drug
the OMB desk officer via one of the
Program—Monthly and Quarterly Drug
BILLING CODE 4163–18–P following transmissions: OMB, Office of
Information and Regulatory Affairs, Reporting Format; Use: Labelers
Attention: CMS Desk Officer, Fax transmit drug product and pricing data
DEPARTMENT OF HEALTH AND Number: (202) 395–5806 or, Email: to CMS within 30 days after the end of
HUMAN SERVICES OIRA_submission@omb.eop.gov. each calendar month and quarter. CMS
To obtain copies of a supporting calculates the unit rebate amount (URA)
Centers for Medicare & Medicaid and the unit rebate offset amount
Services statement and any related forms for the
proposed collection(s) summarized in (UROA) for each new drug application
[Document Identifier: CMS–367] this notice, you may make your request (NDC) and distributes to all State
using one of following: Medicaid agencies. States use the URA
Agency Information Collection to invoice the labeler for rebates and the
1. Access CMS’ Web site address at
Activities: Submission for OMB UROA to report onto the CMS–64. The
http://www.cms.hhs.gov/Paperwork
Review; Comment Request monthly data is used to calculate
ReductionActof1995.
ACTION: Notice. 2. Email your request, including your Federal Upper Limit (FUL) prices for
address, phone number, OMB number, applicable drugs and for states that opt
SUMMARY: The Centers for Medicare & and CMS document identifier, to to use this data to establish their
Medicaid Services (CMS) is announcing Paperwork@cms.hhs.gov. pharmacy reimbursement methodology.
an opportunity for the public to 3. Call the Reports Clearance Office at Form Number: CMS–367 (OMB control
comment on CMS’ intention to collect (410) 786–1326. number: 0938–0578); Frequency:
information from the public. Under the Monthly and Quarterly; Affected Public:
Paperwork Reduction Act of 1995 FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786– Private sector (Business or other for-
(PRA), federal agencies are required to profits); Number of Respondents: 610;
publish a notice in the Federal Register 1326.
Total Annual Responses: 12,810; Total
concerning each proposed collection of SUPPLEMENTARY INFORMATION: Under the Annual Hours: 3,618,703. (For policy
information, including each proposed Paperwork Reduction Act of 1995 (PRA) questions regarding this collection
extension or reinstatement of an existing (44 U.S.C. 3501–3520), federal agencies contact Samone Angel at 410–786–
collection of information, and to allow must obtain approval from the Office of 1123.)
a second opportunity for public Management and Budget (OMB) for each
comment on the notice. Interested collection of information they conduct Dated: July 5, 2016.
persons are invited to send comments or sponsor. The term ‘‘collection of William N. Parham, III,
regarding the burden estimate or any information’’ is defined in 44 U.S.C. Director, Paperwork Reduction Staff, Office
other aspect of this collection of 3502(3) and 5 CFR 1320.3(c) and of Strategic Operations and Regulatory
information, including any of the includes agency requests or Affairs.
following subjects: (1) The necessity and requirements that members of the public [FR Doc. 2016–16221 Filed 7–8–16; 8:45 am]
utility of the proposed information submit reports, keep records, or provide BILLING CODE 4120–01–P
collection for the proper performance of information to a third party. Section
the agency’s functions; (2) the accuracy 3506(c)(2)(A) of the PRA (44 U.S.C.
of the estimated burden; (3) ways to 3506(c)(2)(A)) requires federal agencies
enhance the quality, utility, and clarity to publish a 30-day notice in the
of the information to be collected; and Federal Register concerning each
sradovich on DSK3GDR082PROD with NOTICES
(4) the use of automated collection proposed collection of information,
techniques or other forms of information including each proposed extension or
technology to minimize the information reinstatement of an existing collection
collection burden. of information, before submitting the
DATES: Comments on the collection(s) of collection to OMB for approval. To
information must be received by the comply with this requirement, CMS is
OMB desk officer by August 10, 2016: publishing this notice that summarizes
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Document Created: 2016-07-09 00:21:16
Document Modified: 2016-07-09 00:21:16
| 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 44866 |
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