Proposed Data Collection Submitted for Public Comment and Recommendations, 81146-81147 [2016-27693]

Download as PDF 81146 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices blood biweekly at the clinic or hospital until there are 2 consecutive negative blood tests for ZIKV. Fetal tissue will be collected for pregnancy losses to assess fetal ZIKV infection. All pregnancy outcomes and any additional testing during pregnancy or in the immediate neonatal period as part of clinical care will be abstracted from medical records. Male partners will be recruited via their pregnant partners around the time of their pregnant partners’ enrollment into the study. At enrollment, men will complete a baseline questionnaire and ZIKV symptom questionnaire and provide a blood sample. Urine samples in men will be collected at home every 2 weeks through the second trimester of pregnancy to monitor for incident ZIKV 3 days after delivery. Urine samples and information on infant’s symptoms will be collected every 2 weeks at home visits to monitor for ZIKV infection in infancy. Additionally, any infant health conditions or results from medical testing during this 6-month period conducted as part of routine clinical care will be abstracted from medical records. INS and CDC will use the study results to guide their recommendations to prevent ZIKV infection; to improve counseling of patients about risks to themselves, their pregnancies, their partners, and their infants; and to help agencies prepare to provide services to affected children and families. infection. Men will complete a ZIKV symptom questionnaire at the time of each specimen collection. If a man becomes symptomatic, he will be asked to provide a blood sample at the clinic for ZIKV testing. If ZIKV is detected, semen collection at home will be scheduled every two weeks until there are 2 consecutive negative tests, or the end of pregnancy. In addition, if a man’s at-home urine sample is positive, he will again be asked to participate in semen collection at home every two weeks until there are 2 consecutive negative tests, or the end of pregnancy. All newborns of mothers participating in the study will be followed from birth to 6 months of age. A blood sample will be collected at delivery or no later than ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hours) Number of responses per respondent Total burden hours Respondents Form name Pregnant women ............................... Pregnant women eligibility questionnaire. Pregnant women enrollment questionnaire. Adult symptom questionnaire ........... Pregnant women follow-up questionnaire. Infant symptoms questionnaire ........ Male partner eligibility questionnaire Male enrollment questionnaire ......... Adult symptom questionnaire ........... 6,250 1 5/60 520 5,000 1 20/60 1,666 5,000 5,000 12 12 5/60 15/60 5,000 15,000 4,500 5,000 1,250 1,250 4 1 1 12 5/60 5/60 15/60 5/60 1,500 417 312 1,250 ........................................................... ........................ ........................ ........................ 25,665 Male partners .................................... Total ........................................... 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. 2016–27691 Filed 11–16–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ‘‘Data Calls for the Laboratory Response Network’’ collected from its members concerning their capacity to respond to public health threat emergencies. Written comments must be received on or before January 17, 2017. DATES: asabaliauskas on DSK3SPTVN1PROD with NOTICES [60Day–17–0881; Docket No. CDC–2016– 0109] Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: The Centers for Disease Control and Prevention (CDC), as part of SUMMARY: VerDate Sep<11>2014 21:24 Nov 16, 2016 Jkt 241001 You may submit comments, identified by Docket No. CDC–2017– 0109 by any of the following methods: • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. • Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– D74, Atlanta, Georgia 30329. ADDRESSES: Proposed Data Collection Submitted for Public Comment and Recommendations PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email: omb@cdc.gov. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of E:\FR\FM\17NON1.SGM 17NON1 81147 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology information as well as staff and equipment inventories. However, semiannually or during emergency response the LRN Program Office may conduct a Special Data Call to obtain additional information from LRN Member Laboratories in regards to biological or chemical terrorism preparedness. LRN has used the currently approved generic information collection plan twice during the last three years. Once in 2014, LRN surveyed its members to ascertain which, if any, labs would be willing to test clinical specimens for Ebola virus. The information gathered led to an emergency deployment of a new Ebola assay for LRN members. It is critical for the LRN to know which labs have equipment to support an agent specific assay during an emergency. In 2015, LRN surveyed members via broadcast email asking how many facilities had a specific version of an instrument. The information was used to help the LRN program office determine if new procedures should be written and made available to members to support the instrument in question. Special Data calls may be conducted via queries that are distributed by broadcast emails or by survey tools (i.e. Survey Monkey). This is a request for a three year extension to this generic clearance. The only cost to respondents is their time to respond to the data call. Authorizing legislation comes from Section 301 of the Public Health Service Act. and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project Data Calls for the Laboratory Response Network, (OMB Control No. 0920–0881 exp. 4/30/2017)— Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Laboratory Response Network (LRN) was established by the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti-terrorism policies and assigned specific missions to Federal departments and agencies. The LRN’s mission is to maintain an integrated national and international network of laboratories that can respond to acts of biological, chemical, or radiological terrorism and other public health emergencies. Federal, state and local public health laboratories voluntarily join the LRN. The LRN Program Office maintains a database of information for each member laboratory that includes contact ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hours) Number of responses per respondent Total burden (in hours) Type of respondents Form name Public Health Laboratorians .............. Special Data Call ............................. 136 1 30/60 68 Total ........................................... ........................................................... ........................ ........................ ........................ 68 asabaliauskas on DSK3SPTVN1PROD with NOTICES 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. 2016–27693 Filed 11–16–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10169] Agency Information Collection Activities: Proposed Collection; Comment Request; Correction Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Correction of notice. AGENCY: VerDate Sep<11>2014 21:24 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 This document corrects the information provided for [Document Identifier: CMS–10169] titled ‘‘Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program; Change of Ownership Forms.’’ FOR FURTHER INFORMATION CONTACT: William N. Parham, III, (410) 786–4669. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In the October 14, 2016, issue of the Federal Register (81 FR 71100), we E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81146-81147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0881; Docket No. CDC-2016-0109]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on ``Data Calls for 
the Laboratory Response Network'' collected from its members concerning 
their capacity to respond to public health threat emergencies.

DATES: Written comments must be received on or before January 17, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0109 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of

[[Page 81147]]

Management and Budget (OMB) for each collection of information they 
conduct or sponsor. In addition, the PRA also requires Federal agencies 
to provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each new proposed 
collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Data Calls for the Laboratory Response Network, (OMB Control No. 
0920-0881 exp. 4/30/2017)--Extension--National Center for Emerging and 
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The Laboratory Response Network (LRN) was established by the 
Department of Health and Human Services, Centers for Disease Control 
and Prevention (CDC) in accordance with Presidential Decision Directive 
39, which outlined national anti-terrorism policies and assigned 
specific missions to Federal departments and agencies. The LRN's 
mission is to maintain an integrated national and international network 
of laboratories that can respond to acts of biological, chemical, or 
radiological terrorism and other public health emergencies. Federal, 
state and local public health laboratories voluntarily join the LRN.
    The LRN Program Office maintains a database of information for each 
member laboratory that includes contact information as well as staff 
and equipment inventories. However, semiannually or during emergency 
response the LRN Program Office may conduct a Special Data Call to 
obtain additional information from LRN Member Laboratories in regards 
to biological or chemical terrorism preparedness.
    LRN has used the currently approved generic information collection 
plan twice during the last three years. Once in 2014, LRN surveyed its 
members to ascertain which, if any, labs would be willing to test 
clinical specimens for Ebola virus.
    The information gathered led to an emergency deployment of a new 
Ebola assay for LRN members. It is critical for the LRN to know which 
labs have equipment to support an agent specific assay during an 
emergency. In 2015, LRN surveyed members via broadcast email asking how 
many facilities had a specific version of an instrument. The 
information was used to help the LRN program office determine if new 
procedures should be written and made available to members to support 
the instrument in question.
    Special Data calls may be conducted via queries that are 
distributed by broadcast emails or by survey tools (i.e. Survey 
Monkey).
    This is a request for a three year extension to this generic 
clearance.
    The only cost to respondents is their time to respond to the data 
call. Authorizing legislation comes from Section 301 of the Public 
Health Service Act.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden  per    Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratorians...  Special Data                 136               1           30/60              68
                                 Call.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              68
----------------------------------------------------------------------------------------------------------------


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. 2016-27693 Filed 11-16-16; 8:45 am]
 BILLING CODE 4163-18-P