81 FR 81146 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 222 (November 17, 2016)

Page Range		81146-81147
FR Document		2016-27693

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.

Federal Register, Volume 81 Issue 222 (Thursday, November 17, 2016)

[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81146-81147]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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

81146 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices

blood biweekly at the clinic or hospital infection. Men will complete a ZIKV 3 days after delivery. Urine samples and
until there are 2 consecutive negative symptom questionnaire at the time of information on infant’s symptoms will
blood tests for ZIKV. Fetal tissue will be each specimen collection. If a man be collected every 2 weeks at home
collected for pregnancy losses to assess becomes symptomatic, he will be asked visits to monitor for ZIKV infection in
fetal ZIKV infection. All pregnancy to provide a blood sample at the clinic infancy. Additionally, any infant health
outcomes and any additional testing for ZIKV testing. If ZIKV is detected, conditions or results from medical
during pregnancy or in the immediate semen collection at home will be testing during this 6-month period
neonatal period as part of clinical care scheduled every two weeks until there conducted as part of routine clinical
will be abstracted from medical records. are 2 consecutive negative tests, or the care will be abstracted from medical
Male partners will be recruited via end of pregnancy. In addition, if a man’s records.
their pregnant partners around the time at-home urine sample is positive, he
of their pregnant partners’ enrollment will again be asked to participate in INS and CDC will use the study
into the study. At enrollment, men will semen collection at home every two results to guide their recommendations
complete a baseline questionnaire and weeks until there are 2 consecutive to prevent ZIKV infection; to improve
ZIKV symptom questionnaire and negative tests, or the end of pregnancy. counseling of patients about risks to
provide a blood sample. Urine samples All newborns of mothers participating themselves, their pregnancies, their
in men will be collected at home every in the study will be followed from birth partners, and their infants; and to help
2 weeks through the second trimester of to 6 months of age. A blood sample will agencies prepare to provide services to
pregnancy to monitor for incident ZIKV be collected at delivery or no later than affected children and families.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Respondents Form name responses per
respondents response hours
respondent (in hours)

Pregnant women ............................... Pregnant women eligibility question- 6,250 1 5/60 520
naire.
Pregnant women enrollment ques- 5,000 1 20/60 1,666
tionnaire.
Adult symptom questionnaire ........... 5,000 12 5/60 5,000
Pregnant women follow-up question- 5,000 12 15/60 15,000
naire.
Infant symptoms questionnaire ........ 4,500 4 5/60 1,500
Male partners .................................... Male partner eligibility questionnaire 5,000 1 5/60 417
Male enrollment questionnaire ......... 1,250 1 15/60 312
Adult symptom questionnaire ........... 1,250 12 5/60 1,250

Total ........................................... ........................................................... ........................ ........................ ........................ 25,665

Leroy A. Richardson, its continuing efforts to reduce public Instructions: All submissions received
Chief, Information Collection Review Office, burden and maximize the utility of must include the agency name and
Office of Scientific Integrity, Office of the government information, invites the Docket Number. All relevant comments
Associate Director for Science, Office of the general public and other Federal received will be posted without change
Director, Centers for Disease Control and agencies to take this opportunity to to Regulations.gov, including any
Prevention. comment on proposed and/or personal information provided. For
[FR Doc. 2016–27691 Filed 11–16–16; 8:45 am] continuing information collections, as access to the docket to read background
BILLING CODE 4163–18–P required by the Paperwork Reduction documents or comments received, go to
Act of 1995. This notice invites Regulations.gov.
comment on ‘‘Data Calls for the Please note: All public comment
DEPARTMENT OF HEALTH AND Laboratory Response Network’’ should be submitted through the
HUMAN SERVICES collected from its members concerning Federal eRulemaking portal
Centers for Disease Control and their capacity to respond to public (Regulations.gov) or by U.S. mail to the
Prevention health threat emergencies. address listed above.
DATES: Written comments must be FOR FURTHER INFORMATION CONTACT: To
[60Day–17–0881; Docket No. CDC–2016– received on or before January 17, 2017. request more information on the
0109] proposed project or to obtain a copy of
ADDRESSES: You may submit comments, the information collection plan and
Proposed Data Collection Submitted identified by Docket No. CDC–2017– instruments, contact the Information
for Public Comment and 0109 by any of the following methods: Collection Review Office, Centers for
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Recommendations • Federal eRulemaking Portal: Disease Control and Prevention, 1600
AGENCY: Centers for Disease Control and Regulations.gov. Follow the instructions Clifton Road NE., MS–D74, Atlanta,
Prevention (CDC), Department of Health for submitting comments. Georgia 30329; phone: 404–639–7570;
and Human Services (HHS). • Mail: Leroy A. Richardson, Email: omb@cdc.gov.
ACTION: Notice with comment period. Information Collection Review Office, SUPPLEMENTARY INFORMATION: Under the
Centers for Disease Control and Paperwork Reduction Act of 1995 (PRA)
SUMMARY: The Centers for Disease Prevention, 1600 Clifton Road NE., MS– (44 U.S.C. 3501–3520), Federal agencies
Control and Prevention (CDC), as part of D74, Atlanta, Georgia 30329. must obtain approval from the Office of

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Document Created: 2016-11-17 02:59:49
Document Modified: 2016-11-17 02:59:49

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
Action		Notice with comment period.
Dates		Written comments must be received on or before January 17, 2017.
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: [email protected]
FR Citation		81 FR 81146

81 FR 81146 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 222 (November 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention