Agency Forms Undergoing Paperwork Reduction Act Review, 46677-46678 [2016-16872]

Download as PDF 46677 Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices OMB approval is requested for three years. Participation is based on previous Emergency Epidemic Investigations. There are no costs to respondents. ESTIMATED ANNUALIZED BURDEN HOURS Total number of responses per respondent Number of respondents Average burden per response (in hours) Total burden hours (in hours) Type of respondent Form name Emergency Epidemic Investigation Participants. Emergency Epidemic Investigation Data Collection Instruments. 12,000 1 30/60 6,000 Total ........................................... ........................................................... ........................ ........................ ........................ 6,000 Jeffrey M. Zirger, 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. 2016–16882 Filed 7–15–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention asabaliauskas on DSK3SPTVN1PROD with NOTICES Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 81 FR 30307–30308, dated May 16, 2016) is amended to reflect the reorganization of the Office of the Director, Centers for Disease Control and Prevention. Section C–B, Organization and Functions, is hereby amended as follows: After the title and the mission and function statements for the Office of the Associate Director for Laboratory Science and Safety (CAC) insert the following: Office of the Director (CAC1). (1) Provides scientific, technical, and managerial expertise and leadership in the development and enhancement of laboratory science and safety programs; (2) oversees and monitors the development, implementation, and evaluation of the laboratory safety and quality management programs across CDC; (3) advises on policy, partnerships, and issues management matters; (4) advises on matters related to internal and external public health communications; (5) provides oversight to ensure CDC compliance with VerDate Sep<11>2014 17:52 Jul 15, 2016 Jkt 238001 regulations for select agents and toxins, and the safe possession, use and transfer of select agents and toxins; and (6) leads responses to laboratory incidents and emergencies. Office of Laboratory Science (CACB). (1) Provides high-level oversight and coordination of laboratory quality and safety training programs at all CDC campuses; (2) develops agency-level plans, policies, procedures and guidelines for implementation of quality management programs within Centers, Institute, and Offices (CIOs); (3) assures regulatory compliance and tracking for CDC’s portfolio of laboratory developed tests; and (4) provides oversight of the catalog of laboratory safety training activities and tracking agency-wide progress and compliance with laboratory safety training requirements. Office of Laboratory Safety (CACC). (1) Provides high-level oversight and coordination of laboratory safety at all CDC campuses; (2) develops and assures effectiveness of agency-level plans, policies, manuals and tools for implementation of laboratory safety standards; (3) assures regulatory compliance for biological safety, chemical safety, radiation safety and the possession, use and transport of select agents and toxins; and (4) provides expertise and consultation for biological safety, chemical safety and radiation safety. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2016–16884 Filed 7–15–16; 8:45 am] BILLING CODE 4160–18–P PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day–16–16AVB] 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 E:\FR\FM\18JYN1.SGM 18JYN1 46678 Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices 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 US Zika Pregnancy Registry—New— National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description In May 2015, the World Health Organization reported the first local transmission of Zika virus in the Western Hemisphere, with autochthonous cases identified in Brazil. As of March 16, 2016, local transmission has been identified in at least 32 countries or territories in the Americas. Further spread to other countries in the region is likely. Local vectorborne transmission of Zika virus has not been documented in the 50 U.S. states or the District of Columbia, but has occurred in U.S. territories, including in Puerto Rico, the U.S. Virgin Islands, and American Samoa. However, Zika virus infections have been reported in travelers returning to the United States from areas with active Zika virus transmission. Zika virus infection also has occurred through sexual transmission, which may pose an additional risk to non-travelling pregnant women whose partners may have traveled to areas at high risk for Zika virus acquisition. With the ongoing outbreak in the Americas, the number of Zika virus disease cases among travelers returning to the United States likely will increase, and sexual transmission from male travelers to their sex partners in the United States will likely continue to occur. In addition, mosquito-borne local transmission may occur in states where Aedes species mosquitoes are present. In some Brazilian states where Zika virus transmission has occurred, there has been an increase in cases of infants born with microcephaly. Zika virus infections have been confirmed in several infants with microcephaly and in fetal losses in women infected during pregnancy. In addition to microcephaly, a range of other problems have been detected among fetuses and infants infected with Zika virus before birth, such as absent or poorly developed brain structures, defects of the eye, hearing deficits, and impaired growth. The Ministry of Health in Brazil, with support from the Pan American Health Organization (PAHO), the U.S. Centers for Disease Control and Prevention (CDC), and other partners, is investigating the association between Zika virus infection and microcephaly, as well as other adverse pregnancy and infant outcomes. As part of the public health response to the Zika virus disease outbreak, CDC will conduct supplemental surveillance of antenatal diagnostic testing and clinical outcomes among pregnant women with laboratory evidence of Zika virus or unspecified flavivirus infection and their infants through the U.S. Zika Pregnancy Registry. It is anticipated that the Registry will provide critical information to direct CDC clinical recommendations and public health guidance and messages. The objective of this Registry is to monitor the frequency and types of pregnancy and infant outcomes following Zika virus infection during pregnancy, so as to inform ongoing response efforts for this Zika virus disease outbreak, including recommendations for clinical care, planning for services for pregnant women and infants affected by Zika virus, and improved prevention of Zika virus infections during pregnancy. There are no costs to the respondents other than their time. The total estimated annual burden hours are 2,167. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hrs.) Type of respondents Form name State, Territorial and Local Health Departments. Maternal Health History Form ........................ 100 10 30/60 Supplemental Imaging Form .......................... Laboratory Results Form ............................... Assessment at Delivery Form ........................ Infant Health Follow-Up Form ........................ 100 100 100 100 10 10 10 30 10/60 15/60 30/60 15/60 Clinicians and Other Providers ....................... Jeffrey M. Zirger, 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. 2016–16872 Filed 7–15–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2016–0064; 60 Day–16– 0969] asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4163–18–P Proposed Data Collection Submitted for Public Comment and Recommendations 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 its continuing efforts to reduce public SUMMARY: VerDate Sep<11>2014 17:52 Jul 15, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 ‘‘Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics,’’ a survey to assess dissemination and use of guidance documents about the use of contraceptives and the delivery of quality family planning services. Written comments must be received on or before September 16, 2016. DATES: E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46677-46678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16872]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-16-16AVB]


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

[[Page 46678]]

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

    US Zika Pregnancy Registry--New--National Center for Emerging and 
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    In May 2015, the World Health Organization reported the first local 
transmission of Zika virus in the Western Hemisphere, with 
autochthonous cases identified in Brazil. As of March 16, 2016, local 
transmission has been identified in at least 32 countries or 
territories in the Americas. Further spread to other countries in the 
region is likely. Local vectorborne transmission of Zika virus has not 
been documented in the 50 U.S. states or the District of Columbia, but 
has occurred in U.S. territories, including in Puerto Rico, the U.S. 
Virgin Islands, and American Samoa. However, Zika virus infections have 
been reported in travelers returning to the United States from areas 
with active Zika virus transmission. Zika virus infection also has 
occurred through sexual transmission, which may pose an additional risk 
to non-travelling pregnant women whose partners may have traveled to 
areas at high risk for Zika virus acquisition. With the ongoing 
outbreak in the Americas, the number of Zika virus disease cases among 
travelers returning to the United States likely will increase, and 
sexual transmission from male travelers to their sex partners in the 
United States will likely continue to occur. In addition, mosquito-
borne local transmission may occur in states where Aedes species 
mosquitoes are present.
    In some Brazilian states where Zika virus transmission has 
occurred, there has been an increase in cases of infants born with 
microcephaly. Zika virus infections have been confirmed in several 
infants with microcephaly and in fetal losses in women infected during 
pregnancy. In addition to microcephaly, a range of other problems have 
been detected among fetuses and infants infected with Zika virus before 
birth, such as absent or poorly developed brain structures, defects of 
the eye, hearing deficits, and impaired growth. The Ministry of Health 
in Brazil, with support from the Pan American Health Organization 
(PAHO), the U.S. Centers for Disease Control and Prevention (CDC), and 
other partners, is investigating the association between Zika virus 
infection and microcephaly, as well as other adverse pregnancy and 
infant outcomes.
    As part of the public health response to the Zika virus disease 
outbreak, CDC will conduct supplemental surveillance of antenatal 
diagnostic testing and clinical outcomes among pregnant women with 
laboratory evidence of Zika virus or unspecified flavivirus infection 
and their infants through the U.S. Zika Pregnancy Registry. It is 
anticipated that the Registry will provide critical information to 
direct CDC clinical recommendations and public health guidance and 
messages.
    The objective of this Registry is to monitor the frequency and 
types of pregnancy and infant outcomes following Zika virus infection 
during pregnancy, so as to inform ongoing response efforts for this 
Zika virus disease outbreak, including recommendations for clinical 
care, planning for services for pregnant women and infants affected by 
Zika virus, and improved prevention of Zika virus infections during 
pregnancy.
    There are no costs to the respondents other than their time. The 
total estimated annual burden hours are 2,167.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
State, Territorial and Local Health  Maternal Health History                 100              10           30/60
 Departments.                         Form.
                                     Supplemental Imaging Form..             100              10           10/60
                                     Laboratory Results Form....             100              10           15/60
Clinicians and Other Providers.....  Assessment at Delivery Form             100              10           30/60
                                     Infant Health Follow-Up                 100              30           15/60
                                      Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
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. 2016-16872 Filed 7-15-16; 8:45 am]
 BILLING CODE 4163-18-P
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