Proposed Data Collection Submitted for Public Comment and Recommendations, 26231-26234 [2016-10113]

Download as PDF Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices FEDERAL RESERVE SYSTEM Beach, Missouri; Central Bank of Moberly, Moberly, Missouri; Central Bank of Oklahoma, Tulsa, Oklahoma; Central Bank of Sedalia, Sedalia, Missouri; Central Bank of St. Louis, Clayton, Missouri; Central Bank of The Midwest, Lee’s Summit, Missouri; Central Bank of The Ozarks, Springfield, Missouri; Central Bank of Warrensburg, Warrensburg, Missouri; The Central Trust Bank, Jefferson City, Missouri; and Jefferson Bank of Missouri, Jefferson City, Missouri. Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company Board of Governors of the Federal Reserve System, April 27, 2016. Michael J. Lewandowski, Associate Secretary of the Board. percent of the voting shares of Keystone Investment, Inc., and thereby indirectly acquire voting shares of Bank of Keystone, both in Keystone, Nebraska. Board of Governors of the Federal Reserve System, April 27, 2016. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2016–10238 Filed 4–29–16; 8:45 am] srobinson on DSK5SPTVN1PROD with NOTICES BILLING CODE 6210–01–P The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 17, 2016. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. William C. Wetzeler, individually and acting in concert with Carol L. Schultz, Judith K. Nece, and Andrew J. Schultz, all of Spirit Lake, Iowa, to join the Wetzeler Family Control Group; to retain voting shares of State Banco, LTD, and thereby indirectly retain voting shares of The State Bank, both in Spirit Lake, Iowa. B. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166–2034. Comments can also be sent electronically to Comments.applications@stls.frb.org: 1. Robert R. Hermann, Jr., Palm Beach, Florida; as co-trustee of the Central Bancompany Voting Trust; to acquire voting shares of Central Bancompany, Inc., Jefferson City, Missouri, and thereby indirectly acquire voting shares of Central Bank of Audrain County, Mexico, Missouri; Central Bank of Boone County, Columbia, Missouri; Central Bank of Branson, Branson, Missouri; Central Bank of Lake of The Ozarks, Osage VerDate Sep<11>2014 20:30 Apr 29, 2016 Jkt 238001 [FR Doc. 2016–10239 Filed 4–29–16; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 26, 2016. A. Federal Reserve Bank of Cleveland (Nadine Wallman, Vice President) 1455 East Sixth Street, Cleveland, Ohio 44101–2566. Comments can also be sent electronically to Comments.applications@clev.frb.org: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 26231 1. Ohio Valley Banc Corp, Gallipolis, Ohio; to acquire Milton Bancorp, Inc., and thereby indirectly acquire Milton Banking Company, both in Wellston, Ohio. B. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: 1. The First National Bank of Bemidji ESOP & Trust, Bemidji, Minnesota; to acquire additional voting shares, for a total of 36.63 percent, of First Bemidji Holding Company, and thereby indirectly acquire additional voting shares of The First National Bank of Bemidji, both in Bemidji, Minnesota. Board of Governors of the Federal Reserve System, April 26, 2016. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2016–10102 Filed 4–29–16; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–16–16AFR; Docket No. CDC–2016– 0040] 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 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 an information collection request proposal entitled ‘‘Continuing International and Domestic Information Collections from the 2016 Zika Virus Emergency Response.’’ These collections will allow CDC to continue its ongoing response to the Zika virus outbreak. SUMMARY: Written comments must be received on or before July 1, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC–2016– 0040 by any of the following methods: DATES: E:\FR\FM\02MYN1.SGM 02MYN1 26232 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices • Federal eRulemaking Portal: Regulation.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. srobinson on DSK5SPTVN1PROD with NOTICES 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 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, VerDate Sep<11>2014 20:30 Apr 29, 2016 Jkt 238001 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 Continuing International and Domestic Information Collections from the 2016 Zika Virus Emergency Response—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 Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. Since then, CDC has been responding to increased reports of Zika and has assisted in investigations with PAHO and the Brazil Ministry of Health. The first regional travel notices for Zika in South America and Mexico were posted in December 2015. In December 2015, the Commonwealth of Puerto Rico, a United States territory, reported its first confirmed locally transmitted Zika virus case. Cases of local transmission have recently been confirmed in two other US territories, the United States Virgin Islands and American Samoa. As of April 6, 2016, US territories had reported 351 locally acquired Zika cases and 3 travel-associated Zika cases to CDC. Of the 354 cases reported, 37 were in pregnant women. Zika has not been spread by mosquitoes in the continental United States. However, lab tests have confirmed Zika virus in travelers returning to the United States. These travelers have gotten the virus from mosquito bites and a few non-travelers got Zika through sex. With the recent outbreaks in the Americas, the number of Zika cases among travelers visiting or returning to the United States is increasing. CDC monitors and reports to the public cases of Zika, which will help improve our understanding of how and where Zika is spreading. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito (A. aegypti and A. albopictus). Mosquitoes that spread Zika virus are aggressive daytime biters, but they can also bite at night. A pregnant woman can pass Zika virus to her fetus during pregnancy. CDC is studying how Zika affects pregnancies. Zika is linked to microcephaly, a severe birth defect that is a sign of incomplete brain development. Microcephaly is a condition where a baby’s head is much smaller than expected. During pregnancy, a baby’s head grows because the baby’s brain grows. Microcephaly can occur because a baby’s brain has not developed properly during pregnancy or has stopped growing after birth. In February and March 2016, CDC used OMB emergency clearance procedures to initiate and expedite multiple urgently needed information collections in American Samoa, Puerto Rico, Brazil, and domestically within state, tribal, local, and territorial (STLT) jurisdictions. These procedures have allowed the agency to target and refine public health interventions to arrest ongoing spread of infection. With this notice, the CDC is announcing its intention to seek OMB clearances to continue four Zika-related information collections beyond their current emergency expiration dates. These four projects will be submitted to OMB as standalone ICRs: 1. A call center in CDC’s Emergency Operations Center (EOC) to respond to inquiries on clinical care of persons potentially of interest for Zika virus infection [OMB Control No. 0920–1101, expiration date 8/31/16]. Respondents to this information collection include the general public, clinicians, and employees at STLT health departments. The purpose of this information collection is to document and track clinical inquiries made to the CDC EOC call center and to systematically collect standardized clinical/demographic/ epidemiological information about suspected cases. The emergency clearance for this information collection dealt specifically with Zika-related clinical inquiries. However, the new ICR will cover this project for any EOC activation. Regardless of the disease or hazard being responded to, the EOC operates this call center to answer and respond to clinical inquiries. This information collection is a necessary part of operating this call center and responding to emergency situations. 2. A study, in Puerto Rico, on the persistence of Zika virus in bodily fluids [OMB Control No. 0920–1106, expiration date 9/30/16]. Since getting OMB approval in March 2016, CDC has E:\FR\FM\02MYN1.SGM 02MYN1 26233 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices investigated the persistence of Zika virus in different body fluids (shedding) and its relation to immune response to provide a basis for development of nonblood-based diagnostic tools, and target and refine public health interventions to arrest ongoing spread of infection. CDC has begun a prospective cohort study of symptomatic individuals with reverse transcription-polymerase chain reaction (RT–PCR) positive Zika virus infection and a cross-sectional study of their household contacts. Information collection is expected to conclude within one year. Results and analyses will be used to update relevant counseling messages and recommendations from the CDC. Participants for the shedding study are patients with laboratory-confirmed Zika virus infection and their household contacts. 3. A study, carried out in the United States, on the persistence of Zika virus in the semen and urine of men with laboratory-confirmed Zika virus infection [OMB Control No. 0920–1109, expiration date 9/30/2016]. Since getting emergency OMB approval in March, 2016, specimens have been tested for Zika RNA by reverse 0920–1101, expiration date 8/31/16]. As part of the public health response to the Zika virus disease outbreak, CDC has been collecting information from clinicians in the U.S. about pregnant women they treat who are diagnosed with Zika virus infection. CDC also plans to collect information from clinicians about their patients’ infants in order to better understand the clinical consequences of Zika virus infection in pregnancy and its impact on newborn infants. Information gathered directs public health messages provided by CDC on reducing the risk of adverse outcomes for pregnant women and their infants. These information collections will align with their legislative authority, Section 301 of the Public Health Service Act (42 U.S.C. 241). There are no costs to the respondents other than their time. The total annualized burden requested is 1,146 hours. This number represents the number of burden hours yet to be imposed. It does not include the burden hours sustained during the initial sixmonth emergency clearance period. 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 are recruited through contact with CDC personnel. Urine and semen specimens are selfcollected using home collection kits, a short questionnaire is self-administered, and participants receive a token of appreciation. 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. 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. 4. Registry of pregnant women with laboratory-confirmed Zika virus infections in the U.S. [OMB Control No. ESTIMATED ANNUALIZED BURDEN HOURS 1—CLINICAL INQUIRIES DATABASE Number of respondents Number of responses per respondent Avg. burden per response (in hrs.) Total burden (in hrs.) Type of respondents Form name Local health departments ................. Clinicians and other providers .......... Clinical inquiries database ............... Clinical inquiries database ............... 420 800 1 1 15/60 15/60 105 200 Total ........................................... ........................................................... ........................ ........................ ........................ 305 2—PERSISTENCE OF ZIKA VIRUS IN BODILY FLUIDS STUDY, PUERTO RICO Number of respondents Number of responses per respondent Avg. burden per response (in hrs.) Total burden (in hrs.) Type of respondents Form name Public health personnel ..................... 200 600 8 1 10/60 10/60 267 100 General public ................................... Questionnaire (Symptomatics) .......... Questionnaire (Cross-Sectional household contacts). Eligibility Form ................................... 1,000 1 2/60 33 Total ............................................ ............................................................ ........................ ........................ ........................ 400 3—PERSISTENCE OF ZIKA VIRUS IN BODILY FLUIDS STUDY, UNITED STATES Number of respondents Number of responses per respondent Avg. burden per response (in hrs.) Total burden (in hrs.) srobinson on DSK5SPTVN1PROD with NOTICES Type of respondents Form name General public ................................... Introductory survey ............................ Follow-Up survey ............................... 175 175 1 12 2/60 1/60 6 35 Total ............................................ ............................................................ ........................ ........................ ........................ 41 VerDate Sep<11>2014 20:30 Apr 29, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\02MYN1.SGM 02MYN1 26234 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices 4—PREGNANCY REGISTRY Number of respondents Number of responses per respondent Avg. burden per response (in hrs.) Total burden (in hrs.) Type of respondents Form name State and Local Health Departments Maternal Health History Form ........... Specimen Collection Form ................ Assessment at Delivery Form ........... Infant Health Follow-Up Form ........... 100 100 100 100 5 1 1 1 30/60 15/60 30/60 30/60 250 25 50 50 ............................................................ ........................ ........................ ........................ 400 Clinicians and other providers ........... 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. 2016–10113 Filed 4–29–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–R–131 and CMS–R–244] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by June 1, 2016. srobinson on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:30 Apr 29, 2016 Jkt 238001 When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806 OR, Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. 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 Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: ADDRESSES: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Advance Beneficiary Notice of Noncoverage (ABN); Use: The Advance Beneficiary Notice (ABN) is delivered by Part B paid physicians, providers (including institutional providers like outpatient hospitals), practitioners (such as chiropractors), and suppliers, as well as hospice providers and Religious Nonmedical Health Care Institutions paid under Part A. Home health agencies providing items and services under Part A or Part B also use the ABN. Other Medicare institutional providers paid under Part A use other approved notices for this purpose. With this PRA submission, minimal formatting changes have been made to the ABN form, including the addition of language informing beneficiaries of their rights under Section 504 of the Rehabilitation Act of 1973 (Section 504) by alerting the beneficiary to CMS’s nondiscrimination practices and the availability of alternate forms of this notice, if needed. Additionally, minor language and grammatical changes have been made to the form’s instructions to improve provider/supplier comprehension and decrease the probability of errors in completing the ABN. There are no substantive changes to the form or to the instructions. Form Number: CMS–R– 131 (OMB control number: 0938–0566); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 1,540,850; Total Annual Responses: 63,601,300; Total Annual Hours: 7,420,364. (For policy questions regarding this collection contact Evelyn Blaemire at 410–786–1803.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: The PACE Organization (PO) Application Process in 42 CFR part 460; Use: In general, Programs of All-Inclusive Care for the Elderly (PACE) services are provided through a PO. An entity wishing to E:\FR\FM\02MYN1.SGM 02MYN1

Agencies

[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26231-26234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AFR; Docket No. CDC-2016-0040]


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 an information 
collection request proposal entitled ``Continuing International and 
Domestic Information Collections from the 2016 Zika Virus Emergency 
Response.'' These collections will allow CDC to continue its ongoing 
response to the Zika virus outbreak.

DATES: Written comments must be received on or before July 1, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0040 by any of the following methods:

[[Page 26232]]

     Federal eRulemaking Portal: Regulation.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 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

    Continuing International and Domestic Information Collections from 
the 2016 Zika Virus Emergency Response--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 Pan American Health Organization (PAHO) issued an 
alert regarding the first confirmed Zika virus infections in Brazil. 
Since then, CDC has been responding to increased reports of Zika and 
has assisted in investigations with PAHO and the Brazil Ministry of 
Health. The first regional travel notices for Zika in South America and 
Mexico were posted in December 2015. In December 2015, the Commonwealth 
of Puerto Rico, a United States territory, reported its first confirmed 
locally transmitted Zika virus case. Cases of local transmission have 
recently been confirmed in two other US territories, the United States 
Virgin Islands and American Samoa. As of April 6, 2016, US territories 
had reported 351 locally acquired Zika cases and 3 travel-associated 
Zika cases to CDC. Of the 354 cases reported, 37 were in pregnant 
women. Zika has not been spread by mosquitoes in the continental United 
States. However, lab tests have confirmed Zika virus in travelers 
returning to the United States. These travelers have gotten the virus 
from mosquito bites and a few non-travelers got Zika through sex. With 
the recent outbreaks in the Americas, the number of Zika cases among 
travelers visiting or returning to the United States is increasing. CDC 
monitors and reports to the public cases of Zika, which will help 
improve our understanding of how and where Zika is spreading.
    Zika virus is spread to people primarily through the bite of an 
infected Aedes species mosquito (A. aegypti and A. albopictus). 
Mosquitoes that spread Zika virus are aggressive daytime biters, but 
they can also bite at night. A pregnant woman can pass Zika virus to 
her fetus during pregnancy. CDC is studying how Zika affects 
pregnancies. Zika is linked to microcephaly, a severe birth defect that 
is a sign of incomplete brain development. Microcephaly is a condition 
where a baby's head is much smaller than expected. During pregnancy, a 
baby's head grows because the baby's brain grows. Microcephaly can 
occur because a baby's brain has not developed properly during 
pregnancy or has stopped growing after birth.
    In February and March 2016, CDC used OMB emergency clearance 
procedures to initiate and expedite multiple urgently needed 
information collections in American Samoa, Puerto Rico, Brazil, and 
domestically within state, tribal, local, and territorial (STLT) 
jurisdictions. These procedures have allowed the agency to target and 
refine public health interventions to arrest ongoing spread of 
infection.
    With this notice, the CDC is announcing its intention to seek OMB 
clearances to continue four Zika-related information collections beyond 
their current emergency expiration dates. These four projects will be 
submitted to OMB as standalone ICRs:
    1. A call center in CDC's Emergency Operations Center (EOC) to 
respond to inquiries on clinical care of persons potentially of 
interest for Zika virus infection [OMB Control No. 0920-1101, 
expiration date 8/31/16]. Respondents to this information collection 
include the general public, clinicians, and employees at STLT health 
departments. The purpose of this information collection is to document 
and track clinical inquiries made to the CDC EOC call center and to 
systematically collect standardized clinical/demographic/
epidemiological information about suspected cases. The emergency 
clearance for this information collection dealt specifically with Zika-
related clinical inquiries. However, the new ICR will cover this 
project for any EOC activation. Regardless of the disease or hazard 
being responded to, the EOC operates this call center to answer and 
respond to clinical inquiries. This information collection is a 
necessary part of operating this call center and responding to 
emergency situations.
    2. A study, in Puerto Rico, on the persistence of Zika virus in 
bodily fluids [OMB Control No. 0920-1106, expiration date 9/30/16]. 
Since getting OMB approval in March 2016, CDC has

[[Page 26233]]

investigated the persistence of Zika virus in different body fluids 
(shedding) and its relation to 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. CDC 
has begun a prospective cohort study of symptomatic individuals with 
reverse transcription-polymerase chain reaction (RT-PCR) positive Zika 
virus infection and a cross-sectional study of their household 
contacts. Information collection is expected to conclude within one 
year. Results and analyses will be used to update relevant counseling 
messages and recommendations from the CDC. Participants for the 
shedding study are patients with laboratory-confirmed Zika virus 
infection and their household contacts.
    3. A study, carried out in the United States, on the persistence of 
Zika virus in the semen and urine of men with laboratory-confirmed Zika 
virus infection [OMB Control No. 0920-1109, expiration date 9/30/2016]. 
Since getting emergency OMB approval in March, 2016, specimens have 
been 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 are recruited through 
contact with CDC personnel. Urine and semen specimens are self-
collected using home collection kits, a short questionnaire is self-
administered, and participants receive a token of appreciation. 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. 
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.
    4. Registry of pregnant women with laboratory-confirmed Zika virus 
infections in the U.S. [OMB Control No. 0920-1101, expiration date 8/
31/16]. As part of the public health response to the Zika virus disease 
outbreak, CDC has been collecting information from clinicians in the 
U.S. about pregnant women they treat who are diagnosed with Zika virus 
infection. CDC also plans to collect information from clinicians about 
their patients' infants in order to better understand the clinical 
consequences of Zika virus infection in pregnancy and its impact on 
newborn infants. Information gathered directs public health messages 
provided by CDC on reducing the risk of adverse outcomes for pregnant 
women and their infants.
    These information collections will align with their legislative 
authority, Section 301 of the Public Health Service Act (42 U.S.C. 
241).
    There are no costs to the respondents other than their time. The 
total annualized burden requested is 1,146 hours. This number 
represents the number of burden hours yet to be imposed. It does not 
include the burden hours sustained during the initial six-month 
emergency clearance period.

                                        Estimated Annualized Burden Hours
                                         1--Clinical Inquiries Database
----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg. burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Local health departments......  Clinical                     420               1           15/60             105
                                 inquiries
                                 database.
Clinicians and other providers  Clinical                     800               1           15/60             200
                                 inquiries
                                 database.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             305
----------------------------------------------------------------------------------------------------------------


                        2--Persistence of Zika Virus in Bodily Fluids Study, Puerto Rico
----------------------------------------------------------------------------------------------------------------
                                                                       Number of      Avg. burden
      Type of respondents            Form name         Number of     responses per   per response   Total burden
                                                      respondents     respondent       (in hrs.)      (in hrs.)
----------------------------------------------------------------------------------------------------------------
Public health personnel........  Questionnaire                 200               8           10/60           267
                                  (Symptomatics).
                                 Questionnaire                 600               1           10/60           100
                                  (Cross-Sectional
                                  household
                                  contacts).
General public.................  Eligibility Form.           1,000               1            2/60            33
                                                   -------------------------------------------------------------
    Total......................  .................  ..............  ..............  ..............           400
----------------------------------------------------------------------------------------------------------------


                       3--Persistence of Zika Virus in Bodily Fluids Study, United States
----------------------------------------------------------------------------------------------------------------
                                                                       Number of      Avg. burden
      Type of respondents            Form name         Number of     responses per   per response   Total burden
                                                      respondents     respondent       (in hrs.)      (in hrs.)
----------------------------------------------------------------------------------------------------------------
General public.................  Introductory                  175               1            2/60             6
                                  survey.
                                 Follow-Up survey.             175              12            1/60            35
                                                   -------------------------------------------------------------
    Total......................  .................  ..............  ..............  ..............            41
----------------------------------------------------------------------------------------------------------------


[[Page 26234]]


                                              4--Pregnancy Registry
----------------------------------------------------------------------------------------------------------------
                                                                       Number of      Avg. burden
      Type of respondents            Form name         Number of     responses per   per response   Total burden
                                                      respondents     respondent       (in hrs.)      (in hrs.)
----------------------------------------------------------------------------------------------------------------
State and Local Health           Maternal Health               100               5           30/60           250
 Departments.                     History Form.
                                 Specimen                      100               1           15/60            25
                                  Collection Form.
Clinicians and other providers.  Assessment at                 100               1           30/60            50
                                  Delivery Form.
                                 Infant Health                 100               1           30/60            50
                                  Follow-Up Form.
                                                   -------------------------------------------------------------
    Total......................  .................  ..............  ..............  ..............           400
----------------------------------------------------------------------------------------------------------------


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. 2016-10113 Filed 4-29-16; 8:45 am]
 BILLING CODE 4163-18-P
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