80 FR 67757 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 212 (November 3, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 212 (November 3, 2015)
| Page Range | 67757-67759 | |
| FR Document | 2015-27888 |
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)] [Notices] [Pages 67757-67759] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27888] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-15AEZ] 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 [[Page 67758]] instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC provides guidelines for HIV testing and diagnosis for the United States, as well as technical guidance for its grantees. CDC will use the HIV testing data collected for this project to update these guidance documents to reflect the latest available testing technologies, their performance characteristics, and considerations regarding their use. Specifically, CDC will describe the information on behavioral and clinical characteristics of persons with early infection to help HIV test providers (including CDC grantees) choose which HIV tests to use and target tests appropriately to persons at different levels of risk. This information will primarily be disseminated through guidance documents (and articles in peer-reviewed journals). The primary study population will be persons at high risk for or diagnosed with HIV infection, many of whom will be men who have sex with men (MSM) because the majority of new HIV infections occur each year among this population. The goals of the project are to: (1) Characterize the performance of new HIV tests for detecting established and early HIV infection at the point of care, relative to each other and to currently used gold standard, non-POC tests, and (2) identify behavioral and clinical predictors of early HIV infection. Project DETECT will enroll 1,667 persons annually at the primary study site clinic in Seattle, and an additional 200 persons will be enrolled from other clinics in the greater Seattle area. The study will be conducted in two phases. Phase 1: After a clinic client consents to participate, he/she will be assigned a unique participant ID and will then undergo testing with the 7 new HIV tests under study. While awaiting test results, participants will undergo additional specimen collections and complete the Phase 1 Enrollment Survey. Phase 2: All Phase 1 participants whose results on the 7 tests under investigation are not in agreement with one another (``discordant'') will be considered to have a potential early HIV infection. Nucleic amplification testing that detects viral nucleic acids will be conducted to confirm an HIV diagnosis and rule out false positives. Study investigators expect that each year, 50 participants with discordant test results will be invited to participate in serial follow-up specimen collections to assess the time point at which all HIV test results resolve and become concordant positive (indicating enrollment during early infection) or concordant negative (indicating one or more false-positive test results in Phase 1). The follow-up schedule will consist of up to nine visits scheduled at regular intervals over a 70-day period. At each follow-up visit, participants will be tested with the new HIV tests and additional oral fluid and blood specimens will also be collected for storage and use in future HIV test evaluations at CDC. Participants will be followed up only to the point at which all their test results become concordant. At each time point, participants will be asked to complete the Phase 2 HIV Symptom and Care survey that collects information on symptoms associated with early HIV infection as well as access to HIV care and treatment since the last Phase 2 visit. When all tests become concordant (i.e., at the last Phase 2 visit) participants will complete the Phase 2 behavioral survey to identify any behavioral changes during follow-up. Of the 50 Phase 2 participants, it is estimate that no more than 26 annually will have early HIV infection. All data for the proposed information collection will be collected via an electronic Computer Assisted Self-Interview (CASI) survey. Participants will complete the surveys on an encrypted computer, with the exception of the Phase 2 Symptom and Care survey, which will be administered by a research assistant and then electronically entered into the CASI system. Data to be collected via CASI include questions on socio-demographics, medical care, HIV testing, pre-exposure prophylaxis, antiretroviral treatment, sexually transmitted disease (STD) history, symptoms of early HIV infection, substance use and sexual behavior. Data from the surveys will be merged with HIV test results and relevant clinical data using the unique ID number. Data will be stored on a secure server managed by the University of Washington Department of Medicine IT Services. The participation of respondents is voluntary. There is no cost to the respondents other than their time. The total annual burden hours are 2,110. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hrs.) ---------------------------------------------------------------------------------------------------------------- Persons eligible for study............ Phase 1 Consent......... 2,334 1 15/60 Enrolled participants................. Phase 1 Enrollment 1,667 1 45/60 Survey A. Phase 1 Enrollment 200 1 60/60 Survey B. Phase 2 Consent......... 50 1 15/60 Phase 2 HIV Symptom and 50 9 5/60 Care Survey. Phase 2 Behavioral 50 1 30/60 Survey. ---------------------------------------------------------------------------------------------------------------- [[Page 67759]] 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. 2015-27888 Filed 11-2-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices 67757
EARLY TERMINATIONS GRANTED—Continued
MARCH 1, 2015 THRU SEPTEMBER 30, 2015
20151664 ...... G KKR Asian Fund II Japan AIV L.P.; Bayer AG; KKR Asian Fund II Japan AIV L.P.
20151666 ...... G Amicus Therapeutics, Inc.; Scioderm, Inc.; Amicus Therapeutics, Inc.
20151701 ...... G JLL Partners Fund VII, L.P.; ATS Parent Co., Inc.; JLL Partners Fund VII, L.P.
20151713 ...... G Group 1 Automotive, Inc.; Garlyn O. Shelton 2005 Trust; Group 1 Automotive, Inc.
20151714 ...... G Group 1 Automotive, Inc.; Faye LaJuan Shelton 2005 Trust; Group 1 Automotive, Inc.
09/24/2015
20151195 ...... S Endo International plc; TPG Partners VI, LP; Endo International plc.
20151626 ...... G Carlyle Partners VI, L.P.; Arlington Capital Partners II, L.P.; Carlyle Partners VI, L.P.
20151676 ...... G Hexagon AB; EcoSys Management LLC; Hexagon AB.
20151718 ...... G William H. Gates III; OCI N.V.; William H. Gates III.
09/25/2015
20151620 ...... G LCP VIII (AIV I), L.P.; Johnson Controls Inc.; LCP VIII (AIV I), L.P.
20151720 ...... G General Atlantic Partners 93, L.P.; Avant, Inc.; General Atlantic Partners 93, L.P.
20151721 ...... G Berkshire Fund VIII, L.P.; American Capital Equity III, LP; Berkshire Fund VIII, L.P.
20151722 ...... G ABRY Partners VIII, L.P.; Altaris Health Partners II, L.P.; ABRY Partners VIII, L.P.
20151725 ...... G Devon Energy Corporation; Matador Resources Company; Devon Energy Corporation.
20151727 ...... G FC Trident, LLC; Sentinel Capital Partners IV, L.P.; FC Trident, LLC.
20151738 ...... G XPO Logistics, Inc.; Con-way Inc.; XPO Logistics, Inc.
20151755 ...... G ArcLight Energy Partners Fund VI, L.P.; HOVENSA L.L.C.; ArcLight Energy Partners Fund VI, L.P.
09/28/2015
20151697 ...... G Sumitomo Life Insurance Company; Symetra Financial Corporation; Sumitomo Life Insurance Company.
20151715 ...... G Sanchez Production Partners LP; Sanchez Energy Corporation; Sanchez Production Partners LP.
20151732 ...... G Dot Foods, Inc.; Grabber Construction Products, Inc. Employee Stock Option; Dot Foods, Inc.
20151736 ...... G Flowers Foods, Inc.; Todd C. and Andrea C. Wood; Flowers Foods, Inc.
20151748 ...... G LCP VIII (AIV I), L.P.; Clearview Capital Fund II L.P.; LCP VIII (AIV I), L.P.
09/29/2015
20150271 ...... S Tornier N.V.; Wright Medical Group, Inc.; Tornier N.V.
20151728 ...... G C.L. de Carvalho-Heineken; LBC Founders LLC; C.L. de Carvalho-Heineken.
20151731 ...... G Verizon Communication Inc.; Millennial Media, Inc.; Verizon Communication Inc.
09/30/2015
20151200 ...... G Cox Family Voting Trust u/a/d 7/26/13; Dealertrack Technologies, Inc.; Cox Family Voting Trust u/a/d 7/26/13.
20151410 ...... G ACE Limited; The Chubb Corporation; ACE Limited.
20151729 ...... G Diane M. Hendricks; Compagnie De Saint-Gobain; Diane M. Hendricks.
FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND following: (a) Evaluate whether the
Theresa Kingsberry, Program Support HUMAN SERVICES proposed collection of information is
Specialist, Federal Trade Commission necessary for the proper performance of
Premerger Notification Office, Bureau of Centers for Disease Control and the functions of the agency, including
Competition, Room CC–5301, Prevention whether the information will have
Washington, DC 20024, (202) 326–3100. practical utility; (b) Evaluate the
[30Day–15–15AEZ]
accuracy of the agencies estimate of the
By direction of the Commission. burden of the proposed collection of
Agency Forms Undergoing Paperwork
Donald S. Clark, information, including the validity of
Reduction Act Review
Secretary. the methodology and assumptions used;
[FR Doc. 2015–27992 Filed 11–2–15; 8:45 am] The Centers for Disease Control and (c) Enhance the quality, utility, and
BILLING CODE 6750–01–P
Prevention (CDC) has submitted the clarity of the information to be
following information collection request collected; (d) Minimize the burden of
to the Office of Management and Budget the collection of information on those
(OMB) for review and approval in who are to respond, including through
accordance with the Paperwork the use of appropriate automated,
Reduction Act of 1995. The notice for electronic, mechanical, or other
mstockstill on DSK4VPTVN1PROD with NOTICES
the proposed information collection is technological collection techniques or
published to obtain comments from the other forms of information technology,
public and affected agencies. e.g., permitting electronic submission of
Written comments and suggestions responses; and (e) Assess information
from the public and affected agencies collection costs.
concerning the proposed collection of To request additional information on
information are encouraged. Your the proposed project or to obtain a copy
comments should address any of the of the information collection plan and
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![Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices 67759
Leroy A. Richardson, technological collection techniques or time, CDC also initiated its new CDC
Chief, Information Collection Review Office, other forms of information technology, Surveillance Strategy. These actions
Office of Scientific Integrity, Office of the e.g., permitting electronic submission of provided new guidance for
Associate Director for Science, Office of the responses; and (e) Assess information improvements to the BioSense Program,
Director, Centers for Disease Control and collection costs. which resulted in new requirements for
Prevention. To request additional information on data submission to the BioSense
[FR Doc. 2015–27888 Filed 11–2–15; 8:45 am] the proposed project or to obtain a copy Platform and new requests specified
BILLING CODE 4163–18–P of the information collection plan and below.
instruments, call (404) 639–7570 or CDC requests a three-year Revision
send an email to omb@cdc.gov. Written approval for BioSense. This Revision
DEPARTMENT OF HEALTH AND comments and/or suggestions regarding
HUMAN SERVICES includes new requests for approval to:
the items contained in this notice (1) Change the title of the information
should be directed to the Attention: collection request from BioSense to the
Centers for Disease Control and CDC Desk Officer, Office of Management
Prevention National Syndromic Surveillance
and Budget, Washington, DC 20503 or Program (NSSP); (2) receive data from
[30Day–16–0824] by fax to (202) 395–5806. Written additional state, local, and territorial
comments should be received within 30 health departments; (3) receive from
Agency Forms Undergoing Paperwork days of this notice. state, local, and territorial health
Reduction Act Review departments syndromic surveillance
Proposed Project
The Centers for Disease Control and BioSense (OMB Control No. 0920– data submitted to those health
Prevention (CDC) has submitted the 0824, Expiration 11/30/2015)— departments from urgent care,
following information collection request Revision—Center for Surveillance, ambulatory care and hospital inpatient
to the Office of Management and Budget Epidemiology and Laboratory Services settings (in addition to data from
(OMB) for review and approval in (CSELS), Centers for Disease Control hospital emergency departments,
accordance with the Paperwork and Prevention (CDC). included in the previously approved
Reduction Act of 1995. The notice for information collection request); and (4)
the proposed information collection is Background and Brief Description receive from state, local, and territorial
published to obtain comments from the The BioSense Program was created by health departments additional
public and affected agencies. congressional mandate as part of the syndromic surveillance data elements.
Written comments and suggestions Public Health Security and Bioterrorism The total estimated number of burden
from the public and affected agencies Preparedness and Response Act of 2002 hours has decreased since the
concerning the proposed collection of and was launched by the CDC in 2003. previously approved information
information are encouraged. Your The original BioSense Program collection request because we
comments should address any of the (BioSense 1.0) was intended to serve as inadvertently included estimates for the
following: (a) Evaluate whether the a national level public health syndromic Department of Defense, Department of
proposed collection of information is surveillance system for early detection Veterans Affairs, and the two
necessary for the proper performance of and rapid assessment of potential organizations that provide pharmacy
the functions of the agency, including bioterrorism-related illness and injury. data. We only included estimates for
whether the information will have In 2009, CDC began planning and state, local, and territorial public health
practical utility; (b) Evaluate the developing the computing cloud-based jurisdictions and the private sector
accuracy of the agencies estimate of the BioSense 2.0 Platform. This cloud-based laboratory company that provides
burden of the proposed collection of system would offer secure storage space laboratory data free of charge to CDC in
information, including the validity of for data and data sharing capacity for this information collection request.
the methodology and assumptions used; each state and local health department. There is no burden for the private sector
(c) Enhance the quality, utility, and Since August 2012, when CDC laboratory company for recruitment,
clarity of the information to be submitted a request to OMB for registration, and healthcare data
collected; (d) Minimize the burden of approval of a revision to the BioSense collection. The private sector laboratory
the collection of information on those information collection request, HHS company chose their sharing
who are to respond, including through published new guidance on Meaningful permissions when they registered to use
the use of appropriate automated, Use of Electronic Health Records for the system. The estimated annual
electronic, mechanical, or other syndromic surveillance. During this burden is 39 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
State, Local and Territorial Public Health Departments Recruitment Information Collection 20 1 1
State, Local and Territorial Public Health Departments Registration Information Collection 200 1 5/60
State, Local, and Territorial Public Health Departments Healthcare Information Collection: 20 1 5/60
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Administrator Data Sharing
Agreements/Permissions.
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Document Created: 2018-03-01 11:32:13
Document Modified: 2018-03-01 11:32:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 67757 |
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