A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period, 25289-25290 [2017-11292]

Download as PDF Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Notice May 29, 2017. 10:00 a.m., Wednesday, June 14, 2017. PLACE: The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance). STATUS: Open. MATTERS TO BE CONSIDERED: The Commission will hear oral argument in the matter Secretary of Labor v. Lehigh Anthracite Coal, LLC, et al., Docket Nos. PENN 2014–108, et al. (Issues include whether the Judge erred in concluding that sending a miner into the pit in question constituted ‘‘high negligence’’ rather than reckless disregard’’). Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d). CONTACT PERSON FOR MORE INFO: Emogene Johnson (202) 434–9935/(202) 708–9300 for TDD Relay/1–800–877– 8339 for toll free. TIME AND DATE: PHONE NUMBER FOR LISTENING TO ARGUMENT: 1 (866) 867–4769, Passcode: 678–100. Sarah L. Stewart, Deputy General Counsel. [FR Doc. 2017–11470 Filed 5–30–17; 4:15 pm] BILLING CODE 6735–01–P FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Notice May 29, 2017. 10:00 a.m., Thursday, July 13, 2017. (This meeting had originally been scheduled for June 15, 2017). PLACE: The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance). STATUS: Open. MATTERS TO BE CONSIDERED: The Commission will consider and act upon the following in open session: Secretary of Labor v. Pocahontas Coal Company, LLC, Docket Nos. WEVA 2014–395–R, et al. (Issues include whether the Judge erred in concluding that MSHA had established that a pattern of violations existed at the operator’s mine). mstockstill on DSK30JT082PROD with NOTICES TIME AND DATE: VerDate Sep<11>2014 18:32 May 31, 2017 Jkt 241001 Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d). CONTACT PERSON FOR MORE INFO: Emogene Johnson (202) 434–9935/(202) 708–9300 for TDD Relay/1–800–877– 8339 for toll free. PHONE NUMBER FOR LISTENING TO MEETING: 1–(866) 867–4769, Passcode: 678–100. Sarah L. Stewart, Deputy General Counsel. [FR Doc. 2017–11467 Filed 5–30–17; 4:15 pm] BILLING CODE 6735–01–P GULF COAST ECOSYSTEM RESTORATION COUNCIL [Docket No.: 106012017–1111–13] Notice of Proposed Subaward Under a Council-Selected Restoration Component Award Gulf Coast Ecosystem Restoration Council. ACTION: Notice. AGENCY: The Gulf Coast Ecosystem Restoration Council (Council) publishes notice of a proposed subaward from the Texas Commission on Environmental Quality (TCEQ) to the Houston Parks Board (HPB), a nonprofit organization, for the purpose of acquiring multiple properties in along the Clear Creek Greenway as part of the larger Bayou Greenways Initiative in accordance with the Bayou Greenways Planning and Implementation Award as approved in the Initial Funded Priority List. FOR FURTHER INFORMATION CONTACT: Please send questions by email to raams_pgmsupport@restorethegulf.gov. SUPPLEMENTARY INFORMATION: Section 1321(t)(2)(E)(ii)(III) of the RESTORE Act (33 U.S.C. 1321(t)(2)(E)(ii)(III)) and Treasury’s implementing regulation at 31 CFR 34.401(b) require that, for purposes of awards made under the Council-Selected Restoration Component, a State or Federal award recipient may make a grant or subaward to or enter into a cooperative agreement with a nongovernmental entity that equals or exceeds 10 percent of the total amount of the award provided to the State or Federal award recipient only if certain notice requirements are met. Specifically, at least 30 days before the State or Federal award recipient enters into such an agreement, the Council must publish in the Federal Register SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 25289 and deliver to specified Congressional Committees the name of the recipient and subrecipient; a brief description of the activity, including its purpose; and the amount of the award. This notice accomplishes the Federal Register requirement. Description of Proposed Action As specified in the Initial Funded Priority List, which is available on the Council’s Web site at https:// www.restorethegulf.gov/councilselected-restoration-component/fundedpriorities-list, RESTORE Act funds in the amount of $7,109,000 will support the Bayou Greenways Planning and Implementation Award (Bayou Greenways Award) to TCEQ. TCEQ will provide a subaward in the amount of $7,085,022 to HPB to purchase and conserve approximately 80 to 100 acres of land through fee title acquisition from willing sellers. HPB intends to transfer title of acquired lands to the Houston Parks and Recreation Department for preservation in perpetuity as parkland. The subaward will contribute to the Bayou Greenways Initiative’s long-term goal of preserving and restoring nearly 4,000 acres of riparian buffer corridors along the major waterways (bayous and creeks) running predominately through Harris County and the City of Houston. These waterways are connected to a region known as the Trinity-San Jacinto Estuary (Galveston Bay)—the largest watershed in Texas. Through the Bayou Greenways Initiative, HPB has partnered with the City of Houston and the Harris County Flood Control District to preserve, restore and provide public access these important ecological assets in the 4th largest city in the nation. Will D. Spoon, Program Analyst, Gulf Coast Ecosystem Restoration Council. [FR Doc. 2017–11309 Filed 5–31–17; 8:45 am] BILLING CODE 6560–58–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC–2016–0090; Docket Number NIOSH 288–A] A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease AGENCY: E:\FR\FM\01JNN1.SGM 01JNN1 25290 Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice and extension of comment period. On September 15, 2016 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register announcing a public meeting and request for public comment on a draft testing protocol. Written comments were to be received by December 7, 2016. NIOSH initially extended the public comment period to June 7, 2017 [81 FR 88687]. NIOSH is extending the public comment period for a second time to August 30, 2017. The longer timeframe will allow companies to test the protocol with the proposed challenge agents. FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Alice Hamilton Laboratories, 1090 Tusculum Avenue, MS–R–5, Cincinnati, Ohio 45226, telephone (513) 841–4141 (not a toll free number), Email: DHirst@ cdc.gov. SUMMARY: You may submit comments, identified by CDC–2016–0090 and Docket Number NIOSH 288–A, by either of the following two methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C–34, Cincinnati, Ohio 45226–1998. ADDRESSES: John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2017–11292 Filed 5–31–17; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–17–0263] mstockstill on DSK30JT082PROD with NOTICES 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 VerDate Sep<11>2014 18:32 May 31, 2017 Jkt 241001 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 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 Requirements for the Importation of Nonhuman Primates into the United States (OMB Control No. 0920–0263; Expiration Date 09/30/2017)— Revision—National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC). Background and Brief Description Under the 42 CFR 71.53, CDC collects information pertaining to importers and imported nonhuman primates. This information collection enables CDC to evaluate compliance with pre-arrival of shipment notification requirements, to investigate the number and species of imported nonhuman primates, and to determine if adequate measures being taken for the prevention of exposure to persons and animals during importation. Since May 1990, CDC has monitored the arrival and/or uncrating of certain shipments of non-human primates PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 imported in to the United States. In February 2013, CDC promulgated two regulations pertaining to the importation of nonhuman primates. The first rule, Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples, outlines a process by which importers can send liver tissues to CDC from primates that die during importation from reasons other than trauma (78 FR 9828, February 12, 2013). CDC performs these tests due to the absence of a private sector option. The second rule, Requirements for Importers of Nonhuman Primates, consolidates into 42 CFR 71.53 the requirements previously found in 42 CFR 71.53 with those found in the Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (78 FR 11522, February 15, 2013). It also rescinded the six-month special-permit requirements for cynomolgus, African green, and rhesus monkeys and extended the time period for registration/permit renewal from 180 days to 2 years, reducing much of the respondent burden. CDC feels these regulatory changes and reporting requirements balance the public health risks posed by the importation of nonhuman primates with the burden imposed on regulating their importation. Based on the number of registered importers and the number of filovirus samples processed by CDC, CDC is adjusting downward the number of burden hours for the following collections: • Recordkeeping and reporting requirements for importing NHPs: Notification of shipment arrival 71.53(n) (no form): Reduction of two hours. • Quarantine release 71.53(l) (No form): Reduction of two hours. • 71.53(v): Form: Filovirus Diagnostic Specimen Submission Form for Nonhuman Primate Materials: Reduction of 17 hours. • 71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (Registered Importer): Reduction of one hour. Estimated Annualized Burden Hours All registered importers of nonhuman primates are required by 42 CFR 71.53 to maintain certain disease control procedures and keep certain records. Standard business practices likely dictate that importers already keep records on the origin, transportation, and disposition of the nonhuman primates. Thus, CDC asks for information which should already be maintained by the importers and need only be assembled and reported. The estimate of burden hours totals 922, E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Pages 25289-25290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2016-0090; Docket Number NIOSH 288-A]


A Performance Test Protocol for Closed System Transfer Devices 
Used During Pharmacy Compounding and Administration of Hazardous Drugs; 
Extension of Comment Period

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease

[[Page 25290]]

Control and Prevention (CDC), Department of Health and Human Services 
(HHS).

ACTION: Notice and extension of comment period.

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SUMMARY: On September 15, 2016 the National Institute for Occupational 
Safety and Health (NIOSH) of the Centers for Disease Control and 
Prevention (CDC), published a notice in the Federal Register announcing 
a public meeting and request for public comment on a draft testing 
protocol.
    Written comments were to be received by December 7, 2016. NIOSH 
initially extended the public comment period to June 7, 2017 [81 FR 
88687]. NIOSH is extending the public comment period for a second time 
to August 30, 2017. The longer timeframe will allow companies to test 
the protocol with the proposed challenge agents.

FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Alice 
Hamilton Laboratories, 1090 Tusculum Avenue, MS-R-5, Cincinnati, Ohio 
45226, telephone (513) 841-4141 (not a toll free number), Email: 
DHirst@cdc.gov.

ADDRESSES: You may submit comments, identified by CDC-2016-0090 and 
Docket Number NIOSH 288-A, by either of the following two methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.

John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2017-11292 Filed 5-31-17; 8:45 am]
 BILLING CODE 4163-19-P

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