Unknown. Final order

3,618 words·~16 min read·/register/2015/08/05/2015-19177

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2015-08-05.xml --- 80 150 Wednesday, August 5, 2015 Contents AIRFORCE Air Force Department NOTICES Meetings: United States Air Force Scientific Advisory Board, 46567 2015-19198 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46585-46586 2015-19114 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program:

Inpatient Psychiatric Facilities Prospective Payment System—Update for Fiscal Year Beginning October 1, 2015 (FY 2016), 46652-46728 2015-18903 Civil Rights Civil Rights Commission NOTICES Meetings: California Advisory Committee, 46538 2015-19187 Michigan Advisory Committee, 46538-46539 2015-19185 The Hawaii State Advisory Committee, 46539 2015-19186 Coast Guard Coast Guard RULES Drawbridge Operations: Atlantic Intracoastal Waterway, Little River to Savannah River, 46492-46494 2015-19112 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration Community Living Administration Community Living Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Small Business Innovation Research Program Phase II, 46586-46587 2015-19237 Defense Department Defense Department See Air Force Department See Engineers Corps NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46567-46568 2015-19199 Drug Drug Enforcement Administration NOTICES Manufacturers of Controlled Substances; Registration: Patheon Pharmaceuticals, Inc., 46604 2015-19173 Education Department Education Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Health Education Assistance Loan Program--Forms, 46569-46570 2015-19101 Energy Department Energy Department See Federal Energy Regulatory Commission RULES Energy Conservation Program: Test Procedures for Clothes Washers, 46730-46788 2015-18330 PROPOSED RULES Appliance Standards and Rulemaking Federal Advisory Committee: Establishment of Working Group for Certain Equipment Classes of Refrigeration Systems of Walk-In Coolers and Freezers, 46521-46525 2015-19235 Engineers Engineers Corps NOTICES Meetings:

Board on Coastal Engineering Research, 46568-46569 2015-19242 Environmental Protection Environmental Protection Agency RULES Air Quality Implementation Plans; Approvals and Promulgation: Infrastructure Requirements for the 2008 Ozone and 2010 Sulfur Dioxide National Ambient Air Quality Standards; Pennsylvania, 46494-46508 2015-19090 PROPOSED RULES Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles—Phase 2; Notice of Public Hearings and Comment Period;

Correction, 46526 2015-19297 NOTICES Meetings: Chartered Science Advisory Board; Closed Teleconference, 46575-46576 2015-19257 National Pollutant Discharge Elimination System General Permits: Oil and Gas Exploration Facilities in the Federal Waters of Cook Inlet, AK, 46575 2015-19255 Pesticide Product Registrations: Applications for New Active Ingredients, 46574-46575 2015-19263 Applications for New Uses, 46576-46578 2015-19259 2015-19273 Export Import Export-Import Bank NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 46578-46579 2015-19093 2015-19212 Federal Aviation Federal Aviation Administration PROPOSED RULES Establishment of Class E Airspace: Cottonwood, AZ, 46525-46526 2015-19240 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46579-46580 2015-19155 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Threat and Hazard Identification and Risk Assessment--State Preparedness Report Unified Reporting Tool, 46594-46595 2015-19220 Major Disaster and Related Determinations: Colorado, 46593-46594 2015-19251 Kansas, 46593 2015-19221 Major Disaster Declarations: Kentucky; Amendment No. 2, 46594 2015-19252 Oklahoma; Amendment No. 11, 46595 2015-19218 Oklahoma; Amendment No. 12, 46595 2015-19219 Federal Energy Federal Energy Regulatory Commission NOTICES Applications:

Crown Hydro, LLC, 46573 2015-19207 Hiland Partner Holdings, LLC, 46572-46573 2015-19205 Environmental Assessments; Availability, etc.: Erie Boulevard Hydropower, LP, 46570 2015-19208 Meetings: California Independent System Operator Corp., 46571-46572 2015-19202 Petitions for Declaratory Orders: Starwood Energy Group Global, LLC, Beaver Falls, LLC, et al., 46571 2015-19201 Staff Attendances, 46573-46574 2015-19206 Waiver Requests: Noble Energy, Inc., 46570-46571 2015-19204 Noble Midstream Services, LLC, 46571 2015-19203 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 46580-46581 2015-19258 Federal Mediation Federal Mediation and Conciliation Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 46581-46582 2015-19167 Federal Motor Federal Motor Carrier Safety Administration NOTICES Meetings; Sunshine Act, 46644 2015-19312 Federal Railroad Federal Railroad Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46644-46645 2015-19213 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46582 2015-18572 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 46582 2015-19115 Federal Transit Federal Transit Administration RULES Final Interim Policy Guidance for the Capital Investment Grant Program;

Availability, 46514-46515 2015-19200 Food and Drug Food and Drug Administration RULES Medical Devices; General and Plastic Surgery Devices: Classification of the Internal Tissue Marker, 46485-46486 2015-19177 NOTICES Guidance: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen, 46588-46589 2015-19178 Use of Nanomaterials in Food for Animals, 46587-46588 2015-19179 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 46648 2015-18763 General Services General Services Administration PROPOSED RULES Federal Acquisition Regulations:

Fair Pay and Safe Workplaces; Second Extension of Time for Comments, 46531 2015-19169 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: General Services Administration Acquisition Regulation—Contractor's Qualifications and Financial Information, 46582-46583 2015-19223 General Services Administration Acquisition Regulation—GSA Mentor--Protege Program, 46583-46584 2015-19224 General Services Administration Acquisition Regulation—Preparation, Submission, and Negotiation of Subcontracting Plans, 46584-46585 2015-19222 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Community Living Administration See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Housing Housing and Urban Development Department RULES Affirmatively Furthering Fair Housing;

Correction, 46486-46487 2015-19214 Inter-American Inter-American Foundation NOTICES Meetings; Sunshine Act, 46595 2015-19317 Interior Interior Department See National Park Service See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46648-46649 2015-19247 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Polyester Staple Fiber From the Republic of Korea, 46540-46541 2015-19246 Light-Walled Rectangular Pipe and Tube From Turkey, 2013-2014, 46542-46543 2015-19095 Polyethylene Retail Carrier Bags From the Socialist Republic of Vietnam, 46539-46540 2015-19248 Stainless Steel Bar From Spain, 46541-46542 2015-19104 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Hand Trucks and Certain Parts thereof From China, 46603-46604 2015-19080 Meetings;

Sunshine Act, 46603 2015-19282 Justice Department Justice Department See Drug Enforcement Administration Labor Department Labor Department See Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for a Farm Labor Contractor or Farm Labor Contractor Employee Certificate of Registration, 46604-46605 2015-19170 Fair Pay and Safe Workplaces, 46605 2015-19171 Maritime Maritime Administration PROPOSED RULES Maritime Security Program, 46527-46531 2015-19254 NASA National Aeronautics and Space Administration PROPOSED RULES Federal Acquisition Regulations:

Fair Pay and Safe Workplaces; Second Extension of Time for Comments, 46531 2015-19169 National Archives National Archives and Records Administration NOTICES Records Schedules, 46606-46607 2015-19249 National Highway National Highway Traffic Safety Administration PROPOSED RULES Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles—Phase 2; Notice of Public Hearings and Comment Period; Correction, 46526 2015-19297 NOTICES Importation Eligibility of Nonconforming Vehicles;

Approvals: Model Year 2000 East Lancashire Coachbuilders Limited Double Decker Tri-Axle Buses (with Volvo B7L Chassis), 46645-46646 2015-19210 National Institute National Institute of Standards and Technology NOTICES Federal Information Processing Standards: Permutation-Based Hash and Extendable-Output Functions, etc., 46543-46544 2015-19181 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals PHS Applications and Pre-Award Reporting Requirements, 46591-46593 2015-19250 Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Post-Award Reporting Requirements Including Research Performance Progress Report Collection, 46589-46591 2015-19253 Meetings: National Cancer Institute, 46589 2015-19193 National Center for Complementary and Integrative Health, 46591 2015-19174 National Institute on Aging, 46591 2015-19192 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 46516-46518 2015-19156 Fisheries of the Exclusive Economic Zone Off Alaska:

Squids in the Bering Sea and Aleutian Islands Management Area, 46520 2015-19094 Fisheries of the Northeastern United States: Atlantic Sea Scallop Fishery; Closure of the Mid-Atlantic Access Area to General Category Individual Fishing Quota Scallop Vessels, 46518 2015-19150 Fisheries Off West Coast States: Highly Migratory Species Fishery Management Plan; Revision to Prohibited Species Regulations, 46519-46520 2015-19157 International Fisheries; Pacific Tuna Fisheries: 2015 Bigeye Tuna Longline Fishery Closure in the Eastern Pacific Ocean, 46515-46516 2015-19230 PROPOSED RULES Fisheries of the Northeastern United States:

Atlantic Sea Scallop Fishery; State Waters Exemption, 46531-46533 2015-19149 Fisheries of the Northeastern United States; Atlantic Coastal Fisheries Cooperative Management Act Provisions: American Lobster Fishery, 46533-46537 2015-19233 NOTICES Meetings: Atlantic Highly Migratory Species Advisory Panel, 46544-46545 2015-19148 Permit Applications: Pacific Islands Pelagic Fisheries; American Samoa Longline Limited Entry Program, 46565 2015-19102 Takes of Marine Mammals Incidental to Specified Activities Wharf Recapitalization Project, 46545-46565 2015-19184 Takes of Marine Mammals Incidental to Specified Activities:

Breakwater Replacement Project, Eastport, ME, 46565-46566 2015-19113 National Park National Park Service NOTICES Inventory Completions: Museum of Anthropology, Washington State University, Pullman, WA, 46600 2015-19271 Oregon State University, Department of Anthropology, Corvallis, OR; Corrections, 46596-46597 2015-19241 Tennessee Valley Authority, Knoxville, TN, 46597-46598 2015-19267 Repatriation of Cultural Items: Portland Art Museum, Portland, OR, 46595-46596 2015-19238 The University of Iowa Museum of Natural History, Iowa City, IA, 46601 2015-19264 Washington State Parks and Recreation Commission, Olympia, WA, 46598-46599 2015-19266 Requests for Nominations:

Alaska Region Subsistence Resource Commission Program, 46599-46600 2015-19262 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Community Broadband Summit, 46566-46567 2015-19229 Occupational Safety Health Adm Occupational Safety and Health Administration RULES State Plans for State and Local Government Employers: Maine; Initial Approval Determination, 46487-46492 2015-18942 Personnel Personnel Management Office NOTICES Excepted Service, 46607-46610 2015-19215 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 46610 2015-19117 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations;

Proposed Rule Changes: BATS Exchange, Inc., 46615-46617 2015-19133 Financial Industry Regulatory Authority, Inc., 46630-46631 2015-19130 NASDAQ OMX BX, Inc., 46617-46619 2015-19134 NASDAQ OMX PHLX LLC, 46610-46612, 46619-46620, 46625-46627 2015-19128 2015-19131 2015-19136 National Stock Exchange, Inc., 46620-46625 2015-19124 New York Stock Exchange LLC, 46628-46630 2015-19126 NYSE Arca, Inc., 46612-46615, 46627-46628 2015-19132 2015-19135 NYSE MKT LLC, 46627, 46642-46644 2015-19129 2015-17759 The NASDAQ Stock Market LLC, 46631-46641 2015-19125 2015-19127 Suspension of Trading Orders:

Wonder International Education and Investment Group Corp., 46612 2015-19311 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46601-46603 2015-19191 2015-19194 2015-19195 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See Federal Transit Administration See Maritime Administration See National Highway Traffic Safety Administration RULES Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance:

U.S. Airports, 46508-46514 2015-19078 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Post-Challenge Year Survey--Mayors' Challenge for Safer People and Safer Streets, 46646-46647 2015-19189 Certificate of Authority Applications: Dynamic Airways, Llc for Certificate Authority, 46648 2015-19190 Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service See United States Mint U.S. Mint United States Mint NOTICES Pricing for the 2015 American $1 Coin and Currency Set, 46649 2015-19217 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 46652-46728 2015-18903 Part III Energy Department, 46730-46788 2015-18330 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 80 150 Wednesday, August 5, 2015 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2015-N-2457] Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker AGENCY:

Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration

(FDA)is classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective August 5, 2015. The classification was applicable on December 18, 2014. FOR FURTHER INFORMATION CONTACT: David Talley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G454, Silver Spring, MD 20993-0002, 301-796-4861, *david.talley@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on April 22, 2013, classifying the Moerae Surgical Marking Pen into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On May 3, 2013, VasoPrep Surgical (formerly Moerae Matrix, Inc.) submitted a request for classification of the VasoPrep (formerly Moerae) Surgical Marking Pen under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on December 18, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding § 878.4670. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an internal tissue marker will need to comply with the special controls named in this final order. The device is assigned the generic name internal tissue marker, and it is identified as a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in Table 1. Table 1—Internal Tissue Marker Risks and Mitigation Measures Identified Risks and Mitigation Measures Identified risk Mitigation measures Adverse Tissue Reaction Biocompatibility Testing. Sterilization Testing. Shelf Life/Stability Testing. Performance Testing. Labeling. Ineffective Marking Performance Testing. Shelf Life/Stability Testing. Labeling. Improper Use Labeling. FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness: • The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. • Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated. • Performance data must demonstrate the sterility of the device. • Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life. • Labeling must include: ○ A warning that the device must not be used on a non-sterile surface prior to use internally. ○ An expiration date/shelf life. ○ Single use only labeling must be labeled directly on the device. Internal tissue marker is a prescription device restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 ( *Prescription devices* ). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the internal tissue marker they intend to market. II. Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at *http://www.regulations.gov.* 1. DEN130004 : De Novo Request from VasoPrep Surgical (formerly Moerae Matrix, Inc.), dated May 3, 2013. List of Subjects in 21 CFR Part 878 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows: PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for 21 CFR part 878 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 878.4670 to subpart E to read as follows: § 878.4670 Internal tissue marker.

(a)*Identification.* An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

(b)*Classification.* Class II (special controls). The special controls for this device are:

(1)The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.

(2)Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated.

(3)Performance data must demonstrate the sterility of the device.

(4)Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life.

(5)Labeling must include:

(i)A warning that the device must not be used on a non-sterile surface prior to use internally.

(ii)An expiration date/shelf life.

(iii)Single use only labeling must be labeled directly on the device. Dated: July 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19177 Filed 8-4-15; 8:45 am]

Connectionstraces to 5

Traces to 5 documents

U.S. Code

CFR

5 references not yet in our index