August 17, 2015 – Federal Register Recent Federal Regulation Documents

The National Council on Disability is finalizing regulations which implement the Freedom of Information Act, the Privacy Act of 1974, and the Government in the Sunshine Act. This rule describes the procedures for members of the public to request access to records. In addition, this document also describes procedures for the Council's responses to these requests, including the timeframe for response and applicable fees. These rules should be read in conjunction with the text of the Freedom of Information Act, the Privacy Act of 1974, the Government in the Sunshine Act, and the Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA), in collaboration with the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI) is announcing a public workshop entitled ``Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy.'' The purpose of the public workshop is to discuss important scientific questions about using two of the most ubiquitous and fastest growing data sources, mobile health data and social computing data, focusing especially on the implications for product safety.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Physiological Closed-Loop Controlled (PCLC) Devices.'' The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation. Dates and Times: The public workshop will be held on October 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:/ /www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm. Contact Persons: Bahram Parvinian, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2534, Silver Spring, MD 20993, 301-796-6445, email: Bahram.Parvinian@fda.hhs.gov; and Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-6369, email: Allison.Kumar@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m., October 1, 2015. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, Office of Communication and Education (OCE), Center for Devices and Radiological Health, Food and Drug Administration, 301-796-5661, email: susan.monahan@fda.hhs.gov no later than September 29, 2015. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Susan Monahan to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., October 1, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after October 7, 2015. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meeting_test.htm . To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 15, 2015. All requests to make oral presentations must be received by September 1, 2015. If selected for presentation, any presentation materials must be emailed to Bahram Parvinian and Allison Kumar (see Contact Persons) no later than October 1, 2015. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop to obtain information on challenges related to the design, development, and evaluation of critical care PCLC devices. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is September 1, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at https://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

On April 30, 2015, the Commission submitted to the Congress amendments to the sentencing guidelines and official commentary, which become effective on November 1, 2015, unless Congress acts to the contrary. Such amendments and the reasons for amendment subsequently were published in the Federal Register. 80 FR 25782 (May 5, 2015). The Commission has made technical and conforming amendments, set forth in this notice, to commentary provisions and policy statements related to those amendments.

The Environmental Protection Agency (EPA) is proposing to determine that the Houston-Galveston-Brazoria (HGB) 8-hour ozone nonattainment area is currently attaining the 1997 ozone National Ambient Air Quality Standard (NAAQS). This determination is based upon certified ambient air monitoring data that show the area has monitored attainment of the 1997 ozone NAAQS for the 2012-2014 monitoring period and continues to monitor attainment of the NAAQS based on preliminary 2015 data. If this proposed determination is made final, the requirements for this area to submit an attainment demonstration, a reasonable further progress (RFP) plan, contingency measures, and other State Implementation Plan (SIP) documents related to attainment of the 1997 ozone NAAQS shall be suspended for so long as the area continues to attain the 1997 ozone NAAQS. This proposed action is consistent with EPA's interpretation of certain requirements of part D of title I of the Clean Air Act (CAA or Act).

We are adopting a new airworthiness directive (AD) for REIMS AVIATION S.A. Model F406 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as detachment of the pilot's rudder control pedal in flight. We are issuing this AD to require actions to address the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for British Aerospace Regional Aircraft Jetstream Series 3101 and Jetsream Model 3201 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as missing countersunk washers under the head of the main landing gear trunnion cap tension bolts that could cause fatigue in the bolt shanks. We are issuing this AD to require actions to address the unsafe condition on these products.

The Department of Homeland Security is giving concurrent notice for the newly established ``Department of Homeland Security/CBP- 001, Import Information System, System of Records'' and this proposed rulemaking. In accordance with the Privacy Act of 1974, the Department of Homeland Security concurrently proposes to consolidate, update, and rename two current Department of Homeland Security systems of records titled, ``Department of Homeland Security/U.S. Customs and Border Protection, DHS/CBP-001 Automated Commercial Environment/International Trade Data System System of Records'' and ``Department of Homeland Security/U.S. Customs and Border Protection, DHS/CBP-015 Automated Commercial System System of Records'' as one new system of records. The consolidated system of records notice will be titled, ``Department of Homeland Security/U.S. Customs and Border Protection, DHS/CBP-001 Import Information System System of Records.'' This system of records will continue to collect and maintain records on all commercial goods imported into the United States, as well as information pertaining to the carrier, broker, importer, and other persons associated with the manifest, import, or commercial entry transactions for the goods. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2016. Some of these changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Pathway for Sustainable Growth Reform (SGR) Act of 2013, the Protecting Access to Medicare Act of 2014, the Improving Medicare Post- Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, and other legislation. We also are addressing the update of the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2016. As an interim final rule with comment period, we are implementing the statutory extensions of the Medicare-dependent, small rural hospital (MDH) Program and changes to the payment adjustment for low-volume hospitals under the IPPS. We also are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2016 and implementing certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs) that are participating in Medicare, including related provisions for eligible hospitals and critical access hospitals participating in the Medicare Electronic Health Record (EHR) Incentive Program. We also are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.