Energy Policy and New Uses Office, Agriculture Department 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.'' National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and single-use intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions (510(k)s) for different categories of IODs to mitigate future outbreaks of TASS.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``CMS Risk Adjustment Suite of Systems (RASS),'' System No. 09-70-0508. Payments to Medicare Advantage (MA) organizations, Part D sponsors, and Program of All Inclusive Care for the Elderly (PACE) organizations (collectively referred to as ``MA organizations and other entities'') are adjusted based on the health status of enrolled Medicare beneficiaries (``enrollees''). RASS is established to receive, process, and store the data used to risk-adjust payments based on enrollee health status. The data will be used specifically to develop risk adjustment models and to calculate the risk score for each enrollee. Each MA organization and other entity must submit data to CMS in accordance with CMS regulations and instructions. ``Risk adjustment data'' refers to data submitted in two separate formats: comprehensive data equivalent to Medicare fee-for-service data (often referred to as encounter data); and data in abbreviated formats (often referred to as RAPS data). The MA risk adjustment data addressed by this SOR includes RAPS data submitted by a MA organization in an abbreviated format, as referenced at Sec. 422.310(d)(1), and similar abbreviated risk adjustment data submitted by other MA organizations and other entities. Encounter data has a separate SOR (System No. 09-70-0506).

The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 25, 2015, on the pharmacist's role in chronic kidney disease care. The meeting is open to the public.

The Food and Drug Administration (FDA) is extending the comment period for the document that appeared in the Federal Register of May 19, 2015. In the document, FDA requested comments on draft guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Natural History Database Development. The National Organization for Rare Disorders (NORD) is developing an Internet-based data collection tool with promise to further the accumulation of natural history data for many rare diseases. The goal of this grant is to enable NORD to further develop, refine, and disseminate the database tool.

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).

The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences is evaluating the scientific evidence regarding the association between exposures to perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) and immunotoxicity. OHAT invites the submission of information about ongoing studies or upcoming publications on the immune-related health effects of PFOA or PFOS that might be considered for inclusion in the evaluation. OHAT also invites the nomination of scientific experts to potentially serve as members of an ad hoc expert panel to be convened to peer review the draft NTP monograph resulting from the systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge on August 18, 2015. The challenge will be open until October 31, 2015. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2017. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and lowering sodium consumption. For more information about the initiative, visit www.millionhearts.hhs.gov. To support improved blood pressure control, HHS/CDC is announcing the 2015 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive local and national recognition.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,'' which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 040'' (Recognition List Number: 040), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This draft guidance is not final nor is it in effect at this time.