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

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 6, 2017.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled National Unintentional Drug Overdose Reporting System (NUDORS). CDC will use the information collected to perform fatal unintentional drug overdose surveillance in a quickly and comprehensive way.

The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, ``Neurodiagnostics and Non- Invasive Brain Stimulation Medical Devices Workshop''. The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for neurodiagnostics and non-invasive brain stimulation medical devices and help to speed development and approval of future submissions. Dates and Times: The public workshop will be held on November 19 and 20, 2015, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. 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: https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm 3625, Silver Spring, MD 20993, 301-796-6815, Hilda.Scharen@fda.hhs.gov; or Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Jay.Gupta@fda.hhs.gov, 301-796-2795. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 6, 2015, at 4 p.m. 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 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, susan.monahan@fda.hhs.gov or 301-796-5661 no later than November 5, 2015. To register for the public workshop, please visit FDA's Medical Devices Workshops and Conferences calendar at https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this meeting/public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register (see Contact for special accommodations). 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 available via Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., November 6, 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 November 10, 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.) Comments: 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 December 5, 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 providing comments to the topics 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 Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability and opportunity for public review and comment of the Draft Environmental Assessment (Draft EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The Draft EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection request entitled ``Efficacy Study of a Mobile Application to Provide Comprehensive and Medically Accurate Sexual Health Information for Adolescent Girls''. The study will examine the efficacy of the mobile application in achieving two behavioral outcomes: Use of effective contraception and clinic utilization.

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), HHS is proposing to establish a single, department- wide system of records to cover all HHS payroll records, to be numbered 09-90-1402 and titled ``HHS Payroll Records, HHS/OS.'' The new system will replace two existing systems of records covering payroll records for civilian and commissioned corps personnel (09-40-0006 ``Public Health Service (PHS) Commissioned Corps Payroll Records, HHS/PSC/HRS'' and 09-40-0010 ``Pay, Leave and Attendance Records, HHS/PSC/HRS''). The existing systems were last altered effective September 2012 (see Notice published August 15, 2012 at 77 FR 48984, amending System of Records Notices (SORNs) published December 11, 1998 at 63 FR 68596, to revise the routine use covering disclosures to contractors and to add a new routine use covering disclosures in the course of responding to a data security breach). The existing systems will be considered deleted upon the effective date of the proposed new system. The SORN for the new system includes updates or changes to the System Location, Routine Uses, System Manager, and Record Access Procedure sections, as more fully explained in the ``Supplementary Information'' section of this Notice.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is extending the closing date for the document that appeared in the Federal Register of June 3, 2015. In that document, FDA requested that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of the request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

The Administration for Children and Families extends the comment period for the notice of proposed rulemaking entitled, ``Head Start Performance Standards.'' We take this action to respond to requests from the public for more time to submit comments. The notice of proposed rulemaking and our request for comments appeared in the Federal Register on June 19, 2015. We initially set August 18, 2015 as the deadline for the comment period. To allow the public more time, we extend the comment period for an additional 30 days.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.

This document corrects an error that appeared in the notice published in the July 31, 2015, Federal Register entitled ``Findings of Research Misconduct.''