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

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.''

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70732, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing from McGuckin Methods International, Inc. has expired and AHRQ has delisted the PSO accordingly.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Omega 3 Fatty Acids and Maternal and Child Health, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

The Office of the National Coordinator for Health Information Technology (ONC) is seeking applications to the Health Information Technology Policy Committee (HITPC) and the Health Information Technology Standards Committee (HITSC). Name of Committees: Health IT Standards Committee and Health IT Policy Committee. General Function of the Committees: The HITPC is charged to provide recommendations to the National Coordinator on a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. The HITSC is charged to provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. Date and Time: Applications must be received by 12:00 p.m. on Friday, September 11, 2015. Contact Person: Michelle Consolazio, phone: (202) 341-6144, email: michelle.consolazio@hhs.gov . Background: The Health IT Policy Committee was established under the American Recovery and Reinvestment Act 2009 (ARRA)(P.L. 111-5), section 13101, new Section 3002. Members of the Health IT Policy Committee are appointed in the following manner: 3 members appointed by the Secretary, HHS; 4 members appointed by Congress; 13 members appointed by the Comptroller General of the United States; and other federal members appointed by the President. Applications are being accepted for one of the three members appointed by the Secretary of HHS. Nominees of the HITPC should have experience promoting the meaningful use of health information technology and be knowledgeable in privacy and security issues related to health information. The Health IT Standards Committee was established under the American Recovery and Reinvestment Act 2009 (ARRA) (Pub. L. 111-5), section 13101, new Section 3003. Members of the Health IT Standards Committee are appointed by the Secretary, HHS and shall at least reflect providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and individuals with technical expertise on health care quality, privacy and security, and on the electronic exchange and use of health information. Nominees of the HITSC should have experience promoting the meaningful use of health information technology and be knowledgeable in areas such as: small innovative health care providers, providers participating in payment reform initiatives, accountable care organizations, pharmacists, behavioral health professionals, home health care, purchaser or employer representatives, patient safety, health information technology security, big data, consumer e-health, personal health records, and mobile health applications. Members will be selected in order to achieve a balanced representation of viewpoints, areas of experience, subject matter expertise, and representation of the health care system. Terms will be three (3) years from the appointment date to either the HITSC or HITPC. Members on both Committees serve without pay. However, members will be provided per diem and travel costs for Committee services. The HITPC will be seeking applications for the following area of expertise: Consumer/Patient Representative The HITSC will be seeking applications for the following areas of expertise: Technical Expertise, Small Innovative Provider Technical Expertise, CIO Health Plans Representative Technical Expertise, Health IT (2) Purchaser/Employer Representative Long-term Care Representative Ancillary Healthcare Worker Representative For more information about the HITPC please visit: https:// www.healthit.gov/facas/health-it-policy-committee For more information about the HITSC please visit: https:// www.healthit.gov/facas/health-it-standards-committee. Submitting Applications: Applications should be submitted electronically through the application database FACA application page on the HealthIT.gov Web site at: https://www.healthit.gov/facas/faca- workgroup-membership-application. All applications must be compiled and submitted in one complete package. An application package must include: A short bio, a current CV including contact information and memberships with professional organizations/advisory committees, and two letters of support.