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

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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 28, 2015 (80 FR 44973). The document published with an incorrect docket number. This document corrects that error.

This Notice advises the public that the Indian Health Service (IHS) proposes the geographic boundaries of the Service Delivery Area (SDA) for the reaffirmed Koi Nation of Northern California, formerly known as the Lower Lake Rancheria, California (Indian Entities Recognized and Eligible to Receive Services From the United States Bureau of Indian Affairs, 80 Federal Register 1942 Jan. 14, 2015). The Koi Nation's Federal recognition was reaffirmed by the Assistant Secretary of Indian Affairs on December 29, 2000. The Koi Nation SDA is to be comprised of Lake and Sonoma Counties in the State of California. The counties listed are designated administratively as the SDA, to function as a Purchased/Referred Care (PRC), formerly known as contract health services, SDA, for the purposes of operating a PRC program pursuant to the Indian Self-Determination and Education Assistance Act (ISDEAA), Pub. L. 93-638.

HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds regulations for the purpose of creating Covered Countermeasures Injury Tables. The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus (hereafter referred to as the 2009 H1N1 virus) and other potential pandemic strains, such as H5N1 avian influenza.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the U.S. Departments of Labor, Education, Health and Human Services, Agriculture, and Housing and Urban Development (Departments) are proposing a new information collection: Required Elements for Submission of the Unified or Combined State Plan and Plan Modifications under the Workforce Innovation and Opportunity Act (WIOA) (Pub. L. 113-128).

The Food and Drug Administration (FDA) is announcing the reissuance of a revised draft guidance for industry (Revision 2) entitled ``Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.'' We are reissuing the revised draft guidance to incorporate animal prescription drugs. This reissued revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs, including biologics, and animal prescription drugs, with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers.

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2016 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF PPS's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2016. This final rule also finalizes policy changes, including the adoption of an IRF-specific market basket that reflects the cost structures of only IRF providers, a 1-year phase-in of the revised wage index changes, a 3-year phase-out of the rural adjustment for certain IRFs, and revisions and updates to the quality reporting program (QRP).

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 16, 2015, Volume 80, No. 50, pages 13568-13569 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

The Administration for Community Living (ACL), National Institute on Disability, Independent Living, and Rehabilitation Research (NIDLRR) is announcing an opportunity for public comment on the proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the Small Business Innovation Research Program (SBIR)Phase II.