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

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Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing and Handling of Food
Document Number: 2015-19681
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Irradiation in the Production, Processing and Handling of Food'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Under the Federal Import Milk Act
Document Number: 2015-19669
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations Under the Federal Import Milk Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Patient Safety Organizations: Expired Listing for McGuckin Methods International, Inc.
Document Number: 2015-19660
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
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.
Scientific Information Request on Omega 3 Fatty Acids and Cardiovascular Disease-Update
Document Number: 2015-19659
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
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 Cardiovascular DiseaseUpdate, 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).
Agency for Healthcare Research and Quality
Document Number: 2015-19658
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department
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).
Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-19657
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: 2015-19652
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Management and Budget Office
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-19651
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2015-19626
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-19625
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Fogarty International Center; Notice of Meeting
Document Number: 2015-19624
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Comprehensive Child Welfare Information System
Document Number: 2015-19087
Type: Proposed Rule
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
The Administration for Children and Families proposes to revise the Statewide and Tribal Automated Child Welfare Information System regulations. This proposed rule will remove the requirement for a single comprehensive system and allow title IV-E agencies to implement systems that support current child welfare practice. It also proposes to establish requirements around design, data quality, and data exchange standards in addition to aligning these regulations with current and emerging technology developments to support the administration of title IV-E and IV-B programs under the Social Security Act.
Health IT Policy Committee and Health IT Standards Committee; Call for Applications
Document Number: 2015-19621
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department
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: http:// www.healthit.gov/facas/health-it-policy-committee For more information about the HITSC please visit: http:// 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: http://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.
Health IT Standards Committee; Schedule for the Assessment of Health IT Policy Committee Recommendations
Document Number: 2015-19620
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department
Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the Health IT Standards Committee develop a schedule for the assessment of policy recommendations developed by the Health IT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on August 18, 2014. In anticipation of receiving recommendations originally developed by the Health IT Policy Committee, the Health IT Standards Committee will form task forces that will be convened to address specific issues, as needed. Health IT Standards Committee's Schedule for the Assessment of Health IT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the Health IT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the Health IT Standards Committee is informed of those priority areas, it will: (A) Identify the best mechanism by which to organize itself in order to respond to the National Coordinator within 90 days with, at a minimum, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) An assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the Health IT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon responding to the National Coordinator, the Health IT Standards Committee will: (1) Approve a timeline by which it will deliver recommendations to the National Coordinator; and (2) Determine whether to establish a task force to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the Health IT Standards Committee is expected to address over the coming year include, but may not be limited to: Quality measurement; the extended portfolio of standards for the nationwide health information network; distributed queries and results; radiology; consumer-mediated information exchange; public health; data portability; and a process for the maintenance of standards. For a listing of upcoming Health IT Standards Committee meetings, please visit the ONC Web site at http://www.healthit.gov/facas/ calendar. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2015 Performance Review Board (PRB)
Document Number: 2015-19619
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-19579
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2015-19548
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2015-19547
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: 2015-19546
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Management and Budget Office
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2015-19545
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting.
Document Number: 2015-19544
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting.
Document Number: 2015-19543
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2015-19542
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Health Center Program
Document Number: 2015-19524
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Management and Budget Office
In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 2.04.103, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the exceptions to maximum competition requirements contained in the AAGAM Chapter 2.04.104A-5 to provide additional funding without competition to the 144 Health Center Program award recipients whose budget period ends November 30, 2015, for up to 5 months. The extension allows BPHC to eliminate the December 1 budget period start date by redistributing these grants to established start dates later in the fiscal year, thereby allowing award recipients comparable opportunity to prepare and submit applications while allowing BPHC to remain compliant with internal process timelines.
Statement of Organization, Functions, and Delegations of Authority; Office of the Assistant Secretary for Public Affairs
Document Number: 2015-19522
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Logistics Agency
Medicare, Medicaid, and Children's Health Insurance Programs; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests
Document Number: 2015-19498
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
This notice announces 15 membership appointments to the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the first meeting date for the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on issues related to clinical diagnostic laboratory tests. The membership appointments are for 3 years. This notice also announces the first meeting date of the Panel on Wednesday, August 26, 2015.
Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction
Document Number: 2015-19487
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2015-19471
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department
HHS gives notice of a decision to designate a class of employees from the Westinghouse Electric Corporation in Bloomfield, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Notice of Service Delivery Area Designation for the Koi Nation of Northern California Formerly Known as the Lower Lake Rancheria
Document Number: 2015-19467
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, National Drug Control Policy Office
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.
National Eye Institute; Notice of Meeting
Document Number: 2015-19450
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Cancer Institute: Notice of Closed Meetings
Document Number: 2015-19438
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department
Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period; Correction
Document Number: 2015-19418
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 31, 2015 (80 FR 45661). The document reopened the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products and announced the availability for public comment of amendments to the MRTPAs. The document was published with an incorrect paragraph in the Comments section. This document corrects that error.
Advisory Committee for Women's Services (ACWS); Notice of Meeting
Document Number: 2015-19417
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
Notice of Meeting
Document Number: 2015-19416
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2015-19415
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
Workshop on Alternative Approaches for Identifying Acute Systemic Toxicity: Moving From Research to Regulatory Testing; Notice of Public Meeting; Registration Information
Document Number: 2015-19379
Type: Notice
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the workshop ``Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing.'' Workshop attendees will discuss the state of the science of alternative approaches for identifying acute systemic toxicity and explore ways to facilitate their implementation.
Countermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury Table
Document Number: 2015-19228
Type: Rule
Date: 2015-08-07
Agency: Energy Policy and New Uses Office, Agriculture Department
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.
National Institute on Alcohol Abuse and Alcoholism: Notice of Closed Meetings
Document Number: 2015-19346
Type: Notice
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Alcohol Abuse and Alcoholism: Notice of Closed Meeting
Document Number: 2015-19345
Type: Notice
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-19344
Type: Notice
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Required Elements for Submission of the Unified or Combined State Plan and Plan Modifications Under the Workforce Innovation and Opportunity Act
Document Number: 2015-19286
Type: Notice
Date: 2015-08-06
Agency: Aging Administration, Energy Policy and New Uses Office, Agriculture Department, Food and Nutrition Service, Rural Business-Cooperative Service, Army Department, Committee for Purchase From People Who Are Blind or Severely Disabled, Executive Office of the President, Federal Deposit Insurance Corporation, Occupational Safety and Health Administration
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).
Program Expansion for the National Center for Medical Home Implementation Cooperative Agreement at the American Academy of Pediatrics
Document Number: 2015-19260
Type: Notice
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Management and Budget Office
HRSA announces its intent to award a program expansion supplement in the amount of $300,000 for the National Center for Medical Home Implementation (NCMHI) cooperative agreement. The purpose of the NCMHI cooperative agreement, as stated in the funding opportunity announcement, is to: (1) Support a national resource and technical assistance effort to implement and spread the medical home model to all children and youth, particularly children with special health care needs (CSHCN), children who are vulnerable and/or medically underserved, and pediatric populations served by state public health programs, MCHB, and HRSA; and ( ) support activities of the Healthy Tomorrows Partnership for Children Program (HTPCP) grantees to improve children's health through innovative community-based efforts, and community and statewide partnerships among professionals in health, education, social services, government, and business. The purpose of this notice is to award supplemental funds to develop the Rural IMPACT project to support activities related to child health in rural and underserved communities by the American Academy of Pediatrics, the cooperative agreement awardee who serves as the NCMHI, during the budget period of July 1, 2015, to June 30, 2016. The NCMHI is authorized by the Social Security Act, Title V, Sections 501(a)(1)(D) and 501(a)(2)), (42 U.S.C. 701). The NCHMI is a national resource to implement and spread the medical home model to all children and youth, particularly children with special health care needs and children who are vulnerable and/or medically underserved. The NCMHI supports activities of the Health Tomorrows Partnership for Children Program grantees to improve children's health through innovative community-based efforts, and community and statewide partnerships among professionals in health, education, social services, government, and business.
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Revision 2); Availability
Document Number: 2015-19244
Type: Notice
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
Document Number: 2015-19033
Type: Rule
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
This final rule will update the hospice payment rates and the wage index for fiscal year (FY) 2016 (October 1, 2015 through September 30, 2016), including implementing the last year of the phase-out of the wage index budget neutrality adjustment factor (BNAF). Effective on January 1, 2016, this rule also finalizes our proposals to differentiate payments for routine home care (RHC) based on the beneficiary's length of stay and implement a service intensity add-on (SIA) payment for services provided in the last 7 days of a beneficiary's life, if certain criteria are met. In addition, this rule will implement changes to the aggregate cap calculation mandated by the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act), align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the federal fiscal year starting in FY 2017, make changes to the hospice quality reporting program, clarify a requirement for diagnosis reporting on the hospice claim, and discuss recent hospice payment reform research and analyses.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2016
Document Number: 2015-18973
Type: Rule
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
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).
Implementation of Executive Order 13559 Updating Participation in Department of Health and Human Services Programs by Faith-Based or Religious Organizations and Providing for Equal Treatment of Department of Health and Human Services Program Participants
Document Number: 2015-18256
Type: Proposed Rule
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
The United States Department Health and Human Services (HHS) proposes to amend its general regulations regarding the equal treatment of religious organizations in HHS programs and the protection of religious liberty for HHS social service providers and beneficiaries. Specifically, this proposed rule would: Clarify the definition of direct and indirect financial assistance, replace the term ``inherently religious activities'' with the term ``explicitly religious activities,'' require faith-based organizations administering a program supported with direct HHS financial assistance to provide beneficiaries with a written notice informing them of their religious liberty protections, including the right to a referral to an alternative provider if the beneficiary objects to the religious character of the organization providing services, and add a provision stating that decisions about awards of Federal financial assistance must be free from political interference and based on merit.
Submission for OMB Review; 30 Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA)
Document Number: 2015-19253
Type: Notice
Date: 2015-08-05
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
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.
Submission for OMB Review; 30 Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD/OPERA)
Document Number: 2015-19250
Type: Notice
Date: 2015-08-05
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act (PRA) of 1995, the Office of the Director (OD), Office of Extramural Research (OER), 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 13567-13568 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 sent via email to 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Small Business Innovation Research Program-Phase II
Document Number: 2015-19237
Type: Notice
Date: 2015-08-05
Agency: Energy Policy and New Uses Office, Agriculture Department, Denali Commission
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.