Department of Health and Human Services June 2016 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 390
Reproductive and Environmental Health Network
HRSA announces the award of an extension in the amount of $1,100,000 for the Reproductive and Environmental Health Network (REHN) cooperative agreement. The purpose of the REHN is to improve maternal and fetal health outcomes by providing evidence-based information on the safety of exposures in pregnancy and lactation. The extension will permit the Organization of Teratology Information Specialists (OTIS), the cooperative agreement awardee, during the budget period of 9/1/ 2016-8/31/2017, to continue to provide evidence-based information on the safety of exposures in pregnancy and lactation through individualized risk-assessments and counseling services, developing and disseminating the most current education to providers and the public, improving access to information for hard-to-reach populations, and supporting a national network of resources with centers accessible to each of the 10 HRSA regions.
National Advisory Council on Migrant Health Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the National Advisory Council on Migrant Health (NACMH). The NACMH is authorized under 42 U.S.C. 218, section 217 of the Public Health Service (PHS) Act, as amended and governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2).
Scientific Information Request on Treatment Strategies for Patients With Lower Extremity Chronic Venous Disease (LECVD)
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 Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD), 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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).
Medicare Program; Pre-Claim Review Demonstration for Home Health Services
This notice announces a 3-year Medicare pre-claim review demonstration for home health services in the states of Illinois, Florida, Texas, Michigan, and Massachusetts where there have been high incidences of fraud and improper payments for these services.
Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction
The Food and Drug Administration (FDA or we) is correcting a notice entitled ``Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition'' that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho- phthalates, but omitted two items. This document corrects that error.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Submission for OMB Review; 30-Day Comment Request: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health, the National Institutes of Health, 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 23, 2016, Vol. 81 page 15541 and allowed 60-days for public comment. One public comment was received, requesting a copy of the data collection plans and instruments; the NIMH Office of Autism Research Coordination provided draft copies of the data collection plan and instrument to the requester. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, 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: NIH Desk Officer. Comment 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.
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Arthritis Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Announcing the Intent To Award Single-Source Expansion Supplement Grants to Two Personal Responsibility Education Program Innovative Strategies (PREIS) Grantees
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Adolescent Pregnancy Prevention Program, announces its intent to award a single-source expansion supplement grant of up to $151,265 to Children's Hospital of Los Angeles and up to $55, 917.20 to Education Development Center, Inc.
Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This final rule addresses changes to the Shared Savings Program, including: Modifications to the program's benchmarking methodology, when resetting (rebasing) the ACO's benchmark for a second or subsequent agreement period, to encourage ACOs' continued investment in care coordination and quality improvement; an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program; and policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance
This document contains proposed regulations on the rules for expatriate health plans, expatriate health plan issuers, and qualified expatriates under the Expatriate Health Coverage Clarification Act of 2014 (EHCCA). This document also includes proposed conforming amendments to certain regulations to implement the provisions of the EHCCA. Further, this document proposes standards for travel insurance and supplemental health insurance coverage to be considered excepted benefits and revisions to the definition of short-term, limited- duration insurance for purposes of the exclusion from the definition of individual health insurance coverage. These proposed regulations affect expatriates with health coverage under expatriate health plans and sponsors, issuers and administrators of expatriate health plans, individuals with and plan sponsors of travel insurance and supplemental health insurance coverage, and individuals with short-term, limited- duration insurance. In addition, this document proposes to amend a reference in the final regulations relating to prohibitions on lifetime and annual dollar limits and proposes to require that a notice be provided in connection with hospital indemnity and other fixed indemnity insurance in the group health insurance market for it to be considered excepted benefits.
Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination
The Food and Drug Administration (FDA) is announcing the termination of the Transmissible Spongiform Encephalopathies Advisory Committee. This document removes the Transmissible Spongiform Encephalopathies Advisory Committee from the Agency's list of standing advisory committees.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Correction
This document corrects technical and typographical errors in the proposed rule that appeared in the Federal Register on April 27, 2016 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports.''
Request for Public Comment: 30 Day Information Collection: Indian Self-Determination and Education Assistance Act Contracts
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``Indian Self-Determination and Education Assistance Act Contracts,'' OMB Control Number 0917-0037. IHS is requesting OMB to approve an extension for this collection, which expires on July 31, 2016.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number OMB No. 0937-0025, which expires on November 30, 2016. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 plan entitled ``Generic Clearance for Lyme and other Tickborne Diseases Knowledge, Attitudes, and Practices Surveys.'' CDC's Division of Vector-Borne Diseases (DVBD), National Center for Emerging and Zoonotic Diseases (NCEZID) will use the plan to conduct survey development, pre-testing activities, and survey administration actions in 2016-2018. The data collection for which approval is sought will allow DVBD to use survey results to inform implementation of future TBD prevention interventions.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). This meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/priorities/prevention/advisorygrp/inde x.html.
Announcement of Requirements and Registration for “A Bill You Can Understand” Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health; Correction
This document corrects technical errors that appeared in the notice published in the May 10, 2016 Federal Register entitled ``Announcement of Requirements and Registration for ``A Bill You Can Understand'' Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health.''
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Meredyth M. Forbes, Albert Einstein College of Medicine: Based on an assessment conducted by the Albert Einstein College of Medicine (AECM), an admission from the Respondent, and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Meredyth M. Forbes, former Graduate Student, AECM, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM089979, T32 GM007491, R01 GM55101, and R01 GM88202 and National Institute of Child Health and Human Development (NICHD), NIH, grant T32 HD007502. ORI found that Respondent engaged in research misconduct by intentionally falsifying and/or fabricating data reported in the following three (3) published papers and four (4) meeting presentations:
Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property: U.S. Provisional Patent Application 61/477,020 entitled ``Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent Application 201280029201.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-05], United States Patent Application 14/837,903 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130- 2011/0-US-12], Chinese Patent Application 201610290837.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ``The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.''
Determination of Regulatory Review Period for Purposes of Patent Extension; ALPROLIX
The Food and Drug Administration (FDA) has determined the regulatory review period for ALPROLIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELOCTATE
The Food and Drug Administration (FDA) has determined the regulatory review period for ELOCTATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.
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