Department of Health and Human Services January 2017 – Federal Register Recent Federal Regulation Documents
Results 201 - 237 of 237
Emerging Tick-Borne Diseases and Blood Safety; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Emerging Tick-Borne Diseases and Blood Safety.'' The purpose of the public workshop is to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions. The workshop has been planned in partnership with AABB; America's Blood Centers; National Heart, Lung, and Blood Institute, National Institutes of Health (NIH); the U.S. Department of Defense; and the U.S. Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.
[Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). 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. FDA is establishing a docket for public comments.
Reference Amounts Customarily Consumed: List of Products for Each Product Category; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Reference Amounts Customarily Consumed: List of Products for Each Product Category.'' The draft guidance, when finalized, will provide examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in our regulations.
Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.'' The draft guidance, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format for Nutrition and Supplement Facts labels.
Proposed Changes to the Black Lung Clinics Program for Consideration for the FY 2017 Funding Opportunity Announcement Development
The Federal Office of Rural Health Policy (FORHP) in HRSA published a 30-day public notice in the Federal Register on August 22, 2016 soliciting feedback on a range of issues pertaining to the Black Lung Clinics Program (BLCP). In particular, FORHP requested feedback on how to best determine the needs of coal miners and their families, given the available data, and how to better equip future BLCP grantees to meet those needs. This notice responds to the comments received during this 30-day public notice.
Draft Guidance for Industry: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #243 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists. Use of veterinary drug products in honeybee production is considered as a minor use in minor species in most jurisdictions.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 National Program of Cancer Registries Program Evaluation Instrument.
Proposed Data Collections Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden, 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 the Evaluation of the National Tobacco Prevention and Control Public Education Campaign (The Campaign). The primary objectives of the Campaign are to encourage smokers to quit smoking and to encourage nonsmokers to communicate with smokers about the dangers of smoking. The goal of this evaluation is to gauge the effectiveness of these efforts.
Food and Drug Administration Tribal Consultation Policy; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of the FDA Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy is to further the government-to- government relationship between FDA and American Indian and Alaskan Native Tribes (Indian Tribes) and facilitate tribal consultation with FDA. The FDA Tribal Consultation Policy provides background on FDA's mission and organizational structure and elaborates on the principles and guidelines in the U.S. Department of Health and Human Services (HHS) Tribal Consultation Policy. This policy finalizes the draft FDA Tribal Consultation Policy issued in February 2016.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The National Health Service Corps Loan Repayment Program
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Notice Designating State Title IV-D Child Support Agencies as “Public Bodies”
This notice designates state IV-D child support agencies as public bodies authorized to perform specific functions of the Central Authority under Article 6(3) of the the Hague Convention of 23 November 2007 on the International Recovery of Child Support and Other Forms of Family Maintenance (Convention).and specifies functions to be performed by the state agencies in relation to applications under the Convention.
Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is announcing several actions concerning issues related to batteries used in electronic nicotine delivery systems (ENDS), including electronic cigarettes (e-cigarettes). These actions are intended to give CTP staff an opportunity to hear from the public, including tobacco product manufacturers, importers, researchers, and academic investigators, about ENDS battery safety concerns (e.g., overheating, fire, explosion), risk mitigation, and design parameters. Additionally, FDA is interested in information related to communication to consumers and the general public related to ENDS battery safety concerns. FDA is announcing a public workshop on ENDS batteries and safety hazards. The 2-day public workshop will include presentations and panel discussions about ENDS battery safety concerns as well as how potential safety hazards and risks are communicated to consumers and the general public. In conjunction with the public workshop, FDA is establishing a public docket to gather data and information on hazards and risks associated with the use of batteries in ENDS. Regardless of attendance at the public workshop, interested parties are invited to submit comments, including data and research.
In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This draft guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether or not the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling.
Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Technical Electronic Product Radiation Safety Standards Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2018.
Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.''
Prospective Grant of Exclusive License: Development, Manufacture and Commercialization of Gene Therapy Products for Human Gene Therapy Use To Treat and/or Prevent Methylmalonic Acidemia (MMA)
The National Human Genome Research Institute (NHGRI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to practice the inventions embodied in the Patent Applications listed in the Supplementary Information section of this notice License to Selecta Biosciences (``Selecta'') located in Watertown, Massachusetts.
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The final guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system unless FDA grants a request for a waiver of such requirement because use of electronic means is not reasonable for the person requesting the waiver. This guidance supersedes the revised draft guidance entitled ``Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.''
Premarket Notification (510(k)) Submissions for Bone Anchors; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Bone Anchors.'' The guidance provides recommendations for the information and testing that should be included in premarket submissions for bone anchor (suture anchor) devices used in the appendicular skeleton for attachment of soft tissue to bone. This draft guidance is not final nor is it in effect at this time.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correction and Extension of Comment Period
This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 14, 2016, entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital.'' This document extends the comment period to January 3, 2017 for both the final rule with comment period and the interim final rule with comment period.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 the information collection request titled ``APPLETREE Performance Measures.'' Under the APPLETREE cooperative agreement program (Funding Opportunity Announcement No. CDC-RFA-TS17-1701), awardees will be required to submit an Annual Plan of Work (APOW), several standardized outcome and performance measures, and an Annual Performance Report (APR).
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Biomonitoring of Great Lakes Populations Program III.'' The purpose of the proposed study is to evaluate body burden levels of priority contaminants in Great Lakes residents, particularly those who are at high exposure risk, in the Milwaukee Bay Estuary Area of Concern (AOC) area that was not previously addressed in ATSDR's previous biomonitoring programs around the Great Lakes.
Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry.'' The draft guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/ Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The draft guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under the biologics regulations. The guidance does not apply to test results for ABO and Rh(D) antigens.
Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections
This document corrects technical errors that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability.'' The effective date for the rule was July 5, 2016.
Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)
This final rule implements three new Medicare Parts A and B episode payment models, a Cardiac Rehabilitation (CR) Incentive Payment model and modifications to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee- for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.
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