Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2018-24472
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-24471
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-24470
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-24469
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-24468
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-24467
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-24466
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; National Children's Study (NCS) Vanguard Data and Sample Archive and Access System (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Document Number: 2018-24465
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Healthcare Infection Control Practices Advisory Committee (HICPAC); Correction
Document Number: 2018-24463
Type: Notice
Date: 2018-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2018-24462
Type: Notice
Date: 2018-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (50); the toll-free dial-in number is 1-877-951-7311, with a pass code of 4123441.
Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2018-24461
Type: Notice
Date: 2018-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the CLIAC. The CLIAC, consists of 20 experts including the Chair in the fields associated with microbiology (including bacteriology, mycobacteriology, mycology, parasitology, and virology), immunology (including histocompatibility), chemistry, hematology, pathology (including histopathology and cytology), genetic testing (including cytogenetics); from representatives in the fields of medical technology, public health, and clinical practice; and from consumer representatives. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of microbiology (including bacteriology, mycobacteriology, mycology, parasitology, and virology), immunology (including histocompatibility), chemistry, hematology, pathology (including histopathology and cytology), or genetic testing (including cytogenetics); from representatives in the fields of medical technology, public health, and clinical practice; and from consumer representatives. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of CLIAC objectives (https:// www.cdc.gov/cliac/).
Data Exchange Standards for Improved Interoperability of Multiple Human Service Programs
Document Number: 2018-24459
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, Administration for Children and Families
A series of statutory changes \1\ in recent years require ACF to issue a regulation to establish standards for data exchange for the Social Security Act Title IV programs for child welfare and foster care (title IV-B and IV-E), child support (title IV-D), and Temporary Assistance for Needy Families (TANF, title IV-A). ACF is seeking public comment on the most effective approaches and technological tools to meet the statutory requirements, support program objectives, and expand the ability of these programs to use, share, and analyze data for improved outcomes.
Request for Public Comment on the Proposed Adoption of Administration for Native Americans Program Policies and Procedures
Document Number: 2018-24458
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the final adoption of such changes no less than 30 days before such changes become effective. In accordance with notice requirements of NAPA, ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA's funding opportunities beginning in Fiscal Year (FY) 2019. Changes to FY 2019 Funding Opportunity Announcements (FOAs) will be based on the following previously published programs: Environmental Regulatory Enhancement (ERE), HHS-2018-ACF-ANA-NR-1344; Native American Language Preservation and Maintenance-Esther Martinez Immersion (EMI), HHS-2018-ACF-ANA-NB- 1343; Native American Language Preservation and Maintenance (P&M), HHS- 2018-ACF-ANA-NL-1342; Social and Economic Development Strategies (SEDS), HHS-2018-ACF-ANA-NA-1339; Social and Economic Development Strategies-Alaska (SEDS-AK), HHS-2018-ACF-ANA-NK-1340; and Native Youth Initiative for Leadership, Empowerment, and Development (ILEAD), HHS- 2018-ACF-ANA-NC-1341.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2018-24447
Type: Notice
Date: 2018-11-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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). 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 http:// www.samhsa.gov/workplace.
Final National Occupational Research Agenda for Musculoskeletal Health
Document Number: 2018-24445
Type: Notice
Date: 2018-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the final National Occupational Research Agenda for Musculoskeletal Health.
Draft-National Occupational Research Agenda for Immune, Infectious and Dermal Disease Prevention (IID)
Document Number: 2018-24443
Type: Notice
Date: 2018-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Immune, Infectious and Dermal Disease Prevention (IID) for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2018-0103 in the search field and click ``Search.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping
Document Number: 2018-24442
Type: Notice
Date: 2018-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States
Document Number: 2018-24441
Type: Notice
Date: 2018-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a pilot study entitled ``Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Document Number: 2018-24440
Type: Notice
Date: 2018-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Privacy Act of 1974; Matching Program
Document Number: 2018-24421
Type: Notice
Date: 2018-11-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Office of Personnel Management (OPM), ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act Through an Office of Personnel Management Health Benefit Plan.''
Submission for OMB Review; Comment Request
Document Number: 2018-24347
Type: Notice
Date: 2018-11-07
Agency: Department of Health and Human Services, Administration for Children and Families
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2018-24340
Type: Notice
Date: 2018-11-07
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ on matters related to AHRQ's conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-24339
Type: Notice
Date: 2018-11-07
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 information collection project ``Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS) Survey Database.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Document Number: 2018-24322
Type: Notice
Date: 2018-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension 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 procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926
Document Number: 2018-24321
Type: Notice
Date: 2018-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on individual patient expanded access applications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tropical Disease Priority Review Vouchers
Document Number: 2018-24320
Type: Notice
Date: 2018-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Tropical Disease Priority Review Vouchers.
Meta-Analyses of Randomized Controlled Clinical Trials To Evaluate the Safety of Human Drugs or Biological Products; Draft Guidance for Industry; Availability
Document Number: 2018-24316
Type: Notice
Date: 2018-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Meta- Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.'' This document, when finalized, will provide guidance to applicants submitting investigational new drug applications, new drug applications, biologics license applications, or supplemental applications on the use of meta- analyses of randomized controlled clinical trials (RCTs) to evaluate the safety of human drugs or biological products within the framework of regulatory decision-making.\1\ This draft guidance is also intended for FDA reviewers and for third-party entities that prepare or evaluate meta-analyses assessing the safety of drug products. Specifically, this guidance describes the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the safety of drugs.
Hypertension: Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability
Document Number: 2018-24315
Type: Notice
Date: 2018-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hypertension: Developing Fixed-Combination Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. The guidance focuses on development of two- drug combinations of previously approved drug products. This guidance incorporates the comments received for and finalizes the draft guidance for industry entitled ``Hypertension: Developing Fixed-Dose Combination Drugs for Treatment'' issued on January 26, 2018.
Submission for OMB Review; 30-day Comment Request: Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Document Number: 2018-24313
Type: Notice
Date: 2018-11-07
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with 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.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-24294
Type: Notice
Date: 2018-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2018-24293
Type: Notice
Date: 2018-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-24284
Type: Notice
Date: 2018-11-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-24283
Type: Notice
Date: 2018-11-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Meeting of the Tick-Borne Disease Working Group
Document Number: 2018-24260
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) announces the eighth meeting of the Tick-Borne Disease Working Group (Working Group) on December 3, 2018, from 1:00 p.m. to 4:00 p.m., Eastern Time. The eighth meeting will be an online meeting held via webcast. The Working Group will review the work of the public comments subcommittee, discuss the release of the 2018 Report to Congress, recognize the subcommittee members for their contributions to the 2018 Report, and address the next steps and transition to a new Working Group for the 2020 Report to Congress.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-24259
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, Administration for Children and Families
Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-24247
Type: Notice
Date: 2018-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled ``Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff.'' The guidance provides information on the implementation of the mandatory food recall provisions of the FDA Food Safety Modernization Act (FSMA). The guidance is in the form of Questions and Answers and provides answers to common questions that might arise about the mandatory recall provisions and FDA's plans for their implementation.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-24235
Type: Notice
Date: 2018-11-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-24234
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services
The Agency for Toxic Substance and Disease Registry, 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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, Expiration Date 3/31/2019) ExtensionAgency for Toxic Substances and Disease Registry (ATSDR). To evaluate public health issues at a site resulting from environmental exposure, ATSDR EIs fill data gaps by conducting environmental and biological sampling.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-24233
Type: Notice
Date: 2018-11-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Sudden Death in the Young (SDY) Case Registry''. The goal of the SDY Case Registry is to compile standardized data on sudden and unexpected deaths among infants, children, and young adults, which are not explained by homicides, suicides, overdoses, or the result of an external cause that was the only and obvious reason for the fatal injury, or terminal illnesses.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-24232
Type: Notice
Date: 2018-11-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the opportunity to comment on a proposed extension to information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection project titled ``National Quitline Data Warehouse.'' The National Quitline Data Warehouse (NQDW) collects a core set of information from the 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and the Asian Smoker's Quitline regarding what services telephone quitlines offer to tobacco users as well as the number and type of tobacco users who receive services from telephone quitlines.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-24231
Type: Notice
Date: 2018-11-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Exclusive Patent License: Therapeutics for Insulin Resistance and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NASH/NAFLD)
Document Number: 2018-24225
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Ovensa, Inc. headquartered in Ontario, Canada, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-24224
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Notice of Closed Meeting
Document Number: 2018-24223
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-24222
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-24221
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-23935
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, Office of Inspector General
This notice replaces all language in Part Q (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG) (81 FR 13807, as published March 15, 2016). The Statement of Organization, Functions, and Delegations of Authority conforms to and carries out the statutory requirements for operating OIG. The organizational changes reflected in this notice are primarily to realign the functions within OIG to better reflect the current work environment and priorities and to more clearly delineate responsibilities for the various activities within OIG's offices. OIG was established by law as an independent and objective oversight unit of the Department to carry out the mission of preventing fraud and abuse and promoting economy, efficiency, and effectiveness of HHS programs and operations. In furtherance of this mission, the organization: Conducts and supervises audits, investigations, evaluations, and inspections relating to HHS programs and operations; identifies systemic weaknesses giving rise to opportunities for fraud and abuse in HHS programs and operations and makes recommendations to prevent their recurrence; leads and coordinates activities to prevent and detect fraud and abuse in HHS programs and operations; detects wrongdoers and abusers of HHS programs and beneficiaries so appropriate remedies may be brought to bear, including imposing administrative sanctions against providers of health care under Medicare and Medicaid who commit certain prohibited acts; and keeps the Secretary of Health and Human Services and Congress fully and currently informed about problems and deficiencies in the administration of HHS programs and operations and about the need for and progress of corrective action. In addition, OIG works with the Department of Justice (DOJ), on behalf of the Secretary, to operate the Health Care Fraud and Abuse Control Program. In accordance with authority enacted in its annual appropriations, OIG also provides protection services to the Secretary and conducts criminal investigations of violations of Federal child support provisions. In support of its mission, OIG carries out and maintains an internal quality assurance system and a peer-review system with other Offices of Inspector General, including periodic quality assessment studies and quality control reviews, to provide reasonable assurance that applicable laws, regulations, policies, procedures, standards, and other requirements are followed, are effective, and are functioning as intended in OIG operations. Section Q, Office of Inspector GeneralOrganization
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-24177
Type: Notice
Date: 2018-11-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for class I and unclassified devices, other than implantable, life-sustaining, or life-supporting (I/LS/LS) devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements for these devices before September 24, 2022. This guidance also describes FDA's direct mark compliance policy for class III, LS/ LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as for class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022, and remain in inventory. FDA does not intend to enforce the direct mark requirements for these devices when the device's unique device identifier (UDI) can be derived from other information directly marked on the device. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
Proposed Collection; 60-Day Comment Request; NIH Office of Intramural Training & Education-Application, Registration, and Alumni Systems, Office of the Director
Document Number: 2018-24150
Type: Notice
Date: 2018-11-05
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of Intramural Training & Education (OITE) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Draft Report on Health Research and Development To Stem the Opioid Crisis: A Federal Roadmap; Request for Comments
Document Number: 2018-24149
Type: Notice
Date: 2018-11-05
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Director, National Institutes of Health (NIH), on behalf of the National Science and Technology Council (NSTC); Committee on Science; Fast Track Action Committee on Health Science and Technology Response to the Opioid Crisis (Opioid FTAC), is requesting input on the content of a draft report, ``Health Research and Development to Stem the Opioid Crisis: A Federal Roadmap.''