Department of Health and Human Services 2016 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 3,810
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-29538
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-29531
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Organ Procurement and Transplantation Network
Document Number: 2016-29504
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
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), 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; Children's Hospitals Graduate Medical Education Payment Program Application and Full-Time Equivalent Resident Assessment Forms
Document Number: 2016-29503
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
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), 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.
Council on Graduate Medical Education
Document Number: 2016-29499
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
HHS is hereby giving notice that the Council on Graduate Medical Education (COGME) has been renewed. The effective date of the renewed charter is September 30, 2016.
Zika Health Care Services Program
Document Number: 2016-29492
Type: Notice
Date: 2016-12-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the November 9, 2016 publication of a funding opportunity providing up to $66.1 million available to support prevention activities and treatment services for health conditions related to the Zika virus. The funding opportunity solicited single source emergency applications for a cooperative agreement aimed at supporting prevention activities and treatment services for women (including pregnant women), children, and men adversely or potentially impacted by the Zika virus. Entities eligible to apply for this funding opportunity are states, territories, tribes or tribal organizations, with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention (CDC). As of October 12, 2016, the CDC designated American Samoa, Puerto Rico, the U.S. Virgin Islands, and Florida as areas with laboratory-confirmed active or local Zika virus transmission. As such, this emergency funding opportunity is currently available to the territorial and state health departments in these areas.
National Institute of Nursing Research; Notice of Meeting
Document Number: 2016-29460
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2016-29459
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial review
Document Number: 2016-29456
Type: Notice
Date: 2016-12-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
Document Number: 2016-29454
Type: Notice
Date: 2016-12-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Council for the Elimination of Tuberculosis: Notice of Charter Amendment
Document Number: 2016-29453
Type: Notice
Date: 2016-12-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-29452
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Office of the Secretary
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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-29451
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, Office of the Secretary
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 0990-0416, which expires March 31, 2017. 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.
Announcement of Requirements and Registration for “A Wearable Alcohol Biosensor: A Second Challenge”
Document Number: 2016-29436
Type: Notice
Date: 2016-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Through the ``A Wearable Alcohol Biosensor: A Second Challenge'' (the ``Challenge''), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH), is building upon the success of the previous challenge and searching for a wearable or otherwise discreet device capable of measuring blood alcohol level in real time. The advent of alcohol biosensors that can be worn discreetly and used by individuals in the course of their daily lives will advance the mission of the NIAAA in the arenas of research, treatment, and rehabilitation. Current technological developments in electronics, miniaturization, wireless technology, and biophysical techniques of alcohol detection in humans increase the likelihood of successful development of a useful alcohol biosensor in the near future. The NIH believes that this Challenge will further stimulate investment from public and private sectors in the development of functional alcohol biosensors that will be appealing to individuals, treatment providers, and researchers and will continue to further the NIAAA's mission.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-29428
Type: Notice
Date: 2016-12-08
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 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 revision of the ``SEARCH for Diabetes in Youth Study,'' a national multi-center study aimed at understanding more about diabetes among children and young adults in the United States.
A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period
Document Number: 2016-29411
Type: Notice
Date: 2016-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On September 15, 2016 the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [81 FR 63482] announcing a public meeting and request for public comment on a draft testing protocol. Written comments were to be received by December 7, 2016. In response to a request from interested parties, NIOSH has extended the comment period until June 7, 2017. The longer timeframe will allow companies to acquire the proposed challenge agents and test their CSTDs with the proposed universal CSTD performance test protocol.
Scientific Information Request on Short and Long Term Outcomes After Bariatric Therapies in the Medicare Population
Document Number: 2016-29408
Type: Notice
Date: 2016-12-08
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions to inform our review of Short and Long Term Outcomes after Bariatric Therapies in the Medicare Population, 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).
Submission for OMB Review; Comment Requested
Document Number: 2016-29406
Type: Notice
Date: 2016-12-08
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-29399
Type: Notice
Date: 2016-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2016-29373
Type: Notice
Date: 2016-12-08
Agency: Department of Health and Human Services, Administration for Children and Families
Privacy Act of 1974; Notice To Establish an Exempt System of Records
Document Number: 2016-29059
Type: Notice
Date: 2016-12-08
Agency: Department of Health and Human Services, National Institutes of Health
In accordance with the requirements of the Privacy Act of 1974, as amended, the National Institutes of Health (NIH) proposes to establish a new system of records, to be numbered and titled: SORN 09- 25-0225 ``NIH Electronic Research Administration (eRA) Records, HHS/ NIH/OD/OER,'' which will be related to, but separate from, the system of records covered in SORN 09-25-0036 ``NIH Extramural Awards and Chartered Advisory Committee (IMPAC II), Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH.'' The new system of records will cover records used by NIH throughout the research and development award lifecycle, from application to scientific peer review, post-award monitoring, and close-out. Elsewhere in today's Federal Register, NIH has published a Notice of Proposed Rulemaking (NPRM) proposing to exempt confidential source- identifying material in the new system of records (i.e., material that would inappropriately reveal the identities of referees who provide letters of recommendation and peer reviewers who provide written evaluative input and recommendations to NIH about particular funding applications under an express promise by the government that their identities in association with the written work products they authored and provided to the government will be kept confidential) from certain requirements of the Privacy Act, specifically, from the provisions pertaining to providing an accounting of disclosures, access and amendment and notification. The exemptions and the promises of confidentiality are necessary to protect the integrity of NIH extramural peer review and award processes and ensure that NIH efforts to obtain accurate and objective assessments and evaluations of funding applications from referees and peer reviewers is not hindered. The exemptions will become effective when NIH publishes a Final Rule, which will not occur until the 60-day comment period provided in the NPRM has expired and any comments received on the NPRM (or on this System of Records Notice) have been addressed.
Privacy Act; Implementation
Document Number: 2016-29058
Type: Proposed Rule
Date: 2016-12-08
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to exempt, from certain requirements of the Privacy Act, a subset of records in a new system of records, System No. 09-25-0225, NIH Electronic Research Administration (eRA) Records (NIH eRA Records), which covers records used in managing NIH research and development applications and awards throughout the award lifecycle. Elsewhere in today's Federal Register, HHS has published a proposed System of Records Notice (SORN) for System No. 09-25-0225 for public notice and comment. The subset of records proposed to be exempted is material that would inappropriately reveal the identities of referees who provide letters of recommendation and peer reviewers who provide written evaluative input and recommendations to NIH about particular funding applications under an express promise by the government that their identities in association with the written work products they authored and provided to the government will be kept confidential. Only material that would inappropriately reveal a particular referee or peer reviewer as the author of a specific work product (e.g., reference or recommendation letters, reviewer critiques, preliminary or final individual overall impact/priority scores, and/or assignment of peer reviewers to an application and other evaluative materials and data compiled by NIH/OER) is proposed to be exempted. The exemptions would protect not only an author's name in association with their written work product but any content that could enable the author to be identified from context. The Privacy Act provisions from which the material is proposed to be exempted are those that require the agency to provide an accounting of disclosures, access and amendment, and notification, which are contained in subsections (c)(3) and (d) of the Privacy Act.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-29362
Type: Notice
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of the Secretary
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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-29361
Type: Notice
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0191, scheduled to expire on December 31, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Office of the Assistant Secretary for Financial Resources, Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-29332
Type: Notice
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of the Secretary
Meeting Announcement for the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2016-29331
Type: Notice
Date: 2016-12-07
Agency: Department of Health and Human Services
This notice announces the meeting dates for the Technical Advisory Panel on Medicare Trustee Reports on Monday, December 19, 2016 and Tuesday, December 20, 2016 in Washington, DC.
Announcement of the Award of Five Single-Source Low-Cost Extension Supplement Grants Within the Office of Refugee Resettlement's Unaccompanied Children's Program
Document Number: 2016-29326
Type: Notice
Date: 2016-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, announces the award of five single-source low-cost extension supplement grants for a total of $19,604,765 under the UC Program.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-29310
Type: Notice
Date: 2016-12-07
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 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 proposed information collection project entitled ``Formative Assessment Regarding Contraception Use in the U.S. Virgin Islands (USVI) in the Context of Zika''.
Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9
Document Number: 2016-29303
Type: Notice
Date: 2016-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for GARDASIL 9 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 a patent which claims that human biological product.
Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-29278
Type: Rule
Date: 2016-12-07
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 guidance for industry and FDA staff entitled ``Third- Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA). The guidance is intended to describe the standards for accreditation of third-party certification bodies as required under the final rule entitled ``Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.'' In addition, this guidance discusses specific clauses of ISO/IEC 17021: 2015 and industry practice that are currently being used by third-party certification bodies and that FDA recommends accreditation bodies consider as a model when making accreditation decisions.
Posting Adverse Event Report Data Associated With Conventional Foods, Dietary Supplements, and Cosmetics on the Internet; Availability
Document Number: 2016-29277
Type: Notice
Date: 2016-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of data extracted from adverse event reports from January 2004 to the present involving food (including food additives, color additives, and dietary supplements) and cosmetics regulated by our Center for Food Safety and Applied Nutrition (CFSAN). The data files are being made publicly available on FDA's Web site to improve transparency about adverse event reports involving CFSAN-regulated products and increase awareness about reporting these adverse events to FDA.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-29266
Type: Notice
Date: 2016-12-07
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
Document Number: 2016-28297
Type: Rule
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of Inspector General
In this final rule, OIG amends the safe harbors to the anti- kickback statute by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The OIG also amends the civil monetary penalty (CMP) rules by codifying revisions to the definition of ``remuneration,'' added by the Balanced Budget Act (BBA) of 1997 and the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010 (ACA). This rule updates the existing safe harbor regulations and enhances flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
Document Number: 2016-28293
Type: Rule
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of Inspector General
This final rule amends the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments, and exclusions to improve readability and clarity.
Submission for OMB Review; Comment Request
Document Number: 2016-29210
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2017 Through September 30, 2018; Correction
Document Number: 2016-29184
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, Office of the Secretary
This document corrects a technical error that appeared in the notice published in the November 15, 2016 Federal Register entitled ``Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2017 through September 30, 2018.''
Head Start Program
Document Number: 2016-29183
Type: Rule
Date: 2016-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Head Start will delay the compliance date for background checks procedures described in the Head Start Program Performance Standards final rule that was published in the Federal Register on September 6, 2016. We are taking this action to afford programs more time to implement systems that meet the background checks procedures and to align with deadlines for states complying with background check requirements found in the Child Care and Development Block Grant (CCDBG) Act of 2014.
Submission for OMB Review; Comment Request
Document Number: 2016-29182
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-29176
Type: Notice
Date: 2016-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office for State, Tribal, Local and Territorial Support (OSTLTS)
Document Number: 2016-29175
Type: Notice
Date: 2016-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Invention; Availability for Licensing
Document Number: 2016-29151
Type: Notice
Date: 2016-12-06
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 in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2016-29142
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development Notice of Closed Meeting
Document Number: 2016-29141
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-29140
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2016-29139
Type: Notice
Date: 2016-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion
Document Number: 2016-29134
Type: Rule
Date: 2016-12-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the Computerized Cognitive Assessment Aid for Concussion into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the computerized cognitive assessment aid for concussion's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; Availability
Document Number: 2016-29133
Type: Notice
Date: 2016-12-05
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 revised Compliance Policy Guide (CPG) 615.115 entitled ``Extralabel Use of Medicated Feeds for Minor Species.'' In advance of the January 1, 2017, date on which we anticipate that a number of drugs will convert from over-the-counter (OTC) to veterinary feed directive (VFD) status, this revised CPG clarifies policy and regulatory action guidance to FDA staff on the Agency's exercise of regulatory discretion with regard to the extralabel use of medicated feeds containing those drugs in minor species.
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability
Document Number: 2016-29125
Type: Notice
Date: 2016-12-05
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 for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and form at of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This guidance finalizes the 2014 revised draft guidance entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological ProductsConsiderations, Content, and Format.''
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