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

Results 201 - 250 of 301
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-24515
Type: Notice
Date: 2016-10-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-24514
Type: Notice
Date: 2016-10-12
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Custom Devices; Technical Amendment
Document Number: 2016-24438
Type: Rule
Date: 2016-10-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24513
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Guidance for Industry; Availability
Document Number: 2016-24460
Type: Notice
Date: 2016-10-11
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 ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees to provide recommendations on requests submitted under the SIA regarding nonprescription sunscreen active ingredients and the number of requests to be considered per meeting. The recommendations in this guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the- counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is not required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this guidance pursuant to the SIA, which directs FDA to issue guidance on four topics, including the topic discussed in this guidance. This guidance finalizes the draft guidance on the same topic issued on November 23, 2015.
Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request; Guidance for Industry; Availability
Document Number: 2016-24459
Type: Notice
Date: 2016-10-11
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 ``Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.'' This guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and withdrawing a pending request, as defined by the SIA. The recommendations in this guidance apply to 586A requests and pending requests that seek a determination from FDA of whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. We are issuing this guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn. This guidance finalizes the draft guidance issued on November 23, 2015.
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-24431
Type: Notice
Date: 2016-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter (OTC) home use by lay-users. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types.
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-24430
Type: Notice
Date: 2016-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use in professional healthcare settings. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-24415
Type: Notice
Date: 2016-10-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2016-24413
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, Office of Science Policy, Office of Biotechnology Activities; Notice of Meeting
Document Number: 2016-24412
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-24411
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2016-24410
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health (NIMH); Notice of Meeting
Document Number: 2016-24409
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2016-24408
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24407
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-24406
Type: Notice
Date: 2016-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974
Document Number: 2016-24388
Type: Notice
Date: 2016-10-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a Computer Matching Program that CMS plans to conduct with the Peace Corps (PC).
Privacy Act of 1974, CMS Computer Match No. 2016-14, HHS Computer Match No. 1608
Document Number: 2016-24387
Type: Notice
Date: 2016-10-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Office of Personnel Management (OPM).
Notice of Meetings
Document Number: 2016-24386
Type: Notice
Date: 2016-10-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6).
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)
Document Number: 2016-24365
Type: Notice
Date: 2016-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Health and Nutrition Examination Survey (NHANES) DNA Specimens: Guidelines for Proposals To Use Specimens and Cost Schedule
Document Number: 2016-24349
Type: Notice
Date: 2016-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces reopening of the National Center for Health Statistics' (NCHS) National Health and Nutrition Examination Survey (NHANES) DNA Specimen Repository for research proposals. Blood samples for DNA purification were collected from study participants during NHANES III, NHANES 1999- 2000, NHANES 2001-02, NHANES 2007-08, and NHANES 2009-10 (Office of Management and Budget Control Numbers 0920-0237/0920-0950). Samples from these DNA Specimens are being made available to the research community for genetic testing. The information gained from research using these samples can be combined with the extensive amount of information available in NHANES which describes the prevalence/trends of disease, nutrition, risk behaviors, and environmental exposures in the US population. A more complete description of this program follows.
2018 National Health Interview Survey Questionnaire Redesign
Document Number: 2016-24348
Type: Notice
Date: 2016-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on the redesign of the National Health Interview Survey (NHIS) questionnaire (OMB Control No. 0920-0214, expires 01/31/2019) Any proposed changes will be submitted in future notices in compliance with the Paperwork Reduction Act (PRA). The content and structure of the NHIS will be updated in 2018 to improve the measurement of covered health topics, reduce respondent burden by shortening the length of the questionnaire, harmonize overlapping content with other federal health surveys, establish a long-term structure of ongoing and periodic topics, and incorporate advances in survey methodology and measurement.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-24341
Type: Notice
Date: 2016-10-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
Document Number: 2016-24333
Type: Rule
Date: 2016-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the rule adds 24 entries to this list of drug products, modifies the description of one entry on this list, and revises the list's title and introductory language. These revisions are necessary because information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data Use Agreement and Supplement for 2014 Health Center Patient Survey
Document Number: 2016-24300
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-24266
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-24265
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-24264
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Office of the Director; Amended Notice of Meeting
Document Number: 2016-24257
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2016-24256
Type: Notice
Date: 2016-10-07
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: 2016-24255
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24254
Type: Notice
Date: 2016-10-07
Agency: Department of Health and Human Services, National Institutes of Health
Medical Device User Fee Amendments; Public Meeting; Request for Comments
Document Number: 2016-24237
Type: Notice
Date: 2016-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Medical Device User Fee Amendments.'' The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2018 through 2022. MDUFA authorizes FDA to collect fees and use them for the process for the review of medical device applications. The current legislative authority for MDUFA expires October 1, 2017. At that time, new legislation will be required for FDA to continue collecting medical device user fees in future fiscal years. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Wm. Wrigley Jr. Company; Filing of Color Additive Petition
Document Number: 2016-24208
Type: Proposed Rule
Date: 2016-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2016-24251
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html .
Announcement of Solicitation of Written Comments on Modifications of Healthy People 2020 Objectives
Document Number: 2016-24250
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services solicits written comments regarding a new objective proposed to be added to Healthy People 2020 since the fall 2015 public comment period. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People provides opportunities for public input periodically throughout the decade to ensure that Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.HealthyPeople.gov. This set will reflect further review and deliberation by the topic area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.
Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products
Document Number: 2016-24234
Type: Notice
Date: 2016-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting is intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' The meeting will also provide an opportunity to discuss FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. FDA is seeking input from all stakeholders, including patients, health care providers, health care payers, the pharmaceutical industry, patient advocates, academics, researchers, and other government entities. FDA may hold one or more additional meetings in the future to discuss the risk-benefit paradigm for opioid drug products to ensure that FDA is appropriately considering the full public health impact of prescription opioid drug products and the post-market impact (``real world effects'') of abuse-deterrent opioid drug products.
Head Lice Infestation: Developing Drugs for Topical Treatment; Guidance for Industry; Availability
Document Number: 2016-24233
Type: Notice
Date: 2016-10-06
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 ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials. This guidance finalizes the draft guidance of the same name issued on December 15, 2015.
Tropical Disease Priority Review Vouchers; Guidance for Industry; Availability
Document Number: 2016-24232
Type: Notice
Date: 2016-10-06
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 ``Tropical Disease Priority Review Vouchers.'' There has been significant outside interest in FDA's interpretation of the priority review voucher section in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Food and Drug Administration Amendments Act (FDAAA). This section makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the FD&C Act. This guidance explains to internal and external stakeholders how FDA is implementing the provisions of this section. This guidance finalizes the draft guidance of the same name issued October 2008.
Council on Graduate Medical Education
Document Number: 2016-24167
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Council on Graduate Medical Education (COGME). This meeting will be open to the public. Information about COGME and the agenda for this meeting can be obtained by accessing the COGME Web site at http://www.hrsa.gov/ advisorycommittees/bhpradvisory/COGME.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-24134
Type: Notice
Date: 2016-10-06
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.
Prospective Grant of Exclusive Patent License: Development of a NANOG-Based Therapeutic for Cancer
Document Number: 2016-24133
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Summary Information section of this notice to Inova Health System located in Falls Church, VA.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2016-24132
Type: Notice
Date: 2016-10-06
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 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 requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention (EDHI) Hearing and Screening Follow-up Survey.
National Institute of General Medical Sciences: Notice of Closed Meeting
Document Number: 2016-24131
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases: Notice of Closed Meeting
Document Number: 2016-24130
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases: Notice of Closed Meeting
Document Number: 2016-24129
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging: Notice of Closed Meeting
Document Number: 2016-24128
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-24127
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Document Number: 2016-24126
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health