Department of Health and Human Services August 2017 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-18512
Type: Notice
Date: 2017-08-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities
Document Number: 2017-18471
Type: Notice
Date: 2017-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing support for the most current version of Medical Dictionary for Regulatory Activities (MedDRA), end of support for earlier versions of MedDRA, and an update to the FDA Data Standards Catalog (Catalog) for study data provided in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-18470
Type: Notice
Date: 2017-08-31
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy DevicesDraft Guidance for Industry and Food and Drug Administration Staff.'' When final, this draft guidance will clarify FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. This draft guidance is not final nor is it in effect at this time.
Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-18469
Type: Notice
Date: 2017-08-31
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 ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. The guidance describes the circumstances when real-world evidence can be used, and the scientific criteria that must be fulfilled in order to have confidence in the data. Finally, the guidance describes some examples of actual uses of real-world evidence that have already led to FDA decisions.
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry; Availability
Document Number: 2017-18464
Type: Proposed Rule
Date: 2017-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter SixUse of Heat Treatments as a Process Control.''
Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling; Availability of Documents; Request for Comments; Notice of Expert Panel Meeting
Document Number: 2017-18462
Type: Notice
Date: 2017-08-31
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces an expert panel meeting and is obtaining comment on a proposed approach to genomic dose-response modeling. Prior to the expert panel meeting, NTP will host four webinars that present other approaches to genomic dose- response modeling. The expert panel meeting and four webinar presentations leading up to the meeting are open to the public. Registration is requested for both in-person meeting attendance and oral comment; registration is required to access the meeting webcast. URLs for live and archived pre-meeting webinars will be available at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
Document Number: 2017-18426
Type: Notice
Date: 2017-08-30
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 Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. This meeting will be open to the public. Information about the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda for this meeting can be obtained by contacting CDR Holly Berilla at (301) 443-9965 or hberilla@hrsa.gov.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-18410
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-18407
Type: Notice
Date: 2017-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-18405
Type: Notice
Date: 2017-08-30
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 project titled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-18404
Type: Notice
Date: 2017-08-30
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
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 proposed request to extend the information collect project titled ``Assessment of Chemical Exposures (ACE) Investigations.'' The purpose of ACE Investigations is to focus on performing rapid epidemiological assessments to assist state, regional, local, or tribal health departments (the requesting agencies) to respond to or prepare for acute chemical releases.
Product-Specific Guidance for Digoxin; Draft Revised Guidance for Industry; Availability
Document Number: 2017-18386
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled ``Draft Guidance on Digoxin.'' The guidance, once finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for digoxin tablets.
Determination of Regulatory Review Period for Purposes of Patent Extension; KENGREAL
Document Number: 2017-18380
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KENGREAL 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 drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XTORO
Document Number: 2017-18379
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTORO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
Determination That CENESTIN (Estrogens, Conjugated Synthetic A) Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 Milligrams, and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-18376
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these products, if all other legal and regulatory requirements are met.
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for PROPRANOLOL HYDROCHLORIDE
Document Number: 2017-18375
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, held by Upsher- Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-18344
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-18342
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-18341
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health
Document Number: 2017-18340
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2017-18338
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-18337
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-18275
Type: Notice
Date: 2017-08-30
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medical Device User Fee Rates for Fiscal Year 2018
Document Number: 2017-18378
Type: Notice
Date: 2017-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2018, which apply from October 1, 2017, through September 30, 2018. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2018, you should not submit a FY 2018 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2018 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Generic Drug User Fee Rates for Fiscal Year 2018
Document Number: 2017-18377
Type: Notice
Date: 2017-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document the Food and Drug Administration (FDA or Agency) is announcing fiscal year (FY) 2018 rates for GDUFA fees.
National Cancer Institute; Notice of Meeting
Document Number: 2017-18343
Type: Notice
Date: 2017-08-29
Agency: Department of Health and Human Services
Office of the Director, National Institutes of Health: Notice of Closed Meeting
Document Number: 2017-18339
Type: Notice
Date: 2017-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2017-18254
Type: Notice
Date: 2017-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2017-18226
Type: Notice
Date: 2017-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2018
Document Number: 2017-18222
Type: Notice
Date: 2017-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2018 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).
National Institute of Neurological Disorders and Stroke
Document Number: 2017-18200
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-18199
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-18198
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Notice of Charter Renewal
Document Number: 2017-18197
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection: 60-Day Comment Request; Generic Clearance To Support the Safe to Sleep® Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD)
Document Number: 2017-18196
Type: Notice
Date: 2017-08-28
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD)
Document Number: 2017-18195
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.
Notice of Intent To Establish the Pain Management Best Practices Inter-Agency Task Force and Request for Nominations for Task Force Members
Document Number: 2017-18182
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) hereby gives notice of its intent to establish the Pain Management Best Practices Inter-Agency Task Force (Task Force) pursuant to section 101 of the Comprehensive Addiction and Recovery Act of 2016. The Task Force will consist of representatives of specific Federal agencies and non- federal individuals and entities who represent diverse disciplines and views. The Task Force will provide advice and recommendations for development of best practices for pain management and prescribing pain medication and a strategy for disseminating such best practices to relevant Federal agencies and the general public. Through this notice, HHS is also requesting nominations of individuals who are interested in being considered for appointment to the Task Force. Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Task Force are currently being accepted.
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2017-18161
Type: Notice
Date: 2017-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC). 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.
Meeting of the National Advisory Committee on Rural Health and Human Services
Document Number: 2017-18139
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given of a National Advisory Committee on Rural Health and Human Services (NACRHHS) meeting. The meeting will be open to the public. Informaton about the NACRHHS meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/ advisorycommittees/rural/.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-18137
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-18136
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-18131
Type: Notice
Date: 2017-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Office of the Secretary Notice of Meeting
Document Number: 2017-18123
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2017-18122
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-18121
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering Notice of Meeting
Document Number: 2017-18120
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2017-18119
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2017-18118
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2017-18117
Type: Notice
Date: 2017-08-28
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-18070
Type: Notice
Date: 2017-08-25
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.