Department of Health and Human Services September 19, 2016 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; 30-Day Comment Request; National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request
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. This proposed information collection was previously published in the Federal Register on July 8, 2016, page 44644 (81 FR 44644) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date
The Food and Drug Administration (FDA or we) is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the Federal Register of September 17, 2015.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone and Eleven Other Substances; Request for Comments
The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 12 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).
Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting (which will also be Webcast) entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The goal of this meeting is to provide information and receive comments on the current activities of ICH, as well as the upcoming ICH meetings in Osaka, Japan, in November 2016. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Osaka. The purpose of this public meeting is to solicit public input prior to the next ICH Assembly meeting and the Expert Working Group meetings in Osaka, Japan, scheduled for November 6 through November 11, 2015.
A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. Comments received on this list will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 revision of the National Electronic Health Records Survey (NEHRS), formerly approved as the National Ambulatory Medical Care Survey (NAMCS) National Electronic Health Records Survey (NEHRS). This three year revision request includes an update to the currently approved questionnaire, the addition of a follow-up survey, and a survey name change deleting the National Ambulatory Medical Care Survey (NAMCS) from the title. The purpose of NEHRS is to meet the needs and demands for statistical information about EHR adoption in physician offices in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 a proposed information collection plan entitled Evaluation of Effectiveness of NIOSH Publications: NIOSH Customer Satisfaction and Impact Survey.
Biosimilar User Fee Act; Public Meeting
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect fees and use them for the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting biosimilar biological product user fees in future fiscal years. Following an initial consultation with public stakeholders and discussions with the regulated industry, 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 the public views and comments and revise the recommendations as necessary.
Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.'' This public meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information with FDA about the efforts underway to implement the Drug Supply Chain Security Act's (DSCSA's) product identification requirements, including the use of product identifiers to enhance tracing at the product level.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, 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 a survey entitled ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015- 2025).''
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information to support social and behavioral research used by FDA about drug products.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and Answers.'' The draft questions and answers (Q&As) guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft Q&As guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnology- derived products, intended to treat patients with cancer. The Q&As are intended to provide additional clarity for topics discussed in the ICH guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' (S9 guidance).
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