Department of Health and Human Services May 10, 2018 – Federal Register Recent Federal Regulation Documents
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Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held of the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public via teleconference; a public comment session will be held during the meeting.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Medical Office Survey on Patient Safety Culture Database.''
Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins; Establishment of a Public Docket; Request for Information and Comments
The Food and Drug Administration (FDA or Agency) is establishing a public docket to assist with its development of a policy/guidance document on the assessment of drug-drug interactions (DDIs) for therapeutic proteins (TPs). The Agency split the 2012 DDI draft guidance into two draft guidance documents published in October 2017: ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications.'' The two guidance documents focus on enzyme- and transporter-based DDIs and do not include a discussion on TPs, which was originally included in the 2012 guidance. The Agency is currently revisiting the framework for assessment of DDIs for TPs outlined in the draft 2012 DDI guidance to offer timely and actionable information pertaining to DDIs for TPs and is seeking public input to assist in updating or creating a new framework.
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on MicrosamplingQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question-and-answer (Q&A) guidance provides additional information to facilitate interpretation of the guideline for industry ``S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies'' (S3A guidance), especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies and acknowledges the benefits (and some limitations) of the use of microsampling.
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of new drugs for the treatment of uncomplicated urinary tract infections.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Health Message Testing System (HMTS). The Health Message Testing System (HMTS), a Generic information collection, that enables programs across CDC to collect the information they require in a timely manner.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Assisted Reproductive Technology (ART) Program Reporting'' that collects information on ART cycles to publish information on pregnancy success rates as required under Section 2(a) of the Federal Clinic Success Rate and Certification Act (FCSRCA).
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