Department of Health and Human Services July 24, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Submission for OMB Review; 30-Day Comment Request; DERT Extramural Grantee Data Collection (NIEHS)
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.
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by 1,500 web conference lines. Public participants should pre-register for the meeting as described below. The public is welcome to view/listen to the meeting via Adobe Connect. Pre- registration is required by clicking the links below. Web ID: https://adobeconnect.cdc.gov/e3pmwd6fhge/event/ registration.html. Dial in number: 888-790-3293 (100 seats). Participant code: 3762458.
Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.'' The purpose of the public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential endpoints that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #257 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.'' This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating inborn errors of metabolism (IEM) for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products.
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.'' This proposed information collection was previously published in the Federal Register on May 10th, 2018 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Final National Occupational Research Agenda for Construction
NIOSH announces the availability of the final National Occupational Research Agenda for Construction.
Draft Indian Health Service Strategic Plan Fiscal Year 2018-2022
The Indian Health Service (IHS) is developing an Agency-wide Strategic Plan to guide the work and strengthen partnerships with Tribes and Urban Indian Organizations. The IHS is seeking public comment on its Draft IHS Strategic Plan fiscal year (FY) 2018-2022 (Draft IHS Strategic Plan FY 2018-2022). Additionally, notice is given that the IHS will conduct a Tribal Consultation and Urban Indian Confer regarding the Draft IHS Strategic Plan FY 2018-2022. In addition to the virtual town hall sessions, the IHS will seek other opportunities to solicit input from Tribal and Urban Indian programs on the Draft IHS Strategic Plan FY 2018-2022 during the comment period. For IHS Strategic Plan events during the comment period, please check the IHS Event Calendar at: https://www.ihs.gov/ihscalendar/.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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