Department of Health and Human Services November 1, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Office of Minority Health and Health Equity Public Meeting on Strategies To Improve Health Equity Amidst the Opioid Crisis; Public Meeting
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Office of Minority Health and Health Equity Public Meeting on Strategies to Improve Health Equity Amidst the Opioid Crisis.'' The purpose of this public meeting is to share information and obtain the public's perspectives on the current opioid crisis and how it specifically affects racial and ethnic minority, underrepresented, and underserved populations across the country, approaches to prevent and treat opioid use disorder, and emerging research to improve care, and explore how FDA can support those efforts.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment of chronic hepatitis D virus (HDV) infection. This guidance is intended to provide consistent FDA advice to stakeholders regarding HDV drug development strategies.
Determination That MEXITIL (Mexiletine Hydrochloride) Capsules, 150 Milligrams, 200 Milligrams, and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that MEXITIL (mexiletine hydrochloride) capsules, 150 milligrams (mg), 200 mg, and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 MEXITIL (mexiletine hydrochloride) capsules, 150 mg, 200 mg, and 250 mg, if all other legal and regulatory requirements are met.
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees under the Generic Drug User Fee Amendments of 2017.'' This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application. This draft guidance revises and replaces FDA's draft guidance for industry entitled ``Assessing User Fees under the Generic Drug User Fee Amendments of 2017,'' published in October 2017.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.
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) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' This proposed information collection was previously published in the Federal Register on August 8, 2019, and allowed 60 days for public comment. AHRQ received no comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Supplemental Evidence and Data Request on Interventions for Dyspnea in Patients With Advanced Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Interventions for Dyspnea in Patients with Advanced Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
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