Department of Health and Human Services January 2021 – Federal Register Recent Federal Regulation Documents

Results 201 - 210 of 210
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-29116
Type: Notice
Date: 2021-01-04
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
Document Number: 2020-29091
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the labeling of natural rubber latex condoms.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
Document Number: 2020-29082
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for a voluntary survey for the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress. The proposed survey will be used to determine what food defense activities, if any, State, local, territorial, and/or tribal (SLTT) agencies have completed to date. The information will be compared to the initial baseline data collected by State(s) in 2018.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2020-29079
Type: Notice
Date: 2021-01-04
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/165.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2020-29059
Type: Notice
Date: 2021-01-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Guidance Documents Related to Coronavirus Disease 2019; Availability
Document Number: 2020-29058
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Jerrod Nichols Smith: Debarment Order
Document Number: 2020-29052
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order permanently debarring Jerrod Nichols Smith from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Smith was convicted of multiple felony counts under Federal law for conduct that relates to the regulation of a drug product under the Federal, Food, Drug, and Cosmetic Act (the FD&C Act). Mr. Smith was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of September 27, 2020 (30 days after receipt of the notice), Mr. Smith had not responded. Mr. Smith's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
Alec Burlakoff: Final Debarment Order
Document Number: 2020-29046
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Alec Burlakoff from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Alec Burlakoff was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Burlakoff was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of July 24, 2020 (30 days after receipt of the notice), Mr. Burlakoff had not responded. Mr. Burlakoff's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
Joseph A. Rowan: Final Debarment Order
Document Number: 2020-29045
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Joseph A. Rowan from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Joseph A. Rowan was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Rowan was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of August 6, 2020 (30 days after receipt of the notice), Mr. Rowan had not responded. Mr. Rowan's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
Sunrise Lee: Final Debarment Order
Document Number: 2020-29044
Type: Notice
Date: 2021-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Sunrise Lee from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Lee was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Ms. Lee was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why she should not be debarred. As of October 8, 2020 (30 days after receipt of the notice), Ms. Lee had not responded. Ms. Lee's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this action.
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