Department of Health and Human Services November 18, 2020 – Federal Register Recent Federal Regulation Documents
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Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting to be held on Tuesday, December 1, 2020. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/ advisory-committees/heritable-disorders/.
Prospective Grant of Exclusive Patent License: Treatment and Prevention of Neuropathic Pain With P2Y14 Antagonists
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Saint Louis University, (``SLU''), a non-profit university located in Missouri, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.
Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics
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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection pertaining to ``Expedited Programs for Serious ConditionsDrugs and Biologics.''
Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 19 new drug applications (NDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of NDA 202342, Esomeprazole Strontium Delayed-Release Capsules, Equivalent to (EQ) 20 milligrams (mg) base and EQ 40 mg base, after receiving a withdrawal request from R2 Pharma, LLC, 11550 North Meridian St., Suite 290, Carmel, IN 46032-5505 (R2 Pharma). Because of clerical errors in the Agency's processing of communications regarding this application, FDA has determined that NDA 202342 remains approved. Accordingly, FDA's approval of NDA 202342 remains in effect. There are no changes with respect to the other 18 NDA withdrawals announced in the January 8, 2020 Federal Register notice.
Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry, entitled ``Draft Guidance for Tiotropium Bromide.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation spray.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees
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.
Guidance Documents Related to Coronavirus Disease 2019; Availability
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.
Skin Notation Profiles for Chlorodiphenyl (42% Chlorine) (CAS: 53469-21-9), Cyclohexanol (CAS: 108-93-0), Cyclohexanone (CAS: 108-94-1), Cyclonite (CAS: 121-82-4), and Diethylenetriamine (CAS: 111-40-0)
NIOSH announces the availability of Skin Notation Profiles for Chlorodiphenyl (42% chlorine) (CAS: 53469-21-9), Cyclohexanol (CAS: 108-93-0), Cyclohexanone (CAS: 108-94-1), Cyclonite (CAS: 121-82-4), and Diethylenetriamine (CAS: 111-40-0).
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