Department of Health and Human Services September 21, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Notice of Single-Award Deviation From Competition Requirements for the Severe Combined Immunodeficiency (SCID) Newborn Screening Program at the Jeffrey Modell Foundation
HRSA announces the award of an extension in the amount of $2,000,000 for the Severe Combined Immunodeficiency (SCID) Newborn Screening program at the Jeffrey Modell Foundation (JMF). The extension will allow JMF, the cooperative agreement recipient, during the budget period of May 1, 2017 to April 30, 2018, to provide technical assistance and support to states for the implementation of population based newborn screening for SCID.
2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we), together with the NARMS partner agencies, is announcing a public meeting entitled ``2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System.'' The purpose of the public meeting is to discuss the current status of the National Antimicrobial Resistance Monitoring System (NARMS) and directions for the future.
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints.'' The purpose of the public workshop is to address challenges related to the evaluation of products in pediatric heart failure including population to study, endpoints, and extrapolation of adult efficacy data. The workshop will also provide a forum for discussion on the use of registry data, as well as alternative trial designs and statistical methods.
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. 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 section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (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 the space available. The meeting room accommodates up to 75 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see Contact Person for More Information) no later than 12:00 noon (EDT) on Tuesday, October 23, 2017:
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or the Agency) is announcing that Akzo Nobel Surface Chemistry AB has filed a petition proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture.
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or the Agency) is announcing that Akzo Nobel Surface Chemistry AB has filed a petition proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture.
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