Department of Health and Human Services June 7, 2021 – Federal Register Recent Federal Regulation Documents

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-11881
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-11880
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-11879
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-11872
Type: Notice
Date: 2021-06-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-11843
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-11802
Type: Notice
Date: 2021-06-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other legal and regulatory requirements are met.
Determination That ATROVENT (Ipratropium Bromide) Metered Spray, 0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-11800
Type: Notice
Date: 2021-06-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ATROVENT (ipratropium bromide) metered spray, 0.021 micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.