Department of Health and Human Services July 17, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
AbbVie Inc., et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen
The Food and Drug Administration (FDA) is withdrawing approval of 7 abbreviated new drug applications (ANDAs) for prescription drug products containing more than 325 milligrams (mg) of acetaminophen. The holders of these ANDAs have waived their opportunity for a hearing.
Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Testing as Used by the Food and Drug Administration Center for Tobacco Products
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on quantitative testing as used by the Food and Drug Administration Center for Tobacco Products.
Site Tours Program
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science is announcing an invitation for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or currently regulated tobacco products (i.e., cigarettes, roll-your-own, and smokeless tobacco). These visits are intended to provide CTP staff with the opportunity to gain a better understanding of the tobacco industry and its operations and are not intended as regulatory inspections or facility visits for the purposes of developing Tobacco Product Manufacturing Practice regulations. The purpose of this notice is to alert parties interested in participating in the Site Tours Program to submit requests to CTP.
Interagency Task Force on Antimicrobial Resistance (ITFAR) Public Meeting
The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH), all located within the Department of Health and Human Services, in collaboration with partner agencies, announce a public meeting concerning antimicrobial resistance. CDC, FDA, and NIH serve as Co- Chairs to the Interagency Task Force on Antimicrobial Resistance (ITFAR). The purpose of the meeting is to communicate the strategic direction of ITFAR in the fight against antimicrobial resistance, centering on current work and future direction in this area.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Prospective Grant of Exclusive License: The Development of Chimeric Antigen Receptors Targeting B-Cell Maturation Antigen To Treat or Prevent Cancer and Autoimmune Disease
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Bluebird Bio to practice the inventions embodied in US Provisional Patent Application Serial No. 61/622,600, entitled ``Chimeric Antigen Receptors Targeting B-cell Maturation Antigen'' [HHS Ref. E-040-2012/0-US-01], and International (PCT) Application No. PCT/ US13/32029, entitled ``Chimeric Antigen Receptors Targeting B-cell Maturation Antigen'' [HHS Ref. E-040-2012/0-PCT-02], and all continuing applications and foreign counterparts. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:
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