Department of Health and Human Services January 6, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Announcement of a Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
On December 3, 2014, the National Institutes of Health (NIH) published a request for public comments in the NIH Guide for Grants and Contracts on a draft policy to promote the use of a single Institutional Review Board of record for domestic sites of multi-site studies funded by the NIH. See Guide notice NOT-OD-15-026 at https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html. NIH is publishing this notice in order to inform readers of the Federal Register about the draft policy and the opportunity to comment.
Humic Products Trade Association; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA) is announcing that the Humic Products Trade Assn. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of humate, fulvic acid and humic substances as a source of iron in animal feed.
Determination That REYATAZ (Atazanavir Sulfate) Capsules, 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that REYATAZ (atazanavir sulfate) capsules, 100 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atazanavir sulfate, 100 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
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 (the PRA).
Announcement of the Award of an Urgent Single-Source Grant to the Center for Survivors of Torture in Dallas, TX.
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of an urgent single- source grant in the amount of $250,000 to the Center for Survivors of Torture (CST) in Dallas, TX, to ensure incoming refugee populations in Texas have access to mental health services.
Prospective Grant of Exclusive License: Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific Antibody Conjugate Methods for the Treatment of Cancer
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 HUIYU Pharmaceuticals Co, Ltd located in Neijiang City, CHINA to practice the inventions embodied in U.S. Provisional Patent Application 61/833,732, filed June 11, 2013 entitled ``Her2-Specific Monoclonal Antibodies and Conjugates Thereof'' [HHS Ref. No.: E-351- 2013/0-US-01], and International Application PCT/US2014/041492, filed June 9, 2014 entitled ``Her2-Specific Monoclonal Antibodies and Conjugates Thereof'' [HHS Ref. No.: E-351-2013/0-PCT-02], any PCT, US or foreign applications claiming the benefit of. 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 limited to China, and the field of use may be limited to:
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