Department of Health and Human Services June 23, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 24 of 24
Announcement of Revision to the Department of Health and Human Services Guidance on Procedures for the Provision of Marijuana for Medical Research as Published on May 21, 1999.
Announcement of the elimination of the Public Health Service (PHS) review of non-federally funded research protocols involving marijuana and the utilization of the existing Food and Drug Administration (FDA) Investigational New Drug (IND) process for drug development.
Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements
The Food and Drug Administration (FDA or we) is amending the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.
Veterinary Feed Directive; Correction
The Food and Drug Administration (FDA) is correcting a final rule entitled ``Veterinary Feed Directive'' that appeared in the Federal Register of June 3, 2015 (80 FR 31708). The rule amended FDA's animal drug regulations regarding veterinary feed directive (VFD) drugs. The document published with typographical and formatting errors. This document corrects those errors.
Prospective Grant of Start-up Exclusive Evaluation Option License: A Novel HIV-1 Entry Inhibitor
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 a start-up exclusive evaluation option license agreement to practice the inventions embodied in U.S. Provisional Patent Application No. 61/791,885 (NIH Ref. No. E- 033-2013/0-US-01), filed March 15, 2013; International PCT Application No. PCT/US2014/024120 (NIH Ref. No. E-033-2013/1-PCT-01), filed March 12, 2014; all entitled, ``Stabilized Single Human CD4 Domains and Fusion Proteins;'' and all continuing applications and foreign counterparts to Absino Co., Ltd, a company having a place of business in Beijing, China. The patent rights in these inventions have (a) been assigned to the United States of America, as represented by the Secretary, Department of Health and Human Services who has delegated authority for the licensing of inventions to the National Institutes of Health or (b) been exclusively licensed to the National Institutes of Health. The prospective start-up exclusive evaluation option license territory may be China, the U.S., and Europe, and the field of use may be limited to the development of bispecific multivalent human immunodeficiency virus type 1 (HIV-1) neutralizing fusion proteins as HIV entry inhibitors for the treatment of HIV infections. Upon the expiration or termination of the start-up exclusive evaluation option license, Absino Co., Ltd will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the start-up exclusive evaluation option license with no greater field of use and territory than granted in the start-up exclusive evaluation option license.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication
The Food and Drug Administration (FDA) is republishing in its entirety a final order entitled ``Medical Devices; Gastroenterology- Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation'' that published in the Federal Register on May 28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent omission of information. FDA is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Uses
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products
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.
Medical Examination of Aliens-Revisions to Medical Screening Process
The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is issuing this Notice of Proposed Rulemaking (NPRM) to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Specifically, HHS/CDC proposes to: revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA); revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; clarify and revise the evaluation requirements for tuberculosis; clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and update the titles and designations of federal agencies within the text of the regulation.
National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table
On July 24, 2013, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table). The basis for this change is consistent with the Secretary's findings that intussusceptions can reasonably be determined in some circumstances to be caused by rotavirus vaccines. The Secretary is now making this amendment to the Table and to the Qualifications and Aids to Interpretation (QAI), described below under Background Information, as proposed in the NPRM. These regulations will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
