Department of Health and Human Services June 2015 – Federal Register Recent Federal Regulation Documents
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List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations; Correction
The Food and Drug Administration is correcting a notice entitled ``List of Bulk Drug Substances That May Be Used by an Outsourcing Facility to Compound Drugs for Use in Animals; Request for Nominations'' that appeared in the Federal Register of May 19, 2015 (80 FR 28622). The document announced the intention to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' The document was published with an incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Hearing, Aging, and Direct-to-Consumer Television Advertisements
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 research entitled, ``Hearing, Aging, and Direct-to-Consumer Television Advertisements''. This study will examine how changes to hearing across the lifespan affect the comprehension of direct-to-consumer (DTC) television advertisements for prescription drugs.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed extension of the ``Formative Research and Tool Development'' information collection. Project activities are designed to allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) to conduct formative research information collection activities used to inform many aspects of surveillance, communications, health promotion, and research project development for NCHHSTP's four priority diseases (HIV/AIDS), sexually transmitted diseases/infections (STD/STI), viral hepatitis, tuberculosis elimination (TB), and school and adolescent health (DASH).
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the collection of Minimum Data Elements (MDE) for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). CDC collects information about the cancer screening services provided through the NBCCEDP to support program management.
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.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C., notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https:// www.dhhs.gov/ohrp/sachrp/mtgings/.
Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), July 22, 2015
This notice announces the rescheduling of the June 25, 2015 meeting and announces the new meeting date of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has realigned the Office of Legislative Affairs and Budget (OLAB). This realignment will permit the office to serve as the ACF liaison to the Government Accountability Office (GAO) and to the Office of Inspector General (OIG) for OIG engagements relating to the management of ACF programs.
Agency Information Collection Activities; Submission to OMB for Review and Approval; 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 renewal of the approved information collection assigned OMB control number 0990-0388, scheduled to expire on July 31, 2015. 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.
Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Meal
The Food and Drug Administration (FDA or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of seed meal from a variety of bioengineered safflower in cattle and poultry feeds. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.
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