Department of Health and Human Services December 24, 2014 – Federal Register Recent Federal Regulation Documents

Prospective Grant of Start-Up Exclusive Commercialization License: Anti-Tyrosine Kinase-Like Orphan Receptor 1 Immunotoxins for the Treatment of Human Cancers
Document Number: 2014-30259
Type: Notice
Date: 2014-12-24
Agency: Department of Health and Human Services, National Institutes of Health
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 commercialization license to practice the inventions embodied in U.S. Patent Application 61/172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-US-01], U.S. Patent Application No. 13/990,977 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'' filed June 7, 2013 [HHS Ref. No. E-039-2011/0], U.S. Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], U.S. Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A that Remove Immunogenic Epitopes with Affecting Cytotoxic Activity'' [HHS Ref. E- 292-2007/0-US-01], U.S. Patent Application 61/241,620 entitled ``Improved Pseudomonas Exotoxin A with Reduced Immunogenicity'' [HHS Ref. E-269-2009/0-US-01], U.S. Patent Application 61/483,531 entitled ``Recombinant Immunotoxin Targeting Mesothelin'' [HHS Ref. E-117-2011/ 0-US-01], U.S. Patent Application 61/495,085 entitled ``Pseudomonas Exotoxin A with Less Immunogenic T-Cell/or B-Cell Epitopes'' [HHS Ref. E-174-2011/0-US-01], U.S. Patent Application 61/535,668 entitled ``Pseudomonas Exotoxin A with Less Immunogenic B-Cell Epitopes'' [HHS Ref. E-263-2011/0-US-01], and any PCT, US or foreign applications claiming benefit of the technology families, to Magnifygen, Inc. 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 the development and use of immunotoxins comprising an anti-tyrosine kinase-like orphan receptor 1 monoclonal antibody designated as 2A2, R11, R12, or Y31 and Pseudomonas exotoxin A for the treatment of human cancers as claimed within the scope of the Licensed Patent Rights. For avoidance of doubt, the Licensed Field of Use excludes the development of antibody-drug conjugates and bispecific antibodies comprising said antibodies.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2014-30237
Type: Notice
Date: 2014-12-24
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place via conference call. This call will be open to the public. Individuals who want to make public comments should send their request to cfsac@hhs.gov, by January 7, 2015.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
Document Number: 2014-30157
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Rare Pediatric Disease Priority Review Vouchers; Extension of Comment Period
Document Number: 2014-30154
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice of availability (NOA) that appeared in the Federal Register of November 17, 2014. In the NOA, FDA requested comments on the Agency's implementation of the Rare Pediatric Disease Priority Review Vouchers Program. This action will allow interested persons additional time to submit comments.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2014-30149
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
Food Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
Document Number: 2014-30144
Type: Rule
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is responding to objections we received on the final rule that amended the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except in meat and poultry. After reviewing the objections to the final rule, we have concluded that they do not provide a basis for modifying or revoking the regulation. We are also confirming the effective date of May 21, 2014, for the final rule.
Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Availability
Document Number: 2014-30142
Type: Proposed Rule
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.
Medical Device Classification Procedures; Reclassification Petition: Content and Form; Technical Amendment
Document Number: 2014-30141
Type: Rule
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations for petitioning for device reclassification to update mailing addresses for the petitions. This action is being taken to improve the accuracy of the regulations.
Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability
Document Number: 2014-30109
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension.
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus; Availability
Document Number: 2014-30108
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for two in vitro diagnostic devices for detection of the Ebola Zaire virus. FDA is issuing these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-30083
Type: Notice
Date: 2014-12-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-30027
Type: Notice
Date: 2014-12-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-30026
Type: Notice
Date: 2014-12-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual Harassment Involving Unaccompanied Children
Document Number: 2014-29984
Type: Rule
Date: 2014-12-24
Agency: Department of Health and Human Services, Administration for Children and Families
This IFR proposes standards and procedures to prevent, detect, and respond to sexual abuse and sexual harassment involving unaccompanied children (UCs) in ORR's care provider facilities.