Department of Health and Human Services March 31, 2014 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Survey of Older Americans Act Participants
Document Number: 2014-07148
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2014-07112
Type: Notice
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-07110
Type: Notice
Date: 2014-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 10th, 2014 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Submission for OMB Review; 30-Day Comment Request: Generic Clearance To Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD)
Document Number: 2014-07105
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2013, pages 79472-79473 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Child Health and Human Development, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Patient Safety Organizations: Expired Listing From Society of Hospital Medicine PSO
Document Number: 2014-07097
Type: Notice
Date: 2014-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing from the Society of Hospital Medicine PSO has expired and AHRQ has delisted the PSO accordingly.
Determination of Regulatory Review Period for Purposes of Patent Extension; NULOJIX
Document Number: 2014-07060
Type: Notice
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for NULOJIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
The Food and Drug Administration and Global Engagement: Progress on the Pathway to Global Product Safety
Document Number: 2014-07059
Type: Notice
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Denver District Office, in cosponsorship with the Association of Food and Drug Officials (AFDO), will be hosting the 118th AFDO Annual Educational Conference. During the conference, a 2-day public workshop will be held entitled ``FDA and Global Engagement: Progress on the Pathway to Global Product Safety,'' This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.
Determination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-13
Document Number: 2014-07058
Type: Notice
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for PREVNAR-13 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3); Availability
Document Number: 2014-07046
Type: Proposed Rule
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).'' The draft guidance addresses questions received since the publication of the second edition of the guidance in May 2004 and includes information related to the Food Safety Modernization Act (FSMA), which amended the Federal Food, Drug, and Cosmetic Act, to require the name of any country to which an article has been refused entry be reported in a prior notice. The draft guidance is intended to help the food industry and others comply with prior notice requirements.
Prospective Grant of Exclusive License: Multivalent Vaccines for Rabies Virus and Ebola and Marburg (Filoviruses)
Document Number: 2014-07023
Type: Notice
Date: 2014-03-31
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 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: E-032-2011/0, Blaney et al., ``Multivalent Vaccines for Rabies Virus and Filoviruses,'' U.S. Patent Application Number 61/439,046, filed on February 3, 2011, PCT Application Number PCT/US2012/23575, filed on February 2, 2012, U.S. Patent Application Number 13/983,545, filed on August 2, 2013, European Patent Application Number 12702953.6, filed on February 2, 2012, and Canadian Patent Application Number 2826594, filed on February 2, 2012, to Exxell BIO, Inc., having a place of business in Shoreview, Minnesota, United States of America. The patent rights in these inventions have been assigned to the United States of America and Thomas Jefferson University.
Prospective Grant of Exclusive License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers
Document Number: 2014-07022
Type: Notice
Date: 2014-03-31
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 an exclusive start-up option license to practice the inventions embodied in U.S. Patent Application 61/706,396 entitled ``Mesothelin Antibodies and Methods for Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/0-US-01], PCT Application PCT/US2013/059883 entitled ``Mesothelin Antibodies and Methods for Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/ 0-PCT-02], and all related continuing and foreign patents/patent applications for the technology family, to H2Bio, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to:
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2014-07021
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2014-07020
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2014-07019
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-07018
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-07017
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2014-07016
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-06999
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability
Document Number: 2014-06997
Type: Notice
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA advisory committee members, and FDA staff, entitled ``Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' We are issuing the guidance to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. This guidance replaces the guidance of the same title dated March 2012.
Meeting of the National Biodefense Science Board
Document Number: 2014-06996
Type: Notice
Date: 2014-03-31
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.
Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction
Document Number: 2014-06994
Type: Rule
Date: 2014-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect the withdrawal of approval of new animal drug applications (NADAs) that appeared in the Federal Register of February 27, 2014 (79 FR 10976). That document listed an NADA for which a withdrawal of approval (WOA) was not intended and failed to remove all conditions of use associated with the withdrawn NADAs. This correction is being made to improve the accuracy of the animal drug regulations.
World Trade Center Health Program; Petition 003-Kidney Damage; Finding of Insufficient Evidence
Document Number: 2014-06906
Type: Proposed Rule
Date: 2014-03-31
Agency: Department of Health and Human Services
On January 22, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition to add ``kidney damage'' (Petition 003) to the List of WTC-Related Health Conditions (List). The Administrator has not found sufficient scientific evidence to conduct an analysis of whether to add kidney damage and/or disease to the List. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Countermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury Table
Document Number: 2014-06102
Type: Proposed Rule
Date: 2014-03-31
Agency: Department of Health and Human Services
The Public Readiness and Emergency Preparedness Act (PREP Act) directs the Secretary of Health and Human Services (the Secretary), to establish a Countermeasures Injury Compensation Program (the Program) to provide ``timely, uniform, and adequate compensation'' to eligible individuals who sustain serious physical injuries or to certain survivors of individuals who die as a direct result of the use or administration of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. The Secretary has delegated authority to administer the Program to the Health Resources and Services Administration (HRSA). Through this regulation, the Secretary proposes a Table for pandemic influenza covered countermeasures identified by the Secretary in several PREP Act declarations. This regulation also includes proposed Table time intervals for the first symptom or manifestation of onset of injury, Table injury definitions, and requirements which define the terms and conditions included on the Table. These are considered part of the proposed Table.