Department of Health and Human Services September 2014 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 271
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2014-21951
Type: Notice
Date: 2014-09-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2014-21950
Type: Notice
Date: 2014-09-16
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2014-21918
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2014-21917
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-21909
Type: Notice
Date: 2014-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21885
Type: Notice
Date: 2014-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21881
Type: Notice
Date: 2014-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2014-21859
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21858
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2014-21857
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-21856
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive Evaluation License: Development of Antibody-Drug Conjugates Comprising Topoisomerase Inhibitors for the Treatment of Human Cancers
Document Number: 2014-21855
Type: Notice
Date: 2014-09-15
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 license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/844,027 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2006 [HHS Ref. No. E- 160-2006/0-US-01], PCT Application No. PCT/US2007/078233 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E-160-2006/0-PCT-02], European Patent Application No. 7842310.0 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E- 160-2006/0-EP-03], and U.S. Patent Application No. 12/441,029 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed March 12, 2009 now US Patent No. 8,008,316 issued August 30, 2011 [HHS Ref. No. E-160-2006/0-US-04], and all related continuing and foreign patents/patent applications for the technology family, to Oncolinx, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the development and use of the licensed patent rights as a component of an antibody-drug conjugate for the treatment of human cancers. Upon expiration or termination of the exclusive evaluation option license, Oncolinx will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-21854
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services
Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices
Document Number: 2014-21816
Type: Proposed Rule
Date: 2014-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls). In response to the requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed administrative order to reclassify EPPGs.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Withdrawal of Draft Guidance
Document Number: 2014-21815
Type: Notice
Date: 2014-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of the draft guidance entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator,'' dated October 2011, in response to the requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA) and new input received during a panel meeting.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
Document Number: 2014-21814
Type: Proposed Rule
Date: 2014-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls), and to amend the device identification and reclassify the pacing system analyzers (PSAs) into class II (special controls). Specifically, single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are postamendments class III devices, are proposed to be reclassified to class II devices. FDA is proposing this reclassification based on new information pertaining to the device. This proposed action would implement certain statutory requirements.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-21799
Type: Notice
Date: 2014-09-12
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-21798
Type: Notice
Date: 2014-09-12
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.
Submission for OMB Review; 30-Day Comment Request; Cancer Epidemiology Descriptive Cohort Database (NCI)
Document Number: 2014-21785
Type: Notice
Date: 2014-09-12
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 Institutes of Health (NIH), 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 June 18, 2014, Vol. 79, page 34766 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 Cancer Institute (NCI), 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, OIRAsubmission@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.
Submission for OMB Review; 30-Day Comment Request Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI)
Document Number: 2014-21783
Type: Notice
Date: 2014-09-12
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 Institutes of Health (NIH), 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 May 8, 2014, Vol. 79, No. 89, page 26439 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 Cancer Institute (NCI), 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, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice
Document Number: 2014-21780
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of April 25, 2014 (79 FR 22995). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Allegations of Regulatory Misconduct Associated With Medical Devices
Document Number: 2014-21769
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2014-21762
Type: Notice
Date: 2014-09-12
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Joslyn Manufacturing Company in Fort Wayne, Indiana, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21754
Type: Notice
Date: 2014-09-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products
Document Number: 2014-21729
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of three abbreviated new drug applications (ANDAs) for products containing propoxyphene. The basis for the withdrawals is that the products are no longer shown to be safe because propoxyphene puts patients at risk of potentially serious and even fatal heart rhythm abnormalities. The holders of these ANDAs have waived their opportunity for a hearing.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
Document Number: 2014-21728
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Eye Tracking Study of Direct-to- Consumer Prescription Drug Advertisement Viewing'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Advertisements
Document Number: 2014-21727
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Advertisements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
Document Number: 2014-21726
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing ``Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Health Care Practitioners for Device Labeling Format and Content
Document Number: 2014-21725
Type: Notice
Date: 2014-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
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 the proposed information collection ``Survey of Health Care Practitioners for Device Labeling Format and Content.''
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21722
Type: Notice
Date: 2014-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2014-21721
Type: Notice
Date: 2014-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2014-21720
Type: Notice
Date: 2014-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21719
Type: Notice
Date: 2014-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2014-21718
Type: Notice
Date: 2014-09-12
Agency: Department of Health and Human Services, National Institutes of Health
2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
Document Number: 2014-21633
Type: Rule
Date: 2014-09-11
Agency: Department of Health and Human Services, Office of the Secretary
This final rule introduces regulatory flexibilities and general improvements for certification to the 2014 Edition EHR certification criteria (2014 Edition). It also codifies a few revisions and updates to the ONC HIT Certification Program for certification to the 2014 Edition and future editions of certification criteria as well as makes administrative updates to the Code of Federal Regulations.
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-21594
Type: Notice
Date: 2014-09-11
Agency: Department of Health and Human Services, National Institutes of Health
Findings of Research Misconduct; Correction
Document Number: 2014-21284
Type: Notice
Date: 2014-09-11
Agency: Department of Health and Human Services, Office of the Secretary
This document corrects errors that appeared in the notice published in the July 30, 2014, Federal Register entitled ``Findings of Research Misconduct.''
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute)
Document Number: 2014-21569
Type: Notice
Date: 2014-09-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial review
Document Number: 2014-21568
Type: Notice
Date: 2014-09-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations of Candidates To Serve on the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2014-21567
Type: Notice
Date: 2014-09-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: 2014-21553
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA published a notice in the Federal Register, FR 2014-18735 (August 8, 2014), announcing the meeting of the National Advisory Committee on Rural Health and Human Services in Sioux Falls, South Dakota (Federal Register, Vol. 79, No. 153, 46445). The site for the opening of the meeting has been changed.
Notice of Correction for Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting
Document Number: 2014-21540
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Testing Communications on Biological Products
Document Number: 2014-21533
Type: Notice
Date: 2014-09-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Testing Communications on Biological Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey
Document Number: 2014-21532
Type: Notice
Date: 2014-09-10
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.
Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction
Document Number: 2014-21481
Type: Proposed Rule
Date: 2014-09-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a proposed rule entitled ``Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications'' that appeared in the Federal Register of August, 22, 2014. The document proposed to amend the biologics regulations by removing the general safety test requirements for biological products. The document published with the incorrect title. This document corrects that error.
Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry; Availability
Document Number: 2014-21480
Type: Notice
Date: 2014-09-10
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 industry entitled ``Unique Device Identification System: Small Entity Compliance Guide'' for a final rule published in the Federal Register of September 2013. This small entity compliance guide (SECG) intends to provide, in plain language, the requirements of the regulation and to help small businesses understand and comply with the regulation.
Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents
Document Number: 2014-21479
Type: Rule
Date: 2014-09-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21468
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21467
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21466
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services, National Institutes of Health