Department of Health and Human Services March 22, 2016 – Federal Register Recent Federal Regulation Documents

Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2016-06448
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
This notice sets forth final changes to the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to incorporate the recommendations of the Institute of Medicine (IOM) regarding human gene transfer protocols, as initially outlined by the NIH Office of Science Policy (OSP) in a Federal Register notice issued on October 16, 2015 (80 FR 62543). Following the solicitation of public comment on its original proposal, the NIH is amending the NIH Guidelines in the following areas: (A) The criteria for selecting protocols for in-depth review and public discussion by the NIH Recombinant DNA Advisory Committee (RAC), (B) the process by which human gene transfer protocols are reviewed and registered with the NIH, and (C) the streamlining of the NIH protocol submission requirements under Appendix M-I-A of the NIH Guidelines. In a continuing effort to harmonize with the Food and Drug Administration (FDA) regulations, a change is being made to the reporting requirement for additional clinical trial sites allowing for a delay of 30 days to submit appropriate documentation. The changes set forth in this notice do not affect the responsibility of the Principal Investigator to submit documentation to his or her local oversight bodies and to the NIH, nor do they affect the requirement to submit appropriate documentation to the NIH when new clinical trial sites are registered. The changes also do not affect the responsibility of a Principal Investigator (or a delegated clinical trial sponsor) to submit appropriate and timely follow up information to the NIH as outlined in the NIH Guidelines (e.g., protocol amendments, serious adverse events, annual reports with cumulative safety data).
Request for Public Comment: 30-Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
Document Number: 2016-06445
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 and 164),'' Office of Management and Budget (OMB) Control Number 0917-0030.
Milton W. Chu, M.D.; Filing of Color Additive Petition
Document Number: 2016-06397
Type: Proposed Rule
Date: 2016-03-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Milton W. Chu, M.D., proposing that the color additive regulations be amended to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.
Prospective Grant of Exclusive License: Development and Commercialization of Cancer Immunotherapy
Document Number: 2016-06374
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
This 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 patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Midissia Therapeutics (``MIDISSIA'') located in San Francisco, California, USA.
2016 Parenteral Drug Association/Food and Drug Administration Joint Conference: Aligning Manufacturing Goals With Patient Needs Through Successful Innovation and Compliance
Document Number: 2016-06366
Type: Notice
Date: 2016-03-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public conference, to be held in cosponsorship with the Parenteral Drug Association (PDA), entitled ``Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance.'' The conference will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement of safe and effective medical products. The conference establishes a unique forum to discuss the foundations, emerging technologies, and innovations in regulatory science, as well as the current quality and compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product.
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-06361
Type: Notice
Date: 2016-03-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.'' FDA is confronted with an increasing number of premarket submissions that include an MR Conditional labeling claim for multiconfiguration passive medical devices. The assessment of radiofrequency (RF)-induced heating of such devices, typically comprised of many parts, strongly depends on the specific device geometry and can therefore lead to a prohibitively large number of test cases. This guidance provides an approach to reduce the number of possible device configurations to a manageable number, and it provides guidance on how to assess the RF-induced device heating for an individual configuration.
Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
Document Number: 2016-06360
Type: Proposed Rule
Date: 2016-03-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is proposing these devices be banned.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-06354
Type: Notice
Date: 2016-03-22
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: 2016-06353
Type: Notice
Date: 2016-03-22
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: 2016-06352
Type: Notice
Date: 2016-03-22
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: 2016-06351
Type: Notice
Date: 2016-03-22
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: 2016-06350
Type: Notice
Date: 2016-03-22
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: 2016-06349
Type: Notice
Date: 2016-03-22
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: 2016-06348
Type: Notice
Date: 2016-03-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Council for the Elimination of Tuberculosis (ACET)
Document Number: 2016-06346
Type: Notice
Date: 2016-03-22
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: 2016-06345
Type: Notice
Date: 2016-03-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; the National Maltreatment Reporting System
Document Number: 2016-06342
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the National Maltreatment Reporting System (NAMRS). The proposed collection of information tools may be found in the NAMRS section of the ACL Web site.
National Institute of Environmental Health Sciences, Notice of Closed Meetings
Document Number: 2016-06337
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Document Number: 2016-06336
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute, Notice of Meeting
Document Number: 2016-06335
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review, Notice of Closed Meetings
Document Number: 2016-06334
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health Notice of Meeting
Document Number: 2016-06333
Type: Notice
Date: 2016-03-22
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-day Comment Request: Cancer Genomics Cloud Pilots Survey (NCI)
Document Number: 2016-06332
Type: Notice
Date: 2016-03-22
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 Cancer Institute (NCI), 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 January 13, 2016, Vol. 81 pp.1633 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 (NIH), 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.