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

Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director)
Document Number: 2016-28140
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with 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 August 22, 2016, page 56667 (81 FR 56667) 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.
Indirect Food Additives: Paper and Paperboard Components
Document Number: 2016-28116
Type: Rule
Date: 2016-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of two specific perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods because these uses have been abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of 3M Corporation.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-28107
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, Administration for Children and Families
Solicitation of Written Comments on the Mid-Course Review Working Group Draft Report and Draft Recommendations for Consideration by the National Vaccine Advisory Committee
Document Number: 2016-28090
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (section 2105) (42 U.S. Code 300aa-5). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various Federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in her capacity as the Director of the National Vaccine Program on matters related to vaccine program responsibilities. Recognizing the changes in the immunization landscape, the ASH charged the NVAC to conduct a Mid-course review to evaluate the progress of the National Vaccine Plan and provide recommendations to optimize priority areas. In March 2016, the NVAC formed the Mid-Course Review Working Group. Through a series of conference calls, electronic communication, and public discussions during the NVAC meetings, the working group identified a number of draft recommendations for consideration by the NVAC. These recommendations serve as a useful tool in refining collective strategies for shaping the future of the U.S. immunization enterprise, both domestically and globally. The draft report and draft recommendations from the working group will inform NVAC deliberations as the NVAC finalizes their recommendations for transmittal to the ASH. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in February 2017 at the quarterly NVAC meeting.
Proposed Data Collection Submitted for Public Comment and Recommendations-Zika Virus Associated Neurologic Illness Case Control Study; Correction
Document Number: 2016-28072
Type: Notice
Date: 2016-11-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of November 17, 2016, concerning request for comments on Proposed Data Collection Submitted for Public Comment and RecommendationsZika Virus Associated Neurologic Illness Case Control Study. The document provided the incorrect agency identification number (60Day-17-17ZQ).
Determination of Regulatory Review Period for Purposes of Patent Extension; ANAVIP
Document Number: 2016-28049
Type: Notice
Date: 2016-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ANAVIP 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2016-28048
Type: Notice
Date: 2016-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population'' (E11(R1) addendum). The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is an addendum to the guidance entitled ``E11 Clinical Investigation of Medicinal Products in the Pediatric Population'' (ICH E11 guidance). The draft guidance is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug development.
Determination of Regulatory Review Period for Purposes of Patent Extension; CORE VALVE SYSTEM
Document Number: 2016-28047
Type: Notice
Date: 2016-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for CORE VALVE SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; RUCONEST
Document Number: 2016-28046
Type: Notice
Date: 2016-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for RUCONEST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CERDELGA
Document Number: 2016-28045
Type: Notice
Date: 2016-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for CERDELGA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28043
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-28042
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Charter Renewal
Document Number: 2016-28041
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems
Document Number: 2016-28024
Type: Proposed Rule
Date: 2016-11-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule addresses changes, consistent with the CMCS Informational Bulletin (CIB) concerning ``The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems,'' published on July 29, 2016, to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). The changes prevent increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established in the final Medicaid managed care regulations.
Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute)
Document Number: 2016-28004
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2016-27998
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-27997
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-27996
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27994
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health