Department of Health and Human Services October 16, 2014 – Federal Register Recent Federal Regulation Documents

Statement of Organization, Functions, and Delegations of Authority; Administration for Community Living
Document Number: 2014-24639
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) was created in order to achieve several important objectives: to reduce the fragmentation that currently exists in Federal programs addressing the community living service and support needs of both the aging and disability populations; to enhance access to quality health care and long-term services and supports for all individuals; to promote consistency in community living policy across other areas of the Federal government; and to complement the community infrastructure, as supported by both Medicaid and other Federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities. This reorganization will further advance these objectives by establishing a Center for Consumer Access and Self- Determination to serve as the locus for programs that assist older Americans and people with disabilities to access both health care services and long-term services and supports, as well as initiatives to expand the use of self-directed and person-center service models; and by establishing a Center for Policy and Evaluation to provide a strategic focal point for the development and implementation of policies to improve access to long-term services and supports and enhance opportunities for both populations to live in their communities.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2014-24607
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-24606
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2014-24605
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-24604
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2014-24603
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2014-24602
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-24601
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-24600
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
Document Number: 2014-24599
Type: Notice
Date: 2014-10-16
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.
New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products; Guidance for Industry; Availability
Document Number: 2014-24597
Type: Notice
Date: 2014-10-16
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 ``New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.'' This guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed- combination drug products (fixed combinations). As described in the guidance, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of ``new chemical entity,'' regardless of whether that drug substance is approved in a single-ingredient drug product or in certain fixed- combinations. This guidance finalizes the draft guidance issued in February 2014.
DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)
Document Number: 2014-24593
Type: Proposed Rule
Date: 2014-10-16
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 DSM Nutritional Products, proposing that the food additive regulations be amended to provide for the safe use of Schizochytrium sp. dried algae as a source of docosahexaenoic acid for use in standard pelleted foods for adult dogs.
Announcement of the Award of Two Single-Source Program Expansion Supplement Grants To Support Legal Services to Refugees Under the Unaccompanied Alien Children's Program
Document Number: 2014-24555
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, Administration for Children and Families
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 information collection project: ``Continuing Education for Comparative Effectiveness Research Survey.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 4th, 2014 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment of a Tobacco User Panel
Document Number: 2014-24538
Type: Notice
Date: 2014-10-16
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 establishment of a probability-based panel of tobacco users.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-24513
Type: Notice
Date: 2014-10-16
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 information collection project: ``Care Coordination Quality Measure for Patients in the Primary Care Setting.'' 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 July 30th, 2014 and allowed 60 days for public comment. AHRQ received and responded to comments from two members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Prospective Grant of Exclusive License: Development of T Cell Receptors for Adoptive Transfer in Humans To Treat Cancer
Document Number: 2014-24502
Type: Notice
Date: 2014-10-16
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc., which is located in Los Angeles, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:
Prospective Grant of Exclusive Option License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers
Document Number: 2014-24501
Type: Notice
Date: 2014-10-16
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 General Medical Sciences; Notice of Closed Meeting
Document Number: 2014-24500
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2014-24499
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Public Conference-Vitamin D: Moving Toward Evidence-Based Decision Making for Primary Care
Document Number: 2014-24455
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
A conference to identify issues surrounding evidence-based decision making for vitamin D in primary care will be held December 2- 3, 2014, on the main campus of the National Institutes of Health (NIH) in Bethesda, Maryland. It will also be broadcast as a webinar. The conference discussions will serve to highlight research gaps as well as data and methodological needs relevant to reducing uncertainties surrounding vitamin D in primary care practice. All persons are invited to attend, especially clinical educators, those who develop clinical recommendations, health care providers and researchers. Persons wishing to attend are required to register in advance of the conference.