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

Results 151 - 200 of 282
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.
Regulatory Science Considerations for Software Used in Diabetes Management; Public Workshop; Request for Comments
Document Number: 2014-24451
Type: Notice
Date: 2014-10-15
Agency: Food and Drug Administration, Department of Health and Human Services
Distinguishing Medical Device Recalls From Medical Device Enhancements; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-24446
Type: Notice
Date: 2014-10-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, ``Distinguishing Medical Device Recalls From Medical Device Enhancements.'' This guidance is intended to clarify when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and explain reporting requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling of Natural Rubber Latex Condoms
Document Number: 2014-24445
Type: Notice
Date: 2014-10-15
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, 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 for the labeling of natural rubber latex condoms.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Drug User Fee Cover Sheet
Document Number: 2014-24444
Type: Notice
Date: 2014-10-15
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 ``Animal Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC)
Document Number: 2014-24442
Type: Notice
Date: 2014-10-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-24438
Type: Notice
Date: 2014-10-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Library of Medicine; Notice of Closed Meeting
Document Number: 2014-24425
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-24403
Type: Notice
Date: 2014-10-15
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.
National Library of Medicine; Notice of Meeting
Document Number: 2014-24399
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2014-24398
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2014-24396
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2014-24395
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2014-24394
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2014-24393
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2014-24391
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2014-24390
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2014-24389
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2014-24388
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-24387
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2014-24386
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-24385
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2014-24384
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: 2014-24383
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-24382
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2014-24380
Type: Notice
Date: 2014-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions
Document Number: 2014-24365
Type: Notice
Date: 2014-10-15
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 information collection associated with a survey of pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.
Submission for OMB Review; 30-Day Comment Request; Evaluation of National Institutes of Health International Bilateral Programs (FIC, NCI, NIAAA, NIAID, NICHD, NIDA, NINDS, NIMH, OAR)
Document Number: 2014-24437
Type: Notice
Date: 2014-10-14
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 March 13, 2014 (Vol. 79, P. 14256) 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-24381
Type: Notice
Date: 2014-10-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2014-24339
Type: Notice
Date: 2014-10-14
Agency: Department of Health and Human Services, Administration for Children and Families
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2014-24334
Type: Notice
Date: 2014-10-14
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its nineteenth meeting on November 5-6, 2014. At this meeting, the Commission will conclude discussions related to the BRAIN Initiative and ongoing work in neuroscience, and begin discussions about the role of deliberation and education in bioethics.
Submission for OMB Review; Comment Request
Document Number: 2014-24329
Type: Notice
Date: 2014-10-14
Agency: Department of Health and Human Services, Administration for Children and Families
Flow Cytometric Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-24308
Type: Notice
Date: 2014-10-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Flow Cytometric Devices.'' This draft guidance addresses the current major review concerns regarding submissions for flow cytometric devices used as in vitro diagnostic devices for leukocyte immunophenotyping and provides suggestions on the content of submissions for these types of devices. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements
Document Number: 2014-24293
Type: Notice
Date: 2014-10-14
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.
Medicare Program; CY 2015 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2014-24257
Type: Notice
Date: 2014-10-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2015 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2015, the inpatient hospital deductible will be $1,260. The daily coinsurance amounts for CY 2015 will be: (1) $315 for the 61st through 90th day of hospitalization in a benefit period; (2) $630 for lifetime reserve days; and (3) $157.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; CY 2015 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2014-24250
Type: Notice
Date: 2014-10-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2015. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2015, for these individuals will be $407. The premium for certain other individuals as described in this notice will be $224.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2015
Document Number: 2014-24248
Type: Notice
Date: 2014-10-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2015. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2015 are $209.80 for aged enrollees and $254.80 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2015 is $104.90, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2014 standard premium rate was $104.90.) The Part B deductible for 2015 is $147.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-24244
Type: Notice
Date: 2014-10-10
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.
Submission for OMB Review; Comment Request
Document Number: 2014-24222
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, Administration for Children and Families
Announcement of a Single-Source Grant Award to Lao Family Community Development, Inc., in Oakland, CA
Document Number: 2014-24205
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Community Services (OCS) announces the award of a single-source grant for $686,000 to the Lao Family Community Development, Inc., in Oakland, CA, to support the renovation of a former warehouse, located in the Fruitvale district, into a mixed-use building.
Statewide Data Indicators and National Standards for Child and Family Services Reviews
Document Number: 2014-24204
Type: Rule
Date: 2014-10-10
Agency: Department of Health and Human Services, Administration for Children and Families
On April 23, 2014, the Administration of Children and Families (ACF) published a document in the Federal Register (79 FR 22604). The document provided the Children's Bureau's plan to replace the statewide data indicators used to determine a state's substantial conformity with titles IV-B and IV-E of the Social Security Act through the Child and Family Services Reviews (CFSRs). After consideration of the public comments and additional Children's Bureau analysis, the Children's Bureau is now publishing its final plan. Where relevant, this document addresses key comments from the field in response to the April 23, 2014 Federal Register document.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-24188
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-24187
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services
National Institute on Aging; Notice of Closed Meetings
Document Number: 2014-24186
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-24185
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-24184
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, National Institutes of Health