Department of Health and Human Services May 2013 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 353
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-11602
Type: Notice
Date: 2013-05-16
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. 207 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 Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meetings
Document Number: 2013-11600
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Meetings
Document Number: 2013-11599
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2013-11598
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2013-11582
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-11340
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, Agency for Healthcare Research and Quality Agency Information Collection Activities
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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
State Median Income Estimates for a Four-Person Household: Notice of the Federal Fiscal Year (FFY) 2014 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP)
Document Number: 2013-11575
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, Administration for Children and Families
This notice announces to grantees of the Low Income Home Energy Assistance Program (LIHEAP) the estimated median income of four- person households in each state and the District of Columbia for FFY 2014 (October 1, 2013, to September 30, 2014). LIHEAP grantees that choose to base their income eligibility criteria on these state median income (SMI) estimates may adopt these estimates (up to 60 percent) on their date of publication in the Federal Register or on a later date as discussed in the ``Dates'' section. This enables grantees to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2013, or the beginning of the grantee's fiscal year, whichever is later, such grantees must adjust their income eligibility criteria so that they are in accord with the FFY 2014 SMI. Sixty percent of SMI provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
Medicaid Program; State Disproportionate Share Hospital Allotment Reductions
Document Number: 2013-11550
Type: Proposed Rule
Date: 2013-05-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. This proposed rule delineates a methodology to implement the annual reductions for FY 2014 and FY 2015. The rule also proposes to add additional DSH reporting requirements for use in implementing the DSH health reform methodology.
National Center for Advancing Translational Sciences; Request for Comment on Proposed Methods for Avoiding Duplication, Redundancy and Competition With Industry Activities
Document Number: 2013-11526
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) invites comments regarding proposed methods it will use to avoid duplication, redundancy and competition with industry activities.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-11501
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-11494
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-11493
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2013-11492
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-11491
Type: Notice
Date: 2013-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Zentox Corporation; Withdrawal of Food Additive Petition
Document Number: 2013-11499
Type: Proposed Rule
Date: 2013-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 8A4775) proposing that the food additive regulations be amended to provide for the safe use of monochloramine as an antimicrobial agent in poultry process chiller water.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-11440
Type: Notice
Date: 2013-05-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Submission for OMB Review; Comment Request; OAA Title III-C Evaluation
Document Number: 2013-11388
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services
The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements
Document Number: 2013-11364
Type: Notice
Date: 2013-05-14
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 Product Labeling; Medication Guide Requirements'' 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; Communicating Composite Scores in Direct-to-Consumer Advertising
Document Number: 2013-11363
Type: Notice
Date: 2013-05-14
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.
Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability
Document Number: 2013-11361
Type: Notice
Date: 2013-05-14
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 and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.'' The guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies that use electronic healthcare data. The guidance includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA's review of protocols and final reports that are submitted to the Agency.
Prospective Grant of Exclusive License: Device and System for Expression Microdissection (xMD)
Document Number: 2013-11357
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive commercial license agreement to practice the inventions embodied in International PCT Application S/N PCT/US03/23317 (HHS Ref. No. E-113-2003/0-PCT-02) filed July 23, 2003, which published as WO 2004/068104 on August 12, 2004, now expired; U.S. Patent No. 7,709,047 (HHS Ref. No. E-113-2003/0-US-03) issued May 4, 2010; U.S. Patent Application S/N 12/753,566 (HHS Ref. No. E-113-2003/0-US-07) filed April 2, 2010; U.S. Patent No. 7,695,752 (HHS Ref. No. E-113- 2003/1-US-01) issued April 13, 2010; U.S. Patent Application S/N 12/ 713,105 (HHS Ref. No. E-113-2003/1-US-02) filed February 25, 2010; Australian Patent No. 2003256803 (HHS Ref. No. E-113-2003/0-AU-04) issued January 21, 2010; Australian Patent Application S/N 2009250964 (HHS Ref. No. E-113-2003/0-AU-06) filed July 23, 2009; and Canadian Patent Application S/N 2513646 (HHS Ref. No. E-113-2003/0-CA-05) filed July 23, 2003, all entitled; ``Target Activated Microtransfer;'' and all continuing applications and foreign counterparts to xMD Diagnostics, LLC, a company having a place of business in Maryland. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to the following below. ``Devices, systems, kits and related consumables, and methods using devices, systems, kits and related consumables, for micro-dissection of biological specimens, as covered by the Licensed Patents Rights (the ``Exclusive Field''). xMD Diagnostics, LLC (xMD) shall be the only entity granted rights in the Exclusive Field for commercial or other ``for-profit purposes. Methods, kits, and related consumables that are used independent of the devices or systems by individual researchers employed at non-profit and academic institutions, if such kits were built by the researchers themselves from component parts and used for their own individual research purposes, shall not infringe xMD's rights. Diagnostic services performed using devices, systems, kits and related consumables purchased from xMD (or xMD's authorized distributor(s)) by those persons employed at non-profit and academic institutions that purchased the devices, systems, kits and related consumables used in the diagnostic services, shall not infringe xMD's rights.''
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-11356
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2013-11355
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-11354
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2013-11353
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-11352
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2013-11351
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2013-11350
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2013-11349
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2013-11348
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-11347
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-11346
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-11345
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-11344
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-11343
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-11342
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
Document Number: 2013-11331
Type: Notice
Date: 2013-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2013-11330
Type: Notice
Date: 2013-05-14
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: 2013-11329
Type: Notice
Date: 2013-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2013-11202
Type: Notice
Date: 2013-05-14
Agency: Department of Health and Human Services, Administration for Children and Families
Draft Interagency Risk Assessment-Listeria monocytogenes
Document Number: 2013-11298
Type: Notice
Date: 2013-05-13
Agency: Department of Agriculture, Food Safety and Inspection Service, Food and Drug Administration, Department of Health and Human Services
The United States Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA)/Center for Food Safety and Applied Nutrition (CFSAN) are announcing the availability of the draft ``Interagency Risk AssessmentListeria monocytogenes in Retail Delicatessens.'' This draft quantitative risk assessment (QRA) includes an Interpretive Summary and a Technical Report. The purpose of the draft QRA is to evaluate the conditions, such as Listeria (L.) monocytogenes contamination of certain ready-to-eat (RTE) foods, for example cheese, deli meats, and deli salads; in the retail deli environment; in niches (a harborage site); or on incoming RTE foods, that contribute to cross- contamination and ultimately, to the risk of listeriosis. The draft QRA makes it possible to evaluate the effectiveness of some retail practices and intervention strategies in reducing the predicted risk of listeriosis from some RTE foods that are sliced, packaged, or prepared in retail delicatessens and consumed in the home.
Proposed Collection; 60-Day Comment Request: National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress Reports
Document Number: 2013-11294
Type: Notice
Date: 2013-05-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dorothy Farrell, Center for Strategic Scientific Initiatives, Office of Cancer Nanotechnology Research, National Cancer Institute, 31 Center Drive, Bldg. 31 A, Rm. 10A52, Bethesda, MD 20892 or call non-toll-free number 301-496-5652 or Email your request, including your address to: farrelld@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress Reports, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: National Institutes of Health grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a request for OMB to approve new program specific progress report guidelines for Cancer Nanotechnology Platform Partnerships (CNPP) awarded by the National Cancer Institute (NCI). The CNPPs are part of the Alliance for Nanotechnology in Cancer, a network of awards funded by NCI to promote the application of nanotechnology to cancer research and care. The proposed guidelines request information about award performance related to trans-Alliance collaboration, scientific milestones, progress towards clinical translation and technology commercialization, and education and outreach efforts. The report also gathers information on leveraged funding, patents and publications. The information is gathered every six months. This information is needed to monitor the performance of this special program within NCI, funded through Requests for Applications (RFA CA-09-013, released May 29, 2009) using the cooperative agreement mechanism (U01). The information will be used to monitor individual award performance and the effectiveness of the program as a whole. The respondents are the Principal Investigators of the awards, along with their institutional business officials. The awards are administered by and the reports reviewed by the Office of Cancer Nanotechnology Research (OCNR), part of the Center for Strategic Scientific Initiatives within NCI. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 72.
Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-11286
Type: Notice
Date: 2013-05-13
Agency: Food and Drug Administration, Department of Health and Human Services
Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-11285
Type: Notice
Date: 2013-05-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met.
New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor
Document Number: 2013-11283
Type: Rule
Date: 2013-05-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name and address from Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC. The regulations are also being amended to reflect that Zoetis Inc. is a sponsor of approved NADAs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug Applications and Supporting Regulations and Form FDA 356V
Document Number: 2013-11273
Type: Notice
Date: 2013-05-13
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.
National Advisory Council on Migrant Health; Cancellation of Meeting
Document Number: 2013-11259
Type: Notice
Date: 2013-05-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-11257
Type: Notice
Date: 2013-05-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443-1984.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-11256
Type: Notice
Date: 2013-05-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443- 1984. HRSA especially requests comments on: (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. Information Collection Request Title: Information and Referral and Professional Training Impact Surveys in Health Resources and Services Administration (HRSA)Funded Traumatic Brain Injury Grants (OMB No. 0915-xxxx)New
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-11251
Type: Notice
Date: 2013-05-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration