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

Patient Protection and Affordable Care Act; Program Integrity: Exchange, SHOP, and Eligibility Appeals
Document Number: 2013-21338
Type: Rule
Date: 2013-08-30
Agency: Department of Health and Human Services
This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, this final rule outlines Exchange standards with respect to eligibility appeals, agents and brokers, privacy and security, issuer direct enrollment, and the handling of consumer cases. It also sets forth standards with respect to a State's operation of the Exchange and Small Business Health Options Program (SHOP). It generally is finalizing previously proposed policies without change.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-21258
Type: Notice
Date: 2013-08-30
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-21257
Type: Notice
Date: 2013-08-30
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.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education
Document Number: 2013-21241
Type: Notice
Date: 2013-08-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry # 108 on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway
Document Number: 2013-21236
Type: Notice
Date: 2013-08-30
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.
Proposed Collection; 60-day Comment Request Cancer Trials Support Unit (CTSU) (NCI)
Document Number: 2013-21225
Type: Notice
Date: 2013-08-30
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: Michael Montello, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive Rockville, MD 20850 or call non-toll-free number 240-276-6080 or Email your request, including your address to: montellom@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: Cancer Trials Support Unit (CTSU) (NCI), 0925- 0624, Expiration Date 12/31/2013, REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Cancer Therapy Evaluation Program (CTEP) establishes and supports programs to facilitate the participation of qualified investigators on CTEP- supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Currently guided by the efforts of the Clinical Trials Working Group (CTWG) and the Institute of Medicine (IOM) recommendations to revitalize the Cooperative Group program, CTEP has funded the Cancer Trials Support Unit (CTSU). The CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. In addition, CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk, the CTSU Web site, and the Protocol and Information Office (PIO). An ongoing user satisfaction survey is in place for the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 24,996.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-21211
Type: Notice
Date: 2013-08-30
Agency: Department of Health and Human Services, Administration for Children and Families
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-21191
Type: Notice
Date: 2013-08-30
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 ``Select Updates for Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ``Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems'' guidance (http://www.fda.gov/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations. This draft guidance is not final nor is it in effect at this time.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-21190
Type: Notice
Date: 2013-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Applications for New Awards; Race to the Top-Early Learning Challenge
Document Number: 2013-21139
Type: Notice
Date: 2013-08-30
Agency: Department of Education, Department of Health and Human Services
Final Priorities, Requirements, Definitions, and Selection Criteria; Race to the Top-Early Learning Challenge
Document Number: 2013-21138
Type: Rule
Date: 2013-08-30
Agency: Department of Education, Department of Health and Human Services
The Secretary of Education and the Secretary of Health and Human Services (hereafter ``the Secretaries'') announce priorities, requirements, definitions, and selection criteria for the Race to the TopEarly Learning Challenge (RTT-ELC) program. The Secretaries may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in fiscal year (FY) 2013 and later years. The U.S. Department of Education (ED) and the U.S. Department of Health and Human Services (HHS) (collectively, ``the Departments'') conducted the first competition under the RTT-ELC program in FY 2011 and awarded grants to nine States. In FY 2012, the Departments funded the five next highest-rated applicants on the slate of high-scoring applications from the FY 2011 competition. In order to maintain the overall purpose and structure of the FY 2011 RTT-ELC competition in future competitions, these final priorities, requirements, definitions, and selection criteria are almost identical to the ones used in the FY 2011 competition, with the exception of small language clarifications and eight substantive changes from the prior competition.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-21087
Type: Notice
Date: 2013-08-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-21048
Type: Notice
Date: 2013-08-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2013-21027
Type: Notice
Date: 2013-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-21026
Type: Notice
Date: 2013-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs: Continued Approval of American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP's) Hospital Accreditation Program
Document Number: 2013-21008
Type: Notice
Date: 2013-08-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Submission for OMB Review; Comment Request: Palliative Care: Conversations Matter Evaluation
Document Number: 2013-21005
Type: Notice
Date: 2013-08-28
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 Institute of Nursing Research (NINR), 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 June, 14, 2013, page 35942 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 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. 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. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Palliative Care: Conversations Matter Evaluation, -0925-NewNational Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: NINR developed Palliative Care: Conversations Matter, a pediatric palliative care campaign to address the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Palliative Care: Conversations Matter evaluation will assess the information and materials being disseminated as part of the official campaign. Survey findings will help (1) Determine if the campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand the information needs of health care providers to inform future campaign efforts; and (3) examine how effective the campaign materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 200.
National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, Announces the Following Meeting
Document Number: 2013-20976
Type: Notice
Date: 2013-08-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health: Notice of Charter Renewal
Document Number: 2013-20974
Type: Notice
Date: 2013-08-28
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-20959
Type: Notice
Date: 2013-08-28
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0317, which expires on October 31, 2013. Prior to submitting ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Prescription Drug User Fee Rates for Fiscal Year 2014; Correction
Document Number: 2013-20958
Type: Notice
Date: 2013-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Prescription Drug User Fee Rates for Fiscal Year 2014'' that appeared in the Federal Register of August 2, 2013 (78 FR 46980). The document announced the Fiscal Year 2014 fee rates for the Prescription Drug User Fee Act. The document was published with four errors. This document corrects those errors.
Prospective Grant of Exclusive Patent License: Use of Exenatide for the Treatment of Neurodegenerative Diseases
Document Number: 2013-20945
Type: Notice
Date: 2013-08-28
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 Patent License to Peptron, Inc., a company having a place of business in Daejeon, South Korea, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/309,076, filed July 31, 2001, entitled ``Long-Acting Insulinotropic Peptides and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-01); U.S. Patent No. 7,576,050, issued August 18, 2009, entitled ``GLP-1 Exendin-4 Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-03); U.S. Patent No. 8,278,272, issued October 2, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-14); U.S. Patent Application No. 13/594,313, filed August 24, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-21); PCT Patent Application No. PCT/US2002/024141, filed July 30, 2002, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-PCT-02); Australian Patent No. 2002317599, issued July 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-04); Australian Patent No. 2008202893, issued April 26, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-10); Australian Patent Application No. 2012202081, filed April 11, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-20); Canadian Patent Application No. 2455963, filed January 29, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-CA-05); European Patent No. 1411968, issued September 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-06) and validated in Germany (HHS Ref. No. E-049-2001/0-DE-11), France (HHS Ref. No. E-049-2001/0-FR-12), and Great Britain (HHS Ref. No. E-049- 2001/0-GB-13); European Patent No. 2022505, issued December 14, 2011, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-09) and validated in Germany (HHS Ref. No. E- 049-2001/0-DE-17), France (HHS Ref. No. E-049-2001/0-FR-18), and Great Britain (HHS Ref. No. E-049-2001/0-GB-19); European Patent Application No. 10177860.3, filed September 21, 2010, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-16); Indian Patent Application No. 0488/DELNP/2004, filed February 27, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-IN-07); Japanese Patent Application No. 2003- 517083, filed February 2, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-08); Japanese Patent Application No. 2009-262568, filed November 18, 2009, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E- 049-2001/0-JP-15; and Japanese Patent Application No. 2013-007743, filed January 18, 2013, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-22). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to ``Methods of using exenatide for the treatment of neurodegenerative disease in humans.''
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-20944
Type: Notice
Date: 2013-08-28
Agency: Department of Health and Human Services, National Institutes of Health
The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-20916
Type: Notice
Date: 2013-08-28
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 ``The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.'' This draft guidance answers commonly asked questions about the applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of research and marketing applications for medical devices. This draft guidance is not final nor is it in effect at this time.
Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation; Notice of Meeting
Document Number: 2013-20725
Type: Notice
Date: 2013-08-28
Agency: Department of Health and Human Services, Health Resources and Services Administration, Administration for Children and Families
Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability
Document Number: 2013-20893
Type: Notice
Date: 2013-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.'' This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-20888
Type: Notice
Date: 2013-08-27
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 Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-20887
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-20886
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-20885
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-20884
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-20883
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-20882
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-20881
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent License: Use of Scopolamine to Treat Depression
Document Number: 2013-20880
Type: Notice
Date: 2013-08-27
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 Antares Pharma Inc., a company having a place of business in Ewing, New Jersey, to practice the inventions embodied in the following patent applications and patents: 1. U.S. Patent Application 11/137,114, filed May 25, 2005, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-US-01]; 2. European Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-EP-03]; 3. German Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-DE-07]; 4. French Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-FR-08]; 5. British Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-GB-09]; and 6. Canadian Patent Application 2610025, filed May 18, 2006, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-CA-04. The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to: ``The use of scopolamine for treatment of depression, including major depressive disorder, wherein the route of administration is subcutaneous, intramuscular, or transdermal delivery such as through injection or a patch or topical gel-based product''. This announcement is the second notice to grant an exclusive license to this technology.
Scientific Information Request on Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma
Document Number: 2013-20849
Type: Notice
Date: 2013-08-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on imaging tests for the diagnosis and staging of pancreatic adenocarcinoma. Scientific information is being solicited to inform our review of Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma, which is currently being conducted by the Evidence- based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on imaging tests for the diagnosis and staging of pancreatic adenocarcinoma will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-20826
Type: Notice
Date: 2013-08-27
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: ``Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection
Document Number: 2013-20825
Type: Notice
Date: 2013-08-27
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: ``Pilot Test of an Emergency Department Discharge Tool.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Strengthening the Operating Framework and Furthering the Objectives of Coalition for Accelerating Standards and Therapies Initiative (U24)
Document Number: 2013-20823
Type: Notice
Date: 2013-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Drug Evaluation and Research (CDER) Data Standards Program. The goal of the CDER Data Standards Program is to strengthen and support the Coalition for Accelerating Standards and Therapies (CFAST) Initiative in its efforts to establish and maintain clinical data standards that will enable FDA reviewers to more efficiently perform efficacy analysis of potential new drugs in therapeutic areas that are important to public health.
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed; Availability
Document Number: 2013-20822
Type: Notice
Date: 2013-08-27
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 ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.'' The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators and adequacy of research sites, and determining whether an investigational new drug (IND) application or investigational device exemption (IDE) is required, to protect the rights and welfare of human subjects involved in biomedical research.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Extension
Document Number: 2013-20821
Type: Notice
Date: 2013-08-27
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.
Meeting of the National Vaccine Advisory Committee
Document Number: 2013-20797
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.
Meetings of the National Biodefense Science Board
Document Number: 2013-20793
Type: Notice
Date: 2013-08-27
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 National Biodefense Science Board (NBSB) will be holding a public meeting on September 12, 2013.
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Behavioral Health Patient Empowerment Challenge”
Document Number: 2013-20790
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services
Behavioral health disorders are common in the United States. Approximately 20% of adults and 13% of adolescents suffer from mental disorders each year and 8.7% of Americans aged 12 and older experience substance dependence or abuse each year.1 2 Rates of mental health problems are significantly higher for patients with chronic conditions such as diabetes, asthma, and heart conditions \3\ and failure to treat both physical and mental health conditions results in poorer health outcomes and higher health care costs.\3\ Yet despite the high personal and societal burden of these disorders fewer than half of adults and only one-third of children with mental disorders and only 11 percent of individuals with substance use disorders receive treatment.1 2 For many individuals this results from limited access to care, for others it is a result of reservations about accessing specialty care.
New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol
Document Number: 2013-20538
Type: Rule
Date: 2013-08-27
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 approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Office of the Assistant Secretary for Health, Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-20524
Type: Notice
Date: 2013-08-27
Agency: Department of Health and Human Services, Office of the Secretary
Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals
Document Number: 2013-20740
Type: Notice
Date: 2013-08-26
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the revised International Guiding Principles for Biomedical Research Involving Animals (``Guiding Principles''). The NIH is seeking input from the public on any concerns they may have regarding the revised Guiding Principles.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2013 Performance Review Board (PRB)
Document Number: 2013-20739
Type: Notice
Date: 2013-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2013-20732
Type: Notice
Date: 2013-08-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration