Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents
Results 1,601 - 1,800 of 3,197
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// beta.samhsa.gov/workplace.
Meeting of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System
The Food and Drug Administration (FDA) is classifying the rectal control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the rectal control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback' '' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency; Public Meeting
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for Alpha-1 Antitrypsin Deficiency (AATD). Patient-Focused Drug Development is an FDA performance commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to provide FDA with patients' perspectives on the impact on daily life of AATD. FDA also is seeking patients' perspectives on the available therapies for this disorder.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ryan Asherin, Oregon Health Authority: Based on the report of an investigation conducted by the Oregon Health Authority (OHA) and analysis conducted by ORI in its oversight review, ORI found that Ryan Asherin, former Surveillance Officer and Principal Investigator, OHA, Public Health Division engaged in research misconduct in research supported by the Centers for Disease Control and Prevention (CDC) Emerging Infections Program Grant 5U01CI00306-05. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in the CDC research record, a manuscript submitted to JAMA Intern Med in January 2013, a published CDC report (CDC Morbidity and Mortality Weekly Report 61(09):157-162, March 2012), and presentations in 2012 to CDC and at the 11th Biennial Congress of the Anaerobe Society. ORI found that the Respondent falsified and/or fabricated fifty-six (56) case report forms (CRFs) while acquiring data on the incidence of Clostridium difficile infections in Klamath County, Oregon. Specifically, the Respondent (1) fabricated responses to multiple questions on the CRFs for patient demographic data, patient health information, and Clostridium difficile infection data, including the diagnoses of toxic megacolon and ileus and the performance of a colectomy, with no evidence in patient medical records to support the responses; and (2) falsified the CRFs by omitting data on the CRFs that clearly were included in patient medical records. Mr. Asherin has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of two (2) years, beginning on May 12, 2015:
Meeting of the 2015 Hurricane Sandy Conference: Translating Research Into Practice
The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is hereby giving notice that ASPR will convene a Hurricane Sandy Conference: Translating Research into Practice public meeting on August 10-11, 2015. The purpose of the meeting is to broadly share, with interested stakeholders, outcomes of Hurricane Sandy recovery science research and training projects awarded under ASPR FOAs EP-HIT-13-001 and EP-HIT-14- 001, Centers for Disease Control and Prevention (CDC) FOAs TP13-001 and OH13-002, and National Institute of Environmental Health Sciences (NIEHS) FOAs RFA-ES-13-008 and NOT-ES-13-003. Meeting participants will discuss opportunities to build a community of practice around Hurricane Sandy recovery research and the path forward for translating Hurricane Sandy recovery science research results into practice; highlight Hurricane Sandy recovery science grants as a model for disaster research science preparedness; and demonstrate the benefit of Hurricane Sandy recovery research to the impacted communities.
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals (QIs): Federal Fiscal Years 2013 and 2014
This notice sets forth the states' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the federal fiscal year (FY) 2013 and the preliminary QI allotments for FY 2014. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation.
Medicare Program; Announcement of Request for Applications for the Million Hearts® Cardiovascular Risk Reduction Model
This notice informs interested parties of an opportunity to apply for participation in the Million Hearts[supreg] Cardiovascular Risk Reduction Model. The primary goal of this model is to test whether encouraging physician practices to calculate risk for all of the practice's eligible Medicare beneficiaries, using the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) 10-year pooled cohort risk calculator will prevent the occurrence of first-time heart attacks and strokes.
Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability
This proposed rule would modernize the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The proposed rule would align the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans; implement statutory provisions; strengthen actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; and promote the quality of care and strengthen efforts to reform delivery systems that serve Medicaid and CHIP beneficiaries. It would also ensure appropriate beneficiary protections and enhance policies related to program integrity. This proposed rule would also require states to establish comprehensive quality strategies for their Medicaid and CHIP programs regardless of how services are provided to beneficiaries. This proposed rule would also implement provisions of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.
Request for Information Regarding the Requirements for the Health Plan Identifier
This request for information seeks public comment regarding the health plan identifier (HPID) including the requirements regarding health plan enumeration and the requirement, to use the HPID in electronic health care transactions.
Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), June 25, 2015
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 the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting
This notice announces a forthcoming meeting of public advisory committees of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA's regulatory issues.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
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 regulations requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
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.
Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Hair Specimen for Drug Testing
This document is a request for information regarding specific aspects of the regulatory policies and standards that may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hair specimen).
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016; Request for Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016.'' The document and instructions for submitting comments can be found at www.regulations.gov. This guidance document does not have the force and effect of law.
Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for an additional 30 days, for the notice of availability entitled ``Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'', published in the Federal Register of December 30, 2014. In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Integrated Food Safety System Online Collaboration Development
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the National Center for Food Protection and Defense (NCFPD). The goal of the NCFPD is to provide well-established and high-level access to Food/Agriculture Sector Organizations and coordination of electronic collaborative tools; collaborative support from the Department of Health and Human Services (HHS), the Department of Homeland Security (DHS), and the U.S. Department of Agriculture (USDA). NCFPD also has past experience directly supporting the President's Food Safety Working Group Objectives to integrate the food safety system at all levels.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
The Food and Drug Administration (FDA) is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Pediatric Studies of Meropenem Conducted in Accordance With the Public Health Service Act; Availability of Summary Report and Requested Labeling Changes
The Food and Drug Administration (FDA) is publishing a summary report of the pediatric studies of meropenem conducted in accordance with the Public Health Service Act (the PHS Act) and is making available requested labeling changes for meropenem. The Agency is making this information available consistent with the PHS Act.
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; International Conference on Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
Molecular Characterization of Multiple Myeloma Black/African Ancestry Disparity
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the efforts of the Center for Drug Evaluation and Research (CDER). FDA is announcing its intent to accept and consider a single-source application for the award of a grant to the Multiple Myeloma Service of Memorial Sloan Kettering Cancer Institute. The goal of the cooperative agreement between CDER and the Multiple Myeloma Service of Memorial Sloan Kettering Cancer Institute is to support the development of appropriate methodologies to conduct clinical trial design evaluation and determine extrapolation of findings from the general population to the U.S. Black population.
Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled ``Draft Guidance on Risperidone.'' The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject.
Advisory Council on Alzheimer's Research, Care, and Services
The National Alzheimer's Project Act, Public Law 111-375 (42 U.S.C. 11225), requires that the Secretary of Health and Human Services (HHS) establish the Advisory Council on Alzheimer's Research, Care, and Services. The Advisory Council is governed by provisions of Public Law 92-463 (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. The Secretary of HHS established the Advisory Council to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for seven (7) new non-Federal members of the Advisory Council, one for each category of membership, to replace the seven members whose terms will end September 30th, 2015. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
The Food and Drug Administration (FDA or Agency) is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The rule amended FDA's postmarketing safety reporting regulations for human drugs and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is also announcing the availability of the Safety Reporting Portal (SRP), a Web-based electronic submission system, for the electronic submission of postmarketing individual case safety reports (ICSRs) of adverse events for human drug and nonvaccine biological products. The SRP is intended to facilitate the secure electronic submission of postmarketing ICSRs and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. The SRP creates a simple and efficient mechanism for electronic reporting of ICSRs that does not require an internal database that is compatible with the International Conference on Harmonisation-based direct submission system. FDA is delaying the compliance date for the final rule because FDA understands that not all persons subject to mandatory postmarketing reporting requirements who wish to use the newly available Safety Reporting Portal (SRP) will have the opportunity to register for an account and test the submission process prior to June 10, 2015, the effective date of the final rule.
Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures
The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Request for Comments on the Office of the Assistant Secretary for Preparedness and Response Public Access Plan to Federally Funded Research: Publications and Data
The Department of Health and Human Services (HHS) is hereby requesting public comment on the Assistant Secretary for Preparedness and Response (ASPR) Public Access Plan for Federally Funded Research: Publications and Data. The document is available to the public via https://www.phe.gov/Preparedness/planning/science/Pages/Access Plan.aspx. The public comment period will end 30 days after posting in the Federal Register.
Announcement of Requirements and Registration for: “Harnessing Insights From Other Disciplines To Advance Drug Abuse and Addiction Research” Challenge
The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), is seeking from the general public ideas on how to adapt specialized knowledge from other disciplines to inform new directions and discoveries in drug abuse and addiction research. With the ``Harnessing insights from other disciplines to advance drug abuse and addiction research'' challenge (the ``Challenge''), NIDA aims to gain insights into new methods or approaches that could transform discovery in order to significantly expand our basic knowledge about drug abuse and addiction processes, accelerate the development of novel and more effective prevention and treatment strategies, and/or enhance our capacity to implement, monitor, and improve upon evidence-based interventions. This Challenge is soliciting written proposals that outline novel approaches to addressing research challenges in the drug use and addiction field by leveraging concepts or technologies from other disciplines. This Challenge is being issued as part of NIDA's strategic planning process for 2016-2020. Winning proposals may be used to guide the development of new research programs within NIDA.
Request From the Interagency Committee on Human Nutrition Research (ICHNR) for Comments on the Draft National Nutrition Research Roadmap 2015-2020: Advancing Nutrition Research To Improve and Sustain Health
The Draft National Nutrition Research Roadmap (NNRR) identifies research priorities for human nutrition and describes the role of ICHNR departments and agencies in addressing those priorities over the next five to ten years. ICHNR seeks input about identified research and resource gaps and opportunities and the short- and long- term initiatives proposed to address them. To review the NNRR, please visit https://prevention.nih.gov/nnrr.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements
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.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart MMedical Review Officer (MRO), Section 13.1(b) of the Mandatory Guidelines, ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug test results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall annually publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS. The HHS Secretary approves the following MRO certifying entities that offer MRO certification through examination:
Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Lung, Breast, Bladder, and HPV-Positive Cancers
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 the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0-US-01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0- US-02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E- 273-2009/0-US-03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled ``Methods of growing tumor infiltrating lymphocytes in gas-permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 5. PCT Application No. PCT/US2012/029744 filed March 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 7. U.S. Provisional Patent Application No. 61/846,161 filed July 15, 2013 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-US-01); 8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-PCT-02); The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, manufacture, distribute, sell and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of lung, breast, bladder, and HPV- positive cancers. Specifically excluded from this license are methods of generating or using selected subpopulations of TIL and the use of T cell receptors isolated from TIL.
Determination of Regulatory Review Period for Purposes of Patent Extension; STIVARGA
The Food and Drug Administration (FDA) has determined the regulatory review period for STIVARGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment (HOP Panel) Meeting on August 24-25, 2015
This notice announces the summer meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2015. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights and hospital outpatient therapeutic services supervision issues.
Medicare and Medicaid Programs; Continued Approval of The Joint Commission's Hospice Accreditation Program
This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare Conditions of Participation (CoPs).
Agency Information Collection Activities: Proposed Collection; Comment Request
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
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Substances Prohibited From Use in Animal Food or Feed'' 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; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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.
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2015, expiration date.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program'' 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; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; FLUCELVAX
The Food and Drug Administration (FDA) has determined the regulatory review period for FLUCELVAX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25 Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.
Medicare and Medicaid Programs: Revisions to Deeming Authority Survey, Certification, and Enforcement Procedures
This final rule revises the survey, certification, and enforcement procedures related to CMS oversight of national accrediting organizations (AOs). The revisions implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The revisions also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the statute. The rule also extends some provisions, which are applicable to Medicare-participating providers, to Medicare-participating suppliers subject to certification requirements, and clarifies the definition of ``immediate jeopardy.''
Announcing the Award of a Single-Source Cooperative Agreement to the American Public Human Services Association for the Association of Administrators of the Interstate Compact on the Placement of Children (AAICPC) in Washington, DC
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single-source cooperative agreement in the amount of $1,200,000 for each of 3 years to the American Public Human Services Association for its affiliate the Association of Administrators of the Interstate Compact on the Placement of Children (AAICPC), Washington, DC, for the national expansion of the NEICE to improve the administrative efficiency in the interstate process of the ICPC nationally. The ICPC establishes uniform legal and administrative procedures governing the interstate placement of children for the purposes of foster care, adoption and residential placement in all 52 member jurisdictions of the ICPC. Award funds will support the development of the NEICE beyond the original six pilot sites to include all 50 states, the District of Columbia and the U.S. Virgin Islands. The NEICE system was previously developed as a pilot project through the Partnership Fund for Program Integrity Innovation with funding directed through The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF). Implementation of a national inter-jurisdictional Interstate Compact on the Placement of Children (ICPC) electronic system is intended to improve the administrative efficiency in the interstate process via the ICPC. The AAICPC as an affiliate of the APHSA is uniquely positioned to scale up this project due to their governance of the placement of children across state lines for purposes of foster care, adoption and residential placements.
Notice of Intent To Award a Single Source Non-competing Continuation Cooperative Agreement for Eight Grant Projects Under the “Part A: The Enhanced ADRC Options Counseling Program” Funded in 2012
In 2012, ACL, in partnership with the Centers for Medicare & Medicaid Services (CMS) and the Veterans Health Administration (VHA), issued a special funding opportunity known as the ``Part A: The Enhanced ADRC Options Counseling Program'' (Part A). The Part A grants were awarded to eight states (CT, MA, MD, NH, OR, VT, WI and WA) to develop a NWD System in their state so the federal partners could leverage the experience and models emerging in these states to serve as the basis for the development of national standards. The one year extension will enable the 8 Part A state grantees to continue their work with ACL, CMS and VHA specifically to further refine the tools, metrics and key elements of a NWD System and pilot the Person Centered Counseling training program.
Final Priority. National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training Centers
The Administrator of the Administration for Community Living announces a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, we announce a priority for an RRTC on Outcomes Measurement for Home and Community Based Services. The Administrator of the Administration for Community Living may use this priority for competitions in fiscal year (FY) 2015 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to improved home and community based services for individuals with disabilities.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Proposed Revised Vaccine Information Materials for Seasonal Influenza Vaccines
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for inactivated and live attenuated influenza vaccines.
Proposed Revised Vaccine Information Materials for Pneumococcal Conjugate Vaccine (PCV13)
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statement for pneumococcal conjugate vaccine (PCV13).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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 contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
Government-Owned Inventions; Availability for Licensing
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.
Antimicrobial Animal Drug Sales and Distribution Reporting
The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. At this time, FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. This proposal also includes an additional reporting provision intended to enhance FDA's understanding of antimicrobial animal drug sales intended for use in specific food- producing animal species.
Meetings of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that two meetings are scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meetings will be open to the public. Information about the Advisory Group and the agendas for these meetings can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision to the approved information collection project entitled ``The National Intimate Partner and Sexual Violence Survey (NISVS)''. This project collects information about individual's experiences of sexual violence, stalking and intimate partner violence.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled CDC Burden of Canine Brucellosis Information Collection. This information collection will help to estimate canine brucellosis disease burden in dogs, which will aid in the determination of the public health importance of human B. canis infections, and the potential for zoonotic transmission.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
World Trade Center Health Program Scientific/Technical Advisory Committee: Notice of Charter Renewal
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on May 5, 2015, Volume 80, Number 86, Page 25692. The time and date should have read as follows:
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on April 14, 2015 Volume 80, Number 86, Page 19990. The time and date should have read as follows:
Prospective Grant of Exclusive License: Biomarkers for Acute Ischemic Stroke
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license, to practice the inventions embodied in the following patent applications:
List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations
The Food and Drug Administration (FDA) intends to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' You may nominate specific bulk drug substances for this list. This notice describes the information that should be provided to the Agency in support of each nomination.
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Withdrawal of Compliance Policy Guide; Section 608.400 Compounding of Drugs for Use in Animals
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' The draft guidance describes FDA's policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA's current thinking on the issues addressed by the guidance. FDA is also announcing the withdrawal of the compliance policy guide (CPG) entitled ``Section 608.400 Compounding of Drugs for Use in Animals,'' which was issued in July 2003. This 2003 CPG is being withdrawn because it is no longer consistent with FDA's current thinking on the issues it addresses.
Notice of Intent To Award a Single Source Non-Competing Continuation Cooperative Agreement for Two National Activities Grant Projects Under Section 6 of the Assistive Technology Act of 1998,
The Administration for Community Living (ACL) is transitioning the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) Catalyst Project Assistive Technology Technical Assistance Center (AT TA Center) and the University of New Hampshire Institute on Disability Assistive Technology Public Internet Site (National AT Web site) to ACL as a result of the Workforce Opportunity Improvement Act (Pub. L. 113-128) signed by President Obama in July 2014. The RESNA Catalyst Project is a national training and technical assistance center for assistive technology programs that provides comprehensive information and state-specific, regional and national resources to entities funded under Sections 4 and 5 of the AT Act to improve the implementation and effectiveness of their programs, and to provide appropriate technical assistance and training to entities not funded under the AT Act to improve awareness of and access to assistive technology. The University of New Hampshire Institute on Disability supports the renovation, updating, and maintenance of an accessible National AT Web site that provides the public comprehensive, up-to-date information on accommodating individuals with disabilities and resources related to assistive technology, including but not limited to programs under the AT Act. The RESNA Catalyst Project and New Hampshire National AT Web site previously operated through a cooperative agreement with the U.S. Department of Education, Rehabilitation Services Administration. The Department of Health and Human Services is currently transitioning programs under the AT Act to ACL.
Cooperative Agreement to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The goal of the ICH is to bring together leading global drug regulatory agencies and pharmaceutical manufacturer associations to achieve greater harmonization of technical standards to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations
The Food and Drug Administration (FDA) is announcing the availability of draft recommendations for preparing a Study Data Standardization Plan (Standardization Plan). The Standardization Plan is referenced in the Study Data Technical Conformance Guide (Guide). The Guide supplements the guidance for industry ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' and provides specifications, recommendations, and general considerations on submitting standardized study data using FDA-supported data standards. The Guide recommends that, for clinical and nonclinical studies, sponsors include a plan that describes the submission of standardized study data to FDA. The proposed recommendations describe the information that should be included in the Standardization Plan. The proposed recommendations for creating a Standardization Plan are posted on FDA's Study Data Standards Resources Web page at https://www.fda.gov/ forindustry/datastandards/studydatastandards/default.htm.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Infant Formula Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff.'' This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success. This draft guidance is not final nor is it in effect at this time.
Patient Preference Information-Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Patient Preference InformationSubmission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.'' This document provides guidance on collecting and submitting patient preference information that may be used by FDA staff in decisionmaking relating to premarket approval applications (PMAs), Humanitarian Device Exemption (HDE) applications, and de novo requests. This draft guidance also outlines considerations for including patient preference information in labeling for patients and health care professionals. This draft guidance is not final nor is it in effect at this time.
Food and Drug Administration-American Urological Association-Society of Urologic Oncology Workshop on Partial Gland Ablation for Prostate Cancer; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``AUA-FDA-SUO Workshop on Partial Gland Ablation for Prostate Cancer.'' The topics to be discussed are the technologies and imaging used in partial gland ablation, and the design of clinical trials to measure the most appropriate endpoints for partial gland ablation for prostate cancer. The workshop will be part of the American Urological Association (AUA) annual meeting in New Orleans, LA.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with revised donor deferral recommendations for individuals at increased risk for transmitting human immunodeficiency virus (HIV) infection. The draft guidance document recommends corresponding revisions to donor education materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. The document also incorporates certain other recommendations related to donor education materials and testing contained in the memorandum to blood establishments entitled, ``Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products,'' dated April 23, 1992 (1992 blood memo). The draft guidance, when finalized, is intended to supersede the 1992 blood memo.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.'' The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at FDA. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator's successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations. Details of the informational content of an IND as well as information needed to complete required forms also are provided throughout this guidance.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The Department of Health and Human Services (``HHS'' or ``Department'') is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines), 73 FR 71858 (November 25, 2008) for urine testing.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The Department of Health and Human Services (``HHS'' or ``Department'') is proposing to establish scientific and technical guidelines for the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Recall Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``FDA Recall Regulations'' 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; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions
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.
2015 International Society for Pharmaceutical Engineering/Food and Drug Administration/Product Quality Research Institute Quality Manufacturing Conference
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the International Society for Pharmaceutical Engineering (ISPE), is announcing a meeting entitled ``2015 ISPE/FDA/PQRI Quality Manufacturing Conference,'' formerly known as the annually occurring ``ISPE/FDA Current Good Manufacturing Practices Conference.'' The purpose of the meeting is to discuss the quality of global pharmaceutical manufacturing and the combined efforts of industry leaders and regulators to modernize manufacturing facilities and processes to ensure quality and compliance.
Make-Up Meetings of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces the next meetings of the Community Preventive Services Task Force (Task Force). These meetings will be make-up sessions for the February 25-26, 2015 Task Force Meeting, which was cancelled due to inclement weather. The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the Center for Veterinary Medicine
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the Center for Veterinary Medicine'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Electronic Study Data Submission; Data Standards; Support for the Logical Observation Identifiers Names and Codes
The Food and Drug Administration (FDA) is encouraging sponsors and applicants to provide Logical Observation Identifiers Names and Codes (LOINC) codes (available at https://loinc.org/) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. LOINC code is defined as electronic messages for laboratory test results and clinical observations. The decision to adopt LOINC for lab test results is part of a larger FDA effort to align the use of data standards for clinical research with ongoing nationwide health information technology initiatives. FDA invites public comment on appropriate steps the Agency could take to promote the use and utility of LOINC-coded clinical data submitted to the Agency. The LOINC common terminology will be listed in the FDA Data Standards Catalog that is posted to FDA's Study Data Standards Resources Web page at https://www.fda.gov/forindustry/ datastandards/studydatastandards/default.htm.
Notice of Intent To Award a Single Source Non-Competing Program Expansion Supplement to the National Falls Prevention Resource Center
The Administration for Community Living (ACL) announces its intent to award a single-source program expansion supplement to expand the work of the National Falls Prevention Resource Center (NFPRC). The goals of the NFPRC are to: Increase public education about the risks of falls and how to prevent them; and to support and stimulate the implementation and dissemination of evidence-based community programs and strategies that have been proven to reduce the incidence of falls among seniors. The purpose of this notice is to award supplemental funds to expand work already underway by The National Council on Aging, the grantee who serves as the NFPRC.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) and the Administration for Children and Families (ACF) announce plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA and ACF seek comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.'' This draft guidance is intended to advise the sponsors and individuals involved in the design and implementation of nonclinical studies on the substance and scope of nonclinical information needed to support first-in-human clinical trials, ongoing clinical development, and eventual approval of enzyme replacement therapy (ERT) products for the treatment of rare, life-threatening conditions.
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Draft Guidance for Tobacco Retailers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The draft guidance, when finalized, will represent FDA's current thinking with respect to imposing no-tobacco- sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This draft guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.
Prescription Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA authorizes FDA to collect user fees for the process for the review of human drugs. The current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2018-2022.
Determination That SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance revises the draft guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued February 15, 2012, to provide new and revised questions and answers (Q&As).
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL23(R)); Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing; Revised Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised guidance for industry (GFI) #116 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In this VICH guidance, the recommendation for a second test to evaluate the potential of a chemical to produce chromosomal effects is revised. The revised guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the following three tests: (1) An in vitro chromosomal aberrations test using metaphase analysis, which detects both clastogenicity and aneugenicity; (2) an in vitro mammalian cell micronucleus test, which detects the activity of clastogenicity and aneugenicity; or (3) a mouse lymphoma test, which, with modification, can detect both gene mutation and chromosomal damage. This revised VICH guidance document is intended to facilitate the mutual acceptance of safety data necessary for the establishment of acceptable daily intakes for veterinary drug residues in human food by the relevant regulatory authorities.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Extra Label Drug Use in Animals
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Extra Label Drug Use in Animals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Statewide Data Indicators and National Standards for Child and Family Services Reviews
On October 10, 2014, the Administration of Children and Families (ACF) published a document in the Federal Register (79 FR 61241). The document provided CB's final 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). This document provides corrections to errors and misstatements in that document and some of the calculations of the statewide data indicators.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the National Notifiable Diseases Surveillance System (NNDSS) information collection. The NNDSS is the nation's public health surveillance system that monitors the occurrence and spread of diseases and conditions that are nationally notifiable or under national surveillance.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection for a retrospective evaluation of the prevalence of acute flaccid myelitis with MRI grey matter findings among children aged
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a new information collection request entitled, ``Understanding Barriers and Facilitators to HIV prevention for Men Who Have Sex with Men (MSM)'' to conduct qualitative research with most at risk HIV-negative MSM. The research is intended to understand issues surrounding HIV risk for MSM, identify influences of high risk behaviors and to investigate risk management and resiliency among HIV-negative MSM.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT).
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