Department of Health and Human Services 2014 – Federal Register Recent Federal Regulation Documents
Results 801 - 1,000 of 3,623
Final Policy on Conferring With Urban Indian Organizations
The Indian Health Service (IHS or ``the Agency'') is issuing this Notice to implement the final Policy for conferring with Urban Indian Organizations (UIOs). In March 2010, the Indian Health Care Improvement Act (IHCIA) was reauthorized and amended as part of the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act (together, the Affordable Care Act), Public Law 111-152. One of the changes made to the IHCIA was to create a new requirement that the IHS ``confer'' with UIOs, to the maximum extent practicable, in carrying out the IHCIA.
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 information collection project: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 18th, 2014 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Improving Hospital Informed Consent with Training on Effective Tools and Strategies.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously titled and published as ``Improving Hospital Informed Consent with an Informed Consent Toolkit'' in the Federal Register on July 9th, 2014 and allowed 60 days for public comment. AHRQ received one substantive comment. The purpose of this notice is to allow an additional 30 days for public comment.
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
The Food and Drug Administration (FDA) is revising certain provisions of the proposed rule, issued in July 2013, on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. We are primarily revising the proposed requirements concerning compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities. We are taking this action in response to the extensive public input we have received regarding these provisions and in coordination with revisions we are concurrently making to the proposed rule on current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for human food. We are seeking public comment on the revised proposed FSVP regulations. We are reopening the comment period on the proposed rule only with respect to the specific provisions identified in this Federal Register document.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
The Food and Drug Administration (FDA or we) is proposing to amend certain specific provisions of the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' We are taking this action because the extensive information received in public comments has led to significant changes in our current thinking on certain key provisions of the proposed rule. We are reopening the comment period only with respect to the specific issues identified in this document.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for ``farms'' and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. In that 2013 proposed rule, we proposed to add CGMP requirements for animal food and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action because the input we have received from public comments has led to significant changes in our current thinking on certain key provisions of this proposed rule. We are reopening the comment period only with respect to specific issues identified in this proposed rule.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. Interested persons are invited to send comments regarding this 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: 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.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
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 (PRA).
Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction
The Food and Drug Administration (FDA) is announcing a public meeting and scientific workshop, both of which will provide an opportunity for public comment on the topic of Female Sexual Interest/ Arousal Disorder (FSIAD), the most common form of female sexual dysfunction. FSIAD is a diagnosis that combines two previously distinct disordershypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD). The public meeting will take place on October 27, 2014, and is part of FDA's Patient-Focused Drug Development performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will obtain patients' perspectives on the impact that FSIAD (or a prior diagnosis of HSDD or FSAD) has on their daily lives, as well as their perspectives on the available therapies for these conditions. The scientific workshop will take place on October 28, 2014, and will provide an opportunity for FDA to seek input from experts on scientific issues important to the clinical development of drug products intended to treat FSIAD.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
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 (PRA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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.
Submissions for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; 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 ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' This draft guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices. This draft guidance is not final nor is it in effect at this time.
Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled ``Informed Consent Information Sheet.'' A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information.
Decision To Evaluate a Petition To Designate a Class of Employees From the Idaho National Laboratory in Idaho Falls, Idaho, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 C.F.R. Sec. 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Idaho National Laboratory in Idaho Falls, Idaho, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Idaho National Laboratory. Location: Idaho Falls, Idaho. Job Titles and/or Job Duties: All employees who worked in any area. Period of Employment: January 1, 1949 through December 31, 1970.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2015
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2015. The calendar year 2015 AIC threshold amounts are $150 for ALJ hearings and $1,460 for judicial review.
Proposed Collection; 60-day Comment Request; Office of Minority Health Research Coordination Research Training and Mentor Program Applications
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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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 to address 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.
Submission for OMB Review; 30-day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on Thursday, July 3, 2014, Vol. 79, No. 128, page 38047-38049 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
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 reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Policy Clarification for Fluoroscopic Equipment Requirements; 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 ``Policy Clarification for Fluoroscopic Equipment Requirements.'' This draft guidance describes FDA's intent to clarify the application of certain aspects of the performance standard requirements for fluoroscopic equipment when manufacturers comply with certain International Electrotechnical Commission (IEC) standards. This draft guidance is not final nor is it in effect at this time.
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.
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we announce an Agency for Healthcare Research and Quality Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-010, ``Disseminating and Implementing Evidence from Patient- Centered Outcomes Research in Clinical Practice Using Mobile Health Technology (R21).'' As with other SEP meetings, this meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meeting
In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we announce an Agency for Healthcare Research and Quality Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-009, ``Evaluating AHRQ Initiative to Accelerate the Dissemination and Implementation of PCOR Finding in Primary Care (R01).'' As with other SEP meetings, this meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we announce an Agency for Healthcare Research and Quality Special Emphasis Panel (SEP) meeting on ``AHRQ RFA HS14-008 Accelerating the Dissemination and Implementation of PCOR Findings into Primary Care Practice (R18).'' As with other SEP meetings, this meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meetings
The scientific peer review subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).
Justification of a Single Source Cooperative Agreement Award for the World Health Organization
The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to fund an unsolicited proposal submitted by the World Health Organization (WHO) to support work towards establishing a regulatory pathway at WHO for prequalification of medical countermeasures to be deployed internationally in an emergency, which includes supporting WHO and potential recipient countries to build regulatory capacity for the import, registration, and emergency use of medical countermeasures. The goals of this Cooperative Agreement are to: (1) Using smallpox vaccines as a case study, complete product review and prequalification of smallpox vaccines included in or pledged to the WHO Smallpox Vaccine Emergency Stockpile for emergency use; (2) Establish general regulatory pathways for emergency use authorization and/or a process for emergency prequalification of emergency medical countermeasures and; (3) Support potential recipient WHO member states in building capacities for the import, registration, and emergency use of medical countermeasures. This Cooperative Agreement directly supports several federal initiatives focused on strengthening national and international health security, including HHS's ongoing work within the Global Health Security Initiative (GHSI) to develop an operational framework for the international deployment of medical countermeasures which contemplates the legal, regulatory, and logistical issues to be considered during such a deployment as noted in the 2013 GHSI Ministerial communique.\1\ Additionally, it supports Objective 9 of the Global Health Security Agenda \2\ which calls for improving global access to medical and non- medical countermeasures during health emergencies and the improvement of international deployment capabilities. It also aligns with the HHS Global Health Strategy priority to ``develop policy frameworks, agreements and operational plans to facilitate HHS decision-making in response to both single and multiple international requests for emergency assistance, including for the deployment of medical countermeasures and HHS personnel.'' \3\
Performance Review Board Members
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2014.
Custom Device Exemption; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Custom Device Exemption.'' FDA has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). The intent of this guidance is to define terms used in the custom device exemption, explain how to interpret the ``five units per year of a particular device type'' language contained in the FD&C Act, describe information that FDA proposes manufacturers should submit in the custom device annual report, and provide recommendations on how to submit an annual report for devices distributed under the custom device exemption.
Announcement of Requirements and Registration for the 2014 Food and Drug Administration Food Safety Challenge
The Food and Drug Administration (FDA) is announcing the 2014 FDA Food Safety Challenge, a prize competition under the America COMPETES Reauthorization Act of 2010. The 2014 FDA Food Safety Challenge is an effort to advance breakthroughs in foodborne pathogen detection, specifically with the goal of accelerating the detection of Salmonella in fresh produce. As FDA's food safety program incorporates preventive control measures through the implementation of the FDA Food Safety Modernization Act, quicker detection of these harmful bacteria will help to prevent foodborne illnesses.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL52); Draft Guidance for Industry on Bioequivalence: Blood Level Bioequivalence Study; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI 224) entitled ``Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study'' (VICH GL52). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products.
Medicare Program; Solicitation of Nominations to the Advisory Panel on Hospital Outpatient Payment
This notice solicits nominations for up to four new members to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). There are vacancies on the Panel effective September 30, 2014. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and supervision of hospital outpatient services. The Secretary rechartered the Panel in 2012 for a 2-year period effective through November 19, 2014. CMS intends to recharter the Panel for another 2-year period prior to expiration of the current charter.
Medicare and Medicaid Program; Application From the Joint Commission for Continued Approval of Its Psychiatric Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Submission for OMB Review; 30-Day Comment Request: State and Community Tobacco Control Research Initiative Evaluation (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 6, 2014 (79 FR 32742) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA's approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties. FDA is seeking input on these issues from all stakeholders, including patients, health care providers, the pharmaceutical industry, patient advocates, academics, researchers, and other governmental entities.
Report on the Standardization of Risk Evaluation and Mitigation Strategies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)''. This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into the existing and evolving health care system. FDA is publishing this report to allow the public to provide comment on the report as it relates to PDUFA.
Proposed National Total Worker HealthTM
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the opportunity for comment on the Proposed National Total Worker Health\TM\ Agenda. To view the Agenda and submit written comments, visit, www.regulations.gov, and enter CDC-2014-0014 in the search field and click ``Search.'' There is also an opportunity to submit oral comments at one of three town-hall sessions during the following two scientific meetings: The 1st International Symposium to Advance Total Worker Health\TM\ and The Healthier Federal Workers Conference. For information on how to register for the conferences and town-hall sessions see the Supplementary Section. All comments are welcome, but NIOSH specifically seeks those that address the following questions: Do you see your own organization's goals reflected in the Proposed National Total Worker Health\TM\ Agenda? What are the bridges between your own work and the Proposed National Total Worker Health\TM\ Agenda? Are there any missing components or gaps in the Proposed National Total Worker Health\TM\ Agenda?
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 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; Submission for Office of Management and Budget Review; Comment Request; 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 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 (PRA).
First Annual Neonatal Scientific Workshop-Roadmap for Applying Regulatory Science to Neonates; Notice of Public Workshop
The Food and Drug Administration (FDA) is announcing a public scientific workshop to discuss the roadmap for applying regulatory science to neonates. This public scientific workshop is being co- sponsored with the FDA, the Critical Path Institute (C-Path) and the Burroughs Welcome Fund (BWF). The purpose of the public scientific workshop is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public to determine whether there is sufficient interest on the part of stakeholders to develop a neonatal consortium and to discuss potential working groups dedicated to the regulatory science required to develop neonatal therapeutics.
Prospective Grant of Exclusive License: Direct Impact Corona Ionization Mass Spectrometry
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Food and Drug Administration, an agency within the Department of Health and Human Services, through the National Institutes of Health Office of Technology Transfer is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in HHS Ref. No. E-258-2011/0, ``Direct Impact Corona Ionization (DICI) Mass Spectrometry;'' U.S. Patent 8,704,169, to Vivione Biosciences, Inc., a corporation incorporated under the laws of the State of Arkansas, having a principle place of business at 515 W. Matthews Ave., Jonesboro, AR 72401. The United States of America is the assignee of the patent rights pertaining to this invention. The exclusivity period of the contemplated license may be granted for no more than seven (7) years, may be territorially limited to the United States and may be limited to a field of use directed to direct impact corona ionization mass spectrometry pattern recognition devices and systems for detection of small molecules and microbiological agents.
Reclassification of Iontophoresis Devices Intended for Any Other Purposes
The Food and Drug Administration (FDA) is proposing to reclassify iontophoresis devices intended for any other purposes, a preamendments class III device, into class II (special controls), and to amend the device identification. FDA is proposing this reclassification on its own initiative based on new information. This action implements certain statutory requirements.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance on Estradiol.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal cream. This draft guidance is a revised version of a previously issued draft guidance of the same subject.
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 information collection project: ``TeamSTEPPS 2.0 Online Master Trainer Course.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 14th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ [has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This proposed information collection was previously published in the Federal Register on June 4th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
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.
Call for Participation for Computational Photography Project for Pill Identification (C3PI)
The National Library of Medicine (NLM) invites pharmaceutical manufacturers, re-packagers, wholesalers, and retail and institutional pharmacies to submit prescription drug products for imaging as part of its Computational Photography Project for Pill Identification (C3PI). The NLM is developing the C3PI oral solid dosage formulations (OSDFs) collection as part of an initiative to build a reliable and high- quality image catalog of all OSDF prescription products marketed in the United States. Such a resource can support a number of public safety initiatives, such as in poison control, emergency response, and reduction of medication errors.
Submission for OMB Review; 30-Day Comment Request, Process Assessment Review of the Division of Acquired Immunodeficiency Syndrome (DAIDS) Critical Events, Policy Implementation (CEPI) Program (NIAID)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, 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 April 9, 2013, page 19633 and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Applications for New Awards; Preschool Development Grants-Expansion Grants; Correction
On August 18, 2014, the Departments of Education and Health and Human Services published in the Federal Register (79 FR 48874) a notice inviting applications for new awards for fiscal year 2014 for the Preschool Development GrantsExpansion Grants program. This notice corrects the Executive Summary Selection Criterion (A)(7)(b).
Issuance of Final Guidance Publication
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014.''
Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System
The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes will provide a reasonable assurance of safety and effectiveness of the device. The Agency is proposing to rename the device ``electrical salivary stimulatory system.''
Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System
The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast
The HHS Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) and the USDA Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) are jointly charged with the oversight of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the Webcast is to provide guidance related to the Federal Select Agent Program for interested individuals.
Prospective Grant of Exclusive License: Therapeutics for the Treatment of Lysosomal Storage Disorders
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 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 following invention as embodied in the following patent applications:
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Makoto Suzuki, M.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Makoto Suzuki, currently a Professor in the Department of Thoracic Surgery, Kumamoto University Hospital, Kumamoto, Japan, and formerly a Visiting Scientist in the Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P50 CA070907 and U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in six (6) publications:
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Takao Takahashi, M.D., Ph.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Takao Takahashi, currently a faculty member in the Department of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu, Japan, and formerly a Visiting Scientist in the Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in four (4) publications:
Announcement of the Intent To Award a Single-Source Cooperative Agreement to the Gerontology Institute, University of Massachusetts Boston
The Administration for Community Living (ACL) announces the intent to award a single-source cooperative agreement in the amount of $75,000 to the Gerontology Institute, University of Massachusetts Boston (UMass Boston) to support and stimulate the expansion of work already underway by UMass Boston in providing pension counseling services to residents of the State of Illinois.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evidence-Based Falls Prevention Program Standardized Data Collection
The Administration on Aging (AoA), Administration for Community Living (ACL), is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Proper Justification of Impurity Limits; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsRefuse to Receive for Lack of Proper Justification of Impurity Limits.'' This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements) for which the applicant is seeking approval of a new strength of the drug product. The draft guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Exception From General Requirements for Informed Consent'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug
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.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus (detected in the West Africa outbreak in 2014). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive Standards; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``ANDA Submissions Refuse-to-Receive Standards.'' It finalizes the draft guidance with the same name that published on October 1, 2013. This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements for new strengths). The guidance represents the FDA's current thinking regarding the types of serious deficiencies that may cause FDA to refuse-to-receive the submission.
Interim Guidance for Implementation of the Organizational Integrity of Entities Implementing Programs and Activities Under the Leadership Act
This document provides interim guidance on the implementation of section 301(f) of the Leadership Act in light of the Supreme Court's decision in Agency for Int'l Dev. v. Alliance for Open Soc'y Int'l, Inc., 133 S. Ct. 2321 (2013) (``AOSI decision''). While HHS awarding agencies have implemented the AOSI decision since its issuance, this document serves to clarify HHS policy. HHS is also currently developing an amendment to its regulations listed under ``Organizational Integrity of Entities Implementing Programs and Activities under the Leadership Act'' to ensure consistency with the decision. HHS has been coordinating its implementation activities with the Department of State, Office of the Global AIDS Coordinator (OGAC) and with the United States Agency for International Development (USAID). While issued through OGA, this guidance represents the views of the various agencies within HHS that issue awards with Leadership Act HIV/AIDS funds, namely, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Health Resources and Services Administration.
Specifications for Medical Examinations of Coal Miners
On August 4, 2014, the Department of Health and Human Services (HHS) published an interim final rule to amend its regulations to establish standards for the approval of facilities that conduct spirometry examinations and to require that all coal mine operators submit a plan for the provision of spirometry and X-ray examinations to all surface and underground coal miners. The title of Part 37 was not properly amended to reflect the application of these provisions to all coal miners, including miners who work in or at surface coal mines, and not only underground coal miners.
Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability; Correction
The Food and Drug Administration is correcting a notice entitled ``Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability'' that appeared in the Federal Register of August 29, 2014 (79 FR 51576). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014. The document was published with the incorrect docket number. This document corrects that error.
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.
Prospective Grant of Exclusive Evaluation License: Development of Antibody-Drug Conjugates Comprising Topoisomerase Inhibitors for the Treatment of Human Cancers
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 license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/844,027 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2006 [HHS Ref. No. E- 160-2006/0-US-01], PCT Application No. PCT/US2007/078233 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E-160-2006/0-PCT-02], European Patent Application No. 7842310.0 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E- 160-2006/0-EP-03], and U.S. Patent Application No. 12/441,029 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed March 12, 2009 now US Patent No. 8,008,316 issued August 30, 2011 [HHS Ref. No. E-160-2006/0-US-04], and all related continuing and foreign patents/patent applications for the technology family, to Oncolinx, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the development and use of the licensed patent rights as a component of an antibody-drug conjugate for the treatment of human cancers. Upon expiration or termination of the exclusive evaluation option license, Oncolinx will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices
The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls). In response to the requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed administrative order to reclassify EPPGs.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Withdrawal of Draft Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of the draft guidance entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator,'' dated October 2011, in response to the requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA) and new input received during a panel meeting.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls), and to amend the device identification and reclassify the pacing system analyzers (PSAs) into class II (special controls). Specifically, single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are postamendments class III devices, are proposed to be reclassified to class II devices. FDA is proposing this reclassification based on new information pertaining to the device. This proposed action would implement certain statutory requirements.
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: 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.
Submission for OMB Review; 30-Day Comment Request; Cancer Epidemiology Descriptive Cohort Database (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 18, 2014, Vol. 79, page 34766 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Submission for OMB Review; 30-Day Comment Request Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 8, 2014, Vol. 79, No. 89, page 26439 and allowed 60- days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of April 25, 2014 (79 FR 22995). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Allegations of Regulatory Misconduct Associated With Medical Devices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Joslyn Manufacturing Company in Fort Wayne, Indiana, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products
The Food and Drug Administration (FDA) is withdrawing approval of three abbreviated new drug applications (ANDAs) for products containing propoxyphene. The basis for the withdrawals is that the products are no longer shown to be safe because propoxyphene puts patients at risk of potentially serious and even fatal heart rhythm abnormalities. The holders of these ANDAs have waived their opportunity for a hearing.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Eye Tracking Study of Direct-to- Consumer Prescription Drug Advertisement Viewing'' 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; Prescription Drug Advertisements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Advertisements'' 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; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
The Food and Drug Administration (FDA) is announcing that a collection of information entitled Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing ``Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format'' 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; Survey of Health Care Practitioners for Device Labeling Format and Content
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed information collection ``Survey of Health Care Practitioners for Device Labeling Format and Content.''
2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
This final rule introduces regulatory flexibilities and general improvements for certification to the 2014 Edition EHR certification criteria (2014 Edition). It also codifies a few revisions and updates to the ONC HIT Certification Program for certification to the 2014 Edition and future editions of certification criteria as well as makes administrative updates to the Code of Federal Regulations.
Findings of Research Misconduct; Correction
This document corrects errors that appeared in the notice published in the July 30, 2014, Federal Register entitled ``Findings of Research Misconduct.''
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
HRSA published a notice in the Federal Register, FR 2014-18735 (August 8, 2014), announcing the meeting of the National Advisory Committee on Rural Health and Human Services in Sioux Falls, South Dakota (Federal Register, Vol. 79, No. 153, 46445). The site for the opening of the meeting has been changed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Testing Communications on Biological Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Testing Communications on Biological Products'' 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; Health and Diet Survey
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.
Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction
The Food and Drug Administration is correcting a proposed rule entitled ``Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications'' that appeared in the Federal Register of August, 22, 2014. The document proposed to amend the biologics regulations by removing the general safety test requirements for biological products. The document published with the incorrect title. This document corrects that error.
Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Unique Device Identification System: Small Entity Compliance Guide'' for a final rule published in the Federal Register of September 2013. This small entity compliance guide (SECG) intends to provide, in plain language, the requirements of the regulation and to help small businesses understand and comply with the regulation.
Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents
The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Georgia Tuberculosis Outbreak Among Homeless
The Centers for Disease Control and Prevention (CDC) located within the United States Department of Health and Human Services (HHS) announces a notice of award to the Georgia Department of Public Health, Tuberculosis (TB) Program. This award will be in the amount of $419,095.00. The purpose of this award is to halt the further spread of a drug- resistant strain of tuberculosis associated with multiple homeless shelters in Fulton County, Georgia.
Advisory Committee Renewals; Correction
The Food and Drug Administration (FDA) is correcting a notice entitled ``Advisory Committee Renewals'' that appeared in the Federal Register of August 25, 2014 (79 FR 50658). The document announced the renewal of certain FDA advisory committees by the Commissioner of Food and Drugs. The table in the document contained several errors. This document corrects those errors.
Exploring the Expansion of Conditional Approval to Appropriate Categories of New Animal Drugs
The Food and Drug Administration (FDA) is announcing that it is beginning the exploration process described in a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. Consistent with the performance goal, the FDA is inviting comments in regard to the Agency exploring the use of statutory changes to expand the use of conditional approval beyond new animal drugs intended for minor species or for minor uses in major species to additional categories of new animal drugs as appropriate.
Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds
The Food and Drug Administration (FDA) is announcing that it is beginning the exploration process described in a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. Consistent with the performance goal, FDA is inviting comments in regard to the Agency exploring the use of statutory changes to modify the current requirement that the use of multiple new animal drugs in a combination drug medicated feed be the subject of an approved new animal drug application (NADA). The Agency also is inviting comment on potential changes to procedures and requirements related to the NADA approval process for such products that can be accomplished under the Agency's existing statutory authority.
HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations
Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on May 8, 2013. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created six (6) workgroups to analyze the following areas: (1) Content standards; (2) semantic standards; (3) transport and security; (4) implementation, certification, and testing; (5) architecture, services and application program interfaces (APIs); (6) a steering committee to provide continuity across all other groups. Other groups are convened to address specific issues as needed. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) An assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a report from a workgroup or other special group, the HIT Standards Committee will: (1) Accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the HIT Standards Committee is expected to address over the coming year include, but may not be limited to: Quality measurement; the extended portfolio of standards for the nationwide health information network; distributed queries and results; radiology; consumer-mediated information exchange; public health; data portability; and a process for the maintenance of standards. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at https://www.healthit.gov/facas/calendar. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
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.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
The Food and Drug Administration (FDA) is correcting a document entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction'' that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
