Alcohol, Tobacco, Firearms, and Explosives Bureau – Federal Register Recent Federal Regulation Documents

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Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada
Document Number: 2015-18960
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is announcing the availability of the ``Joint Food and Drug Administration/Health CanadaSant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.'' We are making available an interpretative summary, a technical Quantitative Risk Assessment (QRA) report with appendices, a risk-assessment model, and a document responding to public comments that we received regarding the 2013 ``Draft Joint Food and Drug Administration/Health CanadaSant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.'' The purpose of the QRA is to evaluate the effect of factors such as the microbiological status of milk, cheese-manufacturing steps, and conditions during distribution and storage on the overall risk of invasive listeriosis to the consumer of soft-ripened cheese in the United States or Canada. The QRA makes it possible to evaluate the effectiveness of some process changes and intervention strategies in reducing the risk of listeriosis.
Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop
Document Number: 2015-18957
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability
Document Number: 2015-18956
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry.'' The guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions (hereafter referred to as ``510(k) submission'' or ``510(k)'') for HLA in vitro diagnostic (IVD) device test kits. The guidance applies specifically to nucleic acid-based HLA test kits used for the matching of donors and recipients in transfusion and transplantation, whether testing is for a single locus or for multiple loci simultaneously, for which the premarket submission to FDA will be a 510(k). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2013.
Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections; Public Meeting
Document Number: 2015-18919
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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 nontuberculous mycobacterial (NTM) lung infections. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of NTM lung infections on daily life and patient views on treatment approaches. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat NTM lung infections. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat NTM lung infections. The input from this public meeting will help in developing topics for further discussion.
Outsourcing Facility Fee Rates for Fiscal Year 2016
Document Number: 2015-18916
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2016 rates for the establishment and reinspection fees related to human drug compounding outsourcing facilities (outsourcing facilities) that elect to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2016 rates for the small business establishment fee ($5,203), the non-small business establishment fee ($16,465), and the reinspection fee ($15,610) for outsourcing facilities; provides information on how the fees for FY 2016 were determined; and describes the payment procedures outsourcing facilities should follow.
Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016
Document Number: 2015-18915
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2016.
Prescription Drug User Fee Rates for Fiscal Year 2016
Document Number: 2015-18914
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2016.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016
Document Number: 2015-18913
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2016 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
Document Number: 2015-18912
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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 a survey entitled ``Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities''. The data collection will obtain knowledge of State and local capacities including food safety defense staffing and expertise, laboratory capacities, and information systems to support food and feed safety and defense.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2015-18911
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments
Document Number: 2015-18910
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2016
Document Number: 2015-18909
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2016 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2016.
Biosimilar User Fee Rates for Fiscal Year 2016
Document Number: 2015-18908
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.
Medical Device User Fee Rates for Fiscal Year 2016
Document Number: 2015-18907
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2016, which apply from October 1, 2015, through September 30, 2016. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2016, you should not submit a FY 2016 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2016 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
Document Number: 2015-18906
Type: Notice
Date: 2015-08-03
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2016 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products; Guidance for Industry; Availability
Document Number: 2015-18796
Type: Notice
Date: 2015-07-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #198 entitled ``Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL45). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance is an annex to a VICH guidance GFI #73 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)'' VICH GL3(R). This VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).
Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period
Document Number: 2015-18782
Type: Notice
Date: 2015-07-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products and announcing the availability for public comment of amendments to the MRTPAs. The notice of availability for the originally-filed applications appeared in the Federal Register of August 27, 2014 (79 FR 51183). In that notice, FDA requested comments on the 10 originally-filed MRTPAs that are posted on http:// www.regulations.gov and FDA's Web site. The comment period on these originally-filed applications closed on February 23, 2015. FDA is reopening the comment period to seek comment specifically on amendments made to the originally-filed MRTPAs submitted by Swedish Match North America Inc.
Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products; Extension of Comment Period
Document Number: 2015-18668
Type: Notice
Date: 2015-07-30
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is extending the comment period for the risk assessment entitled ``Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.'' A notice of the availability of the risk assessment and our request for comments appeared in the Federal Register of April 30, 2015. We initially established July 29, 2015, as the deadline for the submission of requested comments that can help improve the ranking model approach, including the specific criteria, scoring, and weighting scheme; the scientific data and assumptions used to inform scoring used in the model; the selection of animal drugs evaluated; and the clarity and the transparency of the risk assessment. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability
Document Number: 2015-18655
Type: Proposed Rule
Date: 2015-07-30
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' The draft guidance, when finalized, will explain to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Veterinary Feed Directive
Document Number: 2015-18650
Type: Notice
Date: 2015-07-30
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Veterinary Feed Directive'' 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; State Enforcement Notifications
Document Number: 2015-18649
Type: Notice
Date: 2015-07-30
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``State Enforcement Notifications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments
Document Number: 2015-18448
Type: Notice
Date: 2015-07-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ``Request for Quality Metrics'' and a public meeting regarding the Agency's plans associated with a quality metrics reporting program. The draft guidance and public meeting are intended to gain stakeholders' perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA's initial set of requests for quality metrics data.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
Document Number: 2015-18410
Type: Notice
Date: 2015-07-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2015-18295
Type: Notice
Date: 2015-07-27
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability
Document Number: 2015-18270
Type: Notice
Date: 2015-07-27
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Analytical Procedures and Methods Validation for Drugs and Biologics.'' This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ``Analytical Procedures and Methods Validation'' and the 1987 FDA guidance for industry on ``Submitting Samples and Analytical Data for Methods Validation.'' This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents
Document Number: 2015-17929
Type: Proposed Rule
Date: 2015-07-27
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Supplemental Proposed Rule To Solicit Comment on Limited Additional Provisions
Document Number: 2015-17928
Type: Proposed Rule
Date: 2015-07-27
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is revising certain provisions of the proposed rule, issued in March 2014, that would amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices (``the NFL/SFL proposed rule''). We are proposing text for the footnotes to be used on the Nutrition Facts label. We are taking this action after completing our consumer research in which we tested various footnote text options for the label. We are also proposing to establish a Daily Reference Value (DRV) of 10 percent of total energy intake from added sugars, proposing to require the declaration of the percent Daily Value (DV) for added sugars on the label, and are providing additional rationale for the declaration of added sugars on the label. We are taking these actions based, in part, on the science underlying a new report released by the 2015 Dietary Guidelines Advisory Committee.
Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments
Document Number: 2015-18149
Type: Notice
Date: 2015-07-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-18142
Type: Notice
Date: 2015-07-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The draft guidance, when finalized, will contain FDA recommendations on third-party auditor/ certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA).
User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
Document Number: 2015-18141
Type: Proposed Rule
Date: 2015-07-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA, the Agency, or we) is issuing this proposed rule to amend the proposed rule, ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications'' (Accreditation of Third-Party Auditors proposed rule) and to propose to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
Document Number: 2015-18140
Type: Notice
Date: 2015-07-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements'' 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; Reclassification Petitions for Medical Devices; Correction
Document Number: 2015-18043
Type: Notice
Date: 2015-07-23
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration is correcting a notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices'' that appeared in the Federal Register of June 12, 2015 (80 FR 33524). The document announced 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. The document inadvertently contained inaccurate information regarding communications with industry, including inaccurate contact information. This document corrects that error.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
Document Number: 2015-18042
Type: Notice
Date: 2015-07-23
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Intent To Review a Study Data Reviewer's Guide Template
Document Number: 2015-18027
Type: Notice
Date: 2015-07-23
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDRG template for regulatory submissions.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products
Document Number: 2015-18026
Type: Notice
Date: 2015-07-23
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Correction
Document Number: 2015-18024
Type: Notice
Date: 2015-07-23
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 30, 2015 (80 FR 37273). The document announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The document was published with an incorrect table title and contents. This document corrects those errors.
Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2015-18023
Type: Notice
Date: 2015-07-23
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2015-17985
Type: Notice
Date: 2015-07-22
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction; Confirmation of Effective Date
Document Number: 2015-17930
Type: Rule
Date: 2015-07-22
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is confirming the effective date of August 26, 2015, for the direct final rule that appeared in the Federal Register of April 13, 2015. The direct final rule amends a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types
Document Number: 2015-17809
Type: Notice
Date: 2015-07-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Medical Device Patient Labeling; Request for Comments; Public Workshop
Document Number: 2015-17800
Type: Notice
Date: 2015-07-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration is announcing the following public workshop entitled ``Medical Device Patient Labeling''. The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health (CDRH) is seeking input into these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental Agencies. Ideas generated during this workshop will help facilitate development or revision of guidances and/or standards for medical device patient labeling. Date and Time: The workshop will be held on September 29, 2015, from 8 a.m. to 5 p.m. and September 30, 2015, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please visit the following Web site: http:// www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm Contact Person: Antoinette (Tosia) Hazlett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002, 301-796-6119, Tosia.Hazlett@fda.hhs gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending the ``Medical Device Patient Labeling'' public workshop must register online by 4 p.m. on September 21, 2015. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the days of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Susan Monahan at least 7 days in advance of the meeting. To register for the public workshop, please visit CDRH's Workshops and Conferences calendar at http://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register (see Contact Person). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on September 21, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 25, 2015. If you have never attended a Connect Pro event before, test your connections at https:// collaboration.fda.gov/common/help/en/support/meeting_test.htm . (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: FDA is holding this public workshop to obtain stakeholder input on medical device patient labeling. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop. The deadline for submitting comments regarding this public workshop is October 30, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in ``Topics for Discussion'', please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at: http://www.regulations.gov. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm.
Cooperative Agreement for Research, Education, and Outreach in Support of the Food and Drug Administration Food Safety Modernization Act
Document Number: 2015-17795
Type: Notice
Date: 2015-07-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of grant funds for a cooperative agreement to support the FDA Food Safety Modernization Act (FSMA) implementation efforts by the Illinois Institute of Technology's (IIT) National Center for Food Safety and Technology (NCFST). The estimated amount of support in fiscal year (FY) 2015 will be for up to $5 million (direct plus indirect costs), with the possibility of 2 additional years of support for up to $7 million each year, subject to the availability of funds. This award will improve public health by continued support of an applied research, education, and outreach program related to the science behind and implementation of preventive controls, and on training and technical assistance.
Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2015-17730
Type: Notice
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) 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.
List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period
Document Number: 2015-17729
Type: Notice
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is extending the nomination period for the notice that appeared in the Federal Register of May 19, 2015. In the notice, FDA requested nominations for a list of bulk drug substances that may be used by facilities registered as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs from bulk substances, in accordance with FDA's draft guidance for industry (GIF) #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' The FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit nominations.
Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability
Document Number: 2015-17726
Type: Notice
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled ``Bioequivalence Recommendations for Lubiprostone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.
Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads
Document Number: 2015-17725
Type: Notice
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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 research entitled, ``Market Claims in Direct-to-Consumer Prescription Drug Print Ads.'' This study will examine the impact of market claim information in direct-to-consumer (DTC) print advertising for prescription drugs.
Regulatory Hearing Before the Food and Drug Administration; Technical Amendment
Document Number: 2015-17714
Type: Rule
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is updating an authority citation for the Code of Federal Regulations. This action is technical in nature and is intended to provide accuracy of the Agency's regulations.
David J. Brancato: Grant of Special Termination; Final Order Terminating Debarment
Document Number: 2015-17712
Type: Notice
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) granting special termination of the debarment of David J. Brancato. FDA bases this order on a finding that Dr. Brancato provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Dr. Brancato's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.
Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2015-17684
Type: Notice
Date: 2015-07-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholdersincluding patient and consumer advocacy groups, health care professionals, and scientific and academic expertsnotify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2015-17559
Type: Notice
Date: 2015-07-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau