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

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Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Document Number: 2015-20554
Type: Rule
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. FDA has determined that Chagas disease and neurocysticercosis satisfy this definition, and therefore is adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain applications for the treatment of Chagas disease and neurocysticercosis may be eligible to receive a PRV if such applications are approved by FDA.
Pediatric Advisory Committee; Notice of Meeting; Correction
Document Number: 2015-20541
Type: Notice
Date: 2015-08-20
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 August 12, 2015 (80 FR 48325). Phenylephrine Hydrochloride was incorrectly linked to DUREZOL (difluprednate ophthalmic emulsion) 0.05% because they were both listed as item number 1 in the numbered list of products to be discussed at the meeting. Phenylephrine Hydrochloride Ophthalmic Solution is a separate stand-alone drug that will be reviewed by the committee and should be listed as item number 2. The other drugs in the numbered list should be renumbered accordingly. This document corrects that error.
Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2015-20540
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program
Document Number: 2015-20430
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), Offices of Device Evaluation (ODE) and In Vitro Diagnostics and Radiation (OIR) are announcing their participation in the International Medical Device Regulators Forum's (IMDRF) Regulated Product Submission Table of Contents Pilot Program. Participation in the Pilot is voluntary and open to applicants who submit premarket approval (PMA) applications or premarket notification (510(k)) to either ODE or OIR. The Pilot project is intended to provide industry, IMDRF, and CDRH staff the opportunity to evaluate the Table of Contents structure and to receive input from industry participants. Participants will be asked to submit their submissions electronically using IMDRF's Table of Contents (ToC) format.
Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees
Document Number: 2015-20429
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the revised fees the Agency will assess for issuing export certificates for devices. The FDA Export Reform and Enhancement Act of 1996 (EREA) provides that any person who exports a device may request FDA certify in writing that the exported device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification and that FDA may charge up to $175 for each certification that is issued within the 20 days. Since February 2003, FDA's costs to process the device certificates have increased; however, the export certificate fee for subsequent certificates has not changed. Because of the increase, FDA is raising the fees for subsequent certificates, from the current fee of $15 to $85, and revising the formula used to calculate the number of original and subsequent device export certificates issued. These changes are necessary to ensure that the program remains self-sustaining and to cover FDA's increased costs, which are currently being covered by appropriated funds. Further, this document explains the costs associated with the export certification program for devices.
Arthritis Advisory Committee; Notice of Meeting
Document Number: 2015-20398
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee; Correction
Document Number: 2015-20397
Type: Notice
Date: 2015-08-19
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 9, 2014 (79 FR 32964). Due to some recent confusion with the 2014 docket, this 2014 notice and all materials associated with it are being moved to a new docket. This document announces the new docket number.
Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
Document Number: 2015-20317
Type: Rule
Date: 2015-08-18
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2
Document Number: 2015-20316
Type: Notice
Date: 2015-08-18
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are announcing support for the 3.2 version (see section II. Exceptions) of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER.
Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry; Availability
Document Number: 2015-20312
Type: Notice
Date: 2015-08-18
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 ``Providing Submissions in Electronic FormatPostmarketing Safety Reports for Vaccines; Guidance for Industry.'' The guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program that is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. FDA published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants required to submit postmarketing safety reports involving vaccine products to comply with the final rule. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2014, and supersedes the document entitled ``Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated September 1998.
Pilot Program for Medical Device Reporting on Malfunctions
Document Number: 2015-20309
Type: Notice
Date: 2015-08-18
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is soliciting nominations for participation in a pilot program for the submission of medical device reports for malfunctions of class I devices and certain class II devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, FDA intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected.
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-20308
Type: Notice
Date: 2015-08-18
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 the guidance entitled ``Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ``Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems'' guidance (http:/ /www.fda.gov/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations.
Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability
Document Number: 2015-20306
Type: Notice
Date: 2015-08-18
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 guidance for industry entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated gonorrhea. This guidance finalizes the draft guidance of the same name issued on June 19, 2014.
Rare Diseases: Common Issues in Drug Development; Draft Guidance for Industry; Availability
Document Number: 2015-20235
Type: Notice
Date: 2015-08-17
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 ``Rare Diseases: Common Issues in Drug Development.'' The purpose of this draft guidance is to advance and facilitate the development of drugs and biologics to treat rare diseases. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to assist sponsors of drug and biological products for treating rare diseases in conducting more efficient and successful development programs.
Botanical Drug Development; Draft Guidance for Industry; Availability
Document Number: 2015-20230
Type: Notice
Date: 2015-08-17
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 entitled ``Botanical Drug Development.'' This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This draft guidance revises the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004.
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-20229
Type: Notice
Date: 2015-08-17
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 the guidance entitled ``Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.'' National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and single-use intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions (510(k)s) for different categories of IODs to mitigate future outbreaks of TASS.
Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Draft Guidance for Industry; Availability
Document Number: 2015-20228
Type: Notice
Date: 2015-08-17
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 ``Qualification of BiomarkerTotal Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This draft guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a ``progressive decline'' in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This draft guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications, new drug applications, and biologics license applications without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. In the Federal Register of January 7, 2014, FDA announced the availability of a final guidance for industry entitled ``Qualification Process for Drug Development Tools'' that described the process that would be used to qualify Drug Development Tools (DDTs) and to make new DDT qualification recommendations available on FDA's Web site. The qualification recommendations in this draft guidance were developed using the process described in that guidance.
Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid
Document Number: 2015-20177
Type: Rule
Date: 2015-08-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is classifying the computerized cognitive assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the computerized cognitive assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2015-20174
Type: Notice
Date: 2015-08-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is extending the comment period for the document that appeared in the Federal Register of May 19, 2015. In the document, FDA requested comments on draft guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Disease Natural History Database Development-(U24)
Document Number: 2015-20130
Type: Notice
Date: 2015-08-17
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 the support of Natural History Database Development. The National Organization for Rare Disorders (NORD) is developing an Internet-based data collection tool with promise to further the accumulation of natural history data for many rare diseases. The goal of this grant is to enable NORD to further develop, refine, and disseminate the database tool.
Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy; Public Workshop; Request for Comments
Document Number: 2015-20129
Type: Notice
Date: 2015-08-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA), in collaboration with the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI) is announcing a public workshop entitled ``Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy.'' The purpose of the public workshop is to discuss important scientific questions about using two of the most ubiquitous and fastest growing data sources, mobile health data and social computing data, focusing especially on the implications for product safety.
Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments
Document Number: 2015-20127
Type: Notice
Date: 2015-08-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Physiological Closed-Loop Controlled (PCLC) Devices.'' The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation. Dates and Times: The public workshop will be held on October 13 and 14, 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., Building 31 Conference Center, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:/ /www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm. Contact Persons: Bahram Parvinian, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2534, Silver Spring, MD 20993, 301-796-6445, email: Bahram.Parvinian@fda.hhs.gov; and Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-6369, email: Allison.Kumar@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m., October 1, 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 permits, onsite registration on the day 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, Office of Communication and Education (OCE), Center for Devices and Radiological Health, Food and Drug Administration, 301-796-5661, email: susan.monahan@fda.hhs.gov no later than September 29, 2015. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at http:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Susan Monahan to register. 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., October 1, 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 October 7, 2015. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meeting_test.htm . To get a quick overview of the Connect Pro program, visit http://www.adobe.com/ go/connectpro_overview. (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.) Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 15, 2015. All requests to make oral presentations must be received by September 1, 2015. If selected for presentation, any presentation materials must be emailed to Bahram Parvinian and Allison Kumar (see Contact Persons) no later than October 1, 2015. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop to obtain information on challenges related to the design, development, and evaluation of critical care PCLC devices. 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 topics. The deadline for submitting comments related to this public workshop is September 1, 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 questions as outlined in section II of this document, please identify the question 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. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at http://www.fda.gov. 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/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
Document Number: 2015-20051
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
National Mammography Quality Assurance Advisory Committee, Renewal
Document Number: 2015-20050
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 6, 2017.
Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-20005
Type: Notice
Date: 2015-08-14
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 entitled ``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,'' which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040
Document Number: 2015-19991
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 040'' (Recognition List Number: 040), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments
Document Number: 2015-19990
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, ``Neurodiagnostics and Non- Invasive Brain Stimulation Medical Devices Workshop''. The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for neurodiagnostics and non-invasive brain stimulation medical devices and help to speed development and approval of future submissions. Dates and Times: The public workshop will be held on November 19 and 20, 2015, from 8:30 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. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm 3625, Silver Spring, MD 20993, 301-796-6815, Hilda.Scharen@fda.hhs.gov; or Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Jay.Gupta@fda.hhs.gov, 301-796-2795. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 6, 2015, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, susan.monahan@fda.hhs.gov or 301-796-5661 no later than November 5, 2015. To register for the public workshop, please visit FDA's Medical Devices Workshops and Conferences calendar at http://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this meeting/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 for special accommodations). 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 available via Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., November 6, 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 November 10, 2015. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_ test.htm. To get a quick overview of the Connect Pro program, visit http:// www.adobe.com/go/connectpro_overview. (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: 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 topics. The deadline for submitting comments related to this public workshop is December 5, 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 providing comments to the topics as outlined in section II of this document, please identify the question 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. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at http://www.fda.gov. 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/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability
Document Number: 2015-19983
Type: Notice
Date: 2015-08-14
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 the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This draft guidance is not final nor is it in effect at this time.
Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)
Document Number: 2015-19884
Type: Proposed Rule
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for chickens, turkeys, swine, dairy cattle, and beef cattle.
Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date
Document Number: 2015-19768
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is extending the closing date for the document that appeared in the Federal Register of June 3, 2015. In that document, FDA requested that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic 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 GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of the request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
Document Number: 2015-19741
Type: Notice
Date: 2015-08-12
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 an opportunity for public comment on our 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. This notice solicits comments on the information collection provisions of the recommended labeling of certain beers subject to our labeling jurisdiction.
Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2015-19740
Type: Notice
Date: 2015-08-12
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 final guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2015-19729
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing and Handling of Food
Document Number: 2015-19681
Type: Notice
Date: 2015-08-11
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, ``Irradiation in the Production, Processing and Handling of Food'' 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; Regulations Under the Federal Import Milk Act
Document Number: 2015-19669
Type: Notice
Date: 2015-08-11
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 ``Regulations Under the Federal Import Milk Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2015-19548
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2015-19547
Type: Notice
Date: 2015-08-10
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction
Document Number: 2015-19487
Type: Notice
Date: 2015-08-07
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 July 28, 2015 (80 FR 44973). The document published with an incorrect docket number. This document corrects that error.
Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period; Correction
Document Number: 2015-19418
Type: Notice
Date: 2015-08-07
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 July 31, 2015 (80 FR 45661). The document reopened the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products and announced the availability for public comment of amendments to the MRTPAs. The document was published with an incorrect paragraph in the Comments section. This document corrects that error.
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Revision 2); Availability
Document Number: 2015-19244
Type: Notice
Date: 2015-08-06
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the reissuance of a revised draft guidance for industry (Revision 2) entitled ``Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.'' We are reissuing the revised draft guidance to incorporate animal prescription drugs. This reissued revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs, including biologics, and animal prescription drugs, with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers.
Use of Nanomaterials in Food for Animals; Guidance for Industry; Availability
Document Number: 2015-19179
Type: Notice
Date: 2015-08-05
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 guidance for industry #220 entitled ``Use of Nanomaterials in Food for Animals.'' The guidance describes FDA's current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. It is intended to assist industry and other stakeholders in identifying potential issues related to the safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.
Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen; Guidance for Industry; Availability
Document Number: 2015-19178
Type: Notice
Date: 2015-08-05
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Over- the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen.'' The guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over-the-counter or OTC, pediatric oral liquid acetaminophen drug products. This guidance provides recommendations regarding acetaminophen concentration, container labels, carton labeling, and packaging of such products, as well as for any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.
Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker
Document Number: 2015-19177
Type: Rule
Date: 2015-08-05
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device
Document Number: 2015-19074
Type: Rule
Date: 2015-08-04
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the external UES compression device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis
Document Number: 2015-19072
Type: Rule
Date: 2015-08-04
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Evidentiary Considerations for Integration of Biomarkers in Drug Development; Notice of Public Meeting; Request for Comments
Document Number: 2015-19037
Type: Notice
Date: 2015-08-04
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA), in collaboration with the University of Maryland's Center of Excellence in Regulatory Science and Innovation and the Critical Path Institute, is announcing a public workshop entitled ``Evidentiary Considerations for Integration of Biomarkers in Drug Development.'' The purpose of the meeting is to discuss current scientific approaches to biomarker development, acceptance, and utility in drug and biologic (hereafter referred to as therapeutic product) development programs.
Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Confirmation of Effective Date
Document Number: 2015-18996
Type: Rule
Date: 2015-08-04
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 July 9, 2015, for the final rule that appeared in the Federal Register of June 8, 2015, and that amended the color additive regulations to expand the permitted uses of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs.
Understanding Potential Intervention Measures To Reduce the Risk of Foodborne Illness From Consumption of Cheese Manufactured From Unpasteurized Milk
Document Number: 2015-18972
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 requesting comments and scientific data and information that would assist us in identifying and evaluating intervention measures that might have an effect on the presence of bacterial pathogens in cheeses manufactured from unpasteurized milk. We are taking this action in light of scientific data on potential health risks associated with consumption of cheese made from unpasteurized milk.
Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop
Document Number: 2015-18969
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 sixth annual scientific workshop co-sponsored by the Agency and the Coalition Against Major Diseases (CAMD) Consortium of the Critical Path Institute (C-Path). The purpose of this public workshop is to initiate constructive discussion among scientists from FDA, the CAMD Consortium, and other interested parties regarding ongoing efforts to develop tools and methods to facilitate drug development for Alzheimer's disease and Parkinson's disease.
Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs; Draft Guidance for Industry; Availability
Document Number: 2015-18968
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 draft guidance for industry entitled ``Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.'' This draft guidance has been developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/ or abbreviated new drug applications (ANDAs), as appropriate, for immediate-release (IR) tablets and capsules that contain highly soluble drug substances. The draft guidance is intended to define when a standard release test and criteria may be used in lieu of extensive method development and specification-setting exercises. When final, this guidance will supersede the guidance for industry on ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms'' (August 1997) for biopharmaceutics classification system (BCS) class 1 and 3 drug substances that meet the criteria in this draft guidance. For class 2 and 4 drug substances, applicants should still refer to the August 1997 guidance mentioned previously.