Alcohol, Tobacco, Firearms, and Explosives Bureau 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonclinical Evaluation of Endocrine-Related Drug Toxicity.'' The purpose of this guidance is to clarify when additional studies are warranted after the standard toxicology tests have been conducted and there is a signal for potential adverse endocrine-related toxicity. This guidance finalizes the draft guidance entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation'' issued on September 20, 2013.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/P Establishments) with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The guidance announced in this notice finalizes the draft guidance of the same title, dated October 2013. The recommendations in the guidance announced in this notice supersedes those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

The Food and Drug Administration (FDA) has determined that GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection entitled ``Environmental Impact Considerations.''

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.

The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide (CPG) Section 435.100, entitled ``Compressed Medical GasesWarning Letters for Specific Violations Covering Liquid and Gaseous Oxygen.''

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research, in cosponsorship with the Drug Information Association (DIA), is announcing a meeting entitled ``FDA/DIA Oligonucleotide-Based Therapeutics Conference 2015'' (FDA/DIA 2015 conference). The purpose of the meeting is to discuss advances, safety, and challenges in the field of oligonucleotide-based therapeutics.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #227 entitled ``Two- Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.'' The guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions to the Center of Veterinary Medicine (CVM) to support approval of a new animal drug or abbreviated new animal drug.

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The guidance represents FDA's current thinking with respect to imposing no-tobacco-sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.

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.

The Food and Drug Administration (FDA) is extending the comment period for the notice of draft guidance availability and public meeting that appeared in the Federal Register of July 28, 2015, and August 7, 2015. In the notice of draft guidance availability and public meeting, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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.

The Food and Drug Administration (FDA) is announcing the recent approval of a drug product under an application for which the sponsor redeemed a rare pediatric disease priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to redeem priority review vouchers submitted by sponsors of product applications that might otherwise not qualify for priority review. These vouchers entitle the holder of such a voucher to priority review of a single human drug application submitted under the FD&C Act or the Public Health Service Act. FDA has approved PRALUENT (alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a priority review.

The Food and Drug Administration (FDA or we) 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. This notice solicits comments on the information collection provisions of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) and the guidance document entitled, ``Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.''

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. This action is in response to a petition filed by Colorcon, Inc. (Colorcon).

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Lisa Coroniti from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Coroniti was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Ms. Coroniti was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Coroniti failed to request a hearing. Ms. Coroniti's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA, or the Agency) is announcing the establishment of a public docket to receive comments from interested parties on enhancing the utility and usability of the Inactive Ingredient Database (IID) (also known as the Inactive Ingredient Guide). These comments will help FDA identify best practices to assist Agency staff in designing the IID and maintaining the information contained therein. We intend to identify and further develop these best practices in a technical guide or draft guidance to be issued at a later date.

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.

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.

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.