> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Federal Register Summaries: 12/19 to 12/30 - URL: https://www.fdaweb.com/federal-register-summaries-12-19-to-12-30/ - Published: 2017-01-03T12:00:00.000Z - Updated: 2026-09-14T21:57:09.000Z - Author: David McFarland - Tags: FDA Policy/General, #legacy-id-D5137611 ***FDA Webview*** posts the Federal Register summaries for notices released during our holiday break (12/19 to 12/30). **ANIMAL DRUGS** **Guide on Question-based Reviews for Animal Drugs** *Federal Register* Notice: FDA has issued a guidance #234 entitled “Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.” The document includes a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016-30613.pdf?ref=fdaweb.com). **Comments Sought on New Animal Drug Reporting** *Federal Register* Notice: FDA is seeking comments on an information collection extension related to: Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species (21 CFR Part 516). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-22/pdf/2016-30770.pdf?ref=fdaweb.com). **DEVICES** **FDA Bans Powdered Gloves Due to Risk Concerns** *Federal Register* Final Rule: FDA has banned powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove because the devices present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling. FDA has concluded that the risks posed by powdered gloves, including health care worker and patient sensitization to natural rubber latex allergens, surgical complications related to peritoneal adhesions, and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, are too great for public health to allow their continued marketing. To view the rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30382.pdf?ref=fdaweb.com). **Emergency Use OK’d for Abbott Zika Detection** *Federal Register* Notice: FDA has issued an Emergency Use Authorization for an Abbott Molecular *in vitro* diagnostic device for detecting the Zika virus. The authorization contains conditions on the emergency use of the device. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016-30532.pdf?ref=fdaweb.com). **Pedicle Screw Systems Reclassified Into Class 2** *Federal Register* final order: FDA has issued a final order to reclassify pedicle screw systems, a preamendments Class 3 device into Class 2 (special controls). It also has renamed the device “thoracolumbosacral pedicle screw systems” and it reclassified dynamicstabilization systems, a subtype of pedicle screw systems when used as an adjunct to fusion, into Class 2 (special controls), and renamed these “semi-rigid systems.” To view the order, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-30/pdf/2016-31670.pdf?ref=fdaweb.com). **Neurovascular Mechanical Thrombectomy Device Classified** *Federal Register* Final Order: FDA has classified the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into Class 2 (special controls). The special controls are identified in the order and will be part of the codified language. To view the order, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-31007.pdf?ref=fdaweb.com). **Comments Sought on UDI Recordkeeping** *Federal Register* Notice: FDA is seeking comments on an information collection extension related to Unique Device Identification Systems. Recordkeeping, reporting, and third-party disclosure requirements are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-30966.pdf?ref=fdaweb.com). **FDA Listing on Device Consensus Standards** *Federal Register* Notice: FDA has published a listing that contains modifications to its list of standards FDA recognizes for use in premarket reviews: “Modifications to the List of Recognized Standards, Recognition List Number: 046.” The listing is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-31008.pdf?ref=fdaweb.com). **Guidance on Device Benefit-Risk for Enforcement Decisions** *Federal Register* Notice: FDA has made available a guidance entitled “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The document is intended to provide clarity for FDA staff and industry on the benefit and risk factors the agency may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-27/pdf/2016-31145.pdf?ref=fdaweb.com). **Guidance on Device Cybersecurity** *Federal Register* Notice: FDA has made available a guidance entitled “Postmarket Management of Cybersecurity in Medical Devices.” The document provides recommendations for managing postmarket cybersecurity vulnerabilities for marketed devices. It also clarifies FDA’s postmarket recommendations to address cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address these as part of the postmarket management of their medical devices. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-28/pdf/2016-31406.pdf?ref=fdaweb.com). **Pediatric Hospital Beds Renamed Medical Cribs** *Federal Register* Final Rule: FDA has renamed pediatric hospital beds as pediatric medical cribs and established special controls for the devices. It has also established a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a Class 2 (special controls) device. In addition, the rule allows both devices to be exempt from premarket notification when used in traditional health care settings, and permits prescription use outside of such settings. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30193.pdf?ref=fdaweb.com). **Workshop on Registries for Ischemic Stroke Intervention Devices** *Federal Register* Notice: FDA has announced a 2/2/17 public workshop entitled “Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention.” The workshop is intended to obtain stakeholders’ input on the coordination of registries for such devices. It will be held in Bethesda, MD at the Ruth L. Kirschstein Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of Health Campus. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-27/pdf/2016-31143.pdf?ref=fdaweb.com). **CDRH Listing of Guidances Being Developed** *Federal Register* Notice: FDA has made available the Web site location where it is posting two lists of guidance documents that CDRH intends to publish in fiscal year 2017\. One list identifies guidance documents that the Center intends to publish within 12 months. The other identifies guidance documents that it will publish as resources permit. In addition, FDA has established a docket where comments can be submitted on the priority of topics for guidance development. To vie the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-31006.pdf?ref=fdaweb.com). **DRUGS** **Regulatory Review Period for Lilly’s Trulicity** *Federal Register* Notice: FDA has determined that the regulatory review period for Eli Lilly’s Trulicity (dulaglutide) is 3,303 days. Of this time, 2,937 days occurred during the testing phase, while 366 days occurred during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30399.pdf?ref=fdaweb.com). **Draft Guide on Radiopharmaceuticals Compounding** *Federal Register* Notice: FDA has made available a draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.” The document outlines FDA’s policy on compounding and repackaging of radiopharmaceuticals for human use by outsourcing facilities. It also describes how FDA intends to apply section 503B of the federal Food, Drug, and Cosmetic Act to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA does not intend to take action for certain violations when an outsourcing facility repackages radiopharmaceuticals. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-29/pdf/2016-31512.pdf?ref=fdaweb.com). **Guidance on Requiring Prescription for Compounded Drugs** *Federal Register* Notice: FDA has made available a guidance on “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The document outlines FDA’s policy concerning certain prescription requirements for compounding human drug products for identified individual patients. It also addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription, and compounding for office use. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-29/pdf/2016-31607.pdf?ref=fdaweb.com). **Correction of Open Docket Comments for Advisory Committee** Federal Register Notice: FDA is correcting an 11/29 *Federal Register* notice entitled “Pharmaceutical Science and Clinical Pharmacology Advisory Committee.” The correction clarifies that a docket for public comment is open until 4/14/2017\. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-28/pdf/2016-31391.pdf?ref=fdaweb.com). **FDA Guide on Biosimilar Clin/Pharm Data** *Federal Register* Notice: FDA has made available a guidance entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The document is intended to outline the clinical pharmacology data necessary for evaluating a proposed biosimilar product. It is one in a series of guidances that the agency is developing to implement the Biologics Price Competition and Innovation Act of 2009\. To view the guidance, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-29/pdf/2016-31511.pdf?ref=fdaweb.com). **Regulatory Review Period for Cosentyx** *Federal Register* Notice: FDA has determined that the regulatory review period for Novartis’ Cosentyx (secukinumab) is 3,381 days. Of this time, 2,926 days occurred during the testing phase of the regulatory review period, while 455 days occurred during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016-30528.pdf?ref=fdaweb.com). **Regulatory Review Period for Amgen’s Imlygic** *Federal Register* Notice: FDA has determined that the regulatory review period for Amgen’s Imlygic (talimogene laherparepvec) is 3,809 days. Of this time, 3,352 days occurred during the testing phase, while 457 days occurred during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-28/pdf/2016-31322.pdf?ref=fdaweb.com). **Panel Meeting to Review Neurocrine Biosciences NDA** *Federal Register* Notice: FDA has announced a 2/16 Psychopharmacologic Drugs Advisory Committee meeting in Hyattsville, MD. The committee will discuss a Neurocrine Biosciences NDA for valbenazine 40 milligram (mg) capsules for treating Tardive Dyskinesia. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-27/pdf/2016-31144.pdf?ref=fdaweb.com). **Guidance on Drug Establishment eSubmissions** *Federal Register* Notice: FDA has made available a draft guidance entitled “Providing Regulatory Submissions in Electronic Format — Submission of Manufacturing Establishment Information.” The guidance discusses the requirements for a valid electronic submission of manufacturing establishment information. It is intended to streamline the review of all drug/biologic manufacturing establishments. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-29/pdf/2016-31626.pdf?ref=fdaweb.com). **28 Sun Pharma ANDA Approvals Withdrawn** *Federal Register* Notice: FDA has withdrawn approval of 28 ANDAs held by Sun Pharmaceutical Industries. The drug products are no longer marketed, and the company has requested that their approvals be withdrawn. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016-30623.pdf?ref=fdaweb.com). **Guidance on Bioequivalence Study Recommendations** *Federal Register* Notice: FDA has made available additional draft and revised draft product-specific bioequivalence recommendations. The recommendations provide product-specific guidance on the design of such studies to support ANDAs. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-30984.pdf?ref=fdaweb.com). **GENERAL** **Final Rule on Combination Product Safety Reporting** *Federal Register* Final Rule: FDA has issued regulations on postmarketing safety reporting requirements for combination products. The rule describes reporting requirements that apply when two or more different types of regulated medical products comprise a combination product and its constituent parts have received FDA marketing authorization. To view the rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016-30485.pdf?ref=fdaweb.com). **Guidance on Botanical Drug Development** *Federal Register* Notice: FDA has made available a guidance entitled “Botanical Drug Development.” The document describes FDA’s current thinking on appropriate development plans for botanical drugs to be submitted in NDAs and specific recommendations for submitting INDs. It also provides general information on the over-the-counter drug monograph system for botanical drugs. To view the guidance, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-29/pdf/2016-31627.pdf?ref=fdaweb.com).