> ## 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.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-248/
- Published: 2016-01-24T12:00:00.000Z
- Updated: 2026-09-15T02:30:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134554

**BIOLOGICS** 
  
**Panel to Discuss Remicade Biosimilar**  
*Federal Register* Notice: FDA’s Arthritis Advisory Committee will meet 2/9, from 7:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Celltrion BLA for CT-P13, a proposed biosimilar to Janssen Biotech Inc.’s Remicade (infliximab) for **(1)** Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; **(2)** reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease; **(3)** reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; **(4)** reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; **(5)** reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients six years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; **(6)** in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; **(7)** reducing signs and symptoms in patients with active ankylosing spondylitis; **(8)** reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and **(9)** treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Contact **Stephanie L. Begansky**, (301) 796-9001\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-19/pdf/2016-00823.pdf?ref=fdaweb.com)  
  
**Panel to Hear Research Program Updates**  
*Federal Register* Notice: FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet 2/16 from 1 p.m. to 5 p.m. at FDA White Oak Conference Center, Rm 1503\. The committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Tumor Vaccines and Biotechnology Branch and the Cellular and Tissue Therapy Branch of the Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapy, CBER. Contact **Janie Kim or Rosanna Harvey**, (301) 796-9016 or (240) 402-8072, janie.kim@fda.hhs.gov or Rosanna.Harvey@fda.hhs.gov. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01165.pdf?ref=fdaweb.com)  
  
**FDA Corrects Notice on Arthritis A/C Meeting**  
*Federal Register* Notice: FDA is correcting a 1/19 Federal Register notice announcing the Arthritis Advisory Committee meeting set to discuss a Celltrion Inc. BLA for a proposed biosimilar to Remicade. The notice contained an incorrect date for individuals requesting oral presentations, and for FDA notifying individuals on their request to speak at the meeting. In FR Doc. 2016-00823, on page 2873, in the third column, in the “Procedure” paragraph, the fourth sentence is corrected to read: “Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 28, 2016.” On page 2873, in the third column, in the “Procedure” paragraph, the last sentence is corrected to read “The contact person will notify interested persons regarding their request to speak by January 29, 2016.” To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-22/pdf/2016-01248.pdf?ref=fdaweb.com)  
  
**DEVICES** 
  
**Panel to Discuss PMAs for Cardiac Monitor, Scaffold**  
*Federal Register* Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 3/15-16, from 8 a.m. to 6 p.m. at Holiday Inn Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. On 3/15, the committee will discuss an Abbott Vascular PMA for the Absorb GT1 Bioresorbable Vascular Scaffold System, a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length <= 24 mm with a reference vessel diameter of >= 2.5 mm and <= 3.75 mm). On 3/16 the committee will discuss an Angel Medical Systems PMA for the AngelMed Guardian System, an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. It is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia. Contact **Dimitrus Culbreath**, (301) 796-6872, [Dimitrus.Culbreath@fda.hhs.gov](mailto:Dimitrus.Culbreath@fda.hhs.gov). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-19/pdf/2016-00824.pdf?ref=fdaweb.com)  
  
**FDA Seeks Selectors, Nominations for Radiation Safety Standards Panel**  
*Federal Register* Notice: FDA is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee notify the agency in writing. It is also requesting nominations for voting industry representatives to serve on the committee. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-19/pdf/2016-00825.pdf?ref=fdaweb.com)   
  
**Guidance on Implanted Hemodialysis Devices**  
*Federal Register* Notice: FDA is making available a guidance entitled Implanted Blood Access Devices for Hemodialysis. It was developed to support the reclassification of the implanted blood access devices for hemodialysis into Class 2 (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis. To download this guidance, click here. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01094.pdf?ref=fdaweb.com)  
  
**Guidance on Submitting Sterility Info in 510(k)s for Sterile Devices**  
*Federal Register* Notice: FDA is making available a guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. It updates and clarifies the information on sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission. To download this guidance, click [here.](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM109897?ref=fdaweb.com) To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01093.pdf?ref=fdaweb.com)  
**Hearing Aid into Class 2**  
*Federal Register* Final order: FDA is classifying the tympanic membrane contact hearing aid into Class 2 (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 tympanic membrane contact hearing aid’s classification. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01090.pdf?ref=fdaweb.com).  
  
**Guidance on Postmarket Device Cybersecurity**  
*Federal Register* Notice: FDA is making available a draft guidance entitled *Postmarket Management of Cybersecurity in Medical Devices*. It informs industry and FDA staff of the its recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482022?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-22/pdf/2016-01172.pdf?ref=fdaweb.com)  
  
**Cranial Electrotherapy Devices into Class 2**  
*Federal Register* Proposed order: FDA proposes an administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments Class 3 device, into Class 2 (special controls). The devices would be subject to premarket notification and FDA would require the filing of a PMA for CES devices intended to treat depression. This action is based on new information pertaining to the device. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient’s head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy. To view this proposed order, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-22/pdf/2016-01173.pdf?ref=fdaweb.com)   
  
**HUMAN DRUGS** 
  
**Drug Products Not Withdrawn for S&E**  
*Federal Register* Notice: FDA has determined that 12 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. These products include GlaxoSmithKline’s Thorazine HCl tablets, Teva Pharmaceutical’s Cytarabine Injectable, and Par Pharmaceutical’s Capoten tablets. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01097.pdf?ref=fdaweb.com).  
  
**Mevacor Not Withdrawn for S&E**  
*Federal Register* Notice: FDA has determined that Mevacor (lovastatin) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01096.pdf?ref=fdaweb.com)  
  
**FDA Renews Pharmaceutical Science Advisory Committee Charter**  
*Federal Register* Notice: FDA is renewing the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (formerly known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined for an additional two years beyond the charter expiration date. The new charter will be in effect until the 1/22/18\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-22/pdf/2016-01181.pdf?ref=fdaweb.com).  
  
**TOBACCO** 
  
**Docket Opened for Psychosocial Predictors of Tobacco Use**  
*Federal Register* Notice: FDA’s Center for Tobacco Products is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may be adapted for or extrapolated to tobacco products. FDA is seeking data and information in the form of reports and manuscripts that are unpublished or not available through indexed bibliographic databases. Comments should be submitted by 3/4/16\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-19/pdf/2016-00836.pdf?ref=fdaweb.com)  
  
**VETERINARY** 
  
**Guidance on Veterinary Parenteral Dosage Forms**  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications*. It provides recommendations on submitting chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This draft guidance is applicable to both NADAs and ANADAs products. To download this guidance, click [here](http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM481721?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-19/pdf/2016-00822.pdf?ref=fdaweb.com).   
  
**FDA Removes Conditional Approval for Kinavet-CA1 Animal Drug**  
*Federal Register* Notice: FDA is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect as of 12/15/15\. Because of this Kinavet-CA1 tablets are now an unapproved new animal drug product with no legal  
marketing status. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01104.pdf?ref=fdaweb.com)  
  
**Guidance on Target Animal Safety Data**  
*Federal Register* Notice: FDA is making available a guidance for industry entitled *Target Animal Safety Data Presentation and Statistical Analysis*. Its purpose is to provide recommendations to industry on the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry). To download this guidance, click [here](http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM440319.pdf?ref=fdaweb.com). To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01098.pdf?ref=fdaweb.com)**FDA Amends Animal Drugs Regs on Conditional Approval**  
*Federal Register* Final rule: FDA is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect. To view this final rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01100.pdf?ref=fdaweb.com).  
  
**GENERAL** 
  
**FDA Submits Info on Dietary Supplement AERs to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act — 21 U.S.C. 379aa-1(b)(1),” has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01103.pdf?ref=fdaweb.com).