Latest Federal Register Notices

BIOLOGICS

Panel to Discuss Southern Hemisphere Influenza Vaccine
Federal Register Notice: FDA will hold a meeting 10/13 of the Vaccines and Related Biological Products Advisory Committee. The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season. The meeting will be held from 1 p.m. to 4:30 p.m. at the FDA White Oak campus in Silver Spring, MD. Contact Sujata Vijh (240) 402-7107, sujata.vijh@fda.hhs.gov or Rosanna Harvey (240) 402-8072, rosanna.harvey@fda.hhs.gov. To view this notice, click here.

Docket Established for Reducing HIV Risk for Blood Donors
Federal Register Notice: FDA is establishing a public docket for comment on the agency’s blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry dated 12/2015. Comments should be submitted by 11/25. To view this notice, click here.

FDA Posts Biosimilar User Fee Rates
Federal Register Notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2017. Under the Biosimilar User Fee Act of 2012 (BsUFA) the initial and annual biological product development (BPD) fee rates for a fiscal year are equal to 10 % of the fee rate established under the Prescription Drug User Fee Act (PDUFA). The rates for an initial BPD are $203,810, for an annual BPD — $203,810; for a reactivation — $407,620; for applications requiring clinical data — $2,038,100; for applications not requiring clinical data — $1,019,050, for a supplement requiring clinical data — $1,019,050; for establishment —$512,200; and for product $97,750. To view this notice, click here.

DEVICES

FDA Posts Modifications to Device Standards
Federal Register Notice: FDA is releasing a publication containing modifications it is making to the list of standards the agency recognizes for use in premarket device reviews entitled “Modifications to the List of Recognized Standards, Recognition List Number: 044.” It aims to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view this notice, click here.

Guidance on Unique Device ID System
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The draft document will define the expected content and forms of the UDI, to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). To download this guidance, click here. To view this notice, click here.

FDA Reclassifies Iontophoresis Devices into Class 2
Federal Register Final order: FDA is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments Class 3 devices (regulated under product code EGJ), into Class 2 (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification. To view this final order, click here.

Guidance on Real-World Evidence to Support Device Decisions
Federal Register Notice: FDA is making available a draft guidance: Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices. The agency is issuing this draft guidance to clarify how it evaluates real-world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an investigational device exemption may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. To download this guidance, click here. To view this notice, click here.

Guidance on Device Adaptive Clinical Study Designs
Federal Register Notice: FDA is making available a guidance entitled Adaptive Designs for Medical Device Clinical Studies. It provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is a design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity. Adaptive designs, can reduce resource requirements and/or increase the chance of study success. To download this guidance, click here. To view this notice, click here.

Comments Sought on Device Pre-Submission Program
Federal Register Notice: FDA is seeking public comment on requests for feedback submitted under the Pre-Submission program for medical devices. A guidance on the topic provides recommendations on the information that should be submitted in a Pre-Submission package and procedures that should be followed for meetings between CDRH and CBER staff and industry representatives or application sponsors. In addition to Pre-Submissions, the guidance addresses other feedback mechanisms including Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, and Submission Issue Meetings and the procedures to request feedback using these mechanisms. Comments should be submitted by 9/26. To view this notice, click here.

Medical Device User Fee Rates Posted
Federal Register Notice: FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year 2017. The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $234,495 for FY 2017. For a panel-track supplement, the rate is 75% of the standard fee; for a 180-day supplement —15% of the standard fee; for a real-time supplement — 7% of the standard fee; for a 510(k) premarket notification — 2% of the standard fee; for a 30-day notice — 1.6% of the standard fee; for a 513(g) request for classification information —1.35% of the standard fee; for an annual fee for periodic reporting concerning a Class 3 device — 3.5% of the standard fee. For all submissions other than a 510(k) premarket notification, a 30-day notice, and a 513(g) request for classification information, the small business fee is 25% of the standard (full) fee for the submission. For a 510(k) premarket notification submission, a 30-day notice, and a 513(g) request for classification information, the small business fee is 50% of the standard (full) fee for the submission. The annual fee for establishment registration, after adjustment, is set at $3,382 for FY 2017. To view this notice, click here.

Guidance on General Wellness Devices
Federal Register Notice: FDA is making available a guidance entitled General Wellness: Policy for Low Risk Devices. It is intended to provide clarity to industry and FDA staff on CDRH’s compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). To download this guidance, click here. To view this notice, click here.

HUMAN DRUGS

Change of Sponsor for 54 NADAs, 14 ANADAs
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications and 14 approved ANADAs from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc. To view this final rule, click here.

FDA Posts Generic Drug User Fee Rates
Federal Register Notice: FDA is announcing the rates for ANDAs ($70,480), prior approval supplements to an approved ANDA ($35,240), drug master files ($51,140), generic drug active pharmaceutical ingredient facilities ($44,234), foreign API facility ($59,234), and finished dosage form facilities ($258,646) and foreign finished dosage form facility ($273,646) user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2017. These fees are effective 10/1 and will remain in effect through 9/30/17. To view this notice, click here.

Prescription Drug User Fee Rates Posted
Federal Register Notice: FDA is announcing the rates for prescription drug user fees for fiscal year (FY) 2017: for an application requiring clinical data ($2,038,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,019,050), for an establishment ($512,200), and for a product ($97,750). To view this notice, click here.

Advisory Panels to Discuss Neuropsychiatric Effects of Smoking Cessation Therapies
Federal Register Notice: FDA will hold a meeting 9/14 of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The meeting will be held from 8 a.m. to 5 p.m. FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will discuss a completed postmarketing-requirement randomized, placebo controlled trial of the neuropsychiatric effects of Chantix (varenicline), Zyban (bupropion), and nicotine replacement therapy, along with relevant published observational studies to determine whether the findings support changes to product labeling. Contact Kalyani Bhatt, (301) 796-9001. To view this notice, click here.

Panel to Discuss Spectrum Pharma NDA
Federal Register Notice: FDA will hold a meeting of the Oncologic Drugs Advisory Committee 9/14, from 8 a.m. to 1 p.m. at the 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 Spectrum Pharmaceuticals NDA for apaziquone for intravesical instillation. The proposed indication is for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer. Contact Lauren D. Tesh, (301) 796-9001. To view this notice, click here.

TOBACCO

FDA Sends Info on Tobacco Health Education to OMB
Federal Register Notice: FDA’s proposed collection of information, “Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986 as Amended by the Family Smoking Prevention and Tobacco Control Act,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.

VETERINARY

FDA Posts Animal Drug User Fee Rates
Federal Register Notice: FDA is announcing the rates and payment procedures for fiscal year 2017 animal drug user fees: $350,700 for an animal drug application; $175,350 for a supplemental animal drug application for which safety or effectiveness data are required and for an animal drug application subject to the criteria set forth in FDCA 512(d)(4); $8,195 for an annual product fee; $111,900 for an annual establishment fee; and $103,100 for an annual sponsor fee. To view this notice, click here.

FDA Posts Generic Animal Drug User Fees for FY 2017
Federal Register Notice: FDA is announcing the fee rates and payment procedures for fiscal year 2017 generic new animal drug user fees: $232,400 for each abbreviated application for a generic new animal drug other than those subject to the criteria in section FDCA 512(d)(4); $116,200 for each abbreviated application for a generic new animal drug subject to the criteria in FDCA 512(d)(4); $10,200 for each generic new animal drug product; $96,350 for each generic new animal drug sponsor paying 100 % of the sponsor fee; $72,263 for each generic new animal drug sponsor paying 75 % of the sponsor fee; and $48,175 for each generic new animal drug sponsor paying 50 % of the sponsor fee. FDA will issue invoices for FY 2017 product and sponsor fees by 12/31. To view this notice, click here.