Latest Federal Register Notices

BIOLOGICS

FDA Proposes Blood Establishment Software into Class 2
Federal Register Proposed rule: FDA is proposing to classify the blood establishment computer software (BECS) and BECS accessories into Class 2 (special controls). The agency is also giving notice that the it does not intend to exempt BECS and BECS accessories from premarket notification requirements of the the FD&C Act. It is also publishing in this document the recommendations of the Blood Product Advisory Committee on the classification of these devices. To view this proposed rule, click here.

DEVICES

FDA Plans Workshop on Device Quality Systems
Federal Register Notice: FDA’s Office of Regulatory Affairs, Southwest Regional Office and the FDA Medical Device Industry Coalition will co-sponsor a public workshop 4/15 entitled “Medical Devices — Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action.” It is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts. The meeting will be held from 8 a.m. to 5 p.m. at Courtyard and Towne Place Suites by Marriott, DFW Airport North/Grapevine, 2200 Bass Pro Ct., Grapevine, TX. Directions and lodging information are available at the FMDIC, Inc. Web site at http://www.fmdic.org/. Contact Staci McAllister, (214) 253-5259, staci.mcallister@fda.hhs.gov. To view this notice, click here.

OMB OKs Info on Medical Device Reporting
Federal Register Notice: FDA’s collection of information entitled “Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting.” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

FDA Proposes PMA Filing for Blood Lancets
Federal Register Proposed order: FDA is issuing a proposed administrative order to require the filing of a PMA following the reclassification of multiple use blood lancets for multiple patient use from Class 1 to Class 3. FDA is summarizing its proposed findings on the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the FD&C Act and the benefits to the public from the use of the device. To view this proposed order, click here.

FDA Proposes Reclassifying 3 Blood Lancets into Class 2
Federal Register Proposed order: FDA is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from Class 1 (general controls) exempt from premarket notification into Class 2 (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information. Comments should be submitted by 6/1. To view this notice, click here.

Device User Fee/Small Business Info Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Medical Device User Fee Small Business Qualification and Certification,” 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.

Guidance on Tubal Implants for Sterilization
Federal Register Notice: FDA is making available a draft guidance entitled Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization. It addresses the inclusion of a boxed warning and a patient decision checklist in the product labeling for the implants and the content and format of those materials. This guidance is being issued in response to information provided to FDA, including in comments made at a 9/24/15 Obstetrics and Gynecology Devices Panel meeting on the risks and benefits of the Essure System for Permanent Birth Control. It also is responding to comments submitted to the associated public docket, that women are not receiving or understanding information relating to the risks and benefits of this type of device. To download this guidance, click here. To view this notice, click here.

Docket Established on Refurbished Devices
Federal Register Notice: FDA is establishing a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices including radiation-emitting devices subject to the electronic product radiation control provisions of FD&C Act. To view this notice, click here. 

FDA Amends Unique Device ID Regulation
Federal Register Final rule: FDA is amending the Unique Device Identification (UDI) System regulation to make editorial changes. FDA is updating the UDI email address to GUDIDSupport@fda.hhs.gov in the following regulations that set forth the procedures for notifying the agency when: (1) Requesting an exception from or alternative to a unique device identifier requirement (Sec. 801.55 (21 CFR 801.55)); (2) requesting continued use of legacy FDA identification numbers assigned to devices (Sec. 801.57 (21 CFR 801.57)); and (3) applying for accreditation as an issuing Agency (Sec. 830.110 (21 CFR 830.110)).To view this final rule, click here.

HUMAN DRUGS

Comments Sought on DTC Advertising Survey
Federal Register Notice: FDA seeks public comment on research entitled “National Direct-to-Consumer Advertising Survey.” Its objective is to survey the public about their experiences with and attitudes toward direct-to-consumer advertising of prescription drugs. To view this notice, click here.

Guidance on INDs for Fecal Microbiota Transplants
Federal Register Notice: FDA is making available a draft document entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry. It provides members of the medical and scientific community and other interested persons with notice that, when finalized, we intend to exercise enforcement discretion under limited conditions, on the investigational new drug requirements for using fecal microbiota for transplantation to treat C. difficile infection not responding to standard therapies. It replaces a guidance of the same title dated 3/2014 and when finalized is intended to supersede the document of the same title dated 7/2013. To download this guidance, click here. To view this notice, click here.

Location Moved for Pediatric Advisory Meeting
Federal Register Notice: FDA is amending the 2/19 notice of meeting of the Pediatric Advisory Committee to reflect a change in the Location portion of the document. On page 8508, in the first column, the Location portion of the document is changed to read as follows: DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 Wisconsin Ave., Bethesda, MD 20814, 301-652-2000. To view this notice, click here.

Review Period Set for Invokana
Federal Register Notice: FDA has determined the regulatory review period for Invokana (canagliflozin) is 2,137 days for extending a patent which claims the human drug product. Invokana is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. To view this notice, click here.

Review Period Set for Anoro Ellipta
Federal Register Notice: FDA has determined the regulatory review period for Glaxo’s Anoro Ellipta (umeclidinium/vilanterol) is 1,589 days for extending a patent which claims the human drug product. It is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. To view this notice, click here.

Comments Sought on Animation in DTC TV Ads
Federal Register Notice: FDA seeks comments on research entitled “Animation in Direct-to-Consumer Advertising.” This study will examine how animation affects the comprehension of direct-to-consumer television advertisements for prescription drugs. Comments should be submitted by 5/2. To view this notice, click here.

Docket Set on Nonclinical Study Data Template
Federal Register Notice: CDER is establishing a public docket to collect comments on a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. As part of FDA’s ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE Nonclinical SRDG template. The purpose of this review is to evaluate the template and determine whether the agency will recommend its use either as is, or in a modified form, for regulatory submissions of nonclinical study data. Comments should be submitted by 5/3. To view this notice, click here.

Guidance on First Responder Compliance with Product Tracing
Federal Register Notice: FDA is making available a guidance for industry entitled Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy. It describes the agency’s compliance policy on certain requirements in the FD&C Act for trading partners engaged in transactions with first responders. To minimize possible disruptions to the activities of first responders, FDA does not intend to take action against certain trading partners and first responders as described in the guidance. The agency says that its compliance policy on the provisions to provide, capture, and maintain product tracing information under FDCA section 582(d)(1) will expire 3/1 and it is important that it provide this information before that date to avoid potential disruptions in the supply chain. To download this guidance, click here. To view this notice, click here.


TOBACCO

FDA Sends Info on Tobacco Substantial Equivalence to OMB
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.


OMB OKs Info on Tobacco Campaign Among LGBT
Federal Register Notice: FDA’s collection of information entitled “Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT),” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

OMB OKs Info on Tobacco Establishment Registration
Federal Register Notice: FDA’s collection of information entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.


VETERINARY

Comments Sought on NADA Reporting
Federal Register Notice: FDA seeks comments on the collection of information, “Reporting Associated With New Animal Drug Applications (NADA) — 21 CFR 514.1, 514.4, 514.5, 514.6, 514.8, 514.11, 558.5.” Comments should be submitted by 5/2. To view this notice, click here. 

GENERAL

FDA Policy on Tribal Consultation Policy
Federal Register Notice: FDA is making available a draft FDA Tribal Consultation Policy and is establishing a docket to receive comments on the document. Its purpose is to establish clear policies to further the government-to-government relationship between FDA and American Indian and Alaskan native tribes and facilitate tribal consultation with FDA. Comments must be received by 5/31. To view this notice, click here.


FDA Submits Info on AERs Electronic Submission to OMB
Federal Register Notice: FDA’s proposed collection of information, “Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal — 21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803,” 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.

OMB OKs Info on Electronic User Fee Forms
Federal Register Notice: FDA’s collection of information entitled “Electronic User Fee Payment Request Forms” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.