Latest Federal Register Notices
BIOLOGICS
Guidance on Reducing HIV Risk in Blood Products
Federal Register Notice: FDA is announcing the availability of a document entitled Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry. It provides blood establishments that collect blood or blood components, including source plasma, with revised donor deferral recommendations for individuals at increased risk for transmitting human immunodeficiency virus (HIV) infection. It recommends corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification, product management, and testing procedures. It finalizes the draft guidance of the same title dated May 2015 and supersedes the memorandum to blood establishments entitled “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.” dated April 23, 1992 (1992 blood memo). To download this guidance, click here. To view this notice, click here.
Guidance on HCT/P Deviation Reporting
Federal Register Notice: FDA is making available a draft document entitled Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry. It provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act nd under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations. To download this guidance, click here. To view this notice, click here.
FDA Removes Hepatitis C Lookback Requirements
Federal Register Final rule: FDA is amending the biologics regulations by removing the Hepatitis C Virus (HCV) “lookback” requirements for review of historical testing records. These regulations expired on 8/24/15 due to the sunset provision provided under the regulation. To view this final rule, click here.
FDA Corrects Notice on HCT/P Public Hearing
Federal Register Notice: FDA is correcting a notification of a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” that appeared in the 10/30/15 Federal Register. It published with conflicting information about who must register for the public hearing. On page 66845, in the third column under DATES, the third sentence is revised to read: “Persons seeking to attend (including FDA employees) or to present at the public hearing must register by January 8, 2016.” Also, on page 66847, in the first column under section IV. Attendance and Registration, the third sentence is revised to read: “Individuals who wish to attend (including FDA employees) or present at the public hearing must [[Page 81234]] register by sending an email to CBERPublicEvents@fda.hhs.gov on or before January 8, 2016, and provide complete contact information, including name, title, affiliation, address, email, and phone number.” To view this notice, click here.
DEVICES
Guidance on Unique Device ID
Federal Register Notice: FDA is making available a draft guidance entitled Unique Device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff. It is intended to outline the agency’s current thinking that for purposes of Unique Device Identification (UDI) labeling and data submission requirements, the term “convenience kit” applies solely to two or more different medical devices packaged together for the convenience of the user, where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. To download this guidance, click here. To view this notice, click here.
FDA Proposes Sunlamp Standards
Federal Register Proposed rule: FDA is proposing to amend the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products. Comments should be submitted by 3/21. To view this proposed rule, click here.
FDA Proposes to Restrict Sunlamp Products
Federal Register Proposed rule: FDA is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals. Comments should be submitted by 3/21. To view this proposed rule, click here.
FDA Proposes Reclassifying Electroconvulsive Therapy Device
Federal Register Proposed order: FDA is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode associated with major depressive disorder or bipolar disorder in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments Class 3 device, into Class 2 (special controls) based on new information. The agency is also proposing to require the filing of a PMA or a notice of completion of a product development protocol for ECT devices for other intended uses specified in this proposed order. To view this proposed order, click here.
Guidance on Electroconvulsive Therapy Devices
Federal Register Notice: FDA is making available a draft guidance entitled Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff. Its purpose is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT Devices into Class II (special controls) for severe major depressive episode associated with major depressive disorder or bipolar disorder in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. To download this guidance, click here. To view this notice, click here.
CDRH to Post FY 2016 Guidance Documents
Federal Register Notice: FDA is announcing the Web site location where it will post two lists of guidance documents that CDRH intends to publish in Fiscal Year 2016. Also, FDA has established a docket, where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed. Comments should be submitted by 2/29. To view this notice, click here.
Guidance on Notifying Public of Postmarket Device Info
Federal Register Notice: FDA is making available a draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals. It describes the agency’s policy for notifying the public about medical device “emerging signals.” Historically, FDA has communicated important medical device postmarket information after having completed an analysis of available data and, in most cases, after having reached a decision about relevant recommendations for the device user community and about whether further regulatory action is warranted. However, in addition to these types of public communications, FDA believes there also is a need to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which it does not yet have specific recommendations. To download this draft guidance, click here. To view this notice, click here.
HUMAN DRUGS
FDA OKs Pharmgate sNADA
Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental NADA filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. It reflects the agency’s effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group’s evaluation of the effectiveness of this drug as well indications for use not subject to this review. To view this final rule, click here.
FDA Proposes to Revise Rx Fixed-Combo Drug Regs
Federal Register Proposed rule: FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing agency policy. To view this proposed rule, click here.
Review Period Set for Jetrea
Federal Register Notice: FDA has determined the regulatory review period for ThromboGenics’ Jetrea (ocriplasmin) is 2,171 days for extending a patent which claims the human biological product. Jetrea is indicated for treating symptomatic vitreomacular adhesion. To view this notice, click here.
Guidance on Emerging Technology in Pharma Manufacturing
Federal Register Notice: FDA is making available a draft guidance for industry entitled Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. It provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls information containing emerging manufacturing technology. The program is open to companies that intend the technology to be submitted as part of an IND, or an original or supplemental NDA, ANDA, or BLA reviewed by the CDER, where that technology meets certain criteria described in the guidance. To download this draft guidance, click here. To view this notice, click here.
Kytril Not Withdrawn for S&E
Federal Register Notice: FDA has determined that Kytril (granisetron hydrochloride) tablets, equivalent 1 mg and 2 mg base, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for Kytril if all other legal and regulatory requirements are met. To view this notice, click here.
Review Period Set for Kadcyla
Federal Register Notice: FDA has determined the regulatory review period for Genentech’s Kadcyla (ado-trastuzumab emtansine) for extending a patent which claims the human biological product. Kadcyla is indicated as a single agent, for treating patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. To view this notice, click here.
FDA Encourages Patient-Focused Drug Development Meetings
Federal Register Notice: FDA is announcing the opportunity for externally-led patient-focused drug development meetings. FDA recognizes that there are many more disease areas than can be addressed in the planned FDA meetings under PDUFA V and it welcomes patient organizations to identify and organize patient-focused collaborations to generate public input on other disease areas, using the process established through Patient-Focused Drug Development as a model. The agency recommends that patient organizations who are interested in conducting an externally-led PFDD meeting initially engage with FDA by submitting a letter of intent to patientfocused@fda.hhs.gov. To view this notice, click here.
Comments Sought on PET Drug CGMPs
Federal Register Notice: FDA is seeking public comment on the information collection contained in its regulations on current good manufacturing practice for positron emission tomography drugs. Comments should be submitted by 2/29. To view this notice, click here.
Guidance on Paliperidone Palmitate
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Draft Guidance on Paliperidone Palmitate. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for paliperidone palmitate extended-release injectable suspension. To view this notice, click here.
GENERAL
Panel to Discuss Food, Aeroallergen Products
Federal Register Notice: FDA’s Allergenic Products Advisory Committee will meet 1/21, from 8:30 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. The committee will meet in an open session to discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease. Contact Janie Kim or Denise Royster, (301) 796-9016 or (240) 402-8158, email: Janie.kim@fda.hhs.gov or Denise.royster@fda.hhs.gov. To view this notice, click here.
Panel to Discuss Risk Communications
Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 2/16 from 9 a.m. to 5 p.m. and February 17, 2016, from 9 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications. Contact Lee L. Zwanziger, (301) 796-9151 or email: RCAC@FDA.HHS.gov. To view this notice, click here.
Comments Sought on Emergency Use Info
Federal Register Notice: FDA is seeking public comment on the proposed extension of the collection of information related to emergency use authorizations by the agency. Comments should be submitted by 2/22. To view this notice, click here.
FDA Sends Info on DTC Ads to OMB
Federal Register Notice: FDA’s proposed collection of information entitled “Hearing, Aging, and Direct-to-Consumer Television Advertisements” 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.
FDA Corrects Notice on Bar Code Labels
Federal Register Notice: FDA is correcting a notice entitled “Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products” that appeared in the 12/15/15 Federal Register. The document was published with an incorrect docket number. To view this notice, click here.
Docket on Emerging Infectious Disease Trials
Federal Register Notice: FDA is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, on clinical trial designs. Comments should be submitted by 1/28. To view this notice, click here.