Latest Federal Register Notices
BIOLOGICS
OMB Clearance Sought on Biologic Naming Guidance
Federal Register Notice: FDA has submitted to OMB for clearance a proposed collection of information contained in the agency’s guidance on “applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure. To view the notice, click here.
Draft Guidance on Genomic Sampling
Federal Register Notice: FDA has released a draft guidance on “E18 Genomic Sampling and Management of Genomic Data.” The document, was prepared under the auspices of the International Council for Harmonization, focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data. The technical aspects of genomic sampling and research are also discussed, and it recognizes the rapidly evolving technological advances in these areas. To view the guidance, click here. To view the notice, click here.
DEVICES
FDA Reclassifies Diurnal Pattern Recorders as Class 2
Federal Register Final Order: FDA is classifying the diurnal pattern recorder system into Class 2 (special controls). FDA believes that the special controls, in addition to general controls, address identified risks and provide reasonable assurance of safety and effectiveness. The nonimplantable, prescription devices use a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure fluctuations. To view this final order, click here.
Panel to Discuss Newborn Screening System
Federal Register Notice: FDA will hold a meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory on 8/10 from 8 a.m. to 6 p.m. at the Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. The panel will vote on information on a de novo request for Baebies, Inc.’s Seeker Newborn Screening System, which uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of a lysosomal storage disorder. Contact Patricio G. Garcia, (301) 796-6875. To view this notice, click here.
Panel to Discuss Diabetes Testing Products
Federal Register Notice: FDA will hold a meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel 7/21-22 from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. On 7/21, the committee will discuss, make recommendations, and vote on a Dexcom, Inc. PMA panel-track supplement for a proposed change in intended use of its Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM. On 7/22, the committee will discuss and make recommendations on an Alere Technologies 510(k) submission for the Alere AfinionTM HbA1c Dx point-of-care test system for the proposed intended use as an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human whole blood to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. Contact Patricio Garcia, 301-796-6875. To view this notice, click here.
Draft Guide on IDEs Available for Medicare Coverage Decisions
Federal Register Notice: FDA has published a draft guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies FDA’s current policy on categorization of IDE devices, which assists CMS in determining whether an IDE device should be covered (reimbursed) by CMS. It also implements a 2015 Memorandum of Understanding between FDA and CMS that streamlines and facilitates the efficient categorization of investigational medical devices in order to support CMS’s ability to make Medicare coverage determinations. To view the guidance, click here. To view the notice, click here.
HUMAN DRUGS
Comments Sought on Good Clinical Practice Guide
Federal Register Notice: FDA is seeking public comment on the collections of information marked as “ADDENDUM” in the draft guidance entitled E6(R2) Good Clinical Practice. The E6(R2) draft guidance was prepared under the auspices of the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Comments should be submitted by 8/1. To view this notice, click here.
https://www.gpo.gov/fdsys/pkg/FR-2016-05-31/pdf/2016-12651.pdf
Public Workshop on Antibacterial Drug Development
Federal Register Notice: Public workshop on “Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media.” The workshop will discussing scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs, and trial population. It will be held 7/18 at FDA’s White Oak, MD campus. To view this notice, click here.
Allergenic Products Panel Renewed
Federal Register Notice: The FDA commissioner is renewing the charter of the Allergenic Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 7/9/18. To view this notice, click here.
Psychopharmacologic Drugs Panel Renewed
Federal Register Notice: The FDA commissioner is renewing the Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/4/18. To view this notice, click here.
Levothroid Tablets Not Withdrawn for S&E
Federal Register Notice: FDA has determined that Levothroid (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for Levothroid if all other legal and regulatory requirements are met. To view this notice, click here.
FDA Corrects Notice on Malaria Drug Workshop
Federal Register Notice: FDA is correcting a 5/10 Federal Register notice that announced a public workshop entitled “Clinical Trial Design Considerations for Malaria Drug Development.” The
document was published with the incorrect title and incorrect Internet address in the Transcripts section. To view this notice, click here.
Review Period Set for Olysio
Federal Register Notice: FDA has determined the regulatory review period for Olysio is 2,006 days for extending a patent which claims the human drug product. Olysio is indicated for treating chronic hepatitis C infection as a component of a combination antiviral treatment regimen. To view this notice, click here.
Draft Guide on Transdermal Patch ANDAs
Federal Register Notice: FDA has published a draft guidance on “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs.” The document provides recommendations for study design and conduct when evaluating the adhesive performance of a transdermal delivery system or a topical patch that will support an ANDA submission. To view the guidance, clickhere. To view the notice, click here.
FDA, AFDO Co-sponsor Conference on Product Safety
Federal Register Notice: FDA’s Philadelphia District Office and the Association of Food and Drug Officials are co-sponsoring a conference on “Collaborating to Strengthen Food, Drug, and Medical Device Safety Systems.” This conference is intended to provide information about FDA drug and device regulation to regulated industry. It will be held on 6/15-19 at the Omni William Penn Hotel in Pittsburgh, PA. To view the notice, click here.
OMB Approval Sought on NADA Information Collection
Federal Register Notice: FDA has submitted to the Office of Management and Budget a proposed information collection extension regarding reporting associated with New Animal Drug Applications. The information collected in the applications is used to review the data, labeling, and manufacturing controls and procedures to evaluate the safety and effectiveness of proposed new animal drugs. To view notice, click here.
Guidance on Expanded Access to Investigational Drugs
Federal Register Notice: FDA has published a guidance on “Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers.” The guidance provides information about implementing regulations on expanded access to investigational drugs for treatment use. FDA received a number of questions concerning implementation of its expanded access regulations and is providing the guidance in a question and answer format to address the most frequently asked questions. To view the guidance, click here. To view the notice, click here.
Pharmacy Compounding Advisory Committee Meeting
Federal Register Notice: FDA has announced a 6/23 Pharmacy Compounding Advisory Committee meeting at its White Oak campus to discuss six bulk drug substances nominated for inclusion on the agency’s bulk drug substances list: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea treeoil, and 2,3-Dimercapto-1-propanesulfonic acid. To view the notice, click here.
GENERAL
FDA $2 Million Grant for WHO Regulatory Systems Improvements
Federal Register Notice: FDA announces its intention to accept and consider a single source application for a $2 million grant toward a cooperative agreement with the World Health Organization for regulatory systems strengthening, development of norms and standards, and innovative research to advance global access to safe and effective biological products that meet international standards. To view this notice, click here.
Toxicological Research Panel Renewed
Federal Register Notice: The FDA commissioner is renewing the Science Advisory Board to the National Center for Toxicological Research for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/2/18. To view this notice, clickhere.
Workshop on DNA Sequencing
Federal Register Notice: FDA will hold a public workshop 9/13-14 entitled “Sequencing Quality Control II.” Its purpose is to define the scope of project and study designs, and solicit participation of DNA sequencing community and stakeholders for data generation, management, analysis, and interpretation. The workshop will be held at Wilson Hall, Bldg. 1, National Institutes of Health (NIH), 31 Center Dr., Bethesda, MD. Contact Weida Tong, (870) 543-7142. To view this notice, clickhere.
FDA Public Workshop on OpenFDA Platform
Federal Register Notice: FDA is holding a public workshop entitled: “OpenFDA Public Workshop.” The workshop is intended to provide a forum for the openFDA system user community to discuss and provide feedback on the platform, application programming interfaces, downloadable harmonized datasets, and possible enhancements. The workshop will be held 6/20 at FDA’s White Oak campus. To view the notice, click here.
Guidance on Streamlined Expanded Use Requests
Federal Register Notice: FDA has released a guidance on “Individual Patient Expanded Access Applications: Form FDA 3926.” The document describes the process for licensed physicians to request expanded access for individual patients. The form provides a streamlined alternative for submitting requests for individual patient expanded access, including for emergency use. To view the guidance, click here. To view the notice, click here.