Department of Health and Human Services June 2014 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 338
Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsContent and Format of Abbreviated New Drug Applications.'' The guidance document is intended to assist applicants in preparing complete and high-quality original abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug, and Cosmetic Act. The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions. This guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information to be submitted in each section of the application.
Determination of Regulatory Review Period for Purposes of Patent Extension; Arctic Front Cryocatheter System
The Food and Drug Administration (FDA) has determined the regulatory review period for Arctic Front Cryocatheter System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; Arcapta Neohaler
The Food and Drug Administration (FDA) has determined the regulatory review period for Arcapta Neohaler and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Zuprevo
The Food and Drug Administration (FDA) has determined the regulatory review period for ZUPREVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish: Availability of Draft Update
In March 2004, the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) (the Agencies) jointly released a document entitled ``What You Need to Know About Mercury in Fish and Shellfish'' (the 2004 advice). FDA and EPA are now announcing a draft update that contains both advice and supplemental questions and answers for those who want to understand the advice in greater detail. FDA and EPA are establishing a public docket and seeking public comment on both the substance of the advice and how best to frame the advice for consumers so that it is both understandable and influential. In addition to inviting public comments, the Agencies intend to seek the input of the FDA Advisory Committee on Risk Communication in a meeting open to the public. The Agencies may also hold public meetings in various locations around the country. Information about any such meetings will be published in the Federal Register once dates and locations are confirmed.
Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products-Recommended Practices; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological ProductsRecommended Practices.'' This guidance describes FDA's current thinking on recommended practices for drug manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs for human use, including drugs licensed as biological products, and approved animal drugs. The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling.
Global Unique Device Identification Database; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Global Unique Device Identification Database (GUDID): Guidance for Industry''. FDA has updated sections of the document, ``Global Unique Device Identification (GUDID): Draft Guidance for Industry'' in order to finalize the sections with the most questions from GUDID submitters. The guidance includes information about how device labelers (in most instances, the device manufacturer) will interface with the GUDID by establishing GUDID accounts and beginning their initial submissions. Draft guidance sections on the device identifier (DI) module have not been finalized in this document and will be addressed in a future document.
Determination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib
The Food and Drug Administration (FDA) has determined the regulatory review period for VANDETANIB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO) for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib
The Food and Drug Administration (FDA) has determined the regulatory review period for Vandetanib and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product. This draft guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA.
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of May 13, 2014, for the final rule that appeared in the Federal Register of April 11, 2014, and that amended the color additive regulations to expand the permitted use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis) as a color additive in food.
OXIPLEX/SP Gel; FzioMed, Incorporated's Petition for Review of the Food and Drug Administration's Denial of Premarket Approval; Notice of Meeting Cancellation
The meeting of the Medical Devices Dispute Resolution Panel scheduled for June 10, 2014, is cancelled. This meeting was announced in the Federal Register of May 14, 2014.
Draft Report on Carcinogens Monograph on Trichloroethylene; Availability of Documents; Request for Comments; Notice of Meeting
The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Trichloroethylene (TCE). This document was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/38853.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
Draft Guidance for Industry on Providing Submissions in Electronic Format-Postmarketing Safety Reports; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatPostmarketing Safety Reports.'' This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drug and biological products. We are issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule.
Determination of Regulatory Review Period for Purposes of Patent Extension; Xience Prime Ll Everolimus Eluting Coronary Stent System
The Food and Drug Administration (FDA) has determined the regulatory review period for Xience Prime Ll Everolimus Eluting Coronary Stent System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; STENDRA
The Food and Drug Administration (FDA) has determined the regulatory review period for STENDRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Kidney Health Initiative (R18)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Drug Evaluation and Research/Office of Medical Policy's Kidney Health Initiative Program. FDA, Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a grant to the American Society of Nephrology (ASN) to support the Kidney Health Initiative (KHI).
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for humanitarian use devices (HUDs).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance which describes our current thinking on the quality factor requirements for eligible infant formulas, the record requirements for eligible infant formulas, and the submission of citizen petitions for eligible infant formulas.
Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled ``Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 18, 2014, Vol. 79, page 15133 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
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