Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 28 abbreviated new drug applications held by Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), U.S. Agent for Sun Pharmaceutical Industries Limited, 270 Prospect Plains Rd., Cranbury, NJ 08512. The drug products are no longer marketed, and Sun Pharmaceutical has requested that the approval of the applications be withdrawn.
Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #234 entitled ``Question- Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' To improve the process for submission and review of chemistry, manufacturing, and controls (CMC) information for animal drugs, the Center for Veterinary Medicine has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed Question-based Review, these questions provide a general framework for original CMC submissions to investigational new animal drug files, generic investigational new animal drug files, new animal drug applications, abbreviated new animal drug applications, conditional approval of applications for conditional approval, and veterinary master files.
Common Formats for Reporting on Health Care Quality and Patient Safety
As authorized by the Secretary of HHS, AHRQ coordinates the development of sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the release of the Common FormatsCommunity Pharmacy Version 1.0.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Generic Clearance for the Collection of Data Through ACTION III Field-Based Investigations to Improve Health Care Delivery.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Abbott Molecular, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Determination of Regulatory Review Period for Purposes of Patent Extension; COSENTYX
The Food and Drug Administration (FDA) has determined the regulatory review period for COSENTYX 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 biological product.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This publication corrects a notice that was published in the Federal Register on December 6, 2016, 2016 Volume 81, Number 234, pages 87938-87939. The dates should read as follows:
Postmarketing Safety Reporting for Combination Products
The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as ``constituent parts'' of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.
State Long-Term Care Ombudsman Programs
In the February 11, 2015 Federal Register, we published a final rule in order to implement provisions of the Older Americans Act (the Act) regarding States' Long-Term Care Ombudsman programs (Ombudsman programs). The effective date was July 1, 2016. This correcting amendment corrects a limited number of technical and typographical errors identified in the February 11, 2015 final rule.
Runaway and Homeless Youth
This final rule reflects existing statutory requirements in the Runaway and Homeless Youth Act and changes made via the Reconnecting Homeless Youth Act of 2008. More specifically, the rule establishes program performance standards for Runaway and Homeless Youth grantees providing services to eligible youth and their families. Revisions have been made to the rule regarding additional requirements that apply to the Basic Center, Transitional Living, and Street Outreach Programs, including non-discrimination, background checks, outreach, and training. Furthermore, the rule updates existing regulations to reflect statutory changes made to the Runaway and Homeless Youth Act, and updates procedures for soliciting and awarding grants. This final rule makes changes to the proposed rule published on April 14, 2014, and is in response to public comments recommending ways to improve the rule.
Flexibility, Efficiency, and Modernization in Child Support Enforcement Programs
This rule is intended to carry out the President's directives in Executive Order 13563: Improving Regulation and Regulatory Review. The final rule will make Child Support Enforcement program operations and enforcement procedures more flexible, more effective, and more efficient by recognizing the strength of existing State enforcement programs, advancements in technology that can enable improved collection rates, and the move toward electronic communication and document management. This final rule will improve and simplify program operations, and remove outmoded limitations to program innovations to better serve families. In addition, the final rule clarifies and corrects technical provisions in existing regulations. The rule makes significant changes to the regulations on case closure, child support guidelines, and medical support enforcement. It will improve child support collection rates because support orders will reflect the noncustodial parent's ability to pay support, and more noncustodial parents will support their children.