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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-87/
- Published: 2016-04-17T12:00:00.000Z
- Updated: 2026-09-14T20:55:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135399

**BIOLOGICS** 
  
**Review Period Set for Gazya**  
*Federal Register* Notice: FDA has determined the regulatory review period for Genentech’s Gazya is 1,698 for extending a patent which claims the human biological product. Gazyva is indicated, in addition with chlorambucil, for treating patients with previously untreated chronic lymphocytic leukemia. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08338.pdf?ref=fdaweb.com)  
  
**FDA Corrects Notice on Zika Virus Guidance**  
*Federal Register* Notice: FDA is correcting a 3/7 *Federal Register* notice, which announced a guidance for industry entitled *Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products*. The document was published with an incorrect docket number in the Addresses section. In FR Doc. 2016-04893, appearing on page 11808 in the following correction is made: 1\. On page 11808, in the third column, the docket number is corrected to read \`\`FDA-2016-D-0768''. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08330.pdf?ref=fdaweb.com).  
  
**Review Period Set for Cyramza**  
*Federal Register* Notice: FDA has determined the regulatory review period for Eli Lilly’s Cyramza (ramucirumab) is 3,521 days for extending a patent which claims the human biological product. Cyramza is indicated for treating gastric cancer. To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08692.pdf?ref=fdaweb.com)  
**Panel to Discuss Merck BLA for C. Difficile**  
*Federal Register* Notice: FDA’s Antimicrobial Drugs Advisory Committee will meet 6/9, from 8:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Merck BLA for bezlotoxumab (MK-6072) injection for the proposed indication of preventing Clostridium difficile infection recurrence. Contact **Lauren D. Tesh**, (301) 796-9001\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08637.pdf?ref=fdaweb.com).  
  
**DEVICES** 
  
**Info on Administrative Detention Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information “Administrative Detention and Banned Medical Devices — 21 CFR 800.55(g)(1) and (g)(2), 800.55(k), 895.21(d), and 895.22,” 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.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-11/pdf/2016-08161.pdf?ref=fdaweb.com)  
  
**FDA Sends Info on Device User Fees to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information “Medical Device User Fee Cover Sheet, Form FDA 3601,” 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](https://www.gpo.gov/fdsys/pkg/FR-2016-04-11/pdf/2016-08154.pdf?ref=fdaweb.com).  
  
**FDA Sends Info on IVD Device Studies to OMB**  
*Federal Register* Notice: FDA is announcing that a proposed collection of information, “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable,” 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](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08329.pdf?ref=fdaweb.com).  
  
**Panel to Discuss St. Jude Medical PMA for Stroke Patients**  
*Federal Register* Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24, 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. The committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical’s Amplatzer Patent Foramen Ovale (PFO) Occluder. It is a percutaneously delivered permanent cardiac implant for PFO closure indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. Contact **Evella** **Washington**, Evella.Washington@fda.hhs.gov, (301) 796-6683\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-13/pdf/2016-08530.pdf?ref=fdaweb.com)  
  
**Info on CDRH Appeals Processes Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Center for Devices and Radiological Health Appeals Processes,” 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.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08685.pdf?ref=fdaweb.com)  
  
**Panel to Discuss Cardiac Device Infections**  
*Federal Register* Notice: FDA will hold a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee 6/2-3, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA will seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: **(1)** The effectiveness of cleaning and disinfection methods for heater-cooler devices; **(2)** the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; **(3)** appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and **(4)** appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Contact **Evella Washington**, (301) 796-5290, Evella.Washington@fda.hhs.gov. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08737.pdf?ref=fdaweb.com).  
  
**HUMAN DRUGS** 
  
**Review Period Set for Aptiom**  
*Federal Register* Notice: FDA has determined the regulatory review period for Bial-Portella’s Aptiom is 2,517 days for extending a patent which claims the human drug product. Aptiom is indicated as an adjunctive treatment of partial-onset seizures. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08334.pdf?ref=fdaweb.com)  
  
**Review Period Set for Bayer’s Adempas**  
*Federal Register* Notice: FDA has determined the regulatory review period for Bayer’s Adempas (riociguat) is 2,394 days for extending a patent which claims the human drug product. Adempas is indicated for treating adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and treatment of pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08337.pdf?ref=fdaweb.com).  
  
**Review Period Set for Pfizer’s Apoquel**  
*Federal Register* Notice: FDA has determined the regulatory review period for Pfizer’s Apoquel (oclacitinib) is 2,226 days for extending a patent which claims the animal drug product. Apoquel is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08333.pdf?ref=fdaweb.com)  
  
**FDA Withdraws Luveris NDA**  
*Federal Register* Notice: FDA is withdrawing approval of an EMD Serono NDA for Luveris (lutropin alpha for injection). The company has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08336.pdf?ref=fdaweb.com).  
  
**FDA Seeks Info on Drug Supply Chain**  
*Federal Register* Notice: FDA is soliciting information on issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with designing and developing a pilot project (s) that FDA establishes under the DSCSA. Comments should be submitted by 5/16\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08681.pdf?ref=fdaweb.com).  
  
**Guidance on Drugs Data Integrity**  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled Data Integrity and Compliance With CGMP. It purpose is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs and is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide FDA’s current thinking on creating and handling data in accordance with CGMP requirements. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08683.pdf?ref=fdaweb.com)  
  
**FDA Releases Product-Specific Bioequivalence Recommendations**  
*Federal Register* Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support ANDAs. These products include: albendazole, amlodipine besylate, betamethasone dipropionate, eluxadoline, and lenvatinib mesylate. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08682.pdf?ref=fdaweb.com).  
  
**FDA Withdraws Xanodyne NDA**  
*Federal Register* Notice: FDA is correcting a 3/10/14 *Federal Register* notice that withdrew approval of 8 NDAs and 46 ANDAs for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of an Xanodyne Pharmaceuticals NDA 017507 for Darvocet-N 100 (propoxyphene napsylate and acetaminophen) Suspension, 100 mg/650 mg/mL. The company wrote to FDA asking it to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. The agency confirms the withdrawal of approval. To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08689.pdf?ref=fdaweb.com)  
**VETERINARY** 
  
**Comments Sought on Animal Feed Standards**  
*Federal Register* Notice: FDA seeks comments on its Animal Feed Regulatory Program Standards. Comments should be submitted by 6/13\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08331.pdf?ref=fdaweb.com).  
  
**CVM Proposes to Withdraw Carbadox in Swine Feed**  
*Federal Register* Notice: The Center for Veterinary Medicine (CVM) is proposing to withdraw approval of NADAs providing for use of carbadox in medicated swine feed. This action is based on CVM’s determination that the use of carbadox under the approved conditions of use results in residues of carcinogenic concern in the edible tissues of the treated swine. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08327.pdf?ref=fdaweb.com).  
  
**Comments Extended on Investigational Mosquitoes**  
*Federal Register* Notice: FDA is extending the comment period for a 3/14 *Federal Register* notice that requested comments on the Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. Comments should be submitted by 5/13\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-14/pdf/2016-08678.pdf?ref=fdaweb.com)  
  
**GENERAL** 
  
**FDA Publishes OMB-Approved Information Collections**  
*Federal Register* Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. These are: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act”; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Substances Generally Recognized as Safe: Notification Procedure; Financial Disclosure by Clinical Investigators; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; and Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-11/pdf/2016-08153.pdf?ref=fdaweb.com).  
  
**Guidance on Drug Product Design to Minimize Errors**  
*Federal Register* Notice: FDA is making available a guidance for industry entitled *Safety Considerations for Product Design to Minimize Medication Errors*. The guidance is intended for sponsors of investigational new drug applications; NDAs, BLAs, ANDAs; and manufacturers of prescription drugs marketed without an approved application or over-the-counter monograph drugs. It provides a set of principles to consider while developing drug products using a systems approach to minimize medication errors related to product design and container closure design. The recommendations are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08335.pdf?ref=fdaweb.com).