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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-97/
- Published: 2016-06-26T12:00:00.000Z
- Updated: 2026-09-14T21:11:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136050

**BIOLOGICS**

**FDA Withdraws Notice on Biological Product Naming**  
Federal Register Withdrawal of notice: FDA withdraws a 6/2 Federal Register notice, which announced that a proposed collection of information, “Guidance for Industry on Nonproprietary Naming of Biological Products,” had been submitted to the Office of Management and Budget. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-06-22/pdf/2016-14722.pdf?ref=fdaweb.com).

**FDA Amends Donor Regs for HCT/Ps**  
*Federal Register* Final rule: FDA is amending certain regulations on donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products, and related labeling. This final rule is in response to the agency’s enhanced understanding in this area and in response to comments from stakeholders about the importance of embryos to individuals and couples seeking access to donated embryos. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-22/pdf/2016-14721.pdf?ref=fdaweb.com)

**DEVICES**

**Guidance on Age, Race, Ethnicity Data in Device Studies**  
*Federal Register* Notice: FDA is making available a draft guidance entitled *Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies*. The purpose of this document is to outline FDA’s proposed recommendations and expectations for evaluating and reporting age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data on the performance of medical devices within specific age, race, and ethnic groups. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM507278?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-20/pdf/2016-14461.pdf?ref=fdaweb.com)

**FDA Corrects Notice on Glucose Test System**  
*Federal Register* Notice: FDA is republishing in its entirety a 5/4 notice entitled “Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format” FDA is correcting the Docket Number to read: Docket No. FDA-2016-P-1026 and is asking for electronic or written comments by 7/20\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-20/pdf/2016-14459.pdf?ref=fdaweb.com)

**Info on Device Accessories Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Medical Device Accessories,” 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-2016-06-21/pdf/2016-14562.pdf?ref=fdaweb.com)

**Guidance on Leveraging Data for Pediatric Device Use**  
*Federal Register* Notice: FDA is making available a final guidance entitled *Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff*. It explains the circumstances in which it may be appropriate to extrapolate existing medical device data to support pediatric device indications in PMAs, humanitarian device exemptions and de novo requests. This guidance also describes FDA’s approach for determining whether extrapolation may be appropriate and the factors that should be considered within a statistical model for extrapolation. To download this guidance, click here. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-06-21/pdf/2016-14640.pdf?ref=fdaweb.com).

**Gynecologic Morcellation Containment System into Class 2**  
*Final order*: FDA is classifying the gynecologic laparoscopic power morcellation containment system into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system’s classification. To view this notice, click[here](https://www.gpo.gov/fdsys/pkg/FR-2016-06-21/pdf/2016-14627.pdf?ref=fdaweb.com).

**HUMAN DRUGS** 
  
**Panel to Discuss Serenity Pharma NDA for Nocturia**  
*Federal Register* Notice: FDA will hold a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee 10/19 from 8:15 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 the efficacy and safety of a Serenity Pharmaceuticals’ NDA for desmopressin, 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray for the proposed treatment of adult onset nocturia. Contact **Kalyani Bhatt**, (301) 796-9001\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-06-20/pdf/2016-14418.pdf?ref=fdaweb.com).

**Review Period Set for Xofigo**  
*Federal Register* Notice: FDA has determined the regulatory review period for Xofigo is 1,945 days for extending a patent which claims the human drug product. FDA has approved for marketing the human drug product Xofigo (radium 223 dichloride) for treating patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-21/pdf/2016-14551.pdf?ref=fdaweb.com)

**FDA Amends Notice of Pediatric Oncology Meeting**  
*Federal Register* Notice: FDA is amending a 6/16 notice of meeting of the Pediatric Oncology Subcommittee to reflect a change in the Procedure portion of the document. The meeting is scheduled to discuss six products in various stages of development for adult cancer indications and the current unmet clinical need in the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma. On page 39274, in the third column, the Procedure portion of the document is changed to read as follows: FDA regrets that it was unable to publish this notice 15 days prior to the June 28 and 29, 2016, Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. Because the Agency believes there is some urgency to bring these issues to public discussion and qualified members of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.” Contact **Lauren D. Tesh** (301) 796-9001\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-23/pdf/2016-14827.pdf?ref=fdaweb.com)

**TOBACCO** 
  
**Info on Tobacco Restrictions Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents,” 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-2016-06-21/pdf/2016-14628.pdf?ref=fdaweb.com).

**FDA Seeks Pilot Participants for Import Communication System**  
*Federal Register* Notice: FDA intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. The agency will need participation from a small group of filers, importers of record, and consignees, who will use the new ITACS Account Management function and provide feedback to FDA. The agency is testing the use of user login accounts, which enable FDA to distribute Notices of FDA Action to users electronically via email (rather than regular mail) and enable users to download Notices of FDA Action from within ITACS. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email by 7/7 at itacssupport@fda.hhs.gov with the subject line “ITACS Pilot Participation Request.” To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-23/pdf/2016-14874.pdf?ref=fdaweb.com)

**FDA Releases ICH Regional Specs for Adverse Event Reporting**  
*Federal Register* Notice: FDA is making [available](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm?ref=fdaweb.com) its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonization (ICH) E2B(R3) Specification. It is making this document available to assist interested parties in electronically submitting individual case safety reports and attachments to CDER and CBER. This document, entitled “FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines.” supplements the “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and Message Specification” final guidance for industry and describes FDA’s technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-06-23/pdf/2016-14845.pdf?ref=fdaweb.com).