> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-246/
- Published: 2016-01-10T12:00:00.000Z
- Updated: 2026-09-15T02:26:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134399

**BIOLOGICS**

  
**Panel to Discuss 2016-2017 Influenza Vaccine**  
*Federal Register* Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 3/4, from 8:30 a.m. to 3 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season. Contact **Sujata Vijh** or **Denise Royster**, (240) 402-7107 or (240) 402-8158, e-mail: Sujata.vijh@fda.hhs.gov or denise.royster@fda.hhs.gov. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-06/pdf/2015-33263.pdf?ref=fdaweb.com)  
  
**Guidance on Hepatitis B Tests for HCT/P Donors**  
*Federal Register* Notice: FDA is making available a draft document entitled *Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry*. It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests in donor testing for hepatitis B virus deoxyribonucleic acid. When finalized, it is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen and total antibody to hepatitis B core antigen, in the document entitled Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 8/2007\. To download this draft guidance, click [here](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM480606.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-08/pdf/2016-149.pdf?ref=fdaweb.com).  
  
**DEVICES**

**Guidance on Unique Device ID Kits**  
*Federal Register* Notice: FDA is making available a draft guidance entitled *Unique Device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff*. It will outline the agency’s current thinking that for purposes of Unique Device Identification (UDI) labeling and data submission requirements, the term “convenience kit” applies solely to two or more different medical devices packaged together for the convenience of the user, where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479242?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-04/pdf/2015-33008.pdf?ref=fdaweb.com).  
  
**FDA Requires PMA/PDP for Transvaginal Surgical Mesh**  
*Federal Register* Final order: FDA is issuing a final order to require the filing of a PMA or notice of completion of a product development protocol for surgical mesh for transvaginal pelvic organ prolapse repair. To view this final order, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-05/pdf/2015-33163.pdf?ref=fdaweb.com).  
  
**Pelvic Organ Prolapse Mesh into Class 3**  
*Federal Register* Final order: FDA is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse repair from Class 2 to Class 3, based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury. To view this final order, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-05/pdf/2015-33165.pdf?ref=fdaweb.com)  
  
**Intravaginal Culture System into Class 2**  
*Federal Register* Final order: FDA is classifying the intravaginal culture 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 intravaginal culture system’s classification. To view this final order, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-06/pdf/2015-33264.pdf?ref=fdaweb.com).  
  
**FDA Changes Agenda for Orthopedic Panel**  
*Federal Register* Notice: FDA is amending the 11/23 *Federal Register* notice of meeting of the Orthopedic and Rehabilitation Devices Panel to reflect a change in the Agenda portion of the document. On page 72972, in the first column, the Agenda portion of the document is changed to read as follows: The committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5\. DDD is confirmed radiologically with one or more of the following factors: **(1)** Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; **(2)** scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or **(3)** herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Contact **Sara Anderson**, Sara.Anderson@fda.hhs.gov, (301) 796-7047\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-06/pdf/2015-33262.pdf?ref=fdaweb.com).  
  
**Comments Reopened on Hearing Aid Guidance**  
*Federal Register* Notice: FDA is reopening the comment period for the draft guidance entitled: *Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products*, which was first announced in the 11/7/13 *Federal Register*. The agency hopes to receive updated comments and any new information. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-07/pdf/2016-00066.pdf?ref=fdaweb.com).  
  
**Workshop on GMPs for Hearing Aids**  
*Federal Register* Notice FDA will hold a public workshop 4/21 entitled “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids.” Participants will discuss the appropriate level of good manufacturing practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. The workshop will be held from 8:30 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact **Srinivas Nandkumar**, (301) 796-6480\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-07/pdf/2016-00065.pdf?ref=fdaweb.com)  
  
**Panel to Discuss Fecal Incontinence Device**  
*Federal Register* Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet 2/25, from 8 a.m. to 6 p.m. and 2/26, from 8 a.m. to 1 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Patricio G. Garcia, Patricio.Garcia@fda.hhs.gov, (301) 796-6875\. The committee will discuss, make recommendations, and vote on information on an Astora Women’s Health, LLC PMA for TOPAS Treatment for Fecal Incontinence, a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). It is intended to treat women with fecal incontinence who have failed more conservative therapies. On 2/26, during session 1, the committee will discuss and make recommendations on the reclassification of urogynecologic surgical mesh instrumentation from Class 1 to Class 2\. The committee, during session 2, will discuss and make recommendations on the classification of the product code “LKX” and the associated device classification name, “Device, Thermal, Hemorrhoids.” Contact **AnnMarie Williams** at annmarie.williams@fda.hhs.gov, (301) 796-5966\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-08/pdf/2016-111.pdf?ref=fdaweb.com).  
  
**HUMAN DRUGS**

  
**Comments Sought on Target Product Profile**  
*Federal Register* Notice: FDA is seeking public comment on the reporting requirements contained in the draft guidance for industry and review staff entitled *Target Product Profile — A Strategic Development Process Tool*. Comments should be submitted by 3/7\. The draft guidance is intended to provide sponsors and FDA review staff with information on target product profiles, which can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review staff to facilitate communication on a particular drug development program. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-01-05/pdf/2015-33127.pdf?ref=fdaweb.com).  
  
**GENERAL**

  
**Public Meeting on FDA’s Plan on Demographic Subgroup Data**  
*Federal Register* Notice: FDA Office of Minority Health, Office of Women’s Health, CBER, CDER, and CDRH will hold a public meeting 2/29 seeking feedback and recommendations from patient groups, consumer groups, regulated industry, academia, and other interested parties on FDA’s progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under the Food and Drug Administration Safety and Innovation Act.” The meeting will be held, from 9 a.m. to 4 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (B & C), Silver Spring, MD. Contact FDA at email: FDASIA907@fda.hhs.gov. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-06/pdf/2015-33261.pdf?ref=fdaweb.com)  
  
**Comments Extended on Sunscreen Guidance**  
*Federal Register* Notice: FDA is extending the comment period until 2/22 in the notice entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability” that appeared in the 11/23/15 *Federal Register*. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-08/pdf/2016-128.pdf?ref=fdaweb.com)