> ## Content Index
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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-104/
- Published: 2016-08-21T12:00:00.000Z
- Updated: 2026-09-14T21:25:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136576

**BIOLOGICS**

CBER Advisory Panel to Hear Research Updates  
*Federal Register* Notice: FDA’s Allergenic Products Advisory Committee will meet 10/27, from 1 p.m. to 4:20 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 by teleconference. In open session, (from 1 p.m. to 3:30 p.m.) the committee will hear updates of research programs in CBER’s Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review. Contact **Janie Kim** or **Denise Royster**, (301) 796-9016 or (240) 402-8158, email: Janie.Kim@fda.hhs.gov or Denise.Royster@fda.hhs.gov. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19338.pdf?ref=fdaweb.com).

**DEVICES**

Guidance on 510(k)s for Electrosurgical Devices  
*Federal Register* Notice: FDA is making available a guidance entitled Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency devices or high-frequency devices. The scope of this document is limited to the Class 2 electrosurgical devices and accessories classified under 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389884?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19404.pdf?ref=fdaweb.com)

Guidance on Bipolar Electrosurgical Vessel Sealers  
*Federal Register* Notice: FDA is making available a guidance entitled Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery. FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. To download this guidance, click [here. ](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389875?ref=fdaweb.com)To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19402.pdf?ref=fdaweb.com).

Guidance on Nucleic Acid Tests for Hepatitis  
*Federal Register* Notice: FDA is making available a guidance for industry 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*. It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular 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. The guidance finalizes the draft guidance of the same title from January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled *Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products* dated 8/2007\. To download this guidance, click [here.](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM516650.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19588.pdf?ref=fdaweb.com)

Info on Device Exports Sent to OMB  
*Federal Register* Notice: FDA’s proposed collection of information, “Export of Medical Devices; Foreign Letters of Approval,” 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-2016-08-19/pdf/2016-19807.pdf?ref=fdaweb.com)

**HUMAN DRUGS**

FDA Sends Info on Patent Claims to OMB  
*Federal Register* Notice: FDA’s proposed collection of information, “Applications for FDA Approval To Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed,” 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-2016-08-15/pdf/2016-19385.pdf?ref=fdaweb.com).

Workshop on Anti-Infective Drug Development for Neonates/Infants  
*Federal Register* Notice: FDA will hold a public workshop 9/15 on anti-infective drug development for neonates and young infants. The agency is interested in discussing the scientific challenges pertaining to development of anti-infective products for neonates and young infants. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of drug development for new and currently marketed anti-infective drugs for neonates and young infants. The workshop will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD. Contact **Lori Benner** and/or **Jessica Barnes**, (301) 796-1300\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19336.pdf?ref=fdaweb.com)

Guidance on Pharmaceutical Co-Crystals  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Regulatory Classification of Pharmaceutical Co-Crystals.* It provides applicants planning to submit NDAs and ANDAs with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. It revises the guidance for industry entitled Regulatory Classification of Pharmaceutical Co-Crystals issued in 4/2013\. To download this guidance, click [here](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM516813?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19596.pdf?ref=fdaweb.com).

Pediatric Panel to Discuss Safety Reviews  
*Federal Register* Notice: FDA will hold a meeting of the Pediatric Advisory Committee 9/14, from 8 a.m. to 5:30 p.m. at DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 Wisconsin Ave., Bethesda, MD. The panel will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. These products include Delzicol, Doryx, Kepivance, Sustiva, and Topamax. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19589.pdf?ref=fdaweb.com)

  
**TOBACCO**  
Tobacco Panel Seeks Industry Selectors, Nominations  
*Federal Register* Notice: FDA is requesting that any industry organizations interested in participating in the selecting a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, notify FDA in writing. FDA is also requesting nominations for a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19312.pdf?ref=fdaweb.com)

**GENERAL**  
FDA Sends Info on Qualified Importer Program to OMB  
*Federal Register* Notice: FDA’s proposed collection of information, “FDA’s Voluntary Qualified Importer Program; Guidance for Industry,” 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-2016-08-17/pdf/2016-19643.pdf?ref=fdaweb.com)

FDA Amends Criteria for Human/Animal Food Deemed GRAS  
*Federal Register* Final rule: FDA is issuing a final rule that amends and clarifies the criteria in its regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. FDA is also amending its regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19164.pdf?ref=fdaweb.com)

Info on Mammography Standards Sent to OMB  
*Federal Register* Notice: FDA’s proposed collection of information “Mammography Quality Standards Act Requirements — 21 CFR Part 900,” 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-2016-08-19/pdf/2016-19808.pdf?ref=fdaweb.com)