> ## 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-255/
- Published: 2016-03-13T12:00:00.000Z
- Updated: 2026-09-15T02:43:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135066

**BIOLOGICS** 
  
**Guidance on HCT/P Donor Screening to Reduce Zika Virus**  
*Federal Register* Notice: FDA is making available a document entitled *Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.* It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for screening donors for evidence of, and risk factors for, infection with Zika virus (ZIKV). The guidance identifies ZIKV as a relevant communicable disease agent or disease (RCDAD) and adds to recommendations contained in the guidance entitled Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 8/2007\. To download this guidance, click [here](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM488582.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04893.pdf?ref=fdaweb.com).  
  
**Guidance on Adverse Reactions Related to HCT/P Products**  
*Federal Register* Notice: FDA is making available a guidance document: *Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271.* It provides establishments that manufacture HCT/Ps for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The guidance also provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A. The guidance supplements section XXII of FDA’s guidance entitled Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 12/2011 and supersedes the guidance entitled Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 11/2005\. The guidance finalizes the draft guidance of the same title dated 2/2015\. To download this guidance, click [here](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM434834.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05215.pdf?ref=fdaweb.com).  
  
**DEVICES** 
  
**Guidance on IDEs for Neurological Devices**  
*Federal Register* Notice: FDA is making available a draft guidance entitled *Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes*. It has been developed to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. To download this draft guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM489111?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04947.pdf?ref=fdaweb.com).  
  
**Guidance on Devices to Treat Fungally-Infected Nails**  
*Federal Register* Notice: FDA is making available a guidance entitled *Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails*. It is intended to provide recommendations on clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM431312?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04946.pdf?ref=fdaweb.com).  
  
**Panel to Discuss Cartiva Synthetic Cartilage Implant**  
*Federal Register* Notice: FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet 4/20, from 8 a.m. to 6 p.m. at the Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss, make recommendations, and vote on a Cartiva Inc. PMA for the Cartiva Synthetic Cartilage Implant, an organic polymer-based biomaterial to mimic biologic cartilage, for treating degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint. Contact **S.J. Anderson**, email: Sara.Anderson@fda.hhs.gov, (301) 796-7047\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04927.pdf?ref=fdaweb.com).  
  
**Workshop on Mass Spectrometry**  
*Federal Register* Notice: FDA will hold a public workshop 5/2 entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The meeting will be held from 8:30 a.m. to 5 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver Spring, MD. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05220.pdf?ref=fdaweb.com)  
  
**CDRH Seeks Participants for Training Program**  
*Federal Register* Notice: CDRH will sponsor the 2016 Experiential Learning Program (ELP). The training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The Center is inviting medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information on ELP. Requests should be submitted by 4/11\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05387.pdf?ref=fdaweb.com).  
  
**FDA Sends Info on IDE Reports to OMB**  
*Federal Register* Notice: FDA proposed collection of information “Investigational Device Exemptions Reports and Records,” 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-2016-03-10/pdf/2016-05385.pdf?ref=fdaweb.com).  
  
**FDA Proposes Cervical Screw Systems into Class 2**  
*Federal Register* Proposed rule: FDA is proposing to classify posterior cervical screw systems into Class 2 (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a prescription device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term “posterior cervical screw systems” is used to distinguish these devices from currently classified pedicle screw spinal systems cleared for use in other spinal regions. To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05384.pdf?ref=fdaweb.com)**HUMAN DRUGS** 
  
**Guidance on Environmental Assessment on Certain Drugs**  
*Federal Register* Notice: FDA is making available a guidance for industry entitled *Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity.* It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444658.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04964.pdf?ref=fdaweb.com)  
  
**Guidance on Mechanism-Based Absorption Modeling**  
*Federal Register* Notice: FDA will hold a public workshop 5/19 entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.” The purpose of the workshop is to share current FDA experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities; discuss current and future utility of mechanism-based absorption modeling and simulation in the development of bioequivalent oral drug products and regulatory reviews; obtain input from various stakeholders on when, where, and how to conduct mechanism-based absorption modeling and simulations in the context of bioequivalent product development; and request comments on these topics. The workshop will be held from 8:30 a.m. to 4:30 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD. Contact **Xinyuan Zhang**, (240) 402-7971, email: Xinyuan.Zhang@fda.hhs.gov or **Liang Zhao** (240) 402-4468, email: Liang.Zhao@fda.hhs.gov. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04965.pdf?ref=fdaweb.com)  
  
**FDA Changes Advisory Committee Name**  
*Federal Register* Final rule: FDA is amending the standing advisory committees regulations to change the name of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to more accurately describes the subject areas for which the committee is responsible. The name change became applicable 1/22\. To view this final rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04940.pdf?ref=fdaweb.com).  
  
**Comments Sought on Superimposed Text in DTC Promos**  
*Federal Register* Notice: FDA is seeking public comment on research entitled “Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs.” This study will examine how the size and presentation of superimposed text (supers) influences the comprehension of direct-to-consumer television advertisements for prescription drugs. Comments should be submitted by 5/9\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05233.pdf?ref=fdaweb.com).  
  
**Guidance on Evaluating Symptoms in COPD**  
*Federal Register* Notice: FDA is making available a draft guidance: *Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use*. It provides a statement of qualification for exploratory use for evaluating respiratory symptoms in chronic obstructive pulmonary disease, a patient-reported outcome instrument, and summarizes the concept of interest and context of use for which the tool is qualified through the CDER’s drug development tool qualification program. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM489526.pdf?ref=fdaweb.com) To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05224.pdf?ref=fdaweb.com).  
  
**Guidance on Pediatric Study Plans Content & Process**  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans*. It revises the draft guidance entitled Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans issued 7/15/13\. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM360507.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05223.pdf?ref=fdaweb.com)  
  
**Public Hearing on Regulatory Science for Generic Drugs**  
*Federal Register* Notice: FDA will hold a public hearing 5/20 that will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders —industry, academia, patient advocates, professional societies, and other interested parties. The agency will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2017 Regulatory Science Plan. The hearing will be held from 9 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05221.pdf?ref=fdaweb.com).  
  
**Comments Sought on Info in Dear Health Care Provider Guidance**  
*Federal Register* Notice: FDA seeks public comments on the information collection associated with the guidance for industry and FDA staff entitled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider letters, which are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. Comments should be submitted by 5/9\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05301.pdf?ref=fdaweb.com)  
  
**Review Period Set for Opsumit**  
*Federal Register* Notice: FDA has determined the regulatory review period for Actelion Pharmaceuticals’ Opsumit (macitentan) is 1,935 days for extending a patent which claims the human drug product. Opsumit is indicated for treating pulmonary arterial hypertension to delay disease progression. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05389.pdf?ref=fdaweb.com)  
  
**Info on Patient Expanded Access Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926,” 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-2016-03-11/pdf/2016-05491.pdf?ref=fdaweb.com)   
  
**VETERINARY** 
  
**FDA Removes Regs on Anitibiotics, Nitrofuran, Sulfonamide in Animal Feed**  
*Federal Register* Final rule: FDA is removing regulations that required sponsors to submit data on the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations. To view this final rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04945.pdf?ref=fdaweb.com).   
  
**TOBACCO** 
  
**Info on Reporting Harmful Tobacco Constituents Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information “Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act,” 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-2016-03-09/pdf/2016-05213.pdf?ref=fdaweb.com)  
  
**GENERAL** 
  
**Guidance on Dietary Supplement Labeling**  
*Federal Register* Notice: FDA is making available a revised guidance for industry entitled *A Dietary Supplement Labeling Guide: Chapter II. Identity Statement*. It is part of a longer guidance entitled A Dietary Supplement Labeling Guide, which covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the U.S. are properly labeled. FDA is revising the guidance to correct an inaccurate statement. To download this guidance, click here. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04948.pdf?ref=fdaweb.com).  
  
**FDA, DIA Plan Statistics Forum**  
*Federal Register* Notice: FDA and the Drug Information Associations will co-sponsor a public conference entitled Tenth Annual DIA/Food and Drug Administration Statistics Forum — 2016\. It is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop and review new drugs and biologics. A primary focus for this public conference will be to establish an ongoing dialogue between industry and regulatory agencies, emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials and measuring the progress being made in designing and implementing innovative solutions. The meeting will be held 4/25, from 1 p.m. to 5:30 p.m.; 4/26, from 8:30 a.m. to 5 p.m.; and 4/27, from 8:30 a.m. to 3:30 p.m. On 4/25, there will also be pre-meeting tutorials from 8:30 a.m. to 12 p.m. and a scientific working group session from 5:40 p.m. to 7 p.m. The meeting will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD. Contact **Meredith Kaganovskiy**, DIA, (215) 442-6117 or **Stephen Wilson**, FDA, (301) 796-0579, Stephen.Wilson@fda.hhs.gov. To view this notice, click [here.  ](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05219.pdf?ref=fdaweb.com)  
**FDA Sends Info on Emergency Use Authorizations to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Public Health Stakeholders,” 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-2016-03-10/pdf/2016-05390.pdf?ref=fdaweb.com)