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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-90/
- Published: 2016-05-08T12:00:00.000Z
- Updated: 2026-09-14T21:00:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135609

**BIOLOGICS** 
  
**FDA Proposes to Update Biological Standards**  
*Federal Register* Proposed rule: FDA is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA aims to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. Comments should be submitted by 7/18\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10386.pdf?ref=fdaweb.com).  

**DEVICES** 
  
**Comments Sought on Exemption for Glucose Test System**  
*Federal Register* Notice: FDA has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Such tests systems are used in diagnosing and treating carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments by 6/3\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10388.pdf?ref=fdaweb.com)

**HUMAN DRUGS** 
**Info on DTC Drug Ad Claims Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Market Claims in Direct-to-Consumer Prescription Drug Print Ads has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10396.pdf?ref=fdaweb.com).

**Several Products Not Withdrawn for S&E**  
*Federal Register* Notice: FDA has determined that several drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. These products include leucovorin calcium, deltasone, Atarax, and Dimetane-DX. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10387.pdf?ref=fdaweb.com)

**FDA Makes Funds Available for Natural History Grants**  
*Federal Register* Notice: FDA is making available grant funds for the support of FDA’s Office of Orphan Products Development Natural History Grants Program. The goal of the program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10398.pdf?ref=fdaweb.com).

**Guidance on Drugs for Chronic Hepatitis C Virus**  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment*. Its purpose is to assist sponsors in all phases of development of direct-acting antiviral drugs for treating chronic hepatitis C. It revises the draft guidance of the same name that was issued on 10/23/13\. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10390.pdf?ref=fdaweb.com).

**Pharmacy Compounding Advisory Panel Renewed**  
*Federal Register* Notice: The FDA commissioner renews the Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/25/18\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-06/pdf/2016-10585.pdf?ref=fdaweb.com). 

**GENERAL** 
  
**Guidance on Special Protocol Assessment**  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Special Protocol Assessment*. It provides information about the procedures and general policies adopted by CDER and CBER for special protocol assessment. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. It revises the 5/17/02 guidance for industry of the same title. To download this guidance, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10391.pdf?ref=fdaweb.com). To view this notice, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM498793.pdf?ref=fdaweb.com)

**Workshop on Extrapolating Data for Pediatric Efficacy**  
*Federal Register* Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 6/1 entitled “Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.” The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. It will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions. It will take place from 8 a.m. to 5 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact **Audrey Thomas**, (301) 796-3520, Audrey.Thomas@fda.hhs.gov. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10397.pdf?ref=fdaweb.com).