> ## 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-154/
- Published: 2017-10-29T12:00:00.000Z
- Updated: 2026-09-14T22:58:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140001

[**Comments Sought on CVM Dispute Resolution Info Collection**](https://www.fdaweb.com/comments-sought-on-cvm-dispute-resolution-info-collection/)  
*Federal Register* notice: FDA seeks comments on an information collection extension about a guidance on dispute resolution procedures for CVM regulatory decisions. 10/27/2017

[**Draft Guide on Generic Drug User Fees**](https://www.fdaweb.com/draft-guide-on-generic-drug-user-fees-2/)  
*Federal Register* notice: FDA releases a draft guidance on “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” 10/27/2017

[**FDA Draft Guide on Pediatric GERD Drug Development**](https://www.fdaweb.com/fda-draft-guide-on-pediatric-gerd-drug-development/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.” 10/27/2017

[**Comments Sought on Dispute Resolution Guidance Extension**](https://www.fdaweb.com/comments-sought-on-dispute-resolution-guidance-extension/)  
*Federal Register*: FDA seeks comments on an information collection extension related to a guidance on formal dispute resolution on drug GMP issues. 10/27/2017

[**Guide on 510(k)s for Device Changes**](https://www.fdaweb.com/guide-on-510-k-s-for-device-changes/)  
*Federal Register* notice: FDA makes available a guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” that clarifies when a change in a legally marketed medical device would require a 510(k) submission. 10/26/2017

[**Draft Guide on Breakthrough Device Program**](https://www.fdaweb.com/draft-guide-on-breakthrough-device-program/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff” that describes policies the agency intends to use to implement the new Breakthrough Devices Program. 10/26/2017

[**2 Draft Guidances on Drug-Drug Interactions**](https://www.fdaweb.com/2-draft-guidances-on-drug-drug-interactions/)  
*Federal Register* notice: FDA makes available two draft guidances entitled “In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies” and “Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications.” 10/25/2017

[**Ovrette Not Withdrawn Due to Safety/Effectiveness: FDA**](https://www.fdaweb.com/ovrette-not-withdrawn-due-to-safety-effectiveness-fda/)  
*Federal Register* notice: FDA determines that HRA Pharma’s Ovrette (norgestrel) tablets, 0.075 mg, was not withdrawn from sale for reasons of safety or effectiveness. 10/25/2017

[**Class 2 for Zinc Transporter 8 Autoantibody Immunological Test**](https://www.fdaweb.com/class-2-for-zinc-transporter-8-autoantibody-immunological-test/)  
*Federal Register* notice: FDA classifies zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls).10/25/2017