Department of Health and Human Services October 12, 2017 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC). This meeting is open to the public, limited only by room seating (36 seats), audio phone lines (50 audio lines) and net conference access (50 net conference lines) available. The public is welcome to listen to the meeting by accessing the call-in number, 1- 888-596-9856, the passcode, 38181337; 50 audio lines will be available. Online Registration Required: In order to expedite the security clearance process required for entry into a Federal building, all BCCEDCAC Meeting attendees must register for the meeting online at least 8 business days in advance at https://www.cdc.gov/cancer/nbccedp/ advisory-committee/registration.htm . Please complete all the required fields and submit your registration no later than November 20, 2017. Each meeting day, in-person attendees must check-in and present identification (driver's license/state issued ID, or passport) to CDC security.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of antiviral drug development for prophylaxis and treatment of disease caused by respiratory syncytial virus (RSV) infection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Requests for Reconsideration at the Division Level Under GDUFA.'' This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance also provides information for applicants to consider before pursuing a request for reconsideration, procedures for submitting a request for reconsideration, and the Agency's process for responding to those requests.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The topics to be discussed will include the current status of electronic submissions and data standards initiatives to improve the predictability and consistency of the electronic submissions process in support of the human drug review program. FDA is seeking input from a variety of stakeholdersindustry, academia, patient advocates, professional societies and other interested partiesas it fulfills its commitment under the Prescription Drug User Fee Act of 2017 (PDUFA) to hold annual public meetings to seek stakeholder input related to enhancing the transparency and accountability of the electronic submission and data standards activities. FDA will use the information from the public meeting to inform the development of the FDA Information Technology (FDA IT) Strategic Plan and electronic submissions gateway target timeframes.