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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
requested to make their presentation on or before September 15, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 16, 2021.
Closed Committee Deliberations: On September 30, 2021, from 10:45 a.m. to 11:45 a.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy 5 U.S.C.
552bc6. The recommendations of the advisory committee regarding the progress of the individual investigators research programs along with other information, will be discussed during this session. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Kathleen Hayes CBERVRBPAC@fda.hhs.gov at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at:
https www.fda.gov/advisorycommittees/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act 5
U.S.C. app. 2.
Dated: August 18, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0891

Reauthorization of the Prescription Drug User Fee Act; Public Meeting;
Request for Comments AGENCY:

Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.

ACTION:

The Food and Drug Administration FDA, the Agency, or we is hosting a virtual public meeting entitled Reauthorization of the Prescription Drug User Fee Act. The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act PDUFA for fiscal years FYs 2023 through 2027. PDUFA
authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years.
Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act FD&C Act directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
DATES: The public meeting will be held on September 28, 2021, from 9 a.m. to 2 p.m. Eastern Time, and will be held by webcast only. Submit either electronic or written comments on this public meeting by October 28, 2021.
ADDRESSES: Registration to attend the virtual meeting and other information can be found at https pdufaviireauthorization.eventbrite.com. See the SUPPLEMENTARY INFORMATION section for registration date and information.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before October 28, 2021. The https www.regulations.gov electronic filing system will accept comments SUMMARY:

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until 11:59 p.m. Eastern Time at the end of October 28, 2021. Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Comments submitted electronically, including attachments, to https
www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone elses Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed see Written/Paper Submissions and Instructions.
Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include the Docket No. FDA
2021N0891 for Reauthorization of the Prescription Drug User Fee Act;
Public Meeting; Request for Comments.
Received comments, those filed in a timely manner see ADDRESSES, will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9

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