76082 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices

and/or go to the Dockets Management comment on this document. Consistent submissions, or information, and Staff, 5630 Fishers Lane, Rm. 1061, with FDA’s regulations, this notice is consider any comments submitted to the Rockville, MD 20852, 240–402–7500. being published with less than 15 days docket, as appropriate. FOR FURTHER INFORMATION CONTACT: prior to the date of the meeting based on You may submit comments as Kelly Covington, Center for Veterinary a determination that convening a follows: meeting of the Vaccines and Related Medicine, Food and Drug Electronic Submissions Administration, 7500 Standish Pl., Biological Products Advisory Rockville, MD 20855, 240–402–5661, Committee as soon as possible is Submit electronic comments in the [email protected]. warranted. This Federal Register notice following way: • SUPPLEMENTARY INFORMATION: In the could not be published 15 days prior to Federal eRulemaking Portal: Federal Register of October 13, 2020, the date of the meeting due to a recent https://www.regulations.gov. Follow the FDA published a notice announcing a submission of a request for Emergency instructions for submitting comments. public meeting and requesting Use Authorization (EUA) for an Comments submitted electronically, comments on a concept paper entitled investigational vaccine to prevent including attachments, to https:// ‘‘Potential Approach for Ranking of Coronavirus Disease 2019 (COVID–19) www.regulations.gov will be posted to Antimicrobial Drugs According to Their and the need for prompt discussion of the docket unchanged. Because your Importance in Human Medicine: A Risk such submission, given the COVID–19 comment will be made public, you are Management Tool for Antimicrobial pandemic. solely responsible for ensuring that your New Animal Drugs’’ with a 94-day DATES: The meeting will be held on comment does not include any comment period. December 10, 2020, from 9 a.m. Eastern confidential information that you or a Interested persons were originally Time to 6 p.m. Eastern Time. third party may not wish to be posted, given until January 15, 2021, to ADDRESSES: Please note that due to the such as medical information, your or comment on the public meeting and impact of this COVID–19 pandemic, all anyone else’s Social Security number, or request for comments. The Agency meeting participants will be joining this confidential business information, such received several requests to allow advisory committee meeting via an as a manufacturing process. Please note interested persons additional time to online teleconferencing platform. that if you include your name, contact comment. The requests conveyed Answers to commonly asked questions information, or other information that concern that the initial 94-day comment including information regarding special identifies you in the body of your period did not allow sufficient time to accommodations due to a disability may comments, that information will be develop a comprehensive response. be accessed at: https://www.fda.gov/ posted on https://www.regulations.gov. • FDA believes that an extension of 60 advisory-committees/about-advisory- If you want to submit a comment days allows adequate time for interested committees/common-questions-and- with confidential information that you persons to submit comments. answers-about-fda-advisory-committee- do not wish to be made available to the public, submit the comment as a Dated: November 20, 2020. meetings. The online web conference written/paper submission and in the Lauren K. Roth, meeting will be available at the following link on the day of the manner detailed (see ‘‘Written/Paper Acting Principal Associate Commissioner for Submissions’’ and ‘‘Instructions’’). Policy. meeting: https://fda.yorkcast.com/ webcast/Play/d75d80a3eb6e419986181 [FR Doc. 2020–26182 Filed 11–25–20; 8:45 am] Written/Paper Submissions c1a881fe2671d. BILLING CODE 4164–01–P FDA is establishing a docket for Submit written/paper submissions as public comment on this meeting. The follows: docket number is FDA–2020–N–1898. • Mail/Hand Delivery/Courier (for DEPARTMENT OF HEALTH AND written/paper submissions): Dockets HUMAN SERVICES The docket will close on December 9, 2020. Submit either electronic or Management Staff (HFA–305), Food and Food and Drug Administration written comments on this public Drug Administration, 5630 Fishers meeting by December 9, 2020. Please Lane, Rm. 1061, Rockville, MD 20852. [Docket No. FDA–2020–N–1898] note that late, untimely filed comments • For written/paper comments will not be considered. Electronic submitted to the Dockets Management Vaccines and Related Biological Staff, FDA will post your comment, as Products Advisory Committee; Notice comments must be submitted on or before December 9, 2020. The https:// well as any attachments, except for of Meeting; Establishment of a Public information submitted, marked and Docket; Request for Comments www.regulations.gov electronic filing system will accept comments until identified, as confidential, if submitted AGENCY: Food and Drug Administration, 11:59 p.m. Eastern Time at the end of as detailed in ‘‘Instructions.’’ HHS. December 9, 2020. Comments received Instructions: All submissions received ACTION: Notice; establishment of a by mail/hand delivery/courier (for must include the Docket No. FDA– public docket; request for comments. written/paper submissions) will be 2020–N–1898 for ‘‘Vaccines and Related considered timely if they are Biological Products; Notice of Meeting; SUMMARY: The Food and Drug postmarked or the delivery service Establishment of a Public Docket; Administration (FDA or Agency) acceptance receipt is on or before that Request for Comments.’’ Received announces a forthcoming public date. comments, those filed in a timely advisory committee meeting of the Comments received on or before manner (see ADDRESSES), will be placed Vaccines and Related Biological December 4, 2020 will be provided to in the docket and, except for those Products Advisory Committee. The the committee. Comments received after submitted as ‘‘Confidential general function of the committee is to December 4, 2020, and by December 9, Submissions,’’ publicly viewable at provide advice and recommendations to 2020, will be taken into consideration https://www.regulations.gov or at the the Agency on FDA’s regulatory issues. by FDA. In the event that the meeting Dockets Management Staff between 9 The meeting will be open to the public. is cancelled, FDA will continue to a.m. and 4 p.m., Monday through FDA is establishing a docket for public evaluate any relevant applications, Friday, 240–402–7500.

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• Confidential Submissions—To the appropriate advisory committee 2020, will be taken into consideration submit a comment with confidential meeting link, or call the advisory by FDA. Oral presentations from the information that you do not wish to be committee information line to learn public will be scheduled between made publicly available, submit your about possible modifications before approximately 12 p.m. Eastern Time comments only as a written/paper joining the meeting. and 1 p.m. Eastern Time. Those submission. You should submit two SUPPLEMENTARY INFORMATION: Agenda: individuals interested in making formal copies total. One copy will include the The meeting presentations will be oral presentations should notify the information you claim to be confidential heard, viewed, captioned, and recorded contact person and submit a brief with a heading or cover note that states through an online teleconferencing statement of the general nature of the ‘‘THIS DOCUMENT CONTAINS platform. The Committee will meet in evidence or arguments they wish to CONFIDENTIAL INFORMATION.’’ FDA open session to discuss EUA of the present, the names and addresses of will review this copy, including the Pfizer-BioNTech COVID–19 Vaccine for proposed participants, and an claimed confidential information, in its the prevention of COVID–19 in indication of the approximate time consideration of comments. The second individuals 16 years of age and older. requested to make their presentation on copy, which will have the claimed EUA authority allows FDA to help confidential information redacted/ or before December 2, 2020. Time strengthen the nation’s public health allotted for each presentation may be blacked out, will be available for public protections against chemical, biological, viewing and posted on https:// limited. If the number of registrants radiological, nuclear (CBRN) threats by requesting to speak is greater than can www.regulations.gov. Submit both facilitating the availability and use of copies to the Dockets Management Staff. be reasonably accommodated during the Medical Countermeasures (MCMs) scheduled open public hearing session, If you do not wish your name and needed during public health FDA may conduct a lottery to determine contact information be made publicly emergencies. Under section 564 of the the speakers for the scheduled open available, you can provide this Federal Food, Drug, and Cosmetic Act information on the cover sheet and not (21 U.S.C. 360bbb–3), FDA may allow public hearing session. The contact in the body of your comments and you unapproved medical products or person will notify interested persons must identify the information as unapproved uses of approved medical regarding their request to speak by ‘‘confidential.’’ Any information marked products to be used in an emergency to December 3, 2020. as ‘‘confidential’’ will not be disclosed diagnose, treat, or prevent serious or For press inquiries, please contact the except in accordance with 21 CFR 10.20 life-threatening diseases or conditions Office of Media Affairs at fdaoma@ and other applicable disclosure law. For caused by CBRN threat agents when fda.hhs.gov or 301–796–4540. more information about FDA’s posting certain statutory criteria have been met, of comments to public dockets, see 80 FDA welcomes the attendance of the including that there are no adequate, public at its advisory committee FR 56469, September 18, 2015, or access approved, and available alternatives. meetings and will make every effort to the information at: https:// Additional information about EUAs can accommodate persons with disabilities. www.govinfo.gov/content/pkg/FR-2015- be found at https://www.fda.gov/ 09-18/pdf/2015-23389.pdf. emergency-preparedness-and-response/ If you require accommodations due to a Docket: For access to the docket to mcm-legal-regulatory-and-policy- disability, please contact Prabhakara read background documents or the framework/emergency-use- Atreya or Kathleen Hayes electronic and written/paper comments authorization. (CBERAdvisoryCommittees@ received, go to https:// FDA intends to make background fda.hhs.gov) at least 7 days in advance www.regulations.gov and insert the material available to the public no later of the meeting. docket number, found in brackets in the than 2 business days before the meeting. FDA is committed to the orderly heading of this document, into the If FDA is unable to post the background conduct of its advisory committee ‘‘Search’’ box and follow the prompts material on its website prior to the meetings. Please visit our website at: and/or go to the Dockets Management meeting, background material will be https://www.fda.gov/advisory- Staff, 5630 Fishers Lane, Rm. 1061, made publicly available on FDA’s Rockville, MD 20852, 240–402–7500. committees/about-advisory-committees/ website at the time of the advisory public-conduct-during-fda-advisory- FOR FURTHER INFORMATION CONTACT: committee meeting. Background committee-meetings for procedures on Prabhakara Atreya or Kathleen Hayes, material and the link to the online public conduct during advisory Center for Biologics Evaluation and teleconference meeting room will be committee meetings. Research, Food and Drug available at https://www.fda.gov/ Administration, 10903 New Hampshire advisory-committees/advisory- Notice of this meeting is given under Ave., Bldg. 71, Rm. 6306, Silver Spring, committee-calendar. Scroll down to the the Federal Advisory Committee Act (5 MD 20993–0002, 240–506–4946 or 301– appropriate advisory committee meeting U.S.C. app. 2). 796–7864, respectively; link. The meeting will include slide Dated: November 23, 2020. [email protected]; presentations with audio components to Lauren K. Roth, or FDA Advisory Committee allow the presentation of materials in a Information Line, 1–800–741–8138 manner that most closely resembles an Acting Principal Associate Commissioner for (301–443–0572 in the Washington, DC in-person advisory committee meeting. Policy. area). A notice in the Federal Register Procedure: Interested persons may [FR Doc. 2020–26229 Filed 11–25–20; 8:45 am] about last minute modifications that present data, information, or views, BILLING CODE 4164–01–P impact a previously announced orally or in writing, on issues pending advisory committee meeting cannot before the committee. All electronic and always be published quickly enough to written submissions submitted to the provide timely notice. Therefore, you Docket (see ADDRESSES) on or before should always check the Agency’s December 4, 2020, will be provided to website at https://www.fda.gov/ the committee. Comments received after advisory-committees and scroll down to December 4, 2020, and by December 9,

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