2020-21630. Vaccines and Related Biological Products Advisory Committee; Amendment of Notice  

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    Food and Drug Administration, HHS.




    The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This meeting was announced in the Federal Register of August 28, 2020. The amendment is being made to reflect changes in the ADDRESSES portion of the document.

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    Prabhakara Atreya or Monique Hill, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 240-506-4946, Prabhakara.Atreya@fda.hhs.gov, or 301-796-4620, monique.hill@fda.hhs.gov, respectively, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.

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    In the Federal Register of August 28, 2020, (85 FR 18985), FDA announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on October 22, 2020. On page 53385, in the first column, the ADDRESSES portion of the document is changed to read as follows:

    The online web conference meeting will be available at the following link: http://fda.yorkcast.com/​webcast/​Play/​c26e83a0f77a412296949f4f43af4c981d.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2020-N-1898. The docket will close on October 15, 2020. Submit either electronic or written comments on this public meeting by October 15, 2020. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 15, 2020. 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.

    Comments received on or before October 15, 2020, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

    You may submit comments as follows:

    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 else's 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 (HFA-305), 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-2020-N-1898 for Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see the ADDRESSES section), 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 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For Start Printed Page 61756more information about FDA's posting of comments to public dockets, see 80 FR 56469, September18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

    This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

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    Dated: September 24, 2020.

    Lauren K. Roth,

    Associate Commissioner for Policy.

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    [FR Doc. 2020-21630 Filed 9-29-20; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Health and Human Services Department
Food and Drug Administration
Document Number:
61755-61756 (2 pages)
Docket Numbers:
Docket No. FDA-2020-N-1898
PDF File: