Vaccines and Related Biological Products Advisory Committee; Amendment of Notice, 61755-61756 [2020-21630]

Download as PDF Federal Register / Vol. 85, No. 190 / Wednesday, September 30, 2020 / Notices II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.regulations.gov, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Dated: September 25, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–21624 Filed 9–29–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1898] Vaccines and Related Biological Products Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 2020, (85 FR 18985), FDA announced that a jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:36 Sep 29, 2020 Jkt 250001 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: https://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. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 61755 • 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 E:\FR\FM\30SEN1.SGM 30SEN1 61756 Federal Register / Vol. 85, No. 190 / Wednesday, September 30, 2020 / Notices more 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-201509-18/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. ADDRESSES: Dated: September 24, 2020. Lauren K. Roth, Associate Commissioner for Policy. 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’’). [FR Doc. 2020–21630 Filed 9–29–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0259] Patient-Focused Drug Development for Stimulant Use Disorder; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: In the Federal Register notice published on March 19, 2020, the Food and Drug Administration (FDA, the Agency, or we) announced the cancellation of the meeting entitled ‘‘Patient-Focused Drug Development for Stimulant Use Disorder’’ originally scheduled to occur on March 10, 2020, as announced in the Federal Register on February 18, 2020. FDA is announcing a new date for the meeting, to occur in a virtual format. The purpose of the public meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder. DATES: The public meeting will be held on October 6, 2020, from 12:30 p.m. Eastern Time to 5 p.m. Eastern Time. Submit either electronic or written comments on this public meeting by December 7, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:36 Sep 29, 2020 Jkt 250001 Please note that due to the impact of the COVID–19 pandemic, all meeting participants will be joining this public meeting via an online conferencing platform. The docket number to accept comments is FDA–2020–N–0259. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2020. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 7, 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. 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.’’ PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Instructions: All submissions received must include the Docket No. FDA– 2020–N–0259 for ‘‘Patient-Focused Drug Development for Stimulant Use Disorder; 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 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.’’ The Agency 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 to 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 this 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 more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/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. FOR FURTHER INFORMATION CONTACT: Lyna Merzoug, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993–0002, 301– 796–6001, PatientFocused@fda.hhs.gov. E:\FR\FM\30SEN1.SGM 30SEN1

Agencies

[Federal Register Volume 85, Number 190 (Wednesday, September 30, 2020)]
[Notices]
[Pages 61755-61756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21630]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1898]


Vaccines and Related Biological Products Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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.

FOR FURTHER INFORMATION CONTACT: 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, [email protected], or 
301-796-4620, [email protected], 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.

SUPPLEMENTARY INFORMATION: 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: https://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

[[Page 61756]]

more 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.

    Dated: September 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21630 Filed 9-29-20; 8:45 am]
BILLING CODE 4164-01-P

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