Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 49546-49548 [2021-19024]

Download as PDF 49546 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: HUMAN FOODS 1 21 CFR section; activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 37,134 1 37,134 0.25 (15 minutes) .................... 9,284 117.201(e); disclosure of food manufacturing facility address. 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 5—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: ANIMAL FOOD 1 Number of respondents 21 CFR section; activity 507.27(b); labeling for the animal food product contains the specific information and instructions needed so the food can be safely used for the intended animal species. 507.7(e)(1); change labels on products with labels. 507.7(e)(2); change address on labeling (sales documents) for qualified facilities. 507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified. 507.28(b); holding and distribution of human food byproducts for use as animal food. Total .................................. 1 There Average burden per disclosure Total hours 10 3,300 0.25 (15 minutes) .................... 825 1,120 4 4,480 1 .............................................. 4,480 974 1 974 1 .............................................. 974 373 312 116,376 0.01 (36 seconds) ................... 1,163.76 40,798 2 81,596 0.25 (15 minutes) .................... 20,399 .............................. .............................. .............................. .................................................. 27,841.76 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 31, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19116 Filed 9–2–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1 Total annual disclosures 330 Based on a review of the information collection since our last request for OMB approval, we have made slight adjustments to reflect a decrease in third-party disclosure burden associated with animal food. In this submission we provide a cumulative estimate for related disclosure activities that we had previously accounted for separately. [Docket No. FDA–2021–N–0897] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Number of disclosures per respondent Food and Drug Administration, HHS. VerDate Sep<11>2014 16:55 Sep 02, 2021 Jkt 253001 Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on October 28, 2021, from 10:30 a.m. to 3 p.m. Eastern Time. ADDRESSES: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https:// www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2021–N–0897. SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 The docket will close on October 27, 2021. Submit either electronic or written comments on this public meeting by October 27, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2021. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 27, 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. Comments received on or before October 14, 2021, 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: E:\FR\FM\03SEN1.SGM 03SEN1 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 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’’). lotter on DSK11XQN23PROD with NOTICES1 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– 2021–N–0897 for ‘‘Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; 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 VerDate Sep<11>2014 16:55 Sep 02, 2021 Jkt 253001 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 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: SheChia Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 240–402–5343, Fax: 301–847–8533, ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 49547 teleconferencing platform. The committee will discuss new drug application (NDA) 214383, PEPAXTO (melphalan flufenamide) for injection submitted by Oncopeptides AB, approved under 21 CFR 314.500 (subpart H, accelerated approval regulations), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The committee will hear an update where the confirmatory trial demonstrated a worse overall survival in the melphalan flufenamide treatment arm compared to the control arm. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. Based on the update provided, the committee will have a general discussion focused on next steps for the product including whether the indication should remain on the market while additional trial(s) are conducted. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 14, 2021, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time E:\FR\FM\03SEN1.SGM 03SEN1 49548 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices requested to make their presentation on or before October 5, 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 October 6, 2021. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. 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 She-Chia Chen (see FOR FURTHER INFORMATION CONTACT) 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/ AboutAdvisoryCommittees/ ucm111462.htm 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 30, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19024 Filed 9–2–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4844] ‘‘Ruby Chocolate’’ Deviating From Identity Standard; Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the extension of a temporary permit issued to Barry Callebaut U.S.A. LLC (the applicant) to market test products (designated as ‘‘ruby chocolate’’) that deviate from the U.S. standards of identity for cacao products. The extension allows the applicant to continue to evaluate commercial viability of the product and lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:55 Sep 02, 2021 Jkt 253001 to collect data on consumer acceptance of the product in support of a petition to establish a standard of identity for ‘‘ruby chocolate.’’ We also invite other interested parties to participate in the market test. DATES: The new expiration date of the permit will be either the effective date of a final rule establishing a standard of identity for ‘‘ruby chocolate’’ that may result from the petition or 30 days after denial of the petition. FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2371; or Carrol Bascus, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. SUPPLEMENTARY INFORMATION: In accordance with § 130.17 (21 CFR 130.17), we issued a temporary permit to Barry Callebaut U.S.A. LLC, 600 West Chicago Ave, Suite 860, Chicago, IL 60654, to market test products identified as ‘‘ruby chocolate’’ that deviate from the requirements of the standards of identity for cacao products in part 163 (21 CFR part 163) (84 FR 64541, November 22, 2019). We issued the permit to facilitate market testing of products that deviate from the requirements of the standard of identity for cacao products issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341). The permit covers limited interstate marketing tests of products identified as ‘‘ruby chocolate.’’ These test products deviate from the U.S. standards of identity for cacao products (§§ 163.111, 163.123, 163.124, 163.130, 163.135, 163.140, and 163.145). For the purpose of this permit, ‘‘ruby chocolate’’ is the solid or semi-plastic food prepared by mixing and grinding cacao fat with one or more of the cacao ingredients (namely, chocolate liquor, breakfast cocoa, cocoa, and low-fat cocoa), citric acid, one or more of optional nutritive carbohydrate sweeteners. ‘‘Ruby chocolate’’ contains not less than 1.5 percent nonfat cacao solids, not less than 2.5 percent by weight of milk fat, not less than 12 percent by weight of total milk solids, not more than 1.5 percent of emulsifying agents, and not more than 5 percent of whey or whey products. It may also contain other ingredients such as antioxidants approved for food use, spices, natural and artificial flavorings, and other seasonings. However, these other ingredients cannot imitate the PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 flavor of chocolate, milk, butter, berry, or another fruit. Additionally, ‘‘ruby chocolate’’ contains no added coloring. The test product ‘‘ruby chocolate’’ contains the principal ingredients used in most of the current standards for cacao products under part 163; however, it deviates from the current standard of identify for chocolate products in terms of its final composition, taste, and color. On February 19, 2021, the applicant asked us to extend the temporary permit so the applicant could have more time to market test the ‘‘ruby chocolate’’ and gain additional consumer acceptance in support of the petition to establish a standard for ‘‘ruby chocolate.’’ We find that it is in the interest of consumers to extend the permit for continued market testing of ‘‘ruby chocolate’’ to gain additional information on consumer expectations and acceptance. Therefore, under § 130.17(i), we are extending the temporary permit granted to Barry Callebaut U.S.A. LLC for temporary marketing of approximately 60 million pounds (27,215,540 kilograms) of ‘‘ruby chocolate’’ to provide continued market testing of the specified amount of product for the applicant on an annual basis. The test products will bear the name ‘‘ruby chocolate.’’ The new expiration date of the permit will be either the effective date of a final rule establishing a standard of identity for ‘‘ruby chocolate’’ that may result from the petition or 30 days after denial of the petition. All other conditions and terms of this permit remain the same. In addition, we invite interested persons to participate in the market test under the conditions of the permit, except for the designated area of distribution. Any person who wishes to participate in the extended market test should notify, in writing, the Branch Chief, Product Evaluation Labeling Branch, Division of Food Labeling and Standards, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. The notification must describe the amount to be distributed, the area of distribution, and include the labeling that will be used for the test product (see § 130.17(i)). For information on what to include in the notification to FDA, see § 130.17(c). Test products must be labeled in accordance with 21 CFR part 101. E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49546-49548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19024]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0897]


Oncologic Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Oncologic Drugs Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to FDA on regulatory issues. The meeting will be 
open to the public. FDA is establishing a docket for public comment on 
this document.

DATES: The meeting will be held on October 28, 2021, from 10:30 a.m. to 
3 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. Answers to 
commonly asked questions about FDA advisory committee meetings may be 
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2021-N-0897. The docket will close on October 
27, 2021. Submit either electronic or written comments on this public 
meeting by October 27, 2021. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before October 27, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of October 27, 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.
    Comments received on or before October 14, 2021, 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:

[[Page 49547]]

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-2021-N-0897 for ``Oncologic Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; 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.'' 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 
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-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.

FOR FURTHER INFORMATION CONTACT: She-Chia Chen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, Fax: 301-847-8533, [email protected], or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area). A notice in the Federal Register about last 
minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check FDA's website at 
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to 
the appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. The committee 
will discuss new drug application (NDA) 214383, PEPAXTO (melphalan 
flufenamide) for injection submitted by Oncopeptides AB, approved under 
21 CFR 314.500 (subpart H, accelerated approval regulations), in 
combination with dexamethasone for the treatment of adult patients with 
relapsed or refractory multiple myeloma who have received at least four 
prior lines of therapy and whose disease is refractory to at least one 
proteasome inhibitor, one immunomodulatory agent, and one CD38-directed 
monoclonal antibody.
    The committee will hear an update where the confirmatory trial 
demonstrated a worse overall survival in the melphalan flufenamide 
treatment arm compared to the control arm. Confirmatory studies are 
post-marketing studies to verify and describe the clinical benefit of a 
drug after it receives accelerated approval. Based on the update 
provided, the committee will have a general discussion focused on next 
steps for the product including whether the indication should remain on 
the market while additional trial(s) are conducted.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting. Background material and the 
link to the online teleconference meeting room will be available at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
will include slide presentations with audio components to allow the 
presentation of materials in a manner that most closely resembles an 
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before October 14, 2021, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 1 p.m. to 2 p.m. Eastern Time. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time

[[Page 49548]]

requested to make their presentation on or before October 5, 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 October 6, 2021.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    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 She-Chia Chen (see FOR FURTHER INFORMATION CONTACT) 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/AboutAdvisoryCommittees/ucm111462.htm 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 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19024 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P

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