Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 26526-26528 [2021-10181]

Download as PDF 26526 Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES from whole animal tissue, or produced in vitro, synthetically or through recombinant expression, and often serve as signaling molecules for many physiologic functions that are regulated by endogenous proteins. Peptides can exhibit distinct combinations of characteristics regarding their chemistry, pharmacology, sites of action, pharmacokinetic disposition, and pharmacodynamics. Although FDA has been regulating peptides for decades, there is a growing appreciation for specific considerations for the design and conduct of clinical pharmacology studies to assess peptides, such as those designed to evaluate the effects of organ impairment or drug interactions. Currently, there are no FDA-published guidance documents on clinical pharmacology assessments that contain specific recommendations for peptides.2 II. Request for Information and Comments Interested persons are invited to provide detailed information and comments on certain aspects of evaluating the clinical pharmacology of peptides. For all questions, organize any discussion by the type of peptide (e.g., isolated from animal source, or produced in vitro, synthetically or through recombinant expression) and route of administration. Please provide the rationale for your suggestions and include supporting data if available. FDA is particularly interested in responses to the following overarching questions: (1) Under what circumstances should the following assessments be warranted or not warranted for peptides? (a) Evaluating pharmacokinetics-based drug-drug interactions (DDIs) (b) Evaluating the pharmacokinetics in hepatic impairment (c) Evaluating immunogenicity and its impact on pharmacokinetics, safety, and efficacy (d) Evaluating QT prolongation (2) In circumstances where the assessments above are warranted, what types of assessments are suitable and why? What are the study design considerations (e.g., in vitro test systems, population, analytes, immunogenicity risk assessment, immunogenicity assay development and validation) for the types of assessments discussed in the following items? Please 2 There is an FDA draft guidance entitled ‘‘ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin’’ (October 2017) that is specific for ANDA applications for chemically synthetized peptides that refers to listed drugs of rDNA origin; available at https://www.fda.gov/media/107622/ download. VerDate Sep<11>2014 19:58 May 13, 2021 Jkt 253001 describe the rationale for any design considerations proposed. (a) For evaluating pharmacokineticsbased DDIs (e.g., in vitro studies, dedicated clinical studies, including cocktail studies, population pharmacokinetic analyses), please discuss the advantages, challenges, and limitations for these assessments. (b) For evaluating pharmacokinetics in hepatic impairment (e.g., dedicated clinical studies, population pharmacokinetic analyses), please discuss the advantages, challenges, and limitations for these assessments. (c) For evaluating immunogenicity and its impact on pharmacokinetics, safety, and efficacy (e.g., antibodies against the active ingredient peptide, peptide-related impurities, or endogenous counterpart, if present, neutralizing activity and antibody titers, cytokine measurements), please discuss the advantages, challenges, and limitations for these assessments. (d) For evaluating cardiac electrophysiology (e.g., hERG inhibition assay, thorough QT assessment) in nonclinical or clinical studies, please discuss the advantages, challenges, and limitations for these assessments. (3) Are there other clinical pharmacology considerations for peptides not covered in the questions above, such as use of pharmacodynamic biomarkers and/or pharmacokinetic assessments for dose selection? If yes, provide a description and rationale for any proposed considerations, as well as approaches, advantages, challenges, and limitations for the assessment. The public comments collected will help FDA develop recommendations for the design and conduct of clinical pharmacology studies important to the understanding of the safe and effective use of peptides and facilitate the regulatory assessment of such studies. III. Electronic Access Persons with access to the internet may obtain relevant clinical pharmacology guidances at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Dated: May 7, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10179 Filed 5–13–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1440] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. 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. SUMMARY: The meeting will be held on June 24, 2021, from 10:30 a.m. to 2:30 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–2020–N–1440. The docket will close on June 23, 2021. Submit either electronic or written comments on this public meeting by June 23, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 23, 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 June 10, 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 DATES: E:\FR\FM\14MYN1.SGM 14MYN1 Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices consider any comments submitted to the docket, as appropriate. You may submit comments as follows: khammond on DSKJM1Z7X2PROD with 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’’). 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–1440 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 VerDate Sep<11>2014 19:58 May 13, 2021 Jkt 253001 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-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 the 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. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 26527 SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss biologics license application (BLA) 761209, for retifanlimab injection, submitted by Incyte Corporation. The proposed indication (use) for this product is for the treatment of adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy. 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 June 10, 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 requested to make their presentation on or before June 2, 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 June 3, 2021. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. E:\FR\FM\14MYN1.SGM 14MYN1 26528 Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices 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/Advisory Committees/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: May 10, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10181 Filed 5–13–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–P–0306] Determination That OVIDE (Malathion) Lotion, 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that OVIDE (malathion) lotion, 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6272, Silver Spring, MD 20993–0002, 240– 825–9944, Kaetochi.Okemgbo@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:58 May 13, 2021 Jkt 253001 Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. OVIDE (malathion) lotion, 0.5%, is the subject of NDA 018613, held by Taro Pharmaceutical Industries, Ltd., and initially approved on August 2, 1982. OVIDE is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. In a letter dated August 19, 2019, Taro Pharmaceutical Industries Ltd. notified FDA that OVIDE (malathion) lotion, 0.5%, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Encube Ethicals Private Ltd. submitted a citizen petition dated March 19, 2021 (Docket No. FDA–2021– P–0306), under 21 CFR 10.30, requesting that the Agency determine whether OVIDE (malathion) lotion, 0.5%, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 based on the information we have at this time, FDA has determined under § 314.161 that OVIDE (malathion) lotion, 0.5% was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that OVIDE (malathion) lotion, 0.5%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of OVIDE (malathion) lotion, 0.5%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list OVIDE (malathion) lotion, 0.5%, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: May 7, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10166 Filed 5–13–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0341] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of SUMMARY: E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26526-26528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10181]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1440]


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 June 24, 2021, from 10:30 a.m. to 
2:30 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-2020-N-1440. The docket will close on June 23, 
2021. Submit either electronic or written comments on this public 
meeting by June 23, 2021. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before June 23, 2021. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of June 23, 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 June 10, 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

[[Page 26527]]

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-1440 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 the 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 biologics license application (BLA) 761209, for 
retifanlimab injection, submitted by Incyte Corporation. The proposed 
indication (use) for this product is for the treatment of adult 
patients with locally advanced or metastatic squamous carcinoma of the 
anal canal (SCAC) who have progressed on or who are intolerant of 
platinum-based chemotherapy.
    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 June 10, 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 
requested to make their presentation on or before June 2, 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 June 3, 2021.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.

[[Page 26528]]

    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: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10181 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P

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