Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period, 107147-107148 [2024-31365]

Download as PDF Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices Silver Spring, MD 20993–0002, 301– 796–3471, Martha.Nguyen@fda.hhs.gov. The holder of an approved application to market a new drug for human use is required to submit annual reports to FDA concerning its approved application in accordance with §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2024 (89 FR 64936), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of two ANDAs because the holder of these ANDAs had repeatedly failed to submit the required annual reports for these ANDAs. The holder of these ANDAs did not respond to the NOOH. Failure to file a written notice of participation and request for 107147 hearing as required by § 314.200 (21 CFR 314.200) constitutes a waiver of the opportunity for hearing by the holder of the ANDAs concerning the proposal to withdraw approval of the ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, FDA is withdrawing approval of the two applications listed in table 1 of this document. TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED Application No. Drug ANDA 207309 ... Metronidazole tablet, 250 milligrams (mg) and 500 mg ........... ANDA 207938 ... Piroxicam capsule, 10 mg and 20 mg ...................................... FDA finds that the holder of the ANDAs listed in table 1 has repeatedly failed to submit reports required by §§ 314.81 and 314.98. In addition, under § 314.200, FDA finds that the holder of the ANDAs has waived its opportunity for a hearing and any contentions concerning the legal status of the drug products. Therefore, based on these findings and pursuant to the authority under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), approval of the ANDAs listed in table 1 and all amendments and supplements thereto, is hereby withdrawn, as of December 31, 2024. Dated: December 23, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024–31360 Filed 12–30–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–2980] Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. khammond on DSK9W7S144PROD with NOTICES ACTION: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled ‘‘Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products,’’ published in the SUMMARY: VerDate Sep<11>2014 18:31 Dec 30, 2024 Jkt 265001 Applicant Flamingo Pharmaceuticals Ltd., U.S. Agent for Flamingo Pharmaceuticals Ltd., 1125 Gaither Rd., Rockville, MD 20850. Do. Federal Register of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information. DATES: FDA is reopening the comment period on the request for information and comments notice published July 25, 2024 (89 FR 60436). Either electronic or written comments must be submitted by March 3, 2025. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 3, 2025. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. 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 00044 Fmt 4703 Sfmt 4703 • 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– 2024–N–2980 for ‘‘Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Request for Information and 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 E:\FR\FM\31DEN1.SGM 31DEN1 107148 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 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: Kunal Naik, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240– 402–8717. SUPPLEMENTARY INFORMATION: khammond on DSK9W7S144PROD with NOTICES I. Background In the Federal Register of July 25, 2024 (89 FR 60436), FDA requested information and comments. Interested persons were originally given until September 23, 2024, to comment on evaluating and mitigating the immunogenicity risk of host cell proteins. Following publication of the July 25, 2024, notice, FDA received a request to allow interested persons additional time to comment. The requester asserted that the time period of 60 days was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. VerDate Sep<11>2014 18:31 Dec 30, 2024 Jkt 265001 II. Electronic Access Persons with access to the internet may obtain relevant guidance at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/ clinical-pharmacology-considerationspeptide-drug-products. Dated: December 23, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024–31365 Filed 12–30–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–5830] Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of Federal advisory committee. ACTION: The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2026, expiration date. DATES: Authority for the Dermatologic and Ophthalmic Drugs Advisory Committee will expire on October 7, 2026, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–2855, DODAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders and makes appropriate recommendations to the Commissioner of Food and Drugs. Pursuant to its charter, the Committee shall consist of a core of 12 voting members including 2 Chairpersons. Members and the Chairpersons are selected by the Commissioner or designee from among authorities knowledgeable in the fields of dermatology, ophthalmology, dentistry, immunology, epidemiology or statistics, and other related professions. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this committee will serve as Special Government Employees or representatives. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative. The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, in connection with a particular committee meeting, specify a quorum that is less than a majority of the current voting members. The Agency’s regulations (21 CFR 14.22(d)) authorize E:\FR\FM\31DEN1.SGM 31DEN1

Agencies

[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Notices]
[Pages 107147-107148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2980]


Evaluating the Immunogenicity Risk of Host Cell Proteins in 
Follow-On Recombinant Peptide Products; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the request for information and 
comments notice entitled ``Evaluating the Immunogenicity Risk of Host 
Cell Proteins in Follow-On Recombinant Peptide Products,'' published in 
the Federal Register of July 25, 2024. FDA is reopening the comment 
period to update comments and to receive any new information.

DATES: FDA is reopening the comment period on the request for 
information and comments notice published July 25, 2024 (89 FR 60436). 
Either electronic or written comments must be submitted by March 3, 
2025.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 3, 2025. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

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-2024-N-2980 for ``Evaluating the Immunogenicity Risk of Host Cell 
Proteins in Follow-On Recombinant Peptide Products; Request for 
Information and 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

[[Page 107148]]

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-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: Kunal Naik, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 240-402-8717.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 25, 2024 (89 FR 60436), FDA 
requested information and comments. Interested persons were originally 
given until September 23, 2024, to comment on evaluating and mitigating 
the immunogenicity risk of host cell proteins.
    Following publication of the July 25, 2024, notice, FDA received a 
request to allow interested persons additional time to comment. The 
requester asserted that the time period of 60 days was insufficient to 
respond fully to FDA's specific requests for comments and to allow 
potential respondents to thoroughly evaluate and address pertinent 
issues.

II. Electronic Access

    Persons with access to the internet may obtain relevant guidance at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-peptide-drug-products.

    Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31365 Filed 12-30-24; 8:45 am]
BILLING CODE 4164-01-P
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