Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability, 59740-59742 [2024-16128]

Download as PDF 59740 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2—Continued Number of responses per respondent Form FDA number/ description 1210.14 ........ 1997/Sanitary inspections of plants. 1993/Application for permit 1815/Permits granted on certificates. 1 1 1 2.0 ....................................... 2 1 1 1 1 1 1 0.5 (30 minutes) .................. 0.5 (30 minutes) .................. 1 1 .............................................. ........................ ........................ ........................ .............................................. 306 1210.20 ........ 1210.23 ........ Total ...... Number of respondents Total annual responses 21 CFR section Average burden per response Total hours TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2 Number of recordkeepers 21 CFR section/activity ddrumheller on DSK120RN23PROD with NOTICES1 1210.15/Pasteurization records ........ 1 The Secretary of Health and Human Services has the discretion to allow Form FDA 1815, a duly certified statement signed by an accredited official of a foreign government, to be submitted in lieu of Forms FDA 1994 and 1995. In the past, Form FDA 1815 has been submitted in lieu of these forms. Because we have not received any Forms FDA 1994 or 1995 in the last 3 years, we assume no more than one will be submitted annually. No burden has been estimated for the tagging requirement in § 1210.22 because the information on the tag is either supplied by us (permit number) or is disclosed to third parties as a usual and customary part of the shipper’s normal business activities (type of product, shipper’s name and address). Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not subject to review by OMB under the PRA. Under 5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of business activities. Based on a review of the information collection since our last OMB approval, we have retained our burden estimate. The estimated number of respondents and hours per response are based on our experience with the import milk permit program and the average number of 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Numbers have been rounded. VerDate Sep<11>2014 18:47 Jul 22, 2024 Jkt 262001 Number of records per recordkeeper Total annual records 1 Average burden per recordkeeping 1 Total hours 0.05 (3 minutes) ............................... 1 import milk permit holders over the past 3 years. However, we have not received any responses in the last 3 years; therefore, we estimate that one or fewer to be submitted annually. Although we have not received any responses in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need for a milk importer. biosimilar products licensed under the Public Health Service Act (PHS Act). DATES: Submit either electronic or written comments on the draft guidance by September 23, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Dated: July 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. Electronic Submissions [FR Doc. 2024–16101 Filed 7–22–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–D–2581] Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.’’ This draft guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable SUMMARY: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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: E:\FR\FM\23JYN1.SGM 23JYN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices • 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–D–2581 for ‘‘Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.’’ Received comments 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-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 VerDate Sep<11>2014 18:47 Jul 22, 2024 Jkt 262001 follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Nidhi Pamidimukkala, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6652, Silver Spring, MD 20993–0002, 301– 796–3397, Nidhi.Pamidimukkala@ fda.hhs.gov; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.’’ This draft guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this notice) made to biosimilar and interchangeable biosimilar products licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)). FDA is publishing this draft guidance to fulfill the commitment made in the 2022 reauthorization of the Biosimilar User Fee Act (BsUFA III, Title IV—Fees Relating to Biosimilar Biological Products, Pub. L. 112–144) for fiscal years 2023 through 2027. This draft guidance is intended to inform applicants on the nature and type of PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 59741 information, for different reporting categories, that applicants should provide to support manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars. In the Federal Register of September 20, 2021 (86 FR 52154), FDA published the notice of availability of a guidance for industry entitled ‘‘Questions and Answers on Biosimilar Development and the BPCI Act,’’ available at https:// www.fda.gov/media/119258/download (Q&A biosimilar development guidance) to provide answers to commonly asked questions from applicants and other interested parties regarding the licensure of biosimilars under the Biologics Price Competition and Innovation Act of 2009. Postapproval manufacturing changes to biosimilars was the subject of Q&A I.20 in the Q&A biosimilar development guidance. FDA did not provide recommendations for interchangeable biosimilar products because FDA had limited knowledge and experience regarding manufacturing changes for licensed interchangeable biosimilar products when that guidance issued. FDA has since determined that the principles that apply to manufacturing changes for biosimilars are relevant to interchangeable biosimilar products. Thus, this draft guidance applies to manufacturing changes made to both licensed biosimilar and licensed interchangeable biosimilar products. FDA may withdraw a Q&A that was previously in a guidance if FDA determines that the issue described in the Q&A is addressed in another guidance. Therefore, FDA intends to withdraw Q&A I.20 from the Q&A biosimilar development guidance when this draft guidance becomes final. FDA intends for this draft guidance to serve as a stand-alone guidance from the Q&A biosimilar development guidance and will not retain the same numbering of that guidance. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of E:\FR\FM\23JYN1.SGM 23JYN1 59742 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR 201.56 and 201.57 pertaining to prescription product labeling requirements have been approved under OMB control number 0910–0572; the collections of information in 21 CFR parts 210 and 211 pertaining to current good manufacturing practice have been approved under OMB control number 0910–0139; the collections of information in section 351(k) of the PHS Act pertaining to biosimilar and interchangeable biosimilar product applications have been approved under OMB control number 0910–0718; and the collections of information in section 351 of the PHS Act and 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: July 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. the Paperwork Reduction Act of 1995 (PRA). FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 21, 2023, the Agency submitted a proposed collection of information entitled ‘‘Survey on Quantitative Claims in Direct-toConsumer Prescription Drug Advertising’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0929. The approval expires on June 30, 2027. A copy of the supporting statement for this information collection is available on the internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: July 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–16096 Filed 7–22–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2024–16128 Filed 7–22–24; 8:45 am] [Docket No. FDA–2024–N–2931] BILLING CODE 4164–01–P Agency Information Collection Activities; Proposed Collection; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: [Docket No. FDA–2023–N–0795] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising AGENCY: Food and Drug Administration, ddrumheller on DSK120RN23PROD with NOTICES1 HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ‘‘Electronic Records: Electronic Signatures’’ has been approved by the Office of Management and Budget (OMB) under SUMMARY: VerDate Sep<11>2014 18:47 Jul 22, 2024 Jkt 262001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which both domestic and foreign bottled SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements. DATES: Either electronic or written comments on the collection of information must be submitted by September 23, 2024. 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 September 23, 2024. 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.’’ E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59740-59742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16128]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2581]


Postapproval Manufacturing Changes to Biosimilar and 
Interchangeable Biosimilar Products: Questions and Answers; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Postapproval Manufacturing Changes to Biosimilar and Interchangeable 
Biosimilar Products: Questions and Answers.'' This draft guidance 
provides answers to commonly asked questions from applicants and other 
interested parties regarding postapproval manufacturing changes made to 
biosimilar and interchangeable biosimilar products licensed under the 
Public Health Service Act (PHS Act).

DATES: Submit either electronic or written comments on the draft 
guidance by September 23, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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:

[[Page 59741]]

     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-D-2581 for ``Postapproval Manufacturing Changes to Biosimilar 
and Interchangeable Biosimilar Products: Questions and Answers.'' 
Received comments 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-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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. The draft guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Nidhi Pamidimukkala, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 301-
796-3397, [email protected]; or James Myers, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Postapproval Manufacturing Changes to Biosimilar and 
Interchangeable Biosimilar Products: Questions and Answers.'' This 
draft guidance provides answers to commonly asked questions from 
applicants and other interested parties regarding postapproval 
manufacturing changes (referred to as manufacturing changes throughout 
this notice) made to biosimilar and interchangeable biosimilar products 
licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)). FDA is 
publishing this draft guidance to fulfill the commitment made in the 
2022 reauthorization of the Biosimilar User Fee Act (BsUFA III, Title 
IV--Fees Relating to Biosimilar Biological Products, Pub. L. 112-144) 
for fiscal years 2023 through 2027. This draft guidance is intended to 
inform applicants on the nature and type of information, for different 
reporting categories, that applicants should provide to support 
manufacturing changes to licensed biosimilars and licensed 
interchangeable biosimilars.
    In the Federal Register of September 20, 2021 (86 FR 52154), FDA 
published the notice of availability of a guidance for industry 
entitled ``Questions and Answers on Biosimilar Development and the BPCI 
Act,'' available at https://www.fda.gov/media/119258/download (Q&A 
biosimilar development guidance) to provide answers to commonly asked 
questions from applicants and other interested parties regarding the 
licensure of biosimilars under the Biologics Price Competition and 
Innovation Act of 2009. Postapproval manufacturing changes to 
biosimilars was the subject of Q&A I.20 in the Q&A biosimilar 
development guidance. FDA did not provide recommendations for 
interchangeable biosimilar products because FDA had limited knowledge 
and experience regarding manufacturing changes for licensed 
interchangeable biosimilar products when that guidance issued. FDA has 
since determined that the principles that apply to manufacturing 
changes for biosimilars are relevant to interchangeable biosimilar 
products. Thus, this draft guidance applies to manufacturing changes 
made to both licensed biosimilar and licensed interchangeable 
biosimilar products.
    FDA may withdraw a Q&A that was previously in a guidance if FDA 
determines that the issue described in the Q&A is addressed in another 
guidance. Therefore, FDA intends to withdraw Q&A I.20 from the Q&A 
biosimilar development guidance when this draft guidance becomes final. 
FDA intends for this draft guidance to serve as a stand-alone guidance 
from the Q&A biosimilar development guidance and will not retain the 
same numbering of that guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Postapproval 
Manufacturing Changes to Biosimilar and Interchangeable Biosimilar 
Products: Questions and Answers.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of

[[Page 59742]]

information. The previously approved collections of information are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR 201.56 and 201.57 pertaining to 
prescription product labeling requirements have been approved under OMB 
control number 0910-0572; the collections of information in 21 CFR 
parts 210 and 211 pertaining to current good manufacturing practice 
have been approved under OMB control number 0910-0139; the collections 
of information in section 351(k) of the PHS Act pertaining to 
biosimilar and interchangeable biosimilar product applications have 
been approved under OMB control number 0910-0718; and the collections 
of information in section 351 of the PHS Act and 21 CFR part 601 have 
been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16128 Filed 7-22-24; 8:45 am]
BILLING CODE 4164-01-P

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