[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Notices]
[Pages 1925-1927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00407]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2512]


Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived 
From Cell Lines of Human or Animal Origin; International Council for 
Harmonisation; 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 final guidance for industry entitled ``Q5A(R2) 
Viral Safety Evaluation of Biotechnology Products Derived from Cell 
Lines of Human or Animal Origin.'' The guidance was prepared under the 
auspices of the International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH). The guidance is 
intended to describe risk-based principles and mitigation strategies to 
assure the viral safety of biotechnology products, including the data 
necessary to submit in a marketing application. The guidance also 
finalizes the updates based on advances in scientific knowledge and 
regulatory expectations to the first version of the ICH guidance for 
industry ``Q5A Viral Safety Evaluation of Biotechnology Products 
Derived from Cell Lines of Human or Animal Origin,'' issued in 
September 1998. Lastly, the guidance replaces the draft guidance 
``Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived 
from Cell Lines of Human or Animal Origin'' issued on November 14, 
2022.

DATES: The announcement of the guidance is published in the Federal 
Register on January 11, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 1926]]

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-2022-D-2512 for ``Q5A(R2) Viral Safety Evaluation of Biotechnology 
Products Derived from Cell Lines of Human or Animal Origin.'' 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 this 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 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 that office in processing 
your requests. The 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Kathryn King, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 240-
402-9634, [email protected]; or James Myers, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6364, Silver Spring, MD 20993-0002, 301-796-5259, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Q5A(R2) Viral Safety Evaluation of Biotechnology Products 
Derived from Cell Lines of Human or Animal Origin.'' The guidance was 
prepared under the auspices of ICH. ICH seeks to achieve greater 
regulatory harmonization worldwide to ensure that safe, effective, 
high-quality medicines are developed, registered, and maintained in the 
most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the 
world, ICH guidelines enhance global drug development, improve 
manufacturing standards, and increase the availability of medications. 
For example, ICH guidelines have substantially reduced duplicative 
clinical studies, prevented unnecessary animal studies, standardized 
the reporting of important safety information, and standardized 
marketing application submissions.
    The six Founding Members of the ICH are FDA; the Pharmaceutical 
Research and Manufacturers of America; the European Commission; the 
European Federation of Pharmaceutical Industries Associations; the 
Japanese Ministry of Health, Labour, and Welfare; and the Japanese 
Pharmaceutical Manufacturers Association. The Standing Members of the 
ICH Association include Health Canada and Swissmedic. ICH membership 
continues to expand to include other regulatory authorities and 
industry associations from around the world (refer to https://www.ich.org/).
    ICH works by engaging global regulatory and industry experts in a 
detailed, science-based, and consensus-driven process that results in 
the development of ICH guidelines. The regulators around the world are 
committed to consistently adopting these consensus-based guidelines, 
realizing the benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in 
the development of each of the ICH guidelines, which FDA then adopts 
and issues as guidance for industry. FDA's guidance documents do not 
establish legally enforceable responsibilities. Instead, they describe 
the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements 
are cited.
    In the Federal Register of November 14, 2022 (87 FR 68176), FDA 
published

[[Page 1927]]

a notice announcing the availability of a draft guidance entitled 
``Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived 
from Cell Lines of Human or Animal Origin.'' The notice gave interested 
persons an opportunity to submit comments by January 13, 2023. After 
consideration of the comments received and revisions to the guideline, 
a final draft of the guideline was submitted to the ICH Assembly and 
endorsed by the regulatory agencies in November 2023.
    This guidance revises and finalizes the updates included in the 
draft guidance issued on November 14, 2022. Like the draft guidance, 
the final guidance reflects updates in scientific advances and 
regulatory expectations since the publication of the ICH guidance for 
industry, ``Q5A Viral Safety Evaluation of Biotechnology Products 
Derived from Cell Lines of Human or Animal Origin,'' issued in 
September 1998. These revisions include descriptions of new classes of 
products now in scope, inclusion of new virus detection technologies, 
clarification of new validation strategies, and considerations specific 
to new manufacturing approaches, such as continuous manufacturing. The 
final guidance expands on the draft by including additional detail on 
the strategy for replacement of conventional testing methods with 
alternatives and additional details to better describe the scope of 
products addressed in the guidance. Additional definitions were added 
to the glossary to better align with terminology elsewhere in the 
guidance as well as guidances that may be read in parallel (e.g., ICH 
guidance for industry ``Q13 Continuous Manufacturing of Drug Substances 
and Drug Products,'' available at https://www.fda.gov/media/165775/download).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Q5A(R2) Viral Safety Evaluation of 
Biotechnology Products Derived from Cell Lines of Human or Animal 
Origin.'' 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 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 parts 210 and 211 pertaining to current good manufacturing 
practice have been approved under OMB control number 0910-0139. The 
collections of information in 21 CFR part 312 for the submissions of 
investigational new drug applications have been approved under OMB 
control number 0910-0014. The collections of information in 21 CFR part 
601 for the submissions of biologics license applications have been 
approved under OMB control number 0910-0338. The collections of 
information 21 CFR part 58 pertaining to good laboratory practices for 
nonclinical laboratory studies have been approved under OMB control 
number 0910-0119.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.regulations.gov, 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, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: January 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00407 Filed 1-10-24; 8:45 am]
BILLING CODE 4164-01-P