[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Pages 81419-81421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4719]


Translation of Good Laboratory Practice Study Reports: Questions 
and Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Translation of GLP Study Reports: Questions and Answers.'' This 
guidance provides information to sponsors and nonclinical laboratories 
regarding the translation of study reports for studies conducted in 
compliance with good laboratory practice (GLP) regulations. GLP studies 
are nonclinical safety studies that include, but are not limited to 
nonclinical toxicology studies, safety pharmacology studies, and device 
safety studies. When study reports of GLP studies are translated from 
the original language into English, adequate documentation is critical 
to ensure

[[Page 81420]]

accurate and complete study data are submitted to FDA. This question-
and-answer document is intended to clarify FDA's recommendations 
concerning the translation of GLP study reports from a non-English 
language into English for nonclinical studies conducted in compliance 
with GLP regulations.

DATES: Submit either electronic or written comments on the draft 
guidance by February 20, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2023-D-4719 for ``Translation of GLP Study Reports: 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.
    <bullet> 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, 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Tahseen Mirza, Center for Drug 
Evaluation and Research, Office of Study Integrity and Surveillance, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
2211, Silver Spring, MD 20993, 301-796-7645; Anne Taylor, Office of the 
Center Director, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911; Judith Davis, Office of Device 
Evaluation, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1216, Silver 
Spring, MD 20993, 301-796-6636; Tong Zhou, Center for Veterinary 
Medicine, Office of New Animal Drug Evaluation, HFV-153, Food and Drug 
Administration, 7500 Standish Place, Rockville, MD, 20855, 240-402-
0826; Yuguang Wang, Center for Food Safety and Applied Nutrition, 
Office of the Center Director, Food and Drug Administration, 5001 
Campus Dr., Rm. 4A035, College Park, MD, 20740, 240- 402-1757; Hans 
Rosenfeldt, Center for Tobacco Products, Office of Science, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 
Silver Spring, MD 20993, 301-796-1327; Darby Hull, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Building, Rockville, MD 20857, 301-796-5949.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Translation of GLP Study Reports: Questions and Answers.'' 
Nonclinical laboratory studies conducted in compliance with GLP 
regulations (21 CFR part 58) are being conducted by testing facilities 
located in foreign countries. In instances where the GLP study report 
is generated in a non-English language, the study report is often 
translated into English for submission to FDA. When translating a study 
report into English from a study conducted in compliance with GLP 
regulations, the translation should be clear, accurate, complete, and 
follow written processes and procedures. The sponsor should ensure that 
the

[[Page 81421]]

translated report is an accurate representation of the original GLP 
study report.
    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 ``Translation 
of GLP Study Reports: 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 information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 
CFR part 58 for good laboratory practice 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 draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.regulations.gov, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: November 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25859 Filed 11-21-23; 8:45 am]
BILLING CODE 4164-01-P