90 FR 48 pgs. 11985-11986 - E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
Type: NOTICEVolume: 90Number: 48Pages: 11985 - 11986
Pages: 11985, 11986Docket number: [Docket No. FDA-2024-D-5601]
FR document: [FR Doc. 2025-04026 Filed 3-12-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-5601]
E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability; reopening of the comment period.
SUMMARY:
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance for industry entitled "E6(R3) Good Clinical Practice: Annex 2," announced in the Federal Register of December 30, 2024. The Agency is taking this action to allow interested persons additional time to submit comments.
DATES:
FDA is reopening the comment period on the draft guidance published December 30, 2024 (89 FR 106519). Submit either electronic or written comments on the draft guidance by March 31, 2025, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.
[top] • 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
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-D-5601 for "E6(R3) Good Clinical Practice: Annex 2." 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)).
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Amy Chi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6334, Silver Spring, MD 20993-0002, Amy.Chi@fda.hhs.gov; 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, Jill.Adleberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In the Federal Register of December 30, 2024 (89 FR 106519), FDA published a notice of availability with a 60-day period to provide comments on the draft guidance entitled "E6(R3) Good Clinical Practice: Annex 2." The draft guidance provides guidance on good clinical practices for trial design and conduct, with a focus on trials with decentralized and pragmatic elements as well as trials that utilize real-world data. Since the original E6 guidance was published in 1996, clinical trials have evolved significantly with new designs and technological innovations. Annex 2 provides additional considerations to the previously published draft guidance entitled "E6(R3) Good Clinical Practice (GCP)," which includes a Principles document and Annex 1. This draft guidance, entitled "E6(R3) Good Clinical Practice: Annex 2," is intended to be read and implemented with E6(R3) Principles and Annex 1.
Interested persons were originally given until February 28, 2025, to submit comments to the docket. FDA has received requests to extend the comment period to allow sufficient time to develop and submit meaningful comments. FDA has considered the requests and is reopening the comment period until March 31, 2025. The Agency believes that reopening the comment period until March 31, 2025, allows adequate additional time for interested persons to submit comments.
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04026 Filed 3-12-25; 8:45 am]
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