2021-18395. Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is extending the comment period for the request for comments that appeared in the Federal Register of June 15, 2021. In that notice, FDA requested comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications (NDAs), abbreviated new animal drug applications (ANDAs), or applications for conditional approval. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

DATES:

FDA is extending the comment period on the request for comments published on June 15, 2021 (86 FR 31720). Submit either electronic or written comments by November 12, 2021.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 12, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 12, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is 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-2020-N-2319 for “Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine.” 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 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:

Charles Andres, Center for Veterinary Medicine (HFV-180), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-402-0653, [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of June 15, 2021, FDA published a request for comments with a 90-day comment period to request comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of NDAs, ANDAs, or applications for conditional approval. Comments on the use of study data exchange standards will help us evaluate the potential use of study data exchange standards for animal studies submitted as part of the new animal drug approval process

Interested persons were originally given until September 13, 2021, to comment on document. The Agency has received a request for a 60-day extension of the comment period. The request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the request for comments. FDA has considered the request and is extending the comment period for the request for comments for 60 days, until November 12, 2021. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments.

Dated: August 20, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.