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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices
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 elses 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.

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Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, 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
2021D1031 for Reporting Amount of Listed Drugs and Biological Products Under Section 510j3 of the FD&C
Act. 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, 2404027500.
Confidential SubmissionsTo 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
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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 FDAs 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-201509-18/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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
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; Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 209930002; or Policy and Regulations Staff, HFV6, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. 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: Neil Stiber, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire
PO 00000

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Ave., Bldg. 51, Rm. 4128, Silver Spring, MD 209930002, 3017968944;
Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 209930002, 240
4027911; Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, HFV210, Rm. 2612, Rockville, MD
20855, 2404025745.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a draft guidance for industry entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510j3 of the FD&C Act. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act CARES
Act was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019 COVID19.
In addition, the CARES Act included authorities to enhance FDAs ability to identify, prevent, and mitigate possible drug shortages by, among other things, improving FDAs visibility into drug supply chains. Section 3112e of the CARES Act Pub. L. 116136 added section 510j3 of the FD&C Act 21
U.S.C. 360j3 to require that each person including repackers and relabelers who registers with FDA
under section 510 of the FD&C Act with regard to a drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
This draft guidance is intended to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510j3 of the FD&C Act. The draft guidance addresses the content of reports, the timing of reports, and the process for report submission.
This draft guidance describes the process that should be used for reporting by each person who registers with FDA under section 510 of the FD&C Act with regard to a listed drug including a finished dosage form product, an active pharmaceutical ingredient, and other listed drugs, except for biological products or categories thereof exempted by an order under section 510j3B. The process described in this guidance applies to such reporting with respect to listed drugs, including medical gases, homeopathic products, products
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