[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Pages 8208-8210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1031]


Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; 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 final guidance for industry entitled ``Reporting 
Amount of Listed Drugs and Biological Products Under Section 510(j)(3) 
of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; 
Availability.'' This guidance addresses the process through which 
registrants of drug establishments should submit reports to FDA on the 
amount of each listed drug manufactured, prepared,

[[Page 8209]]

propagated, compounded, or processed for commercial distribution, as 
required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). This 
guidance finalizes the draft guidance of the same title published on 
November 1, 2021. To allow for the transition of technical updates to 
the NextGen Portal, FDA will delay implementation of the final guidance 
until February 26, 2024. The draft guidance will remain available until 
that date.

DATES: The announcement of the guidance is published in the Federal 
Register on February 6, 2024. Implementation of this guidance will be 
delayed until February 26, 2024, to allow for the transition of 
technical updates to the NextGen Portal.

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:
    <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-2021-D-1031 for ``Reporting Amount of Listed Drugs and Biological 
Products Under Section 510(j)(3) of the Federal Food, Drug, and 
Cosmetic 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, 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 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 to 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Neil Stiber, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4128, Silver Spring, MD 20993-0002, 301-
796-8944; James Myers, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7226, Silver Spring, MD 20993-0002, 240-402-5923; or Linda Walter-
Grimm, Center for Veterinary Medicine, Food and Drug Administration, 
7519 Standish Pl. (HFV-240), Rockville, MD 20855, 240-753-3173.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Reporting Amount of Listed Drugs and Biological Products 
Under Section 510(j)(3) of the FD&C Act.'' On March 27, 2020, the 
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 
116-136) was enacted to aid response efforts and ease the economic 
impact of the Coronavirus Disease 2019 (COVID-19). In addition, the 
CARES Act included authorities to enhance FDA's ability to assess, 
prevent, and mitigate possible drug shortages by, among other things, 
improving FDA's visibility into drug supply chains. Section 3112(e) of 
the CARES Act added section 510(j)(3) of the FD&C Act (21 U.S.C. 
360(j)(3)), which requires 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 guidance describes the process that should be used for such 
reporting by each person who registers with FDA under section 510 of 
the FD&C Act with regard to a listed drug (including a drug

[[Page 8210]]

product that is in finished package form, a drug product that is not in 
finished package form, an active pharmaceutical ingredient, and other 
types of listed drugs, except for biological products or categories 
thereof exempted by an order under section 510(j)(3)(B) of the FD&C 
Act). Listed drugs subject to reporting include human drug products 
(including non-exempt biological products) marketed under an approved 
application, animal drug products marketed under an approved 
application, medical gases, homeopathic products, products marketed in 
accordance with requirements under section 505G of the FD&C Act (21 
U.S.C. 355h), often referred to as over-the-counter monograph drugs, 
and animal drug products that are not approved, conditionally approved, 
or indexed under sections 512, 571, and 572 of the FD&C Act (21 U.S.C. 
360b, 360ccc, and 360ccc-1).
    This guidance finalizes the draft guidance entitled ``Reporting 
Amount of Listed Drugs and Biological Products Under Section 510(j)(3) 
of the FD&C Act'' published on November 1, 2021 (86 FR 60249). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include changes 
to the recommended timeframe for report submission, as well as changes 
to the recommended units for the reporting of drugs that are not drug 
products in finished package form. These changes were made in response 
to public comments received and in the interest of facilitating drug 
amount data submission and improving data accuracy. Revisions also were 
made to clarify the reporting requirements applicable to registrants of 
listed drugs across the drug supply chain, including contract 
manufacturers. Further revisions were made to clarify and further 
detail how FDA plans to use data derived from the drug amount reporting 
program, including data submitted by each registrant in the drug supply 
chain.
    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 ``Reporting Amount of Listed Drugs and 
Biological Products Under Section 510(j)(3) of the FD&C Act.'' 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 part 207 pertaining to registration of producers of drugs and 
listing of drugs in commercial distribution have been approved under 
OMB control number 0910-0045. The collections of information in 21 CFR 
parts 314 and 601 have been approved under OMB control numbers 0910-
0001 and 0910-0338, respectively. The collections of information 
pertaining to notifications of discontinuance or interruption in 
manufacturing under 21 CFR 310.306 and 314.81(b)(3)(iii) have been 
approved under OMB control number 0910-0001. The collections of 
information relating to 21 CFR 600.81 and 600.82 have been approved 
under OMB control number 0910-0308. The collections of information in 
21 CFR parts 210 and 211 relating to current good manufacturing 
practice have been approved under OMB control number 0910-0139. The 
collections of information in 21 CFR 514.80 have been approved under 
OMB control number 0910-0284. The collections of information in 21 CFR 
514.87 have been approved under OMB control number 0910-0659.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, or https://www.regulations.gov.

    Dated: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02369 Filed 2-5-24; 8:45 am]
BILLING CODE 4164-01-P