Document ID: FDA-2021-D-1031-0001
Agency: fda
Document Type: Notice
Title: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Posted Date: 2021-11-01T04:00Z

[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60249-60251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23722]

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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Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Reporting 
Amount of Listed Drugs and Biological Products Under Section 510(j)(3) 
of the FD&C Act.'' This draft guidance addresses the process through 
which registrants of drug establishments should submit to FDA reports 
on the amount of each listed drug manufactured, prepared, propagated, 
compounded, or processed for commercial distribution, as required by 
the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by January 3, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 60250]]

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-2021-D-1031 for ``Reporting Amount of Listed Drugs and Biological 
Products Under Section 510(j)(3) 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, 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)).
    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 20993-0002; or 
Policy and Regulations Staff, HFV-6, 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 Ave., Bldg. 51, Rm. 4128, Silver Spring, MD 20993-0002, 301-
796-8944; Stephen Ripley, 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; Neal Bataller, Center 
for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Place, (HFV-210), Rm. 2612, Rockville, MD 20855, 240-402-5745.

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 510(j)(3) 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 (COVID-19). In addition, the CARES Act 
included authorities to enhance FDA's ability to identify, 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 (Pub. L. 116-136) added section 510(j)(3) of the FD&C Act (21 
U.S.C. 360(j)(3)) 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 510(j)(3) 
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 510(j)(3)(B)). The process described in this 
guidance applies to such reporting with respect to listed drugs, 
including medical gases, homeopathic products, products

[[Page 60251]]

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 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 ``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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA.
    The regulatory citations and associated collections of information 
that OMB approved are as follows:
     Registrants who own or operate a domestic or foreign 
establishment that manufactures, prepares, propagates, compounds, or 
processes a drug must submit to FDA information on the amount of listed 
drugs that they manufacture, prepare, propagate, compound, or process. 
Registrants must submit information on the following listed drugs: (1) 
Finished dosage form products, (2) drug products with active 
pharmaceutical ingredients, and (3) other listed drugs. The collection 
of information under section 510(j)(3) of the FD&C Act (as added by 
section 3112 of the CARES Act) on the amount of listed drug products 
has been approved under OMB control number 0910-0045. FDA is developing 
an electronic portal for registrants to submit this information.
     FDA requires that applicants submit annual reports for 
abbreviated new drug applications, biologics license applications, and 
new drug applications. The collections of information in parts 314 and 
601 have been approved under OMB control numbers 0910-0001 and 0910-
0338.

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.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23722 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P