Notice2021-23722
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Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
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Published
November 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act." This draft guidance addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared,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).
Full Text
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<title>Federal Register, Volume 86 Issue 208 (Monday, November 1, 2021)</title>
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[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60249-60251]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Reporting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 This draft guidance addresses the process through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DATES: Submit either electronic or written comments on the draft
guidance by January 3, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 FD&C Act.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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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:
<bullet> 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.
<bullet> 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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