Notice2021-23396
Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
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Published
October 27, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is proposing to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution; however, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. FDA is proposing to exempt the two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health.
Full Text
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<title>Federal Register, Volume 86 Issue 205 (Wednesday, October 27, 2021)</title>
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[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59395-59397]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23396]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1043]
Exemption of Certain Categories of Biological Products From
Certain Reporting Requirements Under the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
proposing to exempt certain categories of biological products from
certain reporting requirements under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act). Specifically, each person who
registers with FDA with regard to a drug is required to report annually
to FDA on the amount of each listed drug that was manufactured,
prepared, propagated, compounded, or processed by such person for
commercial distribution; however, certain biological products or
categories of biological products may be exempted by order from these
reporting requirements if FDA determines that applying such reporting
requirements is not necessary to protect the public health. FDA is
proposing to exempt the two categories of biological products from
these reporting requirements because the Agency has determined that
applying such requirements is not necessary to protect the public
health.
DATES: Submit either electronic or written comments on the proposed
order by December 27, 2021. Please see section IV of this document for
the proposed effective date when the exemptions apply and for the
proposed effective date of a final order based on this proposed order.
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 December 27, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 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.
[[Page 59396]]
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-N-1043 for ``Exemption of Certain Categories of Biological
Products from Certain Reporting Requirements Under the Federal Food,
Drug, and Cosmetic Act.'' 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
<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.
FOR FURTHER INFORMATION CONTACT: Sana F. Hussain, 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.
SUPPLEMENTARY INFORMATION:
I. Background--Reporting Requirements Under Section 510(j)(3) of the
FD&C Act
On March 27, 2020, the CARES Act (Pub. L. 116-136) was enacted to
aid response efforts and ease the economic impact of the Coronavirus
Disease 2019. In addition, the CARES Act included authorities to
enhance FDA's ability to identify, prevent, and mitigate possible drug
shortages by, among other things, enhancing FDA's visibility into drug
supply chains.
Section 3112(e) of the CARES Act added new paragraph (j)(3) to
section 510 of the FD&C Act (21 U.S.C. 360(j)(3)), which requires that
each person who registers with FDA under section 510 of the FD&C Act
with regard to a drug must report annually to FDA on the amount of each
listed drug that was manufactured, prepared, propagated, compounded, or
processed by such person for commercial distribution. FDA anticipates
that these reporting requirements in section 510(j)(3)(A) of the FD&C
Act will enhance FDA's ability to anticipate and react expeditiously to
drug shortages by enabling the Agency to quickly identify all
manufacturing sites impacted, analyze potential bottlenecks, and
develop options to remediate shortage risks to the product supply
chain.
Under section 510(j)(3)(B) of the FD&C Act, FDA may exempt certain
biological products or categories of biological products regulated
under section 351 of the Public Health Service Act (42 U.S.C. 262) from
some or all of the reporting requirements under section 510(j)(3)(A) of
the FD&C Act, if FDA determines that applying such reporting
requirements is not necessary to protect the public health.
II. Categories of Biological Products Proposed for Exemption
FDA is proposing to exempt the following two categories of
biological products from all of the reporting requirements under
section 510(j)(3)(A) of the FD&C Act pursuant to section 510(j)(3)(B)
of the FD&C Act because FDA has determined that applying such reporting
requirements is not necessary to protect the public health:
<bullet> Blood and blood components for transfusion; and
<bullet> Cell and gene therapy products, where one lot treats a
single patient.
1. Blood and Blood Components for Transfusion
In accordance with section 510(j)(3)(B) of the FD&C Act, FDA is
proposing to exempt blood and blood components for transfusion from the
reporting requirements under section 510(j)(3)(A) of the FD&C Act. In
light of FDA's existing visibility into the supply chain for this
category of products, requiring registrants to report annually under
section 510(j)(3)(A) of the FD&C Act on the amount of such products
manufactured, prepared, propagated, compounded, or processed for
commercial distribution is not needed to enhance the Agency's ability
to identify, prevent, and mitigate possible shortages. As such, FDA has
determined that applying the reporting requirements under section
510(j)(3)(A) of the FD&C Act to this category of biological products is
not necessary to protect the public health.
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Generally, registered blood establishments are inspected on a
biennial basis by the Agency. There are approximately 1,900 registered
blood establishments that manufacture blood and blood components for
transfusion, all located in the United States, except a small number of
United States military blood establishments that are located
internationally in order to provide blood and blood components to
United States military personnel onsite when needed. The supply chains
for blood and blood components for transfusion are well-established and
well-understood based on the nature of the products; namely, blood is
collected from human donors via venipuncture, separated into components
(if applicable), and stored at specified temperatures and under the
complete control of each blood establishment. Additionally, supply
chains for blood and blood components for transfusion are controlled
and secure from initial donation to final product delivery to the
transfusion site and, generally, do not involve wholesale distributors,
brokers, or other intermediaries. Further, many registered blood
establishments voluntarily submit the amount of blood and blood
components for transfusion manufactured as part of the Health and Human
Services National Blood Collection and Utilization Survey (NBCUS),
which, historically, has a high response rate.\1\
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\1\ See <a href="https://doi.org/10.1111/trf.16449">https://doi.org/10.1111/trf.16449</a>. The response rate for
the 2019 NBCUS was 94 percent for community-based blood collection
facilities and 84 percent for hospital-based blood collection
facilities.
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2. Cell and Gene Therapy Products, Where One Lot Treats a Single
Patient
In accordance with section 510(j)(3)(B) of the FD&C Act, FDA is
proposing to exempt cell and gene therapy products, where one lot
treats a single patient, from the reporting requirements under section
510(j)(3)(A) of the FD&C Act. In light of FDA's existing visibility
into the supply chain for this category of products, requiring
registrants to report annually under section 510(j)(3)(A) of the FD&C
Act on the amount of such products manufactured, prepared, propagated,
compounded, or processed for commercial distribution, is not needed to
enhance the Agency's ability to identify, prevent, and mitigate
possible shortages. As such, FDA has determined that applying the
reporting requirements under section 510(j)(3)(A) of the FD&C Act to
this category of biological products is not necessary to protect the
public health.
Manufacturers of cell and gene therapy products, where one lot
treats a single patient, maintain a highly controlled and secure supply
chain from initial request for treatment of a patient to final product
delivery to the site where the treatment occurs. This is because, due
to the nature of these products, manufacturers implement strict chain
of identity procedures to track products through the manufacturing
process, to make sure the correct product gets to the correct patient.
Additionally, the supply chains for these products are well-established
and well-understood from information described in the biologics license
application (BLA), and generally do not involve wholesale distributors,
brokers, or other intermediaries.
Additionally, pursuant to Sec. 600.81 (21 CFR 600.81), the Agency
generally receives lot distribution reports every 6 months from BLA
holders. Specifically, reports submitted to the Agency under Sec.
600.81 include, among other information, the fill lot numbers for the
total number of dosage units of each strength or potency distributed,
the label lot number (if different from fill lot number), the number of
doses in fill lot/label lot, and the date of release of fill lot/label
lot for distribution. For this category of biological products, since
one lot treats a single patient, the lot distribution reports submitted
to the Agency under Sec. 600.81 represent the amount of product
manufactured for commercial distribution, and additional reporting of
such information under section 510(j)(3)(A) of the FD&C Act would be
redundant.
III. Paperwork Reduction Act of 1995
This proposed order contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Information collection associated with section 510(j)(3) of the FD&C
Act, requiring each person who registers with FDA with regard to a drug
to report annually to FDA on the amount of each listed drug that was
manufactured, prepared, propagated, compounded, or processed by such
person for commercial distribution, is approved under OMB control
number 0910-0045. If finalized, we believe the order will reduce burden
associated with the approved information collection by exempting these
biological product categories from such reporting requirements. We
invite comment on our assumptions.
IV. Proposed Effective Date
FDA proposes that any final order based on this proposed order
become effective 30 days after its date of publication in the Federal
Register.
Dated: October 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23396 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P
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