[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59395-59397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 
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.

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:
     Blood and blood components for transfusion; and
     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.

[[Page 59397]]

    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 https://doi.org/10.1111/trf.16449. 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


