Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act, 59395-59397 [2021-23396]

Download as PDF Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved NDA 211673 for marketing the human drug product, XENLETA injection (lefamulin), which is indicated for the treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms. Subsequent to this approval, the USPTO received patent term restoration applications for XENLETA injection (U.S. Patent Nos. 8,071,643 and 8,153,689) from Nabriva Therapeutics GMBH, and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated October 13, 2020, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approvals of XENLETA injection and XENLETA tablets represent the first permitted commercial marketing or use of the products. Thereafter, the USPTO requested that FDA determine the products’ regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for XENLETA injection is 3,595 days. Of this time, 3,351 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 17, 2009. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 17, 2009. VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 2. The date the new drug application (NDA 211673) was initially submitted with respect to the human drug product under section 505 of the FD&C Act: December 19, 2018. FDA has verified the applicant’s claims that the new drug application (NDA) for XENLETA injection (NDA 211673) was initially submitted on December 19, 2018. 3. The date the application was approved: August 19, 2019. FDA has verified the applicant’s claims that NDA 211673 was approved on August 19, 2019. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,465 days or 1,528 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 15, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23386 Filed 10–26–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 59395 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. 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. SUMMARY: 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. DATES: 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. ADDRESSES: E:\FR\FM\27OCN1.SGM 27OCN1 59396 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices 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’’). lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 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-201509-18/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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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. E:\FR\FM\27OCN1.SGM 27OCN1 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices 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 wellestablished 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 lotter on DSK11XQN23PROD with NOTICES1 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. 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. VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 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 § 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 § 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 § 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. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 59397 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–E–1902; FDA– 2020–E–1903; and FDA–2020–E–1904] Determination of Regulatory Review Period for Purposes of Patent Extension; INREBIC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INREBIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. SUMMARY: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by December 27, 2021. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 25, 2022. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 DATES: E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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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