Notice2022-02348
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling-Content and Format; Draft Guidance for Industry; Availability
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Published
February 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format." This draft guidance provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. Appropriate inclusion and consistent placement of immunogenicity information in the Prescribing Information helps to make clinically relevant information accessible to the health care practitioner and promotes the safe and effective use of prescription drug and biological products. When finalized, the recommendations in this guidance will supersede the immunogenicity labeling-specific recommendations in the guidances for industry entitled "Labeling for Biosimilar Products" and "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format."
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6574-6575]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02348]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1041]
Immunogenicity Information in Human Prescription Therapeutic
Protein and Select Drug Product Labeling--Content and Format; Draft
Guidance for Industry; Availability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 the Agency) is
announcing the availability of a draft guidance for industry entitled
``Immunogenicity Information in Human Prescription Therapeutic Protein
and Select Drug Product Labeling--Content and Format.'' This draft
guidance provides recommendations for incorporating clinically relevant
immunogenicity information into the labeling of products having
immunogenicity assessments. Appropriate inclusion and consistent
placement of immunogenicity information in the Prescribing Information
helps to make clinically relevant information accessible to the health
care practitioner and promotes the safe and effective use of
prescription drug and biological products. When finalized, the
recommendations in this guidance will supersede the immunogenicity
labeling-specific recommendations in the guidances for industry
entitled ``Labeling for Biosimilar Products'' and ``Clinical
Pharmacology Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format.''
DATES: Submit either electronic or written comments on the draft
guidance by April 5, 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:
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-1041 for ``Immunogenicity Information in Human Prescription
Therapeutic Protein and Select Drug Product Labeling--Content and
Format.'' 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; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
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: Eric Brodsky, Center for Drug
Evaluation and Research, Food and Drug
[[Page 6575]]
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6485, Silver
Spring, MD 20993, 301-796-0855; or 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Immunogenicity Information in Human Prescription Therapeutic
Protein and Select Drug Product Labeling--Content and Format.''
Evaluation of a therapeutic protein product's and certain select
drug products' immunogenicity (e.g., risk of developing anti-drug
antibodies, including neutralizing antibodies) and its potential
clinical impact generally plays an important role in the assessment of
the product's safety and effectiveness for each proposed indication.
Because some, but not all, anti-drug antibodies have been associated
with safety concerns or loss of effectiveness, FDA believes that
presenting immunogenicity information in a consistent manner would
enable health care practitioners to more easily differentiate products
associated with anti-drug antibodies having clinical effect(s) from
products with anti-drug antibodies that do not have a clinically
meaningful effect on pharmacokinetics, pharmacodynamics, safety, or
effectiveness.
This draft guidance recommends the use of a dedicated
Immunogenicity subsection (subsection 12.6) under the CLINICAL
PHARMACOLOGY section. Information and statements to include in this
subsection (e.g., data on anti-drug antibody incidence, clinical
pharmacologic effects of anti-drug antibodies) are described in the
draft guidance, along with recommended content to include in other
sections of the labeling (e.g., summary of anti-drug antibody-
associated effects on safety and/or effectiveness in the WARNINGS AND
PRECAUTIONS, ADVERSE REACTIONS, and/or CLINICAL STUDIES sections, as
applicable). The labeling recommendations are based on: (1) Adequacy of
the methodology for detection of anti-drug antibodies, (2) sufficiency
of available data to draw clinical conclusions, and (3) whether the
anti-drug antibodies have clinically significant effect(s). In addition
to recommendations on presentation of known immunogenicity information,
this draft guidance also provides recommendations for consistently
stating when such information is unknown, if appropriate. The draft
guidance also provides procedural information, including
recommendations for updating immunogenicity information in the
Prescribing Information of applicable approved products.
When finalized, this guidance will supersede the immunogenicity
labeling-specific recommendations from the guidance for industry
entitled ``Clinical Pharmacology Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format''
(available at <a href="https://www.fda.gov/media/74346/download">https://www.fda.gov/media/74346/download</a>). When
finalized, this guidance will also supersede the recommendations in
section IV.C.3., ADVERSE REACTIONS, Immunogenicity, of the guidance for
industry entitled ``Labeling for Biosimilar Products'' (available at
<a href="https://www.fda.gov/media/96894/download">https://www.fda.gov/media/96894/download</a>), including the statement
``Immunogenicity information for therapeutic protein products is
usually placed in a subsection in the ADVERSE REACTIONS section
entitled Immunogenicity'' and statements recommended for inclusion as
the first paragraph in the ADVERSE REACTIONS subsection that precedes
the immunogenicity data. FDA has verified the website addresses as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
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
``Immunogenicity Information in Human Prescription Therapeutic Protein
and Select Drug Product Labeling--Content and Format.'' 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 new 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 collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 600
have been approved under OMB control number 0910-0308. The collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572. The
collections of information related to pharmacology data have been
approved under OMB control number 0910-0014. The collections of
information submitting biologics license applications under section
351(k) of the Public Health Service Act have been approved under OMB
control number 0910-0719.
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/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</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>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: January 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02348 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P
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