Notice2021-16175
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis; Draft Guidance for Industry; Availability
Primary source
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Published
July 29, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis." The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of post-exposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal.
Full Text
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<title>Federal Register, Volume 86 Issue 143 (Thursday, July 29, 2021)</title>
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[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40851-40853]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16175]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0519]
Rabies: Developing Monoclonal Antibody Cocktails for the Passive
Immunization Component of Post-Exposure Prophylaxis; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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[[Page 40852]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Rabies:
Developing Monoclonal Antibody Cocktails for the Passive Immunization
Component of Post-Exposure Prophylaxis.'' The purpose of this draft
guidance is to help sponsors in the development of anti-rabies virus
monoclonal antibody (mAb) cocktails as an alternative to anti-rabies
virus immunoglobulin (RIG) as the passive immunization component of
post-exposure prophylaxis (PEP) for the prevention of rabies when given
immediately after contact with a rabid or possibly rabid animal.
DATES: Submit either electronic or written comments on the draft
guidance by September 27, 2021 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-0519 for ``Rabies: Developing Monoclonal Antibody Cocktails
for the Passive Immunization Component of Post-Exposure Prophylaxis.''
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. 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: Stephanie Troy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6381, Silver Spring, MD 20993-0002, 240-
402-4656.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Rabies: Developing Monoclonal Antibody Cocktails for the
Passive Immunization Component of Post-Exposure Prophylaxis.'' The
purpose of this draft guidance is to help sponsors in the development
of anti-rabies virus mAb cocktails as an alternative to RIG as the
passive immunization component of PEP for the prevention of rabies when
given immediately after contact with a rabid or possibly rabid animal.
Because of the unique complexities of drug development in this area,
extensive discussion with multiple stakeholders has taken place,
including a public workshop in 2017 and an advisory committee meeting
in 2019. These discussions helped FDA formulate the considerations for
rabies mAb cocktail development that are described in this draft
guidance.
The draft guidance addresses the following topics:
<bullet> Considerations when selecting the mAbs included in the
cocktail
<bullet> The nonclinical and clinical data needed to support
clinical trials of the mAb cocktail in potentially rabies virus-exposed
subjects
<bullet> The clinical data recommended to support an initial
biologics license application submission of the mAb cocktail for a
second-line indication in situations where human-derived RIG is not
available
<bullet> The clinical data recommended to support a first-line
indication for the mAb cocktail
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 ``Rabies:
Developing Monoclonal
[[Page 40853]]
Antibody Cocktails for the Passive Immunization Component of Post-
Exposure Prophylaxis.'' 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 collections
of information associated with submissions of content and format of
labeling for drugs and biologics in 21 CFR 201.56 and 201.57 have been
approved under OMB control number 0910-0572; the collections of
information associated with submissions of investigational new drug
applications in 21 CFR part 312 have been approved under OMB control
numbers 0910-0014; the collections of information associated with
submissions of applications for approval to market a new drug in 21 CFR
part 314 have been approved under 0910-0001; the collections of
information associated with the reporting and recordkeeping of
postmarketing adverse drug experiences have been approved under OMB
control numbers 0910-0001, 0910-0230, 0910-0291, and 0910-0645; and the
collections of information associated with general licensing provisions
for biologics in 21 CFR part 601 have been approved under OMB control
number 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/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: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16175 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P
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