[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Notices]
[Pages 22427-22429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08466]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5573]
Technical Considerations for Demonstrating Reliability of
Emergency-Use Injectors Submitted Under a Biologics License
Application, New Drug Application, or Abbreviated New Drug Application;
Draft Guidance for Industry and Food and Drug Administration;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry and FDA entitled
``Technical Considerations for Demonstrating Reliability of Emergency-
Use Injectors Submitted under a BLA, NDA or ANDA.'' For injectable drug
or biological products that are intended to treat emergent, life-
threatening conditions, it is essential to ensure that the emergency-
use injector will reliably deliver the drug or biological product as
[[Page 22428]]
intended. This is particularly critical for drugs when failure of the
injector may prevent adequate delivery of a life-saving drug to a
patient. The draft guidance describes the technical considerations for
demonstrating reliability of emergency-use injectors under a biologics
license application (BLA), new drug application (NDA), or abbreviated
new drug application (ANDA).
DATES: Submit either electronic or written comments on the draft
guidance by June 22, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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-2019-D-5573 for ``Technical Considerations for Demonstrating
Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or
ANDA: Guidance for Industry and FDA.'' Received comments 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.
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.
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: Patricia Love, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20993, 301-796-8930,
[email protected] or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA entitled ``Technical Considerations for Demonstrating
Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or
ANDA.'' For injectable drug or biological products that are intended to
treat emergent, life-threatening conditions, it is essential to ensure
that the injector will reliably deliver the drug or biological product
as intended. This is particularly critical for drugs when failure of
the emergency-use injector may prevent adequate delivery of a life-
saving drug to a patient. This guidance's focus is emergency-use
injectors marketed with the emergency-use drug/biological product as a
prefilled single entity combination product or as a co-packaged
combination product assigned to the Center for Drug Evaluation and
Research or the Center for Biologics Evaluation and Research with
market authorization under an approved NDA, ANDA, or BLA.
The draft guidance describes the technical considerations for
demonstrating reliability of emergency-use injectors under an NDA,
ANDA, or BLA. For purposes of the draft guidance, reliability is
defined as the probability that the injector will perform as intended,
without failure, for a given time interval under specified conditions.
The document describes information and data that FDA recommends be
included in marketing applications to demonstrate that an emergency-use
injector is reliable, including the details of an example of an
acceptable approach for the mathematical model, statistics, fault tree
analysis, and use of certain current good manufacturing practice
requirements for combination products (21 CFR 4.4(b)(1)(ii) and (iv))
to establish reliability of the emergency-use injector.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115).
[[Page 22429]]
The draft guidance, when finalized, will represent the current thinking
of FDA on ``Technical Considerations for Demonstrating Reliability of
Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.'' 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
This draft guidance refers to currently approved FDA collections of
information. These collections of information 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). The collections of information in 21
CFR part 314 for NDAs have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR part 601 for BLAs have
been approved under OMB control number 0910-0338. The collections of
information in 21 CFR part 814, subpart B, for premarket approval
applications have been approved under OMB control number 0910-0231. The
collections of information section 510(k) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(k)), subpart E for 510(k)
notifications, have been approved under OMB control number 0910-0120.
The collections of information in the guidance for industry and FDA
staff entitled ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844. The collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents or https://www.regulations.gov.
Dated: April 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08466 Filed 4-21-20; 8:45 am]
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