[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Draft Guidance for Industry and Food and Drug Administration; 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the availability of a draft guidance for industry and FDA entitled 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 The draft guidance describes the technical considerations for 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DATES: Submit either electronic or written comments on the draft 
guidance by June 22, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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, 
patricia.love@fda.hhs.gov or d5b6bab8b7bcbbb4a1bcbabb95b3b1b4fbb2baa3.

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]
BILLING CODE 4164-01-P


