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Injectors Submitted Under a Biologics License Application, New Drug Application, or Abbreviated New Drug Application; Draft Guidance for Industry and Food and Drug Administration; Availability, 22427-22429 [2020-08466]
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Federal Register / Vol. 85, No. 78 / Wednesday, April 22, 2020 / Notices
Availability of Rapid COVID–19 Testing
Since the March 20, 2020 Order, rapid
testing for COVID–19 has been
developed that can provide results in
approximately 15 minutes and
manufacturers are currently ramping up
production and distribution of rapid
COVID–19 testing.21 Although rapid
COVID–19 testing could ameliorate
some of the public health concerns
associated with congregate detention in
DHS border facilities, rapid COVID–19
testing is not yet widely available, and
demand outstrips supply. Moreover,
once it is available, rapid COVID–19
testing should be prioritized to certain
key locations, such as hospitals treating
high numbers of COVID–19 patients,
where the ability to quickly determine
whether doctors and nurses have been
infected with COVID–19 could increase
the availability of care providers by
eliminating the need for these
individuals to self-isolate while
awaiting test results.
khammond on DSKJM1Z7X2PROD with NOTICES
Determination and Implementation
Based on the foregoing, I find that the
global presence of COVID–19, including
in Canada, Mexico, still presents a
danger of further introduction of
COVID–19 into the United States. This
is true notwithstanding the community
transmission of COVID–19 in many
locations across the United States. There
are many locations in the United States
the COVID–19 Pandemic (Mar. 20, 2020), available
at https://www.dhs.gov/news/2020/03/20/jointstatement-us-mexico-joint-initiative-combat-covid19-pandemic.
21 For instance, on March 27, 2020, Abbott
received emergency use authorization from the U.S.
Food and Drug Administration (‘‘FDA’’) for the
fastest available point-of-care test for COVID–19.
Abbott, ‘‘Detect COVID–19 in as Little as 5
Minutes’’ (Mar. 27, 2020), https://www.abbott.com/
corpnewsroom/product-and-innovation/detectcovid-19-in-as-little-as-5-minutes.html; see
generally U.S. Food and Drug Administration,
Emergency Use Authorizations, https://
www.fda.gov/medical-devices/emergencysituations-medical-devices/emergency-useauthorizations#covid19ivd. Rapid COVID–19
testing will significantly reduce the time needed to
confirm a suspected diagnosis of COVID–19, which
currently may take as long as three to four days. See
CDC, Order Suspending Introduction of Certain
Persons from Countries where a Communicable
Disease Exists (Mar. 20, 2020), available at https://
www.cdc.gov/quarantine/pdf/CDC-OrderProhibiting-Introduction-of-Persons_Final_3-20-20_
3-p.pdf; see also CDC, Interim Guidelines for
Collecting, Handling, and Testing Clinical
Specimens from Persons for Coronavirus Disease
2019 (COVID–19) (updated Apr. 8, 2020), https://
www.cdc.gov/coronavirus/2019-nCoV/lab/
guidelines-clinical-specimens.html. When a case of
COVID–19 is suspected, the sooner that
confirmatory test results are available, the more
quickly treatment and isolation and quarantine
measures can be implemented, lowering the risk of
infecting others. See CDC, Evaluating and Testing
Persons for Coronavirus Disease 2019 (COVID–19)
(updated Mar. 24, 2020), https://www.cdc.gov/
coronavirus/2019-nCoV/hcp/clinical-criteria.html.
VerDate Sep<11>2014
17:59 Apr 21, 2020
Jkt 250001
near our borders with Canada and
Mexico that have not yet experienced
widespread community transmission.
The on-going COVID–19 pandemic,
including in Canada and Mexico,
remains a serious danger to such
locations.
In the March 20, 2020 Order, I found
the risks troubling partly because
outbreaks of COVID–19 in POEs or
Border Patrol stations would lead U.S.
Customs and Border Protection to
transfer persons with acute
presentations of illness to local or
regional healthcare providers for
treatment, which would exhaust the
local or regional healthcare resources or
at least reduce the availability of such
resources to the domestic population,
and further expose local or regional
healthcare workers to COVID–19.
Millions of Americans are complying
with local and state stay-at-home orders,
engaging in social distancing, and taking
other precautions calculated to slow the
spread, protect others, and relieve the
strain on the healthcare system. Their
efforts would be significantly
undermined if outbreaks of COVID–19
in land POEs or Border Patrol stations
crippled the DHS workforce and local or
regional healthcare systems.
I consulted with DHS before issuing
this Order and requested that DHS
continue to implement the March 20,
2020 Order because CDC does not have
the capability, resources, or personnel
needed to alternatively issue quarantine
or isolation orders.22
The March 20, 2020 Order shall
remain in effect until 11:59 p.m. EDT on
May 20, or until I determine that the
danger of further introduction of
COVID–19 into the United Sates has
ceased to be a serious danger to the
public health, whichever is sooner. I
may further amend or extend the March
20, 2020 Order as needed to protect the
public health.
This Order is not a rule subject to
notice and comment under the
Administrative Procedure Act (APA). In
the event this order qualifies as a rule
subject to notice and comment, a delay
in effective date are not required
because there is good cause to dispense
with prior public notice and the
22 As previously discussed in the March 20, 2020
Order, CDC relies on the Department of Defense,
other federal agencies, and state and local
governments to provide both logistical support and
facilities for federal quarantines. See 42 U.S.C.
268(b) (requiring customs officers to aid in the
enforcement of quarantine regulations). CDC lacks
the resources, staffing, and facilities to quarantine
covered aliens. Similarly, DHS has informed CDC
that in the near term, it is not financially or
logistically practicable for DHS to build additional
facilities at POEs and Border Patrol stations for
purposes of quarantine or isolation.
PO 00000
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22427
opportunity to comment on this order
and a delay in effective date.23 Given
the public health emergency caused by
COVID–19, it would be impracticable
and contrary to the public health—and,
by extension, the public interest—to
delay the issuing and effective date of
this order. In addition, because this
order concerns ongoing discussions
with Canada and Mexico on how to best
control COVID–19 transmission over
our shared borders, it directly
‘‘involve[s] . . . a . . . foreign affairs
function of the United States.’’ 5 U.S.C.
553(a)(1). Notice and comment and a
delay in effective date would not be
required for that reason as well.
*
*
*
*
*
The March 20, 2020 Order shall
remain in effect until 11:59 p.m. EDT on
May 20, 2020.
Authority
The authority for these orders is
Sections 362 and 365 of the Public
Health Service Act (42 U.S.C. 265, 268)
and 42 CFR 71.40.
Dated: April 19, 2020.
Robert K. McGowan,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2020–08605 Filed 4–20–20; 9:00 am]
BILLING CODE 4163–18–P
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.
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 EmergencyUse 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
SUMMARY:
23 See
E:\FR\FM\22APN1.SGM
5 U.S.C. 553(b)(B) and (d)(3).
22APN1
22428
Federal Register / Vol. 85, No. 78 / Wednesday, April 22, 2020 / Notices
intended. This is particularly critical for
drugs when failure of the injector may
prevent adequate delivery of a lifesaving 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:
khammond on DSKJM1Z7X2PROD with 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’’).
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–
VerDate Sep<11>2014
17:59 Apr 21, 2020
Jkt 250001
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-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.
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,
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
combination@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
entitled ‘‘Technical Considerations for
Demonstrating Reliability of EmergencyUse 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 emergencyuse 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 emergencyuse 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).
E:\FR\FM\22APN1.SGM
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Federal Register / Vol. 85, No. 78 / Wednesday, April 22, 2020 / Notices
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Technical Considerations for
Demonstrating Reliability of EmergencyUse 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.
III. Electronic Access
khammond on DSKJM1Z7X2PROD with NOTICES
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/combination-productsguidance-documents or https://
www.regulations.gov.
Dated: April 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:42 Apr 21, 2020
Jkt 250001
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
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–
2018–D–4711 for ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments.’’ 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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
[Docket No. FDA–2018–D–4711]
Nonbinding Feedback After Certain
Food and Drug Administration
Inspections of Device Establishments;
Guidance for Industry and Food and
Drug Administration Staff; Availability
Food and Drug Administration,
HHS.
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.
[FR Doc. 2020–08466 Filed 4–21–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
II. Paperwork Reduction Act of 1995
22429
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments.’’ FDA is
issuing this guidance to comply with
the FDA Reauthorization Act of 2017
(FDARA), which amended the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). This guidance identifies a
standardized method for
communicating and submitting requests
for nonbinding feedback and describes
how FDA evaluates and responds to
such requests.
DATES: The announcement of the
guidance is published in the Federal
Register on April 22, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
