Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Emergency Use Authorization of Medical Products and Related Authorities, 13299-13302 [2019-06553]
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FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
QVAR 40 and QVAR 80
(beclomethasone dipropionate HFA)
inhalation aerosol, 40 mcg and 80 mcg,
are the subject of NDA 020911, held by
TEVA Branded Pharmaceutical Products
R&D, Inc. (TEVA), and initially
approved on September 15, 2000. QVAR
40 and QVAR 80 are indicated for the
maintenance treatment of asthma as a
prophylactic therapy in patients 5 years
of age and older.
Aurolife Pharma LLC submitted a
citizen petition dated September 6, 2018
(Docket No. FDA–2018–P–3412), under
21 CFR 10.30, requesting that the
Agency determine whether QVAR 40
and QVAR 80 (beclomethasone
dipropionate HFA) inhalation aerosol,
40 mcg and 80 mcg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that QVAR 40 and QVAR 80
(beclomethasone dipropionate HFA)
inhalation aerosol, 40 mcg and 80 mcg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that QVAR 40
and QVAR 80 (beclomethasone
dipropionate HFA) inhalation aerosol,
40 mcg and 80 mcg, were withdrawn for
reasons of safety or effectiveness. In
addition, the petitioner provided
information indicating that TEVA made
a business decision to discontinue
manufacturing of these drug products.
We have carefully reviewed our files for
records concerning the withdrawal of
QVAR 40 and QVAR 80
(beclomethasone dipropionate HFA)
inhalation aerosol, 40 mcg and 80 mcg,
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from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that these
drug products were not withdrawn from
sale for reasons of safety or
effectiveness.
Accordingly, the Agency will
continue to list QVAR 40 and QVAR 80
(beclomethasone dipropionate HFA)
inhalation aerosol, 40 mcg and 80 mcg,
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to QVAR 40 and QVAR 80
(beclomethasone dipropionate HFA)
inhalation aerosol, 40 mcg and 80 mcg,
may be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06552 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0976]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance:
Emergency Use Authorization of
Medical Products and Related
Authorities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
SUMMARY:
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13299
solicits comments on the proposed
extension of the collection of
information related to emergency use
authorizations by the Agency.
DATES: Submit either electronic or
written comments on the collection of
information by June 3, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 3, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 3, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0976 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Guidance: Emergency Use
Authorization of Medical Products and
Related Authorities.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
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Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance: Emergency Use
Authorization of Medical Products and
Related Authorities
OMB Control Number 0910–0595—
Extension
The guidance describes the Agency’s
policies applicable to the authorization
of the emergency use of certain medical
products under sections 564, 564A, and
564B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360bbb–3, 360bbb–3a, and 360bbb–3b),
as amended or added by the Project
BioShield Act of 2004 (Pub. L. 108–
276), the Pandemic and All-Hazards
Preparedness Reauthorization Act of
2013 (Pub. L. 113–5), 21st Century
Cures Act (Pub. L. 114–255), and Public
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Law 115–92 (2017). The FD&C Act
permits the Commissioner to authorize
the use of unapproved medical products
or unapproved uses of approved
medical products during an emergency
declared under section 564 of the FD&C
Act. The data to support issuance of an
emergency use authorization (EUA)
must demonstrate that, based on the
totality of the scientific evidence
available to the Commissioner,
including data from adequate and wellcontrolled clinical trials (if available), it
is reasonable to believe that the product
may be effective in diagnosing, treating,
or preventing a serious or lifethreatening disease or condition (21
U.S.C. 360bbb–3(c)). Although the exact
type and amount of data needed to
support an EUA may vary depending on
the nature of the declared emergency
and the nature of the candidate product,
FDA recommends that a request for
consideration for an EUA include
scientific evidence evaluating the
product’s safety and effectiveness,
including the adverse event profile for
diagnosis, treatment, or prevention of
the serious or life-threatening disease or
condition, as well as data and other
information on safety, effectiveness,
risks and benefits, and (to the extent
available) alternatives.
Under section 564 of the FD&C Act,
the FDA Commissioner may establish
conditions on the authorization. Section
564(e) requires the FDA Commissioner
(to the extent practicable given the
circumstances of the emergency) to
establish certain conditions on an
authorization that the Commissioner
finds necessary or appropriate to protect
the public health and permits the FDA
Commissioner to establish other
conditions that he or she finds
necessary or appropriate to protect the
public health. Conditions authorized by
section 564(e) of the FD&C Act include,
for example: Requirements for
information dissemination to healthcare
providers or authorized dispensers and
product recipients; adverse event
monitoring and reporting; data
collection and analysis; recordkeeping
and records access; restrictions on
product advertising, distribution, and
administration; and limitations on good
manufacturing practices requirements.
Some conditions, the statute specifies,
are mandatory to the extent practicable
for authorizations of unapproved
products and discretionary for
authorizations of unapproved uses of
approved products. Moreover, some
conditions may apply to manufacturers
of an EUA product, while other
conditions may apply to any person
who carries out any activity for which
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the authorization is issued. Section 564
of the FD&C Act also gives the FDA
Commissioner authority to establish
other conditions on an authorization
that he or she finds to be necessary or
appropriate to protect the public health.
Additionally, sections 564A and 564B
established streamlined mechanisms to
facilitate preparedness and response
activities involving certain FDAapproved products without requiring
FDA to issue an EUA, including
expiration date extension authority.
For purposes of estimating the annual
burden of reporting (table 1), FDA has
established four categories of
respondents: (1) Those who file a
request for FDA to issue an EUA or a
substantive amendment to an EUA that
has previously been issued, assuming
that a requisite declaration under
section 564 of the FD&C Act has been
made and criteria for issuance have
been met; (2) those who submit a
request for FDA to review information/
data (i.e., a pre-EUA package) for a
candidate EUA product or a substantive
amendment to an existing pre-EUA
package for preparedness purposes; (3)
manufacturers who carry out an activity
related to an unapproved EUA product
(e.g., administering product,
disseminating information) who must
report to FDA regarding such activity;
and (4) public health authorities (e.g.,
State, local) who carry out an activity
(e.g., administering product,
disseminating information) related to an
unapproved EUA product who must
report to FDA regarding such activity or
who submit to FDA an expiration date
extension request for an approved
product.
In some cases, manufacturers directly
submit EUA requests. Often a Federal
Government entity (e.g., Centers for
Disease Control and Prevention,
Department of Defense) requests that
FDA issue an EUA and submits preEUA packages for FDA to review. In
many of these cases, manufacturer
respondents inform these requests and
submissions, which are the activities
that form the basis of the estimated
reporting burdens. However, in some
cases the Federal Government is the sole
respondent; manufacturers do not
inform these requests or submissions.
FDA estimates minimal burden when
the Federal Government performs the
relevant activities. In addition to
variability based on whether there is an
active manufacturer respondent, other
factors also inject significant variability
in estimates for annual reporting
burdens. A second factor is the type of
product. For example, FDA estimates
greater burden for novel therapeutics
than for certain unapproved uses of
approved products. A third significant
factor that injects variability is the type
of submission. For example, FDA
estimates greater burden for ‘‘original’’
EUA and pre-EUA submissions than for
amendments to them, and FDA
estimates minimal burden to issue an
EUA when there is a previously
reviewed pre-EUA package or
investigational application. For
purposes of estimating the reporting
burden, FDA has calculated the
anticipated burden on manufacturers
based on the anticipated types of
responses (i.e., estimated manufacturer
input), types of product, and types of
submission that comprise the described
reporting activities.
For purposes of estimating the annual
burden of recordkeeping, FDA has also
calculated the anticipated burden on
manufacturers and public health
officials associated with administration
of unapproved products authorized for
emergency use, recognizing that the
Federal Government will perform much
of the recordkeeping related to
administration of such products (table
2). FDA is not calculating any
recordkeeping burden for public health
authorities who may need to submit
expiration date extension requests, as
these entities already maintain records
for the products that they stockpile,
which would include records of any
expiration date request or extension.
The guidance refers to previously
approved collections of information.
These collections are subject to review
by the OMB under the PRA. These
collections have been approved as
follows: Adverse experience reporting
for biological products is approved
under OMB control number 0910–0308;
adverse drug experience reporting is
approved under OMB control number
0910–0230; adverse device experience
reporting is approved under OMB
control number 0910–0471;
investigational new drug (IND)
application regulations are approved
under OMB control number 0910–
0014and investigational device
exemption (IDE) reporting is approved
under OMB control number 0910–0078;
current good manufacturing practices
for finished pharmaceuticals are
approved under OMB control number
0910–0139, and for devices under OMB
control number 0910–0073; applications
for marketing a new drug are approved
under OMB control number 0910–0001,
and for biological products under OMB
control number. Any additional burden
imposed by this proposed collection
would be minimal.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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Requests to Issue an EUA or a Substantive Amendment
to an Existing EUA ...........................................................
FDA Review of a Pre-EUA Package or an Amendment
Thereto .............................................................................
Manufacturers of an Unapproved EUA Product ..................
Public Health Authorities; Unapproved EUA Product ..........
Public Health Authorities; Request for Expiration Date Extension ..............................................................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
Type of respondent
Average
burden per
response
(hours)
Total annual
responses
12
2.39
29
45
1,305
32
12
30
1.79
5.8
3
57
70
90
34
2
2
1,938
140
180
1
1
1
2
2
........................
........................
........................
........................
3,565
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of respondent
Total annual
records
Average
burden per
recordkeeping
Total hours
Manufacturers of an Unapproved EUA Product ..................
Public Health Authorities; Unapproved EUA Product ..........
12
30
2
3
24
90
25
3
600
270
Total ..............................................................................
........................
........................
........................
........................
870
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated annual reporting
burden for the information collection
reflects an overall increase of 239 hours
since our last request for OMB approval.
We attribute this adjustment to an
increase in the number of submissions
we received.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06553 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1163]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Providing
Regulatory Submissions in Electronic
and Non-Electronic Format—
Promotional Labeling and Advertising
Materials for Human Prescription
Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 6,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Providing Regulatory Submissions
in Electronic and Non-Electronic
SUMMARY:
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Number of
records per
recordkeeper
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Format—Promotional Labeling and
Advertising Materials for Human
Prescription Drugs.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Providing Regulatory Submissions in
Electronic and Non-Electronic
Format—Promotional Labeling and
Advertising Materials for Human
Prescription Drugs—OMB Control
Number 0910–NEW
This information collection request
supports recommendations found in the
Agency guidance document entitled,
‘‘Providing Regulatory Submissions in
Electronic and Non-Electronic Format—
Promotional Labeling and Advertising
Materials for Human Prescription
Drugs.’’ The guidance document
outlines the requirements and
recommendations for manufacturers,
packers, and distributors (firms) that
may either be the applicant or acting on
behalf of the applicant, to make
submissions pertaining to promotional
materials for human prescription drugs
(‘‘drugs’’) to the Office of Prescription
Drug Promotion (OPDP) in the Center
for Drug Evaluation and Research
(CDER) and the Advertising and
Promotional Labeling Branch (APLB) in
the Center for Biologics Evaluation and
Research (CBER). References to ‘‘drugs’’
in the guidance also include human
biological products that fall within the
definition of ‘‘drug’’ under section
201(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
321(g)).
The guidance describes the various
types of submissions of promotional
materials and general considerations for
submissions. The guidance discusses
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the specific aspects of submission of
promotional materials using module 1
of the electronic Common Technical
Document (eCTD) using version 3.3 or
higher of the us-regional-backbone file.
The guidance does not address the more
general requirements for a valid
electronic submission using eCTD or the
specifications for module 1 of the eCTD.
The guidance contains both binding and
nonbinding provisions. The provisions
that are binding implement section
745A(a) of the FD&C Act (21 U.S.C.
379k–1(a)), which requires that certain
submissions be submitted in electronic
format specified by FDA, beginning no
earlier than 24 months after FDA issues
a final guidance specifying such
electronic submission format.
The guidance provides
recommendations for what to include
with each type of submission and the
number of copies to include if it is a
paper submission. For promotional
labeling submitted for advisory
comments, including resubmissions, a
submission generally includes
correspondence stating that it is a
request for advisory comments, a clean
version of the draft promotional
materials, an annotated copy of the
promotional materials, and the most
current FDA-approved prescribing
information (PI); if applicable, a
submission also includes the FDAapproved patient labeling or Medication
Guide with annotations cross-referenced
to the proposed promotional materials
and annotated references to support
product and disease or epidemiology
claims not contained in the PI crossreferenced to the promotional material.
Amendments should be submitted if the
previous submission to FDA is missing
one or more promotional materials or if
an incorrect document file was included
with a submission in eCTD format.
Amendments should include
correspondence stating it is an
amendment and include the
accompanying materials that were
previously missing, an annotated copy
of the promotional materials that were
omitted from a previous submission to
FDA, the FDA-approved patient labeling
or Medication Guide with annotations
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]]>Agencies
[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13299-13302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06553]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0976]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance: Emergency Use Authorization of Medical
Products and Related Authorities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed extension of the collection of
information related to emergency use authorizations by the Agency.
DATES: Submit either electronic or written comments on the collection
of information by June 3, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 3, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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
[[Page 13300]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0976 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance: Emergency Use
Authorization of Medical Products and Related Authorities.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance: Emergency Use Authorization of Medical Products and Related
Authorities
OMB Control Number 0910-0595--Extension
The guidance describes the Agency's policies applicable to the
authorization of the emergency use of certain medical products under
sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b), as
amended or added by the Project BioShield Act of 2004 (Pub. L. 108-
276), the Pandemic and All-Hazards Preparedness Reauthorization Act of
2013 (Pub. L. 113-5), 21st Century Cures Act (Pub. L. 114-255), and
Public Law 115-92 (2017). The FD&C Act permits the Commissioner to
authorize the use of unapproved medical products or unapproved uses of
approved medical products during an emergency declared under section
564 of the FD&C Act. The data to support issuance of an emergency use
authorization (EUA) must demonstrate that, based on the totality of the
scientific evidence available to the Commissioner, including data from
adequate and well-controlled clinical trials (if available), it is
reasonable to believe that the product may be effective in diagnosing,
treating, or preventing a serious or life-threatening disease or
condition (21 U.S.C. 360bbb-3(c)). Although the exact type and amount
of data needed to support an EUA may vary depending on the nature of
the declared emergency and the nature of the candidate product, FDA
recommends that a request for consideration for an EUA include
scientific evidence evaluating the product's safety and effectiveness,
including the adverse event profile for diagnosis, treatment, or
prevention of the serious or life-threatening disease or condition, as
well as data and other information on safety, effectiveness, risks and
benefits, and (to the extent available) alternatives.
Under section 564 of the FD&C Act, the FDA Commissioner may
establish conditions on the authorization. Section 564(e) requires the
FDA Commissioner (to the extent practicable given the circumstances of
the emergency) to establish certain conditions on an authorization that
the Commissioner finds necessary or appropriate to protect the public
health and permits the FDA Commissioner to establish other conditions
that he or she finds necessary or appropriate to protect the public
health. Conditions authorized by section 564(e) of the FD&C Act
include, for example: Requirements for information dissemination to
healthcare providers or authorized dispensers and product recipients;
adverse event monitoring and reporting; data collection and analysis;
recordkeeping and records access; restrictions on product advertising,
distribution, and administration; and limitations on good manufacturing
practices requirements. Some conditions, the statute specifies, are
mandatory to the extent practicable for authorizations of unapproved
products and discretionary for authorizations of unapproved uses of
approved products. Moreover, some conditions may apply to manufacturers
of an EUA product, while other conditions may apply to any person who
carries out any activity for which
[[Page 13301]]
the authorization is issued. Section 564 of the FD&C Act also gives the
FDA Commissioner authority to establish other conditions on an
authorization that he or she finds to be necessary or appropriate to
protect the public health. Additionally, sections 564A and 564B
established streamlined mechanisms to facilitate preparedness and
response activities involving certain FDA-approved products without
requiring FDA to issue an EUA, including expiration date extension
authority.
For purposes of estimating the annual burden of reporting (table
1), FDA has established four categories of respondents: (1) Those who
file a request for FDA to issue an EUA or a substantive amendment to an
EUA that has previously been issued, assuming that a requisite
declaration under section 564 of the FD&C Act has been made and
criteria for issuance have been met; (2) those who submit a request for
FDA to review information/data (i.e., a pre-EUA package) for a
candidate EUA product or a substantive amendment to an existing pre-EUA
package for preparedness purposes; (3) manufacturers who carry out an
activity related to an unapproved EUA product (e.g., administering
product, disseminating information) who must report to FDA regarding
such activity; and (4) public health authorities (e.g., State, local)
who carry out an activity (e.g., administering product, disseminating
information) related to an unapproved EUA product who must report to
FDA regarding such activity or who submit to FDA an expiration date
extension request for an approved product.
In some cases, manufacturers directly submit EUA requests. Often a
Federal Government entity (e.g., Centers for Disease Control and
Prevention, Department of Defense) requests that FDA issue an EUA and
submits pre-EUA packages for FDA to review. In many of these cases,
manufacturer respondents inform these requests and submissions, which
are the activities that form the basis of the estimated reporting
burdens. However, in some cases the Federal Government is the sole
respondent; manufacturers do not inform these requests or submissions.
FDA estimates minimal burden when the Federal Government performs the
relevant activities. In addition to variability based on whether there
is an active manufacturer respondent, other factors also inject
significant variability in estimates for annual reporting burdens. A
second factor is the type of product. For example, FDA estimates
greater burden for novel therapeutics than for certain unapproved uses
of approved products. A third significant factor that injects
variability is the type of submission. For example, FDA estimates
greater burden for ``original'' EUA and pre-EUA submissions than for
amendments to them, and FDA estimates minimal burden to issue an EUA
when there is a previously reviewed pre-EUA package or investigational
application. For purposes of estimating the reporting burden, FDA has
calculated the anticipated burden on manufacturers based on the
anticipated types of responses (i.e., estimated manufacturer input),
types of product, and types of submission that comprise the described
reporting activities.
For purposes of estimating the annual burden of recordkeeping, FDA
has also calculated the anticipated burden on manufacturers and public
health officials associated with administration of unapproved products
authorized for emergency use, recognizing that the Federal Government
will perform much of the recordkeeping related to administration of
such products (table 2). FDA is not calculating any recordkeeping
burden for public health authorities who may need to submit expiration
date extension requests, as these entities already maintain records for
the products that they stockpile, which would include records of any
expiration date request or extension.
The guidance refers to previously approved collections of
information. These collections are subject to review by the OMB under
the PRA. These collections have been approved as follows: Adverse
experience reporting for biological products is approved under OMB
control number 0910-0308; adverse drug experience reporting is approved
under OMB control number 0910-0230; adverse device experience reporting
is approved under OMB control number 0910-0471; investigational new
drug (IND) application regulations are approved under OMB control
number 0910-0014and investigational device exemption (IDE) reporting is
approved under OMB control number 0910-0078; current good manufacturing
practices for finished pharmaceuticals are approved under OMB control
number 0910-0139, and for devices under OMB control number 0910-0073;
applications for marketing a new drug are approved under OMB control
number 0910-0001, and for biological products under OMB control number.
Any additional burden imposed by this proposed collection would be
minimal.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Requests to Issue an EUA or a 12 2.39 29 45 1,305
Substantive Amendment to an
Existing EUA...................
FDA Review of a Pre-EUA Package 32 1.79 57 34 1,938
or an Amendment Thereto........
Manufacturers of an Unapproved 12 5.8 70 2 140
EUA Product....................
Public Health Authorities; 30 3 90 2 180
Unapproved EUA Product.........
Public Health Authorities; 1 1 1 2 2
Request for Expiration Date
Extension......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,565
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 13302]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers of an Unapproved 12 2 24 25 600
EUA Product....................
Public Health Authorities; 30 3 90 3 270
Unapproved EUA Product.........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 870
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated annual reporting burden for the information
collection reflects an overall increase of 239 hours since our last
request for OMB approval. We attribute this adjustment to an increase
in the number of submissions we received.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06553 Filed 4-3-19; 8:45 am]
BILLING CODE 4164-01-P
