[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]
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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.
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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
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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/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
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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 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\
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Number of Average burden
Type of respondent Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
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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......................
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Total....................... .............. .............. .............. .............. 3,565
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\1\ There 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\
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Number of Average burden
Type of respondent Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Manufacturers of an Unapproved 12 2 24 25 600
EUA Product....................
Public Health Authorities; 30 3 90 3 270
Unapproved EUA Product.........
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Total....................... .............. .............. .............. .............. 870
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\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]
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