[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.


[[Page 13302]]


                               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]
BILLING CODE 4164-01-P


