
[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12739-12741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05390]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0976]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance: Emergency 
Use Authorization of Medical Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 April 
11, 2016.

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 0910-0595. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

Emergency Use Authorization of Medical Products and Related 
Authorities; Guidance for Industry and Public Health Stakeholders OMB 
Control Number 0910-0595-Extension

    The guidance describes the Agency's general recommendations and 
procedures for issuance of emergency use authorizations (EUA) under 
section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 
2004 (Pub. L. 108-276). 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 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 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 health care 
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

[[Page 12740]]

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 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 she finds to be necessary or 
appropriate to protect the public health.
    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.
    In some cases, manufacturers directly submit EUA requests. Often a 
Federal Government entity (e.g., the 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).
    No burden was attributed to reporting or recordkeeping for 
unapproved uses of approved products, since those products are already 
subject to approved collections of information (i.e., adverse 
experience reporting for biological products is approved under OMB 
control number 0910-0308 through February 28, 2018; adverse drug 
experience reporting is approved under OMB control number 0910-0230 
through December 31, 2018; adverse device experience reporting is 
approved under OMB control number 0910-0471 through May 31, 2017; 
investigational new drug application regulations are approved under OMB 
control number 0910-0014 through February 28, 2019; and investigational 
device exemption reporting is approved under OMB control number 0910-
0078 through March 31, 2016). Any additional burden imposed by this 
proposed collection would be minimal.
    In the Federal Register of December 23, 2015 (80 FR 79905), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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
       Type of respondent            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Manufacturer, Request to Issue                 6               3              18              45             810
 an EUA or a Substantive
 Amendment to an Existing EUA...
Manufacturer, Request for FDA                 13               6              78              34           2,652
 Review of a Pre-EUA Package or
 an Amendment Thereto...........
Manufacturer of an Unapproved                  5               2              10               2              20
 EUA Product; Conditions of
 Authorization..................
Public Health Authority;                      30               3              90               2             180
 Unapproved EUA Product;
 Conditions of Authorization....
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    Total.......................  ..............  ..............  ..............  ..............           3,662
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
       Type of respondent            Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Manufacturers of an Unapproved                 5               2              10              25             250
 EUA Product....................

[[Page 12741]]

 
Public Health Authorities;                    30               3              90               3             270
 Unapproved EUA Product.........
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    Total.......................  ..............  ..............  ..............  ..............             520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05390 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P


