
[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75171-75173]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30513]


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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 January 
18, 2013.

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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.

Reporting and Recordkeeping for Emergency Use Authorization of Medical 
Products (OMB Control Number 0910-0595)--Extension

    The guidance describes the Agency's general recommendations and 
procedures for issuance of emergency

[[Page 75172]]

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 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 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 as follows: (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., Center 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 such as with antimicrobial products for 
which there are multiple generic manufacturers, 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 (see Table 2 of this document).
    In the Federal Register of October 1, 2012 (77 FR 59926), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 0910-
0308 through November 30, 2014; Adverse Drug Experience Reporting is 
approved under 0910-0230 through August 31, 2015; Adverse Device 
Experience Reporting is approved under OMB control number 0910-0471 
through May 31, 2014; Investigational New Drug (IND) Application 
Regulations are approved under 0910-0014 through April 30, 2015, and 
Investigational Device Exemption (IDE) Reporting is approved under OMB 
control number 0910-0078 through February 28, 2013. Any additional 
burden imposed by this proposed collection would be minimal.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 75173]]



                                 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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Requests to Issue an EUA or a                  9            1.33              12              33             396
 Substantive Amendment to an
 Existing EUA...................
FDA Review of a Pre-EUA Package               11            1.45              16              35             560
 or an Amendment Thereto........
Manufacturers of an Unapproved                 5            1.6                8               2              16
 EUA Product....................
Public Health Authorities;                    30            3                 90               2             180
 Unapproved EUA Product.........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,152
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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              1.6               8              25             200
 EUA Product...................
Public Health Authorities;                   30              3                90               3             270
 Unapproved EUA Product........
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............             470
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30513 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P


