
[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59926-59928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24043]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 November 30, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: 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,

[[Page 59927]]

when appropriate, and other forms of information technology.

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 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 of Food 
and Drugs 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 Commissioner may establish 
conditions on the authorization. Section 564(e) requires the 
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 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 (see 
table 1 of this document), 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).
    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 59928]]



                                 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.........
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    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 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                 5             1.6               8              25             200
 EUA Product....................
Public Health Authorities;                    30               3              90               3             270
 Unapproved EUA Product.........
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    Total.......................  ..............  ..............  ..............  ..............             470
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 25, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24043 Filed 9-28-12; 8:45 am]
BILLING CODE 4160-01-P


