[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79905-79907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32253]


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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 February 22, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and 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.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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

[[Page 79906]]

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.

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 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 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

[[Page 79907]]

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 
December 31, 2015; 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of
       Type of respondent             No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Requests to Issue an EUA or a                  6               3              18              45             810
 Substantive Amendment to an
 Existing EUA...................
FDA Review of a Pre-EUA Package               13               6              78              34           2,652
 or an Amendment Thereto........
Manufacturers of an Unapproved                 5               2              10               2              20
 EUA Product....................
Public Health Authorities;                    30               3              90               2             180
 Unapproved EUA Product.........
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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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                                                  No. of records                  Average burden
       Type of respondent             No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Manufacturers of an Unapproved                 5               2              10              25             250
 EUA Product....................
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: December 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32253 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P