80 FR 79905 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Emergency Use Authorization of Medical Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 246 (December 23, 2015)

Page Range		79905-79907
FR Document		2015-32253

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.

Federal Register, Volume 80 Issue 246 (Wednesday, December 23, 2015)

[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79905-79907]
From the Federal Register Online [www.thefederalregister.org]
[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, PRAStaff@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,

[[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
----------------------------------------------------------------------------------------------------------------
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.........
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
No. of records Average burden
Type of respondent No. of per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers of an Unapproved 5 2 10 25 250
EUA Product....................
Public Health Authorities; 30 3 90 3 270
Unapproved EUA Product.........
----------------------------------------------------------------------------------------------------------------
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

Document Created: 2018-03-02 09:21:17
Document Modified: 2018-03-02 09:21:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by February 22, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 79905

80 FR 79905 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Emergency Use Authorization of Medical Products

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 246 (December 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration