[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]
[Page 51285-51287]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0163]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance,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
November 5, 2009.
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: 202-395-6974, or e-mailed 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: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794,
JonnaLynn.Capezzuto@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.
Draft Guidance, Emergency Use Authorization of Medical Products--(OMB
Control Number 0910-0595)--Extension
The draft guidance describes the agency's general recommendations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 act) (21
U.S.C. 360bbb-3), which was amended by the Project BioShield Act of
2004 (Pub. L. 108-276). The act permits the FDA Commissioner (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 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 act, the FDA Commissioner may establish
conditions on the approval of an EUA. Section 564(e) requires the FDA
Commissioner (to the extent practicable given the
[[Page 51286]]
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 he finds necessary or appropriate to protect the
public health. Conditions authorized by section 564(e) of the 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 act also gives the FDA Commissioner authority to establish
other conditions on an authorization that he finds to be necessary or
appropriate to protect the public health.
For purposes of estimating the burden of reporting, FDA has
established six categories of respondents: (1) Those who file a Request
for Consideration for an EUA and, in lieu of submitting the data,
provide reference to a pending or approved application; (2) those who
file a Request for Consideration for an EUA, without reference to a
pending or approved application; (3) those who submit pre-EUA
submissions to FDA on a candidate EUA product, which references a
pending or approved application; (4) those who submit pre-EUA
submissions to FDA on a candidate EUA product, for which there is no
reference to a pending or approved application; (5) manufacturers of an
unapproved EUA product who must report to FDA regarding such activity;
and (6) state and local public health officials who carry out an
activity related to an unapproved EUA product (e.g., administering the
product to recipients) and who must report to FDA regarding such
activity.
For purposes of estimating the burden of recordkeeping, FDA has
calculated the anticipated burden on manufacturers of unapproved
products authorized for emergency use. FDA also anticipates that some
state and local public health officials may be required to perform
additional recordkeeping (e.g., related to the administration of
unapproved EUA products to civilians) and calculated a recordkeeping
burden for those activities.
No burden was attributed to reporting or recordkeeping for
unapproved uses of approved products, since those products already are
subject to approved collections of information (adverse experience
reporting for biological products is approved under OMB Control No.
0910-0308 through September 30, 2011; adverse drug experience reporting
is approved under OMB Control No. 0910-0230 through July 31, 2012;
investigational new drug application regulations are approved under OMB
Control No. 0910-0014 through August 31, 2011; and investigational
device exemption reporting is approved under OMB Control Number 0910-
0078 through January 31, 2010). Thus, FDA estimates the burden of this
collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for 5 2 10 15 150
Consideration
; Pending
Application
on File
----------------------------------------------------------------------------------------------------------------
Requests for 4 2 8 50 400
Consideration
; No
Application
Pending
----------------------------------------------------------------------------------------------------------------
Pre-EUA 2 2 4 20 80
Submissions;
Pending
Application
on File
----------------------------------------------------------------------------------------------------------------
Pre-EUA 11 2 22 75 1,650
Submissions;
No
Application
Pending
----------------------------------------------------------------------------------------------------------------
Manufacturers 3 4 12 2 24
of an
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
State and 30 4 360 2 240
Local Public
Health
Officials;
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
Total 2,544
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Recordkeeping Annual Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
Manufacturers 3 4 12 25 300
of an
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
State and 30 4 120 3 360
Local Public
Health
Officials;
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
[[Page 51287]]
Total 660
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual burden estimate for this information collection is 3,204
hours. The estimated reporting burden for this collection is 2,544
hours, and the estimated recordkeeping burden is 660 hours.
In the Federal Register of April 20, 2009 (74 FR 17962), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. However, in the
period of time since the 60-day notice was drafted, there was a
determination of public health emergency involving the 2009 H1N1 virus
and multiple declarations supporting the issuance of EUAs. As a result
of this increased activity and the likelihood of a continued increase
in the number of EUA and pre-EUA submissions, on its own initiative,
FDA is providing estimates based on the number of reports that the
agency received in the past year.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24048 Filed 10-5-09; 8:45 am]
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