[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Pages 51285-51287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24048]


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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of Management and Budget Review; Comment Request; Draft Guidance, 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 [email protected]. 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, 
[email protected].

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Draft Guidance, Emergency Use Authorization of Medical Products--(OMB 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    The draft guidance describes the agency's general recommendations 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\
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                      No. of         Annual Frequency       Total Annual        Hours per
                   Respondents         per Response          Responses           Response         Total Hours
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Requests for                    5                     2                 10                 15                150
 Consideration
 ; Pending
 Application
 on File
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Requests for                    4                     2                  8                 50                400
 Consideration
 ; No
 Application
 Pending
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Pre-EUA                         2                     2                  4                 20                 80
 Submissions;
 Pending
 Application
 on File
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Pre-EUA                        11                     2                 22                 75              1,650
 Submissions;
 No
 Application
 Pending
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Manufacturers                   3                     4                 12                  2                 24
 of an
 Unapproved
 EUA Product
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State and                      30                     4                360                  2                240
 Local Public
 Health
 Officials;
 Unapproved
 EUA Product
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      2,544
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Recordkeeping Annual Burden\1\
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                      No. of         Annual Frequency       Total Annual
                  Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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Manufacturers                   3                     4                 12                 25                300
 of an
 Unapproved
 EUA Product
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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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