[Federal Register Volume 71, Number 137 (Tuesday, July 18, 2006)]
[Notices]
[Pages 40722-40723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11287]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0333]


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of Management and Budget Review; Comment Request; Draft Guidance: 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.

-----------------------------------------------------------------------

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 August 
17, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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Draft Guidance: Emergency Use Authorization of Medical Products

    The Federal Food, Drug, and Cosmetic Act (the act) permits the 
Commissioner of FDA (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 (21 
U.S.C. 360bbb-3). The data to support issuance of an emergency use 
authorization (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 Commissioner may establish 
conditions on the approval of an EUA. 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 
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 Commissioner authority to establish other 
conditions on an authorization that the Commissioner 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 which include: (1) Those who 
file a Request for Consideration for an EUA after a determination of 
actual or potential emergency 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 and the data after a 
determination of actual or potential emergency, without reference to a 
pending or approved application; (3) those who submit data to FDA on a 
candidate EUA product, which is subject to a pending or approved 
application, prior to a determination of actual or potential emergency; 
(4) those who submit data to FDA prior to a determination of actual or 
potential emergency about a candidate EUA product for which there is no 
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 
civilians) 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. The agency anticipates that the 
Federal Government will perform some of the additional recordkeeping 
necessary for unapproved products (e.g., related to the administration 
of unapproved EUA products to military personnel). 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, because those products already 
are subject to approved collections of information (adverse experience 
reporting for biological products is approved under OMB control number 
0910-0308 through May 31, 2005; adverse drug experience reporting is 
approved under OMB control number 0910-0230 through September 30, 2005; 
and investigational new drug applications (IND) regulations are 
approved under OMB control number 0910-0014 through January 31, 2006), 
and any additional burden imposed by this proposed collection would be 
minimal. Thus, FDA estimates the burden of this collection of 
information as follows:

[[Page 40723]]

    The annual burden estimate for this information collection is 1,414 
hours. The estimated reporting burden for this collection is 754 hours 
and the estimated recordkeeping burden is 660 hours.
    In the Federal Register of July 5, 2005 (70 FR 38689), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received on the information 
collection.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                                                           Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Consideration; Pending application on file                  1                     1                  1                 15                 15
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Consideration; No application pending                       1                     1                  1                 50                 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-emergency submissions; Pending application on file                 10                     1                 10                 20                200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-emergency submissions; No application pending                       3                     1                  3                 75                225
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers of an unapproved EUA product                              3                     4                 12                  2                 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
State and local public health officials; Unapproved                    30                     4                120                  2                240
 EUA product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                754
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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       Annual Frequency  of     Total Annual
                                                       Recordkeepers        Recordkeeping          Records       Hours per  Record       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers of an unapproved EUA product                           3                     4                 12                 25                   300
--------------------------------------------------------------------------------------------------------------------------------------------------------
State and local public health officials; Unapproved                 30                     4                120                  3                   360
 EUA product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                660
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11287 Filed 7-17-06; 8:45 am]
BILLING CODE 4160-01-S