Notice: Agency Emergency Processing Under Office of Management and Budget 
Review; Implementation of Sections 222, 223, and 224 of the Food and 
Drug Administration Amendments Act of 2007

Federal Register: May 7, 2008 (Volume 73, Number 89)              
                  Page 25750-25752

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns the requirement established by the Food and Drug 
Administration Amendments Act of 2007 (FDAAA), that device 
establishments must submit registration and listing information by 
electronic means using FDA Form 3673, unless the Secretary of Health 
and Human Services (the Secretary) grants them a waiver from the 
electronic submission requirement.

DATES:  Fax written comments on the collection of information by June 
6, 2008.

[[Page 25751]]


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 baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-NEW and title 
``Implementation of Sections 222, 223, and 224 of the Food and Drug 
Administration Amendments Act of 2007; (21 U.S.C. 360); Emergency 
Request.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13)). Title II of FDAAA (Public 
Law 110-85), enacted September 27, 2007, amends section 510 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) to 
require all domestic and foreign device establishments to submit 
registration and device listing information to FDA by electronic means, 
and specifies the timeframes when establishments are required to submit 
such information. These new registration and listing requirements were 
in effect on October 1, 2007. The proposed collection of information 
concerns the information that owners/operators of device establishments 
must submit electronically in order to register their establishments 
and list their devices using FDA Form No. 3673. In addition, owners/
operators seeking a waiver from the electronic submission requirements 
will need to submit a written request for a waiver to FDA with a 
complete explanation as to why their registration and listing 
information cannot be submitted electronically. See sections 222, 223, 
and 224 of FDAAA. Thus, FDA is requesting emergency processing of this 
new collection of information for electronic registration and listing, 
and information relating to requests for waivers.
    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.

Implementation of Sections 222, 223, and 224 of the Food and Drug 
Administration Amendments Act of 2007; (21 U.S.C. 360); Emergency 
Request

    Sections 222, 223, and 224 of FDAAA, which were in effect on 
October 1, 2007, require that device establishment registrations and 
listings under section 510 of the FD&C Act (including the submission of 
updated information) be submitted to the Secretary by electronic means, 
unless the Secretary grants a request for waiver of the requirement 
because the use of electronic means is not reasonable for the person 
requesting the waiver. FDA expects that 20,000 to 30,000 device 
establishments will need to register electronically between now and 
December 31, 2008. Section 224 of FDAAA requires that these 
establishments also must have an opportunity request waivers. Thus, 
emergency approval of this request is necessary to implement these 
provisions of the statute.
    Section 222 of FDAAA amends section 510(b) of the FD&C Act to 
require domestic establishments to register annually during the period 
beginning October 1 and ending December 31 of each year. Section 222 of 
FDAAA also amends section 510(i)(1) of the FD&C Act to require foreign 
establishments to immediately register upon first engaging in one of 
the covered device activities described under the statute, and they 
must also register annually during the period beginning on October 1 
and ending on December 31 of each year. In addition, section 223 of 
FDAAA amends section 510(j)(2) of the FD&C Act to require 
establishments to list their devices annually with FDA during the 
period beginning on October 1 and ending on December 31 of each year.
    Under FDAAA, device establishment owners/operators are required to 
keep their registration and device listing information up-to-date using 
the agency's new electronic system. Owners/operators of new device 
establishments must use the electronic system to create new accounts, 
new registration records, and new device listings. Section 224 of FDAAA 
amends section 510(p) of the FD&C Act by allowing a person affected to 
request a waiver from the requirement to register electronically when 
the ``use of electronic means'' is not reasonable for the person.
    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
    Section of  the 2007 Amendments        FDA Form No.       Respondents        per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
222\2\                                               3673              2,600                  1              2,704                0.5              1,352
--------------------------------------------------------------------------------------------------------------------------------------------------------
223\2\                                               3673             24,382                  1             24,382               0.25              6,095
--------------------------------------------------------------------------------------------------------------------------------------------------------
224\2\                                  .................             29,370                  1             29,370               0.75             22,028
--------------------------------------------------------------------------------------------------------------------------------------------------------
224\3\                                  .................              2,600                  1              2,600                0.5              1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
224 (waiver request)\2\                 .................                 20                  1                 20                  1                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
224 (waiver request)\3\                 .................                  1                  1                  1                  1                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 25752]]


Total Hours                                                                                                                                       30,796
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One time burden.
\3\ Annual increase in burden.

    The estimates in table 1 of this document are based on FDA's 
experience, data from the device registration and listing database, and 
our estimates of the time needed to complete the previously required 
forms. We estimate that the time needed to enter registration and 
listing information electronically using FDA Form 3673 will not differ 
significantly from the time needed to fill in the paper forms (FDA 
Forms 2891, 2891a, and 2892) that previously were used for this purpose 
because the information required is essentially identical.
    In addition, under section 224 of FDAAA, device establishments 
owner/operators for whom registering and listing by electronic means is 
not reasonable may request a waiver from the Secretary. Because a 
device establishment's owner/operator required to register and list 
would only need to have access to a computer, Internet, and an e-mail 
address for registration and list by electronic means, the agency did 
not anticipate the receipt of a large number of requests for waiver. 
For the first few months of operation of the web-based system, i.e., 
October through December 2007, FDA received fewer than 10 requests for 
waivers from the requirement to submit registration and listing 
information electronically. As data for more than 16,000 establishments 
have been received electronically for the same period, these requests 
amount to less than 1 percent of the total number of establishments 
that have responded.
    Based on information taken from our databases, FDA estimates that 
there are 29,370 owner/operators who collectively register a total of 
33,490 device establishments. The number of respondents listed for 
section 224 of FDAAA in the burden table is 29,370, which corresponds 
to the number of owner/operators who annually register one or more 
establishments. In addition, FDA estimates that 4,988 owner/operators 
are initial importers who must register their establishments but who, 
under FDA's existing regulations, are not required to list their 
devices unless they initiate or develop the specifications for the 
devices or repackage or relabel the devices. The number of respondents 
included in the burden table for section 223 of FDAAA is 24,382, which 
corresponds to the number of owner/operators who list one or more 
devices annually (29,370 - 4,988 = 24,382).
    To calculate the burden estimate for waiver requests under section 
224 of FDAAA, we assume as stated previously that less than one tenth 
of one percent of the 33,490 total device establishments would request 
waivers from FDA. This means the total number of waiver requests would 
probably not exceed 20 requests (33,490 x 0.0006). We also estimate 
that the one-time burden on these establishments would be an hour of 
time for a mid-level manager to draft, approve, and mail a letter. In 
addition, FDA estimates the total number of establishments will 
increase by 2,600 new establishments each year. Of the 2,600 new 
registrants each year, we assume that less than one percent (i.e., 1) 
of these will also request waivers each year. The total, therefore, is 
21 waiver requests, which could increase by only 1 additional request 
each year.

    Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10194 Filed 5-6-08; 8:45 am]

BILLING CODE 4160-01-S