Notice: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Implementation of 
Sections 222, 223, and 224 of the Food and Drug Administration 
Amendments Act of 2007

Federal Register: Volume 77, Number 9 (Friday, January 13, 2012)
                  Pages 2068-2070

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 
February 13, 2012.

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) 395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0625. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-5156, 
Daniel.Gittleson@fda.hhs.gov.

[[Page 2069]]


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.

Implementation of Sections 222, 223, and 224 of the Food and Drug 
Administration Amendments Act of 2007--(OMB Control Number 0910-0625)--
Extension

    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 Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360), 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. There are approximately 24,000 establishments that are 
electronically registered as of September 2011.
    Section 222 of FDAAA amends sections 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 register immediately upon first engaging in one of 
the covered device activities described under the statute, and in 
addition, they must also register annually during the time period 
beginning October 1 and ending December 31 of each year. Further, 
section 223 of FDAAA amends section 510(j)(2) of the FD&C Act to 
require establishments to list their devices with FDA annually, during 
the time period beginning October 1 and ending December 31 of each 
year.
    Under FDAAA, device establishment owners and operators are required 
to keep their registration and device listing information up-to-date 
using the Agency's new electronic system. Owners and 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 an 
affected person to request a waiver from the requirement to register 
electronically when the ``use of electronic means'' is not reasonable 
for the person.
    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 establishment 
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 is required to register and list, 
they would need only to have access to a computer, Internet, and an 
email address for registration and listing by electronic means, the 
Agency did not anticipate receipt of a large number of requests for 
waivers. From the October through December 2007 timeframe, FDA received 
fewer than 10 requests for waivers for the requirement to submit 
registration and listing information electronically. As data for more 
than 16,000 establishments were received electronically for the same 
period, these requests amount to less than 1 percent of the total 
number of establishments that have responded. The number of waiver 
requests received through fiscal year 2011 has remained consistently 
less than 1 percent.
    Based on information taken from our databases, FDA estimates that 
there are 21,254 owner/operators who collectively register a total of 
24,000 device establishments. The number of respondents listed for 
section 222 of FDAAA in table 1 of this document is 21,254, which 
corresponds to the number of owner/operators who annually register. In 
addition, FDA estimates that 3,504 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 
table 1 of this document for section 223 of FDAAA is 17,750, which 
corresponds to the number of owner/operators who annually list one or 
more devices (21,254 - 3,504 = 17,750).
    To calculate the burden estimate for waiver requests under section 
224 of FDAAA, we assume as stated previously, that less than 1 percent 
of the 24,000 total device establishments would request waivers from 
FDA. This means the total number of waiver requests would probably not 
exceed 14 requests (24,000 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 2,162 new 
establishments each year. Of the 2,162 new registrants each year, we 
assume that less than 1 percent (i.e., 1) of these will also request 
waivers each year. The total, therefore, is 14 waiver requests, which 
could increase by only one additional request each year.
    Based on the number of owner operators of foreign establishments 
reflected in our current database, approximately 8,067 owner operators 
will spend an hour annually identifying the name, address, telephone 
and fax numbers, email address, and registration number, if any has 
been assigned, of any importer of the establishment's devices that is 
known to the foreign establishment.
    Also based on the current number of owner/operators in the FDA 
database, we estimate that approximately 1,305 owner operators will 
spend .25 hours each year to identify changes in their U.S. agent's 
name, address, or phone number to FDA.
    The burden estimate for recordkeeping requirements under section 
222 of FDAAA in table 2 of this document complies with the requirement 
that owners or operators keep a list of officers, directors, and 
partners for each establishment. Owners or operators will need to 
provide this information only upon request from FDA. However, it is 
assumed that some effort will need to be expended for keeping such 
lists current.
    The burden estimate for the recordkeeping requirements under 
section 223 of FDAAA in table 2 of this document reflect other 
recordkeeping requirements for devices listed with FDA and the 
requirement to provide these records upon request from FDA. These 
estimates are based on FDA experience.
    In the Federal Register of November 3, 2011 (76 FR 68195), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 2070]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Number of                       Average
           FDAAA Section of the 2007 amendments             FDA form No.      Number of     responses per   Total annual     burden per     Total hours
                                                                             respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
222 \3\..................................................            3673          21,254               1          21,254           0.75          15,941
222 \2\..................................................            3673           2,162               1           2,162           0.50           1,081
222 \3\..................................................            3673           8,067               1           8,067           1              8,067
222 \3\..................................................            3673           1,305               1           1,305           0.25             326
223 \3\..................................................            3673          17,750               1          17,750           1             17,750
224 (waiver request) \2\.................................            3673              14               1              14           1                 14
224 (waiver request) \3\.................................            3673               1               1               1           2                  2
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  ..............  ..............  ..............  ..............  .............          43,181
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One-time burden.
\3\ Annual recurring burden.


                            Table 2--Estimated Average Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Number of                       Average
    FDAAA Section of the 2007         Number of      records per    Total annual     burden per     Total hours
            amendments              recordkeepers   recordkeeper       records     recordkeeping
----------------------------------------------------------------------------------------------------------------
222 \2\..........................          23,806               1          23,806           0.25           5,952
223 \2\..........................          11,746               4          46,984           0.5           23,492
                                  ------------------------------------------------------------------------------
    Total........................  ..............  ..............  ..............  .............          29,444
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Recurring burden.


    Dated: January 9, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-503 Filed 1-12-12; 8:45 am]
BILLING CODE 4160-01-P