[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75723-75724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0499]


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

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 January 
12, 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 0910-0625. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 the Food and Drug Administration 
Amendments Act of 2007 (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. FDA expects 20,000 to 30,000 device establishments to begin 
registering electronically at that time.
    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 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 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.
    In the Federal Register of October 1, 2008 (73 FR 57106), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                               Annual Frequency     Total Annual        Hours per
  Section of the 2007  Amendments       FDA Form No.     No. of  Respondents     per Response        Responses           Response         Total Hours
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222\2\                                            3673                 2,600                  1              2,704                0.5              1,352
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223\2\                                            3673                24,382                  1             24,382               0.25              6,095
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224\2\                               .................                29,370                  1             29,370               0.75             22,028
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224\3 \                              .................                 2,600                  1              2,600                0.5              1,300
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224 (waiver request)\2\              .................                    20                  1                 20                  1                 20
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224 (waiver request)\3\              .................                     1                  1                  1                  1                  1
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Total Hours                                                                                                                                       30,796
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\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.


[[Page 75724]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual
            Section of the 2007 Amendments                Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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222\2\                                                             33,490                     1             29,900               0.25              7,475
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223\2\                                                             16,524                     4             66,096                0.5             33,048
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Total Hours                                                                                                                                       40,523
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Recurring 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 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 e-
mail address for registration and listing by electronic means, the 
agency did not anticipate receipt of a large number of requests for 
waiver. For the first few months of operation of the web-based system, 
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 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 Table 1 of this document 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 Table 1 of this document for section 223 of 
FDAAA is 24,382, which corresponds to the number of owner/operators who 
annually list one or more devices (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 1 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 1 percent (i.e., 1) of 
these will also request waivers each year. The total, therefore, is 21 
waiver requests, which could increase by only one additional request 
each year.
    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 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.

    Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29459 Filed 12-11-08; 8:45 am]
BILLING CODE 4160-01-S