[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57106-57108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the requirement established by 
Title II of the Food and Drug Administration Amendments Act of 2007 
(FDAAA) (Public Law 110-85) that device establishments must submit 
registration and listing information by electronic means, using FDA 
Form 3673, unless the Secretary of the Department of Health and Human 
Services (the Secretary) grants them a waiver from the electronic 
submission requirement.

DATES: Submit written or electronic comments on the collection of 
information by December 1, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    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.

[[Page 57107]]

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. FDA expects 20,000 to 30,000 device establishments to begin 
registering electronically at that time.
    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.
    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.


                                                   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                .25              7,475
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223\2\                                                             16,524                     4             66,096                 .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

[[Page 57108]]

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 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.

    Dated: September 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22989 Filed 9-30-08; 8:45 am]
BILLING CODE 4160-01-S