[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