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, 57106-57108 [E8-22989]
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57106
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
single database to more effectively carry
out this matching program. In order for
TMA to meet the requirements of
current law, CMS agrees to disclose
certain Part A and Part B enrollment
data on this dual eligible population,
which will be used to determine a
beneficiary’s eligibility for care under
CHAMPUS/TRICARE. DEERS will
receive the results of the computer
match and provide the information to
TMA for use in its matching program.
This computer matching agreement
supersedes all existing data exchange
agreements between CMS and DMDC
applicable to the exchange of personal
data for purposes of disclosing
enrollment and eligibility information
for MHS beneficiaries who are Medicare
eligible.
CATEGORIES OF RECORDS AND INDIVIDUALS
COVERED BY THE MATCH:
DEERS will furnish CMS with an
electronic file on a monthly basis
extracted from the DEERS’ systems of
records containing social security
numbers (SSN) for all MHS beneficiaries
who may also be eligible for Medicare
benefits. CMS will match the DEERS
finder file against its ‘‘Medicare
Beneficiary Database’’ system of records
(System No. 09–70–0536), and will
validate the identification of the
beneficiary and provide the Health
Insurance Claim Number that matches
against the SSN and date of birth
provided by DEERS, and also provide
the Medicare Part A entitlement status
and Part B enrollment status of the
beneficiary. CMS’s data will help TMA
to determine a beneficiary’s eligibility
for continued care under TRICARE.
DEERS will receive the results of the
computer match and provide the
information provided to TMA for use in
its program.
jlentini on PROD1PC65 with NOTICES
DESCRIPTION OF RECORDS TO BE USED IN THE
MATCHING PROGRAM:
DoD will use the SOR identified as
S322.50, entitled ‘‘Defense Eligibility
Records,’’ at 69 Federal Register (FR)
33376 (June 15, 2004), as amended by
69 FR 67118 (November 16, 2004). SSNs
of DoD beneficiaries will be released to
CMS pursuant to the routine use set
forth in the system notice, which
provides that data may be released to
HHS ‘‘for support of the DEERS
enrollment process and to identify
individuals not entitled to health care.’’
Identification and Medicare status of
DoD eligible beneficiaries will be
provided to TMA to implement the
statutory program. Therefore, eligibility
information may also be maintained in
the SOR identified as DHA 07, entitled
‘‘Military Health Information System
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
(MHIS),’’ at 70 FR 44574 (August 3,
2005).
The release of the data for CMS is
covered under the ‘‘Enrollment
Database,’’ System No. 09–70–0502
published in the Federal Register at 73
FR 10249 (February 26, 2008). Matched
data will be released to DEERS pursuant
to the routine use number 2 as set forth
in the system notice.
INCLUSIVE DATES OF THE MATCH:
Secretary) grants them a waiver from the
electronic submission requirement.
Submit written or electronic
comments on the collection of
information by December 1, 2008.
DATES:
Submit electronic
comments on the collection of
information to https://
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.
ADDRESSES:
The Matching Program shall become
effective no sooner than 40 days after
the report of the Matching Program is
sent to OMB and Congress, or 30 days
after publication in the Federal
Register, which ever is later. The
matching program will continue for 18
months from the effective date and may
be renewed for an additional 12 month
period as long as the statutory language
for the match exists and other
conditions are met.
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.
[FR Doc. E8–23080 Filed 9–30–08; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4120–01–P
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.
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\01OCN1.SGM
01OCN1
57107
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
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 BURDEN1
Section of
the 2007
Amendments
No. of
Respondents
FDA Form No.
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
2222
3673
2,600
1
2,704
0.5
1,352
2232
3673
24,382
1
24,382
0.25
6,095
2242
29,370
1
29,370
0.75
22,028
2243
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
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.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Section of the 2007 Amendments
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours Per
Record
Total Hours
2222
33,490
1
29,900
.25
7,475
2232
16,524
4
66,096
.5
33,048
Total Hours
1 There
40,523
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
jlentini on PROD1PC65 with NOTICES
2 Recurring
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
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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
E:\FR\FM\01OCN1.SGM
01OCN1
jlentini on PROD1PC65 with NOTICES
57108
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
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.
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0512]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
information collection requirements for
Humanitarian Use Devices.
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 https://
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.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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.
SUPPLEMENTARY INFORMATION:
Medical Devices: Humanitarian Use
Devices—21 CFR Part 814 (OMB
Control Number 0910–0332)—Extension
This collection of information
implements the humanitarian use
device (HUD) provision of section
520(m) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360j(m)) and subpart H, part 814 (21
CFR part 814). Under section 520(m) of
the act, FDA is authorized to exempt a
HUD from the effectiveness
requirements of sections 514 and 515 of
the act (21 U.S.C. 360d and 360e)
provided that the device: (1) Is used to
treat or diagnose a disease or condition
that affects fewer than 4,000 individuals
in the United States; (2) would not be
available to a person with such a disease
or condition unless an exemption is
granted, because there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose the disease
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57106-57108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22989]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours Per
Section of the 2007 Amendments FDA Form No. No. of 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Section of the 2007 Amendments Recordkeepers per Recordkeeping Records Hours Per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
222\2\ 33,490 1 29,900 .25 7,475
--------------------------------------------------------------------------------------------------------------------------------------------------------
223\2\ 16,524 4 66,096 .5 33,048
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours 40,523
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
