Agency Information Collection Activities; Proposed Collection; Comment Request; Implementation of the Food and Drug Administration Amendments Act of 2007, 68195-68197 [2011-28476]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax: (202)
395–7285, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–28510 Filed 11–2–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0755]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Implementation of
the Food and Drug Administration
Amendments Act of 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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)
(Pub. L. 110–85) that device
establishments must submit registration
and listing information by electronic
means, using FDA Form 3673, unless
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:50 Nov 02, 2011
Jkt 226001
the Secretary of the Department of
Health and Human Services (the
Secretary) grants them a waiver from the
electronic submission requirement.
DATES: Submit either written or
electronic comments on the collection
of information by January 3, 2012.
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:
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.
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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
68195
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03NON1.SGM
03NON1
68196
Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDAAA Section of the 2007
Amendments
FDA Form No.
222 3 .........................................................
222 2 .........................................................
222 3 .........................................................
222 3 .........................................................
223 3 .........................................................
224 (waiver request) 2 ..............................
224 (waiver request) 3 ..............................
3673
3673
3673
3673
3673
3673
3673
Total ..................................................
Number of
respondents
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
21,254
2,162
8,067
1,305
17,750
14
1
........................
1
1
1
1
1
1
1
21,254
2,162
8,067
1,305
17,750
14
1
0.75
0.50
1
0.25
1
1
2
15,941
1,081
8,067
326
17,750
14
2
........................
........................
........................
........................
43,181
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
time burden.
3 Annual recurring burden.
2 One
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Annual
frequency of
recordkeeping
222 2 .....................................................................................
223 2 .....................................................................................
23,806
11,746
1
4
23,806
46,984
0.25
0.5
5,952
23,492
Total ..............................................................................
........................
........................
........................
........................
29,444
FDAAA Section of the 2007 Amendments
Total annual
records
Hours per
record
Total hours
1 There
srobinson on DSK4SPTVN1PROD with NOTICES
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 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
VerDate Mar<15>2010
18:00 Nov 02, 2011
Jkt 226001
that have responded. The number of
waiver requests received through fiscal
year 2011 have 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 × 0.0006). We also
estimate that the one-time burden on
these establishments would be an hour
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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
E:\FR\FM\03NON1.SGM
03NON1
Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
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: October 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28476 Filed 11–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0547]
Clinical Development Programs for
Sedation Products; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration’s
(FDA), Center for Drug Evaluation and
Research (CDER) is announcing a
scientific workshop to solicit
information on a variety of issues
related to the clinical development and
use of sedation products in adult and
pediatric age groups. FDA intends to
take into account the information
provided from this workshop as we
develop FDA guidance on clinical
development programs for sedation
products. FDA issued a notice in the
Federal Register of November 29, 2010,
inviting an interested party, or parties,
to facilitate an evaluation of the critical
fundamentals of the science related to
sedation products and to plan and
conduct one or more public meetings to
bring together experts in the field,
including from academia, patient
organizations, and industry, to discuss
these issues. FDA has since determined
that it will facilitate the evaluation
itself, and as a first step, is announcing
this workshop.
Date and Time: The public workshop
will be held on May 3, 2012, from 8:30
a.m. to 5 p.m.
Location: The workshop will be held
at FDA White Oak Campus, 10903 New
Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
VerDate Mar<15>2010
16:50 Nov 02, 2011
Jkt 226001
Contact Person: Mary C. Gross, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, (301) 796–3519, email:
mary.gross@fda.hhs.gov; or Diana
Walker, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
(301) 796–4029, email: Diana.Walker@
fda.hhs.gov.
Registration to Participate in
Scientific Panels: If you wish to
participate as part of a scientific panel,
please email your request to CDER_
Sedation_Workshop@FDA.HHS.gov by
December 2, 2011. As part of your
request, please describe your area of
expertise and interest based on the
questions identified below. If selected, a
subset of panel representatives may be
asked to provide formal presentations
and/or participate in panel discussions.
Registration to Attend the Workshop
and Requests to Participate in Open
Public Hearing: If you wish to attend or
testify at the open public hearing, please
email your registration to CDER_
Sedation_Workshop@FDA.HHS.gov by
April 2, 2012. Those without email
access may register by contacting one of
the persons listed in the Contact Person
section of the document. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email address, and
telephone number. Registration is free
and will be on a first-come, first-served
basis. Early registration is recommended
because seating is limited. FDA may
limit the number of participants from
each organization as well as the total
number of participants based on space
limitations. Registrants will receive
confirmation once they have been
accepted for the workshop. Onsite
registration on the day of the meeting
will be based on space availability. If
registration reaches maximum capacity,
FDA will post a notice closing meeting
registration for the workshop at: https://
www.fda.gov/Drugs/NewsEvents/
ucm221185.htm.
An open public hearing will be held
between 1:30 p.m. to 2:30 p.m. on May
3, 2012, during which speaker
testimony will be accepted. We will try
to accommodate all persons who wish
to testify, however, the duration of each
speaker’s testimony during this open
public hearing may be limited by time
constraints.
Comments: Submit either electronic
or written comments by July 3, 2012.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
68197
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
If you need special accommodations
due to a disability, contact Mary Gross
or Diana Walker (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of November
29, 2010 (75 FR 73104), FDA indicated
that it was seeking information on a
variety of issues related to the clinical
development and use of sedation
products in adult and pediatric age
groups. In the notice, FDA invited any
interested party to take on the role of
facilitating an evaluation of these issues
and as a first step, plan or hold one or
more public meetings to discuss these
issues. FDA was going to take into
account the information provided by
these activities in the development of
guidance on clinical development
programs for sedation products. FDA
has now determined that it will conduct
the evaluation itself, and is announcing
this workshop to further understand the
physiology of sedation and clinical trial
design issues related to the development
of sedation products.
FDA will explore the following topics
during this public workshop:
1. For clinical trials of sedation drug
products, which surgical and diagnostic
procedures would provide the most
relevant efficacy and safety data, while
still allowing for a reasonable level of
feasibility and efficiency?
2. What patient subgroups, other than
pediatric, geriatric, and patients with
hepatic or renal impairment, would
require specific evaluation in clinical
trials involving sedation drug products?
3. What is the most appropriate
primary efficacy endpoint to assess in a
clinical trial of a sedation drug product?
a. Which measurement scales have
been adequately studied and validated
for use in assessing the endpoint
measure recommended previously.
b. Is there a clinically meaningful
effect size that should be considered as
a minimal requirement for a
determination of efficacy?
c. How do the responses to the
previous questions differ, if at all, for
the pediatric population, in particular,
the youngest of these patients who have
no or limited communication skills.
E:\FR\FM\03NON1.SGM
03NON1
]]>Agencies
[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Pages 68195-68197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28476]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0755]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Implementation 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) (Pub. L. 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 either written or electronic comments on the collection
of information by January 3, 2012.
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: 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.
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.
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.
FDA estimates the burden of this collection of information as
follows:
[[Page 68196]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
FDAAA Section of the 2007 Amendments FDA Form No. Number of frequency per Total annual Hours per Total hours
respondents response 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\
----------------------------------------------------------------------------------------------------------------
Annual
FDAAA Section of the 2007 Number of frequency of Total annual Hours per Total hours
Amendments recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
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.
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 have 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
[[Page 68197]]
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: October 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28476 Filed 11-2-11; 8:45 am]
BILLING CODE 4160-01-P
