Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing, 6731-6732 [E8-2079]
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Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices
hours. These figures have been rounded
up. The burden estimates cited in tables
1 and 2 of this document are based
primarily upon the data and methods
provided in FDA’s assessment for fiscal
year (FY) 1999 entitled ‘‘A Cost
Assessment of Medical Device
Tracking.’’ Using implantation
procedures from the National Center for
Health Statistics, FDA applied a 2percent annual growth rate to estimate
the number of procedures for tracked
implant devices for FY1997 through
FY2006. This assessment also used unit
shipment data in combination with
various growth rates to estimate annual
sales distribution for the tracked l/s-l/s
devices over the same time period. In
addition, the assessment also estimated
the burden on industry for developing
and maintaining tracking systems for
these medical devices for FY1997
through FY2006.
For the annual recordkeeping burden,
the number of respondent medical
device manufacturers subject to device
tracking is estimated to be 229 and is
based on data from FDA’s
manufacturers database. FDA issued
tracking orders to 20 additional medical
device manufacturers during the time
period for FY2002 through FY2004.
Under § 821.25(c), the additional
medical device manufacturers
collectively bear a one-time
recordkeeping burden of 10,560 hours to
develop a medical device tracking
system. FDA’s estimate of 17,000
medical device distributor respondents
contained in this assessment, are
derived from Dun & Bradstreet sources
on medical equipment wholesalers,
retailers, home care dealers, and rental
companies. Health Forum, an American
Hospital Association Company,
provided statistics on hospitals.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2078 Filed 2–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N–0016]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Additional Listing
Information for Medical Device
Registration and Listing
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 public
comments on the reporting and
recordkeeping burden associated with
the paperwork requirements under
§ 807.31 (21 CFR 807.31), which
requires device establishments to retain
and, upon FDA’s specific request,
submit certain additional listing
information.
DATES: Submit written or electronic
comments on the collection of
information by April 7, 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472
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
PO 00000
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6731
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.
Additional Listing Information for
Medical Device Registration and
Listing—21 CFR 80.31; (OMB Control
Number 0910–0387)—Extension
The Food and Drug Administration
Amendments Act of 2007 (the 2007
Amendments), enacted September 27,
2007, requires that device establishment
registrations and listings under 21
U.S.C. 360(p) (including the submission
of updated information), be submitted to
the Secretary of Health and Human
Services (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. See section 224 of the 2007
Amendments. The 2007 Amendments
provides for an October 1, 2007,
effective date by which FDA expects
approximately 30,000 establishments to
begin registering. FDA is seeking OMB
approval for the information collected
by electronic means. Registration by
electronic means for device
establishments will mean replacement
of FDA Forms 2891 and 2891a,
‘‘Registration of Device Establishment’’
and FDA Form 2892 ‘‘Medical Device
Listing,’’ with electronic versions.
However, for OMB approval of the
extension request for this collection of
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6732
Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices
information, FDA is revising the scope
to address only the reporting and
recordkeeping requirements by nonelectronic means as described in this
document and set forth under § 807.31
for ‘‘ Additional Listing Information.’’
To reflect the revised scope of this
collection of information, FDA has
modified the title.
Under § 807.31(a) through (d), each
owner or operator is required to
maintain an historical file containing
the labeling and advertisements in use
on the date of initial listing, and in use
after October 10, 1978, but before the
date of initial listing. The owner or
operator must maintain in the historical
file any labeling or advertisements in
which a material change has been made
anytime after initial listing, but may
discard labeling and advertisements
from the file 3 years after the date of the
last shipment of a discontinued device
by an owner or operator. Along with the
recordkeeping requirements, under
§ 807.31(e), the owner or operator must
be prepared to submit to FDA copies of
: (1) All device labeling, (2) all device
labeling and representative advertising,
or (3) only representative package
inserts, depending upon whether the
device is subject to the regulatory
controls under Sections 514 or 515 of
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360d and 360e,
respectively), or restrictions imposed by
21 CFR 801.109 or otherwise by section
520(e) of the act.
The information collected under these
provisions is used by FDA to identify:
(1) Firms subject to FDA’s regulations,
(2) geographic distribution in order to
effectively allocate FDA’s field
resources for these inspections, and (3)
the class of the device that determines
the frequency of inspection. As a result,
when complications occur with a
particular device or component, all
manufacturers of similar or related
devices can easily be identified.
The likely respondents to this
information collection are domestic and
foreign device establishments who must
register and submit a device list to FDA,
e.g., establishments engaged in the
manufacture, preparation, propagation,
compounding, assembly, or processing
of medical devices intended for human
use and commercial distribution.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
807.31(e)
1There
Annual Frequency
of Response
200
Total Annual
Responses
1
Hours per
Response
200
Total Hours
.50
100
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
807.31(a) through (d )
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1There
Annual Frequency
of Recordkeeping
16,200
Total Annual
Records
4
Hours per
Record
64,800
Total Hours
.50
32,400
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual respondent reporting
burden for device establishment
registrations and listing is estimated to
be 100 hours and the annual respondent
recordkeeping burden is estimated to be
32,400 hours. The estimates cited in
tables 1 and 2 of this documet are based
primarily on the annual FDA
accomplishment report, which includes
actual FDA registration and listing data
derived for fiscal year (FY) 2006. These
estimates are also based on FDA
estimates of FY 2006 data from current
systems and conversations with
industry and trade association
representatives. FDA anticipates
reviewing annually, 200 historical files.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through the FDMS only.
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2079 Filed 2–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review:
Comment Request Questionnaire
Cognitive Interview and Pretesting
(ARP/DCCPS/NCI)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 26, 2007 (Vol. 72,
No. 226, p. 65969) and allowed 60 days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
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Sfmt 4703
after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title:
Questionnaire Cognitive Interview and
Pretesting. Type of Information
Collection Request: New. Need and Use
of Information Collection: The purpose
of the data collection is to conduct
cognitive interviews, focus groups, Pilot
household interviews, and experimental
research in laboratory and field settings,
both for applied questionnaire
evaluation and more basic research on
response errors in surveys. The most
common evaluation method is the
cognitive interview, in which a
questionnaire design specialist
interviews a volunteer participant. The
interviewer administers the draft survey
questions as written, but also probes the
participant in depth about
interpretations of questions, recall
processes used to answer them, and
adequacy of response categories to
express answers, while noting points of
confusion and errors in responding.
Interviews are generally conducted in
small rounds of 10–15 interviews. When
possible, cognitive interviews are
conducted in the survey’s intended
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]]>Agencies
[Federal Register Volume 73, Number 24 (Tuesday, February 5, 2008)]
[Notices]
[Pages 6731-6732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N-0016]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Additional Listing Information for Medical Device
Registration and Listing
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 public comments on the reporting and
recordkeeping burden associated with the paperwork requirements under
Sec. 807.31 (21 CFR 807.31), which requires device establishments to
retain and, upon FDA's specific request, submit certain additional
listing information.
DATES: Submit written or electronic comments on the collection of
information by April 7, 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 the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472
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.
Additional Listing Information for Medical Device Registration and
Listing--21 CFR 80.31; (OMB Control Number 0910-0387)--Extension
The Food and Drug Administration Amendments Act of 2007 (the 2007
Amendments), enacted September 27, 2007, requires that device
establishment registrations and listings under 21 U.S.C. 360(p)
(including the submission of updated information), be submitted to the
Secretary of Health and Human Services (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. See section 224 of the 2007
Amendments. The 2007 Amendments provides for an October 1, 2007,
effective date by which FDA expects approximately 30,000 establishments
to begin registering. FDA is seeking OMB approval for the information
collected by electronic means. Registration by electronic means for
device establishments will mean replacement of FDA Forms 2891 and
2891a, ``Registration of Device Establishment'' and FDA Form 2892
``Medical Device Listing,'' with electronic versions. However, for OMB
approval of the extension request for this collection of
[[Page 6732]]
information, FDA is revising the scope to address only the reporting
and recordkeeping requirements by non-electronic means as described in
this document and set forth under Sec. 807.31 for `` Additional
Listing Information.'' To reflect the revised scope of this collection
of information, FDA has modified the title.
Under Sec. 807.31(a) through (d), each owner or operator is
required to maintain an historical file containing the labeling and
advertisements in use on the date of initial listing, and in use after
October 10, 1978, but before the date of initial listing. The owner or
operator must maintain in the historical file any labeling or
advertisements in which a material change has been made anytime after
initial listing, but may discard labeling and advertisements from the
file 3 years after the date of the last shipment of a discontinued
device by an owner or operator. Along with the recordkeeping
requirements, under Sec. 807.31(e), the owner or operator must be
prepared to submit to FDA copies of : (1) All device labeling, (2) all
device labeling and representative advertising, or (3) only
representative package inserts, depending upon whether the device is
subject to the regulatory controls under Sections 514 or 515 of Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d and 360e,
respectively), or restrictions imposed by 21 CFR 801.109 or otherwise
by section 520(e) of the act.
The information collected under these provisions is used by FDA to
identify: (1) Firms subject to FDA's regulations, (2) geographic
distribution in order to effectively allocate FDA's field resources for
these inspections, and (3) the class of the device that determines the
frequency of inspection. As a result, when complications occur with a
particular device or component, all manufacturers of similar or related
devices can easily be identified.
The likely respondents to this information collection are domestic
and foreign device establishments who must register and submit a device
list to FDA, e.g., establishments engaged in the manufacture,
preparation, propagation, compounding, assembly, or processing of
medical devices intended for human use and commercial distribution.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.31(e) 200 1 200 .50 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.31(a) through (d ) 16,200 4 64,800 .50 32,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The annual respondent reporting burden for device establishment
registrations and listing is estimated to be 100 hours and the annual
respondent recordkeeping burden is estimated to be 32,400 hours. The
estimates cited in tables 1 and 2 of this documet are based primarily
on the annual FDA accomplishment report, which includes actual FDA
registration and listing data derived for fiscal year (FY) 2006. These
estimates are also based on FDA estimates of FY 2006 data from current
systems and conversations with industry and trade association
representatives. FDA anticipates reviewing annually, 200 historical
files.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through the FDMS only.
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2079 Filed 2-4-08; 8:45 am]
BILLING CODE 4160-01-S
