Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing, 23467-23468 [E8-9374]
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Federal Register / Vol. 73, No. 84 / Wednesday, April 30, 2008 / Notices
currently in the HDS. FDA believes that
adding the pet food labeling questions
to the HDS is the most cost effective
way of collecting this information and
precludes the need for a separate pet
food labeling survey, thus reducing the
overall burden to the public.
23467
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Statutory Authority
Public Law 110–85
Sec. 1002(a)(3)
1 There
1,000
Dated: April 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9373 Filed 4–29–08; 8:45 am]
Hours per
Response
1,000
[Docket No. FDA–2008–N–0088] (formerly
Docket No. 2008N–0016)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Additional Listing
Information for Medical Device
Registration and Listing
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 30,
2008.
17:09 Apr 29, 2008
Jkt 214001
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.
Additional Listing Information for
Medical Device Registration and
Listing—(OMB Control Number 0910–
0387)—Extension
Food and Drug Administration
VerDate Aug<31>2005
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0387. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rwilkins on PROD1PC63 with NOTICES
1
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
ACTION:
Total Annual
Responses
Total Hours
0.08
80
are no capital costs or operating and maintenance costs associated with this collection of information.
This burden estimate does not
represent a new estimate of burden
hours. Instead, it represents the
estimated number of respondents and
burden hours that will be used from the
current approval for 0910–0545 to
conduct the pet food labeling questions.
The total estimated burden for 0910–
0545 is 1,300 hours. Please note that on
January 15, 2008, the FDA Division of
Dockets Management Web site
transitioned to the Federal Dockets
Management System (FDMS). FDMS is
a Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
AGENCY:
Annual Frequency
per Response
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. FDA expects 20,000 to
30,000 establishments will need to
register between now and December 31,
2008. 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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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 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 in § 807.31 (21 CFR 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 section 514 or section
515 of Federal Food, Drug, and
Cosmetic Act (the act), 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
E:\FR\FM\30APN1.SGM
30APN1
23468
Federal Register / Vol. 73, No. 84 / Wednesday, April 30, 2008 / Notices
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.
In the Federal Register of February 5,
2008 (73 FR 6731), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
807.31(e)
1 There
Annual Frequency
per 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
No. of
Recordkeepers
21 CFR Section
807.31(a through d)
1 There
16,200
Dated: April 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9374 Filed 4–29–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
rwilkins on PROD1PC63 with NOTICES
[Docket No. FDA–2008–N–0222] (formerly
Docket No. 2008N–0007)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Drugs;
Common European Medicines Agency/
Food and Drug Administration
Application Form for Orphan Medicinal
Product Designation (Form FDA 3671)
Food and Drug Administration,
HHS.
ACTION:
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 document 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.
AGENCY:
Annual Frequency
per Recordkeeping
Notice.
VerDate Aug<31>2005
17:09 Apr 29, 2008
Jkt 214001
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 30,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0167. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration,5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Orphan Drugs; Common European
Medicines Agency/Food and Drug
Administration Application Form for
Orphan Medicinal Product Designation
(Form FDA 3671)—(OMB Control
Number 0910–0167)—Extension
Sections 525 and 526 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360aa and 360dd) give FDA
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
statutory authority to do the following:
(1) Provide recommendations on
investigations required for approval of
marketing applications for orphan
drugs, (2) designate eligible drugs as
orphan drugs, (3) set forth conditions
under which a sponsor of an approved
orphan drug obtains exclusive approval,
and (4) encourage sponsors to make
orphan drugs available for treatment on
an ‘‘open protocol’’ basis before the drug
has been approved for general
marketing. The implementing
regulations for these statutory
requirements have been codified under
part 316 (21 CFR part 316) and specify
procedures that sponsors of orphan
drugs use in availing themselves of the
incentives provided for orphan drugs in
the act and sets forth procedures FDA
will use in administering the act with
regard to orphan drugs. Section 316.10
specifies the content and format of a
request for written recommendations
concerning the non-clinical laboratory
studies and clinical investigations
necessary for approval of marketing
applications. Section 316.12 provides
that, before providing such
recommendations, FDA may require
results of studies to be submitted for
review. Section 316.14 contains
provisions permitting FDA to refuse to
provide written recommendations under
certain circumstances. Within 90 days
of any refusal, a sponsor may submit
additional information specified by
FDA. Section 316.20 specifies the
content and format of an orphan drug
application which includes
requirements that an applicant
document that the disease is rare (affects
fewer than 200,000 persons in the
United States annually) or that the
sponsor of the drug has no reasonable
E:\FR\FM\30APN1.SGM
30APN1
]]>Agencies
[Federal Register Volume 73, Number 84 (Wednesday, April 30, 2008)]
[Notices]
[Pages 23467-23468]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9374]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0088] (formerly Docket No. 2008N-0016)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 30,
2008.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0387. Also
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Additional Listing Information for Medical Device Registration and
Listing--(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. FDA expects 20,000 to 30,000 establishments will need
to register between now and December 31, 2008. 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 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 in Sec.
807.31 (21 CFR 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 section 514 or section 515 of
Federal Food, Drug, and Cosmetic Act (the act), 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
[[Page 23468]]
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.
In the Federal Register of February 5, 2008 (73 FR 6731), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per 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 Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
807.31(a 16,200 4 64,800 .50 32,400
through d)
----------------------------------------------------------------------------------------------------------------
\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 document 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.
Dated: April 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9374 Filed 4-29-08; 8:45 am]
BILLING CODE 4160-01-S
