Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly “Reprocessed Single-Use Device Labeling”), 67873-67874 [E8-27178]
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67873
Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices
2011; and (4) identifies technical
resources for use by State courts during
the course of the program. This Program
Instruction contains information
collection requirements pursuant to
receiving a grant award that are found
in Public Law 103–66, as amended by
Public Law 105–89, Public Law 107–
133, Public Law 109–239, and Public
Law 109–288. The agency will use the
information received to ensure
compliance with the statute and provide
Number of
respondents
Instrument
Application .......................................................................................................
Annual program report .....................................................................................
Estimated Total Annual Burden
Hours: 3,952.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 12, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–27234 Filed 11–14–08; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4184–01–P
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18:18 Nov 14, 2008
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2008–N–0571]
Food and Drug Administration,
HHS.
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
reprocessed single-use device labeling.
DATES: Submit written or electronic
comments on the collection of
information by January 16, 2009.
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.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
1
1
Average
burden hours
per response
Total burden
hours
40
36
2,080
1,872
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.
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:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Compliance With
the Medical Device User Fee and
Modernization Act of 2002, as
Amended: Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices (formerly
‘‘Reprocessed Single-Use Device
Labeling’’)
ACTION:
Number of
responses per
respondent
52
52
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
training and technical assistance to the
grantees.
Respondents: State Courts.
Annual Burden Estimates.
E:\FR\FM\17NON1.SGM
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67874
Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices
Compliance With Section 301 of the
Medical Device User Fee and
Modernization Act of 2002, as
Amended: Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices (formerly ‘‘Reprocessed SingleUse Device Labeling’’) (Federal Food,
Drug, and Cosmetic Act, Section 502(u))
(OMB Control Number 0910–0577)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
352), among other things, establishes
requirements that the label or labeling of
a medical device must meet so that it is
not misbranded and subject to
regulatory action. Section 301 of the
Medical Device User Fee and
Modernization Act of 2002 (Public Law
107–250) amended section 502 of the
act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Thus, the name for this information
collection activity has been changed to
more accurately describe the
information collection content.
Section 2(c) of The Medical Device
User Fee Stabilization Act of 2005
(Public Law 109–43) amends section
502(u) of the act by limiting the
provision to reprocessed single-use
devices (SUDs) and the manufacturers
who reprocess them. Under the
amended provision, if the original SUD
or an attachment to it prominently and
conspicuously bears the name of the
manufacturer, then the reprocessor of
the SUD is required to identify itself by
name, abbreviation, or symbol, in a
prominent and conspicuous manner on
the device or attachment to the device.
If the original SUD does not
prominently and conspicuously bear the
name of the manufacturer, the
manufacturer who reprocesses the SUD
for reuse may identify itself using a
detachable label that is intended to be
affixed to the patient record.
The requirements of section 502(u) of
the act impose a minimal burden on
industry. This section of the act only
requires the manufacturer, packer, or
distributor of a device to include their
name and address on the labeling of a
device. This information is readily
available to the establishment and easily
supplied. From its registration and
premarket submission database, FDA
estimates that there are 10
establishments that distribute
approximately 1,000 reprocessed SUDs.
Each response is anticipated to take 0.1
hours resulting in a total burden to
industry of 100 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Section of the Act
502(u)
No. of Responses
per Respondent
10
1 There
Total Annual
Responses
100
1,000
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27178 Filed 11–14–08; 8:45 am]
BILLING CODE 4160–01–S
SOMATULINE DEPOT and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0111]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SOMATULINE DEPOT
jlentini on PROD1PC65 with NOTICES
Food and Drug Administration,
HHS.
ACTION:
Total Hours
.1
100
are no capital costs or operating and maintenance costs associated with this collection of information.
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:
Hours Per
Response
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
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Jkt 217001
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
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Frm 00040
Fmt 4703
Sfmt 4703
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product SOMATULINE
DEPOT (lanreotide). SOMATULINE
DEPOT is indicated for the long-term
treatment of acromegalic patients who
E:\FR\FM\17NON1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Pages 67873-67874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0571]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Compliance With the Medical Device User Fee and Modernization
Act of 2002, as Amended: Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-Use
Device Labeling'')
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 reprocessed single-use device
labeling.
DATES: Submit written or electronic comments on the collection of
information by January 16, 2009.
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 67874]]
Compliance With Section 301 of the Medical Device User Fee and
Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark
of Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-
Use Device Labeling'') (Federal Food, Drug, and Cosmetic Act, Section
502(u)) (OMB Control Number 0910-0577)--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 352), among other things, establishes requirements that the
label or labeling of a medical device must meet so that it is not
misbranded and subject to regulatory action. Section 301 of the Medical
Device User Fee and Modernization Act of 2002 (Public Law 107-250)
amended section 502 of the act to add section 502(u) to require devices
(both new and reprocessed) to bear prominently and conspicuously the
name of the manufacturer, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying the
manufacturer. Thus, the name for this information collection activity
has been changed to more accurately describe the information collection
content.
Section 2(c) of The Medical Device User Fee Stabilization Act of
2005 (Public Law 109-43) amends section 502(u) of the act by limiting
the provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended provision, if the
original SUD or an attachment to it prominently and conspicuously bears
the name of the manufacturer, then the reprocessor of the SUD is
required to identify itself by name, abbreviation, or symbol, in a
prominent and conspicuous manner on the device or attachment to the
device. If the original SUD does not prominently and conspicuously bear
the name of the manufacturer, the manufacturer who reprocesses the SUD
for reuse may identify itself using a detachable label that is intended
to be affixed to the patient record.
The requirements of section 502(u) of the act impose a minimal
burden on industry. This section of the act only requires the
manufacturer, packer, or distributor of a device to include their name
and address on the labeling of a device. This information is readily
available to the establishment and easily supplied. From its
registration and premarket submission database, FDA estimates that
there are 10 establishments that distribute approximately 1,000
reprocessed SUDs. Each response is anticipated to take 0.1 hours
resulting in a total burden to industry of 100 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses per Total Annual Hours Per
Section of the Act Respondents Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
502(u) 10 100 1,000 .1 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27178 Filed 11-14-08; 8:45 am]
BILLING CODE 4160-01-S
