Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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”), 6895-6896 [E9-2902]
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<![CDATA[
6895
Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
170.36
25
1
25
150
3,750
570.36
5
1
5
150
750
Total
4,500
1 There
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
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours Per
Record
Total Hours
170.36(c)(v)
25
1
25
15
375
570.36(c)(v)
5
1
5
15
75
Total
1 There
450
are no capital costs or operating and maintenance costs associated with this collection of information.
In the proposed rule, FDA estimated
that the Center for Food Safety and
Applied Nutrition (CFSAN) would
receive approximately 50 GRAS notices
per year and that the Center for
Veterinary Medicine (CVM) would
receive approximately 10 GRAS notices
per year. Although FDA requested
comment on this estimate, the
comments did not provide useful
information regarding this issue.
Therefore, FDA evaluated the number of
notices received by CFSAN to date.
CFSAN received 274 GRAS notices
during the 11-year period from 1998
through 2008, for an average of
approximately 25 GRAS notices per
year. Based on this experience, FDA is
revising its estimate of the annual
number of GRAS notices submitted to
CFSAN to be 25 or less. FDA also is
revising its estimate of the annual
number of GRAS notices submitted to
CVM to be 5 or less.
Dated: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2861 Filed 2–10–09; 8:45 am]
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BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
in brackets in the heading of this
document.
Food and Drug Administration
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.
[Docket No. FDA–2008–N–0571]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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 March 13,
2009.
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
oira_submissions@OMB.eop.gov. All
comments should be identified with the
OMB control number 0910–0577. Also
include the FDA docket number found
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry and Food and
Drug Administration Staff; 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
E:\FR\FM\11FEN1.SGM
11FEN1
6896
Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices
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.
In the Federal Register of November
17, 2008 (73 FR 67873), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. The agency received one
comment in support of the collection of
information stating that it is necessary
to help reprocessors of SUDs comply
with section 502(u) of the act. The
comment further stated that the
estimated reporting burden did not
appear excessive.
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)
1There
10
Total Annual
Responses
100
Hours per
Response
1,000
Total Hours
.1
100
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2902 Filed 2–10–09; 8:45 am]
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0026]
Apothecon et al.; Withdrawal of
Approval of 103 New Drug
Applications and 35 Abbreviated New
Drug Applications
Food and Drug Administration,
HHS.
Application No.
Silver Spring, MD 20993–0002, 301–
796–3601.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of 103 new drug applications
(NDAs) and 35 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
BILLING CODE 4160–01–S
AGENCY:
Annual Frequency
per Response
DATES:
The
holders of the applications listed in the
table in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications. The applicants have also,
by their requests, waived their
opportunity for a hearing.
SUPPLEMENTARY INFORMATION:
Effective March 13, 2009.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Drug
Applicant
Pronestyl (procainamide hydrochloride (HCl))
Capsules and Injection
Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000
NDA 7–935
Phenergan (promethazine HCl) Tablets
Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101–
8299
NDA 9–193
Cogentin (benztropine mesylate) Tablets
Merck & Co., Inc., Sunneytown Pike, P.O. Box 4, BLA–20, West Point,
PA 19486
NDA 9–986
Deltasone (prednisone) Tablets
Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York,
NY 10017
NDA 10–374
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NDA 7–335
Medihaler-Epi (epinephrine bitartrate)
3M Pharmaceuticals, 3M Center, Bldg. 0275–05–W–12, St. Paul, MN
55144–1000
NDA 10–375
Medihaler-ISO (isoproterenol)
Do.
NDA 10–598
Bendectin (doxylamine succinate and pyridoxine
HCl) Tablets
Sanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807–
0977
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11FEN1
]]>Agencies
[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6895-6896]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2902]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0571]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 March
13, 2009.
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 oira_submissions@OMB.eop.gov. All
comments should be identified with the OMB control number 0910-0577.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry and Food and Drug Administration Staff;
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
[[Page 6896]]
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.
In the Federal Register of November 17, 2008 (73 FR 67873), FDA
published a 60-day notice requesting public comment on the information
collection provisions. The agency received one comment in support of
the collection of information stating that it is necessary to help
reprocessors of SUDs comply with section 502(u) of the act. The comment
further stated that the estimated reporting burden did not appear
excessive.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section of the No. of Annual Frequency Total Annual Hours per
Act Respondents per Response 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.
Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2902 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S
