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; Availability, 25594-25595 [E6-6458]
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Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
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a brief statement of the general nature of
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Dated: April 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–6509 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0401]
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; Availability
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘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.’’ The Medical Device User Fee
and Modernization Act 2002
(MDUFMA), as amended by the Medical
Device User Fee Stabilization Act of
2005 (MDUFSA), requires that FDA
issue guidance identifying the
circumstances in which the name,
abbreviation, or symbol of the
manufacturer of an original device is not
‘‘prominent and conspicuous.’’
MDUFSA requires that FDA issue
VerDate Aug<31>2005
17:38 Apr 28, 2006
Jkt 208001
guidance no later than 180 days after the
date of enactment (August 1, 2005).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies on a 3.5’’ diskette of the
guidance document entitled
‘‘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’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–443–
8818. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this guidance 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.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Casper E. Uldriks, Center for Devices
and Radiological Health (HFZ–300),
Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240–
276–0106.
SUPPLEMENTARY INFORMATION:
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on ‘‘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.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
I. Background
MDUFMA (Public Law 107–250)
amended section 502 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 352) to require a device, or
an attachment to the device, 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.
This labeling provision applied to all
devices and all device manufacturers.
On August 1, 2005, MDUFSA (Public
Law 109–43) amended section 502(u) of
the act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Therefore, section 502(u) of the
act, as amended by MDUFSA, no longer
sets forth requirements for original
equipment manufacturers, unless they
also reprocess SUDs. Under the
amended provision, if an original device
III. Electronic Access
To receive ‘‘ 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’’ by fax, call the CDRH FactsOn-Demand system at 800–899–0381 or
301–827–0111 from a touch-tone
telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to
order a document. Enter the document
number (1217) followed by the pound
sign (#). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy
of the guidance may also do so by using
the Internet. CDRH maintains an entry
on the Internet for easy access to
information including text, graphics,
and files that may be downloaded to a
personal computer with Internet access.
Updated on a regular basis, the CDRH
home page includes device safety alerts,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
or an attachment to it does not
prominently and conspicuously bear the
name of the manufacturer of the original
device, a generally recognized
abbreviation of such name, or a unique
and generally recognized symbol
identifying such manufacturer, the
manufacturer who reprocesses the SUD
may identify itself using a detachable
label on the packaging of the device.
Section 2(c)(2) of MDUFSA requires
that FDA issue guidance not later than
180 days after the date of its enactment
to identify the circumstances under
which the identifying mark of a
manufacturer of an original device is not
‘‘prominent and conspicuous,’’ as used
in section 502(u) of the act. On October
11, 2005, FDA issued draft guidance
describing the circumstances under
which the agency would not consider a
manufacturer’s mark to be prominent
and conspicuous. FDA received several
comments on the draft guidance, all of
which were considered in finalizing the
guidance.
E:\FR\FM\01MYN1.SGM
01MYN1
25595
Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
Federal Register reprints, information
on premarket submissions (including
lists of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Paperwork Reduction Act of 1995
Project: Strategic Prevention
Framework State Incentive Grant (SPF
SIG) Program—New
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Substance Abuse
Prevention (CSAP) is responsible for the
Evaluation of the Strategic Prevention
Framework State Incentive Grant (SPF
SIG) Program. The program is a major
national initiative designed to: (1)
Prevent the onset and reduce the
progression of substance abuse,
including childhood and underage
drinking; (2) reduce substance abuserelated problems in communities; and,
(3) build prevention capacity and
infrastructure at the State/territory and
community levels. Five steps comprise
the SPF:
I Step 1: Profile population needs,
resources, and readiness to address
needs and gaps.
I Step 2: Mobilize and/or build
capacity to address needs.
I Step 3: Develop a comprehensive
strategic plan.
I Step 4: Implement evidence-based
prevention programs, policies, and
practices.
I Step 5: Monitor, evaluate, sustain,
and improve or replace those that fail.
Under a contract with CSAP, an
evaluation team will implement a multimethod quasi-experimental evaluation
at national, State, and community
levels. Evaluation data will be collected
from 26 states receiving grants in 2004
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44
U.S.C. 3501–3520). The collection(s) of
information in this guidance were
approved under OMB control number
0910–0577.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6458 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
and 2005 and as many as 32 non-grantee
states that will serve as a comparison
group. The primary evaluation objective
is to determine the impact of SPF SIG
on the SAMHSA National Outcome
Measures (NOMs).
This notice invites comment on statelevel and community-level data
collection instruments. The instruments
for assessing state-level change will be
included in an OMB review package
submitted immediately after the
expiration of the comment period and
are the main focus of this
announcement. These instruments will
be reviewed first by OMB to ensure that
state-level data collection occurs as
specified in the evaluation plan (on or
before June 30, 2006). Because the states
have not awarded community-level
funding, the evaluators will not initiate
community-level data collection until
late in 2006. Thus, the community-level
survey will be submitted as an
addendum approximately one month
after the comment period expires.
However, the instrument is described in
this notice and comments on the
instrument are invited.
State-Level Data Collection
Two instruments were developed for
assessing state-level effects. Both
instruments are guides for telephone
interviews that will be conducted by
trained interviewers three to four times
over the life of the SPF SIG award. The
Strategic Prevention Framework Index
will be used to assess the relationship
between SPF implementation and
change in the national outcome
measures. The State Infrastructure
Index will capture data to assess
infrastructure change and to test the
relationship of this change to outcomes.
Prevention infrastructure refers to the
organizational features of the system
that delivers prevention services,
including all procedures related to
planning, data management systems,
workforce development, intervention
implementation, evaluation and
monitoring, financial management, and
sustainability. The estimated annual
burden for state-level data collection is
displayed below in the table.
STATE LEVEL BURDEN ESTIMATE
[Year 1]
cchase on PROD1PC60 with NOTICES
Interview guide
SPF Implementation
Index.
VerDate Aug<31>2005
Number of
respondents
Content description
SEW activities, indicators for each SPF step, including cultural competence throughout all
five steps.
18:29 Apr 28, 2006
Jkt 208001
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Number of
responses
26
E:\FR\FM\01MYN1.SGM
Hourly burden
per response
1
01MYN1
3
Total hourly
burden
78
]]>Agencies
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)]
[Notices]
[Pages 25594-25595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6458]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0401]
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; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``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.'' The Medical Device User Fee and Modernization Act 2002
(MDUFMA), as amended by the Medical Device User Fee Stabilization Act
of 2005 (MDUFSA), requires that FDA issue guidance identifying the
circumstances in which the name, abbreviation, or symbol of the
manufacturer of an original device is not ``prominent and
conspicuous.'' MDUFSA requires that FDA issue guidance no later than
180 days after the date of enactment (August 1, 2005).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``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'' to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this guidance 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.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices
and Radiological Health (HFZ-300), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0106.
SUPPLEMENTARY INFORMATION:
I. Background
MDUFMA (Public Law 107-250) amended section 502 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352) to require a
device, or an attachment to the device, 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. This labeling provision applied to all
devices and all device manufacturers.
On August 1, 2005, MDUFSA (Public Law 109-43) amended section
502(u) of the act by limiting the provision to reprocessed single-use
devices (SUDs) and the manufacturers who reprocess them. Therefore,
section 502(u) of the act, as amended by MDUFSA, no longer sets forth
requirements for original equipment manufacturers, unless they also
reprocess SUDs. Under the amended provision, if an original device or
an attachment to it does not prominently and conspicuously bear the
name of the manufacturer of the original device, a generally recognized
abbreviation of such name, or a unique and generally recognized symbol
identifying such manufacturer, the manufacturer who reprocesses the SUD
may identify itself using a detachable label on the packaging of the
device.
Section 2(c)(2) of MDUFSA requires that FDA issue guidance not
later than 180 days after the date of its enactment to identify the
circumstances under which the identifying mark of a manufacturer of an
original device is not ``prominent and conspicuous,'' as used in
section 502(u) of the act. On October 11, 2005, FDA issued draft
guidance describing the circumstances under which the agency would not
consider a manufacturer's mark to be prominent and conspicuous. FDA
received several comments on the draft guidance, all of which were
considered in finalizing the guidance.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on ``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.'' It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
To receive `` 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'' by fax, call
the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a
touch-tone telephone. Press 1 to enter the system. At the second voice
prompt, press 1 to order a document. Enter the document number (1217)
followed by the pound sign (). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
[[Page 25595]]
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH web site may be accessed at
https://www.fda.gov/cdrh. A search capability for all CDRH guidance
documents is available at https://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at https://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collection(s) of information in this guidance were approved under
OMB control number 0910-0577.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Comments received may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6458 Filed 4-28-06; 8:45 am]
BILLING CODE 4160-01-S
