Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 5812-5813 [2012-2555]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
5812
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Notices
environmental strategies and
interventions to improve the health of
students and school staff by promoting
healthy eating, physical activity, and a
tobacco-free lifestyle; (2) supports
implementation and evaluation of a
coordinated approach to school health
and best practices in health education;
physical education and other physical
activity programs; nutrition services;
school health services; school
counseling, psychological, and social
services; health promotion for staff;
family and community involvement;
and school health and safety policies
and environment; (3) provides
leadership and consultation on how
schools work and how to foster effective
collaboration between the public health
and education sectors; (4) documents
and strengthens the scientific
associations among chronic diseaserelated health risks, school-based health
promotion initiatives, and academic
achievement; (5) evaluates school-based
policy, systems, and environmental
changes and interventions to improve
health behaviors and reduce chronic
disease-related health risks among
children and adolescents; (6)
synthesizes and translates scientific
research to develop and disseminate
guidance, tools, and resources to help
schools prevent chronic disease-related
risks among children and adolescents;
(7) supports efforts of national, state,
and local surveillance systems to
monitor chronic disease-related health
risk behaviors among youth, along with
the policies, programs, and practices
schools implement to address those
health risk behaviors; (8) strengthens
efforts of national, state, and local
programs to provide high quality
professional development services to
support school-based chronic disease
prevention policies, programs, and
practices; (9) in accomplishing the
functions listed above, collaborates with
other components of CDC and HHS; the
U.S. Department of Education, U.S.
Department of Agriculture, and other
federal agencies; national professional,
voluntary, and philanthropic
organizations; international agencies;
and other organizations as appropriate;
and (10) assists other nations in
reducing chronic disease-related health
risks among children and adolescents
and in implementing and improving
school health programs.
VerDate Mar<15>2010
17:27 Feb 03, 2012
Jkt 226001
Dated: January 20, 2012.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2012–2531 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 7,
2012.
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) 395–7285, or emailed to
oira_submission@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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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.
SUMMARY:
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices
(OMB Control Number 0910–0577)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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 (Pub. L. 107–
250) amended section 502 of the FD&C
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 (Pub.
L. 109–43) amends section 502(u) of the
FD&C 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 FD&C Act impose a minimal burden
on industry. This section of the FD&C
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 September
27, 2011 (76 FR 59704), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\06FEN1.SGM
06FEN1
5813
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act section
502(u) ...................................................................................
1 There
[FR Doc. 2012–2555 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
10
Total annual
responses
100
Average
burden per
response
1,000
Total hours
.1
100
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 21, 2012, from 8 a.m. to
12:45 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, Fax: (301) 847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–(800)
741–8138 ((301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
VerDate Mar<15>2010
17:27 Feb 03, 2012
Jkt 226001
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
new drug application (NDA) 202497,
MARQIBO (vincristine sulfate
liposomes injection), application
submitted by Talon Therapeutics, Inc.
The proposed indication (use) for this
product is for the treatment of adult
patients with Philadelphia
chromosome-negative acute
lymphoblastic leukemia in second or
greater relapse or whose disease has
progressed following two or more
treatment lines of anti-leukemia
therapy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 6, 2012. Oral
presentations from the public will be
scheduled between approximately
10:45 a.m. and 11:45 a.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
requested to make their presentation on
or before February 27, 2012. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 28, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: January 31, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–2460 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0057]
Cardiovascular Metallic Implants:
Corrosion, Surface Characterization,
and Nickel Leaching; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Pages 5812-5813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2555]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0672]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prominent and
Conspicuous Mark of Manufacturers on Single-Use Devices
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
7, 2012.
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) 395-7285, or emailed to oira_submission@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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
(OMB Control Number 0910-0577)--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C 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 (Pub. L. 107-250) amended
section 502 of the FD&C 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 (Pub. L. 109-43) amends section 502(u) of the FD&C 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 FD&C Act impose a minimal
burden on industry. This section of the FD&C 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 September 27, 2011 (76 FR 59704), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 5813]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FD&C Act section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2555 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P
