General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 52110 [05-17412]
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices
FDA expects that, although all sizes of
business are eligible, small businesses
and very small businesses are the firms
most likely to be able to demonstrate a
need to request an extension to the trans
fat labeling deadline. The agency has
already received three requests from
businesses regarding the trans fat
labeling compliance date of January 1,
2006. Because small businesses are
more likely to submit requests for
extensions, and most of the affected
businesses are small, we use the number
of small businesses as the base to
calculate the reporting burden. The
regulatory flexibility analysis of the
trans fat final rule estimated that 11,180
small businesses will have to revise the
label on their products as a result of the
trans fat final rule. Given that only three
businesses have submitted requests to
FDA so far, FDA estimates that, in the
first year following the issuance of the
guidance, the total number of businesses
that will request a labeling compliance
extension from FDA can be estimated as
approximately 0.5 percent of the
number of small businesses, which
equals 56.
FDA estimates that it will take one
employee approximately 4 hours to put
together a request to FDA and
approximately 1 hour for a supervisor to
look over the request before submitting
it to the agency. Thus, each firm
submitting a compliance extension
request will need 5 hours of employee
time to complete the request. Given that
56 businesses are expected to submit
written requests in year one, the total
burden hours for year one are 280.
In year two, FDA expects about onehalf as many firms to request a labeling
compliance extension. So for year two,
28 firms are expected to file a request
for an extension to the labeling
compliance date. Again, assuming that
it will take 5 hours to complete each
request, the total burden hours for year
two will be 140.
Dated: August 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17413 Filed 8–29–05; 2:49 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
General Hospital and Personal Use
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<18>2005
16:30 Aug 31, 2005
Jkt 205001
ACTION:
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: General Hospital
and Personal Use Devices Panel of the
Medical Devices 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 September 27, 2005, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Scott Colburn, Center
for Devices and Radiological Health
(HFZ–480), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1287,
ext. 177, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512520. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a
presentation on FDA’s Critical Path
Initiative. Subsequently, the committee
will discuss and make
recommendations regarding general
issues related to the model used for
validation testing to support a claim of
decontamination of potentially
transmissible spongiform
encephalopathy (TSE)-contaminated
surgical instruments. Background
information for the topics, including the
agenda and questions for the committee,
will be available to the public 1
business day before the meeting, on the
Internet at https://www.fda.gov/cdrh/
panelmtg.html.
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 by September 13, 2005. Oral
presentations from the public will be
scheduled for approximately 60 minutes
at the beginning of deliberations and for
approximately 30 minutes near the end
of deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before September 13, 2005, 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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
an indication of the approximate time
requested to make their presentation.
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 AnnMarie
Willliams at 240–276–0450, ext. 113, at
least 7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 23, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05–17412 Filed 8–31–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
Health Resources and Services
Administration, HHS.
ACTION: Notice; amendment.
AGENCY:
SUMMARY: The Health Resources and
Services Administration is amending a
notice that appeared in the Federal
Register of August 22, 2005 (70 FR
48962–48963) announcing an Advisory
Commission on Childhood Vaccines
meeting on September 14, 2005. The
document announced that the public
can join the meeting by attending in
person or by audio conference call. The
meeting will now be held by audio
conference call only. This document
amends the notice by changing the place
of the meeting.
FOR FURTHER INFORMATION CONTACT: Ms.
Cheryl Lee at 301–443–2124 or e-mail
clee@hrsa.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
05–16502, beginning on page 48962 in
the Federal Register of Monday, August
22, 2005, make the following
amendment on page 48963 in the third
paragraph: Change place of meeting to
Audio Conference Call.
Dated: August 25, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–17379 Filed 8–31–05; 8:45 am]
BILLING CODE 4165–15–P
E:\FR\FM\01SEN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Notices]
[Page 52110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17412]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
General Hospital and Personal Use Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: 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: General Hospital and Personal Use Devices Panel
of the Medical Devices 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 September 27, 2005, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Scott Colburn, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1287, ext. 177, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512520. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a presentation on FDA's Critical
Path Initiative. Subsequently, the committee will discuss and make
recommendations regarding general issues related to the model used for
validation testing to support a claim of decontamination of potentially
transmissible spongiform encephalopathy (TSE)-contaminated surgical
instruments. Background information for the topics, including the
agenda and questions for the committee, will be available to the public
1 business day before the meeting, on the Internet at https://
www.fda.gov/cdrh/panelmtg.html.
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 by September 13,
2005. Oral presentations from the public will be scheduled for
approximately 60 minutes at the beginning of deliberations and for
approximately 30 minutes near the end of deliberations. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before September
13, 2005, 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
requested to make their presentation.
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 AnnMarie Willliams
at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 23, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17412 Filed 8-31-05; 8:45 am]
BILLING CODE 4160-01-S
