Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 20757-20758 [05-7948]
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Federal Register / Vol. 70, No. 76 / Thursday, April 21, 2005 / Notices
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 15
people. Call the ATSDR/ORR field office
for the conference bridge line and access
code.
Background: A Memorandum of
Understanding (MOU) was signed in
October 1990 and renewed in
September 2000 between ATSDR and
DOE. The MOU delineates the
responsibilities and procedures for
ATSDR’s public health activities at DOE
sites required under sections 104, 105,
107, and 120 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA or ASuperfund@). These
activities include health consultations
and public health assessments at DOE
sites listed on, or proposed for, the
Superfund National Priorities List and
at sites that are the subject of petitions
from the public; and other healthrelated activities such as epidemiologic
studies, health surveillance, exposure
and disease registries, health education,
substance-specific applied research,
emergency response, and preparation of
toxicological profiles.
In addition, under an MOU signed in
December 1990 with DOE and replaced
by an MOU signed in 2000, the
Department of Health and Human
Services (HHS) has been given the
responsibility and resources for
conducting analytic epidemiologic
investigations of residents of
communities in the vicinity of DOE
facilities, workers at DOE facilities, and
other persons potentially exposed to
radiation or to potential hazards from
non-nuclear energy production and use.
HHS has delegated program
responsibility to CDC. Community
involvement is a critical part of
ATSDR’s and CDC’s energy-related
research and activities, and input from
members of the ORRHES is part of these
efforts.
Purpose: The purpose of this meeting
is to address issues that are unique to
community involvement with the
ORRHES, and agency updates.
Matters To Be Discussed: Agenda item
will include a discussion on the draft
TSCA Public Health Assessment,
comments from the Exposure
Investigation Workgroup, and updates
from the Agency.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact:
Marilyn (Palmer) Horton, Designated
Federal Official and Health
Communications Specialist, Division of
Health Assessment and Consultation,
ATSDR, 1600 Clifton Road, NE M/S E–
32 Atlanta, Georgia 30333, telephone 1–
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888–42–ATSDR (28737), fax 404/498–
1744.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
ATDSR.
Dated: April 15, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–7994 Filed 4–20–05; 8:45 am]
20757
All information in this notice of
correction is accurate and replaces
information specified in the April 13
notice. Applications are still due by the
deadline date that was published in the
April 13 notice (May 13 for Letters of
Intent or Preapplications and June 13 for
Applications).
FOR FURTHER INFORMATION CONTACT: For
further information please contact the
Administration on Children, Youth and
Families, Head Start Bureau at (202)
205–8653 or rdailey@acf.hhs.gov.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 14, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 05–7949 Filed 4–20–05; 8:45 am]
BILLING CODE 4184–01–P
Administration for Children and
Families
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Children, Youth and
Families 2005 Head Start Tribally
Controlled Land Grant College and
University Partnerships; Notice of
Correction for the FY 05 Head Start
Tribally Controlled Land Grant College
and University Partnerships Program
Announcement, HHS–2005–ACF–
ACYF–YT–0012, CFDA# 93.600
Food and Drug Administration
Administration on Children,
Youth and Families, Head Start Bureau,
ACF, DHHS.
ACTION: Notice of corrections.
AGENCY:
SUMMARY: This notice is to inform
interested parties of corrections to the
Head Start Tribally Controlled Land
Grant College and University
Partnerships Program Announcement
that was published on Wednesday,
April 13, 2005. The following
corrections should be noted:
(1) Under Priority Areas I, Section VII.
Agency Contacts, Program Office
Contact, please delete the following
name, address, phone number, and email address: Katherine Gray, U.S.
Department of Health and Human
Services, Administration for Children
and Families, ACYF—Head Start
Bureau, 330 C Street, SW., Switzer
Room 2211, Washington, DC 20447.
Phone: 312–353–2260. E-mail:
kgray@acf.hhs.gov.
Please replace the deleted name,
address, phone number, and e-mail
address with the following: Rosalind
Dailey, U.S. Department of Health and
Human Services, Administration for
Children and Families, ACYF—Head
Start Bureau, 330 C Street, SW., Switzer
Room 2211, Washington, DC 20447.
Phone: 202–205–8653. E-mail:
rdailey@acf.hhs.gov.
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Anesthesiology and Respiratory
Therapy 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: Anesthesiology
and Respiratory Therapy 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 May 13, 2005, from 8 a.m. to
5:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A and B,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel Patel, Center for
Devices and Radiological Health (HFZ–
480), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 301–443–8611, ext. 3, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512624. 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 and a presentation by the
Office of Surveillance and Biometrics in
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Federal Register / Vol. 70, No. 76 / Thursday, April 21, 2005 / Notices
the Center for Devices and Radiological
Health outlining their responsibility for
the review of postmarket study design.
The committee will also discuss and
make recommendations regarding
general issues for pulse oximeters. The
issues include the equivalence of
reflectance sensor technology to
transmissive sensor technology;
validation recommendations for
neonatal intended use; and over-thecounter (OTC) use of pulse oximeters.
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 May 3, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by May 3, 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 Shirley
Meeks, Conference Management Staff, at
240–276–0450, ext. 105, 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: April 13, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–7948 Filed 4–20–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0410]
Guidance for Industry and Food and
Drug Administration Staff on
Application User Fees for Combination
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
and FDA staff entitled ‘‘Application
User Fees for Combination Products.’’
This document provides guidance to
industry and FDA staff on marketing
application user fees for combination
products. The guidance also describes
how the ‘‘barrier to innovation’’ waiver
provision under the prescription drug
user fee provisions of the Federal Food,
Drug, and Cosmetic Act (the act) may be
applied to innovative combination
products in the infrequent situation
where FDA requires the submission of
two marketing applications.
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
copies of this guidance to the Office of
Combination Products (HFG–3), 15800
Crabbs Branch Way, Rockville, MD
20855, or FAX: 301–427–1935. Send
one self-addressed adhesive label to
assist that office in processing your
requests. 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.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT:
Mark D. Kramer, Office of Combination
Products (HFG–3), Food and Drug
Administration, 15800 Crabbs Branch
Way, Rockville, MD 20855, 301–427–
1934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Application User Fees for
Combination Products.’’ In the Federal
Register of September 28, 2004 (69 FR
57942), FDA issued a notice of
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availability of a draft guidance
document covering the same topic.
As defined under 21 CFR 3.2(e), a
combination product is a product
comprised of any combination of a drug
and a device; a biological product and
a device; a drug and a biological
product; or a drug, device, and a
biological product. Depending upon the
type of combination product, approval,
clearance, or licensure may be obtained
through submission of a single
marketing application, or through
separate marketing applications for the
individual constituent parts of the
combination product. For most
combination products, a single
marketing application is sufficient for
the product’s approval, clearance, or
licensure. In some cases, two marketing
applications may be submitted for a
combination product when one
application would suffice. For example,
a sponsor may choose to submit two
applications when one would suffice in
order to receive some benefit from
having two applications. In other cases,
FDA may determine that two marketing
applications are necessary.
In 1992, Congress passed the
Prescription Drug User Fee Act
(PDUFA). PDUFA authorized FDA to
collect fees from companies that
produce certain human drug and
biological products. The Medical Device
User Fee and Modernization Act of 2002
amended the act to provide for user fees
for the review of device applications.
When a company requests approval of a
new drug, device, or biological product
prior to marketing, it must submit an
application along with a fee to support
the review process.
This document provides guidance to
industry and FDA staff on marketing
application user fees for combination
products. The guidance document
explains that combination products for
which a single marketing application is
submitted, should be assessed the user
fee associated with that particular type
of marketing application. The document
explains that if a sponsor chooses to
submit two marketing applications
when one would suffice, a user fee for
each application would ordinarily be
assessed. The document also explains
that in the infrequent situation where
FDA requires two marketing
applications for a combination product,
two application fees would ordinarily
be assessed. However, the guidance also
describes how the PDUFA ‘‘barrier to
innovation’’ waiver provision may be
applied to innovative combination
products for which FDA requires the
submission of two marketing
applications. Such a waiver would
provide a reduction in application user
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[Federal Register Volume 70, Number 76 (Thursday, April 21, 2005)]
[Notices]
[Pages 20757-20758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7948]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anesthesiology and Respiratory Therapy 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: Anesthesiology and Respiratory Therapy 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 May 13, 2005, from 8
a.m. to 5:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A and B,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel Patel, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-443-8611, ext. 3, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512624. 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 and a presentation by the Office of Surveillance and
Biometrics in
[[Page 20758]]
the Center for Devices and Radiological Health outlining their
responsibility for the review of postmarket study design. The committee
will also discuss and make recommendations regarding general issues for
pulse oximeters. The issues include the equivalence of reflectance
sensor technology to transmissive sensor technology; validation
recommendations for neonatal intended use; and over-the-counter (OTC)
use of pulse oximeters.
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 May 3, 2005.
Oral presentations from the public will be scheduled for approximately
30 minutes at the beginning of committee deliberations and for
approximately 30 minutes near the end of the deliberations. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person by May 3,
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 Shirley Meeks,
Conference Management Staff, at 240-276-0450, ext. 105, 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: April 13, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7948 Filed 4-20-05; 8:45 am]
BILLING CODE 4160-01-S
