Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability, 69665-69666 [E8-27466]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
that such radiation doses may have
endangered the health of members of this
class. The Subcommittee for Dose
Reconstruction Reviews was established to
aid the Advisory Board in carrying out its
duty to advise the Secretary, HHS, on dose
reconstruction.
Matters to be Discussed: The agenda for the
Subcommittee meeting includes: a discussion
of cases under review from the 6th, 7th, and
8th sets of individual dose reconstructions;
preparation of a letter report on the first 100
dose reconstruction cases reviewed; and, an
update on site-specific dose reconstruction
guidelines.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot attend,
written comments may be submitted. Any
written comments received will be provided
at the meeting and should be submitted to
the contact person below well in advance of
the meeting.
Contact Person for More Information:
Theodore Katz, Executive Secretary, NIOSH,
CDC, 1600 Clifton Road, Mailstop E–20,
Atlanta, GA 30333, Telephone (513) 533–
6800, Toll Free 1(800) CDC–INFO, e-mail
ocas@cdc.gov.
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 the Agency for Toxic
Substances and Disease Registry.
Dated: November 13, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–27447 Filed 11–18–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
69665
Title: Letter of Intent for Indian
Tribes, Tribal organizations or Tribal
consortia to operate a title IV–E program
under the Fostering Connections to
Success and Increasing Adoptions Act
of 2008 (Pub. L. 110–351).
OMB No.: New Collection.
Description: The Administration for
Children and Families is requesting that
Indian tribes, tribal organizations or
tribal consortia that wish to apply for
direct title IV–E funding pursuant to
section 479B of the Social Security Act
send a letter expressing their intent to
facilitate budget and staff planning.
Respondents: Indian Tribes, Tribal
organizations and Tribal consortia.
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Letter of Intent .................................................................................................
cprice-sewell on PROD1PC64 with NOTICES
Instrument
562
1
1
562
Estimated Total Annual Burden
Hours: 562.
In compliance with the requirements
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
VerDate Aug<31>2005
15:14 Nov 18, 2008
Jkt 217001
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 13, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–27358 Filed 11–18–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0526]
Global Harmonization Task Force,
Study Group 1; Proposed and Final
Documents; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of proposed and final
documents that have been prepared by
Study Group 1 of the Global
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Harmonization Task Force (GHTF).
These documents represent a
harmonized proposal and
recommendation from the GHTF Study
Group that may be used by governments
developing and updating their
regulatory requirements for medical
devices. These documents are intended
to provide information only and do not
describe FDA’s current regulatory
requirements; elements of these
documents may not be consistent with
current U.S. regulatory requirements. In
particular, FDA seeks comments on the
advantages and disadvantages of the
approaches in the GHTF documents,
particularly where they are not
consistent with current practices for the
manufacture of products in the United
States.
DATES: Submit written or electronic
comments on these documents by
February 17, 2009. After February 17,
2009, written comments or electronic
comments may be submitted at any time
to the contact persons listed in this
document.
ADDRESSES: Submit written requests for
single copies of these documents to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
E:\FR\FM\19NON1.SGM
19NON1
69666
Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION
section for information on electronic
access to the documents.
Submit written comments concerning
these documents 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.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Ginette Y. Michaud, Center for Devices
and Radiological Health (HFZ–480),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3700.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC64 with NOTICES
I. Background
FDA has participated in a number of
activities to promote the international
harmonization of regulatory
requirements. In September 1992, a
meeting was held in Nice, France by
senior regulatory officials to evaluate
international harmonization. This
meeting led to the development of the
organization now known as GHTF to
facilitate harmonization. Subsequent
meetings have been held in various
locations throughout the world.
The GHTF is a voluntary group of
representatives from national medical
device regulatory authorities and the
regulated industry. Since its inception,
the GHTF has been comprised of
representatives from five founding
members grouped into three
geographical areas: Europe, Asia-Pacific,
and North America, each of which
actively regulates medical devices using
its own unique regulatory framework.
The objective of the GHTF is to
encourage convergence at the global
level of regulatory systems of medical
devices to facilitate trade while
preserving the right of participating
members to address the protection of
public health by regulatory means
considered most suitable. One of the
ways this objective is achieved is by
identifying and developing areas of
international cooperation to facilitate
progressive reduction of technical and
regulatory differences in systems
established to regulate medical devices.
In an effort to accomplish these
objectives, the GHTF formed five study
groups to draft documents and carry on
other activities designed to facilitate
VerDate Aug<31>2005
15:14 Nov 18, 2008
Jkt 217001
global harmonization. This notice
relates to documents that have been
developed by one of the Study Groups
(Study Group 1).
Study Group 1 was initially tasked
with the responsibility of identifying
differences between various regulatory
systems. In 1995, the group was asked
to propose areas of potential
harmonization for premarket device
regulations and possible guidelines that
could help lead to harmonization. As a
result of its efforts, this group has
developed SG1(PD)/N055R6:2008 and
SG1/N045:2008.
The proposed document SG1(PD)/
N055R6:2008 entitled ‘‘Definitions of
the Terms Manufacturer, Authorised
Representative, Distributor and
Importer’’ provides a harmonized
definition of the terms ‘‘manufacturer,’’
‘‘authorised representative,’’
‘‘distributor,’’ and ‘‘importer’’.
The final document SG1/N045:2008
entitled ‘‘Principles of In Vitro
Diagnostic (IVD) Medical Devices
Classification’’ assists a manufacturer in
allocating an IVD medical device to the
appropriate risk class by using a set of
harmonized classification principles. It
bases such classification principles on
an IVD medical device’s intended use
and allows regulatory authorities to rule
upon matters of interpretation for a
particular IVD medical device, when
appropriate.
II. Significance of Guidance
These documents represent
recommendations from the GHTF study
group and do not describe regulatory
requirements. FDA is making these
documents available so that industry
and other members of the public may
express their views and opinions. In
particular, FDA seeks comments on the
advantages and disadvantages of the
approaches in the GHTF documents,
particularly where they are not
consistent with current practices for the
manufacture of products in the United
States.
III. Electronic Access
Persons interested in obtaining a copy
of these documents may do so by using
the Internet. The Center for Devices and
Radiological Health (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,
Federal Register reprints, information
on premarket submissions (including
lists of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
Information on the GHTF may be
accessed at https://www.ghtf.org. The
CDRH Web site may be accessed at
https://www.fda.gov/cdrh.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding these documents.
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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: October 22, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–27466 Filed 11–18–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 73, Number 224 (Wednesday, November 19, 2008)]
[Notices]
[Pages 69665-69666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27466]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0526]
Global Harmonization Task Force, Study Group 1; Proposed and
Final Documents; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of proposed and final documents that have been prepared by
Study Group 1 of the Global Harmonization Task Force (GHTF). These
documents represent a harmonized proposal and recommendation from the
GHTF Study Group that may be used by governments developing and
updating their regulatory requirements for medical devices. These
documents are intended to provide information only and do not describe
FDA's current regulatory requirements; elements of these documents may
not be consistent with current U.S. regulatory requirements. In
particular, FDA seeks comments on the advantages and disadvantages of
the approaches in the GHTF documents, particularly where they are not
consistent with current practices for the manufacture of products in
the United States.
DATES: Submit written or electronic comments on these documents by
February 17, 2009. After February 17, 2009, written comments or
electronic comments may be submitted at any time to the contact persons
listed in this document.
ADDRESSES: Submit written requests for single copies of these documents
to the Division of Small Manufacturers, International, and Consumer
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug
[[Page 69666]]
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 240-276-3151. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
documents.
Submit written comments concerning these documents 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.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ginette Y. Michaud, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3700.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has participated in a number of activities to promote the
international harmonization of regulatory requirements. In September
1992, a meeting was held in Nice, France by senior regulatory officials
to evaluate international harmonization. This meeting led to the
development of the organization now known as GHTF to facilitate
harmonization. Subsequent meetings have been held in various locations
throughout the world.
The GHTF is a voluntary group of representatives from national
medical device regulatory authorities and the regulated industry. Since
its inception, the GHTF has been comprised of representatives from five
founding members grouped into three geographical areas: Europe, Asia-
Pacific, and North America, each of which actively regulates medical
devices using its own unique regulatory framework.
The objective of the GHTF is to encourage convergence at the global
level of regulatory systems of medical devices to facilitate trade
while preserving the right of participating members to address the
protection of public health by regulatory means considered most
suitable. One of the ways this objective is achieved is by identifying
and developing areas of international cooperation to facilitate
progressive reduction of technical and regulatory differences in
systems established to regulate medical devices. In an effort to
accomplish these objectives, the GHTF formed five study groups to draft
documents and carry on other activities designed to facilitate global
harmonization. This notice relates to documents that have been
developed by one of the Study Groups (Study Group 1).
Study Group 1 was initially tasked with the responsibility of
identifying differences between various regulatory systems. In 1995,
the group was asked to propose areas of potential harmonization for
premarket device regulations and possible guidelines that could help
lead to harmonization. As a result of its efforts, this group has
developed SG1(PD)/N055R6:2008 and SG1/N045:2008.
The proposed document SG1(PD)/N055R6:2008 entitled ``Definitions of
the Terms Manufacturer, Authorised Representative, Distributor and
Importer'' provides a harmonized definition of the terms
``manufacturer,'' ``authorised representative,'' ``distributor,'' and
``importer''.
The final document SG1/N045:2008 entitled ``Principles of In Vitro
Diagnostic (IVD) Medical Devices Classification'' assists a
manufacturer in allocating an IVD medical device to the appropriate
risk class by using a set of harmonized classification principles. It
bases such classification principles on an IVD medical device's
intended use and allows regulatory authorities to rule upon matters of
interpretation for a particular IVD medical device, when appropriate.
II. Significance of Guidance
These documents represent recommendations from the GHTF study group
and do not describe regulatory requirements. FDA is making these
documents available so that industry and other members of the public
may express their views and opinions. In particular, FDA seeks comments
on the advantages and disadvantages of the approaches in the GHTF
documents, particularly where they are not consistent with current
practices for the manufacture of products in the United States.
III. Electronic Access
Persons interested in obtaining a copy of these documents may do so
by using the Internet. The Center for Devices and Radiological Health
(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, 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. Information on the GHTF may be accessed at https://
www.ghtf.org. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding these
documents. 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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: October 22, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-27466 Filed 11-18-08; 8:45 am]
BILLING CODE 4160-01-S
