Global Harmonization Task Force, Study Group 4; Final Document; Availability, 15759-15760 [E8-5927]
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Federal Register / Vol. 73, No. 58 / Tuesday, March 25, 2008 / Notices
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACE
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
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: March 19, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–5951 Filed 3–24–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Temporary Assistance for Needy
Families (TANF) State Plan; Guidance.
OMB No.: 0970–0145.
Description: The State plan is a
mandatory statement submitted to the
Secretary of the Department of Health
and Human Services by the State. It
consists of an outline of how the State’s
TANF program will be administered
and operated and certain required
certifications by the State’s Chief
Executive Officer. Its submittal triggers
the State’s family assistance grant
funding and it is used to provide the
public with information about the
program. If a State makes changes in its
program, it must submit a State plan
amendment.
Respondents: The 50 States, the
District of Columbia, Guam, Puerto Rico
and the Virgin Islands.
ANNUAL BURDEN ESTIMATES
No. of
respondents
Instrument
mstockstill on PROD1PC66 with NOTICES
Temporary Assistance for Needy Families (TANF) State Plan Guidance ......
Estimated Total Annual Burden
Hours: 891.
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
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
VerDate Aug<31>2005
18:33 Mar 24, 2008
Jkt 214001
54
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 19, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–5952 Filed 3–24–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0149] (formerly
Docket No. 2007D–0031)
Global Harmonization Task Force,
Study Group 4; Final Document;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a final document that has
been prepared by Study Group 4 of the
Global Harmonization Task Force
(GHTF). This document represents a
harmonized proposal and
recommendation from Study Group 4 of
the GHTF that may be used by
governments developing and updating
their regulatory requirements for
medical devices. This document is
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
No. of
responses per
respondent
0.5
Average
burden hours
per response
33
Total burden
hours
891
intended to provide information only
and does not describe current regulatory
requirements; elements of this
document may not be consistent with
current U.S. regulatory requirements.
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 of the guidance document
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 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
guidance. Submit written comments
concerning this document 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: Jan
Welch, GHTF, Study Group 4, Office of
Compliance, Center for Devices and
Radiological Health (HFZ–320), Food
E:\FR\FM\25MRN1.SGM
25MRN1
15760
Federal Register / Vol. 73, No. 58 / Tuesday, March 25, 2008 / Notices
and Drug Administration, 2094 Gaither
Rd., Rockville, MD 20850, 240–276–
0115.
SUPPLEMENTARY INFORMATION:
mstockstill on PROD1PC66 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 the Global
Harmonization Task Force (GHTF) to
facilitate harmonization. Subsequent
meetings have been held on a yearly
basis 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
their 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 is a
result of a document that has been
developed by one of the Study Groups
(4).
Study Group 4 was initially tasked
with the responsibility of developing
guidance documents on quality systems
auditing practices. As a result of its
efforts, this group has developed
document SG4/N33R16:2007. The final
document (SG4/N33R16:2007) entitled
‘‘Guidelines for Regulatory Auditing of
Quality Management Systems of
Medical Device Manufacturers—Part 3:
Regulatory Audit Reports’’ provides a
structure for audit reports used in
multiple jurisdictions, promoting
consistency and uniformity and should
assist the auditor in preparing a report
VerDate Aug<31>2005
18:33 Mar 24, 2008
Jkt 214001
for use by multiple regulators and/or
auditing organizations. Having reports
that are consistent in content should
facilitate the review and exchange of
audit reports. Acceptance of audit
reports by multiple regulators should
eventually reduce the number of audits
for manufacturers. This document was
announced as available for comment on
February 6, 2007 (72 FR 5443). GHTF
received several comments on the
document proposed on February 6,
2007. In response to the comments,
GHTF made changes to clarify the
document.
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: March 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–5927 Filed 3–24–08; 8:45 am]
BILLING CODE 4160–01–S
II. Significance of Guidance
This document represents
recommendations from the GHTF study
groups and does not describe regulatory
requirements. FDA is making this
document available so that industry and
other members of the public may
express their views and opinions.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance 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. Paperwork Reduction Act of 1995
For this final document, FDA
concludes that there are no collection of
information requirements under the
Paperwork Reduction Act of 1995.
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. Received
comments may be seen in the Division
PO 00000
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Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Notice of Closed
Meeting
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
meeting.
The meeting 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.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Down Syndrome.
Date: April 18, 2008.
Time: 1 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, 5B01, Rockville, MD
20852 (Telephone Conference Call).
Contact Person: Norman Chang, Ph.D.,
Scientific Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01 Bethesda, MD
20892, (301) 496–1485, changnmaiI.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 73, Number 58 (Tuesday, March 25, 2008)]
[Notices]
[Pages 15759-15760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0149] (formerly Docket No. 2007D-0031)
Global Harmonization Task Force, Study Group 4; Final Document;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final document that has been prepared by Study Group
4 of the Global Harmonization Task Force (GHTF). This document
represents a harmonized proposal and recommendation from Study Group 4
of the GHTF that may be used by governments developing and updating
their regulatory requirements for medical devices. This document is
intended to provide information only and does not describe current
regulatory requirements; elements of this document may not be
consistent with current U.S. regulatory requirements.
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 of the guidance
document 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 240-276-3151. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance. Submit written comments concerning this document 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: Jan Welch, GHTF, Study Group 4, Office
of Compliance, Center for Devices and Radiological Health (HFZ-320),
Food
[[Page 15760]]
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0115.
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 the Global Harmonization
Task Force (GHTF) to facilitate harmonization. Subsequent meetings have
been held on a yearly basis 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 their 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 is a result of a document that has been
developed by one of the Study Groups (4).
Study Group 4 was initially tasked with the responsibility of
developing guidance documents on quality systems auditing practices. As
a result of its efforts, this group has developed document SG4/
N33R16:2007. The final document (SG4/N33R16:2007) entitled ``Guidelines
for Regulatory Auditing of Quality Management Systems of Medical Device
Manufacturers--Part 3: Regulatory Audit Reports'' provides a structure
for audit reports used in multiple jurisdictions, promoting consistency
and uniformity and should assist the auditor in preparing a report for
use by multiple regulators and/or auditing organizations. Having
reports that are consistent in content should facilitate the review and
exchange of audit reports. Acceptance of audit reports by multiple
regulators should eventually reduce the number of audits for
manufacturers. This document was announced as available for comment on
February 6, 2007 (72 FR 5443). GHTF received several comments on the
document proposed on February 6, 2007. In response to the comments,
GHTF made changes to clarify the document.
II. Significance of Guidance
This document represents recommendations from the GHTF study groups
and does not describe regulatory requirements. FDA is making this
document available so that industry and other members of the public may
express their views and opinions.
III. Electronic Access
Persons interested in obtaining a copy of the guidance 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. Paperwork Reduction Act of 1995
For this final document, FDA concludes that there are no collection
of information requirements under the Paperwork Reduction Act of 1995.
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. 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 Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: March 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5927 Filed 3-24-08; 8:45 am]
BILLING CODE 4160-01-S
