Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability, 5443-5444 [E7-1864]
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Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices
activities by Government agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
FDA-regulated food facilities (farms,
manufacturers, processors, distributors,
retailers, and restaurants) to better
comply with the regulations authorized
by the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and with food defense guidance,
especially in light of growing concerns
about food defense. Information
presented will be based on agency
position as articulated through
regulation, guidance, and information
previously made available to the public.
Topics to be discussed at the workshop
include: (1) Food defense awareness, (2)
ALERT: The basics, (3) FDA actions on
bioterrorism legislation (food supply),
(4) food recalls, (5) crisis management,
(6) food defense technologies and
methodologies, and other related topics.
FDA expects that participation in this
public workshop will provide regulated
industry with greater understanding of
the regulatory and policy perspectives
on food defense and increase voluntary
compliance and food defense
awareness.
Dated: January 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1865 Filed 2–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0031]
Global Harmonization Task Force,
Study Groups 1, 2, and 4; New
Proposed and Final Documents;
Availability
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of proposed and final
documents that have been prepared by
Study Groups 1, 2, and 4 of the Global
Harmonization Task Force (GHTF).
These documents represent a
harmonized proposal and
recommendation from the GHTF Study
Groups that may be used by
governments developing and updating
their regulatory requirements for
medical devices. These documents are
intended to provide information only
VerDate Aug<31>2005
16:03 Feb 05, 2007
Jkt 211001
and do not describe current regulatory
requirements; elements of these
documents may not be consistent with
current U.S. regulatory requirements.
FDA is requesting comments on these
documents.
DATES: Submit written or electronic
comments on any of the proposed
documents byMay 7, 2007. After May 7,
2007, 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 the documents 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 301–443–8818. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
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.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
For Study Group 1: Ginette Y.
Michaud, Chairperson, GHTF,
Study Group 1, Office of Device
Evaluation, Center for Devices and
Radiological Health (HFZ–480),
Food and Drug Administration,
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–3700.
For Study Group 2: Mary Brady,
GHTF, Study Group 2, Office of
Surveillance and Biometrics, Center
for Devices and Radiological Health
(HFZ–530), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 240–276–
3458.
For Study Group 4: Jacqueline Welch,
GHTF, Study Group 4, Office of
Compliance, Center for Devices and
Radiological Health (HFZ–320),
Food 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
PO 00000
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Fmt 4703
Sfmt 4703
5443
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 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
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 is a
result of documents that have been
developed by three of the Study Groups
(1, 2, and 4).
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 guidance that
could help lead to harmonization. As a
result of its efforts, this group has
developed proposed document
SG1(PD)N044:2006. SG1(PD)N044:2006
(proposed document), entitled ‘‘Role of
Standards,’’ provides guidance on the
use of standards by a manufacturer
when designing a medical device and,
subsequently, when demonstrating the
device conforms to relevant essential
safety and performance criteria. FDA
seeks comment on the document and
particularly ‘‘Section 5.2 Revision or
Replacement of Recognised Standards.’’
This section addresses the use of a
recognized standard during the
transitional period when it is being
replaced by a revised version.
Study Group 4 was initially tasked
with the responsibility of developing
E:\FR\FM\06FEN1.SGM
06FEN1
5444
Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices
guidance documents on quality systems
auditing practices. As a result of its
efforts, this group has developed
document SG4(PD)N33R13:2006.
SG4(PD)N33R13:2006 (proposed
document), entitled ‘‘Guidelines for
Regulatory Auditing of Quality
Management Systems of Medical Device
Manufacturers—Part 3: Regulatory
Audit Reports,’’ suggests 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.
Study Group 2 was initially tasked
with the responsibility of developing
guidance documents that will be used
for the exchange of adverse event
reports. As a result of its efforts, this
group developed SG2N54R8:2006.
SG2N54R8:2006 (final document),
entitled ‘‘Medical Devices Post Market
Surveillance: Global Guidance for
Adverse Event Reporting for Medical
Devices,’’ provides guidance on the type
of adverse events associated with
medical devices that should be reported
by manufacturers to a National
Competent Authority. It elaborates on
the regulatory requirements existing in
the participating member countries.
sroberts on PROD1PC70 with NOTICES
II. Significance of Guidance
These documents represent
recommendations from the GHTF study
groups 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.
III. Electronic Access
Persons interested in obtaining a copy
of the documents may also 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
VerDate Aug<31>2005
16:03 Feb 05, 2007
Jkt 211001
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. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: January 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–1864 Filed 2–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) will publish periodic
summaries of proposed projects being
developed for submission to the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995. To request more information on
the proposed project or to obtain a copy
of the data collection plans, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited 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)
ways to enhance the quality, utility, and
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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.
Proposed Project: Reporting Form for
the MCHB National Hemophilia
Program Grantees and Hemophilia
Treatment Center (HTC) Affiliates
Having Factor Replacement Product
(FRP) Programs—NEW
The Maternal and Child Health
Bureau (MCHB) of the Health Resources
and Services Administration (HRSA) is
planning to implement an annual
reporting form required of grantees of
the MCHB National Hemophilia
Program and their HTC affiliates having
a factor replacement product (FRP)
program. The purpose of the form is to
provide systematic information and data
comprising a financial overview of the
FRP programs of the HTCs receiving
funding through grantees of the MCHB
National Hemophilia Program. The
proposed form will constitute a
reporting requirement for the MCHB
National Hemophilia Program grantees
and their affiliate HTCs having FRP
programs.
Data from the form will provide
quantitative information on the
financial and services provision aspects
of each of the HTC FRP programs under
each of the MCHB National Hemophilia
Program grantees, specifically: (a)
Patient FRP program participation, (b)
FRP program revenue, (c) FRP program
costs, (d) FRP program net income, and
(e) use of FRP program net income. This
form will provide data useful to grantees
and their affiliate HTCs having FRP
programs. Useful data will also be
provided to the MCHB National
Hemophilia Program in order to assess
FRP program performance including
FRP program operational costs
appropriateness, FRP program cost
efficiency, and FRP program services
benefits-information that is essential to
evaluating HTCs having FRP programs,
grantees, and the MCHB National
Hemophilia Program.
Each HTC having an FRP program is
to submit its report to the grantee and
each grantee is to submit the individual
reports of each of their affiliate HTCs
having an FRP program to the MCHB
National Hemophilia Program as a part
of their annual grant application.
The burden estimate for this project is
as follows:
E:\FR\FM\06FEN1.SGM
06FEN1
Agencies
[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Notices]
[Pages 5443-5444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1864]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0031]
Global Harmonization Task Force, Study Groups 1, 2, and 4; New
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 Groups 1, 2, and 4 of the Global Harmonization Task Force (GHTF).
These documents represent a harmonized proposal and recommendation from
the GHTF Study Groups 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
current regulatory requirements; elements of these documents may not be
consistent with current U.S. regulatory requirements. FDA is requesting
comments on these documents.
DATES: Submit written or electronic comments on any of the proposed
documents byMay 7, 2007. After May 7, 2007, 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 the documents
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 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
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. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
For Study Group 1: Ginette Y. Michaud, Chairperson, GHTF, Study
Group 1, Office of Device Evaluation, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3700.
For Study Group 2: Mary Brady, GHTF, Study Group 2, Office of
Surveillance and Biometrics, Center for Devices and Radiological Health
(HFZ-530), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850, 240-276-3458.
For Study Group 4: Jacqueline Welch, GHTF, Study Group 4, Office of
Compliance, Center for Devices and Radiological Health (HFZ-320), Food
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 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 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 is a result of documents that have been
developed by three of the Study Groups (1, 2, and 4).
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 guidance that could help lead
to harmonization. As a result of its efforts, this group has developed
proposed document SG1(PD)N044:2006. SG1(PD)N044:2006 (proposed
document), entitled ``Role of Standards,'' provides guidance on the use
of standards by a manufacturer when designing a medical device and,
subsequently, when demonstrating the device conforms to relevant
essential safety and performance criteria. FDA seeks comment on the
document and particularly ``Section 5.2 Revision or Replacement of
Recognised Standards.'' This section addresses the use of a recognized
standard during the transitional period when it is being replaced by a
revised version.
Study Group 4 was initially tasked with the responsibility of
developing
[[Page 5444]]
guidance documents on quality systems auditing practices. As a result
of its efforts, this group has developed document SG4(PD)N33R13:2006.
SG4(PD)N33R13:2006 (proposed document), entitled ``Guidelines for
Regulatory Auditing of Quality Management Systems of Medical Device
Manufacturers--Part 3: Regulatory Audit Reports,'' suggests 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.
Study Group 2 was initially tasked with the responsibility of
developing guidance documents that will be used for the exchange of
adverse event reports. As a result of its efforts, this group developed
SG2N54R8:2006. SG2N54R8:2006 (final document), entitled ``Medical
Devices Post Market Surveillance: Global Guidance for Adverse Event
Reporting for Medical Devices,'' provides guidance on the type of
adverse events associated with medical devices that should be reported
by manufacturers to a National Competent Authority. It elaborates on
the regulatory requirements existing in the participating member
countries.
II. Significance of Guidance
These documents represent recommendations from the GHTF study
groups 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.
III. Electronic Access
Persons interested in obtaining a copy of the documents may also 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. Comments received may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: January 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-1864 Filed 2-5-07; 8:45 am]
BILLING CODE 4160-01-S