Global Harmonization Task Force, Study Groups 1 and 5; New Proposed and Final Documents; Availability, 38602-38603 [E7-13664]
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38602
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
Social Security Act (the Act), for Part B
and Part A services, respectively. The
authority requiring a beneficiary’s
signature for supplier claims is implicit
in sections 1842(b)(3)(B)(ii) and in
1848(g)(4) of the Act. Because it is very
difficult to obtain a beneficiary’s
signature (or the signature of a person
authorized to sign on behalf of the
beneficiary) on a claim when the
beneficiary is being transported by
ambulance in emergency situations,
CMS is proposing that, for emergency
ambulance transport services, an
ambulance provider or supplier may
submit the claim without a beneficiary’s
signature, as long as certain
documentation requirements are met.
The information collected will be used
by CMS contractors (both, fiscal
intermediaries and carriers) that process
and pay emergency ambulance transport
claims. Form Number: CMS–10242
(OMB#: 0938–New); Frequency:
Reporting: Hourly, Daily, Weekly,
Monthly and Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 9,000; Total Annual
Responses: 6,500,000; Total Annual
Hours: 541,667.
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Financial
Statement of Debtor and Supporting
Regulations in 42 CFR 405.376; Use: 42
CFR 405.376(g) requires that, ‘‘* * * In
determining whether a claim will be
compromised, or collection action
terminated, CMS will consider the
following factors: * * * age and health
of the debtor, present and potential
income, inheritance prospects, possible
concealment or fraudulent transfer of
assets * * *’’ Sections 1842(a)(1)(B) and
(C) of the Social Security Act and 42
CFR 405.376(g) provide the authority for
collection of this information.
In some instances a physician/
supplier who is notified of a debt may
allege inability to immediately repay the
debt in full and may request an
extended repayment schedule.
Alternatively, the debtor may request a
compromise settlement for less than the
full amount due. Before establishing an
extended repayment schedule or
compromise settlement, the CMS’s
Regional Offices and the carrier must
evaluate the provider’s capacity to pay
the debt. Accordingly, the provider is
requested to complete a ‘‘Financial
Statement of Debtor’’ form, CMS–379.
Form Number: CMS–379 (OMB#: 0938–
0270); Frequency: Reporting: Yearly;
Affected Public: Business or other forprofit; Number of Respondents: 500;
VerDate Aug<31>2005
19:05 Jul 12, 2007
Jkt 211001
Total Annual Responses: 500; Total
Annual Hours: 1000.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: National
Implementation of Hospital Consumer
Assessment of Health Providers and
Systems (HCAHPS); Use: The intent of
the HCAHPS initiative is to provide a
standardized survey instrument and
data collection methodology for
measuring patients’ perspectives on
hospital care. While many hospitals
collect information on patient
satisfaction, there is no national
standard for collecting or publicly
reporting this information that would
enable valid comparisons to be made
across all hospitals. In order to make
‘‘apples to apples’’ comparisons to
support consumer choice, it is necessary
to introduce a standard measurement
approach. Hospital Consumer
Assessment of Healthcare Providers and
Systems, also known as the CAHPS
Hospital Survey (HCAHPS) can be
viewed as a core set of questions that
hospitals can combine with their
customized items. HCAHPS was
developed and is being implemented
under the auspices of the Hospital
Quality Alliance, a private/public
partnership that includes hospital
associations, consumer groups, payors
and government agencies that share a
common interest in reporting on
hospital quality.
Beginning in July 2007, participation
in HCAHPS can affect the annual
payment update for the inpatient
prospective payment system (IPPS)
hospitals participating in the Reporting
Hospital Quality Data Annual Payment
Update (RHQDAPU) program; Form
Number: CMS–10102 (OMB#: 0938–
0981); Frequency: Reporting: Monthly;
Affected Public: Individuals or
households; Number of Respondents:
2,820,000; Total Annual Responses:
2,820,000; Total Annual Hours: 329,940.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on September 11, 2007.
PO 00000
Frm 00053
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CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—C,Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: July 3, 2007.
Michelle Shortt,
Director, Regulations Development
Group,Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. E7–13412 Filed 7–12–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0265]
Global Harmonization Task Force,
Study Groups 1 and 5; 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 several proposed and
final documents that have been
prepared by Study Groups 1 and 5 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 by October 11, 2007. After
the 90 day period, 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 guidance 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
E:\FR\FM\13JYN1.SGM
13JYN1
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
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
information regarding 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 information regarding Study
Group 5: Herbert Lerner, GHTF, Study
Group 5, Office of Device Evaluation,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–3641.
SUPPLEMENTARY INFORMATION:
pwalker on PROD1PC71 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.
VerDate Aug<31>2005
19:05 Jul 12, 2007
Jkt 211001
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 two of the Study Groups
(1 and 5).
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 documents
SG1(PD)/N045R12:2007 and SG1(PD)/
N046R3:2007.
SG1(PD)/N045R12:2007 (proposed
document) entitled ‘‘Principles of In
Vitro Diagnostic (IVD) Medical Devices
Classification’’ assists a manufacturer to
allocate its IVD Medical Device to an
appropriate risk class using a set of
harmonized classification principles
based on an IVD Medical Device’s
intended use. This document applies to
IVD Medical Devices.
SG1(PD)/N046R3:2007 (proposed
document) entitled ‘‘Principles of
Conformity Assessment for In Vitro
Diagnostic (IVD) Medical Devices’’
provides an overview of conformity
assessment elements to demonstrate
conformity to GHTF final document
entitled ‘‘Essential Principles of Safety
and Performance for Medical Devices.’’
‘‘Principles of Conformity Assessment
for In Vitro Diagnostic (IVD) Medical
Devices’’ applies to IVD Medical
Devices. It describes the evidence and
procedures that may be used by the
manufacturer to demonstrate that a
medical device is safe and performs as
intended by the manufacturer, and the
process by which a Regulatory
Authority, or Conformity Assessment
Body, may confirm that the procedures
are properly applied by the
manufacturer.
Study Group 5 was initially tasked
with the responsibility of developing
guidance documents on the content and
format for clinical investigation reports
and on how to conduct and document
a clinical evaluation. As a result of its
efforts, this group has developed
documents SG5/N1R8:2007 and SG5/
N2R8:2007.
SG5/N1R8:2007 (final document)
entitled ‘‘Clinical Evidence—Key
Definitions and Concepts’’ introduces
the concepts of clinical evaluation and
clinical evidence, and examines the
relationship between clinical
investigation, clinical data, clinical
evaluation, and clinical evidence. SG5/
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
38603
N2R8:2007 (final document) entitled
‘‘Clinical Evaluation’’ provides guidance
on how to conduct the clinical
evaluation of a medical device as part of
the conformity assessment procedure
prior to placing a medical device on the
market, as well as to support its ongoing
marketing.
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 guidance 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: July 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–13664 Filed 7–12–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\13JYN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38602-38603]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13664]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0265]
Global Harmonization Task Force, Study Groups 1 and 5; 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 several proposed and final documents that have been
prepared by Study Groups 1 and 5 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 by October 11, 2007.
After the 90 day period, 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 guidance
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
[[Page 38603]]
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 information regarding 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 information regarding Study Group 5: Herbert Lerner, GHTF,
Study Group 5, Office of Device Evaluation, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3641.
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 documents that have been
developed by two of the Study Groups (1 and 5).
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 documents SG1(PD)/N045R12:2007 and SG1(PD)/N046R3:2007.
SG1(PD)/N045R12:2007 (proposed document) entitled ``Principles of
In Vitro Diagnostic (IVD) Medical Devices Classification'' assists a
manufacturer to allocate its IVD Medical Device to an appropriate risk
class using a set of harmonized classification principles based on an
IVD Medical Device's intended use. This document applies to IVD Medical
Devices.
SG1(PD)/N046R3:2007 (proposed document) entitled ``Principles of
Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices''
provides an overview of conformity assessment elements to demonstrate
conformity to GHTF final document entitled ``Essential Principles of
Safety and Performance for Medical Devices.'' ``Principles of
Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices''
applies to IVD Medical Devices. It describes the evidence and
procedures that may be used by the manufacturer to demonstrate that a
medical device is safe and performs as intended by the manufacturer,
and the process by which a Regulatory Authority, or Conformity
Assessment Body, may confirm that the procedures are properly applied
by the manufacturer.
Study Group 5 was initially tasked with the responsibility of
developing guidance documents on the content and format for clinical
investigation reports and on how to conduct and document a clinical
evaluation. As a result of its efforts, this group has developed
documents SG5/N1R8:2007 and SG5/N2R8:2007.
SG5/N1R8:2007 (final document) entitled ``Clinical Evidence--Key
Definitions and Concepts'' introduces the concepts of clinical
evaluation and clinical evidence, and examines the relationship between
clinical investigation, clinical data, clinical evaluation, and
clinical evidence. SG5/N2R8:2007 (final document) entitled ``Clinical
Evaluation'' provides guidance on how to conduct the clinical
evaluation of a medical device as part of the conformity assessment
procedure prior to placing a medical device on the market, as well as
to support its ongoing marketing.
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 guidance 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: July 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13664 Filed 7-12-07; 8:45 am]
BILLING CODE 4160-01-S
