Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Hepatitis A Virus Serological Assays; Availability, 6777-6778 [06-1207]
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Federal Register / Vol. 71, No. 27 / Thursday, February 9, 2006 / Notices
A Web
address for the meeting will be available
at: https://www.hhs.gov/healthit.
SUPPLEMENTARY INFORMATION:
Dated: February 1, 2006.
Dana Haza,
Office of Programs and Coordination, Office
of the National Coordinator.
[FR Doc. 06–1180 Filed 2–8–06; 8:45 am]
BILLING CODE 4150–24–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 70 FR 72842–72843,
dated December 7, 2005) is amended to
reflect the title change for the Division
of Injury and Disability Outcomes,
National Center for Injury Prevention
and Control, Centers for Disease Control
and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
Delete in its entirety the title for the
Division of Injury and Disability
Outcomes (CE6) and insert the Division
of Injury Response (CTCE).
Dated: January 27, 2006
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 06–1199 Filed 2–8–06; 8:45 am]
BILLING CODE 4160–18—M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
cprice-sewell on PROD1PC66 with NOTICES
Advisory Committee on Special
Studies Relating to the Possible LongTerm Health Effects of Phenoxy
Herbicides and Contaminants (Ranch
Hand 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
VerDate Aug<31>2005
17:24 Feb 08, 2006
Jkt 208001
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory Committee
on Special Studies Relating to the Possible
Long-Term Health Effects of Phenoxy
Herbicides and Contaminants (Ranch Hand
Advisory Committee).
General Function of the Committee: To
advise the Secretary of Health and Human
Services (the Secretary) and the Assistant
Secretary for Health concerning its oversight
of the conduct of the Ranch Hand study by
the U.S. Air Force and provide scientific
oversight of the Department of Veterans
Affairs Army Chemical Corps Vietnam
Veterans Health Study, and other studies in
which the Secretary or the Assistant
Secretary for Health believes involvement by
the committee is desirable.
Date and Time: The meeting will be held
on February 27, 2006, from 8:30 a.m. to 4
p.m.
Location: Food and Drug Administration,
5630 Fishers Lane, rm. 1066, Rockville, MD.
Contact Person: Leonard Schechtman,
National Center for Toxicological Research
(HFT–10), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857,
301–827–6696, or FDA Advisory Committee
Information Line, 1–800–741–8138 (301–
443–0572 in the Washington, DC area), code
3014512560. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss the
following items: (1) Update on the Institute
of Medicine’s Air Force Health Study
Disposition Study and related closure
activities; (2) updates from the Air Force on
the Viability Study, Compliance Study,
Comprehensive Study, Mortality Update,
Technical Reports, and External
Collaborations.
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 February 17,
2006. Oral presentations from the public will
be scheduled on February 27, 2006, between
approximately 11:30 a.m. and 12:30 p.m.
Time allotted for each presentation may be
limited. Those desiring to make formal oral
presentations should notify the contact
person before February 17, 2006, 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 Leonard
Schechtman at least 7 days in advance of the
meeting.
PO 00000
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Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: February 2, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–1737 Filed2–8–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0385]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document;
Hepatitis A Virus Serological Assays;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance document
entitled ‘‘Guidance for Industry and
FDA Staff: Class II Special Controls
Guidance Document: Hepatitis A Virus
Serological Assays.’’ The guidance
document describes a means by which
these in vitro diagnostic devices for the
laboratory diagnosis of hepatitis A virus
(HAV) may comply with the
requirement of special controls for class
II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a
final rule reclassifying these devices
from class III (premarket approval) into
class II (special controls). HAV
serological assays are in vitro diagnostic
devices used to test for specific
antibodies to support the clinical
laboratory diagnosis of HAV.
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 on a 3.5″ diskette of the
guidance document entitled ‘‘Guidance
for Industry and FDA Staff: Class II
Special Controls Guidance Document:
Hepatitis A Virus Serological Assays’’ 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
E:\FR\FM\09FEN1.SGM
09FEN1
6778
Federal Register / Vol. 71, No. 27 / Thursday, February 9, 2006 / Notices
cprice-sewell on PROD1PC66 with NOTICES
electronic access to the guidance
document.
Submit written comments concerning
this guidance to the Division of Dockets
Management (HFZ–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:
Sally Hojvat, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0496.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September
30, 2004 (69 FR 58371), FDA published
a proposed rule to reclassify HAV
serological assays from class III
(premarket approval) into class II
(special controls). FDA proposed this
action after reviewing information
contained in a reclassification petition
submitted by Beckman Coulter Inc. In
addition, FDA issued a draft class II
special controls guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Hepatitis A
Serological Assays for the Clinical
Laboratory Diagnosis of Hepatitis A
Virus’’ to support the proposed
reclassification. HAV serological assays
are in vitro diagnostic devices that test
for specific antibodies. In conjunction
with other clinical laboratory findings,
the detection of these HAV-specific
antibodies aids in the clinical laboratory
diagnosis of an acute or past infection
by HAV. The comments FDA received
were supportive of the proposed
reclassification, but made some
suggestions on the guidance’s content.
FDA considered the suggestions and
made appropriate revisions. FDA is now
identifying the guidance document
entitled ‘‘Guidance for Industry and
FDA Staff: Class II Special Controls
Guidance Document: Hepatitis A Virus
Serological Assays’’ as the guidance
document that will serve as the special
control for these devices.
The guidance document provides a
means by which HAV serological assays
may comply with the requirement of
special controls for class II devices.
Following the effective date of the final
reclassification rule, any firm
submitting a premarket notification
(510(k)) for HAV serological assays will
need to address the issues covered in
the special controls guidance document.
However, the firm need only show that
VerDate Aug<31>2005
13:56 Feb 08, 2006
Jkt 208001
its device meets the recommendation of
the guidance document or in some other
way provides equivalent assurances of
safety and effectiveness.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on HAV serological
assays. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the applicable
statute and regulations.
III. Electronic Access
To receive ‘‘Guidance for Industry
and FDA Staff: Class II Special Controls
Guidance Document: Hepatitis A Virus
Serological Assays’’ by fax, call the
CDRH Facts-On-Demand system at 800–
899–0381 or 301–827–0111 from a
touch-tone telephone. Press 1 to enter
the system. At the second voice prompt,
press 1 to order a document. Enter the
document number (1536) followed by
the pound sign (#). Follow the
remaining voice prompts to complete
your request.
Persons interested in obtaining a copy
of the guidance may also do so 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
manufacturers’ assistance, information
on video conferencing and electronic
submission, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44
U.S.C. 3501–3520). The collection of
information in part three of this
guidance document has been submitted
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
to OMB for review and was approved
under OMB control number 0910–0120.
The collection of information in part ten
of this guidance document has been
submitted to OMB for review and was
approved under OMB control number
0910–0485.
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. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 06–1207 Filed 2–8–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0020]
Draft Guidance for Industry and Food
and Drug Administration Staff; Draft
Class II Special Controls Guidance
Document: Intervertebral Body Fusion
Device; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Class II Special Controls
Guidance Document: Intervertebral
Body Fusion Device.’’ It was developed
as a special control to support the
reclassification of intervertebral body
fusion devices that contain bone grafting
material from class III (premarket
approval) into class II (special controls).
This draft guidance document describes
a means by which these intervertebral
body fusion devices may comply with
the requirement of special controls for
class II devices. Elsewhere in this issue
of the Federal Register, FDA is
publishing a proposed rule to reclassify
the intervertebral body fusion device
that contains bone grafting material
from class III into class II (special
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Notices]
[Pages 6777-6778]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1207]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0385]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document; Hepatitis A Virus
Serological Assays; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance document entitled ``Guidance for Industry
and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A
Virus Serological Assays.'' The guidance document describes a means by
which these in vitro diagnostic devices for the laboratory diagnosis of
hepatitis A virus (HAV) may comply with the requirement of special
controls for class II devices. Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule reclassifying these devices
from class III (premarket approval) into class II (special controls).
HAV serological assays are in vitro diagnostic devices used to test for
specific antibodies to support the clinical laboratory diagnosis of
HAV.
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 on a
3.5 diskette of the guidance document entitled ``Guidance
for Industry and FDA Staff: Class II Special Controls Guidance
Document: Hepatitis A Virus Serological Assays'' 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
[[Page 6778]]
electronic access to the guidance document.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFZ-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: Sally Hojvat, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 30, 2004 (69 FR 58371), FDA
published a proposed rule to reclassify HAV serological assays from
class III (premarket approval) into class II (special controls). FDA
proposed this action after reviewing information contained in a
reclassification petition submitted by Beckman Coulter Inc. In
addition, FDA issued a draft class II special controls guidance
document entitled ``Class II Special Controls Guidance Document:
Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of
Hepatitis A Virus'' to support the proposed reclassification. HAV
serological assays are in vitro diagnostic devices that test for
specific antibodies. In conjunction with other clinical laboratory
findings, the detection of these HAV-specific antibodies aids in the
clinical laboratory diagnosis of an acute or past infection by HAV. The
comments FDA received were supportive of the proposed reclassification,
but made some suggestions on the guidance's content. FDA considered the
suggestions and made appropriate revisions. FDA is now identifying the
guidance document entitled ``Guidance for Industry and FDA Staff: Class
II Special Controls Guidance Document: Hepatitis A Virus Serological
Assays'' as the guidance document that will serve as the special
control for these devices.
The guidance document provides a means by which HAV serological
assays may comply with the requirement of special controls for class II
devices. Following the effective date of the final reclassification
rule, any firm submitting a premarket notification (510(k)) for HAV
serological assays will need to address the issues covered in the
special controls guidance document. However, the firm need only show
that its device meets the recommendation of the guidance document or in
some other way provides equivalent assurances of safety and
effectiveness.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on HAV serological assays. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the applicable statute and regulations.
III. Electronic Access
To receive ``Guidance for Industry and FDA Staff: Class II Special
Controls Guidance Document: Hepatitis A Virus Serological Assays'' by
fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-
0111 from a touch-tone telephone. Press 1 to enter the system. At the
second voice prompt, press 1 to order a document. Enter the document
number (1536) followed by the pound sign (). Follow the
remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so 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
manufacturers' assistance, information on video conferencing and
electronic submission, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collection of information in part three of this guidance document
has been submitted to OMB for review and was approved under OMB control
number 0910-0120. The collection of information in part ten of this
guidance document has been submitted to OMB for review and was approved
under OMB control number 0910-0485.
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. The guidance and received comments may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-1207 Filed 2-8-06; 8:45 am]
BILLING CODE 4160-01-S
