Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy; Availability, 38661-38662 [E9-18445]
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mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
EOVIST is 3,818 days. Of this time,
3,450 days occurred during the testing
phase of the regulatory review period,
while 368 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
subsection 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 355(i)) became effective: January
21, 1998. The applicant claims January
19, 1998, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
January 21, 1998, which was 30 days
after FDA receipt of the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: July 2, 2007. The
applicant claims June 29, 2007, as the
date the new drug application (NDA) for
EOVIST (NDA 22–090) was initially
submitted. However, FDA records
indicate that NDA 22–090 was
submitted on July 2, 2007.
3. The date the application was
approved: July 3, 2008. FDA has verified
the applicant’s claim that NDA 22–090
was approved on July 3, 2008. This
determination of the regulatory review
period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,699 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by October 5, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 1, 2010. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–18527 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2001–D–0129 (formerly
Docket No. 2001D–0064)]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Dental Amalgam, Mercury, and
Amalgam Alloy; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
Document: Dental Amalgam, Mercury,
and Amalgam Alloy.’’ This guidance
document describes a means by which
manufacturers of dental amalgam,
mercury, and amalgam alloy may
comply with special controls that apply
to these class II devices. Elsewhere in
this issue of the Federal Register, FDA
is publishing a final rule to classify
dental amalgam into class II (special
controls), reclassify dental mercury from
class I (general controls) to class II
(special controls), and designate a
special controls guidance document to
support the class II classification of
these two devices, as well as the current
class II classification of amalgam alloy.
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
entitled ‘‘Class II Special Controls
Guidance Document: Dental Amalgam,
Mercury, and Amalgam Alloy’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
PO 00000
Frm 00085
Fmt 4703
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38661
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. 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.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Michael Adjodha, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2606, Silver Spring,
MD 20993–0002, 301–796–6276.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February
20, 2002 (67 FR 7620), FDA issued a
proposed rule to issue a separate
regulation classifying encapsulated
dental amalgam into class II (special
controls); amending the class II
classification of amalgam alloy by
designating special controls; and
reclassifying dental mercury from class
I (general controls) to class II (special
controls). Also, in the Federal Register
of February 20, 2002 (67 FR 7703), FDA
announced the availability of the draft
guidance entitled ‘‘Special Control
Guidance Document on Encapsulated
Amalgam, Amalgam Alloy, and Dental
Mercury Labeling,’’ which would serve
as a special control for all three devices.
The comment period on the proposed
rule closed on May 21, 2002. FDA
reopened the comment period in July
2002 (67 FR 46991) and again in April
2008 (73 FR 22877) to provide the
public with additional opportunities to
comment and to submit data and
information that may have become
available since publication of the
proposed rule. The comment period
closed on July 28, 2008.
FDA received more than 1,400
comments on the proposed rule and the
draft special controls guidance
document. Because of the intertwined
nature of the proposed rule and the draft
guidance, and because of the significant
overlap in comments, FDA considered
all comments in preparing both the final
rule and the special controls guidance
document. The analysis of comments is
contained in the preamble to the final
rule.
E:\FR\FM\04AUN1.SGM
04AUN1
38662
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
II. Significance of Special Controls
Guidance Document
Guidance documents are also available
at https://www.regulations.gov.
The final rule designates the guidance
document entitled ‘‘Class II Special
Controls Guidance Document: Dental
Amalgam, Mercury, and Amalgam
Alloy’’ as the special control for
mercury, amalgam alloy, and dental
amalgam. FDA believes that adherence
to the recommendations described in
this guidance document, in addition to
the general controls under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.), will provide reasonable
assurance of the safety and effectiveness
of dental amalgam, mercury, and
amalgam alloy. Following the effective
date of the final rule, any firm
submitting a 510(k) premarket
notification for dental amalgam,
mercury, or amalgam alloy, as well as
any firm currently marketing the
devices, must address the issues
covered in the special controls
guidance. The firm must show that its
device addresses the issues of safety and
effectiveness identified in the special
controls guidance, either by following
the recommendations in the guidance or
by some other means that provides
equivalent assurances of safety and
effectiveness.
IV. 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.
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. To receive ‘‘Class II Special
Controls Guidance Document: Dental
Amalgam, Mercury, and Amalgam
Alloy’’ you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number (1192) to
identify the guidance you are
requesting.
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.
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.
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18445 Filed 7–29–09; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders in Newborns and Children;
Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children (ACHDNC).
Dates and Times: September 24, 2009, 8:30
a.m. to 5 p.m. September 25, 2009, 8:30 a.m.
to 3 p.m.
Place: Bethesda Marriott–Pooks Hill, 5151
Pooks Hill Road, Bethesda, MD 20814.
Status: The meeting will be open to the
public with attendance limited to space
availability. Participants are asked to register
for the meeting by going to the registration
web site at https://events.SignUp4.com/
ACHDNC0909. The registration deadline is
Wednesday, September 23, 2009. Individuals
who need special assistance, such as sign
language interpretation or other reasonable
accommodations, should indicate their needs
on the registration web site. The deadline for
special accommodation requests is Friday,
September 18, 2009. If there are technical
problems gaining access to the web site,
please contact Tamar R. Shealy, Meetings
Manager, Conference and Meetings
Management, Altarum Institute, by telephone
(202) 828–5100 or via e-mail
conferences@altarum.org.
Purpose: The Secretary’s ACHDNC was
established to advise and guide the Secretary
regarding the most appropriate application of
universal newborn screening tests,
technologies, policies, guidelines and
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
programs for effectively reducing morbidity
and mortality in newborns and children
having or at risk for heritable disorders. The
ACHDNC also provides advice and
recommendations concerning the grants and
projects authorized under the Public Health
Service Act, 42 U.S.C. 300b-10, (Heritable
Disorders Program) as amended in the
Newborn Screening Saves Lives Act of 2008.
Agenda: The meeting will include
presentations and continued discussions on
the nomination/evaluation process for
newborn screening candidate conditions. The
agenda will include presentations on the
Newborn Screening Use Case, the National
Health Information Network, and Newborn
Screening Quality Measures, as well as
presentations on the continued work and
reports of the ACHDNC’s subcommittees on
laboratory standards and procedures, followup and treatment, and education and
training.
Proposed agenda items are subject to
change as priorities dictate. You can locate
the Agenda, Committee Roster and Charter,
presentations, and meeting materials at the
home page of the Web site at https://
events.SignUp4.com/ACHDNC0909.
Webcast: The meeting will be Webcast.
Information on how to access the Webcast
will be available on the day of the meeting
by clicking on the meeting date link at
https://events.SignUp4.com/ACHDNC0909.
Public Comments: Members of the public
can present oral comments during the public
comment periods of the meeting, which are
scheduled for both days of the meeting.
Those individuals who want to make a
comment are requested to register online by
Wednesday, September 23, 2009, at https://
events.SignUp4.com/ACHDNC0909. Requests
will contain the name, address, telephone
number, and any professional or business
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative. The list of public comment
participants will be posted on the web site.
Written comments should be emailed no later
than Wednesday, September 23, 2009, for
consideration. Comments should be
submitted to Tamar R. Shealy, Meetings
Manager, Conference and Meetings
Management, Altarum Institute, 1200 18th
Street, NW., Suite 700, Washington, DC
20036, telephone: 202 828–5100; fax: 202
785–3083, or e-mail:
conferences@altarum.org.
Contact Person: Anyone interested in
obtaining other relevant information should
write or contact Alaina M. Harris, Maternal
and Child Health Bureau, Health Resources
and Services Administration, Room 18A–19,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone (301)
443–0721, aharris@hrsa.gov. More
information on the Advisory Committee is
available at https://mchb.hrsa.gov/
heritabledisorderscommittee.
Dated: July 28, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–18526 Filed 8–3–09; 8:45 am]
BILLING CODE 4165–15–P
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38661-38662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2001-D-0129 (formerly Docket No. 2001D-0064)]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Dental Amalgam, Mercury,
and Amalgam Alloy; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This
guidance document describes a means by which manufacturers of dental
amalgam, mercury, and amalgam alloy may comply with special controls
that apply to these class II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a final rule to classify dental
amalgam into class II (special controls), reclassify dental mercury
from class I (general controls) to class II (special controls), and
designate a special controls guidance document to support the class II
classification of these two devices, as well as the current class II
classification of amalgam alloy.
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 entitled ``Class II Special Controls Guidance Document: Dental
Amalgam, Mercury, and Amalgam Alloy'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. 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.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Michael Adjodha, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 2606, Silver Spring, MD 20993-0002, 301-
796-6276.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 20, 2002 (67 FR 7620), FDA
issued a proposed rule to issue a separate regulation classifying
encapsulated dental amalgam into class II (special controls); amending
the class II classification of amalgam alloy by designating special
controls; and reclassifying dental mercury from class I (general
controls) to class II (special controls). Also, in the Federal Register
of February 20, 2002 (67 FR 7703), FDA announced the availability of
the draft guidance entitled ``Special Control Guidance Document on
Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling,''
which would serve as a special control for all three devices. The
comment period on the proposed rule closed on May 21, 2002. FDA
reopened the comment period in July 2002 (67 FR 46991) and again in
April 2008 (73 FR 22877) to provide the public with additional
opportunities to comment and to submit data and information that may
have become available since publication of the proposed rule. The
comment period closed on July 28, 2008.
FDA received more than 1,400 comments on the proposed rule and the
draft special controls guidance document. Because of the intertwined
nature of the proposed rule and the draft guidance, and because of the
significant overlap in comments, FDA considered all comments in
preparing both the final rule and the special controls guidance
document. The analysis of comments is contained in the preamble to the
final rule.
[[Page 38662]]
II. Significance of Special Controls Guidance Document
The final rule designates the guidance document entitled ``Class II
Special Controls Guidance Document: Dental Amalgam, Mercury, and
Amalgam Alloy'' as the special control for mercury, amalgam alloy, and
dental amalgam. FDA believes that adherence to the recommendations
described in this guidance document, in addition to the general
controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.), will provide reasonable assurance of the safety and
effectiveness of dental amalgam, mercury, and amalgam alloy. Following
the effective date of the final rule, any firm submitting a 510(k)
premarket notification for dental amalgam, mercury, or amalgam alloy,
as well as any firm currently marketing the devices, must address the
issues covered in the special controls guidance. The firm must show
that its device addresses the issues of safety and effectiveness
identified in the special controls guidance, either by following the
recommendations in the guidance or by some other means that provides
equivalent assurances of safety and effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Dental Amalgam, Mercury, and Amalgam Alloy'' you may either
send an e-mail request to dsmica@fda.hhs.gov to receive an electronic
copy of the document or send a fax request to 301-847-8149 to receive a
hard copy. Please use the document number (1192) to identify the
guidance you are requesting.
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. 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 at https://www.regulations.gov.
IV. 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.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18445 Filed 7-29-09; 4:15 pm]
BILLING CODE 4160-01-S