Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tinnitus Masker Devices; Availability, 67724-67725 [05-22268]
Download as PDF
<![CDATA[
67724
Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/cdrh/fedregin.html.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit written or electronic
comments on this draft guidance by
February 6, 2006.
ADDRESSES: Submit written requests for
single copies on a 3.5″ diskette of the
draft guidance document entitled ‘‘Class
II Special Controls Guidance Document:
Tinnitus Masker Devices’’ 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
draft guidance.
Submit written comments concerning
this draft guidance to the Division of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:
Teresa Cygnarowicz, Center for Devices
and Radiological Health (HFZ–460),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–2980.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) 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. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
013. These modifications to the list or
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: October 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–22267 Filed 11–7–05; 8:45 am]
BILLING CODE 4160–01–S
[Docket No. 2005D–0344]
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
Tinnitus Masker Devices; 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: Tinnitus Masker
Devices.’’ The draft guidance describes
a means by which tinnitus masker
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 amend the
classification regulations for the tinnitus
masker presently classified into class II
(special controls: labeling) to designate
a special control for these devices. The
draft guidance is neither final, nor is it
in effect at this time.
VerDate Aug<31>2005
16:11 Nov 07, 2005
Jkt 208001
DATES:
Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed
rule to amend the classification
regulations for tinnitus masker devices
presently classified into class II (special
controls: labeling) to designate a special
control for the devices. The draft
guidance document describes a means
by which the device may comply with
the requirement of special controls for
class II devices. Following the effective
date of a final rule based on the
proposed rule, any firm submitting a
510(k) premarket notification for the
device will need to address the issues
covered in the special control guidance.
However, the firm need only show that
its device meets the recommendations
of the guidance or in some other way
provides equivalent assurances of safety
and effectiveness.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on tinnitus masker devices. It does not
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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 an
approach satisfies the requirements of
the applicable statute and regulations.
III. Electronic Access
To receive ‘‘Class II Special Controls
Guidance Document: Tinnitus Masker
Devices’’ by fax, call the CDRH FactsOn-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 (1555) followed by the pound
sign (#). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy
of the draft guidance may also do so by
using the Internet. 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
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft 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
collections of information addressed in
the draft guidance document have been
approved by OMB in accordance with
the PRA under the regulations
governing premarket notification
submissions (21 CFR part 807, subpart
E), under OMB control number 0910–
0120. The labeling provisions addressed
in the draft guidance have been
approved by OMB under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
E:\FR\FM\08NON1.SGM
08NON1
Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
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: October 7, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–22268 Filed 11–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0146]
Guidance for Industry: Validation of
Analytical Procedures for Type C
Medicated Feeds; Availability
AGENCY:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry (#135) entitled ‘‘Validation of
Analytical Procedures for Type C
Medicated Feeds.’’ This guidance
represents the agency’s current thinking
on the characteristics that should be
considered during the validation of nonmicrobiological analytical procedures
for the analysis of drugs in Type C
medicated feeds included as part of
original and supplemental new animal
drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) for Type A
medicated articles submitted to FDA.
This guidance is the first in a series of
three guidances that will discuss assay
methods for Type C medicated feeds.
DATES: Submit written or electronic
comments on agency guidance
documents at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
VerDate Aug<31>2005
16:11 Nov 07, 2005
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
Mary G. Leadbetter, Center for
Veterinary Medicine (HFV–141), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
6964, e-mail: mleadbet@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 28,
2004 (69 FR 23209), FDA published a
notice of availability for a draft guidance
entitled ‘‘Validation of Analytical
Procedures for Type C Medicated
Feeds’’ giving interested persons until
July 12, 2004, to comment on the draft
guidance. FDA received no comments
on the draft guidance and no
substantive changes were made in
finalizing this guidance document.
II. Paperwork Reduction Act of 1995
HHS.
ACTION:
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
67725
identified with the docket number
found in brackets in the heading of this
document. A copy of the document and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Copies of the guidance document
entitled ‘‘Validation of Analytical
Procedures for Type C Medicated
Feeds’’ may be obtained from the CVM
Home Page (https://www.fda.gov/cvm)
and from the Division of Dockets
Management Web site (https://
www.fda.gov/ohrms/dockets/
default.htm).
Dated: October 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22222 Filed 11–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
According to the Paperwork
Reduction Act of 1995, a collection of
information must display a valid OMB
control number. The existing valid OMB
control numbers for this information
collection are 0910–0032 and 0910–
0154. This guidance contains no new
collections of information.
Indian Health Service
III. Significance of Guidance
AGENCY:
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the agency’s
current thinking on the topic. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternate method
may be used as long as it satisfies the
requirements of applicable statutes and
regulations.
IV. Comments
As with all FDA’s guidances, the
public is encouraged to submit written
or electronic comments with new data
or other new information pertinent to
this guidance. FDA periodically will
review the comments in the docket, and
where appropriate, will amend the
guidance. The agency will notify the
public of any such amendments through
a notice in the Federal Register.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Two copies of any comments are to be
submitted, except that individuals may
submit one copy. Comments should be
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Proposed Collection: Indian Health
Service Background Investigations of
Individuals in Positions Involving
Regular Contact With or Control Over
Indian Children OPM—306 Request for
Public Comment: 30-Day Notice
Indian Health Service, HHS.
Request for Public Comment:
30-day Proposed Information Collection:
Indian Health Service Background
Investigations of Individuals in
Positions Involving Regular Contact
With or Control Over Indian Children
OPM–306.
ACTION:
SUMMARY: In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed
information collection projects, the
Indian Health Service (IHS) has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection project was published in the
August 3, 2005, Federal Register (70
51826) and allowed 60 days for public
comment. No public comment was
received in response to the notice. The
purpose of this notice is to allow 30
days for public comment to be
submitted to OMB.
PROPOSED COLLECTION: Title:
0917–0028, ‘‘Indian Health Service
Background Investigations of
Individuals in Positions Involving
Regular Contact With or Control Over
E:\FR\FM\08NON1.SGM
08NON1
]]>Agencies
[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67724-67725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0344]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Tinnitus Masker
Devices; 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: Tinnitus Masker Devices.'' The draft guidance
describes a means by which tinnitus masker 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
amend the classification regulations for the tinnitus masker presently
classified into class II (special controls: labeling) to designate a
special control for these devices. The draft guidance is neither final,
nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
February 6, 2006.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Tinnitus Masker Devices'' 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 draft
guidance.
Submit written comments concerning this draft 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: Teresa Cygnarowicz, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2980.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a proposed rule to amend the classification regulations for tinnitus
masker devices presently classified into class II (special controls:
labeling) to designate a special control for the devices. The draft
guidance document describes a means by which the device may comply with
the requirement of special controls for class II devices. Following the
effective date of a final rule based on the proposed rule, any firm
submitting a 510(k) premarket notification for the device will need to
address the issues covered in the special control guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on tinnitus
masker devices. 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 an approach satisfies the requirements of
the applicable statute and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Tinnitus
Masker Devices'' 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 (1555) followed by the pound sign
(). Follow the remaining voice prompts to complete your
request.
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. 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 on the Division of
Dockets Management Internet site at https://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft 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 collections of information addressed in the draft guidance
document have been approved by OMB in accordance with the PRA under the
regulations governing premarket notification submissions (21 CFR part
807, subpart E), under OMB control number 0910-0120. The labeling
provisions addressed in the draft guidance have been approved by OMB
under OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic
[[Page 67725]]
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: October 7, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22268 Filed 11-7-05; 8:45 am]
BILLING CODE 4160-01-S
