Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds; Availability, 67725 [05-22222]
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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]
[Page 67725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22222]
-----------------------------------------------------------------------
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, HHS.
ACTION: 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 non-
microbiological 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 self-addressed 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. 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.
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
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.
III. Significance of Guidance
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 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
