Voluntary Self Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability, 6572-6574 [E7-2232]
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6572
Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Notices
is being administered by telephone to
400 women and men at 16 different
organizations. The survey contains
questions about traditional job stressors
(e.g., changes in workload, social
support, and work roles), stressors not
traditionally examined, but which may
be linked with depressive symptoms
among women (e.g., roles and
responsibilities outside of the
organizational practices/policies of
interest have on depression. Findings
from this prospective study will also
help target future intervention efforts to
reduce occupationally related
depression in women workers. An
extension request is being sought for an
additional three years, in order to finish
data collection. There will be no cost to
the respondents other than their time.
workplace, discrimination, and career
issues) depression symptoms, and
company policies, programs and
practices. One Human Resource (HR)
representative at each company has also
been surveyed about company policies,
programs and practices. Analyses will
determine which work organization
factors are linked with depressive
symptoms and what effect the
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
Respondents
Employees .......................................................................................................
HR Representatives .........................................................................................
No. of
responses per
respondent
400
16
3
1
Average
burden per
response
(in hours)
45/60
20/60
Total burden
(in hours)
900
5
905
Dated: February 5, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–2310 Filed 2–9–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0027]
Voluntary Self Inspection of Medicated
Feed Manufacturing Facilities; Draft
Compliance Policy Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft compliance policy
guide (CPG) entitled ‘‘Voluntary Self
Inspection of Medicated Feed
Manufacturing Facilities.’’ This draft
CPG is intended to provide guidance to
the FDA field offices in prioritizing
inspections of medicated feed
manufacturing facilities for compliance
with Current Good Manufacturing
Practices for Medicated Feeds
regulations (CGMP).
DATES: Submit written or electronic
comments on this draft CPG by April 30,
2007 to ensure their adequate
consideration in preparation of the final
document. Submit written comments on
the information collection requirements
by April 13, 2007. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of this CPG to the Director,
VerDate Aug<31>2005
19:52 Feb 09, 2007
Jkt 211001
Division of Compliance Policy (HFC–
230), Office of Enforcement, Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send two
self-addressed adhesive labels to assist
that office in processing your request, or
fax your request to 301–827–0482.
Submit written comments on this draft
CPG 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.
Comments should be identified with the
full title of the CPG and the docket
number found in brackets in the
heading of this document. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the document.
Submit written comments on the
guidance to the Division of Dockets
Management (address above).
Comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: For
Technical Questions Concerning This
CPG: Paul Bachman, Center for
Veterinary Medicine (HFV–230), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9225, e-mail:
Paul.Bachman@fda.hhs.gov.
distribution of medicated animal feed.
The CPG describes a voluntary self
inspection program whereby firms
would conduct their own inspection on
an annual basis and provide the results
of the inspection to us. The proposed
CPG states that in determining its
inspectional priorities for CGMP
inspections for medicated feed
manufacturing establishments, FDA
intends to consider, among other
factors, whether the firm conducts this
voluntary self inspection. We are calling
this approach ‘‘Voluntary Self
Inspection,’’ but the idea has also been
referred to as ‘‘first-party inspection.’’
In addition to seeking comments on
this concept, we are considering
piloting this new approach for at least
1 year once comments have been
received and evaluated. A pilot would
be announced in a separate Federal
Register document.
I. Background
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). This draft guidance, when
finalized, will represent 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 alternative
method may be used as long as it
satisfies the requirements of applicable
statutes and regulations.
In this CPG, we are announcing a new
proposed approach to assist in
prioritizing inspections to determine an
individual facility’s compliance with
the Federal Food, Drug, and Cosmetics
Act (the act) and CGMP regulations
published in part 225 (21 CFR part 225)
relative to the manufacture and
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
SUPPLEMENTARY INFORMATION:
PO 00000
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E:\FR\FM\12FEN1.SGM
12FEN1
6573
Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Notices
in 44 U.S.C. 3502(3) and 5 CFR 1320.3
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506
(c)(2)(A)) requires Federal agencies to
provide a 60-day notice in the Federal
Register concerning each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, we are publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Voluntary Self Inspection of
Medicated Animal Feed Manufacturing
Facilities.
Description: FDA considers a number
of factors in determining inspectional
priorities and resource allocation for
inspections of medicated feed
manufacturing establishments. The
agency is proposing a new approach to
assist in prioritizing inspections to
determine an individual facility’s
compliance with the act, and CGMP
regulations published in part 225
relative to the manufacture and
distribution of medicated animal feeds.
The CPG describes a voluntary self
inspection program whereby firms
would conduct their own inspection on
an annual basis and provide the results
of the inspection to us. The proposed
CPG states that in determining its
inspectional priorities for CGMP
inspections for medicated feed
manufacturing establishments, FDA
intends to consider, among other
factors, whether the firm conducts this
voluntary self-inspection.
Under this CPG, firms that conduct
Voluntary Self Inspection would: (1)
Submit written notification to local FDA
field office(s) of intent to conduct self
inspections for compliance with CGMP;
(2) submit written reports of self
inspection within sixty (60) days to
local FDA Field Offices; (3) report self
inspection results through the use of
FDA forms 3621 or 3622; and (4) submit
written reports of self reinspection
within ninety (90) days for facilities that
have on going deficiencies which
continue to occur.
We expect approximately 1,000 feed
mills will conduct Voluntary Self
Inspections. Eight hundred of these are
expected to be licensed facilities and
two hundred to be non-licensed
facilities. Completing and sending the
notifications to us is estimated to take
about 15 minutes or 250 hours for the
1,000 firms. We estimate the time to
review any previous self inspections,
conduct an inspection and complete the
report is 9 hours for licensed facilities
and 4 hours for non-licensed facilities.
For the 1,000 firms, self inspection
burden would be 8,000 hours (9 x 800
= 7,200 hours for licensed facilities; 4 x
200 = 800 hours for non-licensed
facilities). Facilities with ongoing
deficiencies would self-reinspect and
report to us. We estimate that 5 percent
or 50 of the facilities will fall into this
category with approximately 40 licensed
facilities (9 hours x 40 firms = 360
hours) and 10 non-licensed facilities (4
hours x 10 = 40) for a total of 400 hours.
Lastly, we estimate that it will take each
facility approximately 1 hour (1 hour x
800 facilities = 800 hours for licensed
and 1 hour x 200 firms = 200 hours for
non-licensed facilities) for a total of
1,000 hours to collect the inspection
forms, various reports and submit to
FDA. For the 1,000 firms, total annual
burden is estimated as 9,650 hours.
Description of Respondents:
Manufacturers of medicated animal
feeds.
We estimate the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Information
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
1,000
1
1,000
.0.25
250
FDA Form no. 3621, Self inspection
report for FDA licensed facilities
8,000
1
800
9
7,200
FDA Form no 3622; Self inspection
report for non-FDA licensed facilities
200
1
200
4
800
Written report of self-reinspection
within ninety (90) days for FDA licensed facilities that have ongoing
deficiencies that continue to occur.
sroberts on PROD1PC70 with NOTICES
Written notification of intent to conduct self inspections to local FDA
field office
40
1
40
9
360
Written report of self-reinspection
within ninety (90) days for nonFDA licensed facilities that have
ongoing deficiencies that continue
to occur.
10
1
10
4
40
Written report to local FDA field Office within sixty (60) days of self inspection-FDA licensed facilities
800
1
800
1
800
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19:52 Feb 09, 2007
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12FEN1
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Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Information
Written report to local FDA field Office within sixty (60) days of self inspection for non-FDA licensed facilities
Annual Frequency
per Response
200
Total Annual
Responses
1
Hours per
Response
200
Total Hours
1
Total
1 There
9,650
are no capital costs or operating and maintenance costs associated with this collection of information.
accessed at https://www.fda.gov/ora
under ‘‘Compliance References.’’
The estimates in table 1 of this
document resulted from discussions
with industry and our experience in
conducting medicated feed facility
inspections.
IV. Comments
This draft CPG is being distributed for
comment purposes only and is not
intended for implementation at this
time. Interested persons may submit to
the Division of Dockets Management
(see ADDRESSES) written or electronic
comments regarding this draft CPG.
Submit written or electronic comments
by (see DATES) to ensure adequate
consideration in preparation of the final
document. Written comments
concerning the information collection
requirements must be received by the
Division of Dockets Management by (see
DATES).
Two paper copies of any comments
are to be submitted, 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. A copy of the
draft guidance 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
Electronic comments may be
submitted on the Internet at https://
www.fda.gov/dockets/ecomments. Once
on this site, select [Docket No. 2007D–
0027] ‘‘Voluntary Self Inspection of
Medicated Feed Manufacturing
Facilities; Draft Compliance Policy
Guide’’ and follow the directions.
Copies of the CPG may also be
downloaded to a personal computer
with access to the Internet. The Office
of Regulatory Affairs home pages
include this draft CPG and may be
sroberts on PROD1PC70 with NOTICES
200
VerDate Aug<31>2005
19:52 Feb 09, 2007
Jkt 211001
Dated: January 29, 2007.
Margaret O’K. Glavin,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. E7–2232 Filed 2–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
Collection of Information
SUMMARY: The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
reinstatement, with change, of a
previously approved collection for
which approval has expired. In
accordance with the Paperwork
Reduction Act of 1995, this notice seeks
comments concerning enrollment for
students and score assessments for
FEMA’s Independent Study Program.
SUPPLEMENTARY INFORMATION: FEMA’s
Emergency Management Institute (EMI)
provides a wide variety of training to
emergency management personnel
throughout the country. The EMI
Independent Study (IS) Program is part
of the FEMA training program
authorized under the Robert T. Stafford
Disaster Relief and Emergency Act,
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Public Law 93–288 as amended. These
courses are offered online by the
Emergency Management Institute (EMI).
The IS Program provides valuable
training to Federal, State, local and
Tribal emergency management
personnel and the general citizenry of
the United States without having to
attend a resident course at EMI, or at a
State-sponsored course. The National
Incident Management System (NIMS) is
our nation’s incident management
system. Homeland Security Presidential
Directive 5, ‘‘Management of Domestic
Incidents’’ requires the adoption of
NIMS by all Federal departments and
agencies. This directive also requires
that Federal preparedness assistance
funding for States, Territories, local
jurisdictions and Tribal entities be
dependent on NIMS compliance.
Title: EMI Independent Study Course
Enrollment and Test Answer Sheet.
Type of Information Collection:
Reinstatement, with change, of a
previously approved collection for
which approval has expired.
OMB Number: 1660–0046.
Form Numbers: FEMA Form 95–23.
Abstract: The IS program office
collect data from FEMA Form 95–23 to
create and update student records and
provide students with credit for training
completion. The system also allows
FEMA to track completions and failures
of course exams. The data on the
electronic form will be encrypted and
sent to the server to be parsed into the
Independent Study database. The paper
version of the form will be scanned and
parsed into the database or key entered
into the database.
Affected Public: Individuals or
Households, Federal Government, and
State, Local or Tribal Government.
Estimated Total Annual Burden
Hours:
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 72, Number 28 (Monday, February 12, 2007)]
[Notices]
[Pages 6572-6574]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2232]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0027]
Voluntary Self Inspection of Medicated Feed Manufacturing
Facilities; Draft Compliance Policy Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft compliance policy guide (CPG) entitled
``Voluntary Self Inspection of Medicated Feed Manufacturing
Facilities.'' This draft CPG is intended to provide guidance to the FDA
field offices in prioritizing inspections of medicated feed
manufacturing facilities for compliance with Current Good Manufacturing
Practices for Medicated Feeds regulations (CGMP).
DATES: Submit written or electronic comments on this draft CPG by April
30, 2007 to ensure their adequate consideration in preparation of the
final document. Submit written comments on the information collection
requirements by April 13, 2007. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of this CPG to the
Director, Division of Compliance Policy (HFC-230), Office of
Enforcement, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send two self-addressed adhesive labels to assist
that office in processing your request, or fax your request to 301-827-
0482. Submit written comments on this draft CPG 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. Comments should be identified
with the full title of the CPG and the docket number found in brackets
in the heading of this document. See the SUPPLEMENTARY INFORMATION
section for electronic access to the document.
Submit written comments on the guidance to the Division of Dockets
Management (address above). Comments should be identified with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: For Technical Questions Concerning
This CPG: Paul Bachman, Center for Veterinary Medicine (HFV-230), Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-
276-9225, e-mail: Paul.Bachman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In this CPG, we are announcing a new proposed approach to assist in
prioritizing inspections to determine an individual facility's
compliance with the Federal Food, Drug, and Cosmetics Act (the act) and
CGMP regulations published in part 225 (21 CFR part 225) relative to
the manufacture and distribution of medicated animal feed. The CPG
describes a voluntary self inspection program whereby firms would
conduct their own inspection on an annual basis and provide the results
of the inspection to us. The proposed CPG states that in determining
its inspectional priorities for CGMP inspections for medicated feed
manufacturing establishments, FDA intends to consider, among other
factors, whether the firm conducts this voluntary self inspection. We
are calling this approach ``Voluntary Self Inspection,'' but the idea
has also been referred to as ``first-party inspection.''
In addition to seeking comments on this concept, we are considering
piloting this new approach for at least 1 year once comments have been
received and evaluated. A pilot would be announced in a separate
Federal Register document.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). This draft
guidance, when finalized, will represent 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 alternative
method may be used as long as it satisfies the requirements of
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined
[[Page 6573]]
in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506 (c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, we are publishing a notice
of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of our
functions, including whether the information will have practical
utility; (2) the accuracy of our estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques, when appropriate,
and other forms of information technology.
Title: Voluntary Self Inspection of Medicated Animal Feed
Manufacturing Facilities.
Description: FDA considers a number of factors in determining
inspectional priorities and resource allocation for inspections of
medicated feed manufacturing establishments. The agency is proposing a
new approach to assist in prioritizing inspections to determine an
individual facility's compliance with the act, and CGMP regulations
published in part 225 relative to the manufacture and distribution of
medicated animal feeds. The CPG describes a voluntary self inspection
program whereby firms would conduct their own inspection on an annual
basis and provide the results of the inspection to us. The proposed CPG
states that in determining its inspectional priorities for CGMP
inspections for medicated feed manufacturing establishments, FDA
intends to consider, among other factors, whether the firm conducts
this voluntary self-inspection.
Under this CPG, firms that conduct Voluntary Self Inspection would:
(1) Submit written notification to local FDA field office(s) of intent
to conduct self inspections for compliance with CGMP; (2) submit
written reports of self inspection within sixty (60) days to local FDA
Field Offices; (3) report self inspection results through the use of
FDA forms 3621 or 3622; and (4) submit written reports of self
reinspection within ninety (90) days for facilities that have on going
deficiencies which continue to occur.
We expect approximately 1,000 feed mills will conduct Voluntary
Self Inspections. Eight hundred of these are expected to be licensed
facilities and two hundred to be non-licensed facilities. Completing
and sending the notifications to us is estimated to take about 15
minutes or 250 hours for the 1,000 firms. We estimate the time to
review any previous self inspections, conduct an inspection and
complete the report is 9 hours for licensed facilities and 4 hours for
non-licensed facilities. For the 1,000 firms, self inspection burden
would be 8,000 hours (9 x 800 = 7,200 hours for licensed facilities; 4
x 200 = 800 hours for non-licensed facilities). Facilities with ongoing
deficiencies would self-reinspect and report to us. We estimate that 5
percent or 50 of the facilities will fall into this category with
approximately 40 licensed facilities (9 hours x 40 firms = 360 hours)
and 10 non-licensed facilities (4 hours x 10 = 40) for a total of 400
hours. Lastly, we estimate that it will take each facility
approximately 1 hour (1 hour x 800 facilities = 800 hours for licensed
and 1 hour x 200 firms = 200 hours for non-licensed facilities) for a
total of 1,000 hours to collect the inspection forms, various reports
and submit to FDA. For the 1,000 firms, total annual burden is
estimated as 9,650 hours.
Description of Respondents: Manufacturers of medicated animal
feeds.
We estimate the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Information Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written notification of intent to conduct self 1,000 1 1,000 .0.25 250
inspections to local FDA field office
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form no. 3621, Self inspection report for FDA 8,000 1 800 9 7,200
licensed facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form no 3622; Self inspection report for non-FDA 200 1 200 4 800
licensed facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written report of self-reinspection within ninety (90) 40 1 40 9 360
days for FDA licensed facilities that have ongoing
deficiencies that continue to occur.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written report of self-reinspection within ninety (90) 10 1 10 4 40
days for non-FDA licensed facilities that have ongoing
deficiencies that continue to occur.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written report to local FDA field Office within sixty 800 1 800 1 800
(60) days of self inspection-FDA licensed facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 6574]]
Written report to local FDA field Office within sixty 200 1 200 1 200
(60) days of self inspection for non-FDA licensed
facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 9,650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates in table 1 of this document resulted from discussions
with industry and our experience in conducting medicated feed facility
inspections.
IV. Comments
This draft CPG is being distributed for comment purposes only and
is not intended for implementation at this time. Interested persons may
submit to the Division of Dockets Management (see ADDRESSES) written or
electronic comments regarding this draft CPG. Submit written or
electronic comments by (see DATES) to ensure adequate consideration in
preparation of the final document. Written comments concerning the
information collection requirements must be received by the Division of
Dockets Management by (see DATES).
Two paper copies of any comments are to be submitted, 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. A copy of the draft guidance 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
Electronic comments may be submitted on the Internet at https://
www.fda.gov/dockets/ecomments. Once on this site, select [Docket No.
2007D-0027] ``Voluntary Self Inspection of Medicated Feed Manufacturing
Facilities; Draft Compliance Policy Guide'' and follow the directions.
Copies of the CPG may also be downloaded to a personal computer with
access to the Internet. The Office of Regulatory Affairs home pages
include this draft CPG and may be accessed at https://www.fda.gov/ora
under ``Compliance References.''
Dated: January 29, 2007.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E7-2232 Filed 2-9-07; 8:45 am]
BILLING CODE 4160-01-S
