[Federal Register Volume 72, Number 28 (Monday, February 12, 2007)]
[Notices]
[Pages 6572-6574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2232]
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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.
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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 http://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: [email protected].
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\
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No. of Annual Frequency Total Annual Hours per
Information Respondents per Response Responses Response Total Hours
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Written notification of intent to conduct self 1,000 1 1,000 .0.25 250
inspections to local FDA field office
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FDA Form no. 3621, Self inspection report for FDA 8,000 1 800 9 7,200
licensed facilities
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FDA Form no 3622; Self inspection report for non-FDA 200 1 200 4 800
licensed facilities
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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.
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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.
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Written report to local FDA field Office within sixty 800 1 800 1 800
(60) days of self inspection-FDA licensed facilities
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Written report to local FDA field Office within sixty 200 1 200 1 200
(60) days of self inspection for non-FDA licensed
facilities
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Total ................. ................. ................. ................. 9,650
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\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 http://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 http://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