[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 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: 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 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