Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application, 55556-55557 [E9-25915]
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Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–25936 Filed 10–27–09; 8:45 am]
BILLING CODE 4150–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0511]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medicated Feed
Mill License Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of a collection of information
and to allow 60 days for public
comment in response to the notice. This
notice solicits comments on the
medicated feed mill licensing
applications.
DATES: Submit written or electronic
comments on the collection of
information by December 28, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.
regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under 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
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) 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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing 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 FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
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.
Medicated Feed Mill License
Application—21 CFR Part 515 (OMB
Control Number 0910–0337)—Extension
The Animal Drug Availability Act
(ADAA) of October 9, 1996, amended
section 512 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360b) to replace the system for the
approval of specific medicated feed
with a general licensing system for feed
mills. Before passage of the ADAA,
medicated feed manufacturers were
required to obtain approval of
Medicated Feed Applications (MFAs),
in order to manufacture certain types of
medicated feeds. An individual
approved MFA was required for each
and every applicable medicated feed.
The ADAA streamlined the paperwork
process for gaining approval to
manufacture medicated feeds by
replacing the MFA system with a
facility license for each medicated feed
manufacturing facility.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
515.10(b)
20
1
20
0.25
5
515.11(b)
75
1
75
0.25
18.75
515.23
40
1
40
0.25
10
0.15
1
0.15
24
3.6
515.30(c)
Total Burden Hours
1 There
37.35
are no capital or operating and maintenance costs associated with this collection of information.
erowe on DSK5CLS3C1PROD with NOTICES
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
510.305
1 There
Annual Frequency
per Recordkeeping
1,070
Total Annual
Records
1
Hours per
Record
1,070
0.03
are no capital or operating and maintenance costs associated with this collection of information.
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32.10
Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
The estimated annual reporting
burden on industry is 37.35 hours as
shown in table 1 of this document.
Industry estimates it takes about 1/4
hour to submit the application. We
estimate 135 original and supplemental
applications, and voluntary revocations
for a total of 33.75 hours (135
submissions x 1/4 hour). An additional
3.6 hours is added for the rare notice of
opportunity for a hearing to not approve
or revoke an application. Finally, we
estimate 30 hours for maintaining and
retrieving labels as required by 21 CFR
510.305 and shown in table 2 of this
document. We estimated 0.03 hours for
each of the approximately 1,000
licensees. Thus, the total annual burden
for reporting and recordkeeping
requirements is estimated to be 67.35
hours.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25915 Filed 10–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0215]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
Requirements for Microbiological
Testing and Corrective Measures for
Bottled Water
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
27, 2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794, email:
JonnaLynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water—21 CFR
129.35(a)(3)(i) and 129.80(g) and (h)
FDA has amended its bottled water
regulations in parts 129 and 165 (21
CFR parts 129 and 165) by requiring that
if any coliform organisms are detected
in weekly total coliform testing of
finished bottled water, followup testing
55557
must be conducted to determine
whether any of the coliform organisms
are E. coli. FDA also amended the
adulteration provision of the bottled
water standard (§ 165.110(d)) to indicate
that finished product that tests positive
for E. coli will be deemed adulterated
under section 402(a)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
342(a)(3)). In addition, FDA amended
the Current Good Manufacturing
Practices (CGMP) regulations for bottled
water in part 129 by requiring that
source water from other than a public
water system (PWS) be tested at least
weekly for total coliform. If any coliform
organisms are detected in the source
water, the bottled water manufacturers
are required to determine whether any
of the coliform organisms are E. coli.
Source water found to contain E. coli is
not considered water of a safe, sanitary
quality and would be unsuitable for
bottled water production. Before a
bottler may use source water from a
source that has tested positive for E.
coli, a bottler must take appropriate
measures to rectify or otherwise
eliminate the cause of the
contamination. A source previously
found to contain E. coli will be
considered negative for E. coli after five
samples collected over a 24-hour period
from the same sampling site are tested
and found to be E. coli negative.
Description of Respondents: The
respondents to this proposed
information collection are domestic and
foreign bottled water manufacturers that
sell bottled water in the United States.
In the Federal Register of May 29,
2009 (74 FR 25752 ), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours
per Record
Total Hours
319 (bottlers subject to
source water and finished product testing)
6
1,914
0.08
153
§§ 129.35(a)(3)(i) and
129.80(h)
erowe on DSK5CLS3C1PROD with NOTICES
§§ 129.35(a)(3)(i) and
129.80(h)
2.5 (bottlers conducting
secondary testing of
source water)
5
12
0.08
1
§§ 129.35(a)(3)(i) and
129.80(h)
2.5 (bottlers rectifying contamination)
3
0.25
2
§ 129.80(g) and (h)
95 (bottlers testing finished product only)
3
0.08
23
7.5
285
Total Annual Burden
1There
179
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55556-55557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25915]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0511]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medicated Feed Mill License Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of a collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the medicated feed mill licensing applications.
DATES: Submit written or electronic comments on the collection of
information by December 28, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under 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 in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) 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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing 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 FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's 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.
Medicated Feed Mill License Application--21 CFR Part 515 (OMB Control
Number 0910-0337)--Extension
The Animal Drug Availability Act (ADAA) of October 9, 1996, amended
section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360b) to replace the system for the approval of specific
medicated feed with a general licensing system for feed mills. Before
passage of the ADAA, medicated feed manufacturers were required to
obtain approval of Medicated Feed Applications (MFAs), in order to
manufacture certain types of medicated feeds. An individual approved
MFA was required for each and every applicable medicated feed. The ADAA
streamlined the paperwork process for gaining approval to manufacture
medicated feeds by replacing the MFA system with a facility license for
each medicated feed manufacturing facility.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual
21 CFR Section No. of Respondents per Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.10(b) 20 1 20 0.25 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.11(b) 75 1 75 0.25 18.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.23 40 1 40 0.25 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.30(c) 0.15 1 0.15 24 3.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden Hours 37.35
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510.305 1,070 1 1,070 0.03 32.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
[[Page 55557]]
The estimated annual reporting burden on industry is 37.35 hours as
shown in table 1 of this document. Industry estimates it takes about 1/
4 hour to submit the application. We estimate 135 original and
supplemental applications, and voluntary revocations for a total of
33.75 hours (135 submissions x 1/4 hour). An additional 3.6 hours is
added for the rare notice of opportunity for a hearing to not approve
or revoke an application. Finally, we estimate 30 hours for maintaining
and retrieving labels as required by 21 CFR 510.305 and shown in table
2 of this document. We estimated 0.03 hours for each of the
approximately 1,000 licensees. Thus, the total annual burden for
reporting and recordkeeping requirements is estimated to be 67.35
hours.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25915 Filed 10-27-09; 8:45 am]
BILLING CODE 4160-01-S
