Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water, 4152-4153 [2013-01032]
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4152
Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices
In the
January 3, 2013 Federal Register (78 FR
308), we published a document
requesting information from hospitals,
electronic health record (EHR) vendors,
and other interested parties regarding
hospital readiness to begin
electronically reporting certain patientlevel data under the Hospital Inpatient
Quality Reporting (IQR) Program using
the Quality Reporting Document
Architecture (QRDA) Category I
beginning with calendar year 2014
discharges.
Because of the scope of the requested
information and inquiries received from
several industry and professional
organizations/associations regarding the
need for additional time to respond to
our request, we are extending the
comment period until February 1, 2013.
SUPPLEMENTARY INFORMATION:
Dated: January 15, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2013–01142 Filed 1–16–13; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0333]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
Requirements for Microbiological
Testing and Corrective Measures for
Bottled Water
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice invites comments on
the procedure by which both domestic
and foreign bottled water manufacturers
mstockstill on DSK4VPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
16:52 Jan 17, 2013
Jkt 229001
that sell bottled water in the United
States maintain records of
microbiological testing and corrective
measures, in addition to existing
recordkeeping requirements.
DATES: Submit either electronic or
written comments on the collection of
information by March 19, 2013.
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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.
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water—21 CFR
129.35(a)(3)(i), 129.80(g), and 129.80(h)
(OMB Control Number 0910–0658)—
Extension
The bottled water regulations in parts
129 and 165 (21 CFR parts 129 and 165)
require that if any coliform organisms
are detected in weekly total coliform
testing of finished bottled water,
followup testing must be conducted to
determine whether any of the coliform
organisms are Escherichia coli. The
adulteration provision of the bottled
water standard (§ 165.110(d)) provides
that a 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,
the current good manufacturing practice
(CGMP) regulations for bottled water in
part 129 require 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 information
collection are domestic and foreign
bottled water manufacturers that sell
bottled water in the United States.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\18JAN1.SGM
18JAN1
4153
Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
21 CFR Section
Number of recordkeepers
§ 129.35(a)(3)(i), § 129.80(h)
319 (bottlers subject to
source water and finished
product testing).
95 (bottlers testing finished
product only).
3 (bottlers conducting secondary testing of source
water).
3 (bottlers rectifying contamination).
6
1,914
0.08
153
3
285
0.08
23
5
15
0.08
1.2
3
9
.25
2
...............................................
..............................
..............................
..............................
179
§ 129.80(g), § 129.80(h) ........
§ 129.35(a)(3)(i), § 129.80(h)
§ 129.35(a)(3)(i), § 129.80(h)
Total Annual Burden .....
mstockstill on DSK4VPTVN1PROD with
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
We therefore conclude that any
additional burden and costs in
recordkeeping based on followup testing
that is required if any coliform
organisms detected in the source water
test positive for E. coli are negligible.
We estimate that the labor burden of
keeping records of each test is about 5
minutes per test. We also require
followup testing of source water and
finished bottled water products for E.
coli when total coliform positives occur.
We expect that 319 bottlers that use
sources other than PWSs may find a
total coliform positive sample about 3
times per year in source testing and
about three times in finished product
testing, for a total of 153 hours of
recordkeeping. In addition to the 319
bottlers, about 95 bottlers that use PWSs
may find a total coliform positive
sample about 3 times per year in
finished product testing, for a total of 23
hours of recordkeeping. Upon finding a
total coliform sample, bottlers will then
have to conduct a followup test for E.
coli.
We expect that recordkeeping for the
followup test for E. coli will also take
about 5 minutes per test. As shown in
table 1 of this document, we expect that
3 bottlers per year will have to carry out
the additional E. coli testing, with a
burden of 1 hour. These bottlers will
also have to keep records about
rectifying the source contamination, for
a burden of 2 hours. For all expected
total coliform testing, E. coli testing, and
source rectification, we estimate a total
burden of 179 hours. We base our
estimate on our experience with the
current CGMP regulations.
VerDate Mar<15>2010
16:52 Jan 17, 2013
Jkt 229001
Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–01032 Filed 1–17–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0032]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling;
Notification Procedures for Statements
on Dietary Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information. 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 an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice invites comments on
the information collection provisions of
the regulation requiring manufacturers,
packers, and distributors of dietary
supplements to notify us that they are
marketing a dietary supplement product
that bears on its label or in its labeling
a statement provided for in the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by March 19, 2013.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
ADDRESSES:
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, we invite
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;
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4152-4153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01032]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0333]
Agency Information Collection Activities; Proposed Collection;
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 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 an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice invites comments on the procedure by which both
domestic and foreign bottled water manufacturers that sell bottled
water in the United States maintain records of microbiological testing
and corrective measures, in addition to existing recordkeeping
requirements.
DATES: Submit either electronic or written comments on the collection
of information by March 19, 2013.
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
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.
Recordkeeping Requirements for Microbiological Testing and Corrective
Measures for Bottled Water--21 CFR 129.35(a)(3)(i), 129.80(g), and
129.80(h) (OMB Control Number 0910-0658)--Extension
The bottled water regulations in parts 129 and 165 (21 CFR parts
129 and 165) require that if any coliform organisms are detected in
weekly total coliform testing of finished bottled water, followup
testing must be conducted to determine whether any of the coliform
organisms are Escherichia coli. The adulteration provision of the
bottled water standard (Sec. 165.110(d)) provides that a 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, the current good manufacturing practice
(CGMP) regulations for bottled water in part 129 require 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 information
collection are domestic and foreign bottled water manufacturers that
sell bottled water in the United States.
FDA estimates the burden of this collection of information as
follows:
[[Page 4153]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of records Total annual Average burden
21 CFR Section Number of recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 129.35(a)(3)(i), Sec. 129.80(h).... 319 (bottlers subject to 6 1,914 0.08 153
source water and finished
product testing).
Sec. 129.80(g), Sec. 129.80(h).......... 95 (bottlers testing finished 3 285 0.08 23
product only).
Sec. 129.35(a)(3)(i), Sec. 129.80(h).... 3 (bottlers conducting 5 15 0.08 1.2
secondary testing of source
water).
Sec. 129.35(a)(3)(i), Sec. 129.80(h).... 3 (bottlers rectifying 3 9 .25 2
contamination).
---------------------------------------------------------------------------
Total Annual Burden..................... .............................. ................. ................. ................. 179
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. We therefore
conclude that any additional burden and costs in recordkeeping based on
followup testing that is required if any coliform organisms detected in
the source water test positive for E. coli are negligible. We estimate
that the labor burden of keeping records of each test is about 5
minutes per test. We also require followup testing of source water and
finished bottled water products for E. coli when total coliform
positives occur. We expect that 319 bottlers that use sources other
than PWSs may find a total coliform positive sample about 3 times per
year in source testing and about three times in finished product
testing, for a total of 153 hours of recordkeeping. In addition to the
319 bottlers, about 95 bottlers that use PWSs may find a total coliform
positive sample about 3 times per year in finished product testing, for
a total of 23 hours of recordkeeping. Upon finding a total coliform
sample, bottlers will then have to conduct a followup test for E. coli.
We expect that recordkeeping for the followup test for E. coli will
also take about 5 minutes per test. As shown in table 1 of this
document, we expect that 3 bottlers per year will have to carry out the
additional E. coli testing, with a burden of 1 hour. These bottlers
will also have to keep records about rectifying the source
contamination, for a burden of 2 hours. For all expected total coliform
testing, E. coli testing, and source rectification, we estimate a total
burden of 179 hours. We base our estimate on our experience with the
current CGMP regulations.
Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01032 Filed 1-17-13; 8:45 am]
BILLING CODE 4160-01-P
