Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water, 55726-55728 [2018-24322]
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55726
Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
Based on data from the Document
Archiving, Reporting and Regulatory
Tracking System for the number of
submissions to FDA using FDA Form
3926 during fiscal years 2015, 2016, and
2017, we estimate that approximately
790 licensed physicians would use FDA
Form 3926 to submit 1.46 requests per
physician (respondent) for individual
patient expanded access, for a total of
1,153 responses annually. Based on
these estimates, FDA calculates the total
annual responses to be 2,394 (1,153
requests for individual patient
expanded access and 1,241 follow-up
submissions) by 790 physicians for an
average of 3.03 responses per
respondent. FDA estimates the average
burden per response to be 45 minutes
(0.75 hour). Based on this estimate, FDA
calculates the total burden to be 1,795
hours.
Dated: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24321 Filed 11–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4130]
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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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
solicits 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.
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:46 Nov 06, 2018
Jkt 247001
Submit either electronic or
written comments on the collection of
information by January 7, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 7,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 7, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–4130 for ‘‘Agency Information
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Collection Activities; Proposed
Collection; Comment Request;
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
E:\FR\FM\07NON1.SGM
07NON1
Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
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
SUPPLEMENTARY INFORMATION:
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 (E. 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,
55727
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.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
Average
burden per
recordkeeping
Total annual
records
Total
hours
§§ 129.35(a)(3)(i) and .....................................................
129.80(h) (bottlers subject to both .................................
source water and finished ..............................................
product testing) ...............................................................
§ 129.80(g) and (h) (bottlers only subject to finished
product testing).
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers conducting
secondary testing of source water).
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers rectifying contamination).
319
6
1,914
0.08 (5 minutes) ..
153
95
3
285
0.08 (5 minutes) ..
23
3
5
15
0.08 (5 minutes) ..
1
3
3
9
0.25 (15 minutes)
2
Total ........................................................................
........................
........................
........................
1 There
amozie on DSK3GDR082PROD with NOTICES1
Number of
records per
recordkeeper
.............................
179
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
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
VerDate Sep<11>2014
17:46 Nov 06, 2018
Jkt 247001
organisms detected in the source water
test positive for E. coli are negligible.
We estimate that the labor burden of
keeping records of each E. coli followup
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
three times per year in source water
testing and about three times in finished
product testing and thus would need to
conduct six tests for E. coli, for a total
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
of 153 hours of recordkeeping. In
addition, about 95 bottlers that use
PWSs may find a total coliform positive
sample about three times per year in
finished product testing and thus would
need to conduct three tests for E. coli,
for a total of 23 hours of recordkeeping.
We expect that three bottlers per year
will test positive for E. coli in source
water and will need to take actions to
rectify or eliminate the cause of the
contamination and verify that E. coli is
negative by taking five samples over a
24-hour period from the same sampling
site that originally tested positive for E.
E:\FR\FM\07NON1.SGM
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55728
Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
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 three bottlers per year will test
positive for E. coli in source water and
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: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24322 Filed 11–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3860]
Hypertension: Developing FixedCombination Drug Products for
Treatment; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Hypertension: Developing FixedCombination Drug Products for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of fixedcombination drug products for the
treatment of hypertension. The guidance
focuses on development of two-drug
combinations of previously approved
drug products. This guidance
incorporates the comments received for
and finalizes the draft guidance for
industry entitled ‘‘Hypertension:
Developing Fixed-Dose Combination
Drugs for Treatment’’ issued on January
26, 2018.
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on November 7, 2018.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
VerDate Sep<11>2014
17:46 Nov 06, 2018
Jkt 247001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
HHS.
ACTION:
Electronic Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3860 for ‘‘Hypertension:
Developing Fixed-Combination Drug
Products for Treatment.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions—To submit
a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Naomi Lowy, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 22, Rm. 4204,
Silver Spring, MD 20993–0002, 301–
796–0692.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Hypertension: Developing FixedCombination Drug Products for
Treatment.’’ The purpose of this
E:\FR\FM\07NON1.SGM
07NON1
]]>Agencies
[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55726-55728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24322]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4130]
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 solicits 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 January 7, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-4130 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping Requirements for
Microbiological Testing and Corrective Measures for Bottled Water.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
[[Page 55727]]
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 (E. 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 129.35(a)(3)(i) 319 6 1,914 0.08 (5 minutes) 153
and.
129.80(h) (bottlers subject to
both.
source water and finished.....
product testing)..............
Sec. 129.80(g) and (h) 95 3 285 0.08 (5 minutes) 23
(bottlers only subject to
finished product testing).
Sec. Sec. 129.35(a)(3)(i) 3 5 15 0.08 (5 minutes) 1
and 129.80(h) (bottlers
conducting secondary testing
of source water).
Sec. Sec. 129.35(a)(3)(i) 3 3 9 0.25 (15 2
and 129.80(h) (bottlers minutes).
rectifying contamination).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 179
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
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 E.
coli followup 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 three times per year in source water testing and
about three times in finished product testing and thus would need to
conduct six tests for E. coli, for a total of 153 hours of
recordkeeping. In addition, about 95 bottlers that use PWSs may find a
total coliform positive sample about three times per year in finished
product testing and thus would need to conduct three tests for E. coli,
for a total of 23 hours of recordkeeping.
We expect that three bottlers per year will test positive for E.
coli in source water and will need to take actions to rectify or
eliminate the cause of the contamination and verify that E. coli is
negative by taking five samples over a 24-hour period from the same
sampling site that originally tested positive for E.
[[Page 55728]]
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 three bottlers per year will test positive for
E. coli in source water and 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: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24322 Filed 11-6-18; 8:45 am]
BILLING CODE 4164-01-P
