[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55726-55728]
[FR Doc No: 2018-24322]

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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.

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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,<PHONE_NUMBER>,
[email protected].

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\
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                                                   Number of                     Average  burden
   21 CFR section; activity        Number of      records per    Total annual          per         Total  hours
                                 recordkeepers   recordkeeper       records       recordkeeping
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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
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\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.

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


5288 Federal Register / Vol. 68, No. 22 / Monday, February 3, 2003 / Notices protests, or motions to intervene must be received on or before the specified comment date for the particular application. o. Filing and Service of Responsive Documents   Any filings must bear in all capital letters the title `` COMMENTS'', `` RECOMMENDATIONS FOR TERMS AND CONDITIONS'', `` PROTEST'', OR `` MOTION TO INTERVENE'', as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application. p. Agency Comments   Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas, Secretary. [ FR Doc. 03   2389 Filed 1   31   03; 8: 45 am]

BILLING CODE 6717   01   P ENVIRONMENTAL PROTECTION AGENCY [ FRL   7446   7]

Agency Information Collection Activities OMB Responses AGENCY: Environmental Protection Agency ( EPA).

ACTION: Notices.

SUMMARY: This document announces the Office of Management and Budget's ( OMB) responses to Agency clearance requests, in compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et. seq.). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

FOR FURTHER INFORMATION CONTACT: Susan Auby at ( 202) 566   1672, or email at auby. susan@ epa. gov. and please refer to the appropriate EPA Information Collection Request ( ICR) Number.

SUPPLEMENTARY INFORMATION: OMB Responses to Agency Clearance Requests OMB Approvals EPA ICR No. 2085.01; 2003 Drinking Water Infrastructure Needs Survey; was approved 11/ 27/ 2002; OMB No. 2040   0251; expires 11/ 30/ 2005. EPA ICR No. 1426.06; EPA Worker Protection Standard for Hazardous Waste Operations and Emergency Response in 40 CFR 311.1 and 311.2; was approved 12/ 20/ 2002; OMB No. 2050   0105; expires 12/ 31/ 2005. EPA ICR No. 1131.07; NSPS for Glass Manufacturing Plants in 40 CFR part 60, subpart CC, was approved 12/ 30/ 2002; OMB No. 2060   0054; expires 12/ 31/ 2005. EPA ICR No. 1031.07; Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment ( TSCA section 8( c)) in 40 CFR part 717; was approved 12/ 30/ 2002; OMB No. 2070   0017; expires 12/ 31/ 2005. EPA ICR No. 0938.09; General Administrative Requirements for Assistance Programs in 40 CFR parts 30 and 31; was approved 12/ 30/ 2002; OMB No. 2030   0020; expires 12/ 31/ 2005. EPA ICR No. 0746.05; NSPS for Calciners and Dryers in Mineral Industries in 40 CFR part 60, subpart UUU; was approved 12/ 30/ 2002; OMB No. 2060   0251; expires 12/ 31/ 2005. EPA ICR No. 1910.02; Synopses of Proposed Contract Actions and Market Research Activity; was approved 12/ 30/ 2002; OMB No. 2030   0039; expires 12/ 31/ 2005. EPA ICR No. 1884.02; TSCA Inventory Update Rule Amendment in 40 CFR part 710; was approved 12/ 31/ 2002; OMB No. 2070   0162; expires 12/ 31/ 2005. EPA ICR No. 0660.08; NSPS for Metal Coil Surface Coating in 40 CFR part 60, subpart TT; was approved 12/ 30/ 2002; OMB No. 2060   0107; expires 12/ 31/ 2005. EPA ICR No. 1867.02; Voluntary Aluminum Industrial Partnership ( VAIP); was approved 12/ 30/ 2002; OMB No. 2060   0411; expires 12/ 31/ 2005. EPA ICR No. 0983.07; NSPS Equipment Leaks of VOC in Petroleum Refineries in 40 CFR part 60, subpart GGG; was approved 12/ 30/ 2002; OMB No. 2060   0067; expires 12/ 31/ 2005. EPA ICR No. 1557.05; NSPS for Municipal Solid Waste Landfills; in 40 CFR part 60, subpart WWW; was approved 12/ 30/ 2002; OMB No. 2060   0220; expires 12/ 31/ 2005. EPA ICR No. 0664.07; NSPS Bulk Gasoline Terminals in 40 CFR part 60, subpart XX; was approved 12/ 30/ 2002; OMB No. 2060   0006; expires 12/ 31/ 2005. EPA ICR No. 1188.07; TSCA section 5( a)( 2) Significant New Use Rules for Existing Chemicals in 40 CFR part 721; was approved on 01/ 13/ 2003; OMB No. 2070   0038; expires on 01/ 31/ 2006.

Short Term Extensions EPA ICR No. 1838.01; Industry Detailed Questionnaire: Phase II Cooling Water Intake Structures; OMB No. 2040   0213; on 12/ 17/ 2002 OMB extended the expiration date through 03/ 31/ 2003. EPA ICR No. 1912.01; Information Collection Request: National Primary Drinking Water Regulation for Lead and Copper ( Final Rule); OMB No. 2040   0210; on 12/ 19/ 2002 OMB extended the expiration date through 03/ 31/ 2003. EPA ICR No. 0794.09; Notification of Substantial Risk of Injury to Health and the Environment under TSCA section 8( e); OMB No. 2070   0046; on 01/ 06/ 2003 OMB extended the expiration date through 04/ 30/ 2003. EPA ICR No. 0795.10; Notification of Chemical Exports   TSCA Section 12( b); OMB No. 2070   0030; on 01/ 06/ 2003 OMB extended the expiration date through 04/ 30/ 2003.

Comments Filed EPA ICR No. 2080.01; Motor Vehicle and Engine Compliance Program Fees ( Proposed Rule); on 12/ 30/ 2002 OMB filed a comment. EPA ICR No. 2079.01; NESHAP: Metal Can Surface Coating ( Proposed Rule); on 01/ 06/ 2003 OMB filed a comment. EPA ICR No. 2050.01; NESHAP for Taconite Iron Ore Processing Industry ( Proposed Rule); on 01/ 06/ 2003 OMB filed a comment.

Dated: January 23, 2003. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 03   2430 Filed 1   31   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OW   2002   0041; FRL   7446   8]

Agency Information Collection Activities; Proposed Collection; Comment Request; ( OMB Control No. 2040   0095, EPA ICR No. 0909.07)

AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces VerDate Dec< 13> 2002 17: 30 Jan 31, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03FEN1. SGM 03FEN1