Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water, 55726-55728 [2018-24322]

Download as PDF 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 07NON1 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