Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water, 11984-11985 [2019-06069]

Download as PDF jbell on DSK30RV082PROD with NOTICES 11984 Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices ‘‘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 Submit written requests for a single hard copy of the draft guidance entitled ‘‘Review and Update of Device Establishment Inspection Processes and Standards’’ to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Tiffany Kelley, Office of Regulatory Affairs, Division of Operational Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–348–1970, Tiffany.Kelley@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled, ‘‘Review and Update of Device VerDate Sep<11>2014 17:48 Mar 28, 2019 Jkt 247001 Establishment Inspection Processes and Standards.’’ FDA is issuing this guidance document to comply with section 702(b) of FDARA (Pub. L. 115– 52), which directs FDA to issue draft guidance that specifies how FDA will review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of August 18, 2017, and update such processes and standards, as needed, through the adoption of uniform processes and standards that meet the criteria set forth in section 704(h)(1)(A) through (D) of the FD&C Act (21 U.S.C. 374(h)(1)(A) through (D)), as added by section 702(a) of FDARA. FDARA 702(b) also requires the draft guidance to provide for standardized methods of communication when communication is required under 704(h)(1), establish a standard timeframe for inspections, and identify practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. II. Significance of Draft Guidance FDA is issuing this draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437. The collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. IV. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet at either https:// www.fda.gov/MedicalDevices/Device RegulationandGuidance/Guidance Documents/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Persons unable to PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 download an electronic copy of ‘‘Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry’’ may send an email request to ORAPolicy Staffs@fda.hhs.gov to receive an electronic copy of the document. Dated: March 25, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06061 Filed 3–28–19; 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; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 29, 2019. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0658. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. E:\FR\FM\29MRN1.SGM 29MRN1 Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices 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 (21 CFR 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 11985 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. In the Federal Register of November 7, 2018 (83 FR 55726), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates 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 .................................................................... ........................ ........................ ........................ .................................. 179 1 There jbell on DSK30RV082PROD with NOTICES Number of records per recordkeeper 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 3 times per year in source water testing and about 3 times in finished product testing and thus would need to conduct 6 tests for E. coli, for a total of 153 hours VerDate Sep<11>2014 17:48 Mar 28, 2019 Jkt 247001 of recordkeeping. In addition, about 95 bottlers that use PWSs may find a total coliform positive sample about 3 times per year in finished product testing and thus would need to conduct 3 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, 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 estimate on our experience with the current CGMP regulations. Dated: March 22, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06069 Filed 3–28–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4609] Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation SUMMARY: E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11984-11985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4130]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recordkeeping 
Requirements for Microbiological Testing and Corrective Measures for 
Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
29, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0658. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 11985]]

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 (21 CFR 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.
    In the Federal Register of November 7, 2018 (83 FR 55726), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates 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 3 times per year in source water testing and 
about 3 times in finished product testing and thus would need to 
conduct 6 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 3 times per year in finished product testing and 
thus would need to conduct 3 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, 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: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06069 Filed 3-28-19; 8:45 am]
BILLING CODE 4164-01-P

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