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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT:

Under the PRA 44 U.S.C. 35013521, 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. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A 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
SUPPLEMENTARY INFORMATION:

comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs 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 Water21 CFR
129.35a3i, 129.80g, and 129.80h OMB Control Number 09100658
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 165.110d 21
CFR 165.110d provides that a finished
product that tests positive for E. coli will be deemed adulterated under section 402a3 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.
342a3. 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 be tested at least weekly for total coliform. If any coliform organisms are detected in the source water, bottled water manufacturers are required to determine whether any of the coliform organisms are E. coli. Source water found to contain E. coli is not considered water of a safe, sanitary quality and would be unsuitable for bottled water production.
Before a bottler may use source water from a source that has tested positive for E. coli, a bottler must take appropriate measures to rectify or otherwise eliminate the cause of the contamination. A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be E. coli negative.
Description of Respondents: The respondents to this information collection are domestic and foreign bottled water manufacturers that sell bottled water in the United States.
FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of recordkeepers
21 CFR section; activity 129.35a3i and 129.80h; bottlers subject to both source water and finished product testing.
129.80g and h; bottlers only subject to finished product testing.
129.35a3i and 129.80h; bottlers conducting secondary testing of source water.
129.35a3i and 129.80h; bottlers rectifying contamination.
Total

lotter on DSK11XQN23PROD with NOTICES1

1 There
Number of records per recordkeeper
Total annual records
Average burden per recordkeeping
Total hours
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

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
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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
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organisms detected in the source water test positive for E. coli are negligible.
Dated: October 22, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202123741 Filed 102921; 8:45 am BILLING CODE 416401P

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