Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water

Forms and Documents

Document Name	Status
Supporting Statement Bottled Water 11-2-09.doc Supporting Statement A	2009-11-02

IC Document Collections

IC ID	Document Title	Status
191477	bottlers rectifying contamination	New
191476	bottlers conducting secondary testing of source water	New
191475	bottlers testing finished product only	New
191474	bottlers subject to source water and finished product testing	New

ICR Details

OMB Control No: 0910-0658	ICR Reference No: 200912-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/09/2010
	Date Received in OIRA: 12/02/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2013	36 Months From Approved
Responses	2,223	0	0
Time Burden (Hours)	179	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Under section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 349(b)(1)), not later than 180 days before the effective date (EPA compliance date) of an NPDWR issued by EPA for a contaminant under section 1412 of the Safe Drinking Water Act (SDWA) (42 U.S.C. 300g-1), the U.S. Food and Drug Administration (FDA) is required to issue a standard of quality regulation for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health. In accordance with section 410(b)(1) of the act, FDA has amended its bottled water regulations in parts 129 and 165 (21 CFR parts 129 and 165) to require coliform testing and recordkeeping.

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Authorizing Statute(s): US Code: 21 USC 349 Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 349 Name of Law: FFDCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 25752	05/29/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 55557	10/28/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
bottlers subject to source water and finished product testing
bottlers testing finished product only
bottlers conducting secondary testing of source water
bottlers rectifying contamination

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,223	0	0	2,223	0	0
Annual Time Burden (Hours)	179	0	0	179	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We estimate burden for the following citations: 21 CFR 129.35(a)(3)(i), 129.80(g), and 129.80(h). The burden in 129.35(a)(3)(i)is new. Current 129.80(g) and (h) do not have OMB approval and thus reflect a violation. These sections have been revised by the final rule. The recordkeeping burden reflects our estimate in new regulations for the additional burden and costs in recordkeeping based on the new testing requirements for source and finished bottled water, as well as the additional burden to maintain records describing corrective measures taken in response to a finding of E. coli in the source water.

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Annual Cost to Federal Government: $50,093

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/02/2009

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