Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0658 Supporting Statement 2016.pdf	Supporting Statement A	Uploaded 2016-03-02	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
191477	bottlers rectifying contamination		Unchanged
191476	bottlers conducting secondary testing of source water		Unchanged
191475	bottlers testing finished product only		Unchanged
191474	bottlers subject to source water and finished product testing		Unchanged

ICR Details

OMB Control No: 0910-0658	ICR Reference No: 201603-0910-001
Status: Historical Active	Previous ICR Reference No: 201303-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/01/2016
	Date Received in OIRA: 03/02/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2019	36 Months From Approved	05/31/2016
Responses	2,223	0	2,223
Time Burden (Hours)	179	0	179
Cost Burden (Dollars)	0	0	0

---

Abstract: This collection request requires respondents to provide testing methods and results relating to the testing of bottled water processed or sold in the United States by US and foreign manufacturers. The reports and records are submitted to ensure compliance with currently approved testing regulation requirements.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 63228	10/19/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 8723	02/22/2016
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

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

---

ICR Summary of Burden

table that charts list 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	2,223	0	0	0	0
Annual Time Burden (Hours)	179	179	0	0	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:

---

Annual Cost to Federal Government: $51,308

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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: 03/02/2016

---