Salt Sources Study

Forms and Documents

Document Name	Status
Study Salt Supplement Questionnaire Form	New
Follow-Up Urine Collection Questionnaire Form	New
24-Hour Urine Collection Form	New
Duplicate Salt Sample Collection Form	New
Food Record Form Form	New
Home Tap Water Questionnaire Form	New
Height and Weight Data Collection Form	New
Participant Questionnaire Form	New
Telephone Recruitment and Screening Form and Instruction	New
Discretionary Salt Use Form	New
Siconolfietal_PaffenbargerQuestionnaire.pdf Supplementary Document	2013-09-04
SaltSourcesStudyPart B_5 20 2013_8_30_2013.doc Supporting Statement B	2013-09-04
Att 21_IRB_UMN_consent form_8_28_2013 RM.doc Supplementary Document	2013-09-04
Att 20_IRB approval.pdf Supplementary Document	2013-06-04
Att 19_Experts Consulted During Salt Sources Development8_28_2013.docx Supplementary Document	2013-09-04
Att 18_Salt Sources Study Contractor and Subcontractors.docx Supplementary Document	2013-06-04
Att 3_Overview of Protocol.docx Supplementary Document	2013-06-04
Att 2B_Summary of Public Comments.docx Supplementary Document	2013-06-04
Att 2A_Federal Register Notice.pdf Supplementary Document	2013-06-04
Att 1_Authorizing Legislation1.doc Supplementary Document	2013-06-04
Att 17C_Study Salt Supplement Record (to be completed by clinic staff).doc Supplementary Document	2013-06-04
Att 17D_Study Salt Supplement Procedures for Study Staff.doc Supplementary Document	2013-06-04
Att 17B_Study Salt Supplement Intructions for Participants.docx Supplementary Document	2013-06-04
Att 16B_Criteria for Redo Collection (Instructions for Study Staff).doc Supplementary Document	2013-06-04
Att 15B_How to collect the urine (24 Hour Urine Collection Instructions).docx Supplementary Document	2013-06-04
Att 10B_Home Tap Water Collection Procedures for Study Staff.doc Supplementary Document	2013-06-04
Att 14B_Duplicate Salt Sample Collection Instructions Sub Study Participants).doc Supplementary Document	2013-06-04
Att 13B_Duplicate Salt Sample Instructions (Non Sub Study).doc Supplementary Document	2013-06-04
Att 12B_Food Record Instructions.docx Supplementary Document	2013-06-04
Att 11B_Food Amounts Booklet.pdf Supplementary Document	2013-06-04
Att 4D_Study Fact Sheet.docx Supplementary Document	2013-06-04
Att 4C_Cover Letter-Phone Recruits.docx Supplementary Document	2013-06-04
Att 4B _Cover Letter-Those who cannot be reached by phone.docx Supplementary Document	2013-06-04
Att 4D_Study Fact Sheet.docx Supplementary Document	2013-06-04
Att 4C_Cover Letter-Phone Recruits.docx Supplementary Document	2013-06-04
Att 4B _Cover Letter-Those who cannot be reached by phone.docx Supplementary Document	2013-06-04
SaltSourcesStudyPart A_5 20 2013_8_30_2013.docx Supporting Statement A	2013-09-04

IC Document Collections

IC ID	Document Title	Status
207200	Study Salt Supplement Questionnaire Form	New
207199	Follow-Up Urine Collection Questionnaire Form	New
207198	24-Hour Urine Collection Form	New
207197	Water Collection Instruction	New
207196	Duplicate Salt Sample Collection Form	New
207195	Food Record Form Form	New
207194	24-Hour Dietary Recall Interview Other-24-Hour Dietary Recall Interview-Introduction Script, Scre	New
207193	Home Tap Water Questionnaire Form	New
207192	Study Orientation Instruction	New
207191	Height and Weight Data Collection Form	New
207190	Participant Questionnaire Form	New
207189	Telephone Recruitment and Screening Form and Instruction	New
207188	Discretionary Salt Use Form	New

ICR Details

OMB Control No: 0920-0982	ICR Reference No: 201306-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 19730
Title: Salt Sources Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/06/2013
	Date Received in OIRA: 06/05/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2015	24 Months From Approved
Responses	4,890	0	0
Time Burden (Hours)	1,372	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC plans to conduct a two-year study to obtain current, accurate information about sources of dietary sodium including sodium inherent in foods, sodium in processed and restaurant foods, and salt added to food at the table and during cooking. Information will be collected from diverse groups of adults at three study sites in three distinct geographic regions.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act-Research and Investigations
  

Citations for New Statutory Requirements: None

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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:
	78 FR 14092	03/04/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 33095	06/03/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Follow-Up Urine Collection Questionnaire	None	Salt Sources Study--Follow-up Urine Collection Questionnaire
Study Salt Supplement Questionnaire	None	Study Salt Supplement Questionnaire
Height and Weight Data Collection	None	Height and Weight Form
Study Orientation
Home Tap Water Questionnaire	None	Home Tap Water Questionnaire
24-Hour Dietary Recall Interview
Food Record Form	None	Food Record Form
Duplicate Salt Sample Collection	None, None	Table Salt Collection ,   Table Salt Collection
Water Collection
24-Hour Urine Collection	None	24-Hour Urine Collection Form
Participant Questionnaire	None	Participant Questionnaire
Discretionary Salt Use	None	Discretionary Salt Use Questions from NHANES 2009
Telephone Recruitment and Screening	None	Telephone Recruitment and Screening Script

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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	4,890	0	0	4,890	0	0
Annual Time Burden (Hours)	1,372	0	0	1,372	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new study supporting HP 2020 objectives and a CDC winnable battle. Existing estimates for sources of dietary sodium are based on data collected > 20 years ago.

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Annual Cost to Federal Government: $547,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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

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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: 06/05/2013

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