Survey on the Occurrence of Foodborne Illness Risks Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025)

Forms and Documents

Document Name	Status
0799 83C non sub change 2019.docx Justification for No Material/Nonsubstantive Change	2019-09-12
Attachment E_CDC-FDA Data Collection Collaboration_June 2017.pdf Supplementary Document	2018-06-26
Attachment D_Industry Introductory Letter-0799-05-01-18.doc Supplementary Document	2018-06-26
Attachment A_DC Protocol for Institutional_Retail.doc Supplementary Document	2018-06-26
0799 Supporting Statement Part B final 6-26-2018.docx Supporting Statement B	2018-07-02
0799 Supporting Statement Part A final 6-26-2018.doc Supporting Statement A	2018-07-02

IC Document Collections

IC ID	Document Title	Status
217135	2019-2020 All Facility Types -- Refusals Instruction	Modified
217133	2019-2020 All Facility Types - Completion of Section 2 Instruction	Modified
217132	2019-2020 Retail Food Stores - Completion of Sections 1 and 3 Instruction	Modified
217131	2019-2020 Schools - Completion of Sections 1 and 3 Other-Survey	Removed
217130	2019-2020 Healthcare Facilities - Completion of Sections 1 and 3 Other-Survey	Removed

ICR Details

OMB Control No: 0910-0799	ICR Reference No: 201909-0910-001
Status: Active	Previous ICR Reference No: 201806-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Survey on the Occurrence of Foodborne Illness Risks Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/13/2019
	Date Received in OIRA: 09/12/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	09/30/2021	09/30/2021
Responses	808	0	2,424
Time Burden (Hours)	1,401	0	3,602
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information on the occurrence of foodborne illness risk factors in select healthcare facilities, schools (K-12), and retail food stores. Foodborne illness risk factors are defined as the preparation practices and employee behaviors most commonly reported to the Centers for Disease Control and Prevention (CDC) as contributing factors to foodborne illness outbreaks at the retail level.

---

Authorizing Statute(s): US Code: 42 USC 243 Name of Law: Public Health Service Act
   US Code: 21 USC 301 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 31 USC 1535 Name of Law: Economic Act
  

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:
	83 FR 5441	02/07/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 38153	08/03/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
2019-2020 All Facility Types -- Refusals
2019-2020 Healthcare Facilities - Completion of Sections 1 and 3
2019-2020 Schools - Completion of Sections 1 and 3
2019-2020 Retail Food Stores - Completion of Sections 1 and 3
2019-2020 All Facility Types - Completion of Section 2

---

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	808	2,424	0	-1,616	0	0
Annual Time Burden (Hours)	1,401	3,602	0	-2,201	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The proposed revisions to this collection of information are expected to decrease burden for its healthcare and school industry stakeholders because their facility types will not be visited at all during this data collection period.

---

Annual Cost to Federal Government: $325,660

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 09/12/2019

---