Prevalence Survey of Healthcare Associated Infections (HAIs) and Antimicrobial Use in U.S. Acute Care Hospitals

Forms and Documents

Document Name	Status
Patient Information Form (PIF) Form	Modified
Healthcare Facility Assessment (HFA) Form	Modified
nejmoa1801550_appendix.pdf Supplementary Document	2019-10-17
nejmoa1801550.pdf Supplementary Document	2019-10-17
RhameSudderth.pdf Supplementary Document	2019-10-17
Attachment_M_InfoDoc_2015_Draft.pdf Supplementary Document	2019-08-19
Attachment_L_ Non-research_Determination.pdf Supplementary Document	2019-08-19
Attachment_K_NCHS_Consultation.pdf Supplementary Document	2019-08-19
Attachment_J_HFA_PIF_Instructions_Draft_Updated.pdf Supplementary Document	2019-08-19
Attachment_I_AQUA_3A_3D_Drafts.pdf Supplementary Document	2019-08-19
Attachment_H_AQUA_PatientAssessment_Draft.pdf Supplementary Document	2019-08-19
Attachment_G_AQUA_CaseEligibility_Draft.pdf Supplementary Document	2019-08-19
Attachment_F_AU_Draft.pdf Supplementary Document	2019-08-19
Attachment_E_HAI_Draft.pdf Supplementary Document	2019-08-19
Attachment_N_Published_60-Day_FRN.pdf Supplementary Document	2019-08-19
Attachment_A2_ARRA.pdf Supplementary Document	2019-08-19
Attachment_A_Title_42_USC_241.pdf Supplementary Document	2019-08-19
SSB (clean version).docx Supporting Statement B	2019-10-17
SSA (clean version).docx Supporting Statement A	2019-10-17

IC Document Collections

IC ID	Document Title	Status
192452	Patient Information Form (PIF) Form	Modified
192451	Healthcare Facility Assessment (HFA) Form	Modified

ICR Details

OMB Control No: 0920-0852	ICR Reference No: 201908-0920-006
Status: Active	Previous ICR Reference No: 201612-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0852
Title: Prevalence Survey of Healthcare Associated Infections (HAIs) and Antimicrobial Use in U.S. Acute Care Hospitals
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 with change	Conclusion Date: 10/18/2019
	Date Received in OIRA: 09/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	12/31/2019
Responses	6,400	0	6,400
Time Burden (Hours)	1,860	0	1,860
Cost Burden (Dollars)	65,770	0	0

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Abstract: Preventing healthcare-associated infections (HAIs) and improving antimicrobial use (AU) are CDC and national priorities. An extension of the prevalence survey’s existing OMB approval is sought to allow a repeat HAI and AU Prevalence Survey to be performed in 2020. A repeat survey will allow assessment of changes in HAI and AU prevalence, pathogen distribution, and quality of antimicrobial prescribing. These data will also allow CDC and its partners to continue to monitor HAI and AU trends, to measure progress in meeting national targets, and to further refine prevention strategies.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
   PL: Pub.L. 111 - 5 1 Name of Law: American Recovery and Reinvestment Act of 2009
  

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:
	84 FR 26876	06/10/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 46533	09/04/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Healthcare Facility Assessment (HFA)	none	Healthcare Facility Assessment
Patient Information Form (PIF)	none	Patient Information

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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	6,400	6,400	0	0	0	0
Annual Time Burden (Hours)	1,860	1,860	0	0	0	0
Annual Cost Burden (Dollars)	65,770	0	0	65,770	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:

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Annual Cost to Federal Government: $1,827,695

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.     No

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)? Yes

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: 09/04/2019

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