Long-term sequela of Rocky Mountain Spotted Fever (RMSF)

Forms and Documents

Document Name	Status
Neurologic Exam Form Form	New
Patient Screening Questionnaire Form	New
9. IRB Continuation Memo.docx Supplementary Document	2019-08-19
8. RMSF-LTS PIA Signed.pdf Supplementary Document	2019-04-11
7. Consent documents.pdf Supplementary Document	2019-04-11
6. IRB Approval.docx Supplementary Document	2019-04-11
5. Chart Abstraction Form.pdf Supplementary Document	2019-04-11
2. 60-day FRN.pdf Supplementary Document	2019-04-11
1. Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2019-04-11
Supporting Statement B_LTS_3-18-2019.docx Supporting Statement B	2019-04-11
Supporting Statement A_LTS_7-22-2019 CLEAN.docx Supporting Statement A	2019-08-19

IC Document Collections

IC ID	Document Title	Status
235657	Neurologic Exam Form Form	New
235656	Patient Screening Questionnaire Form	New

ICR Details

OMB Control No: 0920-1267	ICR Reference No: 201904-0920-004
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19LI
Title: Long-term sequela of Rocky Mountain Spotted Fever (RMSF)
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: 08/28/2019
	Date Received in OIRA: 05/02/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved
Responses	126	0	0
Time Burden (Hours)	42	0	0
Cost Burden (Dollars)	761	0	0

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Abstract: The goal of this study is to describe persistent neurological damage in patients who were hospitalized with RMSF. Resulting data will provide information to healthcare providers, patients, and policy-makers about the long term consequences of severe RMSF, including length of time to recovery, and risk factors during acute illness which may be associated with long-term impairment.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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 2517	02/07/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18846	05/02/2019
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
Neurologic Exam Form	none	Neurologic Exam Form
Patient Screening Questionnaire	none	Patient Screener

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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	126	0	0	126	0	0
Annual Time Burden (Hours)	42	0	0	42	0	0
Annual Cost Burden (Dollars)	761	0	0	761	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 ICR.

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Annual Cost to Federal Government: $137,446

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.     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: 05/02/2019

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