National Disease Surveillance Program

Forms and Documents

Document Name	Status
Non-substantive Change 0920-0009_Acute Flaccid Myelitis Patient Summary Form Final 7272017.docx Justification for No Material/Nonsubstantive Change	2017-08-16
Att H – PIA CJD, Reye Syndrome, Kawasaki syndrome.pdf Supplementary Document	2016-06-02
Att G – PIA AFM.pdf Supplementary Document	2016-06-02
Att C_Surveillance Summaries.docx Supplementary Document	2016-01-04
SSB 0009 10-5-15.docx Supplementary Document	2016-01-04
Att A_Authorizing_Regulations.doc Supplementary Document	2016-01-04
SSB 0009 10-5-15.docx Supporting Statement B	2016-01-04
SSA 0009_OMB rev 0416_NCIRD 0516.docx Supporting Statement A	2016-06-02

IC Document Collections

IC ID	Document Title	Status
219461	Att D-4_Acute Flaccid Myelitis Other-WORD	Modified
219460	Att D-3_Reye Syndrome Other-WORD	Unchanged
219459	Att D2_Kawasaki Syndrome Other-WORD	Unchanged
219458	Att D-1_CJD Other-WORD	Unchanged

ICR Details

OMB Control No: 0920-0009	ICR Reference No: 201708-0920-015
Status: Historical Active	Previous ICR Reference No: 201601-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0009 (17AXX)
Title: National Disease Surveillance Program
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: 09/13/2017
	Date Received in OIRA: 08/16/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	630	0	630
Time Burden (Hours)	173	0	190
Cost Burden (Dollars)	0	0	0

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Abstract: Since 2014, state and local health departments, in consultation with clinicians, have submitted information about suspect cases to CDC. However, CDC has received feedback from the state and local health departments and clinicians about the feasibility of completing the requested information on the currently approved Acute Flaccid Myelitis Patient Summary Form. In order to decrease the overall burden to complete the form, CDC has deleted the clinical sections on the form and in turn, requests the respondents supplement that clinical information with clinical notes, MRI reports, and images.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Research and Investigations Generally
   US Code: 42 USC 301 Name of Law: General Powers and Duties of Public Health Service
  

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:
	80 FR 56997	09/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 78737	12/17/2015
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Att D2_Kawasaki Syndrome
Att D-4_Acute Flaccid Myelitis	0920-0009 (17AXX)	Non-substantive Change 0920-0009_Acute Flaccid Myelitis Patient Summary Form Final 7272017
Att D-3_Reye Syndrome
Att D-1_CJD

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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	630	630	0	0	0	0
Annual Time Burden (Hours)	173	190	0	-17	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: Changing Forms

Short Statement: In order to decrease the overall burden to complete the form, CDC has deleted the clinical sections on the form and in turn, requests the respondents supplement that clinical information with clinical notes, MRI reports, and images.The Acute Flaccid Myelitis: Patient Summary Form format change reduces the total burden hours from 50 to 33 hours because the average burden per response to complete the form is reduced from 30 minutes to 20 minutes.

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Annual Cost to Federal Government: $10,000

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.     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: 08/16/2017

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