National Disease Surveillance Program

Forms and Documents

Document Name	Status
Form 0920-0009 Att D-4_Acute Flaccid Myelitis Form and Instruction	Modified
Non-substantive Change 0920-0009_Acute Flaccid Myelitis Patient Summary Form Final.docx Justification for No Material/Nonsubstantive Change	2019-01-31
AFM-patient-summary-form-update abridged 7.27.2017_edits_20180122_tracked.docx Supplementary Document	2019-01-31
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 Form and Instruction	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: 201901-0920-013
Status: Historical Active	Previous ICR Reference No: 201708-0920-015
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0009-19RH
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: 02/05/2019
	Date Received in OIRA: 02/01/2019
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)	190	0	173
Cost Burden (Dollars)	0	0	0

---

Abstract: Acute flaccid myelitis (AFM) is a rare but serious condition that affects the nervous system, specifically the spinal cord, which can cause the muscles and reflexes in the body not to work normally. CDC does not yet know the cause of these AFM cases and it is unclear what pathogen or immune response is causing the weakness and paralysis. CDC has not yet determined who is at higher risk for developing AFM, or the reasons why they may be at higher risk. Information about cases is collected from state health departments, in consultation with clinicians, using a national case report form. CDC will use this information to describe the illness, identify etiology, modes of transmission, risk factors, and geographic distribution of the neurologic illness. The data will also help inform the baseline rate of AFM in the United States, which is currently unknown. For this ICR CDC is requesting minor changes to a few questions which will cause a minor burden change.

---

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

---

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:
	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

---

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

IC Title	Form No.	Form Name
Att D-4_Acute Flaccid Myelitis	0920-0009	AFM: Patient Summary Form 2019 update
Att D-3_Reye Syndrome
Att D-1_CJD
Att D2_Kawasaki Syndrome

---

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)	190	173	0	17	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: The burden increased slightly because of an increase in the estimation of the time it takes to fill out the AFM instrument.

---

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

---

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: 02/01/2019

---