National Disease Surveillance Program

Forms and Documents

Document Name	Status
Att D-4_Acute Flaccid Myelitis Form and Instruction	Modified
Form 0920-0009 Att D-3_Reye Syndrome Form and Instruction	Unchanged
Form 0920-0009 Att D2_Kawasaki Syndrome Form and Instruction	Unchanged
Form 0920-0009 Att D-1_CJD Form and Instruction	Unchanged
AFM-patient-summary-form-update (track changes).docx Supplementary Document	2019-12-09
0920-0009 Change Request.docx Justification for No Material/Nonsubstantive Change	2019-12-09
H. PIA CJD, Reye Syndrome, Kawasaki.pdf Supplementary Document	2019-06-12
G. PIA AFM.pdf Supplementary Document	2019-06-12
F. Standardized Case Definition for AFM.pdf Supplementary Document	2019-06-12
E. Non-research determination.pdf Supplementary Document	2019-06-12
C. Surveillance Summaries.docx Supplementary Document	2019-06-12
B. 60-day FRN.pdf Supplementary Document	2019-06-12
A. Authorizing legislation.doc Supplementary Document	2019-06-12
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
SSB 0009 - 2019 extension.docx Supporting Statement B	2019-06-12
SSA 0009 - 2019 extension.docx Supporting Statement A	2019-06-12

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 Form and Instruction	Unchanged
219459	Att D2_Kawasaki Syndrome Form and Instruction	Unchanged
219458	Att D-1_CJD Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0009	ICR Reference No: 201912-0920-004
Status: Active	Previous ICR Reference No: 201905-0920-011
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0009
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: 12/12/2019
	Date Received in OIRA: 12/09/2019
Terms of Clearance: Previous terms continue: 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. CDC will work with their OIRA desk officer in advance to determine whether changes should be submitted as revisions or as nonsubstative change request

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	08/31/2022	08/31/2022
Responses	720	0	720
Time Burden (Hours)	167	0	167
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this data collection is to collect disease specific surveillance reports of rare, uncommon, or infrequent diseases. The data will be used to determine the prevalence of diseases dangerous to public health. The data will also be used for planning and evaluating effective programs for prevention and control of infectious diseases. Disease incidence is needed to study present and emerging disease problems. Case data will be transmitted to CDC electronically or hard copy from State and Local Health Departments. This request is to make minor changes to the Acute Flaccid Myelitis Patient Summary Form with no change in burden.

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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:
	84 FR 13927	04/08/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 30121	06/26/2019
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 D-4_Acute Flaccid Myelitis	none	Acute Flaccid Myelitis Patient Summary Form
Att D-3_Reye Syndrome	0920-0009	Reye Syndrome form
Att D-1_CJD	0920-0009	CJD form
Att D2_Kawasaki Syndrome	0920-0009	Kawasaki Syndrome form

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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	720	720	0	0	0	0
Annual Time Burden (Hours)	167	167	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $10,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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

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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: 12/09/2019

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