National Disease Surveillance Program

Forms and Documents

Document Name	Status
Form 0920-0009 Att D-4_Acute Flaccid Myelitis Form and Instruction	Modified
Form 0920-0009 Att D-3_Reye Syndrome Form and Instruction	Modified
Form 0920-0009 Att D2_Kawasaki Syndrome Form and Instruction	Modified
Form 0920-0009 Att D-1_CJD Form and Instruction	Modified
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	Modified
219459	Att D2_Kawasaki Syndrome Form and Instruction	Modified
219458	Att D-1_CJD Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0009	ICR Reference No: 201905-0920-011
Status: Historical Active	Previous ICR Reference No: 201901-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0009
Title: National Disease Surveillance Program
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 without change	Conclusion Date: 08/07/2019
	Date Received in OIRA: 06/26/2019
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. CDC will work with their OIRA desk officer in advance to determine whether changes should be submitted as revisions or as nonsubstative change requests.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	08/31/2019
Responses	720	0	630
Time Burden (Hours)	167	0	190
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. For this Extension CDC is requesting minor changes (clarification) on a form and a minor burden change.

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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	0920-0009	AFM 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	630	0	90	0	0
Annual Time Burden (Hours)	167	190	0	-23	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: For CJD, the estimated number of respondents is decreasing from 20 to 10, resulting in a 6 hour reduction in burden. For KD, the estimated number of respondents will decrease from 55/year to 25/year. The estimated burden will decrease from 110 hours/year to 63 hours/year. For AFM, the number of responses was changed from 1 to 4 in the burden table to reflect the number of outcome responses; the average time for each response is shortened and the overall burden hours increases from 50 to 80 hours

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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: 06/26/2019

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