Enhanced Surveillance for Histoplasmosis

Forms and Documents

Document Name	Status
Case Report Form for Histoplasmosis Enhanced Surveillance - Health Department Personnel Form and Instruction	New
Case Report Form for Histoplasmosis Enhanced Surveillance - Histoplasmosis Cases Form and Instruction	New
Att 4 - Nonresearch determination-signed.pdf Supplementary Document	2018-03-09
Att 5 - Histoplasmosis enhanced surveillance protocol.docx Supplementary Document	2018-03-09
Att 2 - 60-Day FRN - histoplasmosis enhanced surveillance.pdf Supplementary Document	2018-03-09
Att 1 - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2018-03-09
Supporting Statement B - histoplasmosis enhanced surveillance.docx Supporting Statement B	2018-03-09
Supporting Statement A - histoplasmosis enhanced surveillance.docx Supporting Statement A	2018-03-09

IC Document Collections

IC ID	Document Title	Status
230643	Case Report Form for Histoplasmosis Enhanced Surveillance - Health Department Personnel Form and Instruction	New
230642	Case Report Form for Histoplasmosis Enhanced Surveillance - Histoplasmosis Cases Form and Instruction	New

ICR Details

OMB Control No: 0920-1230	ICR Reference No: 201802-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18EV
Title: Enhanced Surveillance for Histoplasmosis
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 without change	Conclusion Date: 05/11/2018
	Date Received in OIRA: 03/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	24 Months From Approved
Responses	600	0	0
Time Burden (Hours)	150	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this enhanced surveillance project is to better describe the epidemiological and clinical characteristics of reported histoplasmosis cases in states where it is reportable. State health department personnel will conduct telephone interviews with reported histoplasmosis cases and will record responses on a standardized form. Data will be used to help inform current routine surveillance practices, and to guide future awareness and educational efforts, and to describe the features of histoplasmosis cases in at least one scientific publication,.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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:
	82 FR 60609	12/21/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 10485	03/09/2018
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
Case Report Form for Histoplasmosis Enhanced Surveillance - Histoplasmosis Cases	NA	Case Report Form for Histoplasmosis Enhanced Surveillance
Case Report Form for Histoplasmosis Enhanced Surveillance - Health Department Personnel	NA	Case Report Form for Histoplasmosis Enhanced Surveillance

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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	600	0	0	600	0	0
Annual Time Burden (Hours)	150	0	0	150	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: Submission of 0920-18EV - Enhanced Surveillance for Histoplasmosis is a New ICR.

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Annual Cost to Federal Government: $7,254

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.     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: 03/13/2018

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