Gonococcal Isolate Surveillance Project

Forms and Documents

Document Name	Status
Demographic/Clinical Data for Sites Conducting Core Surveillance Form	Modified
Demographic/Clinical Data Collection for Enhanced Surveillance - Molecular Form	New
Demographic/Clinical Data Collection for Enhanced Surveillance Form	Modified
Antimicrobial Susceptibility Testing Form	Modified
GISP PIA_0920-0307.pdf Supplementary Document	2021-07-02
Att9 Changes to the ICR_final.docx Supplementary Document	2021-07-02
Att8 Justification of Sensitive Data.docx Supplementary Document	2021-07-02
Att6b Clinic and Laboratory Contacts.docx Supplementary Document	2021-07-02
Att6a CDC Project Participants.docx Supplementary Document	2021-07-02
Att5 IRB Determination.docx Supplementary Document	2021-07-02
Att4 Visualization of Project Components.docx Supplementary Document	2021-07-02
Att2 60 FRN Published 3-8-2021 GISP.pdf Supplementary Document	2021-07-02
Att1 Authorizing Legislation.docx Supplementary Document	2021-07-02
Supporting Statement B_.docx Supporting Statement B	2021-07-02
Supporting Statement A_final.docx Supporting Statement A	2021-07-02

IC Document Collections

IC ID	Document Title	Status
6747	Demographic/Clinical Data for Sites Conducting Core Surveillance Form	Modified
248175	Demographic/Clinical Data Collection for Enhanced Surveillance - Molecular Form	New
232331	Demographic/Clinical Data Collection for Enhanced Surveillance Form	Modified
183167	Control Strain Susceptibility Testing Instruction	Modified
183166	Antimicrobial Susceptibility Testing Form	Modified

ICR Details

OMB Control No: 0920-0307	ICR Reference No: 202106-0920-007
Status: Received in OIRA	Previous ICR Reference No: 201805-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0307
Title: Gonococcal Isolate Surveillance Project
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/02/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2021
Responses	34,992	26,592
Time Burden (Hours)	13,056	11,376
Cost Burden (Dollars)	258,507	226,117

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Abstract: The purpose of these forms is to continue to collect surveillance data on antimicrobial resistance in Neisseria gonorrhoeae. These data are used by public health officials at the national, state, and local level to determine appropriate therapy for gonorrhea. In addition, the data are used to monitor trends N. gonorrhoeae antimicrobial resistance and certain epidemiologic aspects of gonorrhea. This Revision adds collection of remnant nucleic acid amplification test (NAAT) specimens and associated epidemiological data, same data elements (with 2020 updates) as currently participating GISP sites.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	86 FR 13394	03/08/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 35292	07/02/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Antimicrobial Susceptibility Testing	n/a	Antimicrobial Susceptibility Testing
Control Strain Susceptibility Testing
Demographic/Clinical Data Collection for Enhanced Surveillance	n/a	Demographic/Clinical Data Elements for Sites Conducting Enhanced Surveillance
Demographic/Clinical Data Collection for Enhanced Surveillance - Molecular	n/a	Demographic/Clinical Data Elements for Sites Conducting Enhanced Surveillance
Demographic/Clinical Data for Sites Conducting Core Surveillance	n/a	Core Demographic/Clinical Data

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ICR Summary of Burden

	Total Request	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	34,992	26,592	0	0	8,400	0
Annual Time Burden (Hours)	13,056	11,376	0	0	1,680	0
Annual Cost Burden (Dollars)	258,507	226,117	0	0	32,390	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: A collection instrument was added that increased the burden.

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Annual Cost to Federal Government: $1,286,900

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.     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? No

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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: 07/02/2021

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