Gonococcal Isolate Surveillance Project

Forms and Documents

Forms and supporting documents for this ICR

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

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0920-0307	ICR Reference No: 202106-0920-007
Status: Historical Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/15/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/02/2021
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2024	36 Months From Approved	11/30/2021
Responses	34,992	0	26,592
Time Burden (Hours)	13,056	0	11,376
Cost Burden (Dollars)	258,507	0	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

table that charts list of burden

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

table that charts list 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	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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