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 Form	New
Antimicrobial Susceptibility Testing Form	Modified
Att 10. PIA GISP 4-27-2016.pdf Supplementary Document	2018-07-20
Att 9_Changes to the ICR_06252018.docx Supplementary Document	2018-07-20
Att 8_Justification Sensitive data.docx Supplementary Document	2018-07-20
Att 6b_Clinic and Laboratory Contacts.docx Supplementary Document	2018-07-20
Att 6a_CDC ProjectParticipants.docx Supplementary Document	2018-07-20
Att 5b_IRB Determination enhanced GISP.docx Supplementary Document	2018-07-20
Att 5a_IRB Determination Core GISP.docx Supplementary Document	2018-07-20
Att 4_Screenshots.docx Supplementary Document	2018-07-20
Att 2 60 Day FRN Published.pdf Supplementary Document	2018-07-20
Att 1_Authorizing Legislation_March2018.docx Supplementary Document	2018-07-20
SSB_06252018.docx Supporting Statement B	2018-07-20
SSA_06252018_07202018.docx Supporting Statement A	2018-07-20

IC Document Collections

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

ICR Details

OMB Control No: 0920-0307	ICR Reference No: 201805-0920-005
Status: Active	Previous ICR Reference No: 201512-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No:
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: 08/20/2018
	Date Received in OIRA: 07/20/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	02/28/2019
Responses	26,592	0	14,700
Time Burden (Hours)	11,376	0	8,628
Cost Burden (Dollars)	226,117	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 301 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:
	83 FR 5102	02/05/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 34583	07/20/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Demographic/Clinical Data for Sites Conducting Core Surveillance	n/a	Core Demographic/Clinical Data
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

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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	26,592	14,700	0	11,892	0	0
Annual Time Burden (Hours)	11,376	8,628	0	2,748	0	0
Annual Cost Burden (Dollars)	226,117	0	0	226,117	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: There is no change in burden for 20 sentinel sites that will continue to conduct core surveillance. There is an increase in burden for 10 sentinel sites that will begin collecting additional data and specimens for enhanced surveillance. Enhanced surveillance will increase the number of isolates submitted for antimicrobial resistance testing. Measures have been taken to decrease the burden per response, but there is a net increase in burden. There is a decrease in burden associated with control strain susceptibility testing.

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Annual Cost to Federal Government: $1,176,900

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? 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: 07/20/2018

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