Gonococcal Isolate Surveillance Project

Forms and Documents

Document Name	Status
Form CDC73.60A Form 1 - Demographic/Clinical Data Form	Unchanged
Form CDC 73.60-C Rev 08 Form 3: Control Strain Susceptibility Testing Form	Modified
Form CDC 73.60-B Rev 08 Form 2 - Antimicrobial Susceptibility Testing Form	Modified
Att 8 Data Coding Dictionary.doc Supplementary Document	2014-08-08
Justification for Change.docx Justification for No Material/Nonsubstantive Change	2014-08-08
Sup_Statement_B_FINAL.doc Supporting Statement B	2013-07-18
Att 8 Data coding_FINAL.doc Supplementary Document	2013-07-18
Att 7 - Sample Report.doc Supplementary Document	2013-07-18
Att 6b - NonCDCProjectPersonnel.doc.docx Supplementary Document	2013-07-18
Att 6a - CDC ProjectParticipants.doc Supplementary Document	2013-07-18
Att 5_IRB Determination_FINAL.docx Supplementary Document	2013-07-18
Att 4_Screenshots_FINAL.doc Supplementary Document	2013-07-18
Att 3_Proposed Changes_FINAL.docx Supplementary Document	2013-07-18
SupSta_A_2014.doc Supporting Statement A	2014-08-08

IC Document Collections

IC ID	Document Title	Status
6747	Form 1 - Demographic/Clinical Data Form	Unchanged
183167	Form 3: Control Strain Susceptibility Testing Form	Modified
183166	Form 2 - Antimicrobial Susceptibility Testing Form	Modified

ICR Details

OMB Control No: 0920-0307	ICR Reference No: 201408-0920-004
Status: Historical Active	Previous ICR Reference No: 201307-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 14ASS
Title: Gonococcal Isolate Surveillance Project
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/28/2014
	Date Received in OIRA: 08/19/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	08/31/2016	08/31/2016
Responses	14,700	0	14,700
Time Burden (Hours)	8,628	0	8,628
Cost Burden (Dollars)	0	0	0

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Abstract: The Gonococcal Isolate Surveillance Project conducts public health surveillance on antimicrobial susceptibility of Neisseria gonorrhoeae. To provide the most useful and actionable surveillance data and to keep pace with changes in gonorrhea treatment practices, the Gonococcal Isolate Surveillance Project (GISP) occasionally has to update the antimicrobial agents tested in GISP. N. gonorrhoeae susceptibility to spectinomycin has been tested in GISP since 1987. However, spectinomycin is no longer available in the United States. An antibiotic regimen that includes gentamicin, an antimicrobial similar to spectinomycin but that is widely available in the United States, was recently found to be effective for gonorrhea treatment and is likely to be recommended as alternative therapy in the upcoming CDC STD Treatment Guidelines update.

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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:
	78 FR 18600	03/27/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 42956	07/18/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Form 2 - Antimicrobial Susceptibility Testing	CDC 73.60-B Rev 08-2014	Form 2: Antimicrobial Susceptablity Testing
Form 3: Control Strain Susceptibility Testing	CDC 73.60-C Rev 08.2014	Form 3: Control Strain Susceptability Testing
Form 1 - Demographic/Clinical Data	CDC73.60A	Form 1: Demographic/Clinical Data

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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	14,700	14,700	0	0	0	0
Annual Time Burden (Hours)	8,628	8,628	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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:

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Annual Cost to Federal Government: $806,900

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 08/19/2014

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