Gonococcal Isolate Surveillance Project

Forms and Documents

Document Name	Status
Form CDC 73.60A Form 1 - Demographic/Clinical Data Form and Instruction	Modified
Form CDC 73.60-C Form 3: Control Strain Susceptibility Testing Form and Instruction	Modified
Form CDC 73.60-B Form 2 - Antimicrobial Susceptibility Testing Form and Instruction	Modified
Att 7_Data coding guide.pdf Supplementary Document	2015-12-16
Att 6b - Non-CDCProjectParticipants.doc Supplementary Document	2015-12-16
Att 6a - CDC ProjectParticipants.doc Supplementary Document	2015-12-16
Att 5_IRB Determination.docx Supplementary Document	2015-12-16
Att 4_Screenshots.docx Supplementary Document	2015-12-16
Att 2_60 Day FRN Published.pdf Supplementary Document	2015-12-15
Att 8 Data Coding Dictionary.doc Supplementary Document	2014-08-08
SS_B_2015.docx Supporting Statement B	2015-12-15
Sup_Statement_A_122315.doc Supporting Statement A	2015-12-23

IC Document Collections

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

ICR Details

OMB Control No: 0920-0307	ICR Reference No: 201512-0920-005
Status: Historical Active	Previous ICR Reference No: 201408-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Gonococcal Isolate Surveillance Project
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/22/2016
	Date Received in OIRA: 12/23/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved	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 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:
	80 FR 52289	08/28/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 76690	12/10/2015
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Form 1 - Demographic/Clinical Data	CDC 73.60A	Form 1: Demographic/Clinical Data
Form 2 - Antimicrobial Susceptibility Testing	CDC 73.60-B	Form 2: Antimicrobial Susceptibility Testing
Form 3: Control Strain Susceptibility Testing	CDC 73.60-C	Form 3: Control Strain Susceptibility Testing

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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: 12/23/2015

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