Gonococcal Isolate Surveillance Project

Forms and Documents

Document Name	Status
Att8_Data Dictionary.doc Supplementary Document	2007-11-29
Att7_Sample Report.doc Supplementary Document	2007-11-29
Att6b_Sentinel Clinic.doc Supplementary Document	2007-11-29
Att6a_CDC participants.doc Supplementary Document	2007-11-29
Att5_IRB.doc Supplementary Document	2007-11-29
Att2_60dFRN.doc Supplementary Document	2007-11-29
Att1_Justification.doc Supplementary Document	2007-11-29
Att4_Screen shots.doc Supplementary Document	2007-11-29
Sup Statement_A.doc Supporting Statement A	2007-11-29

IC Document Collections

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

ICR Details

OMB Control No: 0920-0307	ICR Reference No: 200712-0920-007
Status: Historical Active	Previous ICR Reference No: 200410-0920-011
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: 03/24/2008
	Date Received in OIRA: 12/20/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2011	36 Months From Approved	03/31/2008
Responses	14,700	0	1,644
Time Burden (Hours)	8,628	0	8,142
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of these forms is to collect surveillance data on antimicrobial resistance in Neisseria gonorrohoeae. These data are used by public health officials at the national, state, and local level to determine appropriate therapy for gonorrohea. In addition, the data are used to monitor trends in certain epidemiologic aspects of gonorrohea, including the Healthy People 2010 goal for repeat gonococcal infections.

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Authorizing Statute(s): PL: Pub.L. 42 - 301 241 Name of Law: Research and Investigation
  

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:
	72 FR 35490	06/28/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 68887	12/06/2007
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 1 - Demographic/Clinical Data
Form 2 - Antimicrobial Susceptibility Testing
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	1,644	0	13,056	0	0
Annual Time Burden (Hours)	8,628	8,142	0	486	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: We added 3 additional clinics in the past 3 years and lost 1 site, for a total of 30 sites in 2007. There has been an increase in the average number of isolates submitted monthly (from 19 in 2003 to 20 in 2007). Because of the current additions the burden for this ICR has an increase of 486 hours of burden.

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Annual Cost to Federal Government: $806,900

Does this IC contain surveys, censuses, or employ statistical methods? No

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/20/2007

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