Mycoplasma Genitalium Treatment Failure Registry

Forms and Documents

Document Name	Status
Form 0920 Att 4_Case Report Form	New
Att 6_NonResearchDermination.docx Supplementary Document	2020-12-11
Att 1 Authorizing Legislation Sec_301 PHSA.docx Supplementary Document	2020-12-11
SSB_MgenRegistry.docx Supporting Statement B	2020-12-11
SSA_MgenResgistry.docx Supporting Statement A	2020-12-11

IC Document Collections

IC ID	Document Title	Status
244889	Att 4_Case Report Form	New

ICR Details

OMB Control No:	ICR Reference No: 202012-0920-005
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20OT
Title: Mycoplasma Genitalium Treatment Failure Registry
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/15/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	100	0
Time Burden (Hours)	100	0
Cost Burden (Dollars)	0	0

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Abstract: The purpose of the Mycoplasma genitalium Treatment Failure Registry is to monitor antibiotic use for cases of M. genitalium that fail treatment with first-line therapy. Data will be collected from approximately 100 healthcare providers annually who care for patients with sexually transmitted Mycoplasma genitalium infections who experience persistent symptoms and treatment failure after receiving standard therapy. Data from the registry will be analyzed to describe the demographic characteristics of patients with treatment failure, frequency of use of second-line antibiotic therapies, and patterns of antibiotic resistance.

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Authorizing Statute(s): US Code: 42 USC 792{295k] Name of Law: Public Helath 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:
	85 FR 34636	06/05/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 80106	12/11/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Att 4_Case Report	0920	Mycoplasma genitalium Treatment Failure Registry Case Report Form

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ICR Summary of Burden

	Total Request	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	100	0	0	100	0	0
Annual Time Burden (Hours)	100	0	0	100	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $20,287

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.     No

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: 12/15/2020

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