Collection Requirements for Compendia for Determination of Medically-Accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

Forms and Documents

Document	Type	Status	Availability
02.2013.CMS-10302 Supporting Statement Part A.doc	Supporting Statement A	Uploaded 2013-06-03	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
191468	Ownership or investment relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia		Modified
191467	Direct or indirect financial relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia		Modified
191466	Minutes and voting records of meetings for the review and disposition of the response		Modified
191465	A listing of all respondents		Modified
191464	A listing of all evidentiary materials reviewed or considered by compendia pursuant to a response		Modified
191463	Internal or external request for listing of therapy recommendation including criteria used to evaluate the response		Modified

ICR Details

OMB Control No: 0938-1078	ICR Reference No: 201306-0938-002
Status: Historical Active	Previous ICR Reference No: 201007-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: 19728
Title: Collection Requirements for Compendia for Determination of Medically-Accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen
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: 07/26/2013
	Date Received in OIRA: 06/05/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved	08/31/2013
Responses	900	0	900
Time Burden (Hours)	5,135	0	5,135
Cost Burden (Dollars)	0	0	0

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Abstract: All currently listed compendia will be required to comply with these provisions, as of January 1, 2010, to remain on the list of recognized compendia. In addition, any compendium that is the subject of a future request for inclusion on the list of recognized compendia will be required to comply with these provisions. No compendium can be on the list if it does not fully meet the standard described in section 1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA.

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Authorizing Statute(s): US Code: 42 USC 1395x(t)(2)(B) Name of Law: Drugs and biologicals
  

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 16507	03/15/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 32657	05/31/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Internal or external request for listing of therapy recommendation including criteria used to evaluate the response
A listing of all evidentiary materials reviewed or considered by compendia pursuant to a response
A listing of all respondents
Minutes and voting records of meetings for the review and disposition of the response
Direct or indirect financial relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia
Ownership or investment relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia

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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	900	900	0	0	0	0
Annual Time Burden (Hours)	5,135	5,135	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: $0

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]? 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: 06/05/2013

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