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
CMS-10302.Emergency Justification.doc	Supplementary Document	Uploaded 2009-11-10	Repair queued
CMS-10302.Supporting Statement Part A.doc	Supporting Statement A	Uploaded 2009-11-10	Repair queued

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

ICR Details

OMB Control No: 0938-1078	ICR Reference No: 200912-0938-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 12/08/2009
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/08/2010
	Date Received in OIRA: 12/02/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2010	6 Months From Approved
Responses	900	0	0
Time Burden (Hours)	5,135	0	0
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.

Emergency Justfication: Please see the attached emergency justification that was approved by OMB.

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

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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
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 57178	11/04/2009
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
A listing of all evidentiary materials reviewed or considered by compendia pursuant to a response
Internal or external request for listing of therapy recommendation including criteria used to evaluate the 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	0	900	0	0	0
Annual Time Burden (Hours)	5,135	0	5,135	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: This is a new information collection requirement. The CY 2010 Physician Fee Schedule contains revisions to the requirements in 42 CFR 414.930. The regulation is on display but has yet to publish. The scheduled publication date of the regulation is 11/25/2009.

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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]? 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)? 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: 12/02/2009

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