View Information Collection Request (ICR) Package
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View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
A listing of all respondents
Direct or indirect financial relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia
Internal or external request for listing of therapy recommendation including criteria used to evaluate the response
Minutes and voting records of meetings for the review and disposition of the response
Ownership or investment relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia
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.
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
Agency Contact:
William Parham 4107864669
Common Form ICR:
No
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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