[Federal Register Volume 74, Number 212 (Wednesday, November 4, 2009)]
[Notices]
[Pages 57178-57179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10302]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

AGENCY: Center for Medicare and Medicaid Services.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this burden 
estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    We are, however, requesting an emergency review of the information 
collection referenced below. In compliance with the requirement of 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have 
submitted to the Office of Management and Budget (OMB) the following 
requirements for emergency review. We are requesting an emergency 
review because the collection of this information is needed before the 
expiration of the normal time limits under OMB's regulations at 5 CFR 
Part 1320(a)(2)(ii). This is necessary to ensure compliance with an 
initiative of the Administration. We cannot reasonably comply with the 
normal clearance procedures because use of the normal clearance 
procedures is reasonably likely to cause a statutory deadline to be 
missed, stated in 5 CFR 1320.13(a)(2)(iii). The Centers for Medicare 
and Medicaid Services (CMS) is requesting that an information 
collection request (ICR) for the Collection Requirements for Compendia 
for Determination of Medically-accepted Indications for Off-label Uses 
of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen, be 
processed under the emergency clearance process. Approval of this 
package is essential in order to comply with the section 182(b) of 
MIPPA amended Section 1861(t)(2)(B) of the Social Security Act (42 
U.S.C. 1395x(t)(2)(B)).
    1. Type of Information Collection Request: New collection; Title of 
Information Collection: Collection Requirements for Compendia for 
Determination of Medically-accepted Indications for Off-label Uses of 
Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen Use: 
Congress enacted the Medicare Improvement of Patients and Providers Act 
(MIPPA). Section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the 
Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the 
following new sentence: `On and after January 1, 2010, no compendia may 
be included on the list of compendia under this subparagraph unless the 
compendia has a publicly transparent process for evaluating therapies 
and for identifying potential conflicts of interest.' We believe that 
the implementation of this statutory provision that compendia have a 
``publicly transparent process for evaluating therapies and for 
identifying potential conflicts of interests'' is best accomplished by 
amending 42 CFR 414.930 to include the MIPPA requirements and by 
defining the key components of publicly transparent processes for 
evaluating therapies and for identifying potential conflicts of 
interests.
    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. 
Form Number: CMS-10302 (OMB: 0938-New); Frequency: Reporting, 
Recordkeeping and Third-party disclosure; Affected Public: Business and 
other for-profits and Not-for-profit institutions; Number of 
Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 
5,135. (For policy questions regarding this collection contact Brijet 
Burton at 410-786-7364. For all other issues call 410-786-1326.)
    CMS is requesting OMB review and approval of this collection by 
December 8, 2009, with a 180-day approval period. Written comments and 
recommendations will be considered from the public if received by the 
individuals designated below by November 30, 2009.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site address at: http://www.cms.hhs.gov/regulations/pra or E-mail 
your request, including your address, phone number, OMB number, and CMS 
document identifier, to [email protected], or call the Reports 
Clearance Office on (410) 786-1326.
    Interested persons are invited to send comments regarding the 
burden or any other aspect of these collections of information 
requirements. However, as noted above, comments on these information 
collection and recordkeeping requirements must be mailed and/or faxed 
to the designees

[[Page 57179]]

referenced below by November 30, 2009.
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    3. By Facsimile or E-mail to OMB. OMB, Office of Information and 
Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-
6974, E-mail: [email protected].

    Dated: October 21, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E9-26541 Filed 11-3-09; 8:45 am]
BILLING CODE 4120-01-P