E9-26541. 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 [e-mail], or call the Reports Clearance Office on [phone].

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 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: [phone], E-mail: [e-mail].

Dated: October 21, 2009.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.