[Federal Register: November 4, 2009 (Volume 74, Number 212)]
[Notices]
[Page 57178-57179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no09-78]
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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 Paperwork@cms.hhs.gov, 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: OIRA_submission@omb.eop.gov.
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