[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41631-41632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10302]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any

[[Page 41632]]

other aspect of this collection of information, including the necessity 
and utility of the proposed information collection for the proper 
performance of the agency's functions, the accuracy of the estimated 
burden, ways to enhance the quality, utility, and clarity of the 
information to be collected, and the use of automated collection 
techniques or other forms of information technology to minimize the 
information collection burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by July 27, 2023.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Extension of a currently 
approved 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: Section 182(b) of the Medicare 
Improvement of Patients and Providers Act (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 control number: 0938-1078); Frequency: 
Annually; 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 Sarah Fulton at 410-786-2749.)

    Dated: June 22, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-13656 Filed 6-26-23; 8:45 am]
BILLING CODE 4120-01-P