[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69745-69746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27385]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10302]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid 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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any 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.
[[Page 69746]]
DATES: Comments must be received by February 18, 2020.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send 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) that are 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.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10302 Collection Requirements for Compendia for Determination of
Medically-Accepted Indications for Off-label Uses of Drugs and
Biologicals in an Anti-Cancer Chemotherapeutic Regimen
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
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: December 16, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-27385 Filed 12-18-19; 8:45 am]
BILLING CODE 4120-01-P