[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Notices]
[Pages 25596-25597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10495]


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

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 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.

DATES: Comments must be received by June 2, 2014.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
CMS or the OMB desk officer via one of the following transmissions:
    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.
    3. OMB, Office of Information and Regulatory Affairs, Attention: 
CMS Desk Officer, Fax Number: (202) 395-5806 or, Email: [email protected].
    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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    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: Reports Clearance Office at (410) 786-
1326.

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: Revision of a currently 
approved collection; Title of Information Collection: Registration, 
Attestation, Dispute & Resolution, Assumptions Document and Data 
Retention Requirements for Open Payments; Use: Section 6002 of the 
Affordable Care Act added section 1128G to the Social Security Act 
(Act), which requires applicable manufacturers and applicable group 
purchasing organizations (GPOs) of covered drugs, devices, biologicals, 
or medical supplies to report annually to CMS certain payments or other 
transfers of value to physicians and teaching hospitals, as well as, 
certain information regarding the ownership or investment interests 
held by physicians or their immediate family members in applicable 
manufacturers or applicable GPOs.
    Specifically, applicable manufacturers of covered drugs, devices, 
biologicals, and medical supplies are required to submit on an annual 
basis the information required in section 1128G(a)(1) of the Act about 
certain payments or other transfers of value made to physicians and 
teaching hospitals (collectively called covered recipients) during the 
course of the

[[Page 25597]]

preceding calendar year. Similarly, section 1128G(a)(2) of the Act 
requires applicable manufacturers and applicable GPOs to disclose any 
ownership or investment interests in such entities held by physicians 
or their immediate family members, as well as information on any 
payments or other transfers of value provided to such physician owners 
or investors. Applicable manufacturers must report the required payment 
and other transfer of value information annually to CMS in an 
electronic format. The statute also provides that applicable 
manufacturers and applicable GPOs must report annually to CMS the 
required information about physician ownership and investment 
interests, including information on any payments or other transfers of 
value provided to physician owners or investors, in an electronic 
format by the same date. Applicable manufacturers and applicable GPOs 
are subject to civil monetary penalties (CMPs) for failing to comply 
with the reporting requirements of the statute. We are required by 
statute to publish the reported data on a public Web site. The data 
must be downloadable, easily searchable, and aggregated. In addition, 
we must submit annual reports to the Congress and each state 
summarizing the data reported. Finally, section 1128G of the Act 
generally preempts state laws that require disclosure of the same type 
of information by manufacturers.
    With this notice, we are announcing the addition of the dispute 
resolution and corrections process to this information collection 
request (ICR). The dispute resolution and corrections process was 
discussed in our initial submission to OMB. However, based on the 
detailed processes of review and corrections as well as the 
sensitivities around these processes, we felt it appropriate to solicit 
additional public feedback on how these interactions would occur. 
Therefore we are resubmitting a revised ICR for OMB review and 
approval. While we are submitting a revision of the entire ICR, we are 
specifically seeking comments on the dispute resolution and comment 
process. Form Number: CMS-10495 (OCN: 0938-1237); Frequency: Once; 
Affected Public: Private sector--business or other for-profits; Number 
of Respondents: 227,157; Total Annual Responses: 457,454; Total Annual 
Hours: 3,099,297. (For policy questions regarding this collection 
contact Melissa Heesters at 410-786-0618.)

    Dated: April 30, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2014-10228 Filed 5-1-14; 11:15 am]
BILLING CODE 4120-01-P