Transparency Reports and Reporting of Physician Ownership or Investment Interests

Forms and Documents

Document Name	Status
Form CMS-10419 ?§403.906 and 404.908(a)-(g) - Applicable GPO Data Collection and Reporting Form	New
Form CMS-10419 403.904 and 404.908(a)-(g) - Applicable Manufacturer Data Collection and Reporting Form	Modified
CMS-10419.Response to 60 day comments PRA.docx Supplementary Document	2013-05-13
CMS-10419_Crosswalk_.pdf Supplementary Document	2013-05-13
CMS-10419.(CLEAN)) - Supporting_Statement_Part_A -7-26-13 (137pm).docx Supporting Statement A	2013-07-26

IC Document Collections

IC ID	Document Title	Status
207934	?§403.906 and 404.908(a)-(g) - Applicable GPO Data Collection and Reporting Form	New
203245	403.904 and 404.908(a)-(g) - Applicable Manufacturer Data Collection and Reporting Form	Modified

ICR Details

OMB Control No: 0938-1173	ICR Reference No: 201305-0938-006
Status: Historical Active	Previous ICR Reference No: 201207-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: 19601
Title: Transparency Reports and Reporting of Physician Ownership or Investment Interests
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/26/2013
	Date Received in OIRA: 05/14/2013
Terms of Clearance: This approval does not cover collections associated with (1) the registration system for applicable manufacturers and applicable GPOs (§ 403.908) and physicians and teaching hospitals (§403.908(g)(2)(b)(ii)(B)); (2) the review process, in which registrants have an opportunity to review submitted information and certify accurate information (§ 403.908(g)(3)(iii)) or initiate a dispute (§ 403.908(g)(3)(iv)); (3) the requirements for applicable manufacturers and applicable GPOs to notify CMS of resolved disputes (§ 403.908(g)(4)) or upon discovering errors or omissions in their reports (§ 403.908(h)); (4) the five-year recordkeeping requirement for applicable manufacturers and applicable GPOs (§ 403.912); and (5) the process for applicable manufacturers and applicable GPOs to request submission extensions from CMS. CMS intends to address these collections in a future PRA package. Consistent with 5 CFR Part 1320, these provisions will not be effective until OMB approves them. If covered by the PRA, CMS will seek approval for information collections that are related to the audit/penalty/appeals process.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved
Responses	1,570	0	0
Time Burden (Hours)	5,232,800	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 6002 of the Affordable Care Act added section 1128G to the Act, which requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare or a State plan under Medicaid or CHIP to report annually to the Secretary certain payments or other transfers of value to physicians and teaching hospitals. Section 1128G of the Act also requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 6002 Name of Law: Transparency Reports and Reporting of Physician Ownership or Investment Interests
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6002 Name of Law: Transparency Reports and Reporting of Physician Ownership or Investment Interests

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AR33	Final or interim final rulemaking	78 FR 9458	02/08/2013

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 9394	02/08/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 26370	05/06/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
§§403.906 and 404.908(a)-(g) - Applicable GPO Data Collection and Reporting	CMS-10419, CMS-10419, CMS-10419	Research Template ,   Physician Ownership Template ,   General Payments (Non-Research) Template
403.904 and 404.908(a)-(g) - Applicable Manufacturer Data Collection and Reporting	CMS-10419, CMS-10419, CMS-10419	Research Template ,   Physician Ownership Template ,   General Payments (Non-Research) Template

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,570	0	1,570	0	0	0
Annual Time Burden (Hours)	5,232,800	0	5,232,800	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/13/2013

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