Safe Harbor for Federally Qualified Health Centers Arrangements

Forms and Documents

Document Name	Status
0990-0322 safeharborforfederally 01_2015.docx Supporting Statement A	2015-01-15
0990-0322_Attachment E.pdf Supplementary Document	2011-07-05
0990-0322_Attachment D.pdf Supplementary Document	2011-07-05
0990-0322_Attachment C.pdf Supplementary Document	2011-07-05
0990-0322_Attachment B.pdf Supplementary Document	2011-07-05
0990-0322_Attachment A.pdf Supplementary Document	2011-07-05

IC Document Collections

IC ID	Document Title	Status
182767	Health Center (administrative professional)	Modified

ICR Details

OMB Control No: 0990-0322	ICR Reference No: 201501-0990-001
Status: Historical Active	Previous ICR Reference No: 201107-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Safe Harbor for Federally Qualified Health Centers Arrangements
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/02/2015
	Date Received in OIRA: 01/26/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	36 Months From Approved
Responses	4,983	0	0
Time Burden (Hours)	4,983	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: We have developed this Safe Harbor regulation in accordance with Congress's direction at section 431 of MMA. Section 431 of MMA amended the anti-kickback statue to create a new safe harbor for certain agreements involving health centers.

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Authorizing Statute(s): PL: Pub.L. 14 - 100 1128b Name of Law: Medicare and Medicaid Patient and Program Protection Act 1987
   US Code: 42 USC 1320 Name of Law: 7a
   US Code: 31 USC 3729 Name of Law: 33
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 59269	10/01/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 2015	01/23/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Health Center (administrative professional)

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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	4,983	0	0	3,110	0	1,873
Annual Time Burden (Hours)	4,983	0	0	3,110	0	1,873
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: There were no changes to the data.

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Annual Cost to Federal Government: $1,136

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]? No

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: 01/26/2015

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