Process for Obtaining Waivers of the Annual Limits Requirements of PHS Act Section 2711

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
195130	Model Notices	New
194479	Waiver Process	Modified

ICR Details

OMB Control No: 0938-1105	ICR Reference No: 201011-0938-005
Status: Historical Active	Previous ICR Reference No: 201010-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Process for Obtaining Waivers of the Annual Limits Requirements of PHS Act Section 2711
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 11/05/2010
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/01/2010
	Date Received in OIRA: 11/04/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	6 Months From Approved	04/30/2011
Responses	2,979,885	0	1,500
Time Burden (Hours)	112,780	0	12,000
Cost Burden (Dollars)	1,459,409	0	0

---

Abstract: The application process will be used by HHS to grant applications a waiver of the limitation on the annual limits requirement.

Emergency Justfication: See attached justification.

---

Authorizing Statute(s): PL: Pub.L. 111 - 148 2711(a)(2) Name of Law: NO LIFETIME OR ANNUAL LIMITS.
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Waiver Process
Model Notices	CMS-10342

---

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	2,979,885	1,500	0	2,978,385	0	0
Annual Time Burden (Hours)	112,780	12,000	0	100,780	0	0
Annual Cost Burden (Dollars)	1,459,409	0	0	1,459,409	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: We revised the information collection request to include the burden associated with MLR data submissions. The burden has been adjusted accordingly.

---

Annual Cost to Federal Government: $432,000

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

---

Common Form ICR:  No

---

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: 11/04/2010

---