Assurance and Certification of Compliance (NPRM)

Forms and Documents

Document Name	Status
Form 690 Assurance of Compliance Form	New
Revised clean 0945-0008 Supporting Statement AoC Nov222019 - 11-26 rev.docx Supporting Statement A	2019-12-02

IC Document Collections

IC ID	Document Title	Status
238746	Assurance of Compliance Form	New
236662	Assurance and Certification Requirements Other-form	New
229949	88.4(a) (Update Policies and Procedures; Train Workforce)	Unchanged
229948	88.4(a) (Review Policies and Procedures)	Unchanged
229875	88.4(a) (Review and sign assurance and certification)	Unchanged

ICR Details

OMB Control No: 0945-0008	ICR Reference No: 201906-0945-003
Status: Active	Previous ICR Reference No: 201801-0945-001
Agency/Subagency: HHS/OCR	Agency Tracking No:
Title: Assurance and Certification of Compliance (NPRM)
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: 12/02/2019
	Date Received in OIRA: 06/25/2019
Terms of Clearance: OMB notes that the final rule associated with this ICR (Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, 84 FR 23170, May 21, 2019) has been vacated and is not currently in effect (See, e.g., State v. United States Department of Health & Human Services, No. 19 Civ. 4676 (PAE), 2019 WL 5781789 (S.D.N.Y. Nov. 6, 2019)). Accordingly, Form HHS-690 is not currently approved for use in connection with this final rule, but approval of HHS-690 is reinstated for use in connection with various other longstanding authorities that are unaffected by the litigation involving the final rule, including 45 CFR 80.4, 84.5, 86.4, 91.33, and 92.5. See Supporting Statement A for more information.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved
Responses	850,926	0	0
Time Burden (Hours)	3,780,716	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Requiring certain recipients and applicants to assure and certify compliance serves two purposes. First, through the act of reading and reviewing the statutory requirements to which recipients or applicants assure and certify compliance, recipients would be apprised of their obligations under the applicable Federal health care conscience and associated anti-discrimination laws. Second, a recipient’s or applicant’s awareness of its obligation would increase the likelihood that it would comply with such laws and consequently afford entities and individuals protection of their conscience rights and protection from coercion or discrimination. Because of this awareness, the Department anticipates that proposed § 88.4 may generate changes in the policies, procedures, and operations of the persons and entities covered

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Authorizing Statute(s): US Code: 42 USC 300a-7 Name of Law: Church Admendment
   US Code: 42 USC 238n Name of Law: Coats-Snowe Amendment,
   PL: Pub.L. 115 - 31 507(d) Name of Law: Consolidated Appropriations Act
   PL: Pub.L. 131 - 135 209 Name of Law: Weldon language applied to Medicare Advantage
   US Code: 42 USC 18023(c) Name of Law: Affordable Care Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0945-AA10	Final or interim final rulemaking	84 FR 23170	05/21/2019

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
88.4(a) (Review and sign assurance and certification)
88.4(a) (Review Policies and Procedures)
88.4(a) (Update Policies and Procedures; Train Workforce)
Assurance and Certification Requirements
Assurance of Compliance	690	Assurance of Compliance

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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	850,926	0	0	850,926	0	0
Annual Time Burden (Hours)	3,780,716	0	0	3,780,716	0	0
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: New collection

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Annual Cost to Federal Government: $123

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 06/25/2019

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