Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)

Forms and Documents

Document Name	Status
Form CMS-367 a, b,c,d Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 Form	Modified
CMS-367 Supporting Statement 7-11-07.doc Supporting Statement A	2007-07-13

IC Document Collections

IC ID	Document Title	Status
8184	Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 Form	Modified

ICR Details

OMB Control No: 0938-0578	ICR Reference No: 200707-0938-008
Status: Historical Active	Previous ICR Reference No: 200405-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/12/2007
	Date Received in OIRA: 07/25/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved	10/31/2007
Responses	8,640	0	2,280
Time Burden (Hours)	127,872	0	54,780
Cost Burden (Dollars)	6,393,600	0	0

---

Abstract: Section 1927 requires drug manufactures to enter into and have in effect a rebate agreement with the Federal Government for States to receive funding for drugs dispensed to Medicaid beneficiaries. The Deficit Reduction Act (DRA) of 2005 modified section 1927 to require additional reporting requirements beyond the quarterly data currently collected. CMS form 367 identifies the data fields that manufacturers must submit to CMS on both a monthly and quarterly basis.

---

Authorizing Statute(s): Statute at Large: 19 Stat. 1927 Name of Statute: null
  

Citations for New Statutory Requirements: Statute at Large: 19 Stat. 1927 Name of Statute: null

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AO20	Final or interim final rulemaking	72 FR 12345	07/17/2007

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534	CMS-367 a, b,c,d	Pricing Data

---

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	8,640	2,280	6,360	0	0	0
Annual Time Burden (Hours)	127,872	54,780	73,092	0	0	0
Annual Cost Burden (Dollars)	6,393,600	0	6,393,600	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: As a result of statutory changes, CMS is now required to collect monthly data as well as additional quarterly data, increasing the total number of collections per year from 4 to 16. In addition, there is a data field currently being collected on a quarterly basis that will now be collected on a monthly basis as well. Because of this statutory change, there will be an increased burden on the manufacturers.

---

Annual Cost to Federal Government: $2,000,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 07/23/2007

---