This information collection is approved through 1-98 under the following conditions: Upon the next submission, HCFA will report on the implementation status of this additionally revised form; reaction by drug manufacturers;and the overall success in reducing the number of disputes between manufacturers and the States. As agreed to by the Agency, HCFA will place the OMB number and the expiration date on the form itself, with the other necessary disclosure statements in the instructions immediately.
Inventory as of this Action
Requested
Previously Approved
01/31/1998
01/31/1998
07/31/1996
2,080
0
1,928
170,560
0
116,896
1,705,600,000
0
0
Section 1927 of the Social Security Act requires drug labelers to enter into and have in effect a rebate agreement with HCFA for States to receive funding for drugs dispensed to Medicaid recipients. 42 CFR 447.534 and 447.536 requires labelers to report specific drug rebate data to States when payment is made.
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:
(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;
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.