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.