The voluntary prescription drug
benefit program was enacted into law on December 8, 2003 in section
101 of Title I of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA). The MMA specifies that the
prescription drug benefit program will be available to
beneficiaries on January 1, 2006. Coverage for the prescription
drug benefit will be provided under private prescription drug
plans, or through Medicare Advantage prescription drug plans.
Organizations offering drug plans will have flexibility in the
design of the prescription drug benefit.
Statute at
Large: 18
Stat. 1860 Name of Statute: null
While there are no program
changes, this is a revised collection. Overall, the annual hour
burden has decreased 28,010,378 hr (from 35,582,601 to 7,572,223
hr). The differences in the burden estimate are due to factors such
as decreases in the number of Part D contracts and in the number of
new Part D enrollees. Our additional experience with the program as
well as data reported by the Part D sponsors have also enabled us
to refine our previous estimates, resulting in a number of
significant changes to the burden. More specifically, in ??
423.120, 423.128, 423.153, and 423.505, the decreased burden is due
to decreases in the number of Part D sponsors. Other changes were
based on additional program experience that permitted a refinement
of our previous estimates of burden hours or number of responses.
In ?? 423.32, 423.44, 423.56, 423.564, 423.568, 423.570, 423.572,
and 423.578, the decreased burden occurred because of decreases in
the number of people newly enrolling in Part D and in the number of
Part D sponsors. Other changes to burden requirements were due to
the correction of errors in previous calculations, new regulatory
requirements associated with Part D IRMAA and additional experience
with the program that permitted a refinement of the estimates.
Finally, in ?? 423.329, 423.336, 423.343, and 423.892 the increase
in burden occurred because of adjustments made to the number of
sponsors included in the estimates.
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.