In response to the statutory mandate
of section 340B(a)(5)(C) to permit the Secretary or manufacturers
to conduct audits of covered entities and because of the potential
for disputes involving covered entities and participating drug
manufacturers, HRSA developed an informal voluntary dispute
resolution process for manufacturers and covered entities who,
prior to filing a request for resolution of a dispute with HRSA,
should attempt in good faith to resolve the dispute. HRSA published
a notice in 1996 and a policy release in 2011 on manufacturer audit
guidelines and the informal dispute resolution process (61 FR 65406
(December 12, 1996) and “Clarification of Manufacturer Audits of
340B Covered Entities,” Release No. 2011-3).
An increase in the number of
respondents increased the total burden hours. Average burden
remains the same as the previous ICR. There is no instrument in
this ICR, duplicated a document from supplements as ROCIS doesn't
allow for a non entry on instruments.
$59,503
No
No
No
No
No
No
Uncollected
Elyana Bowman 301 443-3983
enadjem@hrsa.gov
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:
(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.