Drug Pricing Program Reporting Requirements

ICR 201001-0915-001

OMB: 0915-0176

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-12-28
IC Document Collections
IC ID
Document
Title
Status
6404 Modified
ICR Details
0915-0176 201001-0915-001
Historical Active 200611-0915-002
HHS/HSA
Drug Pricing Program Reporting Requirements
Extension without change of a currently approved collection   No
Regular
Approved without change 02/26/2010
Retrieve Notice of Action (NOA) 01/21/2010
  Inventory as of this Action Requested Previously Approved
02/28/2013 36 Months From Approved 02/28/2010
8 0 8
134 0 134
0 0 0

HRSA's Office of Pharmacy Affairs has audit guidelines and a dispute resolution process for the Drug Pricing Program which necessitate certain reporting and record keeping requirements when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. These requirements provide a formal dispute resolution process for audits and other disputes for covered entities and participating drug manufacturers.

PL: Pub.L. 102 - 585 602 Name of Law: Limitations on Prices of Drugs Purchased by Certain Clinics and Hospitals
  
None

Not associated with rulemaking

  74 FR 48269 09/22/2009
74 FR 68628 12/28/2009
No

1
IC Title Form No. Form Name
Drug Pricing Program Reporting Requirements

  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 8 0 0 0 0
Annual Time Burden (Hours) 134 134 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$8,000
No
No
Uncollected
Uncollected
No
Uncollected
Susan Queen 3014431129

  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.
01/21/2010


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