Drug Pricing Program Reporting Requirements

ICR 201605-0915-003

OMB: 0915-0176

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-09-13
IC Document Collections
ICR Details
0915-0176 201605-0915-003
Historical Active 201302-0915-001
HHS/HSA 18772
Drug Pricing Program Reporting Requirements
Revision of a currently approved collection   No
Regular
Approved with change 09/20/2016
Retrieve Notice of Action (NOA) 05/24/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 09/30/2016
50 0 50
1,948 0 1,188
0 0 0

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). The revision to this package includes additional background information on the dispute resolution process and clarifies the need and proposed use of information regarding the manufacturer audit guidelines and the informal dispute resolution process.

PL: Pub.L. 102 - 585 340B(a)(5)(C) Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  80 FR 246 12/23/2015
81 FR 98 05/20/2016
Yes

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 50 50 0 0 0 0
Annual Time Burden (Hours) 1,948 1,188 0 760 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This increase reflects comments received during the 60-day public comment period indicating that the current burden estimate is understated. Uploaded Summary of Responses to ICR list as ROCIS would not allow closure until an instrument or CFR was attached.

$63,000
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.
05/24/2016


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