View Information Collection Request (ICR) Package
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Burden
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Certification
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0915-0327
ICR Reference No:
201308-0915-006
Status:
Historical Active
Previous ICR Reference No:
201307-0915-006
Agency/Subagency:
HHS/HSA
Agency Tracking No:
20345
Title:
340B Drug Pricing Program Forms
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/03/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/29/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2015
10/31/2015
10/31/2015
Responses
24,464
0
24,464
Time Burden (Hours)
14,705
0
14,705
Cost Burden (Dollars)
0
0
0
Abstract:
HRSA Office of Pharmacy Affairs (OPA) has a process for registering covered entities who choose to participate in the section 340B Drug Pricing Program. These entities must comply with the requirements of 340B (a)(5)(A) of the PHS Act. The 340B Drug Pricing Program forms allow entities to provide registration and certifying information and to determine eligibility for the progam.
Authorizing Statute(s):
PL:
Pub.L. 102 - 585 601-603
Name of Law: Veterans Health Care Act of 1992
US Code:
42 USC 340B
Name of Law: Public Health Service Act
PL:
Pub.L. 111 - 148 7101
Name of Law: Patient Protection and Affordable Care Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
16
IC Title
Form No.
Form Name
340B Program Registrations amp; Certifications for Children's Hospitals
3, 4, 2, 1
Cert state or local government Revised
,
Public OWNERSHIP Revised
,
GPO FOrm
,
2 340B Registration for Children's Hospitals
340B Program Registrations amp; Certifications for Disproportionate Share Hospitals
3, 2, 4, 1
GPO Form
,
Cert state or local government Revised
,
Public OWNERSHIP Revised
,
1 340B Registration-DSH
340B Program Registrations amp; Certifications for Free Standing Cancer Hospitals
1
12 340B Registration Free Standing Cancer Hospitals (Orphan Drug)
340B Program Registrations amp; Certifications for Rural Referral Hospitals
1
13+14 340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug)
340B Program Registrations amp; Certifications for Sole Community Hospitals
1
13+14 340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug)
340B Program Registrations and Certifications for Critical Access Hospitals
1
11 340B Registration Critical Access Hospitals (Orphan Drug)
340B Registration for all other covered entities
1
5 340BRegistration-Covered Entities All Other Revised
Administrative Change Form
1, 1
9 NewChangeFormProposalPaperversion
,
Online version
Administrative Changes for Any Manufacturer
1
340BManufacturerChangeForm Revised
Annual Recertificaion for STD amp; TB
1, 2
7 STD Recert
,
7 TB Recert
Annual Recertification for Family Planning
1
FP Recertification
Annual Recertification for Other Entities
1
8 RW Recert
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program
1
3 340B Registration-Outpatient Facility Revised
Contract Pharmacy Self Certification Form
1
Contract Pharmacy Registrationform Revised
Hospital Annual Recertification
1, 1, 1, 1
Recert-Crtical Access; Sole-community; Rural-Referral centers (Orphan Drug)
,
Recert-Free standing (Orphan Drug)
,
4 Hospital Recertification
,
Recert Attestation
Pharmaceutical Pricing Agreement
ICR Summary of Burden
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
24,464
24,464
0
0
0
0
Annual Time Burden (Hours)
14,705
14,705
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$101,004
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Yes
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jodi Duckhorn 301 443-1984
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/29/2013
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