View Information Collection Request (ICR) Package
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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:
201207-0915-003
Status:
Historical Active
Previous ICR Reference No:
201006-0915-003
Agency/Subagency:
HHS/HSA
Agency Tracking No:
Title:
340B Drug Pricing Program Forms
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
10/10/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/24/2012
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2015
36 Months From Approved
10/31/2012
Responses
24,436
0
18,044
Time Burden (Hours)
14,649
0
2,811
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):
US Code:
42 USC 340B
Name of Law: Public Health Service Act
PL:
Pub.L. 111 - 148 7101-7102
Name of Law: Patient Protection and Affordable Care Act
PL:
Pub.L. 102 - 585 601-603
Name of Law: Veterans Health Care Act of 1992
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 148 7101-7102 Name of Law: Patient Protection and Affordable Care Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 16042
03/19/2012
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 42747
07/20/2012
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 & Certifications for Children's Hospitals
1, 2, 3, 4
340B Registration Children's and Free Standing Cancer Hospitals revised
,
GPOform Revised
,
Cert state or local government Revised
,
Public OWNERSHIP Revised
340B Program Registrations & Certifications for Disproportionate Share Hospitals
1, 3, 2, 4
340B Registration-DSH Revised
,
GPOform Revised
,
Cert state or local government Revised
,
Public OWNERSHIP Revised
340B Program Registrations & Certifications for Free Standing Cancer Hospitals
1
340B Registration Children's and Free Standing Cancer Hospitals revised
340B Program Registrations & Certifications for Sole Community Hospitals
1
340B Registration-RRC and SCH Revised
340B Program Registrations and Certifications for Critical Access Hospitals
1
340B Registration-CAH Revised
340B Registration for all other covered entities
1
340BRegistration-Covered Entities All Other Revised
34B Program Registrations & Certifications for Rural Referral Hospitals
1
340B Registration-RRC and SCH Revised
Administrative Change Form
1
340B Participatant Change Request Revised
Administrative Changes for Any Manufacturer
1
340BManufacturerChangeForm Revised
Annual Recertificaion for STD & TB
1, 2
STD-Recert
,
TB-Recertification
Annual Recertification for Family Planning
1
FP-Recert
Annual Recertification for Other Entities
1
RW-Recert
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program
1
340B Registration-Outpatient Facility Revised
Contract Pharmacy Self Certification Form
1
Contract Pharmacy Registrationform Revised
Hospital Annual Recertification
1a, 1b
Hospital Recertification
,
Recertattestation Revised
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
24,436
18,044
526
200
5,666
0
Annual Time Burden (Hours)
14,649
2,811
527
200
11,111
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
A portion of the increase is associated with the implementation of provisions of section 340B of the Public Health Service Act that were amended by sections 7101 and 7102 of the Affordable Care Act. This includes an expansion of eligible entities for the program under section 340B(a)(4) to include the addition of Free Standing Cancer Hospitals, Critical Access Hospitals (CAH), Rural Referral Centers (RRC) and Sole Community Hospitals (SCH). The amended statute also includes new covered entity compliance provisions in section 340B(a)(2) requiring the Secretary to adopt integrity provisions to improve oversight of program compliance, enable covered entities to regularly update information on the 340B website, and to verify information on the website.
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:
07/24/2012
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