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:
200908-0915-002
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/HSA
Agency Tracking No:
Title:
340B Drug Pricing Program Forms
Type of Information Collection:
Existing collection in use without an OMB Control Number
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/27/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/19/2009
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2012
36 Months From Approved
Responses
13,113
0
0
Time Burden (Hours)
1,505
0
0
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 program.
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
73 FR 65609
11/04/2008
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 40821
08/13/2009
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
10
IC Title
Form No.
Form Name
340B Program Registrations & Certifications for Children's Hospitals
IC 2-B, IC 2-A, IC 2-C
340B Program Registrations & Certifications for Disproportionate Share Hospitals
IC 1-A, IC 1-C, IC 1-B
340B Registration for all other covered entities
IC 5
Administrative Change Form
IC 9
Annual Recertificaion for STD & TB
Annual Recertification for Family Planning
Annual Recertification for Other Entities
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program
IC 3-B, IC 3-B
Contract Pharmacy Self Certification Form
IC 10
Hospital Annual Recertification
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
13,113
0
0
9,092
0
4,021
Annual Time Burden (Hours)
1,505
0
0
1,160
0
345
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:
This a new collection of information from Children's Hospitals for registration and certification in the 340B Drug Pricing Program. In addition, approval is requested for enrollment and certification forms that have been in use without approval. This ICR is being submitted for OMB approval to ensure PRA compliance for the new registration and certification forms as well as for the forms that are in use without approval.
Annual Cost to Federal Government:
$44,203
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
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:
Susan Queen 301 443-1129
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:
08/19/2009
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