View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
201908-0915-001
Status:
Historical Active
Previous ICR Reference No:
201604-0915-002
Agency/Subagency:
HHS/HSA
Agency Tracking No:
20345
Title:
Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/12/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/08/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2022
36 Months From Approved
11/30/2019
Responses
94,629
0
56,705
Time Burden (Hours)
44,660
0
27,594
Cost Burden (Dollars)
0
0
0
Abstract:
Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted as Section 340B of the Public Health Service Act (PHS Act; ‘‘Limitation on Prices of Drugs Purchased by Covered Entities’’), provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a Pharmaceutical Pricing Agreement (PPA) with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula (‘‘ceiling price’’). A manufacturer subject to a PPA must offer all covered outpatient drugs at no more than the ceiling price to a covered entity listed in the 340B Program database. The manufacturer shall rely on the information in the 340B database to determine if the covered entity is participating in the 340B Program or for any notifications of changes to eligibility that may occur within a quarter. By signing the PPA, the manufacturer agrees to comply with all applicable statutory and regulatory requirements, including any changes that occur after execution of the PPA. Covered entities which choose to participate in the 340B Program must comply with the requirements of Section 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, Section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity.
Authorizing Statute(s):
PL:
Pub.L. 102 - 585 601-602
Name of Law: Veterans Health Care Act of 1992
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
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 20373
05/09/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 38639
08/07/2019
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
340B Registration for all other covered entities
1
340BRegistration-Covered Entities All Other-Revised
Annual Recertificaion for STD amp; TB
1, 2
STD-Recertification
,
TB-Recertification
Annual Recertification for Community Health Centers
1
Conmmunity Health Center Recert
Annual Recertification for Other Entities
2
RW-Recertification-Revised
Contract Pharmacy Registration Form
1, 2
Contract Pharmacy Registration-Revised
,
Contract Pharmacy Termination
Contracted Pharmacy Services Registration and Recertifications
3.2, 3.1
Contract Pharmacy Registration.pdf
,
Contract Pharmacy Termination.pdf
Hospital Enrollment, Additions and Recertifcations
1.8, 1.7, 1.9, 1.1, 1.2, 1.4, 1.10, 1.5, 1.3, 1.6, 1.11
340B Registration DSH Parent.pdf
,
340B Registration Children's Hospital PED Parent.pdf
,
340B Registration CAN Parent.pdf
,
340B Registration Hospital Outpatient Facility.pdf
,
340B Registration RRC and SCH Parent.pdf
,
340B Registration CAH Parent.pdf
,
340B Recertification DSH.pdf
,
340B Recertification SCH and RRC.pdf
,
340B Recertification PED.pdf
,
340B Recertification CAH.pdf
,
340B Recertification CAN.pdf
Manufacturer Data Required to Verify 340 B Ceiling Price
7
Manufacturer Data Fields for 340B Ceiling Price.pdf
Pharmaceutical Pricing Agreement
1
Manufacturer Pharma Pricing Agreement (PPA)
Pharmaceutical Pricing Agreement and PPA Addendum
6
Manufacturer PPA and addendum.pdf
Registrations and Recertifications for Entities other than Hospitals
2.1, 2.2, 2.3, 2.4, 2.5, 2.6
340B Registration CHC and FQHCLA.pdf
,
340B Registration STD and TB.pdf
,
340B Registration-Covered Entities All Other Non-Hospitals.pdf
,
340B Recertfication STD and TB.pdf
,
340B Recertification CHC and FQHCLA.pdf
,
340B Recertification Covered Entities All Other Non-Hospital..pdf
Registrations for Community Health Centers
1
340BRegistration-Covered Entities - Community Health Center.docx
Registrations for STD/TB Clinics
1, 2
340BRegistration-Covered Entities STD-Revised
,
340BRegistration-Covered Entities TB-Revised
Submission of Administrative Changes for Any Manufacturer
5
340B Manufacturer Change Form.pdf
Submission of Administrative Changes for any Covered Entities
4
340B Covered Entity Change Request.pdf
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
94,629
56,705
0
63,289
-25,365
0
Annual Time Burden (Hours)
44,660
27,594
0
31,900
-14,834
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:
Yes
Burden Reduction Due to:
Using Information Technology
Short Statement:
The anticipated burden has increased due to updates made to the estimated number of covered entity respondents and responses per respondent based on 2018 registration and recertification data. Improvements in OPAIS database has reduced the burden on most of the forms.
Annual Cost to Federal Government:
$4,000,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
Elyana Bowman 301 443-3983 enadjem@hrsa.gov
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:
08/08/2019
An official website of the United States government
The .gov means it's official.
The site is secure.
