340B Drug Pricing Program Forms

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Manufacturer Data Required to Verify 340 B Ceiling Price Calculations	Form	New	Available
Form 1 Pharmaceutical Pricing Agreement	Form and Instruction	Modified	Available
Form 1 340B Program Registrations and Certifications for Critical Access Hospitals	Form	Modified	Available
Form 1 340B Program Registrations amp; Certifications for Sole Community Hospitals	Form	Modified	Available
Form 1 340B Program Registrations amp; Certifications for Rural Referral Hospitals	Form	Modified	Available
Form 1 340B Program Registrations amp; Certifications for Free Standing Cancer Hospitals	Form	Modified	Available
Form 1 Administrative Changes for Any Manufacturer	Form	Modified	Available
Form 1 Contract Pharmacy Self Certification Form	Form	Modified	Available
Form 1 Administrative Change Form	Form and Instruction	Modified	Available
Form 2 Annual Recertification for Other Entities	Form	Modified	Repair queued
Form 1 Annual Recertificaion for STD amp; TB	Form	Modified	Available
Form 1 Annual Recertification for Family Planning	Form	Modified	Available
Form 1 340B Registration for all other covered entities	Form and Instruction	Modified	Available
Form 1 Hospital Annual Recertification	Form	Modified	Available
Form 1 Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	Form and Instruction	Modified	Available
Form 3 340B Program Registrations amp; Certifications for Children's Hospitals	Form	Modified	Available
Form 1 340B Program Registrations amp; Certifications for Disproportionate Share Hospitals	Form	Modified	Available
60-day FRN.pdf	Supplementary Document	Uploaded 2015-04-27	Available
30-day FRN.pdf	Supplementary Document	Uploaded 2015-04-27	Available
List of all ICR documents.docx	Supplementary Document	Uploaded 2015-04-27	Available
FinalRevised0327Supporting Statement A.docx	Supporting Statement A	Uploaded 2015-09-21	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
216088	Manufacturer Data Required to Verify 340 B Ceiling Price Calculations	Form	New
203465	Pharmaceutical Pricing Agreement	Form and Instruction	Modified
203464	340B Program Registrations and Certifications for Critical Access Hospitals	Form	Modified
203463	340B Program Registrations amp; Certifications for Sole Community Hospitals	Form	Modified
203462	340B Program Registrations amp; Certifications for Rural Referral Hospitals	Form	Modified
203461	340B Program Registrations amp; Certifications for Free Standing Cancer Hospitals	Form	Modified
203460	Administrative Changes for Any Manufacturer	Form	Modified
190354	Contract Pharmacy Self Certification Form	Form	Modified
190353	Administrative Change Form	Form and Instruction	Modified
190352	Annual Recertification for Other Entities	Form	Modified
190351	Annual Recertificaion for STD amp; TB	Form	Modified
190350	Annual Recertification for Family Planning	Form	Modified
190349	340B Registration for all other covered entities	Form and Instruction	Modified
190348	Hospital Annual Recertification	Form	Modified
190347	Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	Form and Instruction	Modified
190346	340B Program Registrations amp; Certifications for Children's Hospitals	Form	Modified
190345	340B Program Registrations amp; Certifications for Disproportionate Share Hospitals	Form	Modified

ICR Details

OMB Control No: 0915-0327	ICR Reference No: 201504-0915-001
Status: Historical Active	Previous ICR Reference No: 201308-0915-006
Agency/Subagency: HHS/HSA	Agency Tracking No: 20345
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 without change	Conclusion Date: 09/28/2015
	Date Received in OIRA: 05/01/2015
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	10/31/2015
Responses	52,591	0	24,464
Time Burden (Hours)	27,054	0	14,705
Cost Burden (Dollars)	0	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 58791	09/30/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 22208	04/21/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 17

table that charts list of burden

IC Title	Form No.	Form Name
Manufacturer Data Required to Verify 340 B Ceiling Price Calculations	1	Manufacturer Data Fields for 340B Ceiling Price - FINAL VERSION
340B Registration for all other covered entities	2, 1, 3, 4	340BRegistration-Covered Entities - Community Health Center ,   340BRegistration-Covered Entities All Other-Revised ,   340BRegistration-Covered Entities STD-Revised ,   340BRegistration-Covered Entities TB-Revised
Annual Recertification for Family Planning	1	FP-Recert
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	1	3 340B Registration-Outpatient Facility Revised
Hospital Annual Recertification	2, 3, 1	Public Ownership-Revised.docx ,   Recert-Free standing Cancer Hospital (Orphan Drug)-Revised.pdf ,   Recert-Critical Access; Sole-community; Rural-Referral centers (Orphan Drug)-Revised
Annual Recertificaion for STD amp; TB	1, 2	STD-Recertification ,   TB-Recertification
Administrative Change Form	1	340B Participant Change Request-Revised
Contract Pharmacy Self Certification Form	1, 2	Contract Pharmacy Registration-Revised ,   Contract Pharmacy Termination
Annual Recertification for Other Entities	2, 1	RW-Recertification-Revised ,   Conmmunity Health Center Recert
340B Program Registrations amp; Certifications for Children's Hospitals	1, 2, 3	Public Ownership-Revised.docx ,   340B Registration Children's Hospital -Revised ,   Cert state or local government-Revised
340B Program Registrations amp; Certifications for Disproportionate Share Hospitals	1, 3, 2	340B Registration DSH-Revised ,   Public Ownership-Revised ,   Cert state or local government-Revised.docx
Administrative Changes for Any Manufacturer	1	340B Manufacturer Change Form-Revised
340B Program Registrations amp; Certifications for Free Standing Cancer Hospitals	1	340B Registration Free Standing Cancer-Revised
340B Program Registrations amp; Certifications for Rural Referral Hospitals	1	340B Registration Rural Referral and Sole Community Hospitals (Orphan Drug)-REVISED
340B Program Registrations amp; Certifications for Sole Community Hospitals	1	340B Registration Rural Referral and Sole Community Hospitals (Orphan Drug)-REVISED
340B Program Registrations and Certifications for Critical Access Hospitals	1	340B Registration-CAH-Revised
Pharmaceutical Pricing Agreement	1	Manufacturer Pharma Pricing Agreement (PPA)

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ICR Summary of Burden

table that charts list 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	52,591	24,464	0	28,127	0	0
Annual Time Burden (Hours)	27,054	14,705	0	12,349	0	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: Currently, there are 14,704 total reporting and record keeping burden hours in the OMB inventory. HRSA is requesting 27,483.5 burden hours, an increase of 12,779.5 hours. The increase is associated in part with the implementation of manufacturer data collection provisions of section 340B of the Public Health Service Act that were amended by section 7102 of the Affordable Care Act, enabling the Secretary to verify the accuracy of ceiling prices calculated by manufacturers and charged to covered entities by comparing them with ceiling prices calculated by the Secretary. In order to perform the comparison, HRSA must require manufacturers to submit the quarterly pricing data containing the average manufacturer price, unit rebate amount, package sizes, National Drug Code, and the manufacturer-determined 340B ceiling prices. The anticipated burden has also increased due to updates made to the estimated number of covered entity respondents and responses per respondent based on 2014 registration and recertification data; we have additionally modified the way respondents and responses are counted to more accurately reflect the number of organizations registering for the program and the number of locations registered by each of those organizations.

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Annual Cost to Federal Government: $3,751,617

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

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Common Form ICR:  No

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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: 05/01/2015

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