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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 6 Manufacturer PPA.pdf	Form and Instruction	Modified	Available
Form 6 Pharmaceutical Pricing Agreement and PPA Addendum	Form and Instruction	Modified	Repair queued
Form 7 Manufacturer Data Fields for 340B Ceiling Price.pdf	Form	Modified	Available
Form 7 Manufacturer Data Required to Verify 340 B Ceiling Price	Form	Modified	Repair queued
Form 5 340B Manufacturer Change Form.pdf	Form and Instruction	Modified	Available
Form 5 Submission of Administrative Changes for Any Manufacturer	Form and Instruction	Modified	Repair queued
Form 4 340B Covered Entity Change Request.pdf	Form	Modified	Available
Form 4 Submission of Administrative Changes for any Covered Entities	Form	Modified	Repair queued
Form 3.2 Contract Pharmacy Termination.pdf	Form	Modified	Available
Form 3.1 Contract Pharmacy Registration.pdf	Form	Modified	Available
Form 3.1 Contracted Pharmacy Services Registration and Recertifications	Form	Modified	Repair queued
Form 2.6 340B Recertification Covered Entities All Other Non-Hospital..pdf	Form	Modified	Available
Form 2.5 340B Recertification CHC and FQHCLA.pdf	Form	Modified	Available
Form 2.4 340B Recertfication STD and TB.pdf	Form	Modified	Available
Form 2.3 340B Registration-Covered Entities All Other Non-Hospitals.pdf	Form and Instruction	Modified	Available
Form 2.2 340B Registration STD and TB.pdf	Form and Instruction	Modified	Available
Form 2.1 340B Registration CHC and FQHCLA.pdf	Form and Instruction	Modified	Available
Form 2.1 Registrations and Recertifications for Entities other than Hospitals	Form and Instruction	Modified	Repair queued
Form 1.11 340B Recertification CAN.pdf	Form	Modified	Available
Form 1.10 340B Recertification CAH.pdf	Form	Modified	Available
Form 1.9 340B Recertification Childrens Hospital.pdf	Form	Modified	Available
Form 1.8 340B Recertification SCH and RRC.pdf	Form	Modified	Available
Form 1.7 340B Recertification DSH.pdf	Form	Modified	Available
Form 1.6 340B Registration CAH Parent.pdf	Form	Modified	Available
Form 1.5 340B Registration RRC and SCH Parent.pdf	Form	Modified	Available
Form 1.4 340B Registration Hospital Outpatient Facility.pdf	Form	Modified	Available
Form 1.3 340B Registration CAN Parent.pdf	Form	Modified	Available
Form 1.2 340B Registration Children's Hospital.pdf	Form	Modified	Available
Form 1.1 340B Registration DSH Parent.pdf	Form	Modified	Available
Form 1.1 Hospital Enrollment, Additions and Recertifcations	Form	Modified	Repair queued
Revised Supporting Statement A_0915-0327.docx	Supporting Statement A	Uploaded 2022-11-15	Repair queued
Attachment III_Summary 60D ICR Comment on OMB No. 0915-0327.xlsx	Supplementary Document	Uploaded 2022-11-08	Repair queued
Attachment II_60 Day FRN Published.pdf	Supplementary Document	Uploaded 2022-11-08	Missing upstream
Attachment I_phs-act-section-340b.pdf	Supplementary Document	Uploaded 2022-11-08	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
221302	Pharmaceutical Pricing Agreement and PPA Addendum	Form and Instruction	Modified	Manufacturer PPA.pdf
221302	Pharmaceutical Pricing Agreement and PPA Addendum	Form and Instruction	Modified
216088	Manufacturer Data Required to Verify 340 B Ceiling Price	Form	Modified	Manufacturer Data Fields for 340B Ceiling Price.pdf
216088	Manufacturer Data Required to Verify 340 B Ceiling Price	Form	Modified
203460	Submission of Administrative Changes for Any Manufacturer	Form and Instruction	Modified	340B Manufacturer Change Form.pdf
203460	Submission of Administrative Changes for Any Manufacturer	Form and Instruction	Modified
190353	Submission of Administrative Changes for any Covered Entities	Form	Modified	340B Covered Entity Change Request.pdf
190353	Submission of Administrative Changes for any Covered Entities	Form	Modified
190348	Contracted Pharmacy Services Registration and Recertifications	Form	Modified	Contract Pharmacy Termination.pdf
190348	Contracted Pharmacy Services Registration and Recertifications	Form	Modified	Contract Pharmacy Registration.pdf
190348	Contracted Pharmacy Services Registration and Recertifications	Form	Modified
190347	Registrations and Recertifications for Entities other than Hospitals	Form	Modified	340B Recertification Covered Entities All Other Non-Hospital..pdf
190347	Registrations and Recertifications for Entities other than Hospitals	Form	Modified	340B Recertification CHC and FQHCLA.pdf
190347	Registrations and Recertifications for Entities other than Hospitals	Form	Modified	340B Recertfication STD and TB.pdf
190347	Registrations and Recertifications for Entities other than Hospitals	Form and Instruction	Modified	340B Registration-Covered Entities All Other Non-Hospitals.pdf
190347	Registrations and Recertifications for Entities other than Hospitals	Form and Instruction	Modified	340B Registration STD and TB.pdf
190347	Registrations and Recertifications for Entities other than Hospitals	Form and Instruction	Modified	340B Registration CHC and FQHCLA.pdf
190347	Registrations and Recertifications for Entities other than Hospitals	Form and Instruction	Modified
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Recertification CAN.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Recertification CAH.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Recertification Childrens Hospital.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Recertification SCH and RRC.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Recertification DSH.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Registration CAH Parent.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Registration RRC and SCH Parent.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Registration Hospital Outpatient Facility.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Registration CAN Parent.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Registration Children's Hospital.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified	340B Registration DSH Parent.pdf
190345	Hospital Enrollment, Additions and Recertifcations	Form	Modified

ICR Details

OMB Control No: 0915-0327	ICR Reference No: 202208-0915-001
Status: Historical Active	Previous ICR Reference No: 201908-0915-001
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 with change	Conclusion Date: 01/05/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/29/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2026	36 Months From Approved	01/31/2023
Responses	109,982	0	94,629
Time Burden (Hours)	59,359	0	44,660
Cost Burden (Dollars)	0	0	0

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Abstract: Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service (PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS (Secretary) that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed statutorily defined 340B ceiling prices. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that 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) of the PHS Act prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the covered entity.

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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

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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:
	87 FR 35983	07/14/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 65212	10/28/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

IC Title	Form No.	Form Name
Contracted Pharmacy Services Registration and Recertifications	3.1, 3.2	Contract Pharmacy Registration.pdf ,   Contract Pharmacy Termination.pdf
Hospital Enrollment, Additions and Recertifcations	1.1, 1.2, 1.4, 1.10, 1.5, 1.3, 1.6, 1.11, 1.8, 1.7, 1.9	340B Registration DSH Parent.pdf ,   340B Registration Children's Hospital.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 Childrens Hospital.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 and PPA Addendum	6	Manufacturer PPA.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
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

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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	109,982	94,629	0	15,353	0	0
Annual Time Burden (Hours)	59,359	44,660	0	14,699	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Currently, there are 58,159 reporting and record keeping burden hours in the OMB inventory. HRSA is requesting 59,359 burden hours, an increase of 1,200 hours. The anticipated burden has increased due to updates made to the estimated number of covered entity respondents and responses per respondent based on 2021 registration and recertification data. All changes in burden hours are due to adjustments in agency estimates due to the potential number of respondents, which is not a result of any action of the Federal government.

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Annual Cost to Federal Government: $4,611,195

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? No

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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: 11/29/2022

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