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

Document Name	Status
Form 6 Pharmaceutical Pricing Agreement and PPA Addendum Form and Instruction	Modified
Form 1 Registrations for STD/TB Clinics Form and Instruction	Removed
Form 1 Registrations for Community Health Centers Form and Instruction	Removed
Form 7 Manufacturer Data Required to Verify 340 B Ceiling Price Form	Modified
Form 1 Pharmaceutical Pricing Agreement Form and Instruction	Removed
Form 5 Submission of Administrative Changes for Any Manufacturer Form and Instruction	Modified
Form 1 Contract Pharmacy Registration Form Form	Removed
Form 4 Submission of Administrative Changes for any Covered Entities Form	Modified
Form 2 Annual Recertification for Other Entities Form	Removed
Form 1 Annual Recertificaion for STD amp; TB Form	Removed
Form 1 Annual Recertification for Community Health Centers Form	Removed
Form 1 340B Registration for all other covered entities Form and Instruction	Removed
Form 3.1 Contracted Pharmacy Services Registration and Recertifications Form	Modified
Form 2.1 Registrations and Recertifications for Entities other than Hospitals Form and Instruction	Modified
Form 1.1 Hospital Enrollment, Additions and Recertifcations Form	Modified
Supporting Statement A.docx Supporting Statement A	2019-08-05
0327 60 Day FRN.pdf Supplementary Document	2019-08-05

IC Document Collections

IC ID	Document Title	Status
221302	Pharmaceutical Pricing Agreement and PPA Addendum Form and Instruction	Modified
221299	Registrations for STD/TB Clinics Form and Instruction	Removed
221298	Registrations for Community Health Centers Form and Instruction	Removed
216088	Manufacturer Data Required to Verify 340 B Ceiling Price Form	Modified
203465	Pharmaceutical Pricing Agreement Form and Instruction	Removed
203460	Submission of Administrative Changes for Any Manufacturer Form and Instruction	Modified
190354	Contract Pharmacy Registration Form Form	Removed
190353	Submission of Administrative Changes for any Covered Entities Form	Modified
190352	Annual Recertification for Other Entities Form	Removed
190351	Annual Recertificaion for STD amp; TB Form	Removed
190350	Annual Recertification for Community Health Centers Form	Removed
190349	340B Registration for all other covered entities Form and Instruction	Removed
190348	Contracted Pharmacy Services Registration and Recertifications Form	Modified
190347	Registrations and Recertifications for Entities other than Hospitals Form and Instruction	Modified
190345	Hospital Enrollment, Additions and Recertifcations Form	Modified

ICR Details

OMB Control No: 0915-0327	ICR Reference No: 201908-0915-001
Status: 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
	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
Registrations for Community Health Centers	1	340BRegistration-Covered Entities - Community Health Center.docx
Annual Recertification for Community Health Centers	1	Conmmunity Health Center Recert
Registrations for STD/TB Clinics	1, 2	340BRegistration-Covered Entities STD-Revised ,   340BRegistration-Covered Entities TB-Revised
Annual Recertificaion for STD amp; TB	1, 2	STD-Recertification ,   TB-Recertification
Annual Recertification for Other Entities	2	RW-Recertification-Revised
Pharmaceutical Pricing Agreement	1	Manufacturer Pharma Pricing Agreement (PPA)
Contracted Pharmacy Services Registration and Recertifications	3.2, 3.1	Contract Pharmacy Registration.pdf ,   Contract Pharmacy Termination.pdf
Submission of Administrative Changes for any Covered Entities	4	340B Covered Entity Change Request.pdf
Hospital Enrollment, Additions and Recertifcations	1.1, 1.2, 1.4, 1.5, 1.3, 1.6, 1.10, 1.11, 1.8, 1.7, 1.9	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
Submission of Administrative Changes for Any Manufacturer	5	340B Manufacturer Change Form.pdf
340B Registration for all other covered entities	1	340BRegistration-Covered Entities All Other-Revised
Contract Pharmacy Registration Form	1, 2	Contract Pharmacy Registration-Revised ,   Contract Pharmacy Termination
Pharmaceutical Pricing Agreement and PPA Addendum	6	Manufacturer PPA and addendum.pdf
Manufacturer Data Required to Verify 340 B Ceiling Price	7	Manufacturer Data Fields for 340B Ceiling Price.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

---

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

---

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

---