340B Drug Pricing Program Forms

Forms and Documents

Document Name	Status
Form 1 340B Program Registrations and Certifications for Critical Access Hospitals Form and Instruction	New
Form 1 340B Program Registrations & Certifications for Sole Community Hospitals Form and Instruction	New
Form 1 34B Program Registrations & Certifications for Rural Referral Hospitals Form and Instruction	New
Form 1 340B Program Registrations & Certifications for Free Standing Cancer Hospitals Form and Instruction	New
Form 1 Administrative Changes for Any Manufacturer Form and Instruction	New
Form 1 Contract Pharmacy Self Certification Form Form and Instruction	Modified
Form 1 Administrative Change Form Form and Instruction	Modified
Form 1 Annual Recertification for Other Entities Form and Instruction	Modified
Form 1 Annual Recertificaion for STD & TB Form and Instruction	Modified
Form 1 Annual Recertification for Family Planning Form and Instruction	Modified
Form 1 340B Registration for all other covered entities Form and Instruction	Modified
Form 1a Hospital Annual Recertification Form and Instruction	Modified
Form 1 Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program Form and Instruction	Modified
Form 1 340B Program Registrations & Certifications for Children's Hospitals Form and Instruction	Modified
Form 1 340B Program Registrations & Certifications for Disproportionate Share Hospitals Form and Instruction	Modified
THE SUPPORTING STATEMENT.docx Supporting Statement A	2012-10-10

IC Document Collections

IC ID	Document Title	Status
203465	Pharmaceutical Pricing Agreement Other-Program Agreement Form	New
203464	340B Program Registrations and Certifications for Critical Access Hospitals Form and Instruction	New
203463	340B Program Registrations & Certifications for Sole Community Hospitals Form and Instruction	New
203462	34B Program Registrations & Certifications for Rural Referral Hospitals Form and Instruction	New
203461	340B Program Registrations & Certifications for Free Standing Cancer Hospitals Form and Instruction	New
203460	Administrative Changes for Any Manufacturer Form and Instruction	New
190354	Contract Pharmacy Self Certification Form Form and Instruction	Modified
190353	Administrative Change Form Form and Instruction	Modified
190352	Annual Recertification for Other Entities Form and Instruction	Modified
190351	Annual Recertificaion for STD & TB Form and Instruction	Modified
190350	Annual Recertification for Family Planning Form and Instruction	Modified
190349	340B Registration for all other covered entities Form and Instruction	Modified
190348	Hospital Annual Recertification Form and Instruction	Modified
190347	Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program Form and Instruction	Modified
190346	340B Program Registrations & Certifications for Children's Hospitals Form and Instruction	Modified
190345	340B Program Registrations & Certifications for Disproportionate Share Hospitals Form and Instruction	Modified

ICR Details

OMB Control No: 0915-0327	ICR Reference No: 201207-0915-003
Status: Historical Active	Previous ICR Reference No: 201006-0915-003
Agency/Subagency: HHS/HSA	Agency Tracking No:
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 with change	Conclusion Date: 10/10/2012
	Date Received in OIRA: 07/24/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	36 Months From Approved	10/31/2012
Responses	24,436	0	18,044
Time Burden (Hours)	14,649	0	2,811
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): US Code: 42 USC 340B Name of Law: Public Health Service Act
   PL: Pub.L. 111 - 148 7101-7102 Name of Law: Patient Protection and Affordable Care Act
   PL: Pub.L. 102 - 585 601-603 Name of Law: Veterans Health Care Act of 1992
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 7101-7102 Name of Law: Patient Protection and Affordable Care Act

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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:
	77 FR 16042	03/19/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 42747	07/20/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 16

IC Title	Form No.	Form Name
340B Program Registrations & Certifications for Children's Hospitals	1, 2, 3, 4	340B Registration Children's and Free Standing Cancer Hospitals revised ,   GPOform Revised ,   Cert state or local government Revised ,   Public OWNERSHIP Revised
340B Program Registrations & Certifications for Disproportionate Share Hospitals	1, 3, 2, 4	340B Registration-DSH Revised ,   GPOform Revised ,   Cert state or local government Revised ,   Public OWNERSHIP Revised
Administrative Changes for Any Manufacturer	1	340BManufacturerChangeForm Revised
340B Program Registrations & Certifications for Free Standing Cancer Hospitals	1	340B Registration Children's and Free Standing Cancer Hospitals revised
34B Program Registrations & Certifications for Rural Referral Hospitals	1	340B Registration-RRC and SCH Revised
340B Program Registrations & Certifications for Sole Community Hospitals	1	340B Registration-RRC and SCH Revised
340B Program Registrations and Certifications for Critical Access Hospitals	1	340B Registration-CAH Revised
Pharmaceutical Pricing Agreement
340B Registration for all other covered entities	1	340BRegistration-Covered Entities All Other Revised
Annual Recertification for Family Planning	1	FP-Recert
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	1	340B Registration-Outpatient Facility Revised
Hospital Annual Recertification	1a, 1b	Hospital Recertification ,   Recertattestation Revised
Annual Recertificaion for STD & TB	1, 2	STD-Recert ,   TB-Recertification
Administrative Change Form	1	340B Participatant Change Request Revised
Contract Pharmacy Self Certification Form	1	Contract Pharmacy Registrationform Revised
Annual Recertification for Other Entities	1	RW-Recert

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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	24,436	18,044	526	200	5,666	0
Annual Time Burden (Hours)	14,649	2,811	527	200	11,111	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: No

Burden Reduction Due to:

Short Statement: A portion of the increase is associated with the implementation of provisions of section 340B of the Public Health Service Act that were amended by sections 7101 and 7102 of the Affordable Care Act. This includes an expansion of eligible entities for the program under section 340B(a)(4) to include the addition of Free Standing Cancer Hospitals, Critical Access Hospitals (CAH), Rural Referral Centers (RRC) and Sole Community Hospitals (SCH). The amended statute also includes new covered entity compliance provisions in section 340B(a)(2) requiring the Secretary to adopt integrity provisions to improve oversight of program compliance, enable covered entities to regularly update information on the 340B website, and to verify information on the website.

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Annual Cost to Federal Government: $101,004

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: 07/24/2012

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