340B Drug Pricing Program Forms

Forms and Documents

Document Name	Status
Form 340B -7 Contract Pharmacy Self Certification Form Form and Instruction	Modified
Form 340B-6 Administrative Change Form Form and Instruction	Modified
Form 340B 1 340B Registration for all other covered entities Form and Instruction	Modified
Form 340B-3a Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program Form and Instruction	Modified
Form 340B- 9a 340B Program Registrations & Certifications for Children's Hospitals Form and Instruction	Modified
Form 340B-10b 340B Program Registrations & Certifications for Disproportionate Share Hospitals Form and Instruction	Modified
340B_change.doc Justification for No Material/Nonsubstantive Change	2010-06-08

IC Document Collections

IC ID	Document Title	Status
190354	Contract Pharmacy Self Certification Form Form and Instruction	Modified
190353	Administrative Change Form Form and Instruction	Modified
190352	Annual Recertification for Other Entities Other-Screenshot for electronic re-certification	Modified
190351	Annual Recertificaion for STD & TB Other-Screenshot for electronic re-certification	Modified
190350	Annual Recertification for Family Planning Other-Screenshot for electronic Re-certification	Modified
190349	340B Registration for all other covered entities Form and Instruction	Modified
190348	Hospital Annual Recertification Other-Screenshot for electronic re-certification	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: 201006-0915-003
Status: Historical Active	Previous ICR Reference No: 200908-0915-002
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: 340B Drug Pricing Program Forms
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/28/2010
	Date Received in OIRA: 06/11/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	08/31/2012	08/31/2012
Responses	18,044	0	13,113
Time Burden (Hours)	2,811	0	1,505
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: PL: Pub.L. 111 - 148 7101 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Hospital Annual Recertification
Annual Recertificaion for STD & TB
Administrative Change Form	340B-6	Administrative Change Form
Contract Pharmacy Self Certification Form	340B -7	Contract Pharmacy Self-Certification Form
Annual Recertification for Other Entities
340B Program Registrations & Certifications for Children's Hospitals	340B- 9a, 340B -9b, 340B -9c	Hospital Registration Form ,   Certification of State/Local Contract ,   Certification of Non GPO
340B Program Registrations & Certifications for Disproportionate Share Hospitals	340b-10a, 340B-10b, 340B-10c	Certification of State/Local Contract ,   Certification of Non GPO ,   Hospital Registration
340B Registration for all other covered entities	340B 1	340B Registration Form
Annual Recertification for Family Planning
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	340B-3a, 340B -3b	DSH Outpatient Form ,   Children's Hospital Outpatient Form

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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	18,044	13,113	4,931	0	0	0
Annual Time Burden (Hours)	2,811	1,505	1,306	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a request for a non-material or non-substantive change to increase the estimated number of respondents and reflect the covered entities that are newly eligible to participate in the 340B Program due to Section 7101 of the Patient Protection and Affordable Care Act. This non-substantive change will impose an estimated annual average total burden of an additional 1,306 hours.

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Annual Cost to Federal Government: $44,203

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]? Uncollected

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: 06/11/2010

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