340B Drug Pricing Program Forms

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
190354	Contract Pharmacy Self Certification Form	New
190353	Administrative Change Form	New
190352	Annual Recertification for Other Entities	New
190351	Annual Recertificaion for STD & TB	New
190350	Annual Recertification for Family Planning	New
190349	340B Registration for all other covered entities	New
190348	Hospital Annual Recertification	New
190347	Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	New
190346	340B Program Registrations & Certifications for Children's Hospitals	New
190345	340B Program Registrations & Certifications for Disproportionate Share Hospitals	New

ICR Details

OMB Control No: 0915-0327	ICR Reference No: 200908-0915-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: 340B Drug Pricing Program Forms
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/27/2009
	Date Received in OIRA: 08/19/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	36 Months From Approved
Responses	13,113	0	0
Time Burden (Hours)	1,505	0	0
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 program.

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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
  

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 65609	11/04/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 40821	08/13/2009
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
340B Registration for all other covered entities	IC 5
Annual Recertification for Family Planning
Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program	IC 3-B, IC 3-B
Hospital Annual Recertification
Annual Recertificaion for STD & TB
Administrative Change Form	IC 9
Contract Pharmacy Self Certification Form	IC 10
Annual Recertification for Other Entities
340B Program Registrations & Certifications for Children's Hospitals	IC 2-B, IC 2-A, IC 2-C
340B Program Registrations & Certifications for Disproportionate Share Hospitals	IC 1-A, IC 1-C, IC 1-B

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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	13,113	0	0	9,092	0	4,021
Annual Time Burden (Hours)	1,505	0	0	1,160	0	345
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: This a new collection of information from Children's Hospitals for registration and certification in the 340B Drug Pricing Program. In addition, approval is requested for enrollment and certification forms that have been in use without approval. This ICR is being submitted for OMB approval to ensure PRA compliance for the new registration and certification forms as well as for the forms that are in use without approval.

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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]? Uncollected

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: 08/19/2009

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