Hemophilia Treatment Center Factor Replacement Product Data Sheet

Forms and Documents

Document Name	Status
Form Data Sheet Hemophilia Treatment Center Factor Replacement Data Sheet Form	New
Hemophilia responses.doc Supplementary Document	2007-10-23
Hemo Fed 6-5-07.doc Supplementary Document	2007-07-06
FINALCommittee of 10000 edits 6-27-2007.doc Supplementary Document	2007-07-06
FINALHemo Alliance edits 6-27-2007.doc Supplementary Document	2007-07-06
Baxter edits 6-05-2007.doc Supplementary Document	2007-07-06
PPTA edits 6-05-2007.doc Supplementary Document	2007-07-06
HEMOPHILIA REGIONAL COORDINATORS.doc Supplementary Document	2007-07-06
2HEMOPI.RevLet.doc Supplementary Document	2007-07-06
OIG report.pdf Supplementary Document	2007-07-06
FEDERALLY FUNDED HEMOPHILIA TREATMENT CENTERS.doc Supplementary Document	2007-07-06
FINAL Supporting Statement for a Factor Replacement Product-6-5-07.doc Supporting Statement A	2007-07-06

IC Document Collections

IC ID	Document Title	Status
181184	Hemophilia Treatment Center Factor Replacement Data Sheet Form	New

ICR Details

OMB Control No: 0915-0312	ICR Reference No: 200707-0915-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Hemophilia Treatment Center Factor Replacement Product Data Sheet
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/26/2007
	Date Received in OIRA: 07/13/2007
Terms of Clearance: This ICR is approved consistent with memo of 10-19-07.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved
Responses	68	0	0
Time Burden (Hours)	2,040	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for approval of an annual reporting form to be submitted by grantees funded by HRSA's Maternal and Child Health Bureau's National Hemophilia Program and their Hemophilia Treatment Center affiliates having a 340B Factor Replacement Product Program. This data form will be used to help ensure appropriate 340B program implementation.

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Authorizing Statute(s): US Code: 42 USC 701(a)2 Name of Law: Special Projects of Regional and National Significance
   PL: Pub.L. 103 - 262 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 5444	02/06/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 37248	07/09/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Hemophilia Treatment Center Factor Replacement Data Sheet	Data Sheet	Data Sheet

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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	68	0	0	68	0	0
Annual Time Burden (Hours)	2,040	0	0	2,040	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: No

Burden Reduction Due to:

Short Statement: The HHS Office of Inspector General conducted a review of selected Hemophilia Treatment Centers and concluded that HRSA did not have sufficient controls over the grantees that subcontract with the Hemophilia Treatment Centers to ensure that funds were used for their intended purposes and to further program objectives. HRSA has now drafted a data sheet to help ensure appropropriate 340B program implementation. It is for this data sheet that HRSA is now requesting OMB approval.

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Annual Cost to Federal Government: $4,500

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)? Uncollected

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: 07/13/2007

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