PDUFA Pilot Project Proprietary Name Review

Forms and Documents

Document Name	Status
OMB passback questions a.doc Supplementary Document	2009-09-24
Pdufa passback OMB.doc Supplementary Document	2009-09-24
concept pilot pro names.pdf Supplementary Document	2009-06-24
ProprietaryNamesPilotProgram SS 2 2009[1].doc Supporting Statement A	2009-09-24

IC Document Collections

IC ID	Document Title	Status
190782	Registration Instruction	New
189782	PDUFA Pilot Project Proprietary Name Review	New

ICR Details

OMB Control No: 0910-0648	ICR Reference No: 200907-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: PDUFA Pilot Project Proprietary Name Review
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 with change	Conclusion Date: 09/25/2009
	Date Received in OIRA: 07/01/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement, revised burden estimates, revised instrument, and FDA memo of 9/24/09. FDA has clarified that policy decisions will not flow directly from this study alone, as it is a qualitative study on a very small sample and is more akin to a formative or "proof of concept" investigation. As such, FDA is encouraged to engage in further, more rigorous study (e.g. a peer review process or expert solicitation process) in order to establish more reliably what the best methodologies may be for assessing the safety of a proprietary drug name, particularly if FDA is considering making such methodologies mandatory on the part of industry. We understand that rulemaking would be required before such data analysis and submission can be made mandatory. Finally, FDA is reminded that the cost and burden estimates provided in the supporting statement should match that which is submitted through ICRAS/ROCIS.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved
Responses	45	0	0
Time Burden (Hours)	9,613	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA also agreed to develop and implement a voluntary pilot program to enable pharmaceutical firms participating in the pilot to evaluate proposed proprietary names and to submit the data generated from those evaluations to the FDA for review. The concept paper is intended to help pharmaceutical firms choose appropriate proprietary names for their drug and biological products before submitting marketing applications to FDA and describes how pharmaceutical firms may use "best practices" to carry out their own proprietary name reviews and provide FDA with the data that result from those reviews.

---

Authorizing Statute(s): PL: Pub.L. 110 - 121 823 Name of Law: FDAAA
  

Citations for New Statutory Requirements: Statute at Large: 110 Stat. 823 Name of Statute: null

---

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:
	73 FR 78813	12/23/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 28706	06/17/2009
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Registration
PDUFA Pilot Project Proprietary Name Review

---

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	45	0	20	25	0	0
Annual Time Burden (Hours)	9,613	0	9,600	13	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: This is a new collection.

---

Annual Cost to Federal Government: $3,332

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

---

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: 07/01/2009

---