Pharmaceutical Development Study

Forms and Documents

Document Name	Status
Supporting Statement Part B.doc Supporting Statement B	2007-05-04
supplementalattachments.doc Supplementary Document	2007-02-28
Supporting Statement.doc Supporting Statement A	2007-02-28

IC Document Collections

IC ID	Document Title	Status
180768	Pharmaceutical Development Study Other-Research/timeline/questionaire	New

ICR Details

OMB Control No: 0910-0604	ICR Reference No: 200706-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Pharmaceutical Development Study
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: 08/20/2007
	Date Received in OIRA: 06/20/2007
Terms of Clearance: Approved as amended by FDA email memos and consistent with the following terms of clearance: (1)FDA will ensure that respondents are aware, consistent with Article 13.10 of the CRADA, that "...by entering into this CRADA, the Government does not directly or indirectly endorse any product or service that is or will be provided, whether directly or indirectly related to either this CRADA or to any patent or other intellectual-property license or agreement that implements this CRADA by Collaborator, its successors, assignees, or licensees."(2) FDA will make it clear that the study results are not statistically representative of the industry as a whole, (3) FDA will be careful in characterizing any of the results of this survey as "best or worst practices," focusing instead on the challenges and range of practices that exist in the areas studied.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved
Responses	25	0	0
Time Burden (Hours)	500	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The U.S. Food and Drug Administration and Conformia are working together under a Cooperative Research and Development Agreement (CRADA) to conduct a research study on the challenges that drug product companies face in managing relevant development history information which is critical to the success of bringing best/first in-class, products of quality, to market as efficiently as possible. Through this CRADA, Conformia will utilize a survey based research approach including interviews, review of existing material, and questionnaires in gathering information to give an opportunity for FDA to gain insights into current industry practices and provide the opportunity to better understand the specific factors that contribute to drug development difficulties.

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Authorizing Statute(s): US Code: 42 USC 300(a)(4) 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:
	70 FR 54388	09/14/2005
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 7556	02/13/2006
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Pharmaceutical Development Study

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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	25	0	0	25	0	0
Annual Time Burden (Hours)	500	0	0	500	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 FDA has recognized that the drug development process needs to be streamlined and optimized to ensure that new and innovative therapeutics can be introduced into the market place as efficiently as possible. This proposed collection of information will help the FDA gather in the information it needs from industry to develop more definitive steps towards helping industry achieve the levels of efficiency across the drug develpment spectrum that are becoming essential to ensure continued innovation and growth.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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: 06/19/2007

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