Pharmaceutical Development Study

ICR 200706-0910-002

OMB: 0910-0604

Federal Form Document

Forms and Documents
Supporting Statement B
Supplementary Document
Supporting Statement A
IC Document Collections
ICR Details
0910-0604 200706-0910-002
Historical Active
Pharmaceutical Development Study
New collection (Request for a new OMB Control Number)   No
Approved with change 08/20/2007
Retrieve Notice of Action (NOA) 06/20/2007
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 " 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
08/31/2010 36 Months From Approved
25 0 0
500 0 0
0 0 0

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.

US Code: 42 USC 300(a)(4) Name of Law: Public Health Service Act

Not associated with rulemaking

  70 FR 54388 09/14/2005
71 FR 7556 02/13/2006

IC Title Form No. Form Name
Pharmaceutical Development Study

  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
Miscellaneous Actions
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.

Yes Part B of Supporting Statement
Saleda Perryman


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:
    (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;
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.

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