[Federal Register Volume 71, Number 29 (Monday, February 13, 2006)]
[Notices]
[Pages 7556-7558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1918]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0353]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Pharmaceutical 
Development Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
15, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Pharmaceutical Development Study

    FDA's Office of Pharmaceutical Science of the Center for Drug 
Evaluation and Research is proposing collaboration under a Cooperative 
Research and Development Agreement (CRADA) with Conformia Software, 
Inc., of Redwood City, CA (hereafter referred to as ``CRADA Partner''), 
to collect information using focus group discussions with firms to 
determine what factors may influence pharmaceutical development. These 
factors include development information bottlenecks, pilot plant 
information management, manufacturing science, information retrieval, 
quality systems and preclinical development challenges.
    FDA has introduced three new initiatives to help manufacturers 
develop higher quality drugs faster and cheaper. These initiatives 
include, but are not limited to, the following:
     Challenge and Opportunity on the Critical Path to New 
Medical Products (commonly referred to as the ``Critical Path 
Initiative'')
     Pharmaceutical cGMPs for the 21st Century--A Risk Based 
Approach
     International Conference on Harmonisation (ICH) Steering 
Committee Guidelines--Pharmaceutical Development, ICH Q8 (Defining the 
Design Space)
    The proposed study is designed to augment and support these 
initiatives by providing practical industry experience and feedback to 
help FDA refine these initiatives. The scope of the proposed 
collaboration is aligned with FDA's ``Critical Path'' of development; 
specifically, the area between selection of drug candidates and 
commercial manufacturing.
    Gathering information through this collaboration represents 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. There is a perceived 
reluctance by industry to share information with regulatory bodies 
(outside of the formal review processes). Therefore, obtaining 
necessary and timely information through this collaboration will help 
the Critical Path Initiative progress.
    The information collected will be used to create a clearer picture 
of current developmental bottlenecks, identify current State practices, 
highlight potential improvements in production, and provide feedback to 
FDA on the impact of current regulatory guidance.
    Use of information: The three groups who will be involved with the 
study may benefit by the collection of this information as follows:
     Industry--Participants will compare current drug 
development practices and processes identified in the study with 
current FDA guidance. Companies will be able to gain a better 
understanding of the steps needed to achieve the operational goals 
introduced through the Critical Path, ICH-Q8, and Pharmaceutical cGMPs 
for the 21st Century.

[[Page 7557]]

     FDA--In its Critical Path Initiative, FDA has called for 
better tools and techniques to be developed to help facilitate and 
improve productivity. The information gained will provide a better 
understanding of what steps will be needed to achieve this goal: To 
help companies reduce time spent in pharmaceutical development and 
speed the adoption of new technologies aimed at producing higher 
quality products at reduced costs.
     CRADA Partner--In collaboration with FDA, the CRADA 
Partner will use research findings to better understand informational 
requirements of companies in the area of pharmaceutical development, 
particularly as they relate to accomplishing the goals of the three FDA 
initiatives described previously in this document. This includes tools 
that may be utilized within the company environment to reduce 
bottlenecks and enhance communication of key pharmaceutical 
information, as well as tools that may assist FDA in the review of 
pharmaceutical development submissions.
    Thus the study will assist all three party's understanding of the 
requirements to address the current state in dealing with 
pharmaceutical development challenges.
    Confidentiality of respondents: The CRADA Partner will provide an 
``Informed Consent'' form to all companies that participate in the 
study. This form highlights and assures all participants that company-
specific responses (or responses unique to a specific company) will 
not, under any circumstances, be divulged to other participants or FDA 
without the company's prior consent. The CRADA Partner will also 
provide a confidential disclosure agreement to all participants, 
assuring them confidentiality of disclosed information and adherence to 
the Privacy Act.
    Participation in the study: The CRADA Partner will post on its Web 
site an invitation for industry to participate in the study. It will 
also fax the invitation to 20 of the top pharmaceutical companies and 
20 of the top biotech companies. The invitation will be sent to the 
offices of regulatory affairs, research and development, and 
information management. FDA will also post the CRADA abstract on its 
Web site along with instructions on how to participate in the study. 
Within each company separate, small focus groups will be formed for the 
three offices. Company management in consultation with the CRADA 
Partner will determine the actual makeup of the focus groups, but the 
objective is to have a cross-functional representation of experienced 
employees from each office.
    Method of study: The CRADA Partner will conduct a preliminary phase 
of the study with individual representatives of nine firms (through 
dialogue with the Vice President (VP) of Development), who volunteer 
for participation in the study. VP of Development and the CRADA Partner 
will determine the specific representation from each company jointly, 
but the objective will be to include representatives from the office of 
regulatory affairs, research and development, and information 
technology. The results of these preliminary interviews will be used to 
refine the full study agenda, which will be used to conduct focus group 
discussions from 25 companies. Both the preliminary phase and the final 
study agenda will include review and comment by FDA technical and 
regulatory experts and CRADA Partner personnel.
    The CRADA Partner will summarize interview findings for the full 
study and will remove references to specific firms, or information that 
could be used to identify specific firms, before sharing information 
with FDA. Followup questions will be identified by consultation between 
FDA and CRADA Partner personnel and these questions will be addressed 
in subsequent focus group interviews. Although companies are strongly 
encouraged to participate in these followup interviews, they may 
discontinue participation at any time.
    As an incentive for companies to participate in the study, the 
CRADA Partner will prepare a confidential report that contrasts 
practices in each company in comparison with aggregated information 
from other companies. At all times, the identity of a participating 
firm will be limited to the company itself and to the CRADA Partner. 
This blinded methodology is an industry standard methodology for other 
areas of current State best practices research.
    FDA personnel in collaboration will review final results with the 
CRADA Partner to determine appropriate next steps. These next steps may 
include training sessions with industry to increase industry awareness 
of pharmaceutical development practices and opportunities for improving 
these in conjunction with FDA's manufacturing and related 
industrialization initiatives; industry workshops to discuss and 
explore findings of the study; a publication or publications 
summarizing the study results; additional studies to further expand 
FDA's understanding of particular aspects of pharmaceutical development 
that may benefit from regulatory reform and steamlining; and 
adjustments to FDA's regulatory strategy to help remove unnecessary or 
unintended burdens on industry.
    In the Federal Register of September 14, 2005 (70 FR 54388), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                           Annual Frequency per
    No. of Respondents           Response          Total Annual Responses    Hours per Response     Total Hours
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25                                            1                         25                    25             500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 7558]]

    Dated: February 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1918 Filed 2-10-06; 8:45 am]
BILLING CODE 4160-01-S