[Federal Register: February 13, 2006 (Volume 71, Number 29)]
[Notices]
[Page 7556-7558]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe06-73]
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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