[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Pages 54388-54390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18163]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0353]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a proposed Pharmaceutical Development
Study.
DATES: Submit written or electronic comments on the collection of
information by November 14, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Pharmaceutical Development Study
FDA's Office of Pharmaceutical Science (OPS) 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 pre-clinical development challenges.
The 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 Harmonization (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 experiences 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 development 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:
[[Page 54389]]
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.
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. 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 the
FDA without the company's prior consent. The CRADA Partner will also
provide a Confidential Disclosure Agreement (CDA) 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. The 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. Follow-on 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 follow-on 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 which 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual
No. of Respondents per Response Responses Hours per Response Total Hours
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25 1 25 20 500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 54390]]
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18163 Filed 9-13-05; 8:45 am]
BILLING CODE 4160-01-S