[Federal Register: September 14, 2005 (Volume 70, Number 177)]
[Page 54388-54390]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 
     Pharmaceutical cGMPs for the 21st Century--A Risk Based 
     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 
    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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                            Annual Frequency        Total Annual
   No. of Respondents         per Response            Responses        Hours per Response        Total Hours
25                                 1                    25                    20                   500
\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]