Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Development Study, 54388-54390 [05-18163]
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54388
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
impact of Head Start Programs. The
September 28–29, 2005 meeting
provides an opportunity for the
Advisory Committee to provide advice
on the analysis plans for the study
following the June 2005 release on the
first impact findings.
DATES: September 28 (9 a.m.–4 p.m.)
and 29 (9 a.m.–12:30 p.m.), 2005.
Place: Bethesda Park Clarion Hotel,
8400 Wisconsin Avenue, Bethesda, MD
20814; Phone: (301) 654–1000; Fax:
(301) 654–0751.
SUPPLEMENTARY INFORMATION: This
meeting is open to the public and is
barrier free. Meeting records will also be
open to the public and will be kept at
the Aerospace Building, 370 L’Enfant
Promenade, SW., Washington, DC
20447. The Administration for Children
and Families also intends to make
material related to this meeting
available on the Office of Planning,
Research and Evaluation Web site
(https://www.acf.hhs.gov/programs/opre/
index.html). An interpreter for the deaf
and hearing impaired will be available
upon advance request by calling Xtria at
703–821–6182.
FOR FURTHER INFORMATION CONTACT:
Maria Woolverton at 202–205–4039 for
substantive information. Contact ACF
Office of Public Affairs at 202–401–9215
for press inquiries. Contact Xtria at 703–
821–6182 for logistical information.
Dated: September 7, 2005.
Naomi Goldstein,
Director, Office of Planning, Research and
Evaluation, ACF.
[FR Doc. 05–18257 Filed 9–13–05; 8:45 am]
BILLING CODE 4184–01–M
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.
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
VerDate Aug<18>2005
16:17 Sep 13, 2005
Jkt 205001
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: https://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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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.
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:
E:\FR\FM\14SEN1.SGM
14SEN1
54389
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
• 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 crossfunctional 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 BURDEN1
Annual Frequency
per Response
No. of Respondents
25
1There
Total Annual
Responses
1
Hours per Response
25
20
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<18>2005
16:17 Sep 13, 2005
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PO 00000
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E:\FR\FM\14SEN1.SGM
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Total Hours
500
54390
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0349]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Food and Drug
Administration Survey of Current
Manufacturing Practices in the Food
Industry
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 a 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 survey of current
manufacturing practices in the food
industry. The purpose of the proposed
survey is to improve FDA’s
understanding of current food industry
manufacturing practices. The
information will be used to assess what
impact, if any, new manufacturing
requirements would make on the food
industry.
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: https://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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
VerDate Aug<18>2005
16:17 Sep 13, 2005
Jkt 205001
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 concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
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.
FDA Survey of Current Manufacturing
Practices in the Food Industry
The authority for FDA to collect the
information derives from the FDA
Commissioner’s authority, as specified
in section 903(d)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)).
FDA’s regulations in part 110 of Title
21 of the Code of Federal Regulations
(21 CFR part 110) describe the methods,
equipment, facilities and controls for
producing processed food, hereafter
referred to as food CGMPs. As the
minimum sanitary and processing
requirements for producing safe and
wholesome food, CGMPs are an
important part of regulatory control of
the nation’s food supply. FDA believes
that it is necessary to revisit and
modernize the food CGMPs. Since the
food CGMPs were last revised in 1986,
there have been significant changes in
food production technology and
important advances in the
understanding of foodborne illnesses.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Accordingly, the agency will rigorously
assess the impacts of any modernization
policies on food facilities. To assess the
impacts of the modernization policy,
information is needed to help
understand baseline or current industry
practice. At present, however, FDA
lacks baseline information on the nature
of current manufacturing practices that
would serve as part of a regulatory
impact analysis.
FDA plans to conduct an Internet
survey of all domestic FDA-registered
facilities that primarily manufacture or
process food and all foreign FDAregistered facilities that primarily
manufacture or process food, which are
located in those countries that are the
largest food exporters to the United
States: Japan, Canada, China, France,
Italy and Mexico. The Internet survey
will be supplemented by extended case
study interviews with selected
respondents from the survey. The
survey and extended case studies will
solicit detailed information about six
key topics relevant to the food CGMPs
modernization effort: employee training,
sanitation and personal hygiene,
allergen controls, process controls, postproduction processing, and
recordkeeping. Additionally, FDA will
collect information on establishment
characteristics, such as facility size and
industry, which are expected to
correlate with the presence or absence
of various manufacturing practices, such
as electronic recordkeeping, ongoing
employee training in food safety, and
product-to-label conformance
procedures. The case study interviews
will provide qualitative, in-depth
information about various factors that
influence decisions to implement these
types of manufacturing practices, as
well as about the circumstances that
underlie the cost and effectiveness of
such programs. The survey will be sent
to every FDA-registered facility in the
United States, Japan, Canada, China,
France, Italy and Mexico that primarily
manufactures or processes food
products and that included an e-mail
address with their registration.
Participation will be voluntary and the
respondent identifiers that would
permit an association of specific
responses to specific respondents will
not be accessible to FDA.
The proposed Internet survey will
collect the information from
respondents electronically. With a
custom-designed online survey system,
responses will be entered directly into
a computer database, eliminating the
need for additional coding and data
entry operations. Also, the system will
ensure that conditional questions are
asked in proper order, freeing the
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Pages 54388-54390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18163]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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\
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4160-01-S
