Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Development Study, 7556-7558 [E6-1918]
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7556
Federal Register / Vol. 71, No. 29 / Monday, February 13, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
45 minutes or
.75 hrs.
45 minutes or
.75 hrs.
45 minutes or
.75 hrs.
RI 15-month, parent child add-on survey .........................................................
400
1
RI 15-month, youth survey ................................................................................
298
1
RI 15-month, direct child assessment ...............................................................
164
1
Estimated Total Annual Burden
Hours: 646.5.
Additional Information
Copies of the proposed collection may
be obtained by writing to The
Administration for Children and
Families, Office of Information Services,
370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. E-mail:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF. E-mail:
Katherine_T._Astrich@omb.eop.gov.
Pharmaceutical Development Study
Dated: February 7, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–1294 Filed 2–10–06; 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; Submission for Office of
Management and Budget Review;
Comment Request; Pharmaceutical
Development Study
AGENCY:
Food and Drug Administration,
rwilkins on PROD1PC63 with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
VerDate Aug<31>2005
17:38 Feb 10, 2006
Jkt 208001
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.
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Total burde
hours
300
223.5
123
(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.
E:\FR\FM\13FEN1.SGM
13FEN1
7557
Federal Register / Vol. 71, No. 29 / Monday, February 13, 2006 / Notices
• 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 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. 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 BURDEN1
No. of Respondents
Annual Frequency per
Response
25
rwilkins on PROD1PC63 with NOTICES
1There
Total Annual Responses
1
Hours per Response
25
25
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
17:38 Feb 10, 2006
Jkt 208001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
E:\FR\FM\13FEN1.SGM
13FEN1
Total Hours
500
7558
Federal Register / Vol. 71, No. 29 / Monday, February 13, 2006 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301)–443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Maternal and Child
Health Services Title V Block Grant
Program—Guidance and Forms for the
Title V Application/Annual Report,
OMB No. 0915–0172: Revision
The Health Resources and Services
Administration (HRSA) proposes to
revise the Maternal and Child Health
Services Title V Block Grant Program—
Guidance and Forms for the
Application/Annual Report. The
guidance is used annually by the 50
States and 9 jurisdictions in making
application for Block Grants under Title
V of the Social Security Act, and in
preparing the required annual report.
The proposed revisions follow and
build on extensive consultation received
from a workgroup convened to provide
suggestions to improve the guidance
and forms. In addition, the proposed
revisions are editorial and ttechnical
revisions based on the experience of the
States and jurisdictions in using the
guidance and forms since 2003.
Two new performance measures were
developed (obesity in children aged 2 to
5 years; and smoking in the last
trimester of pregnancy) and two existing
performance measures were either
removed entirely (low birth weight) or
incorporated into an existing health
status capacity indicator (eligible
children receiving services under
Medicaid). This will result in no net
increase in the number of performance
measures. In addition, the directions in
the guidance for the Health Systems
Capacity Indicators (HSCI) were
expanded to enhance clarification. This
proposed change will make it easier for
the States to report on these indicators.
The existing electronic system used
by the States to submit their Block Grant
Application and Annual Report has also
been enhanced. First, using the
electronic system, the narrative from the
prior year’s submission is available
online in the system so that the
applicant need only edit those sections
that have changed. This feature reduces
burden by avoiding duplicating
material. For national performance
measures 2–6, the data obtained from
the National Survey of Children with
Number of
respondents
Type of respondent
Special Health Care Needs are prepopulated which eliminates the need to
retrieve and enter data from this survey,
unless the States choose to use another
data source. Also, notes from the prior
year’s submission are available to the
States allowing for more efficient
updating through edits rather then
recreating them. Data are entered once
(in a data entry field on a given form),
and where those data are referenced
elsewhere, the value is copied and
displayed. The electronic system
includes an automatic character counter
that tells the user how many characters
the States have left. This eliminates the
need to independently track entries
against the Maternal and Child Health
Bureau’s limits for each section to
ensure compliance. The electronic
system includes forms status checker
and data alerts, which conduct
automated checks on data validity, data
consistency, and application
completeness, as well as value tolerance
checks. This feature facilitates
application review and eliminates much
of the previously required data cleaning
activity. Also, this allows the user to
obtain an immediate update at any point
in time on the completeness and
compliance of the application, reducing
the need to conduct a review of the
application. Data are saved directly to
the HRSA server so that no manual
transmission is required. Finally, the
automatic commitment of data to the
HRSA server eliminates the need for
version control or data migration.
The estimated average annual burden
per year is as follows for the Annual
Report and Application without the
Needs Assessment:
Responses
per respondent
Burden hours
per response
Total burden
hours
States ...............................................................................................................
Jurisdictions .....................................................................................................
50
9
1
1
297
120
14,868
1,077
Total ..........................................................................................................
59
........................
........................
15,945
Number of respondents
Burden hours
per response
Responses
per respondent
States/Jurisdictions ..........................................................................................
59
378.5
1
22,303
Total Average Burden for 3 year cycle ....................................................
........................
........................
........................
18,064
Burden in the 3 Year Reporting Cycle
for the Annual Report and Application
with Needs Assessment is:
rwilkins on PROD1PC63 with NOTICES
Needs assessment
Written comments and
recommendations concerning the
VerDate Aug<31>2005
17:38 Feb 10, 2006
Jkt 208001
proposed information collection should
be sent within 30 days of this notice to:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Total burden
hours
John Kraemer, Human Resources and
Housing Branch, Office of Management
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 71, Number 29 (Monday, February 13, 2006)]
[Notices]
[Pages 7556-7558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1918]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per
No. of Respondents Response Total Annual Responses Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
25 1 25 25 500
----------------------------------------------------------------------------------------------------------------
\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
