Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program, 40719-40720 [05-13829]
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Federal Register / Vol. 70, No. 134 / Thursday, July 14, 2005 / Notices
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located at: https://www.acf.hhs.gov/
grants/.
Additional information about this
program and its purpose can be located
on the following Web sites: https://
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For general questions regarding this
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Health and Human Services,
Administration for Children and
Families, Office of Community Services’
Operations Center, 1515 Wilson Blvd.,
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800–281–9519, E-mail:
OCSGRANTS@acf.hhs.gov.
Applicants will not be sent
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applications.
Dated: July 8, 2005.
Josephine Robinson,
Director, Office of Community Services.
[FR Doc. 05–13893 Filed 7–13–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0262]
Submission of Chemistry,
Manufacturing, and Controls
Information in a New Drug Application
Under the New Pharmaceutical Quality
Assessment System; Notice of Pilot
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is seeking
pharmaceutical companies to volunteer
to participate in a pilot program
involving the submission of chemistry,
manufacturing, and controls (CMC)
information consistent with the new
pharmaceutical quality assessment
system. The purpose of the pilot
program is twofold. First, the pilot
program will provide participating
pharmaceutical companies with an
opportunity to submit critical CMC
information that demonstrates their
understanding of quality by design,
product knowledge, and process
understanding of the drug substance
and drug product in a new drug
application (NDA). Second, the pilot
program will enable the public and
regulated industry to provide feedback
that will assist FDA in developing a
guidance for industry on the new
quality assessment system.
VerDate jul<14>2003
18:32 Jul 13, 2005
Jkt 205001
Submit written and electronic
requests to participate in the pilot
program by October 31, 2005. Submit
written and electronic comments on this
pilot program by December 31, 2006.
ADDRESSES: Submit written requests to
participate in the pilot program and
written comments on the program to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic requests to
participate and electronic comments to
https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Michael Folkendt, Center for Drug
Evaluation and Research (HFD–800),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, email: folkendtm@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
The Office of New Drug Chemistry
(ONDC) in the Office of Pharmaceutical
Science, Center for Drug Evaluation and
Research, is establishing a modern, riskbased pharmaceutical quality
assessment system, as described in a
September 2004 White Paper entitled
‘‘ONDC’s New Risk-Based
Pharmaceutical Quality Assessment
System’’ (https://www.fda.gov/cder/gmp/
gmp2004/ondc_reorg.htm). This White
Paper was published as part of the FDA
final report on ‘‘Pharmaceutical cGMPs
for the 21st Century—A Risk-Based
Approach’’ (https://www.fda.gov/cder/
gmp/gmp2004/
GMP_finalreport2004.htm).
The new quality assessment system
will focus on critical pharmaceutical
quality attributes (related to chemistry,
formulation, manufacturing process
design, and product performance) and
their relevance to safety and
effectiveness. The principles underlying
this new quality assessment system can
be found in the February 2005
International Conference on
Harmonization (ICH) draft guidance
entitled ‘‘Q8 Pharmaceutical
Development’’ (https://www.fda.gov/
cder/guidance/6672dft.pdf) and the
September 2004 FDA guidance for
industry entitled ‘‘PAT—A Framework
for Innovative Pharmaceutical
Development, Manufacturing, and
Quality Assurance’’ (https://
www.fda.gov/cder/guidance/
6419fnl.htm). These principles include
the following: (1) Ensuring product
quality and performance through the
design of effective and efficient
manufacturing processes; (2)
establishing product and process
specifications based on a mechanistic
understanding of how formulation and
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
40719
process factors affect product
performance; and (3) where applicable,
continuous ‘‘real time’’ quality
assurance.
The new quality assessment system is
intended to facilitate innovation and
improvement throughout the product
lifecycle and to provide regulatory
flexibility for specification setting and
postapproval changes based on
scientific knowledge and understanding
of product and process by applying
quality-by-design principles. To take
full advantage of the new quality
assessment system, including
appropriate regulatory flexibility,
applicants should provide information
in the CMC section of an NDA that
demonstrates their product knowledge
and process understanding at the time
of submission. A CMC submission
under the new system should contain a
more comprehensive Quality Overall
Summary (Module 2.3 of the ICH
Common Technical Document (CTD)
‘‘M4Q: The CTD—Quality’’) and a more
expansive Pharmaceutical Development
section (Module 3.2.P.2, of the CTD). It
should also include more relevant
information on critical quality attributes
and how they relate to clinical safety
and effectiveness. The information
provided should do the following: (1)
Provide an appropriate level of
confidence that quality has been built
into the product by demonstrating the
extent of product knowledge and
process understanding at the time of
submission, including information
explaining critical steps and in-process
controls to facilitate setting
scientifically sound specifications and
acceptance criteria, and (2) identify
possible sources of variability in
manufacturing by explaining how
associated risks can be mitigated. At the
same time, there would be less need for
information that could be handled
through inspectional oversight of
current good manufacturing practices
(cGMP) requirements (e.g., executed
batch record, redundant
chromatographic data, standard
operating procedures). The pilot is also
intended to provide enhanced clarity by
distinguishing between information
submitted and used in the
pharmaceutical assessment process and
information that is a condition of
approval (e.g., that cannot be modified
without further application/supplement
review).
II. Description of Pilot Program
The pilot program will provide
additional information for ONDC to use
in implementing the new quality
assessment system. FDA will work with
each participant on an individual basis,
E:\FR\FM\14JYN1.SGM
14JYN1
40720
Federal Register / Vol. 70, No. 134 / Thursday, July 14, 2005 / Notices
with review of the application being the
primary goal. The process will include
appropriate coordination between
agency review and inspection staff.
Based on experience gained during the
pilot program and internal knowledge of
manufacturing science, FDA will
develop procedures and guidance for
implementing the new quality
assessment system.
A. Scope
This program will be limited to 12
original NDAs to be submitted by
December 31, 2006, in the CTD format,
paper or electronic. If an applicant
believes that a particular CMC
supplement would be a good candidate
for this pilot program, the applicant is
encouraged to first contact ONDC to
discuss its acceptability. Acceptance
into this program will depend on the
soundness of the drug development
plan and the potential of the proposed
application to affect the development of
the new quality assessment system.
Every effort will be made to ensure that
all pharmaceutical companies have the
opportunity to participate and that
many different drug product types are
included in this pilot program.
This pilot program only affects the
CMC section of the NDA. Existing
regulations and requirements for the
submission of an NDA will not be
waived, suspended, or modified for
purposes of this pilot program.
Participants must submit the NDA,
paper or electronic, in accordance with
21 CFR part 314 and other relevant
regulations.
B. Process
Interested parties should submit to
the Division of Dockets Management
(see ADDRESSES) a written request to
participate in the pilot program
(identified with the docket number
found in brackets in the heading of this
document). The request should include
the following items: (1) The contact
person’s name, company name,
company address, and telephone
number; (2) the name of the drug
product and a brief description (e.g.,
dosage form, indication); (3) a summary
of the drug development plan; (4) a
statement of the potential of the
proposed application to affect the
development of the new quality
assessment system; and (5) a timeline
for end-of-phase-2 and pre-NDA
meetings and NDA submission. All
pharmaceutical companies requesting
participation in the pilot program will
be notified of their acceptance in
writing by ONDC within 60 days of
receipt of the request.
VerDate jul<14>2003
18:32 Jul 13, 2005
Jkt 205001
Potential participants are encouraged
to discuss their plans to participate in
this pilot program with ONDC (e.g., as
part of an end-of-phase-2 or pre-NDA
meeting). Meeting requests for
participating applicants should be
submitted in accordance with the CDER
guidance for industry on ‘‘Formal
Meetings With Sponsors and Applicants
for PDUFA Products’’ (https://
www.fda.gov/cder/guidance/
2125fnl.htm). Once agreement is
reached on participation in this
program, the applicant can meet with
ONDC as frequently as needed before
the submission and during the review
process by submitting requests directly
to ONDC.
The quality assessment under this
pilot program will be conducted under
the direct oversight of the ONDC Office
Director by a team of experienced
scientists who have a good
understanding of the new quality
assessment system and a strong
scientific background in pharmaceutical
development and manufacturing.
A pharmaceutical company may
withdraw from participation in the pilot
program at any time before the NDA is
submitted by notifying ONDC in writing
that it wishes to withdraw from the
program.
III. Comments
Interested persons may submit written
comments on this pilot program to the
Division of Dockets Management (see
ADDRESSES). Two copies of any
comments are to be submitted, except
that individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. FDA will
consider these comments when
developing a guidance on the new
pharmaceutical quality assessment
system. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. While detailed
information on participating NDAs will
not be publicly available, names of
participating applicants will be made
public.
Dated: July 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–13829 Filed 7–13–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0133]
‘‘Guidance for Industry: Assessing
Donor Suitability and Blood and Blood
Product Safety in Cases of Known or
Suspected West Nile Virus Infection;’’
Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug Administration
(FDA) is correcting a notice that
appeared in the Federal Register of June
30, 2005 (70 FR 37863). The document
announced the availability of a guidance
document entitled ‘‘Guidance for
Industry: Assessing Donor Suitability
and Blood and Blood Product Safety in
Cases of Known or Suspected West Nile
Virus Infection.’’ The document
published with inadvertent errors. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning (HF–27), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
05–12960, appearing on page 37863 in
the Federal Register of Thursday, June
30, 2005, the following correction is
made:
1. On page 37864, in the second
column, under the section heading ‘‘II.
Paperwork Reduction Act of 1995’’, the
second sentence is corrected to read:
‘‘The collection of information in this
guidance for 21 CFR 601.12 was
approved under OMB control number
0910–0338; § 606.170(b) (21 CFR
606.170(b)) has been approved under
OMB control number 0910–0116; and
§ 606.171 has been approved under
OMB control number 0910–0458.’’
Dated: July 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–13830 Filed 7–13–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–4971–N–35]
Notice of Submission of Proposed
Information Collection to OMB;
Voucher Homeownership Program
Implementation Survey
Office of the Chief Information
Officer, HUD.
AGENCY:
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 70, Number 134 (Thursday, July 14, 2005)]
[Notices]
[Pages 40719-40720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13829]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0262]
Submission of Chemistry, Manufacturing, and Controls Information
in a New Drug Application Under the New Pharmaceutical Quality
Assessment System; Notice of Pilot Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is seeking
pharmaceutical companies to volunteer to participate in a pilot program
involving the submission of chemistry, manufacturing, and controls
(CMC) information consistent with the new pharmaceutical quality
assessment system. The purpose of the pilot program is twofold. First,
the pilot program will provide participating pharmaceutical companies
with an opportunity to submit critical CMC information that
demonstrates their understanding of quality by design, product
knowledge, and process understanding of the drug substance and drug
product in a new drug application (NDA). Second, the pilot program will
enable the public and regulated industry to provide feedback that will
assist FDA in developing a guidance for industry on the new quality
assessment system.
DATES: Submit written and electronic requests to participate in the
pilot program by October 31, 2005. Submit written and electronic
comments on this pilot program by December 31, 2006.
ADDRESSES: Submit written requests to participate in the pilot program
and written comments on the program to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic requests to
participate and electronic comments to https://www.fda.gov/dockets/
ecomments.
FOR FURTHER INFORMATION CONTACT: Michael Folkendt, Center for Drug
Evaluation and Research (HFD-800), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, e-mail: folkendtm@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Office of New Drug Chemistry (ONDC) in the Office of
Pharmaceutical Science, Center for Drug Evaluation and Research, is
establishing a modern, risk-based pharmaceutical quality assessment
system, as described in a September 2004 White Paper entitled ``ONDC's
New Risk-Based Pharmaceutical Quality Assessment System'' (https://
www.fda.gov/cder/gmp/gmp2004/ondc_reorg.htm). This White Paper was
published as part of the FDA final report on ``Pharmaceutical cGMPs for
the 21st Century--A Risk-Based Approach'' (https://www.fda.gov/cder/gmp/
gmp2004/GMP_finalreport2004.htm).
The new quality assessment system will focus on critical
pharmaceutical quality attributes (related to chemistry, formulation,
manufacturing process design, and product performance) and their
relevance to safety and effectiveness. The principles underlying this
new quality assessment system can be found in the February 2005
International Conference on Harmonization (ICH) draft guidance entitled
``Q8 Pharmaceutical Development'' (https://www.fda.gov/cder/guidance/
6672dft.pdf) and the September 2004 FDA guidance for industry entitled
``PAT--A Framework for Innovative Pharmaceutical Development,
Manufacturing, and Quality Assurance'' (https://www.fda.gov/cder/
guidance/6419fnl.htm). These principles include the following: (1)
Ensuring product quality and performance through the design of
effective and efficient manufacturing processes; (2) establishing
product and process specifications based on a mechanistic understanding
of how formulation and process factors affect product performance; and
(3) where applicable, continuous ``real time'' quality assurance.
The new quality assessment system is intended to facilitate
innovation and improvement throughout the product lifecycle and to
provide regulatory flexibility for specification setting and
postapproval changes based on scientific knowledge and understanding of
product and process by applying quality-by-design principles. To take
full advantage of the new quality assessment system, including
appropriate regulatory flexibility, applicants should provide
information in the CMC section of an NDA that demonstrates their
product knowledge and process understanding at the time of submission.
A CMC submission under the new system should contain a more
comprehensive Quality Overall Summary (Module 2.3 of the ICH Common
Technical Document (CTD) ``M4Q: The CTD--Quality'') and a more
expansive Pharmaceutical Development section (Module 3.2.P.2, of the
CTD). It should also include more relevant information on critical
quality attributes and how they relate to clinical safety and
effectiveness. The information provided should do the following: (1)
Provide an appropriate level of confidence that quality has been built
into the product by demonstrating the extent of product knowledge and
process understanding at the time of submission, including information
explaining critical steps and in-process controls to facilitate setting
scientifically sound specifications and acceptance criteria, and (2)
identify possible sources of variability in manufacturing by explaining
how associated risks can be mitigated. At the same time, there would be
less need for information that could be handled through inspectional
oversight of current good manufacturing practices (cGMP) requirements
(e.g., executed batch record, redundant chromatographic data, standard
operating procedures). The pilot is also intended to provide enhanced
clarity by distinguishing between information submitted and used in the
pharmaceutical assessment process and information that is a condition
of approval (e.g., that cannot be modified without further application/
supplement review).
II. Description of Pilot Program
The pilot program will provide additional information for ONDC to
use in implementing the new quality assessment system. FDA will work
with each participant on an individual basis,
[[Page 40720]]
with review of the application being the primary goal. The process will
include appropriate coordination between agency review and inspection
staff. Based on experience gained during the pilot program and internal
knowledge of manufacturing science, FDA will develop procedures and
guidance for implementing the new quality assessment system.
A. Scope
This program will be limited to 12 original NDAs to be submitted by
December 31, 2006, in the CTD format, paper or electronic. If an
applicant believes that a particular CMC supplement would be a good
candidate for this pilot program, the applicant is encouraged to first
contact ONDC to discuss its acceptability. Acceptance into this program
will depend on the soundness of the drug development plan and the
potential of the proposed application to affect the development of the
new quality assessment system. Every effort will be made to ensure that
all pharmaceutical companies have the opportunity to participate and
that many different drug product types are included in this pilot
program.
This pilot program only affects the CMC section of the NDA.
Existing regulations and requirements for the submission of an NDA will
not be waived, suspended, or modified for purposes of this pilot
program. Participants must submit the NDA, paper or electronic, in
accordance with 21 CFR part 314 and other relevant regulations.
B. Process
Interested parties should submit to the Division of Dockets
Management (see ADDRESSES) a written request to participate in the
pilot program (identified with the docket number found in brackets in
the heading of this document). The request should include the following
items: (1) The contact person's name, company name, company address,
and telephone number; (2) the name of the drug product and a brief
description (e.g., dosage form, indication); (3) a summary of the drug
development plan; (4) a statement of the potential of the proposed
application to affect the development of the new quality assessment
system; and (5) a timeline for end-of-phase-2 and pre-NDA meetings and
NDA submission. All pharmaceutical companies requesting participation
in the pilot program will be notified of their acceptance in writing by
ONDC within 60 days of receipt of the request.
Potential participants are encouraged to discuss their plans to
participate in this pilot program with ONDC (e.g., as part of an end-
of-phase-2 or pre-NDA meeting). Meeting requests for participating
applicants should be submitted in accordance with the CDER guidance for
industry on ``Formal Meetings With Sponsors and Applicants for PDUFA
Products'' (https://www.fda.gov/cder/guidance/2125fnl.htm). Once
agreement is reached on participation in this program, the applicant
can meet with ONDC as frequently as needed before the submission and
during the review process by submitting requests directly to ONDC.
The quality assessment under this pilot program will be conducted
under the direct oversight of the ONDC Office Director by a team of
experienced scientists who have a good understanding of the new quality
assessment system and a strong scientific background in pharmaceutical
development and manufacturing.
A pharmaceutical company may withdraw from participation in the
pilot program at any time before the NDA is submitted by notifying ONDC
in writing that it wishes to withdraw from the program.
III. Comments
Interested persons may submit written comments on this pilot
program to the Division of Dockets Management (see ADDRESSES). Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. FDA will consider
these comments when developing a guidance on the new pharmaceutical
quality assessment system. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. While detailed information on participating NDAs will
not be publicly available, names of participating applicants will be
made public.
Dated: July 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-13829 Filed 7-13-05; 8:45 am]
BILLING CODE 4160-01-S
