Danisco USA, Inc.; Withdrawal of Food Additive Petition; Correction, 37974 [E8-14998]
Download as PDF
<![CDATA[
37974
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
applications may also include qualityby-design approaches to multiple unit
operations and the stage of product
development. For original applications,
it would be of value to enter the pilot
well in advance of submitting the
application. Entry during the
appropriate stage of development, as an
investigational new drug (IND), would
facilitate working with the agency on
quality-by-design approaches.
Because the number of biotechnology
product applications submitted is
relatively low compared to smallmolecule drugs, the pilot will have an
extended submission period. Written
requests to participate in this pilot
program for products regulated by OBP
may be submitted from the date of the
publication of this notice until
September 30, 2009. This pilot program
will be limited to 10 supplements to be
submitted by March 31, 2010, and 5
original applications for products
reviewed by OBP (BLA or NDA) in
Common Technical Document (CTD)
format, paper or electronic. As noted in
the previous paragraph, it is preferable
for original applications to enter the
pilot as INDs. The INDs must be
submitted before March 31, 2010. Due to
resource considerations, participation in
the program may be limited to a total of
three pilot submissions to OBP per
quarter.
Every effort will be made to ensure
that a variety of pharmaceutical
companies and complex biotechnology
product types are included in this pilot
program. This pilot affects the CMC
section of the submission; however,
supportive data may relate to other
disciplines. Existing regulations and
requirements for the submission of a
supplement or marketing application
(BLA or NDA) will not be waived,
suspended, or modified for purposes of
this pilot program. Participants must
submit the application supplement or
original application, paper or electronic,
in accordance with 21 CFR parts 314
and 601 and other relevant regulations.
B. Process and How to Request
Participation in the Pilot
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 information: (1) The
contact person’s name, company name,
company address, and telephone
number; (2) the name of the drug
product and a brief description of the
drug substance, dosage form, indication,
and stage of development; (3) a
summary of the approaches that define
relevant attributes and process
parameters; (4) a statement describing
the manufacturing changes to be
included in an Expanded Change
Protocol; and (5) a timeline for
requested premeetings and for the
submission. All pharmaceutical
companies requesting participation in
the pilot program will be notified of
their acceptance in writing by OBP
within 60 days of receipt of the request.
Potential participants are encouraged
to discuss their plans to participate in
this pilot program with OBP.
Discussions with potential applicants
can facilitate appropriate pilot
applications. Meeting requests for
potential applicants should be
submitted in accordance with FDA’s
guidance for industry on ‘‘Formal
Meetings With Sponsors and Applicants
for PDUFA Products,’’ February 2000
(https://www.fda.gov/cder/guidance/
2125fnl.htm). Once an application is
selected for participation in this
program, the applicant can meet with
OBP as needed before the submission
and during the review process by
sending requests directly to OBP.
The quality assessment under this
pilot program will be conducted under
the direct oversight of the OBP Office
Director by a team of experienced OBP
scientists who have a strong scientific
background in product quality,
biochemistry, biology and structure/
function relationships. OBP will be
assisted by the Office of Compliance on
proposed current good manufacturing
practices (CGMP) and facility
approaches and other disciplines, as
appropriate. ONDQA and FDA’s Center
for Biologics Evaluation and Research
will also coordinate with OBP to
facilitate a consistent general approach
to quality-by-design principles.
After the application or amendment
has been submitted into the pilot
program, the submission may be
withdrawn or amended within an
agreed upon timeframe to not delay
approval.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VerDate Aug<31>2005
18:51 Jul 01, 2008
Jkt 214001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14999 Filed 7–1–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1986–F–0277] (formerly
Docket No. 1986F–0364)
Danisco USA, Inc.; Withdrawal of Food
Additive Petition; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
document announcing the withdrawal,
without prejudice to a future filing, of
a food additive petition (FAP 6A3958)
that appeared in the Federal Register of
June 20, 2008. FDA is correcting the
addresses of both Pfizer, Inc., and
Danisco USA, Inc.
DATES: This correction is effective July
2, 2008.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Regulations Editorial
Section (HF–27), Food and Drug
Administration, 5600 Fishers Ln.,
Rockville, MD 20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
E8–13998, published on June 20, 2008
(73 FR 35142), the following corrections
are made:
1. On page 35143, in the first column,
in the SUPPLEMENTARY INFORMATION
section, the address for Pfizer, Inc., is
corrected to read ‘‘235 East 42d St., New
York, NY 10017’’.
2. Also on page 35143, in the first
column, in the SUPPLEMENTARY
INFORMATION section, the address for
Danisco USA, Inc., is corrected to read
‘‘565 Taxter Rd., suite 590, Elmsford,
NY 10523’’.
Dated: June 26, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E8–14998 Filed 7–1–08; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 73, Number 128 (Wednesday, July 2, 2008)]
[Notices]
[Page 37974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14998]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1986-F-0277] (formerly Docket No. 1986F-0364)
Danisco USA, Inc.; Withdrawal of Food Additive Petition;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
document announcing the withdrawal, without prejudice to a future
filing, of a food additive petition (FAP 6A3958) that appeared in the
Federal Register of June 20, 2008. FDA is correcting the addresses of
both Pfizer, Inc., and Danisco USA, Inc.
DATES: This correction is effective July 2, 2008.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Regulations Editorial
Section (HF-27), Food and Drug Administration, 5600 Fishers Ln.,
Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION: In FR Doc. E8-13998, published on June 20,
2008 (73 FR 35142), the following corrections are made:
1. On page 35143, in the first column, in the SUPPLEMENTARY
INFORMATION section, the address for Pfizer, Inc., is corrected to read
``235 East 42d St., New York, NY 10017''.
2. Also on page 35143, in the first column, in the SUPPLEMENTARY
INFORMATION section, the address for Danisco USA, Inc., is corrected to
read ``565 Taxter Rd., suite 590, Elmsford, NY 10523''.
Dated: June 26, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. E8-14998 Filed 7-1-08; 8:45 am]
BILLING CODE 4160-01-S
