
[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Notices]
[Page 47806-47807]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se09-52]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0355]


Submission of Quality Information for Biotechnology Products in
the Office of Biotechnology Products; Notice of Extension of Deadlines
to Request Participation in Pilot Program and to Submit Applications;
and Notice of Increase in the Number of Original Applications in Pilot
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
extension of the deadline for submitting requests to participate in a
pilot program involving the submission of quality (chemistry,
manufacturing, and controls (CMC)) information for biotechnology
products in an Expanded Change Protocol consistent with the principles
of quality-by-design and risk management in pharmaceutical
manufacturing. Because the deadline for requests to participate in the
pilot is being extended, FDA is also extending the application
submission deadlines. FDA is also announcing an increase in the number
of original applications being accepted into the pilot program.

DATES: Submit written and electronic requests to participate in the
pilot program by September 30, 2010. Submit investigational new drug
(IND) applications and postapproval supplements by March 31, 2011.

ADDRESSES: Submit written requests to participate in the pilot 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 in the pilot to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Marilyn Welschenbach, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 21, rm.
1514, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, e-mail:
Marilyn.Welschenbach@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 2, 2008 (73 FR 37972) (the July 2,
2008, notice), FDA announced that it is seeking volunteers from
pharmaceutical companies to participate in a pilot program involving
the submission of quality (CMC) information for biotechnology products
in an Expanded Change Protocol, consistent with the principles of
quality-by-design and risk management in pharmaceutical manufacturing.
As explained in the July 2, 2008, notice, the Office of Pharmaceutical
Science (OPS), in FDA's Center for Drug Evaluation and Research (CDER),
is establishing a quality-by-design, risk-based approach to
pharmaceutical quality, which is based on the FDA final report on
``Pharmaceutical cGMPs for the 21st Century--A Risk-Based Approach''
(http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm). The new
quality-by-design approach will focus on critical quality attributes
related to chemistry, formulation, and process design. Under quality-
by-design, manufacturing will depend on a risk-based approach linking
attributes and processes to product performance, safety, and efficacy.
    The principles underlying this new approach to a quality-by-design,
risk-based assessment can be found in the International Conference on
Harmonisation guidances, ``Q8(R1) Pharmaceutical Development,'' June
2009 (http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf), and
``Q9 Quality Risk

[[Page 47807]]

Management (ICH),'' June 2006 (http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm073511.pdf), and
FDA's guidances for industry entitled ``PAT--A Framework for Innovative
Pharmaceutical Development, Manufacturing, and Quality Assurance,''
September 2004 (http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm070305.pdf), and
``Quality Systems Approach to Pharmaceutical CGMP Regulations,''
September 2006 (http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf).
Quality-by-design and risk-based approaches are also described in ``Q10
Pharmaceutical Quality Systems,'' April 2009 (http://www.fda.gov/
downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
ucm073517.pdf).
    The agency's Office of New Drug Quality Assessment in OPS, CDER,
initiated a pilot program (70 FR 40719, July 14, 2005) to gain
experience in assessing CMC sections of new drug applications (NDAs)
that demonstrate an applicant's product knowledge and process
understanding at the time of submission. This pilot was extremely
useful in helping identify appropriate information to be shared
regarding quality-by-design for small molecules. Although many of the
principles of quality-by-design apply equally to small molecules and
more complex pharmaceuticals, the ability to assess relevant attributes
is a much greater challenge for complex pharmaceuticals.
    Because the pilot program initiated in 2005 proved constructive, on
July 2, 2008, FDA announced this pilot program to provide additional
information to FDA for use in facilitating quality-by-design, risk-
based approaches for complex molecules. Based on experience gained
during the pilot program and prior knowledge, FDA will develop
procedures to facilitate implementing a quality-by-design, risk-based
approach for complex products. In addition, the experience gained by
FDA under this pilot is expected to facilitate the development of
guidance for industry. The pilot is open to original submissions and
postapproval supplements to biologics license applications (BLAs) and
NDAs reviewed by the Office of Biotechnology Products (OBP).
    The July 2, 2008, notice provided deadlines related to the
submission of certain information related to the pilot program. To
ensure inclusive and relevant results from the pilot program, this
document extends the deadline for requests to participate in this pilot
program for products regulated by OBP from September 30, 2009, to
September 30, 2010. Because the deadline for requests to participate in
the pilot is being extended, FDA is also extending the application
submission deadlines. As explained in the July 2, 2008, notice, it is
preferable for original applications to enter the pilot as INDs. FDA is
extending the deadline for submission of INDs from March 31, 2010, to
March 31, 2011. FDA is also extending the deadline for submission of
postapproval supplements from March 31, 2010, to March 31, 2011. In
addition, the pilot is being expanded from five to eight original
applications for products reviewed by OBP (BLA or NDA) in Common
Technical Document format, paper or electronic. See the July 2, 2008,
notice for instructions on submitting requests to participate in the
pilot program and additional information regarding the pilot program.

    Dated: September 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22378 Filed 9-16-09; 8:45 am]

BILLING CODE 4160-01-S
