[Federal Register Volume 74, Number 179 (Thursday, September 17, 2009)]
[Notices]
[Pages 47806-47807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22378]


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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: 
[email protected].

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