[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31943-31944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12539]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0558]
Draft Guidance for Industry on Contract Manufacturing
Arrangements for Drugs: Quality Agreements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Contract
Manufacturing Arrangements for Drugs: Quality Agreements.'' This
guidance describes our current thinking on defining, establishing, and
documenting the responsibilities of each party (or all parties)
involved in the contract manufacturing of drugs subject to Current Good
Manufacturing Practice (CGMP). In particular, we describe how parties
involved in the contract manufacturing of drugs can utilize Quality
Agreements to delineate their responsibilities and assure drug quality,
safety, and efficacy.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 29, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or
Communications Staff (HFV-12), Center for Veterinary Medicine (CVM),
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paula Katz, Center for Drug Evaluation
and Research, Bldg. 51, Rm. 4314, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993, 301-796-6972; or Stephen
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and
Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD
20852-1448, 301-827-6210; or Jonathan Bray, Center for Veterinary
Medicine (HFV-232),
[[Page 31944]]
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855,
240-276-9228.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Contract Manufacturing Arrangements for Drugs: Quality
Agreements.'' This draft guidance describes the FDA's current thinking
on defining, establishing, and documenting the responsibilities of each
party (or all parties) involved in the contract manufacturing of drugs
subject to CGMP. Although written Quality Agreements are not explicitly
required under existing CGMP regulations for human drugs and do not
relieve any party to a contract of their responsibilities under CGMPs
or under the Federal Food, Drug, and Cosmetic Act, this draft guidance
explains how Owners and Contracted Facilities can draw on quality
management principles to carry out the complicated process of contract
drug manufacturing by defining, establishing, and documenting the
responsibilities of all parties involved in drug manufacturing,
testing, or other support operations. In particular, this guidance
describes FDA's recommendation that Owners and Contracted Facilities
implement written Quality Agreements as a tool to delineate
responsibilities and assure the quality, safety, and effectiveness of
drug products.
We are considering including examples or references to examples of
Quality Agreements in the guidance. Stakeholders are encouraged to
provide specific comments on publicly available and useful Quality
Agreements for contract arrangements for the manufacturing of drugs.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
III. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and
have been approved under OMB control numbers 0910-0014 and 0910-0001.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov.
Dated: May 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12539 Filed 5-24-13; 8:45 am]
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