[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Draft Guidance for Industry on Contract Manufacturing 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availability of a draft guidance for industry entitled ``Contract 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 29, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
BILLING CODE 4160-01-P