81 FR 84597 - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 226 (November 23, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.

[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84597-84598]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28122]



[[Page 84597]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0558]


Contract Manufacturing Arrangements for Drugs: Quality 
Agreements; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Contract 
Manufacturing Arrangements for Drugs: Quality Agreements.'' This 
guidance describes FDA's current thinking on defining, establishing, 
and documenting manufacturing activities of the parties involved in 
contract drug manufacturing subject to current good manufacturing 
practice (CGMP) requirements. In particular, we describe how parties 
involved in contract drug manufacturing can use quality agreements to 
delineate their manufacturing activities to ensure compliance with 
CGMP.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov/.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0558 for ``Contract Manufacturing Arrangements for Drugs: 
Quality Agreements.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov/ or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Bldg., 4th Floor, Silver Spring, MD 20993-0002; the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Policy and Regulations Staff, HFV-6, Center for Veterinary 
Medicine, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Paula Katz, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4330, Silver Spring, MD 20993-0002, 301-796-6972; Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, Center for 
Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 
Standish Pl., Rm. 130, Rockville, MD 20855, 240-402-5623.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Contract Manufacturing Arrangements for Drugs: Quality 
Agreements.'' This guidance describes FDA's current thinking on 
defining, establishing, and documenting manufacturing activities of the 
parties involved in contract drug manufacturing subject to CGMP 
requirements. Owners and contract facilities can draw on quality 
management principles to carry out the complicated process of contract 
drug manufacturing by defining, establishing, and documenting their 
activities for ensuring compliance with CGMP and to ensure the quality, 
safety, and effectiveness of drugs.

[[Page 84598]]

    This guidance replaces the draft guidance of the same name that 
published in the Federal Register of May 28, 2013 (78 FR 31943). We 
have carefully reviewed and considered the comments that were received 
on the draft guidance and have made changes for clarification. In 
particular, our revisions clarified the scope and applicability of the 
guidance and key terms used in the guidance.
    Regarding scope and applicability, we have clarified that the 
guidance is limited to commercial manufacturing activities. Although 
the principles articulated may be useful in approaching quality 
agreements for other kinds of activities, such as clinical research, 
development, or distribution, these are outside the scope of this 
particular document.
    Many comments concerned the terms ``owner'' and ``contract 
facility.'' Although some comments recommended that this guidance adopt 
the terms ``contract giver'' and ``contract acceptor,'' these terms do 
not align with our goal of showing how the parties to a contract 
manufacturing arrangement can work together to define, establish, and 
document agreements that delineate manufacturing activities and ensure 
compliance with CGMP.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Contract Manufacturing Arrangements for 
Drugs: Quality Agreements. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This 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 number 0910-0139.

III. 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 https://www.regulations.gov/.

    Dated: November 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28122 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P