[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41545-41546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15099]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1594]


Quality Metrics Technical Conformance Guide--Technical 
Specifications Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a Technical Specifications Document entitled 
``Quality Metrics Technical Conformance Guide, Version 1.0.'' This 
Guide provides technical recommendations for the submission of quality 
metric data. It serves as the technical reference for implementation of 
the draft FDA guidance for industry, when finalized, on ``Request for 
Quality Metrics,'' dated July 28, 2015.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2016-D-1594 for ``Quality Metrics Technical Conformance Guide--
Technical Specifications Document.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://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 http://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 http://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 the draft guide to the 
Division of Drug Information, Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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. All comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 
[email protected], 301-796-3257; or 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a Technical Specifications 
Document for industry entitled ``Quality Metrics Technical Conformance 
Guide, Version 1.0.'' This Guide supplements the draft FDA guidance for 
industry on ``Request for Quality Metrics,'' available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm455957.pdf, and provides recommendations about submission 
of records and other information that will support FDA's calculation of 
quality metrics as part of the process validation lifecycle and 
pharmaceutical quality system (PQS) assessment. Since publication of 
``Pharmaceutical Current Good Manufacturing Practices (CGMPs)

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for the 21st Century--A Risk Based Approach'' in 2004,\1\ CDER has 
continued to promote its vision of a maximally efficient, agile, 
flexible manufacturing sector that reliably produces high-quality drug 
products without extensive regulatory oversight. The draft guidance for 
industry on ``Request for Quality Metrics'' and this technical 
reference document continues the outreach policy of FDA so as to ensure 
successful implementation of CDER's objectives outlined in the 21st 
Century publication. The objectives of CDER's metric program can best 
be achieved through collaboration and mutual recognition of standards 
for metric indicators and data exchange/reporting.
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    \1\ http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/ucm137175.htm (Fall 2004) (last visited: March 17, 2016).
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    The purpose of this Guide is to provide technical recommendations 
for the submission of quality metric data. It is intended to ensure 
clear expectations for industry on the submission of quality metric 
data as described in the ``Request for Quality Metrics'' draft 
guidance. We note that the comment period for that draft guidance 
closed in November 2015 and that the comments that were received are 
undergoing evaluation. This Guide is intended to be a companion 
document to the July 28, 2015, draft guidance. There may be 
modifications to the draft guidance and this guide based on our 
evaluation of the submitted comments. Our goal is to institute 
efficient regulatory review, compliance oversight, and inspection 
policies established on risk-based methods, including quality metric 
reporting. This Guide is intended to facilitate collaboration between 
industry and FDA regarding the best methodologies to address all issues 
of implementation. Due to the inherent variability among reporting 
establishments' implementation of the process validation lifecycle and 
PQS assessment, it is difficult to identify and compare quality issues 
between firms. As such, FDA recognizes the importance of industry input 
and agreement regarding standardized indicators of manufacturing and 
product quality.
    This guide is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The current version of the guide 
will represent the current thinking of FDA on this topic. 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. Paperwork Reduction Act of 1995

    This guide refers to previously approved collections of information 
that are subject to review by the Office of Management and Budget under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Relevant to 
this collection of information, FDA published a document entitled 
``Request for Quality Metrics; Notice of Draft Guidance and Public 
Meeting; Request for Comments'' in the Federal Register of July 28, 
2015 (80 FR 44973). In Section IV, ``Paperwork Reduction Act of 1995,'' 
FDA estimated the burden that would cover the use of technical 
standards discussed in this draft guide.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guide at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15099 Filed 6-24-16; 8:45 am]
 BILLING CODE 4164-01-P