Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments, 44973-44977 [2015-18448]
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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
Based on data shared by another
Federal Agency, FDA estimates that 135
establishments will initially submit one
report, and then will submit
confirmation or update reports on a
semiannual basis.
FDA estimates that the confirmation
or updating of registration information
as required by section 905 will take 12
minutes annually per confirmation or
update per establishment.
FDA estimates that the submission of
product listings required by section 905
for each establishment will take 2 hours
initially. FDA also estimates that the
confirmation or updating of product
listing information required by section
905 will take 48 minutes annually for
two confirmations or updates per
establishment.
FDA estimates that obtaining an
optional Dun and Bradstreet D–U–N–S
number will take 0.5 hours, and that 8
respondents (1 percent × 135 = 1.35 of
establishments required to register
under section 905, and 5 percent × 135
= 6.75 of submitters required to list
ingredients under section 904) will not
already have a Dun and Bradstreet D–U–
N–S number.
FDA estimates that the submission of
ingredient listing information as
required by section 904 of the act will
take 3 hours per tobacco product.
Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18410 Filed 7–27–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2537]
Request for Quality Metrics; Notice of
Draft Guidance Availability and Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of meeting; notice of
draft guidance availability, request for
comments.
ACTION:
The Food and Drug
Administration (FDA), Center for Drug
Evaluation and Research (CDER) and
Center for Biologics Evaluation and
Research (CBER), is announcing the
availability of a draft guidance for
industry entitled ‘‘Request for Quality
Metrics’’ and a public meeting regarding
the Agency’s plans associated with a
quality metrics reporting program. The
draft guidance and public meeting are
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SUMMARY:
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intended to gain stakeholders’
perspectives on various aspects of the
development and planned
implementation of a quality metrics
program launched under the authority
of the Food, Drug, and Cosmetic Act
(the FD&C Act). The guidance includes
an explanation of how FDA intends to
use quality metrics data to further
develop the FDA’s risk-based inspection
scheduling, to identify situations in
which there may be a risk for drug
supply disruption, to improve the
efficiency and effectiveness of
establishment inspections, and to
improve FDA’s evaluation of drug
manufacturing and control operations.
FDA expects that the initial use of the
metrics will be to consider a decreased
surveillance inspection frequency for
certain establishments. For example,
establishments that have highly
controlled manufacturing processes
have the potential to be inspected less
often (as a lower priority for inspection)
than similar establishments that
demonstrate uncontrolled processes (as
a higher priority for inspection). In
addition, FDA intends to consider
whether these metrics may provide a
basis for FDA to use improved riskbased principles to determine the
appropriate reporting category for
postapproval manufacturing changes.
FDA intends to consider the input from
this public meeting as we finalize this
guidance and the planned
implementation of this program,
including FDA’s initial set of requests
for quality metrics data.
DATES: The meeting will be held on
August 24, 2015, from 8:30 a.m. to 5
p.m. The meeting may be extended or
end early depending on the level of
public participation. Register to attend
or present at the meeting by August 7,
2015, (see section V.C. for information
on how to register or make a
presentation at the meeting). If you
cannot attend in person, information
about how you can access a live Web
cast will be located at https://
www.fda.gov/Drugs/NewsEvents/
ucm451529.htm.
Submit either electronic or written
comments concerning the draft
guidance and collection of information
proposed in the draft guidance by
September 28, 2015.
ADDRESSES: The meeting will be held at
FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (Rm. 1503
Section B/C), Silver Spring, MD 20993–
0002. Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
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performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or 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. 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.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 240–402–7800.
Submit electronic comments on the
draft guidance to https://
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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, email: Althea.Cuff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
More than a decade ago, FDA
launched an initiative to encourage the
implementation of a modern, risk-based
pharmaceutical quality assessment
system. As part of this initiative, and in
recognition of the increasing complexity
of pharmaceutical manufacturing, FDA
developed a 21st century vision for
manufacturing and quality with input
from academia and industry. The
desired state was described as follows:
‘‘A maximally efficient, agile, flexible
pharmaceutical manufacturing sector
that reliably produces high-quality drug
products without extensive regulatory
oversight.’’ 1
There has been significant progress
toward this vision in the intervening
1 See ‘‘FDA Pharmaceutical Quality Oversight:
One Quality Voice’’ at https://www.fda.gov/
downloads/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
UCM442666.pdf.
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years, as evidenced by programs and
guidance from FDA around major
initiatives such as pharmaceutical
development and quality by design
(QbD), quality risk management and
pharmaceutical quality systems, process
validation, and process analytical
technology (PAT), among others. These
programs and guidances are intended to
promote effective use of the most
current pharmaceutical science and
engineering principles and knowledge
throughout the lifecycle of a product.
Despite these achievements, however,
we have not fully realized our 21st
century vision for manufacturing and
quality—there continue to be indicators
of serious product quality defects. The
Agency has found that the majority of
drug shortages stem from quality
concerns—substandard manufacturing
facilities or processes are discovered, or
significant quality defects are identified
in finished product, necessitating
remediation efforts to fix the issue,
which in turn, may interrupt
production, and cause a shortage of
drugs.2 Taking action to reduce drug
shortages remains a top priority for
FDA.
The continued existence of product
quality issues may point to increased
complexities in the supply chain, a lack
of innovation in manufacturing, a
failure to adopt modern manufacturing
technologies and robust quality
management systems, or other factors.
Title VII of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) amended the FD&C Act to
provide FDA with a number of new
authorities to drive safety and quality
throughout the drug supply chain.
Section 706 of FDASIA amended
section 704(a) of the FD&C Act (21
U.S.C. 374(a)) by adding section
704(a)(4), under which FDA may require
the submission of any records or other
information that FDA may inspect
under section 704 of the FD&C Act, in
advance or in lieu of an inspection, by
requesting the records or information
from a person that owns or operates an
establishment that is engaged in the
manufacture, preparation, propagation,
compounding, or processing of a drug.
As described in the draft guidance,
under this authority, FDA intends to
make an initial set of requests for
quality metrics data to owners and
2 In 2012, for example, based on information
collected from manufacturers, FDA determined that
66 percent of disruptions in drug manufacturing
were the result of either (1) efforts to address
product-specific quality failures or (2) broader
efforts to remediate or improve an unsafe
manufacturing facility. ‘‘FDA’s Strategic Plan for
Preventing and Mitigating Drug Shortages’’, see
figure 2, at https://www.fda.gov/downloads/drugs/
drugsafety/drugshortages/ucm372566.pdf.
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operators of certain human drug
establishments. FDA intends to make its
requests at the time the guidance is
finalized and to provide notice of its
requests in the Federal Register. FDA
would use the data it receives to
calculate quality metrics and to inform
decisions about how to develop its
program. FDA may add to, revise, or
remove quality metrics data and
establishments in such future requests
to reflect the Agency’s understanding of
current manufacturing and
establishment considerations and the
utility of the data received to date.
FDA used the following criteria for
the selection of the quality metrics
described in the guidance: Objective,
subject to inspection under section 704
of the FD&C Act, and valuable in
assessing the overall state of quality of
the product and process, commitment to
quality by the manufacturer, and the
health (i.e., effective functioning) of the
associated Pharmaceutical Quality
System(s), while avoiding any undue
reporting burden.
CGMP regulations for human drugs
expect an ongoing program to maintain
and evaluate product and process data
that relate to product quality (21 CFR
211.180(e)). Manufacturers are expected
to use a quality program in order to
support process validation, and the
metrics described in this guidance could
be a part of such a program. As
discussed in the guidance, FDA
encourages manufacturers to routinely
use additional quality metrics beyond
the metrics described in this guidance
in performing these evaluations.
FDA intends to use quality metrics
data to further develop the FDA’s riskbased inspection scheduling, to identify
situations in which there may be a risk
for drug supply disruption, to improve
the efficiency and effectiveness of
establishment inspections, and to
improve FDA’s evaluation of drug
manufacturing and control operations.
FDA expects that the initial use of the
metrics will be to consider a decreased
surveillance inspection frequency for
certain establishments. For example,
establishments that have highly
controlled manufacturing processes
have the potential to be inspected less
often (as a lower priority for inspection)
than similar establishments that
demonstrate uncontrolled processes (as
a higher priority for inspection). In
addition, FDA intends to consider
whether these metrics may provide a
basis for FDA to use improved riskbased principles to determine the
appropriate reporting category for
postapproval manufacturing changes.
In the context of developing this
program, to identify some types of
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mutually useful and objective quality
metrics, FDA has consulted with
stakeholders through various trade and
professional association meetings, and a
Federal Register document we
published on February 12, 2013 (78 FR
9928) soliciting initial input on the use
of manufacturing quality metrics as it
relates to drug shortages. These efforts
have generated several categories of
quality-related information that CDER
and CBER have considered in
developing the quality metrics
discussed in the guidance.
As described in the guidance, FDA
intends to collect and use quantitative
quality metrics data to calculate four
quality metrics. Notably, FDA has
considered requesting data on the
‘‘Right First Time’’ metric, which is a
measure of the rework/reprocessing rate
or the number of lots released without
any processing deviations. We believe
that a Right First Time metric can be a
useful metric for establishments to
measure as part of their own quality
metrics program and a leading indicator
for product quality. However, as part of
our stakeholder consultation, we have
also received mixed industry feedback
on how to define this metric, whether
this metric may be less relevant for
finished dosage forms than for active
pharmaceutical ingredient (API)
manufacturing (where rework is more
common), and whether this metric is
suitably robust for use in our program.
We are requesting further input on this
topic (see section V.B.).
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 current thinking of FDA
on request for quality metrics. 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. Specific Request for Comments and
Information
In addition to comments on the
guidance generally, FDA is requesting
comments and related supporting
information on the following topics, as
described in the draft guidance: (1)
Optional metrics related to quality
culture and process capability/
performance, (2) frequency of quality
metrics data reporting, (3) an alternative
approach to reduce the reporting burden
based on the data collection timeframe,
and (4) an alternative approach that
would allow inclusion of a limited text
field for data points or metrics. FDA has
described these potential alternative
approaches in the draft guidance and is
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seeking public comment on these and
any other alternative approaches.
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III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
IV. Paperwork Reduction Act of 1995
The draft guidance contains
information collection provisions that
are subject to review by OMB under the
Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501–3520). The title,
description, and respondent description
of the information collection are given
under this section with an estimate of
the annual reporting burden. Included
in the estimate is the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing the collection of information.
We invite comments on these topics:
(1) Whether the proposed collection of
information is necessary for the proper
performance of FDA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
FDA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Request for Quality Metrics;
Guidance for Industry.
Description: FDA intends to use
quality metrics data to further develop
the FDA’s risk-based inspection
scheduling, to identify situations in
which there may be a risk for drug
supply disruption, to improve the
efficiency and effectiveness of
establishment inspections, and to
improve FDA’s evaluation of drug
manufacturing and control operations.
FDA expects that the initial use of the
metrics will be to consider a decreased
surveillance inspection frequency for
certain establishments. For example,
establishments that have highly
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controlled manufacturing processes
have the potential to be inspected less
often (as a lower priority for inspection)
than similar establishments that
demonstrate uncontrolled processes (as
a higher priority for inspection). In
addition, FDA intends to consider
whether these metrics may provide a
basis for FDA to use improved riskbased principles to determine the
appropriate reporting category for
postapproval manufacturing changes.
Section 704(a)(4)(A) of the FD&C Act,
added by section 706 of FDASIA,
authorizes FDA to request from a person
that owns or operates an establishment
that is engaged in the manufacture,
preparation, propagation, compounding,
or processing of a drug in advance or in
lieu of an inspection any records or
other information that we may inspect
under section 704 of the FD&C Act,
provided that we request submission of
the information within a reasonable
time frame, within reasonable limits,
and in a reasonable manner. The draft
guidance is intended to describe a set of
requests for data under section 704(a)(4)
of the FD&C Act that FDA intends to
give notice of in the Federal Register at
the time the guidance is finalized. In
general, the information needed to
respond to FDA’s proposed requests is
developed and maintained in the course
of manufacturing drugs under existing
current good manufacturing practice
(CGMP) for finished pharmaceuticals in
part 211 (21 CFR part 211), and for APIs
under section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)), and could
be reviewed during an FDA inspection
of a drug establishment. FDA has OMB
approval for the information collection
currently required under part 211 (OMB
control number 0910–0139) and, in
table 2, we have calculated the burden
for preparing and maintaining the
information collection for APIs as
currently required under section
501(a)(2)(B) of the FD&C Act but not
currently included under OMB control
number 0910–0139.
FDA intends to request quality
metrics data from owners and operators
of certain establishments registered
under section 510 of the FD&C Act (21
U.S.C. 360), as described in the draft
guidance. FDA intends to request that
such establishments compile reports
containing the following quality metrics
data, segregated by quarter, by product,
and establishment:
• The number of lots attempted of the
product.
• The number of specification-related
rejected lots of the product, rejected
during or after manufacturing.
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• The number of attempted lots
pending disposition for more than 30
days.
• The number of out-of-specification
(OOS) results for the product, including
stability testing.
• The number of lot release and
stability tests conducted for the product.
• The number of OOS results for lot
release and stability tests for the product
which are invalidated due to lab error.
• The number of product quality
complaints received for the product.
• The number of lots attempted
which are released for distribution or for
the next stage of manufacturing the
product.
• If the associated annual product
reviews (APRs) or product quality
reviews (PQRs) were completed within
30 days of annual due date for the
product.
• The number of APRs or PQRs
required for the product.
In addition to the baseline metrics
described previously, FDA is requesting
public comment on whether to include
the option of submitting additional,
optional metrics as evidence of
manufacturing robustness and a
commitment to quality:
• Senior Management Engagement—
Was each APR or PQR reviewed and
approved by the following: (1) The head
of the quality unit, (2) the head of the
operations unit, (3) both, or (4) neither?
• Corrective Action and Preventive
Action (CAPA) Effectiveness—What
percentage of your corrective actions
involved re-training of personnel (i.e., a
root cause of the deviation is lack of
adequate training)?
• Process Capability/Performance—A
‘‘yes’’ or ‘‘no’’ value of whether the
establishment’s management calculated
a process capability or performance
index for each critical quality attribute
as part of that product’s APR or PQR.
• Process Capability/Performance—A
‘‘yes’’ or ‘‘no’’ value of whether the
establishment’s management has a
policy of requiring a CAPA at some
lower process capability or performance
index.
• Process Capability/Performance—If
‘‘yes’’ to the previous question—What is
the process capability or performance
index that triggers a CAPA? If ‘‘no’’ to
the previous question—please do not
respond.
We estimate the submission of
approximately 63,000 product reports to
FDA containing the 15 quality metrics
data outlined in this document and
described in the draft guidance (‘‘Total
Annual Reponses’’ in table 1). We
estimate that approximately 6,300
establishments will compile and submit
these reports, including covered
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establishments, reporting
establishments, and unregistered foreign
establishments, as described in the draft
guidance (‘‘Number of Respondents’’ in
table 1). We specifically request
comment on our estimate of 6,300
establishments and the types of
establishments that will participate in
compiling and reporting quality metrics
data.
Our estimate of 63,000 reports is
based on the following: Approximately
25,000 reports for drugs subject to
approved applications (that is, drugs
subject to either approved applications
under section 505 of the FD&C Act (21
U.S.C. 355) or under section 351 of the
PHS Act, or covered by a submission to
a drug master file that is intended to
support an application, and
approximately 38,000 reports for drugs
not subject to approved applications
(that is, drugs not subject to either
approved applications under section
505 of the FD&C Act or under section
351 of the PHS Act (e.g., drugs marketed
pursuant to an OTC monograph and
marketed unapproved drugs)).
Our estimate of 6,300 establishments
is based on data from FDA’s Document
Archiving, Reporting & Regulatory
Tracking System and the Electronic
Drug Registration and Listing System.
We estimate that reporting the quality
metrics data described previously for
each affected product will take
approximately 10.6 hours (‘‘Average
Burden per Response’’ in table 1). This
is a weighted average of the estimate for
‘‘drugs subject to approved
applications’’ (finished product and
API) (15.75 hours) and ‘‘drugs not
subject to approved applications’’
(finished product and API) (7 hours).
The time estimate for application and
non-application products differs
because the groupings are different (e.g.,
different strengths are grouped in an
application and are not grouped for
national drug code). These burden hour
estimates are based on information
provided by CGMP regulatory
compliance experts at FDA and in
industry. Therefore, we estimate
approximately 667,800 total burden
hours for compiling and reporting
quality metrics data under the draft
guidance (‘‘Total Hours’’ in table 1). We
believe that the estimated burden for the
initial set of requests represents a
conservative estimate of the annual
burden of responding to any future
information requests under the quality
metrics program.
The burden hour estimate includes
the time for compiling information that
we understand is currently developed
and maintained in the course of
manufacturing drugs in compliance
with part 211 and section 501(a)(2)(B) of
the FD&C Act, and the time for
populating spreadsheet(s) for reporting
to FDA. The estimate does not include
burden hours currently approved under
OMB control number 0910–0139 for
information collection under part 211.
In table 2, we have calculated the
burden for information collection for
APIs as currently required under section
501(a)(2)(B) of the FD&C Act but not
currently included under OMB control
number 0910–0139.
The draft guidance requests that all
reports be submitted through the FDA
Electronic Submission Gateway (ESG).
We are not estimating any additional
burden associated with accessing the
ESG because reporting establishments,
which are subject to FDA’s
establishment registration and drug
listing regulations (21 CFR part 207), are
required to use the ESG to submit
information, and the burdens associated
with these submissions are approved
under OMB control number 0910–0045.
To date, we have not identified any
reporting establishments that are not
already reporting to the ESG.
In table 1, we estimate the reporting
burden for the information collection in
the draft guidance.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Draft guidance for industry on request for quality metrics
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Collecting and Reporting to FDA Quality Metric Inputs ......
6,300
10
63,000
10.6 hours
667,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In table 2, we estimate the
recordkeeping burden for preparing and
maintaining CGMP records for APIs that
are not currently included under OMB
control number 0910–0139.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Section 501(a)(2)(B) of the FD&C Act
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Preparing and Maintaining CGMP Records for APIs (not
currently included under OMB control number 0910–
0139) ................................................................................
1,260
256
322,560
.82 hours
264,499
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Title: Request for Quality Metrics;
Public Meeting.
The information collection associated
with the public meeting is exempt from
OMB regulations on the PRA as follows:
5 CFR 1320.3(h)(8) (exemption from the
definition of ‘‘information’’): Facts or
opinions obtained or solicited at or in
connection with public hearings or
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meetings. 5 CFR 1320.3(h)(4)
(exemption from the definition of
‘‘information’’): Facts or opinions
submitted in response to general
solicitations of comments from the
public, published in the Federal
Register or other publications,
regardless of the form or format thereof,
provided that no person is required to
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supply specific information pertaining
to the commenter, other than that
necessary for self-identification, as a
condition of the agency’s full
consideration of the comment.
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V. Attendance and/or Participation at
the Public Meeting
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A. Purpose and Scope of the Meeting
The purpose of this meeting and
public docket is for CDER and CBER to
hear from stakeholders any questions,
concerns, and suggestions regarding the
proposed plans for the scope and
implementation of the quality metrics
reporting program proposed in this
guidance.
B. Questions to Stakeholders
FDA seeks input from stakeholders
and other members of the public on the
following meeting questions:
1. Are there other objective metrics
that FDA should request in advance of
or in lieu of an inspection that FDA
should collect to improve our
understanding of products and
establishments for purposes of more
informed, risk-based inspection
scheduling and identification of
potential product shortages?
2. Are the definitions of the metrics
and associated data requests selected
adequate and clear?
3. Are the metrics requested from
each business segment/type clear and
appropriate?
4. Should the Agency explore
collecting metrics from high-risk
excipient producers, and if so, which
excipients should be considered highrisk and what metrics should apply?
5. Should the Agency explore
collecting metrics from the medical gas
manufacturing industry?
6. Should the Agency add the ‘‘Right
First Time’’ metric (see section I.), and
if so, should the definition be a rework/
reprocessing rate or a measure of lots
manufactured without processing
deviations?
7. What data standards/mechanisms
would be useful to aid reporting and
how should the submissions be
structured?
8. Are there reporting hurdles to
collecting metrics by reporting
establishment/product (segmented by
site) versus by site (segmented by
product), and how can they be
overcome?
9. FDA may consider whether to
require the submission of quality
metrics on a recurring basis. How
frequently should metrics be reported
and/or segmented within the reporting
period (e.g., annually, semiannually, or
quarterly)?
C. Meeting Participation and Request To
Present
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
VerDate Sep<11>2014
19:17 Jul 27, 2015
Jkt 235001
seating. Attendance will be free and on
a first-come, first-served basis. If you
wish to attend (either in person or by
Web cast (see Streaming Web Cast of the
Public Meeting)) and/or present at the
meeting, please register for the meeting
and/or make a request for oral
presentations or comments by visiting
https://qualitymetrics-publicmeeting.eventbrite.com on or before
August 7, 2015. The registration request
should contain complete contact
information for each attendee (i.e.,
name, title, affiliation, address, email
address, telephone number, and priority
number(s)). Those without email access
can register by contacting Althea Cuff by
August 7, 2015 (see FOR FURTHER
INFORMATION CONTACT).
FDA will try to accommodate all
persons who wish to make a
presentation. Individuals wishing to
present should identify the number of
the topic, or topics, they wish to address
(see section V.B.). This will help FDA
organize the presentations. FDA will
notify registered presenters of their
scheduled presentation times. The time
allotted for each presentation will
depend on the number of individuals
who wish to speak. Once FDA notifies
registered presenters of their scheduled
times, they are encouraged to submit an
electronic copy of their presentation to
Althea Cuff at Althea.Cuff@fda.hhs.gov
on or before August 7, 2015. If time
permits, individuals or organizations
that did not register in advance may be
granted the opportunity to make a
presentation.
Persons registered to make an oral
presentation are encouraged to arrive at
the meeting room early and check in at
the onsite registration table to confirm
their designated presentation time. An
agenda for the meeting and other
background materials will be made
available 3 days before the meeting at
https://www.fda.gov/Drugs/NewsEvents/
ucm451529.htm. If you need special
accommodations because of a disability,
please contact Althea Cuff (see FOR
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
Meeting Registration and Request to
Present: The meeting is free and seating
will be on a first-come, first-served
basis. If you wish to attend or make an
oral presentation, see section V.C. for
information on how to register and the
deadline for registration. If you cannot
attend in person, information about how
you can access a live Web cast will be
located at https://www.fda.gov/Drugs/
NewsEvents/ucm451529.htm.
Transcripts: As soon as a transcript is
available, it will be accessible at
https://www.regulations.gov. It may also
be viewed at the Division of Dockets
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
44977
Management (see ADDRESSES). A
transcript will also be available in either
hard copy or on CD–ROM, after
submission of a Freedom of Information
request. Send written requests to the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Streaming Web Cast of the Public
Meeting: For those unable to attend in
person, FDA will provide a live Web
cast of the meeting. To join the meeting
via the Web cast, please go to https://
collaboration.fda.gov/qmpm2015/. An
agenda will be posted on the FDA Web
site at https://www.fda.gov/Drugs/News
Events/ucm451529.htm prior to the
meeting.
Docket Comments: Regardless of
attendance at the public meeting,
interested persons may submit either
electronic or written comments
regarding this document to the public
docket (see ADDRESSES) by (see DATES).
Given that time will be limited at the
public meeting, FDA encourages all
interested persons to comment in
writing to ensure that their comments
are considered.
VI. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.fda.
gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm or https://
www.regulations.gov.
Dated: July 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18448 Filed 7–27–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Chronic Fatigue
Syndrome Advisory Committee
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC) will hold a
meeting. The meeting will be open to
the public.
SUMMARY:
E:\FR\FM\28JYN1.SGM
28JYN1
Agencies
[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44973-44977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18448]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2537]
Request for Quality Metrics; Notice of Draft Guidance
Availability and Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting; notice of draft guidance availability,
request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER), is announcing the availability of a draft guidance for
industry entitled ``Request for Quality Metrics'' and a public meeting
regarding the Agency's plans associated with a quality metrics
reporting program. The draft guidance and public meeting are intended
to gain stakeholders' perspectives on various aspects of the
development and planned implementation of a quality metrics program
launched under the authority of the Food, Drug, and Cosmetic Act (the
FD&C Act). The guidance includes an explanation of how FDA intends to
use quality metrics data to further develop the FDA's risk-based
inspection scheduling, to identify situations in which there may be a
risk for drug supply disruption, to improve the efficiency and
effectiveness of establishment inspections, and to improve FDA's
evaluation of drug manufacturing and control operations. FDA expects
that the initial use of the metrics will be to consider a decreased
surveillance inspection frequency for certain establishments. For
example, establishments that have highly controlled manufacturing
processes have the potential to be inspected less often (as a lower
priority for inspection) than similar establishments that demonstrate
uncontrolled processes (as a higher priority for inspection). In
addition, FDA intends to consider whether these metrics may provide a
basis for FDA to use improved risk-based principles to determine the
appropriate reporting category for postapproval manufacturing changes.
FDA intends to consider the input from this public meeting as we
finalize this guidance and the planned implementation of this program,
including FDA's initial set of requests for quality metrics data.
DATES: The meeting will be held on August 24, 2015, from 8:30 a.m. to 5
p.m. The meeting may be extended or end early depending on the level of
public participation. Register to attend or present at the meeting by
August 7, 2015, (see section V.C. for information on how to register or
make a presentation at the meeting). If you cannot attend in person,
information about how you can access a live Web cast will be located at
https://www.fda.gov/Drugs/NewsEvents/ucm451529.htm.
Submit either electronic or written comments concerning the draft
guidance and collection of information proposed in the draft guidance
by September 28, 2015.
ADDRESSES: The meeting will be held at FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503
Section B/C), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or 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. 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. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-7800.
Submit electronic comments on the draft guidance to https://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. All comments should be identified with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-4061, email: Althea.Cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
More than a decade ago, FDA launched an initiative to encourage the
implementation of a modern, risk-based pharmaceutical quality
assessment system. As part of this initiative, and in recognition of
the increasing complexity of pharmaceutical manufacturing, FDA
developed a 21st century vision for manufacturing and quality with
input from academia and industry. The desired state was described as
follows: ``A maximally efficient, agile, flexible pharmaceutical
manufacturing sector that reliably produces high-quality drug products
without extensive regulatory oversight.'' \1\
---------------------------------------------------------------------------
\1\ See ``FDA Pharmaceutical Quality Oversight: One Quality
Voice'' at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf.
---------------------------------------------------------------------------
There has been significant progress toward this vision in the
intervening
[[Page 44974]]
years, as evidenced by programs and guidance from FDA around major
initiatives such as pharmaceutical development and quality by design
(QbD), quality risk management and pharmaceutical quality systems,
process validation, and process analytical technology (PAT), among
others. These programs and guidances are intended to promote effective
use of the most current pharmaceutical science and engineering
principles and knowledge throughout the lifecycle of a product.
Despite these achievements, however, we have not fully realized our
21st century vision for manufacturing and quality--there continue to be
indicators of serious product quality defects. The Agency has found
that the majority of drug shortages stem from quality concerns--
substandard manufacturing facilities or processes are discovered, or
significant quality defects are identified in finished product,
necessitating remediation efforts to fix the issue, which in turn, may
interrupt production, and cause a shortage of drugs.\2\ Taking action
to reduce drug shortages remains a top priority for FDA.
---------------------------------------------------------------------------
\2\ In 2012, for example, based on information collected from
manufacturers, FDA determined that 66 percent of disruptions in drug
manufacturing were the result of either (1) efforts to address
product-specific quality failures or (2) broader efforts to
remediate or improve an unsafe manufacturing facility. ``FDA's
Strategic Plan for Preventing and Mitigating Drug Shortages'', see
figure 2, at https://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm372566.pdf.
---------------------------------------------------------------------------
The continued existence of product quality issues may point to
increased complexities in the supply chain, a lack of innovation in
manufacturing, a failure to adopt modern manufacturing technologies and
robust quality management systems, or other factors. Title VII of the
Food and Drug Administration Safety and Innovation Act (FDASIA) amended
the FD&C Act to provide FDA with a number of new authorities to drive
safety and quality throughout the drug supply chain. Section 706 of
FDASIA amended section 704(a) of the FD&C Act (21 U.S.C. 374(a)) by
adding section 704(a)(4), under which FDA may require the submission of
any records or other information that FDA may inspect under section 704
of the FD&C Act, in advance or in lieu of an inspection, by requesting
the records or information from a person that owns or operates an
establishment that is engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug. As described in the
draft guidance, under this authority, FDA intends to make an initial
set of requests for quality metrics data to owners and operators of
certain human drug establishments. FDA intends to make its requests at
the time the guidance is finalized and to provide notice of its
requests in the Federal Register. FDA would use the data it receives to
calculate quality metrics and to inform decisions about how to develop
its program. FDA may add to, revise, or remove quality metrics data and
establishments in such future requests to reflect the Agency's
understanding of current manufacturing and establishment considerations
and the utility of the data received to date.
FDA used the following criteria for the selection of the quality
metrics described in the guidance: Objective, subject to inspection
under section 704 of the FD&C Act, and valuable in assessing the
overall state of quality of the product and process, commitment to
quality by the manufacturer, and the health (i.e., effective
functioning) of the associated Pharmaceutical Quality System(s), while
avoiding any undue reporting burden.
CGMP regulations for human drugs expect an ongoing program to
maintain and evaluate product and process data that relate to product
quality (21 CFR 211.180(e)). Manufacturers are expected to use a
quality program in order to support process validation, and the metrics
described in this guidance could be a part of such a program. As
discussed in the guidance, FDA encourages manufacturers to routinely
use additional quality metrics beyond the metrics described in this
guidance in performing these evaluations.
FDA intends to use quality metrics data to further develop the
FDA's risk-based inspection scheduling, to identify situations in which
there may be a risk for drug supply disruption, to improve the
efficiency and effectiveness of establishment inspections, and to
improve FDA's evaluation of drug manufacturing and control operations.
FDA expects that the initial use of the metrics will be to consider a
decreased surveillance inspection frequency for certain establishments.
For example, establishments that have highly controlled manufacturing
processes have the potential to be inspected less often (as a lower
priority for inspection) than similar establishments that demonstrate
uncontrolled processes (as a higher priority for inspection). In
addition, FDA intends to consider whether these metrics may provide a
basis for FDA to use improved risk-based principles to determine the
appropriate reporting category for postapproval manufacturing changes.
In the context of developing this program, to identify some types
of mutually useful and objective quality metrics, FDA has consulted
with stakeholders through various trade and professional association
meetings, and a Federal Register document we published on February 12,
2013 (78 FR 9928) soliciting initial input on the use of manufacturing
quality metrics as it relates to drug shortages. These efforts have
generated several categories of quality-related information that CDER
and CBER have considered in developing the quality metrics discussed in
the guidance.
As described in the guidance, FDA intends to collect and use
quantitative quality metrics data to calculate four quality metrics.
Notably, FDA has considered requesting data on the ``Right First Time''
metric, which is a measure of the rework/reprocessing rate or the
number of lots released without any processing deviations. We believe
that a Right First Time metric can be a useful metric for
establishments to measure as part of their own quality metrics program
and a leading indicator for product quality. However, as part of our
stakeholder consultation, we have also received mixed industry feedback
on how to define this metric, whether this metric may be less relevant
for finished dosage forms than for active pharmaceutical ingredient
(API) manufacturing (where rework is more common), and whether this
metric is suitably robust for use in our program. We are requesting
further input on this topic (see section V.B.).
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 current thinking of FDA on request for
quality metrics. 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. Specific Request for Comments and Information
In addition to comments on the guidance generally, FDA is
requesting comments and related supporting information on the following
topics, as described in the draft guidance: (1) Optional metrics
related to quality culture and process capability/performance, (2)
frequency of quality metrics data reporting, (3) an alternative
approach to reduce the reporting burden based on the data collection
timeframe, and (4) an alternative approach that would allow inclusion
of a limited text field for data points or metrics. FDA has described
these potential alternative approaches in the draft guidance and is
[[Page 44975]]
seeking public comment on these and any other alternative approaches.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://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 https://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
The draft guidance contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent
description of the information collection are given under this section
with an estimate of the annual reporting burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information.
We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Request for Quality Metrics; Guidance for Industry.
Description: FDA intends to use quality metrics data to further
develop the FDA's risk-based inspection scheduling, to identify
situations in which there may be a risk for drug supply disruption, to
improve the efficiency and effectiveness of establishment inspections,
and to improve FDA's evaluation of drug manufacturing and control
operations. FDA expects that the initial use of the metrics will be to
consider a decreased surveillance inspection frequency for certain
establishments. For example, establishments that have highly controlled
manufacturing processes have the potential to be inspected less often
(as a lower priority for inspection) than similar establishments that
demonstrate uncontrolled processes (as a higher priority for
inspection). In addition, FDA intends to consider whether these metrics
may provide a basis for FDA to use improved risk-based principles to
determine the appropriate reporting category for postapproval
manufacturing changes.
Section 704(a)(4)(A) of the FD&C Act, added by section 706 of
FDASIA, authorizes FDA to request from a person that owns or operates
an establishment that is engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug in advance or in lieu
of an inspection any records or other information that we may inspect
under section 704 of the FD&C Act, provided that we request submission
of the information within a reasonable time frame, within reasonable
limits, and in a reasonable manner. The draft guidance is intended to
describe a set of requests for data under section 704(a)(4) of the FD&C
Act that FDA intends to give notice of in the Federal Register at the
time the guidance is finalized. In general, the information needed to
respond to FDA's proposed requests is developed and maintained in the
course of manufacturing drugs under existing current good manufacturing
practice (CGMP) for finished pharmaceuticals in part 211 (21 CFR part
211), and for APIs under section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)), and could be reviewed during an FDA inspection of
a drug establishment. FDA has OMB approval for the information
collection currently required under part 211 (OMB control number 0910-
0139) and, in table 2, we have calculated the burden for preparing and
maintaining the information collection for APIs as currently required
under section 501(a)(2)(B) of the FD&C Act but not currently included
under OMB control number 0910-0139.
FDA intends to request quality metrics data from owners and
operators of certain establishments registered under section 510 of the
FD&C Act (21 U.S.C. 360), as described in the draft guidance. FDA
intends to request that such establishments compile reports containing
the following quality metrics data, segregated by quarter, by product,
and establishment:
The number of lots attempted of the product.
The number of specification-related rejected lots of the
product, rejected during or after manufacturing.
The number of attempted lots pending disposition for more
than 30 days.
The number of out-of-specification (OOS) results for the
product, including stability testing.
The number of lot release and stability tests conducted
for the product.
The number of OOS results for lot release and stability
tests for the product which are invalidated due to lab error.
The number of product quality complaints received for the
product.
The number of lots attempted which are released for
distribution or for the next stage of manufacturing the product.
If the associated annual product reviews (APRs) or product
quality reviews (PQRs) were completed within 30 days of annual due date
for the product.
The number of APRs or PQRs required for the product.
In addition to the baseline metrics described previously, FDA is
requesting public comment on whether to include the option of
submitting additional, optional metrics as evidence of manufacturing
robustness and a commitment to quality:
Senior Management Engagement--Was each APR or PQR reviewed
and approved by the following: (1) The head of the quality unit, (2)
the head of the operations unit, (3) both, or (4) neither?
Corrective Action and Preventive Action (CAPA)
Effectiveness--What percentage of your corrective actions involved re-
training of personnel (i.e., a root cause of the deviation is lack of
adequate training)?
Process Capability/Performance--A ``yes'' or ``no'' value
of whether the establishment's management calculated a process
capability or performance index for each critical quality attribute as
part of that product's APR or PQR.
Process Capability/Performance--A ``yes'' or ``no'' value
of whether the establishment's management has a policy of requiring a
CAPA at some lower process capability or performance index.
Process Capability/Performance--If ``yes'' to the previous
question--What is the process capability or performance index that
triggers a CAPA? If ``no'' to the previous question--please do not
respond.
We estimate the submission of approximately 63,000 product reports
to FDA containing the 15 quality metrics data outlined in this document
and described in the draft guidance (``Total Annual Reponses'' in table
1). We estimate that approximately 6,300 establishments will compile
and submit these reports, including covered
[[Page 44976]]
establishments, reporting establishments, and unregistered foreign
establishments, as described in the draft guidance (``Number of
Respondents'' in table 1). We specifically request comment on our
estimate of 6,300 establishments and the types of establishments that
will participate in compiling and reporting quality metrics data.
Our estimate of 63,000 reports is based on the following:
Approximately 25,000 reports for drugs subject to approved applications
(that is, drugs subject to either approved applications under section
505 of the FD&C Act (21 U.S.C. 355) or under section 351 of the PHS
Act, or covered by a submission to a drug master file that is intended
to support an application, and approximately 38,000 reports for drugs
not subject to approved applications (that is, drugs not subject to
either approved applications under section 505 of the FD&C Act or under
section 351 of the PHS Act (e.g., drugs marketed pursuant to an OTC
monograph and marketed unapproved drugs)).
Our estimate of 6,300 establishments is based on data from FDA's
Document Archiving, Reporting & Regulatory Tracking System and the
Electronic Drug Registration and Listing System. We estimate that
reporting the quality metrics data described previously for each
affected product will take approximately 10.6 hours (``Average Burden
per Response'' in table 1). This is a weighted average of the estimate
for ``drugs subject to approved applications'' (finished product and
API) (15.75 hours) and ``drugs not subject to approved applications''
(finished product and API) (7 hours). The time estimate for application
and non-application products differs because the groupings are
different (e.g., different strengths are grouped in an application and
are not grouped for national drug code). These burden hour estimates
are based on information provided by CGMP regulatory compliance experts
at FDA and in industry. Therefore, we estimate approximately 667,800
total burden hours for compiling and reporting quality metrics data
under the draft guidance (``Total Hours'' in table 1). We believe that
the estimated burden for the initial set of requests represents a
conservative estimate of the annual burden of responding to any future
information requests under the quality metrics program.
The burden hour estimate includes the time for compiling
information that we understand is currently developed and maintained in
the course of manufacturing drugs in compliance with part 211 and
section 501(a)(2)(B) of the FD&C Act, and the time for populating
spreadsheet(s) for reporting to FDA. The estimate does not include
burden hours currently approved under OMB control number 0910-0139 for
information collection under part 211. In table 2, we have calculated
the burden for information collection for APIs as currently required
under section 501(a)(2)(B) of the FD&C Act but not currently included
under OMB control number 0910-0139.
The draft guidance requests that all reports be submitted through
the FDA Electronic Submission Gateway (ESG). We are not estimating any
additional burden associated with accessing the ESG because reporting
establishments, which are subject to FDA's establishment registration
and drug listing regulations (21 CFR part 207), are required to use the
ESG to submit information, and the burdens associated with these
submissions are approved under OMB control number 0910-0045. To date,
we have not identified any reporting establishments that are not
already reporting to the ESG.
In table 1, we estimate the reporting burden for the information
collection in the draft guidance.
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Draft guidance for industry on request for quality metrics Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collecting and Reporting to FDA Quality Metric Inputs.............. 6,300 10 63,000 10.6 hours 667,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In table 2, we estimate the recordkeeping burden for preparing and
maintaining CGMP records for APIs that are not currently included under
OMB control number 0910-0139.
Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Section 501(a)(2)(B) of the FD&C Act Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing and Maintaining CGMP Records for APIs (not currently 1,260 256 322,560 .82 hours 264,499
included under OMB control number 0910-0139)......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Title: Request for Quality Metrics; Public Meeting.
The information collection associated with the public meeting is
exempt from OMB regulations on the PRA as follows: 5 CFR 1320.3(h)(8)
(exemption from the definition of ``information''): Facts or opinions
obtained or solicited at or in connection with public hearings or
meetings. 5 CFR 1320.3(h)(4) (exemption from the definition of
``information''): Facts or opinions submitted in response to general
solicitations of comments from the public, published in the Federal
Register or other publications, regardless of the form or format
thereof, provided that no person is required to supply specific
information pertaining to the commenter, other than that necessary for
self-identification, as a condition of the agency's full consideration
of the comment.
[[Page 44977]]
V. Attendance and/or Participation at the Public Meeting
A. Purpose and Scope of the Meeting
The purpose of this meeting and public docket is for CDER and CBER
to hear from stakeholders any questions, concerns, and suggestions
regarding the proposed plans for the scope and implementation of the
quality metrics reporting program proposed in this guidance.
B. Questions to Stakeholders
FDA seeks input from stakeholders and other members of the public
on the following meeting questions:
1. Are there other objective metrics that FDA should request in
advance of or in lieu of an inspection that FDA should collect to
improve our understanding of products and establishments for purposes
of more informed, risk-based inspection scheduling and identification
of potential product shortages?
2. Are the definitions of the metrics and associated data requests
selected adequate and clear?
3. Are the metrics requested from each business segment/type clear
and appropriate?
4. Should the Agency explore collecting metrics from high-risk
excipient producers, and if so, which excipients should be considered
high-risk and what metrics should apply?
5. Should the Agency explore collecting metrics from the medical
gas manufacturing industry?
6. Should the Agency add the ``Right First Time'' metric (see
section I.), and if so, should the definition be a rework/reprocessing
rate or a measure of lots manufactured without processing deviations?
7. What data standards/mechanisms would be useful to aid reporting
and how should the submissions be structured?
8. Are there reporting hurdles to collecting metrics by reporting
establishment/product (segmented by site) versus by site (segmented by
product), and how can they be overcome?
9. FDA may consider whether to require the submission of quality
metrics on a recurring basis. How frequently should metrics be reported
and/or segmented within the reporting period (e.g., annually,
semiannually, or quarterly)?
C. Meeting Participation and Request To Present
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance will
be free and on a first-come, first-served basis. If you wish to attend
(either in person or by Web cast (see Streaming Web Cast of the Public
Meeting)) and/or present at the meeting, please register for the
meeting and/or make a request for oral presentations or comments by
visiting https://qualitymetrics-public-meeting.eventbrite.com on or
before August 7, 2015. The registration request should contain complete
contact information for each attendee (i.e., name, title, affiliation,
address, email address, telephone number, and priority number(s)).
Those without email access can register by contacting Althea Cuff by
August 7, 2015 (see FOR FURTHER INFORMATION CONTACT).
FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the topic, or topics, they wish to address (see section V.B.). This
will help FDA organize the presentations. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Once FDA notifies registered presenters of their scheduled
times, they are encouraged to submit an electronic copy of their
presentation to Althea Cuff at Althea.Cuff@fda.hhs.gov on or before
August 7, 2015. If time permits, individuals or organizations that did
not register in advance may be granted the opportunity to make a
presentation.
Persons registered to make an oral presentation are encouraged to
arrive at the meeting room early and check in at the onsite
registration table to confirm their designated presentation time. An
agenda for the meeting and other background materials will be made
available 3 days before the meeting at https://www.fda.gov/Drugs/NewsEvents/ucm451529.htm. If you need special accommodations because of
a disability, please contact Althea Cuff (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the meeting.
Meeting Registration and Request to Present: The meeting is free
and seating will be on a first-come, first-served basis. If you wish to
attend or make an oral presentation, see section V.C. for information
on how to register and the deadline for registration. If you cannot
attend in person, information about how you can access a live Web cast
will be located at https://www.fda.gov/Drugs/NewsEvents/ucm451529.htm.
Transcripts: As soon as a transcript is available, it will be
accessible at https://www.regulations.gov. It may also be viewed at the
Division of Dockets Management (see ADDRESSES). A transcript will also
be available in either hard copy or on CD-ROM, after submission of a
Freedom of Information request. Send written requests to the Division
of Freedom of Information (ELEM-1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Streaming Web Cast of the Public Meeting: For those unable to
attend in person, FDA will provide a live Web cast of the meeting. To
join the meeting via the Web cast, please go to https://collaboration.fda.gov/qmpm2015/. An agenda will be posted on the FDA
Web site at https://www.fda.gov/Drugs/NewsEvents/ucm451529.htm prior to
the meeting.
Docket Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments
regarding this document to the public docket (see ADDRESSES) by (see
DATES). Given that time will be limited at the public meeting, FDA
encourages all interested persons to comment in writing to ensure that
their comments are considered.
VI. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov.
Dated: July 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18448 Filed 7-27-15; 8:45 am]
BILLING CODE 4164-01-P