[Federal Register: May 23, 2006 (Volume 71, Number 99)]
[Notices]
[Page 29624-29626]
[DOCID:fr23my06-40]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0187; FRL-8173-1]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the April 4-6, 2006 HSRB
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public
teleconference meeting to discuss its draft HSRB report from the April
4-6, 2006 HSRB meeting.

DATES: The date for the teleconference will be held on June 8, 2006,
from 1:30-4 p.m. (Eastern Time).
    Location: The meeting will take place via telephone only.
    Meeting Access: For information on access or services for
individuals with disabilities, please contact the DFO at least 10
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT so that appropriate arrangements can be
made.
    Procedures for Providing Public Input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Unit
I.D. of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
obtain the call-in number and access code to participate in the
telephone conference, request a current draft copy of the Board's
report or who wish further information may contact Paul I. Lewis,
Designated Federal Officer (DFO), EPA, Office of the Science Advisory,
(8105), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; or via telephone/voice mail at<PHONE_NUMBER> or
via e-mail at<EMAIL_ADDRESS>General information concerning the
EPA HSRB can be on the EPA Web site at http://www.epa.gov/osa/hsrb/.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2006-0187, by one of the following methods: http://www.regulations.gov:
 Follow the on-line instructions for submitting

comments.
    E-mail<EMAIL_ADDRESS>    Mail: ORD Docket, Environmental Protection Agency, Mailcode:
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

    Hand Delivery: EPA Docket Center (EPA/DC), Room B102, EPA West
Building, 1301 Constitution Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA-ORD-2006-0187. Deliveries are only accepted
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0187. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA, without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.

I. Public Meeting

A. Does This Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies
on substances regulated by EPA or to persons who are or may be required
to conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other
Related Information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
Federal Register listings at http://www.epa.gov/fedrgstr/    Docket: All documents in the docket are listed in the http://.

http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/

DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
ORD Docket is<PHONE_NUMBER>.
    The April 4-6, 2006 HSRB meeting draft report is now available. You
may obtain electronic copies of this document, and certain other
related documents that might be available electronically, from the
regulations.gov Web site and the HSRB Internet Home Page at http://www.epa.gov/osa/hsrb/.
 For questions on document availability or if you

do not have access to the Internet, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

C. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. Provide specific examples to illustrate your concerns.
    5. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

D. How May I Participate in This Meeting?

    You may participate in this meeting by following the instructions
in this section. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be
accepted up to May 31, 2006. To the extent that time permits,
interested persons who have not pre-registered may be permitted by the
Chair of the HSRB to present oral comments at the meeting. Each
individual or group wishing to make brief oral comments to the HSRB is
strongly advised to submit their request (preferably via e-mail) to the
DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon,
eastern time, May 31, 2006, in order to be included on the meeting
agenda and to provide sufficient time for the HSRB Chair and HSRB DFO
to review the meeting agenda to provide an appropriate public comment
period. The request should identify the name of the individual making
the presentation and the organization (if any) the individual will
represent. Oral comments before the HSRB are limited to 5 minutes per
individual or organization. Please note that this includes all
individuals appearing either as part of, or on behalf of an
organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand these time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, there may be flexibility in
time for public comments.
    2. Written comments. Although you may submit written comments at
any time, for the HSRB to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least 5 business days prior to the beginning of
this teleconference. If you submit comments after this date, those
comments will be provided to the Board members, but you should
recognize that the Board members may not have adequate time to consider
those comments prior to making a decision. Thus, if you plan to submit
written comments, the Agency strongly encourages you to submit such
comments no later than noon, Eastern Time, May 31, 2006. You should
submit your comments using the instructions in Unit 1.C. of this
notice. In addition, the

Agency also requests that person(s) submitting comments directly to the
docket also provide a copy of their comments to the DFO listed under
FOR FURTHER INFORMATION CONTACT. There is no limit on the length of
written comments for consideration by the HSRB.

E. Background

    The EPA Human Studies Review Board will be reviewing its draft
report from the April 4-6, 2006 HSRB meeting. Background on the April
4-6, 2006 HSRB meeting can be found at 71 FR 12194 (March 9, 2006) and
at the HSRB Web site http://www.epa.gov/osa/hsrb/.

    Dated: May 16, 2006.
George Gray,
EPA Science Advisor.
[FR Doc. E6-7830 Filed 5-22-06; 8:45 am]

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[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42815-42818]
[FR Doc No: 2017-19258]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4765]

Center for Devices and Radiological Health Premarket Approval
Application Critical to Quality Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency or we)
Center for Devices and Radiological Health (CDRH or Center), Office of
Compliance (OC) and Office of In Vitro Diagnostics and Radiological
Health (OIR) is announcing its Premarket Approval Application Critical
to Quality (PMA CtQ) pilot program. Participation in the PMA CtQ pilot
program is voluntary and the program aims to evaluate device design and
manufacturing process quality information early on to assist FDA in its
review of the PMA manufacturing section and post-approval inspections.
This voluntary pilot program is part of the FDA's ongoing Case for
Quality effort to apply innovative strategies that promote medical
device quality and is a joint effort between the FDA's CDRH and Office
of Regulatory Affairs (ORA). The pilot program is intended to provide
qualifying PMA applicants with the option to engage FDA on development
of CtQ controls for their device and forego the standard PMA
preapproval inspection. FDA would in turn, focus on the PMA applicant's
implementation of the CtQ controls during a postmarket inspection.

DATES: FDA is seeking participation in the voluntary PMA CtQ pilot
program starting from September 29, 2017. See the ``Participation''
section for instructions on how to submit a request to participate.
This pilot program will run from September 29, 2017, to December 31,
2018. The voluntary PMA CtQ pilot program will accept the first nine
participants with submissions that meet the acceptance criteria.

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-

2017-N-4765 for ``Center for Devices and Radiological Health Premarket
Approval Application Critical to Quality Pilot Program.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bleta Vuniqi, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3463, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CDRH believes that proactive engagement with PMA applicants and a
focused inspectional approach will promote quality in device design and
manufacturing. CDRH plans to initiate the voluntary PMA CtQ pilot
program focusing on activities critical to product and process quality
starting September 29, 2017. The Center intends to work collaboratively
with PMA applicants identified to participate in the PMA CtQ pilot
program to define characteristics of the PMA device that are critical
to product quality and how these characteristics are controlled in
design and manufacturing prior to the postmarket inspection. PMA
applicants can expect discussions during the inspection to relate to
those factors most likely to impact device quality by working with FDA,
before PMA approval, on defining activities critical to product and
process quality. Improvements in overall device quality may reduce
device failures and recalls, and translate into more efficient
utilization of resources for CDRH, ORA, and the device industry.
Previously, CDRH's OC completed the implantable devices containing
batteries Critical to Quality Inspection pilot which established a
collaborative framework for determining specific operations, design
considerations, and controls that most impact the quality and safety of
these devices (Ref. 1). Post-inspection feedback from ORA and CDRH's OC
indicated that FDA can improve its approach for medical device
inspections by focusing on areas critical to quality of the device,
which in turn will change the compliance focus to influence better
device quality. In addition, feedback received from industry
participants indicated that many of the risks for devices reside in
product and process design and post-production activities.
    Whether firms are appropriate candidates for participation in this
voluntary PMA CtQ pilot program is determined based on the factors
listed in Section A. Participation Criteria. Upon applicant's pre-PMA
q-submission meeting request, FDA will identify appropriate candidates
to participate in this voluntary pilot program. Due to resource
constraints, we intend to limit this voluntary pilot program to a
maximum of nine participants. FDA intends to work with each
participating applicant to identify characteristics of its device and
its manufacture that are critical to its quality, which may include
specific device features or quality control practices. The identified
CtQ characteristics and controls will help focus FDA's post-approval
inspectional approach.
    The aim of the voluntary PMA CtQ pilot program is to have the
applicant discuss device design and manufacturing process quality
information with FDA early on to assist FDA in its review of the PMA
manufacturing section and post-approval inspections. The goal of this
voluntary pilot program is to streamline the premarket approval process
while assuring that a firm's quality system includes rigorous controls
for features and characteristics considered critical to the safety and
effectiveness of the device. FDA believes that focusing on these
activities may also lead to fewer device failures, a decrease in device
recalls, and improved device innovation and efficiencies. For
participants in the voluntary PMA CtQ pilot program, FDA intends to
forego conducting a preapproval inspection, which it would usually
conduct, and instead conduct a more focused post-approval inspection.
That post-approval inspection would focus on the design, manufacturing,
and quality assurance practices identified by the applicant in its PMA.
In addition, this voluntary pilot program is part of the FDA's ongoing
Case for Quality effort to apply innovative strategies that promote
medical device quality instead of focusing only on compliance with the
Quality System regulation (Ref. 2). This voluntary PMA CtQ pilot
program does not represent a new requirement; instead, it is an
opportunity to promote quality in device manufacturing, timely review
of the PMA manufacturing section and more effective use of inspectional
resources, and an enhanced opportunity to engage with firms regarding
device quality prior to marketing of the device. This voluntary PMA CtQ
pilot program augments the FDA's traditional Quality System Inspection
Technique (QSIT) inspectional approach, and does not replace it (Ref.
3).
    Combination products, products regulated by the Center for
Biologics Evaluation and Research, and companion diagnostic In Vitro
Diagnostic devices that require coordination with the Center for Drug
Evaluation and Research are not within the scope of this voluntary PMA
CtQ pilot program.

A. Participation Criteria

    Firms that are appropriate to participate in this voluntary PMA CtQ
pilot program are those firms submitting an original PMA who follow the
procedures set out in Section B and who also:

    1. Submit a request for a pre-PMA q-submission meeting, and
    a. Provide the recommended information identified in the guidance
document, ``Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug Administration
Staff'' dated February 18, 2014 (Ref. 4), along with a statement of
interest for participation in this voluntary PMA CtQ pilot program in
the applicant's cover letter.
    b. Provide a list of PMA-related facilities responsible for the
manufacture, processing, packing, or installation with the applicant's
pre-PMA q-submission submission package.
    c. If available, submit a draft list of critical characteristics
for the device which is the subject of the PMA application.
    2. As part of the PMA application, include the proposed list of
critical characteristics as well as their associated controls for the
device which is the subject of the PMA. The list should include
characteristics where failure in meeting the characteristic would have
a reasonable likelihood or a remote likelihood of causing a death or
serious injury.
    3. Have their PMA application accepted and filed for review by FDA
(Ref. 5).
    4. Have not had Quality System deficiencies identified in FDA's
review of the manufacturing section of the applicant's PMA (Ref. 6).
    5. Have had an FDA inspection of the PMA-related facilities
conducted at least once within the last 5 years.
    6. An FDA inspection of the PMA-related facilities has not been
classified as Official Action Indicated or been subject to a judicial
action (e.g., seizure or injunction, including consent decrees) within
the last 5 years (Ref. 7).

B. Procedures

    Postmarket inspections under this proposed voluntary PMA CtQ pilot
program will be conducted in accordance with FDA's general
establishment inspection authority in section 704(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)). FDA intends for the
investigator to follow the current medical device inspection model as
outlined in the 2017 FDA Investigations Operations Manual (IOM) Chapter
5 and FDA Compliance Program 7383.001 ``Medical Device Premarket
Approval and Postmarket Inspections'' dated March 5, 2012, with the
following exceptions: (1) The inspection is conducted in the postmarket
setting and (2) the postmarket inspection includes an evaluation of
critical control measures for the production of the device are
implemented (Ref. 8-10). Section 5.1.2 of the IOM provides the
inspection may be directed for ``obtaining specific information on new
technologies, good commercial practices, or data for establishing food
standards or other regulations.''
    Additionally, FDA intends on soliciting feedback from ORA, industry
participants, and CDRH's OC/OIR staff during the voluntary PMA CtQ
pilot program. Feedback from participants will be gathered through
meetings and questions proposed in Appendices A and B (Ref. 11).
    The following captures FDA's expected process for the voluntary PMA
CtQ pilot program:
    1. A firm submits a pre-PMA q-submission meeting request at least
75-90 days in advance of submission of the PMA application following
the recommendations outlined in the guidance document ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' (Ref. 4) dated
February 18, 2014. Additional expectations, include:
    a. Providing a statement in the pre-PMA q-submission to support
being considered for participation in the voluntary PMA CtQ pilot
program.
    b. Providing a list of PMA-related facilities responsible for the
manufacture, processing, packing, or installation for the device which
is the subject of the PMA as part of the applicant's pre-PMA q-
submission package.
    c. If available, submitting a draft list of critical
characteristics for the device which is the subject of the PMA
application.
    2. During the pre-PMA q-submission meeting, FDA clearly
communicates the voluntary PMA CtQ pilot program expectations and
discusses and provides the applicant's proposed draft list of critical
characteristics for the PMA device and provide feedback.
    3. Once a firm has expressed interest in participating in the
voluntary PMA CtQ pilot program, CDRH determines whether:
    a. all PMA-related facilities have been inspected within the last 5
years, and
    b. all of the inspections of the PMA-related facilities have not
been classified as Official Action Indicated and have not been subject
to a judicial action (e.g., a seizure or injunction action, including a
consent decree) within the last 5 years.
    4. The PMA application:
    a. Is accepted and filed for review by FDA.
    b. Includes as part of the manufacturing section the proposed list
of device critical characteristics as well as their associated
controls, which may include certain design, manufacturing, or quality
assurance practices. The list of critical characteristics identified in
4(b) is based on risk to the patient or user, including whether failure
in meeting the characteristic can have a reasonable likelihood or a
remote likelihood of causing a death or serious injury.
    c. Is accompanied by a streamlined process validation report to
CDRH OC or OIR no later than day 45 within the PMA application process.
    5. CDRH OC/OIR completes the following during review of the PMA
application:
    a. Checks the CtQ information for clarity, completeness, and
relevance to the Quality System regulation within days 1-45, with the
goal to have the list of device critical characteristics as well as
their associated controls finalized by day 60 of the 180-day clock.
    b. Reviews the manufacturing section of the PMA application within
the first 30 days of the 180-day clock. If Quality System deficiencies
are identified during this review, then the PMA application would no
longer be appropriate for inclusion in this voluntary PMA CtQ pilot
program. The reviewer would follow the current established procedures
and place the PMA application on ``hold'' pending correction of the
deficiencies.
    c. Reviews the validation report identified in section B.4(c)
within 30 calendar days of receipt. Any concerns raised by the
validation report review may result in the issuance of a deficiency
letter that will place the PMA on ``hold'' pending Good Manufacturing
Practices corrections.
    d. Provides an inspectional assignment to the investigator and
makes necessary technical expertise available to the ORA. The critical
characteristics and controls will help guide the investigator and
appropriately focus their activities during the postmarket inspection.
In addition, CDRH intends to include CtQ and control information in an
inspectional assignment and contact the investigator(s) to discuss
critical control measures and expectations prior to the inspection.
    6. Following an approval decision, FDA conducts the postmarket
inspection in accordance with the 2017 FDA IOM, Compliance Program
7382.845, and Compliance Program 7383.001 (Ref. 8-10) utilizing
elements

of QSIT, and informed by the PMA CtQ information developed jointly by
FDA and the PMA applicant.
    7. Following completion of the inspection, participating FDA
Offices and applicants provide the information/data needed to assess
the voluntary PMA CtQ pilot program's impact on resource utilization
and quality focus, utilizing the evaluation forms provided in
Appendices A and B (Ref. 11).
    During this voluntary PMA CtQ pilot program, CDRH staff intends to
be available to answer questions or concerns that may arise. The
voluntary PMA CtQ pilot program participants will be asked to comment
on and discuss their experiences with the PMA CtQ pilot submission
process. Comments and discussions may assist FDA in determining whether
the goals of this voluntary PMA CtQ pilot program goal are clearly
communicated and attainable.

II. Duration of the Premarket Approval Application Critical to Quality
Pilot Program

    FDA intends to accept requests for participation in the voluntary
PMA CtQ pilot program from September 29, 2017, to December 31, 2018, or
until such time as when a total of nine PMAs have been enrolled.

III. Paperwork Reduction Act of 1995

    This notice 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). The
collections of information in 21 CFR part 814, subparts A through E
have been approved under OMB control number 0910-0231; the collections
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. Implantable Devices that Contain Batteries Critical to Quality
Inspection Pilot. Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/UCM469128.pdf.
2. FDA's Case for Quality, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm.
3. FDA's Guide to Inspections of Quality Systems, Quality System
Inspection Technique, available at http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm.
4. FDA Guidance for Industry and FDA Staff ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' dated February
18, 2014. Available at<EMAIL_ADDRESS>5. FDA's Guidance for Industry and FDA Staff: Acceptance and Filing
Reviews for Premarket Approval Applications (PMAs) at<EMAIL_ADDRESS>6. FDA's Guidance for Industry and FDA Staff: Quality System
Information for Certain Premarket Application Reviews, available at
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070897.htm.
7. FDA's Official Action Indicated, available at http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212061.pdf.
8. 2017 FDA Investigations Operations Manual (IOM) Chapter 5 at
<EMAIL_ADDRESS>9. FDA Compliance Program 7383.001 at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/UCM295570.pdf.
10. FDA Compliance Program 7382.845 at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM244277.pdf.
11. Appendices A and B.

    Dated: September 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19258 Filed 9-11-17; 8:45 am]
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