[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22205-22206]
[FR Doc No: 2015-09176]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0975]

Acceptance of Medical Device Clinical Data From Studies Conducted
Outside the United States; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Acceptance of Medical
Device Clinical Data from Studies Conducted Outside the United States;
Draft Guidance for Industry and Food and Drug Administration Staff.''
This draft guidance articulates FDA's current policy of accepting
scientifically valid clinical data obtained from foreign clinical
studies in support of premarket submissions for devices. The guidance
describes special considerations that apply when using such data,
including applicability to populations within the United States and
study design issues and provides recommendations to assist sponsors in
ensuring their data are adequate under applicable FDA standards to
support approval or clearance of the device in the United States. This
guidance is not intended to announce new policy, but to describe FDA's
existing approach to this topic. This draft guidance is not final nor
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 20, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Acceptance of Medical Device Clinical Data from Studies Conducted
Outside the United States; Draft Guidance for Industry and Food and
Drug Administration Staff'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Aaliyah Eaves-Lea[ntilde]os, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5420, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>. For questions regarding this document concerning
devices regulated by CBER, contact Stephen Ripley, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA), Public Law 112-144
(2012), adding a new provision, section 569B, to the Federal Food,
Drug, and Cosmetic Act (FD&C Act) codifying FDA's longstanding policy
of accepting adequate, ethically-derived, scientifically valid data
without regard to where a clinical study is conducted. Sponsors may
choose to conduct multinational clinical studies under a variety of
scenarios. FDA acknowledges, however, that certain challenges exist in
using data derived from studies of devices from sites from outside the
United States (OUS) to support an FDA

marketing decision. These challenges may include differences between
the OUS and U.S. clinical conditions, regulatory requirements
(including human subject protections), and/or study populations that
may be sufficient to affect the adequacy of the data for use in
establishing the safety and/or effectiveness of the studied device.
This guidance focuses on considerations sponsors of device submissions
should take into account when initiating, or relying on previously
collected data from, an OUS clinical study to support an
Investigational Device Exemption, Premarket Notification (510(k)), De
Novo Petition, Humanitarian Device Exemption, or Premarket Approval
Application. This guidance also notes other important considerations to
take into account when initiating or relying on OUS data. FDA believes
that promoting greater clarity concerning FDA's use of foreign study
data will minimize the possibility for additional or duplicative U.S.
studies, further efforts to harmonize global clinical trial standards,
and promote public health and innovation.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on acceptance
of clinical data from foreign studies conducted OUS. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Centers for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Acceptance of Medical Device
Clinical Data from Studies Conducted Outside the United States; Draft
Guidance for Industry and Food and Drug Administration Staff'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1741 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently 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 parts 50 and 56 have been approved
under OMB control number 0910-0755; the collections of information in
21 CFR part 601 have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
812 has been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231; the collections of information in 21 CFR
part 814, subpart H have been approved under OMB control number 0910-
0332; and the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09176 Filed 4-20-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2367-2368]
[FR Doc No: 2017-00094]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2537]

Submission of Quality Metrics Data; Revised Draft Guidance for
Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the notice of revised draft guidance availability
that appeared in the Federal Register of November 25, 2016. The Agency
is taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of revised
draft guidance availability published on November 25, 2016 (81 FR
85226). Submit either electronic or written comments by March 27, 2017.

ADDRESSES: You may submit comments by any of the following methods:

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 Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-2537 for ``Submission of Quality Metrics Data; Revised Draft
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number(s), found in brackets
in the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301-
796-3257 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 25,
2016, FDA published a notice of revised draft guidance availability
with a 60-day comment period. Comments on the notice of revised draft
guidance availability will inform FDA's development and proposed
implementation of a voluntary phase of the quality metrics program.
    FDA is extending the comment period for an additional 60 days,
until March 27, 2017. The Agency believes that a 60-day extension of
the comment period for the notice of revised draft guidance
availability will provide adequate time for interested persons to
submit comments without significantly delaying Agency decision making
on these important issues.

    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00094 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-P


July 2, 2015

MEMORANDUM

SUBJECT:	Files on CD for EPA-HQ-OAR-2014-0827-DRAFT-0453 for GEM  -  Greenhouse Gas Emission Model Executable File

FROM:	Christine Brunner       Assessment and Standards Division       Office of Transportation and Air Quality

TO:	Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

The enclosed CD contains the following file associated with docket item EPA-HQ-OAR-201-0827-DRAFT-0453.

1) GEM_P2v1.0_setup_x64.exe

There is no restriction on this file.