Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Draft Guidance for Industry; Availability, 14904-14905 [2017-05818]
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Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices
institutions would provide great insight
to FDA review staff. The Center
encourages applicants to consider
including opportunities to discuss
patient perspective and meeting the
challenges of quality systems design and
management as they contribute to the
success of the device development life
cycle.
CDRH is committed to advancing
regulatory science, providing industry
with predictable, consistent,
transparent, and efficient regulatory
pathways, and helping to ensure
consumer confidence in medical
devices marketed in the United States
and throughout the world. The ELP is
intended to provide CDRH staff with an
opportunity to understand the policies,
laboratory and manufacturing practices,
and the challenges addressing patient
perspective/input, quality system
management, and other challenges that
impact the device development life
cycle. This component is a collaborative
effort to enhance communication and
facilitate the premarket review process.
The Center is committed to
understanding current industry
practices, innovative technologies,
regulatory impacts and needs, and how
patient perspective and quality systems
management advances the development
and evaluation of innovative devices,
and to monitoring the performance of
marketed devices.
These formal training visits are not
intended for FDA to inspect, assess,
judge, or perform a regulatory function
(e.g., compliance inspection), but rather,
they are an opportunity to provide
CDRH review staff a better
understanding of the products they
review, how they are developed, the
voice of the patient, challenges related
to quality systems development and
management in the product life cycle,
and how medical devices fit into the
larger health care system. CDRH is
formally requesting participation from
companies, academia, and clinical
facilities, medical device incubators and
accelerators, health insurers, health
technology assessment groups, and
others, including those that have
previously participated in the ELP or
other FDA site visit programs.
CDRH encourages applicants to
consider including opportunities to
discuss how patient perspective and
effective quality systems management
contribute to the success of the device
development life cycle. Additional
information regarding the CDRH ELP,
including the table of areas of interest,
submission dates and deadlines, a
sample request, and an example of the
site visit agenda, is available on CDRH’s
Web site at: https://www.fda.gov/
VerDate Sep<11>2014
17:13 Mar 22, 2017
Jkt 241001
scienceresearch/
sciencecareeropportunities/
ucm380676.htm. The Center encourages
applicants to consider including
opportunities to discuss patient
perspective and meeting the challenges
of Quality Systems Design and
Management as they contribute to the
success of the device development life
cycle.
II. CDRH ELP
A. Areas of Interest
In this training program, groups of
CDRH staff will observe operations in
the areas of research, device
development, in making coverage
decisions and assessments,
incorporating patient information and
reimbursement, manufacturing,
academia, and health care facilities. The
areas of interest for visits include
various topics identified by managers at
CDRH. These areas of interest are listed
publicly and are intended to be updated
quarterly.
To submit a proposal addressing one
of the Center’s training needs, visit the
link for the table of areas of interest to
be addressed at: https://www.fda.gov/
ScienceResearch/
ScienceCareerOpportunities/
UCM380676.htm
Once you have determined an area of
interest to address in your ELP proposal,
follow the instructions in section III to
properly fill out the site visit request
template and agenda provided at: https://
www.fda.gov/downloads/
ScienceResearch/
ScienceCareerOpportunities/
UCM392988.pdf and at: https://
www.fda.gov/downloads/
ScienceResearch/
ScienceCareerOpportunities/
UCM487190.pdf.
B. Site Selection
CDRH will be responsible for CDRH
staff travel expenses associated with the
site visits. CDRH will not provide funds
to support the training provided by the
site to the ELP. Selection of potential
facilities will be based on CDRH’s
priorities for staff training and resources
available to fund this program. In
addition to logistical and other resource
factors, all sites must have a successful
compliance record with FDA or another
Agency with which FDA has a
memorandum of understanding (if
applicable). If a site visit involves a visit
to a separate physical location of
another firm under contract with the
site, that firm must agree to participate
in the ELP and must also have a
satisfactory compliance history, and
must be listed in the proposal along
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with a Facility Establishment Identifier
number (FEI #) if applicable.
III. Request to Participate
Submit proposals for participation
with the docket number found in the
brackets in the heading of this
document. Received requests may be
seen in the Division of Dockets
Management (see ADDRESSES) between
9 a.m. and 4 p.m., Monday through
Friday.
Additional information regarding the
CDRH ELP, including a sample request
and an example of a site visit agenda
and submission deadlines, is available
on CDRH’s Web site at: https://
www.fda.gov/scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
Dated: March 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05763 Filed 3–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0198]
Delayed Graft Function in Kidney
Transplantation: Developing Drugs for
Prevention; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Delayed
Graft Function in Kidney
Transplantation: Developing Drugs for
Prevention.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
prevention of delayed graft function
(DGF) in kidney transplantation.
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 June 21, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
E:\FR\FM\23MRN1.SGM
23MRN1
Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–0198 for ‘‘Delayed Graft
Function in Kidney Transplantation:
Developing Drugs for Prevention; Draft
Guidance for Industry; Availability.’’
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
VerDate Sep<11>2014
17:13 Mar 22, 2017
Jkt 241001
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: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of 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. 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.
FOR FURTHER INFORMATION CONTACT:
Ozlem Belen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 6118,
Silver Spring, MD 20993–0002, 301–
796–0676.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Delayed Graft Function in Kidney
Transplantation: Developing Drugs for
Prevention.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
prevention of DGF in kidney
transplantation.
This draft guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
14905
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on developing drugs for the prevention
of DGF in kidney transplant. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
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 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: March 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05818 Filed 3–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Oncology 1 Basic Translational.
Date: April 6, 2017.
Time: 1:00 p.m. to 5:00 p.m.
E:\FR\FM\23MRN1.SGM
23MRN1
Agencies
[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14904-14905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05818]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-0198]
Delayed Graft Function in Kidney Transplantation: Developing
Drugs for Prevention; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Delayed
Graft Function in Kidney Transplantation: Developing Drugs for
Prevention.'' The purpose of this guidance is to assist sponsors in the
clinical development of drugs for the prevention of delayed graft
function (DGF) in kidney transplantation.
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 June 21, 2017.
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
[[Page 14905]]
instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-0198 for ``Delayed Graft Function in Kidney Transplantation:
Developing Drugs for Prevention; Draft Guidance for Industry;
Availability.'' 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: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of 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. 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.
FOR FURTHER INFORMATION CONTACT: Ozlem Belen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 6118, Silver Spring, MD 20993-0002, 301-
796-0676.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Delayed Graft Function in Kidney Transplantation: Developing
Drugs for Prevention.'' The purpose of this guidance is to assist
sponsors in the clinical development of drugs for the prevention of DGF
in kidney transplantation.
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 developing
drugs for the prevention of DGF in kidney transplant. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that 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 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: March 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05818 Filed 3-22-17; 8:45 am]
BILLING CODE 4164-01-P