82 FR 14904 - Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 55 (March 23, 2017)

Page Range		14904-14905
FR Document		2017-05818

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.''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.

Federal Register, Volume 82 Issue 55 (Thursday, March 23, 2017)

[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14904-14905]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-05818]

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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Drugs for Prevention; Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled ``Delayed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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 21, 2017.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: http://www.regulations.gov.
Follow the

[[Page 14905]]

instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

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

14904 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices

institutions would provide great insight scienceresearch/ with a Facility Establishment Identifier
to FDA review staff. The Center sciencecareeropportunities/ number (FEI #) if applicable.
encourages applicants to consider ucm380676.htm. The Center encourages
III. Request to Participate
including opportunities to discuss applicants to consider including
patient perspective and meeting the opportunities to discuss patient Submit proposals for participation
challenges of quality systems design and perspective and meeting the challenges with the docket number found in the
management as they contribute to the of Quality Systems Design and brackets in the heading of this
success of the device development life Management as they contribute to the document. Received requests may be
cycle. success of the device development life seen in the Division of Dockets
CDRH is committed to advancing cycle. Management (see ADDRESSES) between
regulatory science, providing industry 9 a.m. and 4 p.m., Monday through
with predictable, consistent, II. CDRH ELP Friday.
transparent, and efficient regulatory A. Areas of Interest Additional information regarding the
pathways, and helping to ensure CDRH ELP, including a sample request
consumer confidence in medical In this training program, groups of and an example of a site visit agenda
devices marketed in the United States CDRH staff will observe operations in and submission deadlines, is available
and throughout the world. The ELP is the areas of research, device on CDRH’s Web site at: http://
intended to provide CDRH staff with an development, in making coverage www.fda.gov/scienceresearch/
opportunity to understand the policies, decisions and assessments, sciencecareeropportunities/
laboratory and manufacturing practices, incorporating patient information and ucm380676.htm.
and the challenges addressing patient reimbursement, manufacturing,
Dated: March 17, 2017.
perspective/input, quality system academia, and health care facilities. The
Leslie Kux,
management, and other challenges that areas of interest for visits include
various topics identified by managers at Associate Commissioner for Policy.
impact the device development life [FR Doc. 2017–05763 Filed 3–22–17; 8:45 am]
cycle. This component is a collaborative CDRH. These areas of interest are listed
effort to enhance communication and publicly and are intended to be updated BILLING CODE 4164–01–P

facilitate the premarket review process. quarterly.
The Center is committed to To submit a proposal addressing one
of the Center’s training needs, visit the DEPARTMENT OF HEALTH AND
understanding current industry HUMAN SERVICES
practices, innovative technologies, link for the table of areas of interest to
regulatory impacts and needs, and how be addressed at: http://www.fda.gov/ Food and Drug Administration
patient perspective and quality systems ScienceResearch/
management advances the development ScienceCareerOpportunities/ [Docket No. FDA–2017–D–0198]
and evaluation of innovative devices, UCM380676.htm
Once you have determined an area of Delayed Graft Function in Kidney
and to monitoring the performance of Transplantation: Developing Drugs for
marketed devices. interest to address in your ELP proposal,
follow the instructions in section III to Prevention; Draft Guidance for
These formal training visits are not
properly fill out the site visit request Industry; Availability
intended for FDA to inspect, assess,
judge, or perform a regulatory function template and agenda provided at: http:// AGENCY: Food and Drug Administration,
(e.g., compliance inspection), but rather, www.fda.gov/downloads/ HHS.
they are an opportunity to provide ScienceResearch/ ACTION: Notice of availability.
CDRH review staff a better ScienceCareerOpportunities/
understanding of the products they UCM392988.pdf and at: http:// SUMMARY: The Food and Drug
review, how they are developed, the www.fda.gov/downloads/ Administration (FDA or Agency) is
voice of the patient, challenges related ScienceResearch/ announcing the availability of a draft
to quality systems development and ScienceCareerOpportunities/ guidance for industry entitled ‘‘Delayed
management in the product life cycle, UCM487190.pdf. Graft Function in Kidney
and how medical devices fit into the Transplantation: Developing Drugs for
B. Site Selection Prevention.’’ The purpose of this
larger health care system. CDRH is
formally requesting participation from CDRH will be responsible for CDRH guidance is to assist sponsors in the
companies, academia, and clinical staff travel expenses associated with the clinical development of drugs for the
facilities, medical device incubators and site visits. CDRH will not provide funds prevention of delayed graft function
accelerators, health insurers, health to support the training provided by the (DGF) in kidney transplantation.
technology assessment groups, and site to the ELP. Selection of potential DATES: Although you can comment on
others, including those that have facilities will be based on CDRH’s any guidance at any time (see 21 CFR
previously participated in the ELP or priorities for staff training and resources 10.115(g)(5)), to ensure that the Agency
other FDA site visit programs. available to fund this program. In considers your comment on this draft
CDRH encourages applicants to addition to logistical and other resource guidance before it begins work on the
consider including opportunities to factors, all sites must have a successful final version of the guidance, submit
discuss how patient perspective and compliance record with FDA or another either electronic or written comments
effective quality systems management Agency with which FDA has a on the draft guidance by June 21, 2017.
contribute to the success of the device memorandum of understanding (if
sradovich on DSK3GMQ082PROD with NOTICES

ADDRESSES: You may submit comments
development life cycle. Additional applicable). If a site visit involves a visit as follows:
information regarding the CDRH ELP, to a separate physical location of
including the table of areas of interest, another firm under contract with the Electronic Submissions
submission dates and deadlines, a site, that firm must agree to participate Submit electronic comments in the
sample request, and an example of the in the ELP and must also have a following way:
site visit agenda, is available on CDRH’s satisfactory compliance history, and • Federal eRulemaking Portal: http://
Web site at: http://www.fda.gov/ must be listed in the proposal along www.regulations.gov. Follow the

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Document Created: 2017-03-23 02:45:20
Document Modified: 2017-03-23 02:45:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		82 FR 14904

82 FR 14904 - Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 55 (March 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration