Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry; Availability, 31325-31327 [2019-13969]
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Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
FDA in writing. FDA is also requesting
nominations for a nonvoting industry
representative to fill an upcoming
vacancy on DGMPAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for an
upcoming vacancy effective with this
notice.
Any industry organizations
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by July 31, 2019 (see sections I and
III of this document for further details).
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by July 31, 2019.
DATES:
All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives
should be submitted electronically by
accessing FDA’s Advisory Committee
Membership Nomination Portal at
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Office of Management,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5264, Silver Spring, MD 20993–
0002, 301–796–5960, Fax: 301–847–
8505, email: Margaret.Ames@
fda.hhs.gov.
Section
520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as
amended, provides that DGMPAC shall
be composed of two representatives of
interests of the device manufacturing
industry. The Agency is requesting
nominations for a nonvoting industry
representative to fill an upcoming
vacancy on DGMPAC. FDA is
publishing a separate document
announcing the request for notification
for voting members on DGMPAC.
khammond on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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Jkt 247001
I. Function of DGMPAC
DGMPAC reviews proposed
regulations regarding good
manufacturing practices governing the
methods used in, and the facilities and
controls used for, the manufacture,
packaging, storage, installation, and
servicing of devices, and makes
recommendations regarding the
feasibility and reasonableness of those
proposed regulations. The committee
also reviews and makes
recommendations on proposed guidance
developed to assist the medical device
industry in meeting the good
manufacturing practice requirements
and provides advice with regard to any
petition submitted by a manufacturer for
an exemption or variance from good
manufacturing practice regulations.
II. Qualifications
Persons nominated for DGMPAC
should possess appropriate
qualifications to understand and
contribute to the committee’s work as
described in the committee’s function.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
their current re´sume´. The letter will also
state that it is the responsibility of the
interested organizations to confer with
one another and to select a candidate,
within 60 days after the receipt of the
FDA letter, to serve as the nonvoting
member to represent industry interests
for the committee. The interested
organizations are not bound by the list
of nominees in selecting a candidate.
However, if no individual is selected
within 60 days, the Commissioner will
select the nonvoting member to
represent industry interests.
IV. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nominations
must include a current, complete
re´sume´ or curriculum vitae for each
nominee, including current business
address, telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
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Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the device
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: June 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13991 Filed 6–28–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2016]
Epidermolysis Bullosa: Developing
Drugs for Treatment of Cutaneous
Manifestations; 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 final
guidance for industry entitled
‘‘Epidermolysis Bullosa: Developing
Drugs for Treatment of Cutaneous
Manifestations.’’ The purpose of this
guidance is to assist sponsors with the
development of drugs for treatment or
prevention of the serious cutaneous
manifestations of the heterogeneous
group of disorders collectively known as
epidermolysis bullosa (EB). This
guidance focuses on drug development
SUMMARY:
E:\FR\FM\01JYN1.SGM
01JYN1
31326
Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
and trial design issues specific to the
treatment of EB, including FDA’s
current thinking on clinical trial
endpoint considerations. There is not
yet sufficient clinical trial experience to
establish definitive endpoints. This
guidance incorporates the comments
received for and finalizes the draft
guidance of the same name issued on
June 18, 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on July 1, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time 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’’).
khammond on DSKBBV9HB2PROD with NOTICES
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–
2018–D–2016 for ‘‘Epidermolysis
VerDate Sep<11>2014
19:58 Jun 28, 2019
Jkt 247001
Bullosa: Developing Drugs for
Treatment of Cutaneous
Manifestations.’’ 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/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this 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 the Office of Communication,
Outreach, and Development, Center for
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Barbara Gould, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5166,
Silver Spring, MD 20993–0002, 301–
796–4224; 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,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Epidermolysis Bullosa: Developing
Drugs for Treatment of Cutaneous
Manifestations.’’ The purpose of this
guidance is to assist sponsors with the
development of drugs for treatment or
prevention of the serious cutaneous
manifestations of the heterogeneous
group of disorders collectively known as
EB. This guidance focuses on drug
development and trial design issues
specific to the treatment of EB,
including FDA’s current thinking on
endpoint considerations. There is not
yet sufficient clinical trial experience to
establish definitive endpoints. This
guidance incorporates the comments
received for and finalizes the draft
guidance of the same name issued on
June 18, 2018 (83 FR 28240). All the
public comments received on the draft
guidance have been considered, and the
guidance has been revised as
appropriate along with a few editorial
changes.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Epidermolysis
Bullosa: Developing Drugs for
Treatment of Cutaneous
Manifestations.’’ 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. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
E:\FR\FM\01JYN1.SGM
01JYN1
Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
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 312 have
been approved under OMB control
number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Dated: June 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13969 Filed 6–28–19; 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 Meetings
khammond on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: HIV/AIDS Population and
Behavioral Research.
Date: July 16, 2019.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: John H. Newman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3222,
MSC 7808, Bethesda, MD 20892, (301) 435–
0628, newmanjh@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
VerDate Sep<11>2014
19:58 Jun 28, 2019
Jkt 247001
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Population Sciences and
Epidemiology.
Date: July 24, 2019.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kate Fothergill, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3142,
Bethesda, MD 20892, 301–435–2309,
fothergillke@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Glial development, myelination and
remyelination.
Date: July 24, 2019.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Peter B. Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–13941 Filed 6–28–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
[DHS–2019–0029]
Project 25 Compliance Assessment
Program (P25 CAP)
Science and Technology
Directorate, Department of Homeland
Security.
ACTION: Notice of information collection;
request for comment.
AGENCY:
The Department of Homeland
Security (DHS) invites the general
public to comment on updated data
collection forms for DHS Science and
Technology (S&T) Directorate’s Project
25 (P25) Compliance Assessment
Program (CAP): Supplier’s Declaration
of Compliance (SDoC) (DHS Form 10044
(6/08)) and an accompanying Summary
Test Report (STR) (DHS Form 10056 (9/
08)). The collections are posted on the
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
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31327
dhs.gov website (https://www.dhs.gov/
science-and-technology/p25-cap). The
attacks of September 11, 2001, and the
destruction of Hurricane Katrina made
apparent the need for emergency
response radio systems that can
interoperate, regardless of which
organization manufactured the
equipment. Per congressional direction,
DHS and the National Institute of
Standards and Technology (NIST)
developed the P25 CAP to improve the
emergency response community’s
confidence in purchasing land mobile
radio (LMR) equipment built to P25
LMR standards. Equipment suppliers
provide the information to publicly
attest to their products’ compliance with
a specific set of P25 standards. The
SDoC, and its STR, which substantiates
the declaration, constitutes a company’s
formal, public attestation of compliance
with the standards for the equipment. In
turn, first responders at local, tribal,
state, and federal levels across multiple
disciplines including law enforcement,
fire, and emergency medical services
personnel, will use this information to
identify P25 compliant communications
system products. The P25 CAP Program
Manager performs a simple
administrative review to ensure the
documentation is complete and accurate
in accordance with the current P25 CAP
processes.
DATES: Comments are encouraged and
accepted until July 31, 2019.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer, via electronic
mail to dhsdeskofficer@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
DHS/S&T System Owner: Sridhar
Kowdley, Sridhar.kowdley@
HQ.DHS.GOV, (202) 254–8804 (Not a
toll free number).
SUPPLEMENTARY INFORMATION: DHS, in
accordance with the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., provides the general public and
Federal agencies with an opportunity to
comment on proposed, revised, and
continuing collection of information.
DHS is soliciting comments on the
proposed Information Collection
Request (ICR) that is described below.
The Department of Homeland Security
is especially interested in public
comment addressing the following
issues: (1) Is this collection necessary to
the proper functions of the Department;
(2) will this information be processed
and used in a timely manner; (3) is the
estimate of burden accurate; (4) how
E:\FR\FM\01JYN1.SGM
01JYN1
Agencies
[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Notices]
[Pages 31325-31327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13969]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2016]
Epidermolysis Bullosa: Developing Drugs for Treatment of
Cutaneous Manifestations; 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 final guidance for industry entitled
``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous
Manifestations.'' The purpose of this guidance is to assist sponsors
with the development of drugs for treatment or prevention of the
serious cutaneous manifestations of the heterogeneous group of
disorders collectively known as epidermolysis bullosa (EB). This
guidance focuses on drug development
[[Page 31326]]
and trial design issues specific to the treatment of EB, including
FDA's current thinking on clinical trial endpoint considerations. There
is not yet sufficient clinical trial experience to establish definitive
endpoints. This guidance incorporates the comments received for and
finalizes the draft guidance of the same name issued on June 18, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on July 1, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-2018-D-2016 for ``Epidermolysis Bullosa: Developing Drugs for
Treatment of Cutaneous Manifestations.'' 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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 the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Barbara Gould, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5166, Silver Spring, MD 20993-0002, 301-
796-4224; 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, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of
Cutaneous Manifestations.'' The purpose of this guidance is to assist
sponsors with the development of drugs for treatment or prevention of
the serious cutaneous manifestations of the heterogeneous group of
disorders collectively known as EB. This guidance focuses on drug
development and trial design issues specific to the treatment of EB,
including FDA's current thinking on endpoint considerations. There is
not yet sufficient clinical trial experience to establish definitive
endpoints. This guidance incorporates the comments received for and
finalizes the draft guidance of the same name issued on June 18, 2018
(83 FR 28240). All the public comments received on the draft guidance
have been considered, and the guidance has been revised as appropriate
along with a few editorial changes.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Epidermolysis Bullosa: Developing Drugs
for Treatment of Cutaneous Manifestations.'' 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. This guidance is not subject to
Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that
[[Page 31327]]
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 312 have been approved under
OMB control number 0910-0014.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: June 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13969 Filed 6-28-19; 8:45 am]
BILLING CODE 4164-01-P