83 FR 28240 - Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 117 (June 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 117 (June 18, 2018)
| Page Range | 28240-28241 | |
| FR Document | 2018-12976 |
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)] [Notices] [Pages 28240-28241] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12976] ----------------------------------------------------------------------- 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[Docket No. FDA-2018-D-2016] Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this draft guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders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). There is an unmet medical need for EB patients due to the paucity of effective treatment options. DATES: Submit either electronic or written comments on the draft guidance by August 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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 [[Page 28241]] 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; 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 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.thefederalregister.org/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 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, or 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 draft 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 draft guidance for industry entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this draft 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. There is an unmet medical need for EB patients due to the paucity of effective treatment options. 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 ``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 draft 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 part 312 have been approved under OMB control number 0910-0014. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: June 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12976 Filed 6-15-18; 8:45 am] BILLING CODE 4164-01-P
![28240 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
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28, 2018. June 28, 2018. No commercial or participating in the meeting follows:
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
Request to Special Submit either electronic or written
Date Address Preregister Electronic address make an oral accommodations comments
presentation
July 12, 2018, Food and Drug Ad- July 5, 2018: https://www.fda.gov/ June 28, 2018 June 28, 2018: Clos- Submit Comments by September
from 8:30 a.m. ministration, Center Closing date Food/NewsEvents/ ing date to request 25, 2018 to: https://
until 3 p.m. EDT. for Food Safety and for registration. WorkshopsMeetings special accom- www.regulations.gov, or Dock-
Applied Nutrition, Conferences/de- modations due to a ets Management Staff (HFA–
Wiley Auditorium, fault.htm. disability. 305), Food and Drug Adminis-
5001 Campus tration, 5630 Fishers Lane,
Drive, College Park, Rm. 1061, Rockville, MD
MD 20740. 20852.
Dated: June 8, 2018. or prevention of the serious cutaneous such as medical information, your or
Leslie Kux, manifestations of the heterogeneous anyone else’s Social Security number, or
Associate Commissioner for Policy. group of disorders collectively known as confidential business information, such
[FR Doc. 2018–12939 Filed 6–15–18; 8:45 am] epidermolysis bullosa (EB). There is an as a manufacturing process. Please note
BILLING CODE 4164–01–P
unmet medical need for EB patients due that if you include your name, contact
to the paucity of effective treatment information, or other information that
options. identifies you in the body of your
DEPARTMENT OF HEALTH AND DATES: Submit either electronic or comments, that information will be
HUMAN SERVICES written comments on the draft guidance posted on https://www.regulations.gov.
by August 17, 2018 to ensure that the • If you want to submit a comment
Food and Drug Administration Agency considers your comment on this with confidential information that you
draft guidance before it begins work on do not wish to be made available to the
[Docket No. FDA–2018–D–2016]
the final version of the guidance. public, submit the comment as a
Epidermolysis Bullosa: Developing ADDRESSES: You may submit comments written/paper submission and in the
Drugs for Treatment of Cutaneous on any guidance at any time as follows: manner detailed (see ‘‘Written/Paper
Manifestations; Draft Guidance for Submissions’’ and ‘‘Instructions’’).
Electronic Submissions
Industry; Availability Written/Paper Submissions
Submit electronic comments in the
AGENCY: Food and Drug Administration, following way: Submit written/paper submissions as
HHS. • Federal eRulemaking Portal: follows:
ACTION: Notice of availability. https://www.regulations.gov. Follow the
instructions for submitting comments. • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug Comments submitted electronically, written/paper submissions): Dockets
Administration (FDA or Agency) is including attachments, to https:// Management Staff (HFA–305), Food and
amozie on DSK3GDR082PROD with NOTICES1
announcing the availability of a draft www.regulations.gov will be posted to Drug Administration, 5630 Fishers
guidance for industry entitled the docket unchanged. Because your Lane, Rm. 1061, Rockville, MD 20852.
‘‘Epidermolysis Bullosa: Developing comment will be made public, you are • For written/paper comments
Drugs for Treatment of Cutaneous solely responsible for ensuring that your submitted to the Dockets Management
Manifestations.’’ The purpose of this comment does not include any Staff, FDA will post your comment, as
draft guidance is to assist sponsors with confidential information that you or a well as any attachments, except for
the development of drugs for treatment third party may not wish to be posted, information submitted, marked and
VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1](https://thefederalregister.org/doc/83_FR_28357/page/1.svg)
![Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28241
identified, as confidential, if submitted and Drug Administration, 10001 New III. Electronic Access
as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Persons with access to the internet
Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– may obtain the draft guidance at https://
must include the Docket No. FDA– 0002, or Office of Communication, www.fda.gov/Drugs/
2018–D–2016 for ‘‘Epidermolysis Outreach, and Development, Center for GuidanceCompliance
Bullosa: Developing Drugs for Biologics Evaluation and Research, RegulatoryInformation/Guidances/
Treatment of Cutaneous Manifestations; Food and Drug Administration, 10903 default.htm, https://www.fda.gov/
Draft Guidance for Industry.’’ Received New Hampshire Ave., Bldg. 71, Rm. BiologicsBloodVaccines/
comments will be placed in the docket 3128, Silver Spring, MD 20993–0002.
and, except for those submitted as GuidanceCompliance
Send one self-addressed adhesive label RegulatoryInformation/default.htm, or
‘‘Confidential Submissions,’’ publicly to assist that office in processing your
viewable at https://www.regulations.gov https://www.regulations.gov.
requests. See the SUPPLEMENTARY
or at the Dockets Management Staff INFORMATION section for electronic Dated: June 12, 2018.
between 9 a.m. and 4 p.m., Monday access to the draft guidance document. Leslie Kux,
through Friday. Associate Commissioner for Policy.
• Confidential Submissions—To FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–12976 Filed 6–15–18; 8:45 am]
submit a comment with confidential Barbara Gould, Center for Drug
Evaluation and Research, Food and BILLING CODE 4164–01–P
information that you do not wish to be
made publicly available, submit your Drug Administration, 10903 New
comments only as a written/paper Hampshire Ave., Bldg. 22, Rm. 5166,
DEPARTMENT OF HEALTH AND
submission. You should submit two Silver Spring, MD 20993–0002, 301–
HUMAN SERVICES
copies total. One copy will include the 796–4224; or Stephen Ripley, Center for
information you claim to be confidential Biologics Evaluation and Research, Food and Drug Administration
with a heading or cover note that states Food and Drug Administration, 10903
‘‘THIS DOCUMENT CONTAINS New Hampshire Ave., Bldg. 71, Rm. [Docket No. FDA–2016–D–2569]
CONFIDENTIAL INFORMATION.’’ The 7301, Silver Spring, MD 20993–0002,
Agency will review this copy, including 240–402–7911. S9 Nonclinical Evaluation for
the claimed confidential information, in Anticancer Pharmaceuticals—
SUPPLEMENTARY INFORMATION:
its consideration of comments. The Questions and Answers; International
second copy, which will have the I. Background Council for Harmonisation; Guidance
claimed confidential information for Industry; Availability
FDA is announcing the availability of
redacted/blacked out, will be available a draft guidance for industry entitled AGENCY: Food and Drug Administration,
for public viewing and posted on ‘‘Epidermolysis Bullosa: Developing HHS.
https://www.regulations.gov. Submit Drugs for Treatment of Cutaneous
both copies to the Dockets Management ACTION: Notice of availability.
Manifestations.’’ The purpose of this
Staff. If you do not wish your name and draft guidance is to assist sponsors with SUMMARY: The Food and Drug
contact information to be made publicly the development of drugs for treatment Administration (FDA or Agency) is
available, you can provide this or prevention of the serious cutaneous announcing the availability of a final
information on the cover sheet and not manifestations of the heterogeneous guidance for industry entitled ‘‘S9
in the body of your comments and you group of disorders collectively known as Nonclinical Evaluation for Anticancer
must identify this information as EB. There is an unmet medical need for Pharmaceuticals—Questions and
‘‘confidential.’’ Any information marked EB patients due to the paucity of Answers.’’ The guidance was prepared
as ‘‘confidential’’ will not be disclosed under the auspices of the International
effective treatment options.
except in accordance with 21 CFR 10.20 Council for Harmonisation of Technical
and other applicable disclosure law. For This draft guidance is being issued
consistent with FDA’s good guidance Requirements for Pharmaceuticals for
more information about FDA’s posting Human Use (ICH), formerly the
of comments to public dockets, see 80 practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will International Conference on
FR 56469, September 18, 2015, or access Harmonisation of Technical
the information at: https://www.gpo.gov/ represent the current thinking of FDA
on ‘‘Epidermolysis Bullosa: Developing Requirements for Registration of
fdsys/pkg/FR-2015-09-18/pdf/2015- Pharmaceuticals for Human Use. The
23389.pdf. Drugs for Treatment of Cutaneous
Manifestations.’’ It does not establish guidance consists of questions and
Docket: For access to the docket to answers that were developed to provide
read background documents or the any rights for any person and is not
binding on FDA or the public. You can additional clarity about anticancer
electronic and written/paper comments pharmaceutical development described
received, go to https:// use an alternative approach if it satisfies
the requirements of the applicable in the ICH guidance ‘‘S9 Nonclinical
www.regulations.gov and insert the Evaluation for Anticancer
docket number, found in brackets in the statutes and regulations. This guidance
is not subject to Executive Order 12866. Pharmaceuticals’’ that was published in
heading of this document, into the 2010 (ICH S9 (2010)), as well as to
‘‘Search’’ box and follow the prompts II. Paperwork Reduction Act of 1995 continue progress in the 3Rs of
and/or go to the Dockets Management Reduction, Refinement, and
Staff, 5630 Fishers Lane, Rm. 1061, This draft guidance refers to
previously approved collections of Replacement in the use of animals.
Rockville, MD 20852.
amozie on DSK3GDR082PROD with NOTICES1
You may submit comments on any information that are subject to review by DATES: The announcement of the
guidance at any time (see 21 CFR the Office of Management and Budget guidance is published in the Federal
10.115(g)(5)). (OMB) under the Paperwork Reduction Register on June 18, 2018.
Submit written requests for single Act of 1995 (44 U.S.C. 3501–3520). The ADDRESSES: You may submit either
copies of the draft guidance to the collections of information in 21 CFR electronic or written comments on
Division of Drug Information, Center for part 312 have been approved under Agency guidances at any time as
Drug Evaluation and Research, Food OMB control number 0910–0014. follows:
VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1](https://thefederalregister.org/doc/83_FR_28357/page/2.svg)
Document Created: 2018-06-18 15:49:56
Document Modified: 2018-06-18 15:49:56
| 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 | Submit either electronic or written comments on the draft guidance by August 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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. | |
| FR Citation | 83 FR 28240 |
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