83 FR 62582 - Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 233 (December 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 233 (December 4, 2018)
| Page Range | 62582-62583 | |
| FR Document | 2018-26333 |
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)] [Notices] [Pages 62582-62583] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26333] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3632] Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. DATES: Submit either electronic or written comments on the draft guidance by February 4, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-3632 for ``Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.'' 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. 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: Evangela Covert, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5234, Silver Spring, MD 20993-0002, 301- 796-4075. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic NASH with liver fibrosis. The draft guidance also identifies knowledge gaps that represent important challenges in [[Page 62583]] the development of drugs for this indication. This draft guidance does not address the clinical development of drugs for the treatment of cirrhosis caused by NASH. 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 ``Non- Cirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment.'' 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 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 part 312 addressing investigational new drug applications and 21 CFR part 314 addressing new drug applications have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The collections of information in 21 CFR parts 50 and 56 (Protection of Human Subjects: Informed Consent; Institutional Review Boards) have been approved under OMB control number 0910-0755. 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: November 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26333 Filed 12-3-18; 8:45 am] BILLING CODE 4164-01-P
![62582 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
§ 60.30, including but not limited to: Comments submitted electronically, claimed confidential information
Must be timely (see DATES), must be including attachments, to https:// redacted/blacked out, will be available
filed in accordance with § 10.20, must www.regulations.gov will be posted to for public viewing and posted on
contain sufficient facts to merit an FDA the docket unchanged. Because your https://www.regulations.gov. Submit
investigation, and must certify that a comment will be made public, you are both copies to the Dockets Management
true and complete copy of the petition solely responsible for ensuring that your Staff. If you do not wish your name and
has been served upon the patent comment does not include any contact information to be made publicly
applicant. (See H. Rept. 857, part 1, 98th confidential information that you or a available, you can provide this
Cong., 2d sess., pp. 41–42, 1984.) third party may not wish to be posted, information on the cover sheet and not
Petitions should be in the format such as medical information, your or in the body of your comments and you
specified in 21 CFR 10.30. anyone else’s Social Security number, or must identify this information as
Submit petitions electronically to confidential business information, such ‘‘confidential.’’ Any information marked
https://www.regulations.gov at Docket as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
No. FDA–2013–S–0610. Submit written that if you include your name, contact except in accordance with 21 CFR 10.20
petitions (two copies are required) to the information, or other information that and other applicable disclosure law. For
Dockets Management Staff (HFA–305), identifies you in the body of your more information about FDA’s posting
Food and Drug Administration, 5630 comments, that information will be of comments to public dockets, see 80
Fishers Lane, Rm. 1061, Rockville, MD posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
20852. • If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Dated: November 28, 2018.
do not wish to be made available to the 23389.pdf.
Leslie Kux, public, submit the comment as a Docket: For access to the docket to
Associate Commissioner for Policy. written/paper submission and in the read background documents or the
[FR Doc. 2018–26290 Filed 12–3–18; 8:45 am] manner detailed (see ‘‘Written/Paper electronic and written/paper comments
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
docket number, found in brackets in the
DEPARTMENT OF HEALTH AND Submit written/paper submissions as
heading of this document, into the
HUMAN SERVICES follows:
‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for
Food and Drug Administration and/or go to the Dockets Management
written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
[Docket No. FDA–2018–D–3632] Management Staff (HFA–305), Food and
Rockville, MD 20852.
Drug Administration, 5630 Fishers
You may submit comments on any
Noncirrhotic Nonalcoholic Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments guidance at any time (see 21 CFR
Steatohepatitis With Liver Fibrosis: 10.115(g)(5)).
Developing Drugs for Treatment; Draft submitted to the Dockets Management
Staff, FDA will post your comment, as Submit written requests for single
Guidance for Industry; Availability copies of the draft guidance to the
well as any attachments, except for
AGENCY: Food and Drug Administration, information submitted, marked and Division of Drug Information, Center for
HHS. identified, as confidential, if submitted Drug Evaluation and Research, Food
ACTION: Notice of availability. as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
Instructions: All submissions received Hampshire Ave., Hillandale Building,
SUMMARY: The Food and Drug must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
Administration (FDA or Agency) is 2018–D–3632 for ‘‘Noncirrhotic 0002. Send one self-addressed adhesive
announcing the availability of a draft Nonalcoholic Steatohepatitis With Liver label to assist that office in processing
guidance for industry entitled Fibrosis: Developing Drugs for your requests. See the SUPPLEMENTARY
‘‘Noncirrhotic Nonalcoholic Treatment.’’ Received comments will be INFORMATION section for electronic
Steatohepatitis With Liver Fibrosis: placed in the docket and, except for access to the draft guidance document.
Developing Drugs for Treatment.’’ This those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
draft guidance is intended to assist Submissions,’’ publicly viewable at Evangela Covert, Center for Drug
sponsors in the clinical development of https://www.regulations.gov or at the Evaluation and Research, Food and
drugs for the treatment of noncirrhotic Dockets Management Staff between 9 Drug Administration, 10903 New
nonalcoholic steatohepatitis (NASH) a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 5234,
with liver fibrosis. Friday. Silver Spring, MD 20993–0002, 301–
DATES: Submit either electronic or • Confidential Submissions—To 796–4075.
written comments on the draft guidance submit a comment with confidential SUPPLEMENTARY INFORMATION:
by February 4, 2019 to ensure that the information that you do not wish to be
Agency considers your comment on this made publicly available, submit your I. Background
draft guidance before it begins work on comments only as a written/paper FDA is announcing the availability of
the final version of the guidance. submission. You should submit two a draft guidance for industry entitled
ADDRESSES: You may submit comments copies total. One copy will include the ‘‘Noncirrhotic Nonalcoholic
on any guidance at any time as follows: information you claim to be confidential Steatohepatitis With Liver Fibrosis:
with a heading or cover note that states Developing Drugs for Treatment.’’ This
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS draft guidance is intended to assist
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The sponsors in the clinical development of
following way: Agency will review this copy, including drugs for the treatment of noncirrhotic
• Federal eRulemaking Portal: the claimed confidential information, in NASH with liver fibrosis. The draft
https://www.regulations.gov. Follow the its consideration of comments. The guidance also identifies knowledge gaps
instructions for submitting comments. second copy, which will have the that represent important challenges in
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![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62583
the development of drugs for this DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
indication. This draft guidance does not HUMAN SERVICES confidential business information, such
address the clinical development of as a manufacturing process. Please note
drugs for the treatment of cirrhosis Food and Drug Administration that if you include your name, contact
caused by NASH. [Docket No. FDA–2015–N–3815] information, or other information that
identifies you in the body of your
This draft guidance is being issued
Agency Information Collection comments, that information will be
consistent with FDA’s good guidance posted on https://www.regulations.gov.
Activities; Proposed Collection;
practices regulation (21 CFR 10.115). • If you want to submit a comment
Comment Request; Electronic
The draft guidance, when finalized, will with confidential information that you
Submission of Medical Device
represent the current thinking of FDA Registration and Listing do not wish to be made available to the
on ‘‘Non-Cirrhotic Nonalcoholic public, submit the comment as a
Steatohepatitis with Liver Fibrosis: AGENCY: Food and Drug Administration, written/paper submission and in the
Developing Drugs for Treatment.’’ It HHS. manner detailed (see ‘‘Written/Paper
does not establish any rights for any ACTION: Notice. Submissions’’ and ‘‘Instructions’’).
person and is not binding on FDA or the Written/Paper Submissions
SUMMARY: The Food and Drug
public. You can use an alternative Administration (FDA or Agency) is
approach if it satisfies the requirements Submit written/paper submissions as
announcing an opportunity for public follows:
of the applicable statutes and comment on the proposed collection of • Mail/Hand delivery/Courier (for
regulations. This guidance is not subject certain information by the Agency. written/paper submissions): Dockets
to Executive Order 12866. Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
II. Paperwork Reduction Act of 1995 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
This draft guidance refers to Federal Register concerning each • For written/paper comments
previously approved collections of proposed collection of information, submitted to the Dockets Management
information found in FDA regulations. including each proposed extension of an Staff, FDA will post your comment, as
These collections of information are existing collection of information, and well as any attachments, except for
subject to review by the Office of to allow 60 days for public comment in information submitted, marked and
Management and Budget (OMB) under response to the notice. This notice identified, as confidential, if submitted
the Paperwork Reduction Act of 1995 solicits comments on information as detailed in ‘‘Instructions.’’
(44 U.S.C. 3501–3520). The collections collection associated with electronic Instructions: All submissions received
of information in 21 CFR part 312 submission of medical device must include the Docket No. FDA–
registration and listing. 2015–N–3815 for ‘‘Agency Information
addressing investigational new drug
DATES: Submit either electronic or Collection Activities; Proposed
applications and 21 CFR part 314
written comments on the collection of Collection; Comment Request;
addressing new drug applications have
information by February 4, 2019. Electronic Submission of Medical
been approved under OMB control Device Registration and Listing.’’
ADDRESSES: You may submit comments
numbers 0910–0014 and 0910–0001, Received comments, those filed in a
respectively. The collections of as follows. Please note that late,
untimely filed comments will not be timely manner (see ADDRESSES), will be
information in 21 CFR parts 50 and 56 placed in the docket and, except for
considered. Electronic comments must
(Protection of Human Subjects: those submitted as ‘‘Confidential
be submitted on or before February 4,
Informed Consent; Institutional Review 2019. The https://www.regulations.gov Submissions,’’ publicly viewable at
Boards) have been approved under OMB electronic filing system will accept https://www.regulations.gov or at the
control number 0910–0755. comments until 11:59 p.m. Eastern Time Dockets Management Staff between 9
III. Electronic Access at the end of February 4, 2019. a.m. and 4 p.m., Monday through
Comments received by mail/hand Friday.
Persons with access to the internet delivery/courier (for written/paper • Confidential Submissions—To
may obtain the draft guidance at either submissions) will be considered timely submit a comment with confidential
https://www.fda.gov/Drugs/ if they are postmarked or the delivery information that you do not wish to be
GuidanceComplianceRegulatory service acceptance receipt is on or made publicly available, submit your
Information/Guidances/default.htm or before that date. comments only as a written/paper
https://www.regulations.gov. submission. You should submit two
Electronic Submissions copies total. One copy will include the
Dated: November 29, 2018. Submit electronic comments in the information you claim to be confidential
Leslie Kux, following way: with a heading or cover note that states
Associate Commissioner for Policy. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2018–26333 Filed 12–3–18; 8:45 am] https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
instructions for submitting comments. Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
such as medical information, your or contact information to be made publicly
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Document Created: 2018-12-04 00:42:38
Document Modified: 2018-12-04 00:42:38
| 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 February 4, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Evangela Covert, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5234, Silver Spring, MD 20993-0002, 301- 796-4075. | |
| FR Citation | 83 FR 62582 |
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