[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58724-58726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23926]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-4042]
Chronic Hepatitis D Virus Infection: Developing Drugs for
Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Chronic
Hepatitis D Virus Infection: Developing Drugs for Treatment.'' The
purpose of this draft guidance is to assist sponsors in all phases of
development of antiviral drugs for the treatment of chronic hepatitis D
virus (HDV) infection. This guidance is intended to provide consistent
FDA advice to stakeholders regarding HDV drug development strategies.
DATES: Submit either electronic or written comments on the draft
guidance by December 31, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
[[Page 58725]]
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-2019-D-4042 for ``Chronic Hepatitis D Virus Infection: 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.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 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: Aimee Hodowanec, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6341, Silver Spring, MD 20993-0002, 240-
402-5752.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Chronic Hepatitis D Virus Infection: Developing Drugs for
Treatment.'' The purpose of this draft guidance for industry is to
provide consistent recommendations for the development of antiviral
drugs for the treatment of chronic HDV infection. The guidance
addresses all phases of drug development, from nonclinical
considerations to phase 3 trial design recommendations.
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 ``Chronic
Hepatitis D Virus Infection: 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.
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 (PRA) (44 U.S.C. 3501-3520).
The collection of information in 21 CFR part 314 for the submission of
new drug applications (NDAs) has been approved under OMB control number
0910-0001. The submission of biologics license applications (BLAs) has
been approved under OMB control number 0910-0338. The collection of
information in 21 CFR part 312, including submissions under subpart E,
has been approved under OMB control number 0910-0014. The submission of
prescription drug labeling under 21 CFR 201.56 and 201.57 has been
approved under OMB control number 0910-0572. The submission of
medication guides under 21 CFR part 208 has been approved under OMB
control number 0910-0393. The submission of prescription drug
advertisements under 21 CFR 202.1 has been approved under OMB control
number 0910-0686.
The collection of information in the guidance for industry entitled
``Formal Meetings between the FDA and Sponsors or Applicants of PDUFA
(Prescription Drug User Fee Act) Products'' (available at https://www.fda.gov/media/109951/download), including requests for pre-NDA and
pre-BLA meetings and other meetings, has been approved under OMB
control number 0910-0429. The collection of information in the guidance
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' (available at https://www.fda.gov/media/86377/download),
[[Page 58726]]
including fast track designation, breakthrough therapy designation,
accelerated approval, and priority review designation, has been
approved under OMB control number 0910-0765.
In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment and obtain OMB
approval for any information collections recommended in this guidance
that are new or that would represent material modifications to those
previously approved collections of information found in FDA regulations
or guidances.
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: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23926 Filed 10-31-19; 8:45 am]
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