83 FR 55187 - Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 213 (November 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 213 (November 2, 2018)
| Page Range | 55187-55188 | |
| FR Document | 2018-23951 |
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)] [Notices] [Pages 55187-55188] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23951] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3903] Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and postmarketing phases. DATES: Submit either electronic or written comments on the draft guidance by January 2, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-3903 for ``Chronic Hepatitis B 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 [[Page 55188]] 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: Poonam Mishra, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6100, Silver Spring, MD 20993, 301-796- 1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic HBV infection from the initial IND through the NDA/BLA and postmarketing phases. The guidance includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials. The guidance discusses phase 3 trial design considerations and efficacy endpoints for the development of combination therapies for the treatment of chronic HBV infection. Drug development considerations for specific subpopulations such as patients coinfected with hepatitis D virus or human immunodeficiency virus and pediatric HBV-infected patients are also included. 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 B 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. 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 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 collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The submission of prescription drug labeling under 21 CFR 201.56 and 201.57 has been approved under OMB control number 0910-0572. 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, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23951 Filed 11-1-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices 55187
Additionally, an estimated 996 local Implementation grant, a competitive NWD local-level entities, for an annual
agencies will take approximately three funding opportunity funded in 2016 burden of 2,400 hours. This burden
hours to collect the data and one hour through 2018. Each state entity estimate is calculated based upon
to submit the data to their lead NWD submitting data will receive local-level information provided by a current VDC
System state agency. If all state and data from designated NWD System program provider testing a
local agencies respond bi-annually, the entities. The estimated response burden demonstration of the VDC tool. The
national burden estimate for the NWD includes time to review the instructions, NWD MT and the VDC tool have been
MT would be a total of 8,080 hours gather existing information, and developed to increase ease and
annually. This burden estimate is complete and review the data entries in uniformity of reporting and improve the
calculated based upon a sample of three a web-based system. ability of ACL to manage and analyze
states that tested a demonstration of the An estimated 400 VDC program
data.
NWD MT as a part of the grantee entities will respond to the VDC Tool on
requirements under the NWD System a monthly basis, all of which are also
Responses
Number of Hours per Annual burden
Respondent/data collection activity per
respondents response hours
respondent
NWD Management Tool data collection and entry—State Level .................... 56 2 1.0 112
NWD Management Tool data collection and entry—Local Level ................... 996 2 4.0 7,968
Veteran Directed Care Tool ............................................................................. 400 12 0.5 2,400
Total: ......................................................................................................... 1,452 ........................ ........................ 10,480
Dated: October 23, 2018. Electronic Submissions information submitted, marked and
Mary Lazare, Submit electronic comments in the identified, as confidential, if submitted
Principal Deputy Administrator. following way: as detailed in ‘‘Instructions.’’
[FR Doc. 2018–24053 Filed 11–1–18; 8:45 am] • Federal eRulemaking Portal: Instructions: All submissions received
BILLING CODE 4154–01–P https://www.regulations.gov. Follow the must include the Docket No. FDA–
instructions for submitting comments. 2018–D–3903 for ‘‘Chronic Hepatitis B
Comments submitted electronically, Virus Infection: Developing Drugs for
DEPARTMENT OF HEALTH AND including attachments, to https:// Treatment.’’ Received comments will be
HUMAN SERVICES www.regulations.gov will be posted to placed in the docket and, except for
the docket unchanged. Because your those submitted as ‘‘Confidential
Food and Drug Administration comment will be made public, you are Submissions,’’ publicly viewable at
[Docket No. FDA–2018–D–3903] solely responsible for ensuring that your https://www.regulations.gov or at the
comment does not include any Dockets Management Staff between 9
Chronic Hepatitis B Virus Infection: confidential information that you or a a.m. and 4 p.m., Monday through
Developing Drugs for Treatment; Draft third party may not wish to be posted, Friday.
Guidance for Industry; Availability such as medical information, your or • Confidential Submissions—To
anyone else’s Social Security number, or submit a comment with confidential
AGENCY: Food and Drug Administration,
confidential business information, such information that you do not wish to be
HHS.
as a manufacturing process. Please note made publicly available, submit your
ACTION: Notice of availability. that if you include your name, contact comments only as a written/paper
SUMMARY: The Food and Drug information, or other information that submission. You should submit two
Administration (FDA or Agency) is identifies you in the body of your copies total. One copy will include the
announcing the availability of a draft comments, that information will be information you claim to be confidential
guidance for industry entitled ‘‘Chronic posted on https://www.regulations.gov. with a heading or cover note that states
Hepatitis B Virus Infection: Developing • If you want to submit a comment ‘‘THIS DOCUMENT CONTAINS
Drugs for Treatment.’’ The purpose of with confidential information that you CONFIDENTIAL INFORMATION.’’ The
this guidance is to assist sponsors in the do not wish to be made available to the Agency will review this copy, including
clinical development of drugs and public, submit the comment as a the claimed confidential information, in
biologics for the treatment of chronic written/paper submission and in the its consideration of comments. The
hepatitis B virus (HBV) infection from manner detailed (see ‘‘Written/Paper second copy, which will have the
the initial investigational new drug Submissions’’ and ‘‘Instructions’’). claimed confidential information
application (IND) through the new drug redacted/blacked out, will be available
Written/Paper Submissions for public viewing and posted on
application (NDA)/biologics license
application (BLA) and postmarketing Submit written/paper submissions as https://www.regulations.gov. Submit
phases. follows: both copies to the Dockets Management
• Mail/Hand Delivery/Courier (for Staff. If you do not wish your name and
DATES: Submit either electronic or written/paper submissions): Dockets contact information to be made publicly
written comments on the draft guidance Management Staff (HFA–305), Food and available, you can provide this
by January 2, 2019 to ensure that the Drug Administration, 5630 Fishers information on the cover sheet and not
Agency considers your comment on this Lane, Rm. 1061, Rockville, MD 20852. in the body of your comments and you
draft guidance before it begins work on • For written/paper comments must identify this information as
the final version of the guidance. submitted to the Dockets Management ‘‘confidential.’’ Any information marked
ADDRESSES: You may submit comments Staff, FDA will post your comment, as as ‘‘confidential’’ will not be disclosed
on any guidance at any time as follows: well as any attachments, except for except in accordance with 21 CFR 10.20
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![55188 Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
and other applicable disclosure law. For pediatric HBV-infected patients are also DATES: The public workshop will be
more information about FDA’s posting included. held on December 6, 2018, from 8:30
of comments to public dockets, see 80 This draft guidance is being issued a.m. to 4:30 p.m. See the
FR 56469, September 18, 2015, or access consistent with FDA’s good guidance SUPPLEMENTARY INFORMATION section for
the information at: https://www.gpo.gov/ practices regulation (21 CFR 10.115). registration date and information.
fdsys/pkg/FR-2015-09-18/pdf/2015- The draft guidance, when finalized, will ADDRESSES: The public workshop will
23389.pdf. represent the current thinking of FDA be held at FDA’s White Oak Campus,
Docket: For access to the docket to on ‘‘Chronic Hepatitis B Virus Infection: 10903 New Hampshire Ave., Bldg. 31
read background documents or the Developing Drugs for Treatment.’’ It Conference Center, the Great Room (Rm.
electronic and written/paper comments does not establish any rights for any 1503), Silver Spring, MD 20993–0002.
received, go to https:// person and is not binding on FDA or the Entrance for the public workshop
www.regulations.gov and insert the public. You can use an alternative participants (non-FDA employees) is
docket number, found in brackets in the approach if it satisfies the requirements through Building 1 where routine
heading of this document, into the of the applicable statutes and security check procedures will be
‘‘Search’’ box and follow the prompts regulations. This guidance is not subject performed. For parking and security
and/or go to the Dockets Management to Executive Order 12866. information, please refer to https://
Staff, 5630 Fishers Lane, Rm. 1061, II. Paperwork Reduction Act of 1995 www.fda.gov/AboutFDA/Workingat
Rockville, MD 20852. FDA/BuildingsandFacilities/
This guidance refers to previously WhiteOakCampusInformation/
You may submit comments on any
approved collections of information that ucm241740.htm.
guidance at any time (see 21 CFR
are subject to review by the Office of Docket: For access to the docket to
10.115(g)(5)).
Management and Budget (OMB) under read background documents go to
Submit written requests for single the Paperwork Reduction Act of 1995
copies of the draft guidance to the https://www.regulations.gov and insert
(PRA) (44 U.S.C. 3501–3520). The the docket number, found in brackets in
Division of Drug Information, Center for collections of information in 21 CFR
Drug Evaluation and Research, Food the heading of this document, into the
parts 312 and 314 have been approved ‘‘Search’’ box and follow the prompts
and Drug Administration, 10001 New under OMB control numbers 0910–0014
Hampshire Ave., Hillandale Building, and/or go to the Dockets Management
and 0910–0001, respectively. The Staff, 5630 Fishers Lane, Rm. 1061,
4th Floor, Silver Spring, MD 20993– submission of prescription drug labeling
0002. Send one self-addressed adhesive Rockville, MD 20852.
under 21 CFR 201.56 and 201.57 has
label to assist that office in processing FOR FURTHER INFORMATION CONTACT: Joan
been approved under OMB control
your requests. See the SUPPLEMENTARY Ferlo Todd, Food and Drug
number 0910–0572.
INFORMATION section for electronic Administration, Center for Drug
access to the draft guidance document. III. Electronic Access Evaluation and Research, Office of
Persons with access to the internet Hematology and Oncology Products,
FOR FURTHER INFORMATION CONTACT:
may obtain the draft guidance at either 10903 New Hampshire Ave., Bldg. 22,
Poonam Mishra, Center for Drug
https://www.fda.gov/Drugs/Guidance Rm. 2139, Silver Spring, MD 20993–
Evaluation and Research, Food and
ComplianceRegulatoryInformation/ 0002, 301–796–6079, Joan.Todd@
Drug Administration, 10903 New
Guidances/default.htm or https:// fda.hhs.gov.
Hampshire Ave., Bldg. 22, Rm. 6100,
Silver Spring, MD 20993, 301–796– www.regulations.gov. SUPPLEMENTARY INFORMATION:
1500. Dated: October 29, 2018. I. Background
SUPPLEMENTARY INFORMATION: Leslie Kux,
Hemophilia is a bleeding disorder
Associate Commissioner for Policy. caused by deficiency of coagulation
I. Background [FR Doc. 2018–23951 Filed 11–1–18; 8:45 am] factor VIII (hemophilia A) or
FDA is announcing the availability of BILLING CODE 4164–01–P coagulation factor IX (hemophilia B).
a draft guidance for industry entitled Hemophilia treatment strategies are
‘‘Chronic Hepatitis B Virus Infection: intended to prevent or control bleeding
Developing Drugs for Treatment.’’ The DEPARTMENT OF HEALTH AND and the attendant complications.
purpose of this guidance is to assist HUMAN SERVICES Recently, hemophilia treatment
sponsors in the clinical development of strategies have led to the development
Food and Drug Administration
drugs and biologics for the treatment of of factor concentrates, recombinant
chronic HBV infection from the initial [Docket No. FDA–2018–N–3693] DNA technology products, antibodies,
IND through the NDA/BLA and and potential curative strategies such as
postmarketing phases. The guidance Product Development in Hemophilia; gene therapy. These new emerging
includes general considerations for Public Workshop technologies raise new considerations
nonclinical toxicology and virology AGENCY: Food and Drug Administration, about trial design, novel endpoints,
studies, early phase clinical HHS. patient-reported outcomes, and long-
development, clinical pharmacology ACTION: Notice of public workshop. term safety collection.
assessments, and phase 3 safety and This public workshop is intended to
efficacy trials. The guidance discusses SUMMARY: The Food and Drug provide a platform for engaging in a
phase 3 trial design considerations and Administration (FDA, the Agency, or discussion with experts in hemophilia
efficacy endpoints for the development we) is announcing the following public treatment, patients, and caregivers. The
of combination therapies for the workshop entitled ‘‘Product purpose of this workshop is to advance
treatment of chronic HBV infection. Development in Hemophilia.’’ The further development of patient-
Drug development considerations for purpose of the public workshop is to experience and patient-reported
specific subpopulations such as patients discuss issues related to development outcomes for use in clinical trials,
coinfected with hepatitis D virus or and regulation of novel hemophilia facilitate reliable and interpretable
human immunodeficiency virus and products. measurements of factor VIII/IX activity
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Document Created: 2018-11-02 01:10:06
Document Modified: 2018-11-02 01:10:06
| 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 January 2, 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 | Poonam Mishra, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6100, Silver Spring, MD 20993, 301-796- 1500. | |
| FR Citation | 83 FR 55187 |
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