83 FR 32136 - Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 133 (July 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 133 (July 11, 2018)
| Page Range | 32136-32137 | |
| FR Document | 2018-14749 |
[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)] [Notices] [Pages 32136-32137] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14749] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1835] Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance revises the draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention'' issued on November 23, 2007. DATES: Submit either electronic or written comments on the draft guidance by September 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-1835 for ``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability.'' 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)). [[Page 32137]] 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: Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6370, Silver Spring, MD 20993-0002, 301- 796-1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance addresses nonclinical development, key study design considerations for animal efficacy studies to support potential new drug application (NDA)/biologics license application (BLA) submissions under the animal rule (21 CFR part 314, subpart I, for drugs and 21 CFR part 601, subpart H, for biologics), and considerations for obtaining a human safety database. This draft guidance revises the draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention'' issued on November 23, 2007 (72 FR 65750). The revisions intend to streamline the guidance and incorporate input from a public workshop in 2009 and an advisory committee meeting in 2011. This revision contains the following changes: Modification and integration of several sections to focus on multidisciplinary considerations for studies in animal models of orthopoxvirus disease, including: [cir] Considerations for preliminary assessments of antiviral activity in animal models [cir] Key study design considerations for animal efficacy studies to support potential NDA/BLA submissions under the animal rule [cir] Selection of an effective dose in humans Additional clarification on the following: [cir] Key nonclinical virology issues related to drug development under the animal rule [cir] Key pharmacology/toxicology issues [cir] Considerations regarding healthy volunteer safety trials, safety data from non-smallpox clinical experience, clinical trials in the event of a public health emergency, individual patient expanded access investigational new drug applications for emergency use, and emergency use authorization [cir] Key clinical pharmacology issues that may be affected by limitations in collecting clinical data [cir] Key chemistry, manufacturing, and controls issues, such as the importance of developing formulations for patients who are unable to swallow solid oral dosage formulations, as well as the importance of generating stability data needed to support a long expiration dating period 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 developing drugs for the treatment and prevention of smallpox (variola virus) infection. 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. The 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 collection of information in 21 CFR part 312 (investigational new drug applications) has been approved under OMB control number 0910-0014. The collection of information in 21 CFR part 314 (NDAs) has been approved under OMB control number 0910-0001. The collection of information resulting from special protocol assessments has been approved under OMB control number 0910-0470. The collection of information resulting from emergency use authorization of medical products has been approved under OMB control number 0910-0595. The collection of information resulting from individual patient expanded access applications has been approved under OMB control number 0910- 0814. The collection of information resulting from good laboratory practices has been approved under OMB control number 0910-0119. 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: July 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14749 Filed 7-10-18; 8:45 am] BILLING CODE 4164-01-P
![32136 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
making formal oral presentations should SUMMARY: The Food and Drug well as any attachments, except for
notify the contact person and submit a Administration (FDA or Agency) is information submitted, marked and
brief statement of the general nature of announcing the availability of a draft identified, as confidential, if submitted
the evidence or arguments they wish to guidance for industry entitled as detailed in ‘‘Instructions.’’
present, the names and addresses of ‘‘Smallpox (Variola Virus) Infection: Instructions: All submissions received
proposed participants, and an Developing Drugs for Treatment or must include the Docket No. FDA–
indication of the approximate time Prevention.’’ The purpose of this draft 2018–D–1835 for ‘‘Smallpox (Variola
requested to make their presentation on guidance is to assist sponsors in all Virus) Infection: Developing Drugs for
or before July 19, 2018. Time allotted for phases of development of antiviral Treatment or Prevention; Draft
each presentation may be limited. If the drugs for the treatment or prevention of Guidance for Industry; Availability.’’
number of registrants requesting to smallpox (variola virus) infection. This Received comments will be placed in
speak is greater than can be reasonably draft guidance revises the draft guidance the docket and, except for those
accommodated during the scheduled for industry entitled ‘‘Smallpox submitted as ‘‘Confidential
open public hearing session, FDA may (Variola) Infection: Developing Drugs for Submissions,’’ publicly viewable at
conduct a lottery to determine the Treatment or Prevention’’ issued on https://www.regulations.gov or at the
speakers for the scheduled open public November 23, 2007. Dockets Management Staff between 9
hearing session. The contact person will DATES: Submit either electronic or a.m. and 4 p.m., Monday through
notify interested persons regarding their written comments on the draft guidance Friday.
request to speak by July 20, 2018. by September 10, 2018 to ensure that • Confidential Submissions—To
Persons attending FDA’s advisory the Agency considers your comment on submit a comment with confidential
committee meetings are advised that this draft guidance before it begins work information that you do not wish to be
FDA is not responsible for providing on the final version of the guidance. made publicly available, submit your
access to electrical outlets. comments only as a written/paper
ADDRESSES: You may submit comments
For press inquiries, please contact the submission. You should submit two
Office of Media Affairs at fdaoma@ on any guidance at any time as follows:
copies total. One copy will include the
fda.hhs.gov or 301–796–4540. Electronic Submissions information you claim to be confidential
FDA welcomes the attendance of the with a heading or cover note that states
Submit electronic comments in the
public at its advisory committee ‘‘THIS DOCUMENT CONTAINS
following way:
meetings and will make every effort to
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
accommodate persons with disabilities. Agency will review this copy, including
https://www.regulations.gov. Follow the
If you require accommodations due to a the claimed confidential information, in
instructions for submitting comments.
disability, please contact Philip A. its consideration of comments. The
Comments submitted electronically,
Bautista (see FOR FURTHER INFORMATION second copy, which will have the
including attachments, to https://
CONTACT) at least 7 days in advance of claimed confidential information
www.regulations.gov will be posted to
the meeting. redacted/blacked out, will be available
FDA is committed to the orderly the docket unchanged. Because your
comment will be made public, you are for public viewing and posted on
conduct of its advisory committee https://www.regulations.gov. Submit
meetings. Please visit our website at solely responsible for ensuring that your
comment does not include any both copies to the Dockets Management
https://www.fda.gov/ Staff. If you do not wish your name and
AdvisoryCommittees/ confidential information that you or a
third party may not wish to be posted, contact information to be made publicly
AboutAdvisoryCommittees/ available, you can provide this
ucm111462.htm for procedures on such as medical information, your or
anyone else’s Social Security number, or information on the cover sheet and not
public conduct during advisory in the body of your comments and you
committee meetings. confidential business information, such
as a manufacturing process. Please note must identify this information as
Notice of this meeting is given under
that if you include your name, contact ‘‘confidential.’’ Any information marked
the Federal Advisory Committee Act (5
information, or other information that as ‘‘confidential’’ will not be disclosed
U.S.C. app. 2).
identifies you in the body of your except in accordance with 21 CFR 10.20
Dated: June 28, 2018. and other applicable disclosure law. For
comments, that information will be
Leslie Kux, posted on https://www.regulations.gov. more information about FDA’s posting
Associate Commissioner for Policy. • If you want to submit a comment of comments to public dockets, see 80
[FR Doc. 2018–14795 Filed 7–10–18; 8:45 am] with confidential information that you FR 56469, September 18, 2015, or access
BILLING CODE 4164–01–P do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Food and Drug Administration Written/Paper Submissions received, go to https://
[Docket No. FDA–2018–D–1835] Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
Smallpox (Variola Virus) Infection: • Mail/Hand Delivery/Courier (for heading of this document, into the
daltland on DSKBBV9HB2PROD with NOTICES
Developing Drugs for Treatment or Written/Paper Submissions): Dockets ‘‘Search’’ box and follow the prompts
Prevention; Draft Guidance for Management Staff (HFA–305), Food and and/or go to the Dockets Management
Industry; Availability Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
HHS. • For written/paper comments You may submit comments on any
submitted to the Dockets Management guidance at any time (see 21 CFR
ACTION: Notice of availability.
Staff, FDA will post your comment, as 10.115(g)(5)).
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![Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 32137
Submit written requests for single • Additional clarification on the number 0910–0814. The collection of
copies of the draft guidance to the following: information resulting from good
Division of Drug Information, Center for Æ Key nonclinical virology issues laboratory practices has been approved
Drug Evaluation and Research, Food related to drug development under under OMB control number 0910–0119.
and Drug Administration, 10001 New the animal rule III. Electronic Access
Hampshire Ave., Hillandale Building, Æ Key pharmacology/toxicology issues
4th Floor, Silver Spring, MD 20993– Æ Considerations regarding healthy Persons with access to the internet
0002. Send one self-addressed adhesive volunteer safety trials, safety data may obtain the draft guidance at either
label to assist that office in processing from non-smallpox clinical https://www.fda.gov/Drugs/Guidance
your requests. See the SUPPLEMENTARY experience, clinical trials in the event ComplianceRegulatoryInformation/
INFORMATION section for electronic of a public health emergency, Guidances/default.htm or https://
access to the draft guidance document. individual patient expanded access www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: investigational new drug applications Dated: July 2, 2018.
Jeffrey Murray, Center for Drug for emergency use, and emergency use Leslie Kux,
Evaluation and Research, Food and authorization Associate Commissioner for Policy.
Drug Administration, 10903 New Æ Key clinical pharmacology issues that [FR Doc. 2018–14749 Filed 7–10–18; 8:45 am]
Hampshire Ave., Bldg. 22, Rm. 6370, may be affected by limitations in
BILLING CODE 4164–01–P
Silver Spring, MD 20993–0002, 301– collecting clinical data
796–1500. Æ Key chemistry, manufacturing, and
controls issues, such as the DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION:
importance of developing HUMAN SERVICES
I. Background formulations for patients who are
unable to swallow solid oral dosage National Institutes of Health
FDA is announcing the availability of
formulations, as well as the
a draft guidance for industry entitled
importance of generating stability data National Cancer Institute Cancellation;
‘‘Smallpox (Variola Virus) Infection:
needed to support a long expiration Notice of Meeting
Developing Drugs for Treatment or
dating period
Prevention.’’ The purpose of this draft Notice is hereby given of the
guidance is to assist sponsors in all This draft guidance is being issued cancellation of the National Cancer
phases of development of antiviral consistent with FDA’s good guidance Institute Special Emphasis Panel,
drugs for the treatment or prevention of practices regulation (21 CFR 10.115). August 7, 2018, 10:00 a.m. to August 7,
smallpox (variola virus) infection. This The draft guidance, when finalized, will 2018, 5:00 p.m., National Cancer
draft guidance addresses nonclinical represent the current thinking of FDA Institute Shady Grove, 9609 Medical
development, key study design on developing drugs for the treatment Center Drive, 7W260, Rockville, MD
considerations for animal efficacy and prevention of smallpox (variola 20850 which was published in the
studies to support potential new drug virus) infection. It does not establish Federal Register on June 8, 2018, 83 FR
application (NDA)/biologics license any rights for any person and is not 26703.
application (BLA) submissions under binding on FDA or the public. You can This meeting has been cancelled due
the animal rule (21 CFR part 314, use an alternative approach if it satisfies to no proposal submissions.
subpart I, for drugs and 21 CFR part 601, the requirements of the applicable
statutes and regulations. This guidance Dated: July 5, 2018.
subpart H, for biologics), and
is not subject to Executive Order 12866. Melanie J. Pantoja,
considerations for obtaining a human
Program Analyst, Office of Federal Advisory
safety database. II. The Paperwork Reduction Act of Committee Policy.
This draft guidance revises the draft 1995 [FR Doc. 2018–14757 Filed 7–10–18; 8:45 am]
guidance for industry entitled
This draft guidance refers to BILLING CODE 4140–01–P
‘‘Smallpox (Variola) Infection:
previously approved collections of
Developing Drugs for Treatment or
information that are subject to review by
Prevention’’ issued on November 23,
the Office of Management and Budget DEPARTMENT OF HOUSING AND
2007 (72 FR 65750). The revisions
(OMB) under the Paperwork Reduction URBAN DEVELOPMENT
intend to streamline the guidance and
Act of 1995 (44 U.S.C. 3501–3520). The
incorporate input from a public [Docket No. FR–7001–N–35]
collection of information in 21 CFR part
workshop in 2009 and an advisory
312 (investigational new drug
committee meeting in 2011. This 30-Day Notice of Proposed Information
applications) has been approved under
revision contains the following changes: Collection: Production of Material or
OMB control number 0910–0014. The
• Modification and integration of collection of information in 21 CFR part
Provision of Testimony by HUD in
several sections to focus on Response to Demands in Legal
314 (NDAs) has been approved under
multidisciplinary considerations for Proceedings Among Private Litigants
OMB control number 0910–0001. The
studies in animal models of collection of information resulting from AGENCY: Office of the Chief Information
orthopoxvirus disease, including: special protocol assessments has been Officer, HUD.
Æ Considerations for preliminary approved under OMB control number ACTION: Notice.
assessments of antiviral activity in 0910–0470. The collection of
daltland on DSKBBV9HB2PROD with NOTICES
animal models information resulting from emergency SUMMARY: HUD is seeking approval from
Æ Key study design considerations for use authorization of medical products the Office of Management and Budget
animal efficacy studies to support has been approved under OMB control (OMB) for the information collection
potential NDA/BLA submissions number 0910–0595. The collection of described below. In accordance with the
under the animal rule information resulting from individual Paperwork Reduction Act, HUD is
Æ Selection of an effective dose in patient expanded access applications requesting comment from all interested
humans has been approved under OMB control parties on the proposed collection of
VerDate Sep<11>2014 16:26 Jul 10, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1](https://thefederalregister.org/doc/83_FR_32269/page/2.svg)
Document Created: 2018-07-10 23:53:56
Document Modified: 2018-07-10 23:53:56
| 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 September 10, 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 | Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6370, Silver Spring, MD 20993-0002, 301- 796-1500. | |
| FR Citation | 83 FR 32136 |
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