[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32136-32137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Treatment or Prevention; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Smallpox 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 The purpose of this draft guidance is to assist sponsors 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 This draft guidance 
revises the draft guidance for industry entitled ``Smallpox (Variola) 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DATES: Submit either electronic or written comments on the draft 
guidance by September 10, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.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)).

[[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


