32136 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 19, 2018. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 20, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Philip A. 

Bautista (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: June 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14795 Filed 7–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

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Prevention; Draft Guidance for 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)). 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 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: 

Æ Considerations for preliminary 

assessments of antiviral activity in 

animal models 

Æ Key study design considerations for 

animal efficacy studies to support 

potential NDA/BLA submissions 

under the animal rule 

Æ Selection of an effective dose in 

humans 

• Additional clarification on the 

following: 

Æ Key nonclinical virology issues 

related to drug development under 

the animal rule 

Æ Key pharmacology/toxicology issues 

Æ 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 

Æ Key clinical pharmacology issues that 

may be affected by limitations in 

collecting clinical data 

Æ 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/Guidance

ComplianceRegulatoryInformation/ 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute Cancellation; 

Notice of Meeting 

Notice is hereby given of the 

cancellation of the National Cancer 

Institute Special Emphasis Panel, 

August 7, 2018, 10:00 a.m. to August 7, 

2018, 5:00 p.m., National Cancer 

Institute Shady Grove, 9609 Medical 

Center Drive, 7W260, Rockville, MD 

20850 which was published in the 

Federal Register on June 8, 2018, 83 FR 

26703. 

This meeting has been cancelled due 

to no proposal submissions. 

Dated: July 5, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–14757 Filed 7–10–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–7001–N–35] 

30-Day Notice of Proposed Information 

Collection: Production of Material or 

Provision of Testimony by HUD in 

Response to Demands in Legal 

Proceedings Among Private Litigants 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: HUD is seeking approval from 

the Office of Management and Budget 

(OMB) for the information collection 

described below. In accordance with the 

Paperwork Reduction Act, HUD is 

requesting comment from all interested 

parties on the proposed collection of 


daltland on DSKBBV9HB2PROD with NOTICES