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copies of the draft guidance to the 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access to the draft guidance document.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a draft guidance for industry entitled 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draft guidance addresses nonclinical 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This draft guidance revises the draft 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 


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