Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42903 

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copies of the draft guidance to the 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, or Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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access to the draft guidance document.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: Julia 

Beaver, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2100, Silver Spring, 

MD 20993–0002, 240–402–0489; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Hematologic Malignancy and 

Oncologic Disease: Considerations for 

Use of Placebos and Blinding in 

Randomized Controlled Clinical Trials 

for Drug Product Development.’’ This 

draft guidance provides 

recommendations to industry regarding 

the use of placebos and blinding in 

randomized controlled clinical trials in 

development programs for drug or 

biological products for the treatment of 

hematologic malignancies and oncologic 

diseases regulated by CDER and CBER. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 the use of placebos and blinding in 

randomized controlled clinical trials for 

drug product development for 

hematologic malignancy and oncologic 

disease. 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 draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 Application) 

has been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR parts 50 and 56 

(Protection of Human Subjects: 

Informed Consent; Institutional Review 

Boards) have been approved under OMB 

control number 0910–0755. 

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, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: August 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18339 Filed 8–23–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3030] 

Site Visit Training Program for Office 

of Pharmaceutical Quality Staff; 

Information Available to Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Center for Drug 

Evaluation and Research (CDER) in the 

Food and Drug Administration (FDA) is 

announcing the Fiscal Year 2019 CDER 

Office of Pharmaceutical Quality (OPQ) 

Staff Experiential Learning Site Visit 

Program. The purpose of this document 

is to invite pharmaceutical companies 

interested in participating in this 

program to submit a site visit proposal 

to CDER’s OPQ. 

DATES: Submit either an electronic or 

written proposal to participate in this 

program by November 23, 2018. See 

section IV of this document for 

information on what to include in such 

proposals. 

FOR FURTHER INFORMATION CONTACT: 

Janet Wilson, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4642, Silver Spring, 

MD 20993–0002, 240–402–3969, email: 

CDEROPQSiteVisits@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A critical part of the commitment by 

CDER to make safe and effective highquality drugs available to the American 

public is gaining an understanding of all 

aspects of a drug’s development and 

commercial life cycle, including the 

variety of drug manufacturing 

operations. To support this 

commitment, CDER has initiated 

various training and development 

programs including the FY2019 

Experiential Learning Site Visit 

program. This site visit program is 

designed to offer experiential and 

firsthand learning opportunities that 

will provide OPQ staff with a better 

understanding of the pharmaceutical 

industry and its operations, as well as 

the challenges that impact a drug’s 

developmental program and commercial 

life cycle. The goal of these visits is to 

enhance OPQ staff exposure to the drug 

development and manufacturing 

processes in industry; therefore, a tour 

of pharmaceutical company facilities, 

including manufacturing and laboratory 

operations, is an integral part of the 

experience. 

II. The Site Visit Program 

In this site visit program, groups on 

average of 15 to 20 OPQ staff—who have 

experience in a variety of backgrounds, 

including science, medicine, statistics, 

manufacturing, engineering, testing, and 

project management—will observe 

operations of commercial 

manufacturing, pilot plants (if 

applicable), and testing over a 1- to 2- 

day period. To facilitate the learning 

process for OPQ staff, overview 

presentations by industry related to 

drug development, manufacturing and 

testing may be included. 

OPQ encourages companies engaging 

in the development and manufacturing 

of both active pharmaceutical 

ingredients (small and large molecules) 

and drug products to respond. Please 

note that this site visit program is not 

intended to supplement or replace a 

regulatory inspection, e.g., a 

preapproval inspection, prelicense 

inspection, or a surveillance inspection. 


daltland on DSKBBV9HB2PROD with NOTICES
42904 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 

OPQ staff participating in this 

program will benefit by gaining a better 

understanding of current industry 

practices, processes, and procedures. 

Participating sites will have an 

opportunity to showcase their 

technologies and their actual 

manufacturing and testing facilities. 

Although observation of all aspects of 

drug development and production 

would be beneficial to OPQ staff, OPQ 

has identified a number of areas of 

particular interest to its staff. The 

following list identifies some examples 

of these areas but is not intended to be 

exhaustive, mutually exclusive, or to 

limit industry response: 

• Drug products 

Æ Solutions, suspensions, emulsions, 

and semisolids 

Æ Modified- and immediate-release 

formulations 

Æ Drug-device combination products 

(e.g., inhalation products, transdermal 

systems, implants intended for drug 

delivery, and prefilled syringes) 

• Active pharmaceutical ingredients 

manufactured by 

Æ Chemical synthesis 

Æ Fermentation 

Æ Biotechnology 

• Design, development, manufacturing 

and controls 

Æ Engineering controls for aseptic 

processes 

Æ Novel delivery technologies 

Æ Hot melt extrusion 

Æ Soft-gel encapsulation 

Æ Lyophilization 

Æ Blow-Fill-Seal and isolators 

Æ Spray-drying 

Æ Process analytical technology, 

measurement systems, and real-time 

release testing 

• Emerging technologies 

Æ Continuous manufacturing 

Æ 3-dimensional printing 

Æ Nanotechnology 

III. Site Selection 

Selection of potential facilities will be 

based on the priorities developed for 

OPQ staff training, the facility’s current 

compliance status with FDA, and in 

consultation with the appropriate FDA 

district office. All travel expenses 

associated with this program will be the 

responsibility of OPQ; therefore, 

selection will be based on the 

availability of funds and resources for 

the fiscal year. OPQ will not provide 

financial compensation to the 

pharmaceutical site as part of this 

program. 

IV. Proposals for Participation 

Companies interested in offering a site 

visit or learning more about this site 

visit program should respond by 

submitting a proposal directly to Janet 

Wilson (see DATES and FOR FURTHER

INFORMATION CONTACT sections of this 

document for more information). To aid 

in OPQ’s site selection and planning, 

your proposal should include the 

information below: 

• A contact person, 

• Site visit location(s), 

• Facility Establishment Identifier 

and Data Universal Numbering System 

numbers, as applicable, 

• Maximum number of FDA staff that 

can be accommodated during a site visit 

(maximum of 20), 

• A proposed agenda outlining the 

learning objectives and associated 

activities for the site visit, 

• Maximum number of site visits (no 

more than 2) that your site would be 

willing to host by the close of the 

government fiscal year, September 30, 

2019, and 

• Proposed dates for each site visit 

(i.e. month and week). 

Please note that the requested 

proposed agenda will be reviewed to 

determine the educational benefit to 

OPQ in conducting the visit, and 

selected sites may be asked to refine the 

agenda to maximize the educational 

benefit. After a site is selected, OPQ will 

communicate with the contact person 

for the site to determine the actual dates 

for the visit. 

Proposals submitted without this 

minimum information will not be 

considered. Based on response rate and 

type of responses, OPQ may or may not 

consider alternative pathways to 

meeting our training goals. 

Dated: August 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18305 Filed 8–23–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0567] 

Designating Additions to the Current 

List of Tropical Diseases in the Federal 

Food, Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Federal Food, Drug, and 

Cosmetic Act (FD&C Act) authorizes the 

Food and Drug Administration (FDA or 

Agency) to award priority review 

vouchers (PRVs) to tropical disease 

product applicants when the 

applications meet certain criteria. The 

FD&C Act lists the diseases that are 

considered tropical diseases for 

purposes of obtaining PRVs and 

provides for Agency expansion of that 

list to include other diseases that satisfy 

the definition of ‘‘tropical diseases’’ as 

set forth in the FD&C Act. The Agency 

has determined that chikungunya virus 

disease, Lassa fever, rabies, and 

cryptococcal meningitis satisfy this 

definition and is therefore adding them 

to the list of designated tropical diseases 

whose product applications may result 

in the award of PRVs. Sponsors 

submitting certain drug or biological 

product applications for the prevention 

or treatment of chikungunya virus 

disease, Lassa fever, rabies, and 

cryptococcal meningitis may be eligible 

to receive a PRV if such applications are 

approved by FDA. 

DATES: This order is effective August 24, 

2018. 

ADDRESSES: Submit electronic 

comments on additional diseases 

suggested for designation to https://

www.regulations.gov. Submit written 

comments on additional diseases 

suggested for designation to the Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

All comments should be identified with 

the docket number found in brackets in 

the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Schumann, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6242, 

Silver Spring, MD 20993–0002, 301– 

796–1300, Katherine.Schumann@

fda.hhs.gov; or Office of 

Communication, Outreach and 

Development (OCOD), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 1–800–835–4709 or 240– 

402–8010, ocod@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background: Priority Review Voucher 

Program 

II. Diseases Being Designated 

A. Chikungunya Virus Disease 

B. Lassa Fever 

C. Rabies 

D. Cryptococcal Meningitis 

III. Process for Requesting Additional 

Diseases To Be Added to the List 

IV. Paperwork Reduction Act 

V. References 


daltland on DSKBBV9HB2PROD with NOTICES