42902 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

3397 ............... 155 1.6903 262 0.5 (30 minutes) .................................................................. 131 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 1,724 hours and a 

corresponding decrease of 3,448 

responses. We attribute this program 

change to the restructuring of the 

Prescription Drug Use Fee Program fees. 

The FD&C Act, as amended by the 

Prescription Drug User Fee 

Amendments of 2017 (PDUFA VI), 

authorizes FDA to collect application 

fees for certain applications for the 

review of human drug and biological 

products and discontinued the 

supplement fee. This resulted in the 

removal of supplements from the 

Prescription Drug User Fee Cover Sheet, 

therefore reducing the burden for this 

collection of information. 

Dated: August 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18307 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–D–3092] 

Hematologic Malignancy and 

Oncologic Disease: Considerations for 

Use of Placebos and Blinding in 

Randomized Controlled Clinical Trials 

for Drug Product Development; 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 

‘‘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draft guidance provides 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 the Center for 

Drug Evaluation and Research (CDER) 

and the Center for Biologics Evaluation 

and Research (CBER). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 23, 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–3092 for Hematologic 

Malignancy and Oncologic Disease: 

Considerations for Use of Placebos and 

Blinding in Randomized Controlled 

Clinical Trials for Drug Product 

Development. 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 


daltland on DSKBBV9HB2PROD with NOTICES
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