30752 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

The Quality Metrics Site Visit 

Program does not supplement or replace 

a regulatory inspection (e.g., a 

preapproval inspection, pre-license 

inspection, or a surveillance 

inspection). 

III. Site Selection 

Selection of potential facilities will be 

based on the priorities developed for 

CDER and CBER 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 

FDA; therefore, selection will be based 

on the availability of funds and 

resources for the fiscal year. FDA 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 Tara 

Gooen Bizjak or Stephen Ripley (see FOR

FURTHER INFORMATION CONTACT). To aid 

in FDA’s site selection and planning, 

your proposal should include the 

following information: 

• 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 10), 

• a description of the development, 

history, and ongoing management of the 

quality metrics program; 

• a sample agenda outlining the 

proposed learning objectives and 

associated activities for the site visit; 

and 

• preferred dates for a quality metrics 

site visit. 

Proposals submitted without this 

minimum information will not be 

considered. 

Dated: June 25, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14006 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1772] 

Oncology Therapeutic 

Radiopharmaceuticals: Nonclinical 

Studies and Labeling 

Recommendations; Draft Guidance for 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 

‘‘Oncology Therapeutic 

Radiopharmaceuticals: Nonclinical 

Studies and Labeling 

Recommendations.’’ The purpose of this 

draft guidance is to assist sponsors in 

designing appropriate nonclinical 

studies before initiation of first-inhuman (FIH) trials and through product 

approval. In addition, this draft 

guidance provides recommendations for 

product labeling, such as duration of 

contraception to minimize potential risk 

to a developing embryo/fetus and 

recommendations for lactating women 

to minimize potential risk to a nursing 

infant. This draft guidance intends to 

provide recommendations for 

nonclinical programs in a unique and 

challenging area of product 

development, provide a more consistent 

approach in nonclinical studies and 

product labeling, and reduce the 

conduct of nonclinical studies that are 

not informative for product use. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 28, 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–1772 for ‘‘Oncology 

Therapeutic Radiopharmaceuticals: 

Nonclinical Studies and Labeling 

Recommendations; 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30753 

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)). 

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: 

Haleh Saber, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2117, Silver Spring, 

MD 20993–0002, 301–796–7550, or John 

Leighton, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2204, Silver Spring, 

MD 20993–0002, 301–796–7550. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Oncology Therapeutic 

Radiopharmaceuticals: Nonclinical 

Studies and Labeling 

Recommendations.’’ This draft guidance 

presents FDA’s current thinking on 

nonclinical studies needed to support 

FIH studies and for approval for 

therapeutic radiopharmaceuticals. In 

this draft guidance, the term therapeutic 

radiopharmaceutical refers to a 

pharmaceutical that contains a 

radionuclide and is used in patients 

with cancer for the treatment or for 

palliation of tumor-related symptoms 

(e.g., pain). This draft guidance 

discusses the following concepts: (1) 

Evaluation of toxicities from the ligand; 

(2) evaluation of radiation toxicities; 

and (3) information for product labeling 

as related to reproductive toxicity, 

genotoxicity, carcinogenicity, 

contraception, and use in lactating 

women. 

Currently, no FDA or International 

Council for Harmonisation guidance 

addresses nonclinical studies 

supporting FIH trials and approval for 

radiopharmaceuticals for treatment of 

cancer. The guidance for industry 

entitled ‘‘Nonclinical Evaluation of Late 

Radiation Toxicity of Therapeutic 

Radiopharmaceuticals’’ (available at 

https://www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM079242.pdf) describes nonclinical 

studies to address late radiation toxicity 

only. This draft guidance provides 

further clarification of recommendations 

made in that guidance for the timing 

and design of late radiation toxicity 

studies. This draft guidance intends to 

bring consistency in nonclinical safety 

assessment and in product labeling for 

therapeutic radiopharmaceuticals and to 

reduce the number of nonclinical 

studies that are not informative for 

product use. 

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 nonclinical studies and labeling 

recommendations for oncology 

therapeutic radiopharmaceuticals. 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 312.23(a)(8) for 

submitting pharmacological and 

toxicology information has been 

approved under OMB control number 

0910–0014; the collection of 

information in 21 CFR 201.56 and 

201.57 for preparing human 

prescription drug labeling has been 

approved under OMB control number 

0910–0572; and the collection of 

information in the ‘‘Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products; 

Requirements for Pregnancy and 

Lactation Labeling’’ final rule has been 

approved under OMB control number 

0910–0624. 

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: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14055 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0793] 

Sun Pharmaceutical Industries, Ltd., 

and Sun Pharma Global FZE; 

Withdrawal of Approval of Four 

Abbreviated New Drug Applications; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on March 14, 2018. The notice 

announced the voluntary withdrawal of 

approval of four abbreviated new drug 

applications (ANDAs) from two 

applicants, effective April 13, 2018. In 

particular, the notice indicated that FDA 

was withdrawing approval of the 

following ANDA after receiving a 

withdrawal request from Sun 

Pharmaceutical Industries, Ltd., c/o Sun 

Pharmaceutical Industries, Inc. (Sun 

Pharmaceutical), 2 Independence Way, 

Princeton, NJ 08540: ANDA 076045, 

Lorazepam Tablets USP, 0.5 milligram 

(mg), 1 mg, and 2 mg. Before withdrawal 

of this ANDA became effective, 

however, Sun Pharmaceutical informed 

FDA that it did not want approval of the 

ANDA withdrawn. Because Sun 

Pharmaceutical timely requested that 

approval of this ANDA not be 

withdrawn, the approval of ANDA 

076045 is still in effect. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 


sradovich on DSK3GMQ082PROD with NOTICES