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copies of the draft guidance to the 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access to the draft guidance document.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a draft guidance for industry entitled 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 This draft guidance 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this draft guidance, the term therapeutic 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
30754 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Wednesday, March 

14, 2018 (83 FR 11208), appearing on 

page 11208 in FR Doc. 2018–05120, the 

following correction is made: 

1. On page 11208, the entry for ANDA 

076045 in the table is removed. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14050 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Faculty Loan Repayment 

Program, OMB No. 0915–0150— 

Extension 

AGENCY: Health Resources and Services 

Administration, (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than July 30, 2018. 

ADDRESSES: Submit your comments 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Faculty Loan Repayment Program OMB 

No. 0915–0150—Extension. 

Abstract: HRSA administers the 

Faculty Loan Repayment Program 

(FLRP). FLRP provides degree-trained 

health professionals from disadvantaged 

backgrounds based on environmental 

and/or economic factors the opportunity 

to enter into a contract with HHS in 

exchange for the repayment of 

qualifying educational loans for a 

minimum of 2 years of service as a fulltime or part-time faculty member at 

eligible health professions schools. 

Need and Proposed Use of the 

Information: The information collected 

will be used to evaluate applicants’ 

eligibility to participate in FLRP and to 

monitor FLRP-related activities. 

Likely Respondents: FLRP applicants 

and institutions providing employment 

to the applicants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Eligible Applications ............................................................. 111 1 111 1.00 111.00 

Institution/Loan Repayment Employment Form * ................ 111 1 111 1.00 111.00 

Authorization to Release Information Form ......................... 111 1 111 0.25 27.75 

Total .............................................................................. 333 ........................ ........................ ........................ 249.75 

* Respondent for this form is the institution for the applicant. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–13955 Filed 6–28–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Cell and Molecular Biology. 

Date: July 11–12, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Amy Kathleen Wernimont, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6198, 

Bethesda, MD 20892, 301–827–6427, 

amy.wernimont@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: AIDS and AIDS Related Research. 

Date: July 13, 2018. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 


sradovich on DSK3GMQ082PROD with NOTICES