27784 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2156] 

Ferring Pharmaceuticals, Inc.; 

Withdrawal of Approval of Two 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of two 

abbreviated new drug applications 

(ANDAs) from Ferring Pharmaceuticals, 

Inc. (Ferring). Ferring notified the 

Agency in writing that the drug 

products were no longer marketed and 

requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of July 

16, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002, 240–402–7945, 

Trang.Tran@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Ferring 

has informed FDA that the drug 

products listed in the table are no longer 

marketed and has requested that FDA 

withdraw approval of the applications 

under the process described in 

§ 314.150(c) (21 CFR 314.150(c)). 

Ferring has also, by its request, waived 

its opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

Application No. Drug Applicant 

ANDA 073598 ..... Menotropins (follicle-stimulating hormone (FSH)/luteinizing hormone 

(LH)) for Injection, 75 international units (IU)/75 IU per vial.

Ferring Pharmaceuticals, Inc., 100 Interpace Pkwy., 

Parsippany, NJ 07054. 

ANDA 073599 ..... Menotropins (FSH/LH) for Injection, 150 IU/150 IU per vial ................. Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of July 16, 2018. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on July 16, 2018 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12762 Filed 6–13–18; 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; Zika Virus Pilot Project, OMB 

No. 0906–xxxx—NEW 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

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 16, 2018. 

ADDRESSES: Submit your comments, 

including the ICR 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: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference, in compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995. 

Information Collection Request Title: 

Zika Virus Pilot Project, OMB No. 0906– 

xxxx—NEW 

Abstract: HRSA is requesting the 

Organ Procurement and Transplantation 

Network (OPTN) perform a federally 

sponsored data collection as part of a 

pilot project to monitor the testing of 

deceased potential donors possibly 

exposed to the Zika virus (ZIKV). The 

Zika Pilot Project will have a 12-month 

performance period enabling OPTN to 

develop a plan to collect data on ways 

for organ procurement organizations 

(OPOs) to deploy ZIKV donor screening 

tests of blood products. The testing is 

available under an investigational new 

drug application for use on a voluntary 

basis in the evaluation of deceased 

persons as potential solid organ donors. 

OPTN will conduct an analysis of the 

data collected under this project to 

determine the potential effect of making 

available screening tests for ZIKV, when 

appropriate, to improve transplant 

safety. OPTN will convene a group of 

stakeholders to provide guidance and 

monitor progress on the ZIKV pilot 

project. 

Need and Proposed Use of the 

Information: ZIKV is prevalent in 

several areas of the United States. 

Currently, there is not a ZIKV screening 

procedure for OPOs to implement 

during the organ allocation process. 

HRSA requested OPTN to conduct a 

pilot project to monitor the testing of 

deceased donors potentially exposed to 

ZIKV. The goals of the pilot project are 

to: 

• Collaborate with experts to define 

necessary data elements to understand 

the impact of ZIKV testing in deceased 

organ donors; 

• Deploy a data collection tool to a 

limited number of OPOs that agree to 

participate in the pilot project; and 

• Assess the ability of OPTN to 

respond to a public health situation by 

collecting data from impacted members 

of the transplant community to assess 

the national experience. 

Likely Respondents: Organ 

Procurement Organizations. 

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 


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