36604 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

1On April 30, 2018, Bayer filed a submission 

titled ‘‘Request for Clarification of FDA Granting of 

a Petition for Stay of Action.’’ Bayer requested that 

FDA clarify that the stay allowed new 

manufacturing only until May 2, 2018, with 

shipment of product permitted until November 2, 

2018. Breckenridge/Nexgen responded to Bayer’s 

request for clarification and argued that Bayer’s 

submission should have been a petition for 

reconsideration and that it failed to meet the 

standards required for reconsideration. Regardless 

of whether Bayer’s submission should have been a 

petition for reconsideration, FDA’s letter granting 

the stay provides that the order is stayed until 

November 2, 2018, without the limitations Bayer 

now requests. 

click on the Device Registration and 

Listing Module (DRLM) of FURLS 

button. New establishments will need to 

register and existing establishments will 

update their annual registration using 

choices on the DRLM menu. When you 

choose to register or update your annual 

registration, the system will prompt you 

through the entry of information about 

your establishment and your devices. If 

you have any problems with this 

process, email: reglist@cdrh.fda.gov or 

call 301–796–7400 for assistance. (Note: 

This email address and this telephone 

number are for assistance with 

establishment registration only; they are 

not to be used for questions related to 

other aspects of medical device user 

fees.) Problems with the BER system 

should be directed to https://

www.accessdata.fda.gov/scripts/email/ 

cber/bldregcontact.cfm or call 240–402– 

8360. 

D. Enter Your DFUF Order PIN and PCN 

After completing your annual or 

initial registration and device listing, 

you will be prompted to enter your 

DFUF order PIN and PCN, when 

applicable. This process does not apply 

to establishments engaged only in the 

manufacture, preparation, propagation, 

compounding, or processing of licensed 

biologic devices. CBER will send 

invoices for payment of the 

establishment registration fee to such 

establishments. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16178 Filed 7–27–18; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0549] 

Prescription Polyethylene Glycol 3350; 

Denial of a Hearing and Order 

Withdrawing Approval of Abbreviated 

New Drug Applications; Temporary 

Stay of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice that the effective date of an April 

2, 2018, order denying requests for a 

hearing and withdrawing approval of 

abbreviated new drug applications 

(ANDAs) for certain prescription 

laxatives with the active ingredient 

polyethylene glycol 3350 (PEG 3350) is 

stayed until November 2, 2018. 

DATES: FDA is staying the effective date 

of the April 2, 2018, order withdrawing 

approval of ANDAs for certain 

prescription laxatives with the active 

ingredient PEG 3350 until November 2, 

2018. 

ADDRESSES: For access to the docket, 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, 

between 9 a.m. and 4 p.m., Monday 

through Friday. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: Julie 

Finegan, Office of Scientific Integrity, 

Office of the Chief Scientist, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 4218, 

Silver Spring, MD 20993–0002, 301– 

796–8618. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 2, 2018 (83 FR 

13994), FDA denied requests for hearing 

and issued an order withdrawing 

approval of ANDAs for certain 

prescription laxatives with the active 

ingredient PEG 3350. The effective date 

of the order was May 2, 2018. Between 

April 6, 2018, and April 13, 2018, FDA 

received petitions for stay under § 10.35 

(21 CFR 10.35) on behalf of four ANDA 

holders: Breckenridge Pharmaceutical, 

Inc. and Nexgen Pharma, Inc. (hereafter 

Breckenridge/Nexgen) who submitted a 

joint petition; Lannett Company, Inc.; 

and Paddock Laboratories, Inc. 

(collectively the ANDA holders). 

Breckenridge/Nexgen, Lannett, and 

Paddock petitioned FDA to stay its 

order withdrawing the approval of their 

ANDAs for prescription PEG 3350 and 

argued that all four criteria for a 

mandatory stay under § 10.35(e) were 

met. Bayer Healthcare, LLC, (Bayer) 

which holds an approved New Drug 

Application for MiraLAX, an over-thecounter laxative containing PEG 3350, 

responded. Bayer argued that the 

petitioners failed to meet any of the 

factors in § 10.35(e).1

By a letter dated April 16, 2018, the 

Acting Chief Scientist, pursuant to 

authority delegated by the 

Commissioner, concluded that the 

ANDA holders had not met the criteria 

for a mandatory stay under § 10.35(e). 

The Acting Chief Scientist granted a 

temporary, discretionary stay of the 

effective date of the order until 

November 2, 2018. As described in the 

April 16, 2018, letter, based upon 

information submitted by the ANDA 

holders and not disputed by Bayer, it 

would likely be difficult for 

manufacturers of OTC PEG 3350 

products to compensate for the removal 

of prescription PEG 3350 products 

within 30 days. The letter explained 

that public health interests would not be 

served should the 30-day effective date 

negatively impact the availability of 

PEG 3350, particularly given that the 

basis of the withdrawal of the ANDA 

products is not an issue of safety or 

efficacy. The April 16, 2018, letter 

additionally noted that FDA has 

provided lengthier time frames to phase 

out manufacturing and distribution of 

affected products in other cases. While 

the Acting Chief Scientist rejected the 

petitioners’ arguments that financial 

hardship and harm to reputation 

resulting from the withdrawal order rise 

to the level of irreparable injury 

necessary for a mandatory stay under 

§ 10.35(e), she agreed that there may 

some validity to the petitioner’s 

concerns of harm to their business 

interests as a result of the 30-day 

effective date. The Acting Chief 

Scientist concluded that it is in the 

public interest and in the interest of 

justice to stay the effective date of the 

April 2, 2018, order until November 2, 

2018. 

The parties’ submissions and the 

Agency’s orders are available at https:// 

www.regulations.gov and with the 

Dockets Management Staff (see 

ADDRESSES). 

FDA is providing notice of the 

decision to grant a temporary stay in 

accordance with § 10.35(f). 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16148 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 


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