83972 Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 

method for sponsors to provide only the 

information required by § 316.20 for 

FDA to make a decision. 

During this public health emergency 

associated with the COVID–19 

pandemic, the OOPD is providing 

sponsors with increased flexibility for 

submission of orphan drug designation 

requests and related submissions 

(amendments, annual reports, etc.). 

During this public health emergency, 

orphan drug designation, humanitarian 

use device designation, and rare 

pediatric disease designation requests 

and submissions may be submitted 

electronically by email to the OOPD. 

When transmitting information to the 

Orphan Drug Designation Program via 

email, please utilize the mailbox 

orphan@fda.hhs.gov. We recommend 

using the automated read receipt feature 

to avoid having to call to verify receipt 

of the email. We also strongly encourage 

sponsors and others who plan to email 

information to FDA that is considered to 

be private, sensitive, proprietary, or 

commercial confidential to send it from 

an FDA-secured email address, which is 

provided by FDA, so the transmission is 

encrypted. The OOPD will assume that 

the addresses of emails received or 

email addresses provided as a point of 

contact are FDA secure when 

responding to those email addresses. 

In the Federal Register of October 2, 

2020 (85 FR 62306), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Content and format of a request for designation; request 

for verification of status; amendment to designation ....... 534 1.25 668 135 90,180 

§§ 316.20, 316.21, 316.26 (Form FDA 4035) ...................... 534 1.25 668 32 21,376 

§ 316.22; Notifications of changes in agents ....................... 132 1 132 2 264 

§ 316.24(a); Deficiency letters and granting orphan-drug 

designation ....................................................................... 20 1 20 2 40 

§ 316.27; Submissions to change ownership of orphandrug designation ............................................................... 104 1 104 5 520 

§ 316.30; Annual reports ...................................................... 744 1 744 3 2,232 

§ 316.36; Assurance of the availability of sufficient quantities of the orphan drug; holder’s consent for the approval of other marketing applications for the same drug 1 3 3 15 45 

Guidance Recommendations: Meeting requests to OOPD 

and related submission packages .................................... 2,508 1 2,508 3.595 9,016 

Total .............................................................................. ........................ ........................ ........................ ........................ 123,673 

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

Based on our evaluation, we have 

adjusted the currently approved burden 

estimate we attribute to information 

collection activities associated with our 

Orphan Drug program to reflect an 

increase in submissions. This notice 

corrects the mathematical error 

published in the 60-day notice, which 

indicated that the total burden was 

123,623. 

Dated: December 17, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28349 Filed 12–22–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2267] 

Endo Pharmaceuticals, Inc.; 

Withdrawal of Approval of a New Drug 

Application for OPANA (Oxymorphone 

Hydrochloride) Extended-Release 

Tablets 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of the new drug application 

(NDA) for OPANA (oxymorphone 

hydrochloride) extended-release (ER) 

tablets (NDA 201655), held by Endo 

Pharmaceuticals, Inc., 1400 Atwater Dr., 

Malvern, PA 19355 (Endo). Endo 

requested that the approval of this 

application be withdrawn and has 

waived its opportunity for a hearing. 

DATES: Withdrawal of approval is 

applicable December 23, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137. 

SUPPLEMENTARY INFORMATION: On June 

22, 2006, FDA approved NDA 021610 

for OPANA ER (oxymorphone 

hydrochloride). On December 9, 2011, 

FDA approved a new formulation of 

OPANA ER (oxymorphone 

hydrochloride) tablets, 5 milligrams 

(mg), 7.5 mg, 10 mg, 15 mg, 20 mg, 30 

mg, and 40 mg, under NDA 201655 

(‘‘reformulated OPANA ER’’) for the 

management of pain severe enough to 

require daily, around-the-clock, longterm opioid treatment and for which 

alternative treatment options are 

inadequate. Over the course of 2011 and 

2012, Endo removed the original 

formulation from the market. 

Reformulated OPANA ER was 

intended by the sponsor to be resistant 

to physical and chemical manipulation 

for abuse by snorting or injecting. 

Although the reformulated product met 

the regulatory standards for approval, 

FDA determined that the data did not 

show that product could be expected to 


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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83973 

meaningfully reduce abuse and declined 

the company’s request to include 

labeling describing potentially abusedeterrent properties for OPANA ER. 

Based on postmarketing data, FDA 

later observed that there was a 

significant shift in the route of abuse 

from nasal to injection following the 

product’s reformulation. Injection abuse 

of reformulated OPANA ER has been 

associated with a serious outbreak of 

HIV and hepatitis C, as well as cases of 

a serious blood disorder (thrombotic 

microangiopathy). On June 8, 2017, FDA 

requested that Endo remove 

reformulated OPANA ER from the 

market based on its concern that the 

benefits of the drug may no longer 

outweigh its risks due to the public 

health consequences of abuse (see 

https://www.fda.gov/news-events/pressannouncements/fda-requests-removalopana-er-risks-related-abuse). On July 6, 

2017, Endo announced it would 

voluntarily remove reformulated 

OPANA ER from the market. 

On October 3, 2017, Endo requested 

withdrawal of NDA 201655 for 

reformulated OPANA ER under 

§ 314.150(d) (21 CFR 314.150(d)) and 

waived its opportunity for a hearing. For 

the reasons discussed above, and 

pursuant to the applicant’s request, 

approval of NDA 201655 for 

reformulated OPANA ER (oxymorphone 

hydrochloride) extended-release tablets, 

and all amendments and supplements 

thereto, is withdrawn under 

§ 314.150(d). Distribution of 

reformulated OPANA ER into interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(a) and 

331(d)). 

Dated: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28283 Filed 12–22–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2272] 

Hospira, Inc., et al.; Withdrawal of 

Approval of 27 New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 27 new drug 

applications (NDAs) from multiple 

applicants. The applicants 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 

January 22, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their 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 

NDA 008809 ............. M.V.I.-12 Adult (ascorbic acid, biotin, cyanocobalamin, dexpanthenol, 

ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride (HCl), riboflavin 5’-phosphate sodium, thiamine HCl, vitamin A, and vitamin E) Injection, 10 milligrams (mg)/milliliters (mL), 0.006 mg/mL, 0.5 micrograms (mcg)/ 

mL, 1.5 mg/mL, 20 International Units (IU)/mL, 0.04 mg/mL, 4 mg/mL, 0.4 

mg/mL, 0.36 mg/mL, 0.3 mg/mL, 330 Units/mL, and 1 IU/mL; and 20 mg/mL, 

0.006 mg/mL, 0.05 mcg/mL, 1.5 mg/mL, 0.0005 mg/mL, 0.06 mg/mL, 4 mg/ 

mL, 0.6 mg/mL, 0.36 mg/mL, 0.6 mg/mL, 0.1 mg/mL, and 1 mg/mL.

M.V.I.-12 Adult (ascorbic acid, biotin, cyanocobalamin, dexpanthenol, 

ergocalciferol, folic acid, niacinamide, pyridoxine HCl, riboflavin, thiamine 

HCl, vitamin A, and vitamin E) Injection, 20 mg/mL, 0.006 mg/mL, 0.5 mcg/ 

mL, 1.5 mg/mL, 20 IU/mL, 0.6 mg/mL, 4 mg/mL, 0.4 mg/mL, 0.36 mg/mL, 

0.6 mg/mL, 330 Units/mL, and 1 IU/mL..

Hospira, Inc., 275 North Field Dr., Lake 

Forest, IL 60045. 

NDA 017673 ............. Aminosyn (amino acids) Injection, 5% (5 grams (g)/100 mL), 7% (7 g/100 mL), 

7% (pH6) (7 g/100 mL), 8.5% (8.5 g/100 mL), 8.5% (pH6) (8.5 g/100 mL), 

10% (10 g/100 mL), and 10% (pH6) (10 g/100 mL).

Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic) Injection, 

8.5% (8.5 g/100mL), 102 mg/100 mL, 487 mg/100 mL, 28 mg/100 mL, and 

425 mg/100 mL..

Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride) Injection, 8.5% (8.5 g/100 

mL), 102 mg/100 mL, 522 mg/100 mL, and 410 mg/100 mL..

ICU Medical, Inc., 600 North Field Dr., 

Lake Forest, IL 60045. 

NDA 017735 ............. Modicon 28 (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/0.5 mg ..... Janssen Pharmaceuticals, Inc., 1125 

Trenton-Harbourton Rd., Titusville, 

NJ 08560. 

NDA 017743 ............. Brevicon 28-Day (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/0.5 

mg.

Allergan Sales, LLC, 5 Giralda Farms, 

Madison, NJ 07940. 

NDA 017789 ............. Aminosyn 3.5% (amino acids) Injection, 3.5% (3.5 g/100 mL).

Aminosyn 3.5% M (amino acids, magnesium acetate, phosphoric acid, potassium acetate, and sodium chloride) Injection, 3.5% (3.5 g/100 mL), 21 mg/ 

100 mL, 40 mg/100 mL, 128 mg/100 mL, and 234 mg/100 mL..

Aminosyn 3.5% M (amino acids, magnesium acetate, potassium acetate, and 

sodium chloride) Injection, 3.5% (3.5 g/100 mL), 21 mg/100 mL, 128 mg/100 

mL, and 234 mg/100 mL..


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