Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83971 

2. ‘‘This VFD authorizes the use of the 

VFD drug(s) cited in this order in the 

following FDA-approved, conditionally 

approved, or indexed combination(s) in 

medicated feed that contains the VFD 

drug(s) as a component. ’’ (List specific 

approved, conditionally approved, or 

indexed combination medicated feeds 

following this statement.) 

(§ 558.6(b)(6)(ii)). 

3. ‘‘This VFD authorizes the use of the 

VFD drug(s) cited in this order in any 

FDA-approved, conditionally approved, 

or indexed combination(s) in medicated 

feed that contains the VFD drug(s) as a 

component’’ (§ 558.6(b)(6)(iii)). 

These labeling statements are not 

subject to review by OMB because, as 

stated previously, they are a ‘‘public 

disclosure of information originally 

supplied by the Federal government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)) and therefore do not 

constitute a ‘‘collection of information’’ 

under the PRA (44 U.S.C. 3501, et seq.). 

Based on a review of the information 

collection since our last request for 

OMB approval, there has been a 

significant increase in the number of 

VFD distributors due to changes to the 

VFD regulations that were implemented 

in 2017. Since implementation, the 

number of approved VFD drugs has 

increased. 

Dated: December 17, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28353 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–2014–N–0386] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Orphan Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 22, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0167. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Orphan Drugs 

OMB Control Number 0910–0167— 

Revision 

This information collection supports 

FDA regulations implementing sections 

525, 526, 527, and 528 of the Federal 

Food, Drug and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360aa, 360bb, 360cc, and 

360dd), as well as related guidance. 

Sections 525, 526, 527, and 528 of the 

FD&C Act pertain to the development of 

drugs for rare diseases or conditions, 

including biological products and 

antibiotics, otherwise known or referred 

to as ‘‘Orphan Drugs.’’ Specifically, 

section 525 of the FD&C Act requires 

written recommendations on studies 

required for approval of a marketing 

application for a drug for a rare disease 

or condition. The information collection 

in 21 CFR 316.10, 316.12, and 316.14 is 

approved under OMB control numbers 

0910–0001 and 0910–0014. Section 526 

of the FD&C Act provides for 

designation of drugs as orphan drugs 

when certain conditions are met, section 

527 provides conditions under which a 

sponsor of an approved orphan drug 

enjoys exclusive FDA marketing 

approval for that drug for the orphan 

indication for a period of 7 years, and, 

finally, section 528 is intended to 

encourage sponsors to make 

investigational orphan drugs available 

for treatment of persons in need on an 

open protocol basis before the drug has 

been approved for general marketing. 

Open protocols may permit patients 

who are not part of the formal clinical 

investigation to obtain treatment where 

adequate supplies exist and no 

alternative effective therapy is available. 

We have issued regulations in part 

316 (21 CFR part 316) to implement the 

Orphan Drug provisions of the FD&C 

Act and to set forth procedures and 

requirements related to requesting 

recommendations for investigations of 

drugs for rare diseases or conditions, 

requesting designation of a drug for a 

rare disease or condition, or requesting 

exclusive approval for a drug for a rare 

disease or condition. To assist 

respondents and to be consistent with 

§ 316.50, our Office of Orphan Products 

Development (OOPD) maintains and 

makes publicly available guidance 

documents that apply to the Orphan 

Drug provisions of the FD&C Act and 

regulations in part 316. The list is 

maintained on the internet and 

guidance documents are issued in 

accordance with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

Accordingly, we are revising the 

information collection to include 

Agency guidance. The document 

entitled ‘‘Meetings with the Office of 

Orphan Products Development: 

Guidance for Industry, Researchers, 

Patient Groups, and Food and Drug 

Administration Staff’’ provides 

recommendations to industry, 

researchers, patient groups, and other 

stakeholders interested in requesting a 

meeting, including a teleconference, 

with OOPD on issues related to orphan 

drug designation requests, humanitarian 

use device designation requests, rare 

pediatric disease designation requests, 

funding opportunities through the 

Orphan Products Grants Program and 

the Pediatric Device Consortia Grants 

Program, and orphan product patientrelated topics of concern. It is also 

intended to assist OOPD staff in 

addressing such meeting requests. This 

guidance describes procedures for 

requesting, preparing, scheduling, 

conducting, and documenting such 

meetings and discusses background 

information we recommend be included 

in such requests. Information collection 

attendant to recommendations in the 

guidance are currently approved under 

OMB control number 0910–0787; 

however, for efficiency of Agency 

operations, we are consolidating it into 

this related information collection. The 

guidance is available at https://

www.fda.gov/media/92815/download. 

The FDA Orphan Drug Designation 

Request Form (Form FDA 4035) is 

intended to benefit sponsors who desire 

to seek orphan designation of drugs 

intended for rare diseases or conditions 

from only FDA. The form is a simplified 


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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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