Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 7843 

an opportunity to request a hearing, 

providing 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Marmas received the proposal and 

notice of opportunity for a hearing on 

November 12, 2021. Ms. Marmas failed 

to request a hearing within the 

timeframe prescribed by regulation and 

has, therefore, waived her opportunity 

for a hearing and waived any 

contentions concerning her debarment. 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(D) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Brenda K. 

Marmas has engaged in a pattern of 

importing or offering for import 

misbranded drugs (i.e., in an amount, 

frequency, or dosage that is inconsistent 

with her personal or household use) that 

are not designated in an authorized 

electronic data interchange system as 

products regulated by FDA. FDA finds 

that this pattern of conduct should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Ms. Marmas is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

applicable (see DATES). Pursuant to 

section 301(cc) of the FD&C Act (21 

U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of any drug or controlled 

substance by, with the assistance of, or 

at the direction of Ms. Marmas is a 

prohibited act. 

Any application by Ms. Marmas for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2021– 

N–1030 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

Publicly available submissions will be 

placed in the docket and will be 

viewable at http://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02801 Filed 2–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0556] 

Development of Non-Opioid 

Analgesics for Acute Pain; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Development of Non-Opioid 

Analgesics for Acute Pain.’’ In 

connection with the SUPPORT for 

Patients and Communities Act 

(SUPPORT Act), the purpose of this 

guidance is to spur the development of 

alternatives to opioids for the 

management of acute pain by providing 

information about product 

development-related issues, ‘‘opioidsparing’’ claims, and expedited 

programs as they pertain to this 

purpose. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 11, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0556 for ‘‘Development of NonOpioid Analgesics for Acute Pain.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

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.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 


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7844 Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 

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, 240–402–7500. 

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: 

Theresa Wells, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5373, 

Silver Spring, MD 20993–0002, 703– 

380–3900. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Development of Non-Opioid 

Analgesics for Acute Pain.’’ This draft 

guidance is written in connection with 

section 3001 of the SUPPORT Act to 

provide information that will be useful 

in the development of non-opioid 

analgesics for the management of acute 

pain and, thereby, spur the development 

of such products. 

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 ‘‘Development of Non-Opioid 

Analgesics for Acute Pain.’’ 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 312 for 

conducting clinical trials and collecting 

data for such trials have been approved 

under OMB control number 0910–0014; 

the collections of information pertaining 

to Electronic Records and Electronic 

Signatures have been approved under 

OMB control number 0910–0303; the 

collections of information pertaining to 

the Requirements on Content and 

Format of Labeling for Human 

Prescriptions for ‘‘opioid-sparing’’ 

claims have been approved under OMB 

control number 0910–0572; and the 

collections of information found in the 

Guidance for Industry on Expedited 

Programs for Serious Condition—Drugs 

and Biologics for expedited pathways to 

support the development program for 

non-opioid analgesics have been 

approved under OMB control number 

0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: February 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02858 Filed 2–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4853] 

Receipt of Notice That a Patent 

Infringement Complaint Was Filed 

Against a Biosimilar or 

Interchangeable Biosimilar Applicant 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing 

notice that an applicant for a biologics 

license application (BLA) for a 

biosimilar or interchangeable biosimilar 

product submitted under the Public 

Health Service Act (PHS Act) (a 

‘‘subsection (k) applicant’’) notified 

FDA that an action for patent 

infringement was filed in connection 

with the applicant’s BLA. Under the 

PHS Act, within 30 days after the 

subsection (k) applicant is served with 

a complaint in an action for patent 

infringement described under the PHS 

Act, the subsection (k) applicant shall 

provide the Secretary of HHS with 

notice and copy of such complaint. FDA 

is required to publish notice of the 

complaint in the Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 1132, 

Silver Spring, MD 20993–0002, 301– 

796–1042, Sandra.Benton@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) was 

enacted as part of the Patient Protection 

and Affordable Care Act (Pub. L. 111– 

148) on March 23, 2010. The BPCI Act 

amended the PHS Act and created an 

abbreviated licensure pathway for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological reference 

product. Section 351(k) of the PHS Act 

(42 U.S.C. 262(k)) sets forth the 

requirements for an application for a 

proposed biosimilar product and an 

application or a supplement for a 

proposed interchangeable product. 

Section 351(l) of the PHS Act (42 

U.S.C. 262(l)) describes certain 

procedures for exchanging patent 

information and resolving patent 

disputes between a subsection (k) 

applicant and the holder of the BLA 

reference product. If a subsection (k) 

applicant is served with a complaint in 

an action for a patent infringement 

described in section 351(l)(6) of the PHS 

Act, the subsection (k) applicant is 

required to provide the Secretary with 

notice and a copy of the complaint 

within 30 days of service. FDA is 

required to publish notice of a 

complaint received under section 

351(l)(6)(C) of the PHS Act in the 

Federal Register. 

FDA received notice of the following 

complaint under section 351(l)(6)(C) of 

the PHS Act: AbbVie Inc. and AbbVie 

Biotechnology Ltd. v. Alvotech HF, 

1:21–cv–02258 (N.D. Ill., filed April 27, 

2021). 

FDA has only a ministerial role in 

publishing notice of a complaint 

received under section 351(l)(6)(C) of 

the PHS Act and does not perform a 

substantive review of the complaint. 

Dated: February 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02799 Filed 2–9–22; 8:45 am] 

BILLING CODE 4164–01–P 


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