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copies of the draft guidance to the 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access to the draft guidance document.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a draft guidance for industry entitled 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This draft guidance is being issued 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The draft guidance, when finalized, will 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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