Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 41133 

individuals who have expertise and 

qualifications necessary to contribute to 

the accomplishments of the Committee’s 

objectives. Nominees will be selected 

based on expertise in the fields of 

pertinent disciplines involved in injury, 

violence, and drug overdose prevention, 

including, but not limited to, 

epidemiology, statistics, trauma surgery, 

rehabilitation medicine, behavioral 

science/psychology, health economics, 

program evaluation, political science, 

law, criminology, informatics, and other 

aspects of injury management. Federal 

employees will not be considered for 

membership. Members may be invited 

to serve for up to four-year terms. 

Selection of members is based on 

candidates’ qualifications to contribute 

to the accomplishment of BSC, NCIPC 

objectives (https://www.cdc.gov/injury/ 

bsc/). 

DATES: Nominations for membership on 

the BSC, NCIPC must be received no 

later than September 1, 2022. Packages 

received after this time will not be 

considered for the current membership 

cycle. 

ADDRESSES: All nominations should be 

emailed to ncipcbsc@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Arlene Greenspan, DrPH, MPH, PT, 

Associate Director for Science, NCIPC, 

CDC, 4770 Buford Highway NE, 

Mailstop S–1069, Atlanta, Georgia 

30341; Telephone: (770) 488–1279; 

Email: ncipcbsc@cdc.gov. 

SUPPLEMENTARY INFORMATION: The U.S. 

Department of Health and Human 

Services policy stipulates that 

committee membership be balanced in 

terms of points of view represented and 

the Committee’s function. 

Appointments shall be made without 

discrimination on the basis of age, race, 

ethnicity, gender, sexual orientation, 

gender identity, HIV status, disability, 

and cultural, religious, or 

socioeconomic status. Nominees must 

be U.S. citizens and cannot be full-time 

employees of the U.S. Government. 

Current participation on federal 

workgroups or prior experience serving 

on a federal advisory committee does 

not disqualify a candidate; however, 

HHS policy is to avoid excessive 

individual service on advisory 

committees and multiple committee 

memberships. Committee members are 

Special Government Employees, 

requiring the filing of financial 

disclosure reports at the beginning and 

annually during their terms. CDC 

reviews potential candidates for BSC, 

NCIPC membership each year and 

provides a slate of nominees for 

consideration to the Secretary of HHS 

for final selection. HHS notifies selected 

candidates of their appointment near 

the start of the term in September, or as 

soon as the HHS selection process is 

completed. Note that the need for 

different expertise varies from year to 

year and a candidate who is not selected 

in one year may be reconsidered in a 

subsequent year. Candidates should 

submit the following items: 

D Cover letter stating area of expertise. 

D Current curriculum vitae, including 

complete contact information 

(telephone numbers, mailing address, 

email address). 

D At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. Candidates 

may submit letter(s) from current HHS 

employees if they wish, but at least one 

letter must be submitted by a person not 

employed by an HHS agency (i.e., CDC, 

NIH, FDA, SAMHSA, etc.). 

Nominations may be submitted by the 

candidate himself or herself or by the 

person/organization recommending the 

candidate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–14714 Filed 7–8–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2120 and FDA– 

2020–E–2121] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; TABRECTA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for TABRECTA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 9, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

January 9, 2023. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 9, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 9, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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’’). 


khammond on DSKJM1Z7X2PROD with NOTICES
41134 Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 

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 Nos. FDA– 

2020–E–2120 and FDA–2020–E–2121 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; TABRECTA.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 § 10.20 (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 

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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, TABRECTA 

(capmatinib). TABRECTA is indicated 

for the treatment of adult patients with 

metastatic non-small cell lung cancer 

whose tumors have a mutation that 

leads to mesenchymal-epithelial 

transition exon 14 skipping as detected 

by an FDA approved test. This 

indication is approved under 

accelerated approval based on overall 

response rate and duration of response. 

Continued approval for this indication 

may be contingent upon verification and 

description of clinical benefit in 

confirmatory trial(s). Subsequent to this 

approval, the USPTO received patent 

term restoration applications for 

TABRECTA (U.S. Patent Nos. 7,767,675; 

8,420,645) from Incyte Corp. and Incyte 

Holdings Corp., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

January 4, 2021, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

TABRECTA represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

TABRECTA is 4,164 days. Of this time, 

4,015 days occurred during the testing 

phase of the regulatory review period, 

while 149 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: December 13, 

2008. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on December 13, 2008. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 10, 2019. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

TABRECTA (NDA 213591) was initially 

submitted on December 10, 2019. 

3. The date the application was 

approved: May 6, 2020. FDA has 

verified the applicant’s claim that NDA 

213591 was approved on May 6, 2020. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 5 years of patent 

term extension. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 41135 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: July 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14674 Filed 7–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–1385] 

Patient-Focused Drug Development: 

Selecting, Developing, or Modifying 

Fit-for-Purpose Clinical Outcome 

Assessments; Draft Guidance for 

Industry, Food and Drug 

Administration Staff, and Other 

Stakeholders; Availability; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Patient-Focused Drug 

Development: Selecting, Developing, or 

Modifying Fit-for-Purpose Clinical 

Outcome Assessments; Draft Guidance 

for Industry, Food and Drug 

Administration Staff, and Other 

Stakeholders; Availability’’ that 

appeared in the Federal Register of June 

30, 2022. The document announced the 

publication of a draft guidance, the third 

in a series of four methodological 

patient-focused drug development 

guidance documents that describe how 

stakeholders (patients, researchers, 

medical product developers, and others) 

can collect and submit patient 

experience data and other relevant 

information from patients and 

caregivers to be used for medical 

product development and regulatory 

decision-making. The document was 

published with the incorrect docket 

number. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy, Planning, 

Legislation and International Affairs, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

3330, Silver Spring, MD 20993–0002, 

301–796–9115, email: Lisa.Granger@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Friday, June 30, 

2022 (87 FR 39101), in FR Doc. 2022– 

13952, the following corrections are 

made: 

1. On page 39101, in the third column 

in the header of the document, ‘‘Docket 

No. FDA–2018–N–2455’’ is corrected to 

read ‘‘Docket No. FDA–2022–D–1385.’’ 

2. On page 39102, in first column in 

‘‘Instructions,’’ ‘‘Docket No. FDA–2018– 

N–2455’’ is corrected to read ‘‘Docket 

No. FDA–2022–D–1385.’’ 

Dated: July 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14677 Filed 7–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2143] 

Xellia Pharmaceuticals USA, LLC; 

Withdrawal of Approval of an 

Abbreviated New Drug Application for 

Bacitracin for Injection 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is withdrawing the approval of 

an abbreviated new drug application 

(ANDA) for bacitracin for injection, 

50,000 units/vial (ANDA 203177), held 

by Xellia Pharmaceuticals USA, LLC 

(Xellia). Xellia has requested 

withdrawal of approval of this 

application and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of July 

11, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Sungjoon Chi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6216, 

Silver Spring, MD 20993–0002, 301– 

402–9674, Sungjoon.Chi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

January 31, 2020, FDA requested that all 

application holders of bacitracin for 

injection voluntarily request withdrawal 

of approval of their applications under 

§ 314.150(d) (21 CFR 314.150(d)). 

Bacitracin for injection is an antibiotic 

for intramuscular administration, the 

use of which is limited to the treatment 

of infants with pneumonia and 

empyema caused by staphylococci 

shown to be susceptible to the drug. 

Bacitracin for injection poses serious 

risks, including nephrotoxicity and 

anaphylactic reactions. Health care 

professionals generally no longer use 

bacitracin for injection to treat infants 

with pneumonia and empyema because 

other effective FDA-approved 

treatments are available that do not have 

these risks. 

In April 2019, FDA’s Antimicrobial 

Drugs Advisory Committee met and 

discussed the safety and effectiveness of 

bacitracin for injection. The advisory 

committee voted almost unanimously, 

with one abstention, that the benefits of 

bacitracin for intramuscular injection do 

not outweigh its risks, including 

nephrotoxicity and anaphylactic 

reactions, for the drug’s only approved 

indication. Based on FDA’s review of 

currently available data and 

information, the Agency believes that 

the potential problems associated with 

bacitracin for injection are sufficiently 

serious that the drug should be removed 

from the market. 

In a letter dated June 14, 2021, Xellia 

requested that FDA withdraw approval 

of ANDA 203177 under § 314.150(d) 

and waived its opportunity for a 

hearing. Therefore, for the reasons 

discussed above, which the applicant 

does not dispute in its letter requesting 

withdrawal of approval under 

§ 314.150(d), FDA’s approval of ANDA 

203177 and all amendments and 

supplements thereto, is withdrawn (see 

DATES). Distribution of Xellia’s 

bacitracin for injection (50,000 units/ 

vial) 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, 


khammond on DSKJM1Z7X2PROD with NOTICES