Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34765 

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, BALVERSA 

(erdafitinib) indicated for the treatment 

of adult patients with locally advanced 

or metastatic urothelial carcinoma that 

has susceptible FGFR3 or FGFR2 genetic 

alterations and progressed during or 

following at least one line of prior 

platinum-containing chemotherapy 

including within 12 months of 

neoadjuvant or adjuvant platinumcontaining chemotherapy. Patients are 

selected for therapy based on an FDAapproved companion diagnostic for 

BALVERSA. This indication is 

approved under accelerated approval 

based on tumor response rate. 

Continued approval for this indication 

may be contingent upon verification and 

description of clinical benefit in 

confirmatory trials. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

BALVERSA (U.S. Patent No. 8,895,601) 

from Astex Therapeutics Ltd. and the 

USPTO requested FDA’s assistance in 

determining the patent’s 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 

BALVERSA 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 

BALVERSA is 2,179 days. Of this time, 

1,972 days occurred during the testing 

phase of the regulatory review period, 

while 207 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: April 26, 2013. FDA has 

verified the applicant’s claim that the date 

the investigational new drug application 

became effective was on April 26, 2013. 

2. The date the application was initially 

submitted with respect to the human drug 

product under section 505 of the FD&C Act: 

September 18, 2018. FDA has verified the 

applicant’s claim that the new drug 

application (NDA) for BALVERSA (NDA 

212018) was initially submitted on 

September 18, 2018. 

3. The date the application was approved: 

April 12, 2019. FDA has verified the 

applicant’s claim that NDA 212018 was 

approved on April 12, 2019. 

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 application for patent extension, 

this applicant seeks 691 days of patent 

term extension. 

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: June 22, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13973 Filed 6–29–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1207] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Plant Varieties 

Intended for Food Use 

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 July 30, 

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 0910–0583. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

New Plant Varieties Intended for Food 

Use 

OMB Control Number 0910–0583— 

Revision 

This information collection supports 

recommendations found in Agency 

guidance pertaining to new plant 

varieties intended for food use. 

Respondents to the collection of 

information are developers of new plant 

varieties intended for food use. 


jbell on DSKJLSW7X2PROD with NOTICES
34766 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

I. Consultation Procedures: Foods 

Derived From New Plant Varieties; 

Form FDA 3665 

The Agency guidance document 

entitled ‘‘Guidance on Consultation 

Procedures: Foods Derived From New 

Plant Varieties,’’ which is available on 

our website at https://www.fda.gov/ 

FoodGuidances, describes our 

consultation process for the evaluation 

of information on new plant varieties 

provided by developers. We believe this 

consultation process will help ensure 

that human and animal food safety 

issues or other regulatory issues (e.g., 

labeling) are resolved prior to 

commercial distribution. Additionally, 

such communication will help to ensure 

that any potential food safety issues 

regarding a new plant variety are 

resolved during development and will 

help to ensure that all market entry 

decisions by the industry are made 

consistently and in full compliance with 

the standards of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). 

Since 1992, when FDA issued its 

‘‘Statement of Policy: Foods Derived 

From New Plant Varieties’’ (the 1992 

policy) (57 FR 22984, May 29, 1992), we 

have encouraged developers of new 

plant varieties, including those varieties 

that are developed through 

biotechnology, to consult with FDA 

during the plant development process to 

discuss possible scientific and 

regulatory issues that might arise. In the 

1992 policy, we explained that under 

the FD&C Act developers of new foods 

(in this document food refers to both 

human and animal food) have a 

responsibility to ensure that the foods 

they offer to consumers are safe and in 

compliance with all requirements of the 

FD&C Act (57 FR 22984 at 22985). 

Respondents may use Form FDA 3665, 

submitted via the Electronic 

Submissions Gateway (https://

www.fda.gov/industry/electronicsubmissions-gateway), to request 

consultation. 

II. Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by 

New Plant Varieties Intended for Food 

Use; Form FDA 3666 

Since May 29, 1992, when we issued 

a policy statement on foods derived 

from new plant varieties, including 

those varieties that are developed 

through biotechnology, we have 

encouraged developers of new plant 

varieties to consult with us early in the 

development process to discuss possible 

scientific and regulatory issues that 

might arise (57 FR 22984). The guidance 

entitled ‘‘Recommendations for the 

Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by 

New Plant Varieties Intended for Food 

Use’’ (https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industryrecommendations-early-food-safetyevaluation-new-non-pesticidal-proteinsproduced) continues to foster early 

communication by encouraging 

developers to submit to us their 

evaluation of the food safety of their 

new proteins. Such communication 

helps to ensure that any potential food 

safety issues regarding a new protein in 

a new plant variety are resolved early in 

development, prior to any possible 

inadvertent introduction into the food 

supply of the new protein. 

We believe that any food safety 

concern related to such material 

entering the food supply would be 

limited to the potential that a new 

protein in food from the plant variety 

could cause an allergic reaction in 

susceptible individuals or could be a 

toxin. The guidance describes the 

procedures for early food safety 

evaluation of new proteins produced by 

new plant varieties, including 

bioengineered food plants, and the 

procedures for communicating with us 

about the safety evaluation. 

Interested persons may use Form FDA 

3666 to transmit their submission to the 

Office of Food Additive Safety in the 

Center for Food Safety and Applied 

Nutrition (CFSAN). Form FDA 3666 is 

entitled ‘‘Early Food Safety Evaluation 

of a New Non-Pesticidal Protein 

Produced by a New Plant Variety (New 

Protein Consultation)’’ and may be used 

in lieu of a cover letter for a New 

Protein Consultation (NPC). The form 

may be accessed at FDA’s web page for 

forms (https://www.fda.gov/about-fda/ 

reports-manuals-forms/forms) using the 

search term ‘‘3666.’’ To enable fieldfillable functionality of FDA forms, they 

must be downloaded. Form FDA 3666 

prompts a submitter to include certain 

elements of an NPC in a standard format 

and helps the respondent organize their 

submission to focus on the information 

needed for our safety review. The form, 

and elements prepared as attachments 

to the form, may be prepared using the 

CFSAN Online Submission Module 

(https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/ 

cfsan-online-submission-module-cosm). 

Once the submission is prepared, it may 

be submitted in electronic format via the 

Electronic Submissions Gateway 

(https://www.fda.gov/industry/ 

electronic-submissions-gateway), paper 

format, or as electronic files on physical 

media with paper signature page. 

In the Federal Register of November 

23, 2020 (85 FR 74734), we published a 

60-day notice requesting public 

comment on information collection 

associated with the guidance document 

‘‘Recommendations for the Early Food 

Safety Evaluation of New Non-Pesticidal 

Proteins Produced by New Plant 

Varieties Intended for Food Use.’’ No 

comments were received. 

In the Federal Register of March 4, 

2021 (86 FR 12688), we published a 60- 

day notice requesting public comment 

on information collection associated 

with the guidance document ‘‘Early 

Food Safety Evaluation of New NonPesticidal Proteins Produced by New 

Plant Varieties Intended for Food Use.’’ 

No comments were received. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Agency guidance recommendations; 

information collection Form FDA No. Number of responses 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Consultation Procedures: Foods Derived From New Plant Varieties 

Initial consultation .................................... None 20 2 40 4 160 

Final consultation ..................................... 3665 12 1 12 150 1,800 

Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use 

First four data components ...................... 3666 6 1 6 4 24 

Two other data components .................... 3666 6 1 6 16 96 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34767 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Agency guidance recommendations; 

information collection Form FDA No. Number of responses 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total .................................................. ........................ ........................ ........................ 64 ........................ 2,080 

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

For efficiency of Agency operations, 

we are consolidating these related 

information collections. We retain our 

estimate of burden associated with the 

individual collection activities but have 

increased burden in OMB control 

number 0910–0583 by 52 responses and 

1,960 hours annually to reflect the 

reorganization of the information 

collection. Upon OMB approval of our 

request, we intend to discontinue OMB 

control number 0910–0704. 

Dated: June 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13953 Filed 6–29–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2192; FDA– 

2020–E–2194; FDA–2020–E–2195] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; OXBRYTA 

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 OXBRYTA 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 August 30, 2021. 

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 

December 27, 2021. 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 August 30, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 30, 2021. 

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’’). 

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–2192; FDA–2020–E–2194; and 

FDA–2020–E–2195, for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

OXBRYTA.’’ 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. 


jbell on DSKJLSW7X2PROD with NOTICES