30942 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

with the Department of Homeland 

Security (DHS), to work together with 

State, local, territorial, and tribal 

governments to monitor and measure 

progress in food defense. 

In 2015, the initial NAFDS Report to 

Congress detailed the specific Federal 

response to food and agriculture defense 

goals, objectives, key initiatives, and 

activities that HHS, USDA, DHS, and 

other stakeholders planned to 

accomplish to meet the objectives 

outlined in FSMA. The NAFDS charts a 

direction for how Federal Agencies, in 

cooperation with SLTT governments 

and private sector partners, protect the 

nation’s food supply against intentional 

contamination. Not later than 4 years 

after the initial NAFDS Report to 

Congress (2015), and every 4 years 

thereafter (i.e., 2019, 2023, 2027, etc.), 

HHS, USDA, and DHS are required to 

revise and submit an updated report to 

the relevant committees of Congress. 

FDA is the Agency primarily 

responsible for obtaining the 

information from Federal and SLTT 

partners to complete the NAFDS Report 

to Congress. An interagency working 

group will conduct the survey and 

collect and update the NAFDS as 

directed by FSMA, including 

developing metrics and measuring 

progress for the evaluation process. 

The survey of Federal and State 

partners will be used to determine what 

food defense activities, if any, Federal 

and/or SLTT agencies have completed 

(or are planning on completing) from 

2021 to 2025. Planning for the local, 

territorial, and tribal information 

collections will commence during this 

period of renewal. The survey will 

continue to be repeated approximately 

every 2 to 4 years, as described in 

section 108 of FSMA. The NAFDS 

survey is being administered for the 

purpose of monitoring progress in food 

and agricultural defense by government 

agencies. 

A purposive sampling strategy is 

employed, such that the government 

agencies participating in food and 

agricultural defense are asked to 

respond to the voluntary survey. Food 

defense leaders responsible for 

conducting food defense activities 

during a food emergency for their 

jurisdiction are identified and will 

receive an emailed invitation to 

complete the survey online; they will be 

provided with a web link to the survey. 

The survey will be conducted 

electronically on the FDA.gov web 

portal, and results will be analyzed by 

the interagency working group. 

Description of Respondents: 

Respondents to this collection are SLTT 

government representatives (survey 

respondents) who are food defense 

leaders responsible for conducting food 

defense activities during a food 

emergency for their jurisdictions. 

In the Federal Register of January 4, 

2021 (86 FR 104), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

SLTT Surveys ...................................................................... 500 1 500 0.33 

(20 minutes) 

165 

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

The FDA Office of Partnerships 

reviewed the questionnaire and 

provided the estimate of time to 

complete the survey. The total burden is 

based on our previous experiences 

conducting surveys. The burden has 

been revised to reflect the total number 

of States and possible number of local, 

tribal, and territorial entities that may 

partake of the survey. Based on a review 

of the information collection since our 

last request for OMB approval, we have 

increased our burden estimate by 149 

hours (from 16.17 to 165 hours) and 451 

respondents (from 49 to 500 

respondents). 

Dated: June 7, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12188 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2019–E–5338; FDA– 

2019–E–5346; and FDA–2019–E–5343] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EVENITY 

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 EVENITY 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 

biological 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 9, 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 7, 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 9, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 9, 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. 


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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 30943 

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– 

2019–E–5338; FDA–2019–E–5343; 

FDA–2019–E–5346, For Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; EVENITY. 

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 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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product EVENITY 

(romosozumab-aqqg). EVENITY is 

indicated for the treatment of 

osteoporosis in postmenopausal women 

at high risk for fracture, defined as a 

history of osteoporotic fracture, or 

multiple risk factors for fracture; or 

patients who have failed or are 

intolerant to other available 

osteoporosis therapy. Subsequent to this 

approval, the USPTO received patent 

term restoration applications for 

EVENITY (U.S. Patent Nos. 7,592,429; 

8,017,120; and 8,440,193) from Amgen 

Inc., and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated December 23, 2019, FDA 

advised the USPTO that this human 

biological product had undergone a 

regulatory review period and that the 

approval of EVENITY 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 

EVENITY is 4,519 days. Of this time, 

3,524 days occurred during the testing 

phase of the regulatory review period, 

while 995 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 (21 U.S.C. 355(i)) 

became effective: November 26, 2006. 

The applicant claims December 8, 2006, 


khammond on DSKJM1Z7X2PROD with NOTICES
30944 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

as the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was November 26, 

2006, which was 30 days after FDA 

receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): July 19, 2016. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

EVENITY (BLA 761062) was initially 

submitted on July 19, 2016. 

3. The date the application was 

approved: April 9, 2019. FDA has 

verified the applicant’s claim that BLA 

761062 was approved on April 9, 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 applications for patent extension, 

this applicant seeks 1,550 days, 1,575 

days or 1,827 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 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12199 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2303] 

Core Patient-Reported Outcomes in 

Cancer Clinical Trials; 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 ‘‘Core 

Patient-Reported Outcomes in Cancer 

Clinical Trials.’’ This draft guidance 

provides recommendations to sponsors 

regarding the collection of a core set of 

patient-reported clinical outcomes in 

cancer clinical trials and related 

considerations for instrument selection 

and trial design. This guidance focuses 

on patient-reported outcome (PRO) 

measures and is specific to registration 

trials for anti-cancer therapies intended 

to demonstrate an effect on survival, 

tumor response, or delay in the 

progression of a malignancy. The draft 

guidance recommendations supplement 

previous guidance on use of PRO 

measures in clinical trials by providing 

additional considerations specific to the 

cancer clinical trial setting. The draft 

guidance is intended to facilitate 

generation of high-quality data on a core 

set of patient-reported symptom and 

functional impacts that are important 

contributors to a patient’s health-related 

quality of life. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 9, 2021 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– 

2020–D–2303 for ‘‘Core PatientReported Outcomes in Cancer Clinical 

Trials.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES