Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 30941 

evaluation of surveillance and 

prevention activities. The OD2A TA 

Center is designed to enhance the 

efficiency, coordination, and 

effectiveness of TA efforts by 

streamlining and centralizing the 

provision of overdose surveillance and 

prevention TA. TA to OD2A recipients 

is divided into four different levels with 

multiple modes of TA delivery and 

involves a wide range of TA providers 

including CDC staff, internal and 

external subject matter experts (SMEs), 

and program partners, as well as 

contract staff. 

The evaluation consists of two webbased surveys designed to collect 

process and outcome measures about 

TA access, utilization, and outcomes 

across all 66 OD2A recipient programs. 

The Technical Assistance Feedback 

Form will be administered to collect 

immediate feedback following 

individual TA encounters and group 

events such as webinars and in-person 

trainings. The Annual OD2A TA Survey 

will be distributed twice (mid-point and 

final) to assess satisfaction with overall 

TA provided and the extent to which 

TA supports informed implementation 

of OD2A strategies. The information 

obtained through this evaluation will 

allow TA providers to assess OD2A 

recipients’ experience and utility of 

knowledge and resources gained 

through individual TA support, peer-topeer sessions, and other group trainings. 

Ultimately, the evaluation data will 

inform subsequent rounds of TA and 

allow TA providers to make necessary 

adjustments to the overall TA strategy 

for continuous quality improvement. 

This will ensure recipients have the 

support necessary to implement 

strategies that will improve opioid 

surveillance and prevention policies 

and practices within their communities. 

The total annualized burden estimate 

is 222 hours. There is no cost to 

respondents other than the time to 

participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

OD2A Recipients ............................................ TA Feedback Form ........................................ 671 2 5/60 

Annual OD2A Survey ..................................... 440 1 13/60 

Email invitation and reminders for OD2A 

Survey.

440 1 2/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–12208 Filed 6–9–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1129] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; National 

Agriculture and Food Defense Strategy 

Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 12, 

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 0910–0855. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

National Agriculture and Food Defense 

Strategy Survey 

OMB Control Number 0910–0855— 

Extension 

We are seeking OMB approval of the 

National Agriculture and Food Defense 

Strategy (NAFDS) under section 108 of 

the FDA Food and Safety Modernization 

Act (FSMA). This is a voluntary survey 

of State, local, territorial, and/or tribal 

(SLTT) governments intended to gauge 

government activities in food and 

agriculture defense from intentional 

contamination and emerging threats. 

The collected information will be 

included in the mandatory NAFDS 

followup Report to Congress. The 

authority for us to collect the 

information derives from the 

Commissioner of Food and Drugs’ 

authority provided in section 

1003(d)(2)(C) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(C)). 

Protecting the nation’s food and 

agriculture supply against intentional 

contamination and other emerging 

threats is an important responsibility 

shared by SLTT governments as well as 

private sector partners. On January 4, 

2011, the President signed into law 

FSMA. FSMA focuses on ensuring the 

safety of the U.S. food supply by 

shifting the efforts of Federal regulators 

from response to prevention and 

recognizes the importance of 

strengthening existing collaboration 

among all stakeholders to achieve 

common public health and security 

goals. FSMA identifies some key 

priorities for working with partners in 

areas such as reliance on Federal, State, 

and local agencies for inspections; 

improving foodborne illness 

surveillance; and leveraging and 

enhancing State and local food safety 

and defense capacities. Section 108 of 

FSMA (NAFDS) requires the 

Department of Health and Human 

Services (HHS) and the U.S. Department 

of Agriculture (USDA), in coordination 


khammond on DSKJM1Z7X2PROD with NOTICES
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. 


khammond on DSKJM1Z7X2PROD with NOTICES