Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 34025 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption for this 

device, under section 520(g) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360j(g)), became 

effective: November 10, 2016. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) for human tests to 

begin, as required under section 520(g) 

of the FD&C Act, became effective 

November 10, 2016. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): November 30, 

2018. FDA has verified the applicant’s 

claim that the premarket approval 

application (PMA) for GORE 

CARDIOFORM ASD OCCLUDER (PMA 

050006 S071) was initially submitted 

November 30, 2018. 

3. The date the application was 

approved: May 28, 2019. FDA has 

verified the applicant’s claim that PMA 

050006 S071 was approved on May 28, 

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 556 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. 2021–13687 Filed 6–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0281] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before August 27, 2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0281–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Prevention 

Communication Formative Research. 

Type of Collection: Revision. 

OMB No.: 0990–0281. 

Abstract: The Office of Disease 

Prevention and Health Promotion 

(ODPHP) is focused on developing and 

disseminating health information to the 

public. ODPHP faces an increasingly 

urgent interest in finding effective ways 

to communicate health information to 

America’s diverse population. ODPHP 

strives to be responsive to the needs of 

America’s diverse audiences while 

simultaneously serving all Americans 

across a range of channels, from print to 

new communication technologies. To 

carry out prevention information efforts, 

ODPHP is committed to conducting 

formative and usability research to 

provide guidance on the development 

and implementation of their 

communication and education efforts. 

The information collected will be used 

to improve communication, products, 

and services that support key office 

activities including: Healthy People, 

Dietary Guidelines for Americans, 

Physical Activity Guidelines for 

Americans, the Move Your Way 

Campaign and the President’s Council 

on Sports, Fitness & Nutrition. ODPHP 

communicates through its website 

(www.health.gov) and through other 

channels including social media, print 

materials, interactive training modules, 

and reports. Data collection will be 

qualitative and quantitative and may 

include in-depth interviews, focus 

groups, web-based surveys, omnibus 

surveys, card sorting, and various forms 

of usability testing of materials and 

interactive tools to assess the public’s 

understanding of disease prevention 

and health promotion content, 

responses to prototype materials, and 

barriers to effective use. 

The program is requesting a 3-year 

extension of the clearance. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

In-depth interviews—Screener ........................................................................ 1,500 1 10/60 250 

In-depth interviews—Instrument ...................................................................... 500 1 1.00 500 

Focus groups—Screener ................................................................................. 2,925 1 10/60 487.5 


khammond on DSKJM1Z7X2PROD with NOTICES
34026 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 

ANNUALIZED BURDEN HOUR TABLE—Continued 

Forms 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Focus groups—Instrument .............................................................................. 975 1 1.50 1,462.5 

Intercept interviews .......................................................................................... 5,250 1 5/60 437.50 

Cognitive testing of instruments—Screener .................................................... 150 1 10/60 25 

Cognitive testing of instruments—Cognitive test ............................................. 50 1 2.00 100 

Web-based surveys—Screener ....................................................................... 30,000 1 5/60 2,500 

Web-based surveys—Survey .......................................................................... 10,000 1 15/60 2,500 

Omnibus surveys ............................................................................................. 2,100 1 10/60 350 

Gatekeeper reviews ......................................................................................... 325 1 30/60 162.5 

Card sorting—Screener ................................................................................... 600 1 10/60 100 

Card sorting—Card sort ................................................................................... 200 1 1.00 200 

Usability and prototype testing of materials (print and web)—Screener ......... 1,800 1 10/60 300 

Usability and prototype testing of materials (print and web)—usability tests 600 1 1.00 600 

Total .......................................................................................................... ........................ ........................ ........................ 9,975.00 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–13737 Filed 6–25–21; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Opportunity To 

Become a Healthy People 2030 

Champion 

AGENCY: Office of Disease Prevention 

and Health Promotion, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services’ (HHS) 

Office of Disease Prevention and Health 

Promotion (ODPHP) invites public and 

private sector organizations that support 

Healthy People 2030 (HP2030), the 

nation’s disease prevention and health 

promotion plan, to become a Healthy 

People 2030 Champion (HP2030 

Champion). 

Eligibility: Any organization may 

apply to be a HP2030 Champion. The 

selected HP2030 Champions will be 

recognized for their commitment and 

work toward achieving HP2030’s vision 

of a society in which all people can 

achieve their full potential for health 

and well-being across the lifespan. 

HP2030 Champions. HP2030 

Champions can be public and private 

organizations such as those at the state, 

local, county, and tribal levels, nongovernmental organizations, non-profit 

organizations, businesses, academic 

organizations, organizations that impact 

health outcomes, philanthropic 

organizations, and tribal organizations 

that identify themselves as being 

aligned with or promoting HP2030, 

HP2030’s vision, and HP2030’s 

overarching goals. All organizations 

may apply. Applicants for HP2030 

Champions shall submit a letter of 

interest and identify how they address 

or support health promotion, disease 

prevention, social determinants of 

health (SDOH), health disparities, 

health equity, and/or well-being and 

work in alignment with HP2030 through 

activities, donations, or other means. 

Applicants for HP2030 Champions will 

be evaluated according to the 

organization’s commitment to support 

the overarching goals of Healthy People 

2030 and the Healthy People 2030 

objectives. Individuals are not eligible to 

be HP2030 Champions. 

HP2030 Champions will receive 

recognition from ODPHP on Health.gov/ 

healthypeople2030, a digital HP2030 

Champion badge for their website to 

highlight their support of HP2030, and 

HP2030 information, tools and 

resources for dissemination. 

The following activities may be 

considered as an organization’s 

demonstrated commitment to HP2030’s 

overarching goals and objectives: 

• Promoting and increasing access to 

disease prevention and health 

promotion activities; 

• Providing access to training or 

certification programs for disease 

prevention and health promotion; 

• Addressing SDOH, eliminating 

disparities, achieving health equity, 

and/or promoting well-being; 

• Providing training and other 

necessary resources to adapt or modify 

disease prevention and health 

promotion activities to meet the needs 

of diverse populations, address SDOH, 

eliminate disparities, achieve health 

equity, and/or promote well-being; 

• Developing partnerships across a 

variety of sectors, including business, 

community, academia, education, faithbased, government, health care, media, 

public health, and technology; 

• Working across sectors to address 

SDOH, eliminate disparities, and 

achieve health equity; 

• Evaluating health promotion and 

disease prevention programs or 

partnering with academic institutions or 

public health organizations to evaluate 

health promotion and disease 

prevention activities; 

• Including information in their 

public facing materials about programs 

for disease prevention, health 

promotion, addressing SDOH, 

eliminating disparities, achieving health 

equity, and/or promoting well-being in 

community needs assessments; 

• Adopting or implementing the 

HP2030 framework (i.e., vision, mission, 

overarching goals, foundational 

principles), Leading Health Indicators 

(LHIs), Overall Health and Well-Being 

Measures (OHMs) and/or HP2030 

objectives in their strategic plan; 

• Promoting HP2030; providing 

opportunities and venues for disease 

prevention and health promotion 

activities; 

• Partnering with national, state, 

tribal, or local volunteer organizations 

to provide education, training, or 

programs regarding health promotion, 

disease prevention, SDOH, health 

disparities, health equity, and wellbeing; 

• Supporting an entity with the 

responsibility to organize and 

coordinate efforts within and across 

sectors to foster health promotion and 

well-being; 

• Promoting collaboration across all 

levels, including neighborhoods, 

communities, tribes, cities, states, 

counties, and localities, to increase and 

expand participation in health 


khammond on DSKJM1Z7X2PROD with NOTICES