Agency Information Collection Request; 60-Day Public Comment Request, 34025-34026 [2021-13737]
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34025
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
SUMMARY:
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
In-depth interviews—Screener ........................................................................
In-depth interviews—Instrument ......................................................................
Focus groups—Screener .................................................................................
VerDate Sep<11>2014
17:39 Jun 25, 2021
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Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses per
respondents
1,500
500
2,925
E:\FR\FM\28JNN1.SGM
1
1
1
28JNN1
Average
burden per
response
10/60
1.00
10/60
Total burden
hours
250
500
487.5
34026
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
ANNUALIZED BURDEN HOUR TABLE—Continued
Forms
(if necessary)
Average
burden per
response
Total burden
hours
Focus groups—Instrument ..............................................................................
Intercept interviews ..........................................................................................
Cognitive testing of instruments—Screener ....................................................
Cognitive testing of instruments—Cognitive test .............................................
Web-based surveys—Screener .......................................................................
Web-based surveys—Survey ..........................................................................
Omnibus surveys .............................................................................................
Gatekeeper reviews .........................................................................................
Card sorting—Screener ...................................................................................
Card sorting—Card sort ...................................................................................
Usability and prototype testing of materials (print and web)—Screener .........
Usability and prototype testing of materials (print and web)—usability tests
975
5,250
150
50
30,000
10,000
2,100
325
600
200
1,800
600
1
1
1
1
1
1
1
1
1
1
1
1
1.50
5/60
10/60
2.00
5/60
15/60
10/60
30/60
10/60
1.00
10/60
1.00
1,462.5
437.50
25
100
2,500
2,500
350
162.5
100
200
300
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
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.
AGENCY:
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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondents
Number of
respondents
VerDate Sep<11>2014
17:39 Jun 25, 2021
Jkt 253001
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,
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Notices]
[Pages 34025-34026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13737]
-----------------------------------------------------------------------
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 [email protected] 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:
[email protected], 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
----------------------------------------------------------------------------------------------------------------
Number of Average
Forms (if necessary) Number of responses per burden per Total burden
respondents respondents response 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
[[Page 34026]]
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 1,800 1 10/60 300
(print and web)--Screener......................
Usability and prototype testing of materials 600 1 1.00 600
(print and web)--usability tests...............
---------------------------------------------------------------
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
