Attachment G: 60D FRN

18544

Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices

for an average of 2,095 recall
terminations annually, and we assume
an average of 10 hours is needed for the
corresponding information collection
activity. To determine burden

associated with recall status reports we
divided the average number of annual
submissions (36,127) by the average
number of annual respondents (2,779)
and assume 10 hours is necessary for

the corresponding information
collection, resulting in 361,270 hours
annually.

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Recall communications; § 7.49 .........
1 There

Number of
disclosures
per
respondent

Number of
respondents

Activity; 21 CFR section

I

2,779

I

445

Total annual
disclosures

I

1,236,655

Average burden per disclosure

I 0.05 (3 minutes) ...............................

Total hours

61,832.75

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

To determine burden associated with
recall communication disclosures
described in § 7.49, we calculated an
average of 445 disclosures per recall and
attribute 3 minutes for each disclosure,
resulting in 61,832.75 burden hours
annually.
These estimates reflect an overall
decrease in the average number of
annual responses by 245,846 and a
decrease in the average number of
annual burden hours by 70,949.25 since
our last submission for OMB review and
approval of the information collection.
Dated: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07287 Filed 4–8–21; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Virtual Stakeholder Listening Session
in Preparation for the 74th World
Health Assembly
Subject: Office of Global Affairs:
Virtual Stakeholder Listening Session in
preparation for the 74th World Health
Assembly.
Time and date: The session will be
held on Thursday, May 13, 2021, from
10:00 a.m.–12:00 p.m. Eastern Time
(ET).
Place: The session will be held
virtually, and registration is required.
Please RSVP by April 29, 2021 by
sending your full name, email address,
and organization to OGA.RSVP@
hhs.gov. OGA encourages early
registration.
Status: Open, but requiring RSVP to
OGA.RSVP@hhs.gov to register.
Purpose: The U.S. Department of
Health and Human Services (HHS)—
charged with leading the U.S. delegation
to the 74th World Health Assembly—
will hold an informal Stakeholder
Listening Session on Thursday, May 13,
10:00 a.m.–12:00 p.m. ET. The listening

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session will be held virtually, and the
meeting link will be shared with
registered participants prior to the
session.
The Stakeholder Listening Session
will help the HHS Office of Global
Affairs prepare the U.S. delegation to
the World Health Assembly by taking
full advantage of the knowledge, ideas,
feedback, and suggestions from all
communities interested in and affected
by agenda items to be discussed at the
74th World Health Assembly. Your
input will contribute to U.S. positions
as we negotiate these important health
topics with our international colleagues.
The listening session will be
organized by agenda item, and
participation is welcome from
stakeholder communities, including:
• Public health and advocacy groups;
• State, local, and Tribal groups;
• Private industry;
• Minority health organizations; and
• Academic and scientific
organizations.
All agenda items to be discussed at
the 74th World Health Assembly can be
found at this website: https://
apps.who.int/gb/e/e_wha74.html.
RSVP: Registration is required for the
event. Please send your full name, email
address, and organization to
OGA.RSVP@hhs.gov to register. Please
RSVP no later than Thursday, April 29,
2021.
Written comments are welcome and
encouraged, even if you are planning on
attending the virtual session. Please
send written comments to the email
address: OGA.RSVP@hhs.gov.
We look forward to hearing your
comments related to the 74th World
Health Assembly agenda items.
Dated: March 31, 2021.
Loyce Pace,
Director, Office of Global Affairs.
[FR Doc. 2021–07299 Filed 4–8–21; 8:45 am]
BILLING CODE 4150–38–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]

Agency Information Collection
Request—60-Day Public Comment
Request
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:

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 June 8, 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–New–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: Components
Study of REAL Essential Curriculum.
Type of Collection: New.
SUMMARY:

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Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
OMB No. 0990–NEW—Office of
Population Affairs—OASH–OS
Abstract
The Office of Population Affairs
(OPA), U.S. Department of Health and
Human Services (HHS) is requesting 3
years of approval by OMB on a new
collection. The Components Study of
REAL Essential Curriculum will identify
the components that matter the most for
promoting positive health behaviors and
outcomes among adolescents. The study
will examine program components (for
example, content and dosage),

implementation components (for
example, attendance and engagement),
and contextual components (for
example, participant characteristics) to
determine which components influence
participant outcomes the most. In
addition, the study will measure youth
engagement in programming from
various perspectives and examine the
role of engagement as a mediating factor
to achieving youth outcomes. Sites
participating in the study will use the
REAL Essentials Advance (REA)
relationship curriculum, a popular
program among federal pregnancy

prevention grantees. The study will
enroll schools from spring to fall 2022
(and possibly spring 2023, if necessary).
The study will collect youth outcomes
surveys at baseline, at program exit and
6 months following the completion of
the program. The study will also collect
extensive implementation data, which
includes youth engagement exit ticket
surveys after REA sessions, focus groups
with youth and program facilitator logs
and attendance records. Study staff will
also interview facilitators and site
leadership.

ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response

Respondents
(if necessary)

Youth Outcome Survey Baseline ......
Youth Outcome Survey—Program
Exit.
Youth Outcome Survey—Six Month
Follow-up.
Youth Focus Group Topic Guide ......
Youth Engagement Exit ticket ..........
Fidelity Log ........................................
Facilitator Interview Topic Guide ......
District/CBO Leadership Interview
Topic Guide.

Youth ................................................
Youth ................................................

507
507

1
1

40/60
40/60

338
338

Youth ................................................

480

1

40/60

320

Youth ................................................
Youth ................................................
Program Facilitators .........................
Facilitators ........................................
District/School/CBO leadership ........

133
533
13
5
11

1
12
24
2
2

90/60
2/60
10/60
1
45/60

200
213
52
10
17

Total ...........................................

...........................................................

........................

44

........................

1488

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–07285 Filed 4–8–21; 8:45 am]
BILLING CODE 4150–34–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Nbutyldeoxynojirimycin To Treat SmithLemli Opitz Syndrome (SLOS) and
Diseases That Exhibit a Similar NPCLike Cellular Phenotype
AGENCY:

National Institutes of Health,

DHHS.
ACTION:

Notice.

17:45 Apr 08, 2021

this notice to SubRed Pty Ltd located in
Australia, registered in Victoria.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Child Health and Human Development
c/o National Cancer Institute’s
Technology Transfer Center on or before
April 26, 2021 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Alan Hubbs, Ph.D., Senior
Technology Transfer Manager at
Telephone (240)–276–5530 or at Email:
hubbsa@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement:
Intellectually Property

The National Institute of
Child Health and Human Development,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. and foreign Patents and Patent
Applications listed in the
Supplementary Information section of

SUMMARY:

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Forms
(if necessary)

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1. Great Britain Patent Application
No. 712494.4, filed on June 27, 2007
[HHS Reference No. E–206–2007–0–GB–
01];
2. PCT Patent Application No. PCT/
GB2008/002207, filed June 26, 2008
[HHS Reference No. E–206–2007–0–
PCT–02];
3. Issued Australian Patent No.
2008269585, filed on June 26, 2008,

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Total burden
hours

Issued July 2, 2015 [HHS Reference No.
E–206–2007–0–AU–03];
4. Issued Canadian Patent No.
2691937, filed on June 26, 2008, Issued
January 23, 2018 [HHS Reference No. E–
206–2007–0–CA–04];
5. Issued European Patent No.
2182936, filed on June 26, 2008, Issued
April 1, 2020 [HHS Reference No. E–
206–2007–0–EP–05];
6. Issued US Patent No. 8,557,844,
filed January 19, 2010, Issued October
15, 2013 [HHS Reference No. E–206–
2007/0–US–06];
7. Issued United States Patent No.
9,428,541, filed on September 13, 2013,
Issued August 30, 2016 [HHS Reference
No. E–206–2007–0–US–09]
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America. The prospective exclusive
license territory may be world-wide,
and the field of use may be limited to
the use of Licensed Patent Rights for the
following: ‘‘The use of Nbutyldeoxynojirimycin in humans to
treat Smith-Lemli Opitz Syndrome
(SLOS) and diseases that exhibit a
similar NPC-like cellular phenotype.’’

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