Agency Information Collection Request; 60-Day Public Comment Request, 17845-17846 [2021-07039]
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17845
Federal Register / Vol. 86, No. 64 / Tuesday, April 6, 2021 / Notices
food product benefits consumers who
purchase that food product. Because
even small exposure to a food allergen
can potentially cause an adverse
reaction, consumers use food labeling
information to help determine their
product choices.
Based on a review of the information
collection since our last request for
OMB approval, we are decreasing our
burden estimate for the redesign of
labels. FALCPA was enacted in 2004,
and we issued associated Agency
guidance in 2015. Firms have had
substantial time to redesign their labels
for compliance with section 403(w) of
the FD&C Act. We do not anticipate any
firms needing to redesign their label to
come into compliance with section
403(w)(1) of the FD&C Act. Thus, we are
decreasing the number of respondents
redesigning their label from 3,875 to 1
and the number of hours from 62,000 to
16. We estimate one respondent for the
purpose of maintaining this information
collection provision.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Total annual
responses
Average burden
per response
Total hours
403(w)(6); petition for exemption .....................................
403(w)(7); notification ......................................................
5
5
1
1
5
5
100
68
500
340
Total ..........................................................................
........................
..........................
........................
..........................
840
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
B. Reporting
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses
perrespondent
Number of
respondents
FD&C Section; Activity
Under sections 403(w)(6) and (7) of
the FD&C Act, respondents may request
from us a determination that an
ingredient is exempt from the labeling
requirement of section 403(w)(1) of the
FD&C Act. An ingredient may obtain an
exemption through submission and
approval of a petition containing
scientific evidence that demonstrates
that the ingredient ‘‘does not cause an
allergic response that poses a risk to
human health’’ (section 403(w)(6) of the
FD&C Act). This section also states that
‘‘the burden shall be on the petitioner to
provide scientific evidence (including
the analytical method used to produce
the evidence) that demonstrates that
such food ingredient, as derived by the
method specified in the petition, does
not cause an allergic response that poses
a risk to human health.’’ Alternately, an
ingredient may become exempt through
submission of a notification containing
scientific evidence showing that the
ingredient ‘‘does not contain allergenic
protein’’ or that there has been a
previous determination through a
premarket approval process under
section 409 of the FD&C Act that the
ingredient ‘‘does not cause an allergic
response that poses a risk to human
health’’ (section 403(w)(7) of the FD&C
Act).
We issued a guidance document
entitled ‘‘Guidance for Industry: Food
Allergen Labeling Exemption Petitions
and Notifications,’’ which is available
on our website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-food-allergen-labelingexemption-petitions-and-notifications.
The guidance sets forth our
recommendations with regard to the
information that respondents should
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submit in such a petition or notification.
The guidance states that to evaluate
these petitions and notifications, we
will consider scientific evidence that
describes: (1) The identity or
composition of the ingredient; (2) the
methods used to produce the ingredient;
(3) the methods used to characterize the
ingredient; (4) the intended use of the
ingredient in food; and (5) either (a) for
a petition, data and information,
including the expected level of
consumer exposure to the ingredient,
that demonstrate that the ingredient,
when manufactured and used as
described, does not cause an allergic
response that poses a risk to human
health; or (b) for a notification, data, and
information that demonstrate that the
ingredient, when manufactured as
described, does not contain allergenic
protein, or documentation of a previous
determination under a process under
section 409 of the FD&C Act that the
ingredient does not cause an allergic
response that poses a risk to human
health. We use the information
submitted in the petition or notification
to determine whether the ingredient
satisfies the criteria of section 403(w)(6)
and (7) of the FD&C Act for granting the
exemption.
Dated: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07002 Filed 4–5–21; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS 4040–0018]
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 June 7, 2021.
ADDRESSES: Submit your comments to
Ed.Calimag@hhs.gov or (202) 690–7569.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 4040–0018–60D
and project title for reference to
Ed.Calimag@hhs.gov, or call (202) 690–
7569, 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.
SUMMARY:
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17846
Federal Register / Vol. 86, No. 64 / Tuesday, April 6, 2021 / Notices
Title of the Collection: SF–428
Tangible Personal Property Report.
Type of Collection: Reinstatement of
an expired information collection.
OMB No.: 4040–0018.
Abstract: Reporting on the status of
Federally-owned property, including
disposition, is necessitated in 2 CFR
part 215, the ‘‘Uniform Administrative
Requirements for Grants and
Agreements with Institutions of Higher
Education, Hospitals, and Other NonProfit Organizations’’, and the ‘‘Uniform
Administrative Requirements for Grants
and Agreements with State and Local
Governments’’, Additionally, Public
Law 106–107, the Federal Financial
Assistance Management Improvement
Act requires that agencies ’’simplify
Federal financial assistance application
and reporting requirements.’’ 31 U.S.C.
6101, Section 3.
Agencies are currently using a variety
of forms to account for both Federallyowned and grantee owned equipment
and property. During the public
consultation process mandated by
Public Law 106–107, grant recipients
requested a standard form to help them
submit appropriate property
information when required. The Public
Law 106–107 Post Awards Subgroup
developed a new standard form, the
Tangible Personal Property Report, for
submission of the required data. The
form consists of the cover sheet (SF–
428), three attachments to be used as
required: Annual Report, SF–428–A;
Final Report, SF–428–B; Disposition
Request/Report, SF–428–C and a
Supplemental Sheet, SF–428S to
provide detailed individual item
information when required.
Changes shall be made to the form
and instructions of the SF–428–B and
the SF–428–C.
ANNUALIZED BURDEN HOUR TABLE
Respondents
(if necessary)
SF–428 Tangible Personal Property Report.
Grant applicants .............................
2,000
1
1
2,000
Total .........................................
.........................................................
2,000
1
1
2,000
Sherrette A. Funn,
Paperwork Reduction Act Report Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–07039 Filed 4–5–21; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Amy F. Petrik, Ph.D., 240–627–3721;
amy.petrik@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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17:34 Apr 05, 2021
Jkt 253001
Number of
respondents
Number of
responses per
respondents
Forms
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows:
Newcastle Disease Virus-Like Particle
Displaying Prefusion Stabilized SARS–
CoV–2 Spike and Its Use
Description of Technology:
SARS–CoV–2 has resulted in a global
pandemic, sparking urgent vaccine
development efforts. The trimeric
SARS–CoV–2 spike stabilized in its
prefusion conformation by the addition
of 2 proline mutations (‘‘SARS–CoV–2
S2P’’) is the antigenic basis of SARS–
CoV–2 vaccines that are currently
authorized for use in the United States.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
sought to optimize the presentation of
SARS–CoV–2 S2P to the immune
system with the goal of eliciting a strong
and durable immune response. The
researchers designed fusion proteins
made of SARS–CoV–2 S2P and
Newcastle Disease fusion
transmembrane domain and cytosolic
tail which form virus like particles
(VLPs) displaying the SARS–CoV–2 S2P
on the particle surface.
SARS–CoV–2 S2P displaying
Newcastle Disease virus-like particles
(‘‘S2P–NDVLP’’) elicited a robust
immune response two weeks after a
single immunization. The S2P–NDVLP
also elicited an improved
immunogenicity despite delivering a
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Average burden
per response
Total burden
hours
lower number of SARS–CoV–2 S2P
antigens than the soluble SARS–CoV–2
S2P to which they were compared. This
improved immunogenicity is likely due
to several characteristics of S2P–
NDVLPs such as the mass and large size
of the VLP particle that can result in a
strong immune response and increase
uptake of the S2P by dendritic cells
Displaying multiple SARS–CoV–2 S2P
on a single particle could allow multiple
B-cell receptors on individual B cells to
bind that single particle, thereby crosslinking the B-cell receptors and
activating those B cells. Lastly, the lipid
membrane of the S2P–NDVLP could
allow the immunogen to more closely
mimic the real virus and boost immune
response.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• A single dose SARS–CoV–2 vaccine
Competitive Advantages:
• S2P–NDVLP with potential to elicit
higher levels of neutralizing antibodies
than current vaccines with a single dose
Development Stage: Preclinical
Research.
Inventors: Peter D. Kwong (NIAID);
Yongping Yang (NIAID); Wei Shi
(NIAID); John R. Mascola (NIAID);
Olubukola Abiona (NIAID); Kizzmekia
Corbett (NIAID); Barney Graham
(NIAID).
Publications: Yang, Y et al., (2021).
Newcastle Disease Virus-Like Particles
Displaying Prefusion-Stabilized SARS–
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]]>Agencies
[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Notices]
[Pages 17845-17846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07039]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS 4040-0018]
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 June 7, 2021.
ADDRESSES: Submit your comments to [email protected] or (202) 690-
7569.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 4040-0018-60D and
project title for reference to [email protected], or call (202) 690-
7569, 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.
[[Page 17846]]
Title of the Collection: SF-428 Tangible Personal Property Report.
Type of Collection: Reinstatement of an expired information
collection.
OMB No.: 4040-0018.
Abstract: Reporting on the status of Federally-owned property,
including disposition, is necessitated in 2 CFR part 215, the ``Uniform
Administrative Requirements for Grants and Agreements with Institutions
of Higher Education, Hospitals, and Other Non-Profit Organizations'',
and the ``Uniform Administrative Requirements for Grants and Agreements
with State and Local Governments'', Additionally, Public Law 106-107,
the Federal Financial Assistance Management Improvement Act requires
that agencies ''simplify Federal financial assistance application and
reporting requirements.'' 31 U.S.C. 6101, Section 3.
Agencies are currently using a variety of forms to account for both
Federally-owned and grantee owned equipment and property. During the
public consultation process mandated by Public Law 106-107, grant
recipients requested a standard form to help them submit appropriate
property information when required. The Public Law 106-107 Post Awards
Subgroup developed a new standard form, the Tangible Personal Property
Report, for submission of the required data. The form consists of the
cover sheet (SF-428), three attachments to be used as required: Annual
Report, SF-428-A; Final Report, SF-428-B; Disposition Request/Report,
SF-428-C and a Supplemental Sheet, SF-428S to provide detailed
individual item information when required.
Changes shall be made to the form and instructions of the SF-428-B
and the SF-428-C.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms Respondents Number of responses per Average burden Total burden
(if necessary) respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
SF-428 Tangible Personal Grant 2,000 1 1 2,000
Property Report. applicants.
-----------------------------------------------------------------
Total.................... ............... 2,000 1 1 2,000
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Report Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-07039 Filed 4-5-21; 8:45 am]
BILLING CODE 4151-AE-P
