Sugars That Are Metabolized Differently Than Traditional Sugars; Extension of Comment Period
| Published date | 18 December 2020 |
| Record Number | 2020-27749 |
| Section | Notices |
| Court | Food And Drug Administration |
82489
Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices
Because FDA is developing two new
training programs, Trainee Program and
Reagan-Udall Fellowship, our estimated
burden for the information collection
reflects an overall increase of 2 hours.
FDA has removed the Commissioner’s
Fellowship Program and Regulatory
Science Internship Program from this
information collection as these
programs have been discontinued.
FDA published a 30-day notice for
this information collection on February
3, 2020 (85 FR 5966). FDA is reopening
the 30-day comment period in order to
satisfy PRA requirements. No changes
have been made to the information
collection.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27963 Filed 12–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1359]
Sugars That Are Metabolized
Differently Than Traditional Sugars;
Extension of Comment Period
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notification; extension of
comment period.
SUMMARY
: The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notice entitled ‘‘Sugars that Are
Metabolized Differently than Traditional
Sugars’’ that appeared in the Federal
Register of October 19, 2020. We are
taking this action in response to a
request from stakeholders to extend the
comment period to allow additional
time for interested persons to develop
and submit data, information, and/or
comments for this request for
information and comments.
DATES
: FDA is extending the comment
period on the notice published October
19, 2020 (85 FR 66335). Submit either
electronic or written comments on the
notice by February 16, 2021.
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 February 16,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 16, 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.
Electronic Submissions
Submit electronic comments in the
following way:
•Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
•If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
•Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
•For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–1359 for ‘‘Sugars that Are
Metabolized Differently than Traditional
Sugars.’’ Received comments, those
filed in a timely manner (see
ADDRESSES
), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m. Eastern Time,
Monday through Friday, 240–402–7500.
•Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-2015-
09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT
:
Blakeley Fitzpatrick, Office of Nutrition
and Food Labeling, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1450.
SUPPLEMENTARY INFORMATION
:
I. Background
In the Federal Register of October 19,
2020 (85 FR 66335), we published a
notice requesting information and
comments entitled ‘‘Sugars that Are
Metabolized Differently Than
Traditional Sugars.’’ This action opened
a docket with a 60-day comment period
to receive information and comments
related to the nutrition labeling of
sugars that are metabolized differently
than traditional sugars.
FDA has received a request for a 60-
day extension for this comment period
in order to allow additional time for
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Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices
interested persons to develop and
submit data, information, and/or
comments for this notice. We have
concluded that it is reasonable to extend
the comment period for 60 days. FDA
believes that this extension allows
adequate time for any interested persons
to submit data, information, and/or
comments.
Dated: December 11, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27749 Filed 12–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Maternal,
Infant, and Early Childhood Home
Visiting Program Performance
Measurement Information System,
OMB No. 0906–0017, Revision
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION
: Notice.
SUMMARY
: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES
: Comments on this ICR should be
received no later than February 16,
2021.
ADDRESSES
: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, 14N136B, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT
: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION
:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Performance Measurement Information
System, OMB No. 0906–0017, Revision.
Abstract: This clearance request is for
continued approval of the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program
Performance Measurement Information
System.
The MIECHV Program, administered
by HRSA in partnership with the
Administration for Children and
Families, supports voluntary, evidence-
based home visiting services to pregnant
women and to parents with young
children up to kindergarten entry.
States, certain non-profit organizations,
and Tribal entities are eligible to receive
funding from the MIECHV program and
have the flexibility to tailor the program
to serve the specific needs of their
communities. HRSA is revising the data
collection forms for the MIECHV
program by making the following
changes:
•Form 1, Table 1: Update table to
include reporting for gender non-
conforming participants and unknown/
did not report participant gender.
•Form 1, Tables 3, 4, 6, 7, 8, 9, 10,
11, and 18: Update tables to include
reporting for gender non-conforming
participants and unknown/did not
report adult participant gender.
•Form 1, Tables 3, 5, 6, 7, 18, 19, and
20: Update tables to remove index child
gender reporting.
•Form 1, Table 15: Change table title
to ‘‘Home Visits’’.
•Form 1, Table 15: Update table to
collect the number of home visits
completed virtually.
•Form 1, Tables 4, 9, 10, and 18:
Update tables to include reporting for
new and continuing adult participants.
•Form 1, Tables 5, 19, and 20:
Update tables to include reporting for
new and continuing index children.
•Form 1, Table 16: Add new table to
include reporting on father and
additional caregiver engagement.
•Form 1, Tables 16, 17, 18, 19, 20,
and 21: Update table numbers to reflect
the addition of Table 16.
•Form 2, Measure 13: Change
measure name to ‘‘Behavioral Concern
Inquiries’’
•Form 2, Measure 16: Update
measure to reflect caregiver health
insurance coverage status.
•Form 2: Add two measures to
collect information on substance use
screening and referrals.
Need and Proposed Use of the
Information: HRSA uses performance
information to demonstrate program
accountability and continuously
monitor and provide oversight to
MIECHV Program awardees. The
information is also used to provide
quality improvement guidance and
technical assistance to awardees and
help inform the development of early
childhood systems at the national, state,
and local level. HRSA is seeking to
revise demographic, service utilization,
and select clinical indicators for
participants enrolled in home visiting
services. In addition, HRSA will collect
a set of standardized performance and
outcome indicators that correspond
with the statutorily identified
benchmark areas.
This information will be used to
demonstrate awardees’ compliance with
legislative and programmatic
requirements. It will also be used to
monitor and provide continued
oversight for awardee performance and
to target technical assistance resources
to awardees. In the future, HRSA
anticipates that MIECHV funding
decisions may be allocated, in part,
based on awardee performance,
including on benchmark performance
areas. This notice is subject to the
appropriation of funds, and is a
contingency action taken to ensure that,
should funds become available for this
purpose, information can be collected in
a timely manner.
Likely Respondents: MIECHV Program
awardees that are states, territories, and,
where applicable, nonprofit
organizations providing home visiting
services within states.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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