Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices 82489 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
82490 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, evidencebased 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 nonconforming 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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