82488 Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total number 

of 

respondents 

Total number 

of 

responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Annual burden 

hours 

RFP and Contract ................................................................ 50 4.5 4 900 300 

Emergency Funding Request .............................................. 21 1 2 42 14 

Biennial Reports ................................................................... 54 1.5 1.5 121.5 40.5 

Advance Planning Document .............................................. 44 3.6 120 19,008 6,336 

Operational Advance Planning Document ........................... 10 3 30 900 300 

Independent Verification and Validation (ongoing) .............. 3 12 10 360 120 

Independent Verification and Validation (semiannually) ..... 4 6 16 384 128 

Independent Verification and Validation (quarterly) ............ 10 12 30 3,600 1,200 

System Certification ............................................................. 3 3 240 2,160 720 

Estimated Total Annual Burden 

Hours: 9,158.50. 

Authority: 45 CFR part 95, subpart F. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–27916 Filed 12–17–20; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1072] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Participation in Food and Drug 

Administration Fellowship and 

Traineeship Programs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 19, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0780. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Application for Participation in FDA 

Fellowship and Traineeship Programs 

OMB Control Number 0910–0780— 

Revision 

Sections 1104, 1302, 3301, 3304, 

3320, 3361, 3393, and 3394 of Title 5 of 

the United States Code authorize 

Federal Agencies to rate applicants for 

Federal jobs. The proposed information 

collection involves brief online 

applications completed by applicants 

applying to FDA’s Fellowship and 

Traineeship programs. These voluntary 

online applications will allow the 

Agency to easily and efficiently elicit 

and review information from students 

and healthcare professionals who are 

interested in becoming involved in 

FDA-wide activities. The process will 

reduce the time and cost of submitting 

written documentation to the Agency 

and lessen the likelihood of applications 

being misrouted within the Agency mail 

system. It will assist the Agency in 

promoting and protecting the public 

health by encouraging outside persons 

to share their expertise with FDA. 

In the Federal Register of October 19, 

2018 (83 FR 53065), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Medical Device Fellowship Program ................................... 250 1 250 1 250 

FDA Traineeship Program ................................................... 1,000 1 1,000 1 1,000 

Reagan-Udall Fellowship at FDA ........................................ 50 1 50 1 50 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,300 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


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