2676 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices 

2https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/user-fees-513grequests-information. 

Drug Administration Staff’’ 2 assists 

FDA staff and regulated industry by 

describing the user fees associated with 

513(g) requests. The Medical Device 

User Fee Cover Sheet (Form FDA 3601), 

which accompanies the supplemental 

material described in this information 

collection is approved under OMB 

control number 0910–0511. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Devices and Radiological Health 513(g) requests ............................................................................... 114 1 114 12 1,368 

Center for Biologics Evaluation and Research 513(g) requests ............................................................................... 4 1 4 12 48 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,416 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 5, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00470 Filed 1–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0008] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Circulatory System Devices Panel of the 

Medical Devices Advisory Committee. 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. The meeting will be open to the 

public. 

DATES: The meeting will take place 

virtually on February 17, 2021, from 9 

a.m. Eastern Time to 6 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, 

MD 20993–0002, aden.asefa@

fda.hhs.gov, 301–796–0400, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On February 

17, 2021, the committee will discuss, 

make recommendations, and vote on 

information regarding the premarket 

approval application (PMA) for the 

Lutonix 014 Drug Coated Balloon 

Percutaneous Transluminal Angioplasty 

(PTA) catheter. The proposed Indication 

for Use for the Lutonix 014 Drug Coated 

Balloon PTA catheter is indicated for 

percutaneous transluminal angioplasty, 

after appropriate vessel preparation, of 

obstructive de novo or non-stented 

restenotic lesions in native popliteal, 

tibial, and peroneal arteries up to 320 

mm in length and 2.0 to 4.0 mm in 

diameter. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

advisory-committees/medical-devicesadvisory-committee/circulatory-systemdevices-panel. Select the link for the 

2021 Meeting Materials. The meeting 

will include slide presentations with 

audio components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 10, 2021. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. Eastern Time and 2 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person (see FOR

FURTHER INFORMATION CONTACT). The 

notification should include a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices 2677 

requested to make their presentation on 

or before February 2, 2021. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 3, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00469 Filed 1–12–21; 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: Scientific 

Registry of Transplant Recipients 

Information Collection Effort for 

Potential Donors for Living Organ 

Donation OMB No. 0906–0034— 

Extension 

Correction 

In notice document 2020–28017 

appearing on pages 83098–83099 in the 

issue of Monday, December 21, 2020, 

make the following correction: 

(1) On page 83098, in the second 

column, in the DATES section, change 

‘‘January 20, 2021’’ to read ‘‘January 21, 

2021.’’ 

[FR Doc. C1–2020–28017 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Privacy Act of 1974; System of 

Records 

AGENCY: National Institutes of Health 

(NIH), Department of Health and Human 

Services (HHS). 

ACTION: Notice of a Modified System of 

Records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, the Department of Health 

and Human Services is updating and 

renaming an existing system of records 

maintained by the National Institutes of 

Health (NIH), 09–25–0165, ‘‘National 

Institutes of Health (NIH) Office of Loan 

Repayment and Scholarship (OLRS) 

Record System, HHS/NIH/OD’’ (to be 

renamed ‘‘NIH Loan Repayment 

Records’’). In a separate Notice of 

Proposed Rulemaking (NPRM) 

published elsewhere in today’s Federal 

Register, HHS/NIH is proposing to 

exempt a subset of records in the system 

of records from certain requirements of 

the Privacy Act, based on subsection 

(k)(5) of the Privacy Act. 

DATES: The comment period for this 

modified System of Records Notice 

(SORN) is co-extensive with the 60-day 

comment period provided in the 

companion NPRM also published in 

today’s Federal Register. Written 

comments on the SORN should be 

submitted on or before March 15, 2021. 

The modified SORN will be applicable 

when the proposed exemptions are 

made effective by publication of a Final 

Rule, which will not occur until after 

the 60-day comment period ends and 

any comments received on the NPRM 

(or on this SORN) have been addressed. 

ADDRESSES: You may submit comments, 

identified by the Privacy Act System of 

Records Number (09–25–0165), by any 

of the following methods: Email: 

privacy@mail.nih.gov and include 

Privacy Act System of Record (PA SOR) 

number (09–25–0165) in the subject line 

of the message. Phone: (301) 402–6201. 

Fax: (301) 402–0169. Mail or handdelivery: NIH Privacy Act Officer, Office 

of Management Assessment, National 

Institutes of Health, 6011 Executive 

Blvd., Suite 601, MSC 7669, Rockville, 

MD 20852. Comments received will be 

available for public inspection at this 

same address from 9 a.m. to 3 p.m., 

Monday through Friday, except federal 

holidays. Please call 301–496–4606 for 

an appointment. 

FOR FURTHER INFORMATION CONTACT: 

General questions about the proposed 

modified system of records may be 

submitted to Celeste Dade-Vinson, NIH 

Privacy Act Officer, Office of 

Management Assessment, Office of the 

Director, National Institutes of Health 

(NIH), 6011 Executive Blvd., Suite 601, 

MSC 7669, Rockville, MD 20852, or 

telephone 301 402–6201. 

SUPPLEMENTARY INFORMATION: This 

system of records (hereafter referred to 

as the ‘‘NIH Loan Repayment Records’’), 

covers records maintained in a 

particular NIH information technology 

(IT) system managed by NIH’s Division 

of Loan Repayment (DLR) that are used 

to manage and evaluate the intramural 

and extramural educational Loan 

Repayment Programs (LRP) at NIH. As 

of the date of this publication, there are 

eight such programs that provide 

student loan repayments for qualified 

individuals who agree to conduct 

biomedical and behavioral research; 

recipients include NIH employee 

researchers as well as scientists 

conducting research at non-profit 

organizations outside NIH. Scholarship 

program records at NIH are now covered 

by the following NIH SORNs, so are 

omitted from modified SORN 09–25– 

0165: 

• 09–25–0014—Clinical Research: 

Student Records, HHS/NIH/OD/OIR/ 

OE 

• 09–25–0108—Personnel: Guest 

Researchers, Special Volunteers, and 

Scientists Emeriti, HHS/NIH/OHRM 

• 09–25–0140—International Scientific 

Researchers in Intramural 

Laboratories, ORS/DIRS 

• 09–25–0158—Administration Records 

of Applicants and Awardees of the 

Intramural Research Training Awards 

Program, HHS/NIH/OD/OE 

The System of Records Notice (SORN) 

for System 09–25–0165 has been 

reformatted in accordance with OMB 

Circular A–108 and updated with these 

changes: 

• System name. The system name has 

been changed from ‘‘National Institutes 

of Health (NIH) Office of Loan 

Repayment and Scholarship Records 

system, HHS/NIH/OD’’ to ‘‘NIH Loan 

Repayment Records.’’ 

• Throughout the SORN. References 

to scholarship program records have 

been omitted; for example, the 

abbreviation ‘‘LRSPs’’ is now ‘‘LRPs.’’ 

• System Location and System 

Manager. Office names and addresses 

have been updated. 

• Authority. This section has been 

updated to remove all authorities