2674 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices 

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. 

Extralabel Drug Use for Animals—21 

CFR 530 

OMB Control Number 0910–0325— 

Extension 

The Animal Medicinal Drug Use 

Clarification Act of 1994 (Pub. L. 103– 

396) allows a veterinarian to prescribe 

the extralabel use of approved new 

animal drugs. Also, it permits FDA, if it 

finds that there is a reasonable 

probability that the extralabel use of an 

animal drug may prevent the risk to the 

public health, to establish a safe level 

for a residue from the extralabel use of 

the drug and to require the development 

of an analytical method for the detection 

of residues above that established safe 

level (21 CFR 530.22(b)). Although to 

date, we have not established a safe 

level for a residue from the extralabel 

use of any new animal drug and, 

therefore, have not required the 

development of analytical methodology, 

we believe that there may be instances 

when analytical methodology will be 

required. We are, therefore, estimating 

the reporting burden based on two 

methods being required annually. The 

requirement to establish an analytical 

method may be fulfilled by any 

interested person. We believe that the 

sponsor of the drug will be willing to 

develop the method in most cases. 

Alternatively, FDA, the sponsor, and 

perhaps a third party may cooperatively 

arrange for method development. The 

respondents may be sponsors of new 

animal drugs; State, Federal, and/or 

State Agencies; academia; or 

individuals. 

In the Federal Register of August 6, 

2020 (85 FR 47794), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. One comment was received 

but was not responsive to topics 

solicited regarding the information 

collection. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

530.22(b); Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320 

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. 2021–00475 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–2010–N–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration-Regulated 

Products: Export Certificates 

Correction 

In notice document 2020–28064 

appearing on pages 83091–83092 in the 

issue of Monday, December 21, 2020, 

make the following correction: 

On page 83091, in the second column, 

in the DATES section, change ‘‘January 

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

[FR Doc. C1–2020–28064 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0913] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; 513(g) Request for 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information and to 

allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection burden estimate for requests 

for a written statement from FDA 

regarding the classification and 

regulatory requirements that may be 

applicable to a particular device (513(g) 

requests). 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 15, 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 March 15, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 15, 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 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices 2675 

1https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/fda-and-industryprocedures-section-513g-requests-informationunder-federal-food-drug-and-cosmetic. 

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– 

2014–N–0913 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 513(g) 

Request for Information.’’ 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., 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.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its 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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

513(g) Request for Information 

OMB Control Number 0910–0705— 

Extension 

This information collection supports 

Agency regulations and accompanying 

guidance. Section 513(g) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360c(g)) provides a 

means for obtaining the Agency’s views 

about the classification and regulatory 

requirements that may be applicable to 

a particular device. Section 513(g) 

provides that, within 60 days of the 

receipt of a written request of any 

person for information respecting the 

class in which a device has been 

classified or the requirements applicable 

to a device under the FD&C Act, the 

Secretary of Health and Human Services 

shall provide such person a written 

statement of the classification (if any) of 

such device and the requirements of the 

FD&C Act applicable to the device. 

Regulations governing medical device 

classification procedures are codified 

under 21 CFR part 860. 

The guidance document entitled 

‘‘FDA and Industry Procedures for 

Section 513(g) Requests for Information 

Under the Federal Food, Drug, and 

Cosmetic Act; Guidance for Industry 

and Food and Drug Administration 

Staff’’ 1 establishes procedures for 

submitting, reviewing, and responding 

to requests for information respecting 

the class in which a device has been 

classified or the requirements applicable 

to a device under the FD&C Act that are 

submitted in accordance with section 

513(g) of the FD&C Act. FDA does not 

review data related to substantial 

equivalence or safety and effectiveness 

in a 513(g) request for information. 

FDA’s responses to 513(g) requests for 

information are not device classification 

decisions and do not constitute FDA 

clearance or approval for marketing. 

Classification decisions and clearance or 

approval for marketing require 

submissions under different sections of 

the FD&C Act. 

Relatedly, the FD&C Act, as amended 

by the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), requires FDA to collect user fees for 

513(g) requests for information. The 

guidance document entitled ‘‘User Fees 

for 513(g) Requests for Information; 

Guidance for Industry and Food and 

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