31722 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 

intended to support the approval of 

NADAs, ANADAs, or applications for 

conditional approval (for example, 

animal drug sponsor, test facility, 

developer, vendor, user of electronic 

data capture (EDC) and data 

visualization software, or study data 

quality control (QC) and quality 

assurance (QA) specialist). 

II. Other Issues for Consideration 

CVM seeks to continuously enhance 

review efficiency and interactions with 

the animal health industry. As part of 

our continued effort to engage with the 

animal health industry, we are 

interested in understanding more about 

the experiences and familiarity of those 

involved in animal drug development 

with the use of data exchange standards. 

We specifically request public comment 

regarding the questions below. When 

submitting comments, it would help us 

if commenters would identify their 

animal health industry sector (for 

example, animal drug sponsor, test 

facility, developer, vendor, user of EDC 

and data visualization software, or study 

data QC and QA specialist). We will 

consider the comments as we evaluate 

the potential use of study data exchange 

standards for animal studies submitted 

as part of the new animal drug approval 

process. 

1. Which study data exchange 

standards are you currently using, if 

any, for the submission of study data to 

CVM; and which tools do you use to 

review, analyze, or validate the study 

data? 

2. If study data exchange standards 

are included as part of your study data 

management process, when are they 

incorporated (for example, in protocol 

development, EDC database and case 

report form development, post-study 

processing)? 

3. What are the potential benefits or 

anticipated challenges to the animal 

health industry of harmonizing CVM’s 

data exchange standards expectations 

with other FDA Centers’ expectations? 

4. What can CVM do to help industry 

to be more prepared for, or to reduce the 

burden of implementing, the use of 

study data exchange standards? 

5. What other comments do you have 

regarding the use of study data exchange 

standards for submission of study data 

to CVM? 

Dated: June 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12503 Filed 6–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0390] 

Lederle Laboratories et al.; Withdrawal 

of Approval of 12 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on May 12, 2021. The 

document announced the withdrawal of 

approval of 12 abbreviated new drug 

applications (ANDAs) from multiple 

applicants, withdrawn as of June 11, 

2021. The document indicated that FDA 

was withdrawing the approval of ANDA 

060164, Nystatin Ointment, held by 

Lederle Laboratories. However, the 

document published with an incorrect 

application number for this product. 

This document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Wednesday, May 12, 

2021 (86 FR 26058), appearing on page 

26058 in FR Doc. 2021–09980, the 

following correction is made: 

On page 26058, in the first column, in 

the first line in the table, the application 

number ‘‘060164’’ is corrected to read 

‘‘061064’’. 

Dated: June 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12557 Filed 6–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0493] 

Medical Devices; Exemption From 

Premarket Notification: Powered 

Patient Transport, All Other Powered 

Patient Transport 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that it has received a 

petition requesting exemption from the 

premarket notification requirements for 

the generic device type, powered patient 

transport, all other powered patient 

transport. These devices are motorized 

devices used to mitigate mobility 

impairment caused by injury or other 

disease by moving a person from one 

location or level to another, such as up 

and down flights of stairs. This device 

type does not include motorized threewheeled vehicles or wheelchairs, and is 

distinct from the device type, powered 

patient transport, powered patient 

stairway chair lifts, which is classified 

separately within the same regulation. 

FDA is publishing this notice to obtain 

comments in accordance with 

procedures established by the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). 

DATES: Submit either electronic or 

written comments by August 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 August 16, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 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 


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Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 31723 

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– 

2021–N–0493 for ‘‘Medical Devices; 

Exemption from Premarket Notification: 

Powered Patient Transport, All Other 

Powered Patient Transport.’’ 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 office 

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: Dan 

Reed, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1526, Silver Spring, 

MD 20993–0002, 240–402–4717. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory Background 

Under section 513 of the FD&C Act 

(21 U.S.C. 360c), FDA classifies devices 

into one of three regulatory classes: 

Class I, class II, or class III. FDA 

classification of a device is determined 

by the amount of regulation necessary to 

provide a reasonable assurance of safety 

and effectiveness. Pursuant to section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and the implementing 

regulations, part 807 (21 CFR part 807), 

persons who intend to market a new 

device are required to submit and obtain 

clearance of a premarket notification 

(510(k)) containing information that 

allows FDA to determine whether the 

new device is ‘‘substantially equivalent’’ 

within the meaning of section 513(i) of 

the FD&C Act to a legally marketed 

device that does not require premarket 

approval. 

On November 21, 1997, section 206 of 

the Food and Drug Administration 

Modernization Act (Pub. L. 105–115) 

added new section 510(m) to the FD&C 

Act. On December 13, 2016, section 

3054 of the 21st Century Cures Act (Pub. 

L. 114–255) (Cures Act) amended 

section 510(m) of the FD&C Act. As 

amended, section 510(m)(1) of the FD&C 

Act requires FDA, within 90 days after 

enactment of the Cures Act and once 

every 5 years thereafter, to publish in 

the Federal Register a list of each type 

of class II device that does not require 

a report under section 510(k) of the 

FD&C Act to provide reasonable 

assurance of safety and effectiveness. 

As amended by the Cures Act, section 

510(m)(2) of the FD&C Act provides 

that, 1 calendar day after the date of 

publication of the final list mentioned 

in section 510(m)(1)(B), FDA may 

exempt a class II device from the 

requirement to submit a report under 

section 510(k) of the FD&C Act, upon its 

own initiative or receipt of a petition 

from an interested person, if FDA 

determines that a report under section 

510(k) is not necessary to assure the 

safety and effectiveness of the device. 

To do so, FDA must publish in the 

Federal Register notice of its intent to 

exempt the device, or the petition, and 

provide a 60-calendar day period for 

public comment. Within 120 days after 

the issuance of this notice, FDA must 

publish an order in the Federal Register 

that sets forth its final determination 

regarding the exemption of the device 

that was the subject of the notice. If FDA 

fails to respond to a petition under this 

section within 180 days of receiving it, 

the petition shall be deemed granted. 

The generic device type, powered 

patient transport is classified under 

§ 890.5150 (21 CFR 890.5150). On 

March 4, 2013, in response to a petition, 

FDA created a separate classification for 

powered patient stairway chair lifts 

(§ 890.5150(a)), providing a conditional 

exemption from premarket notification 

for this device type, product code PCD 

(78 FR 14015). The classification change 

retained premarket notification 

requirements for all other powered 

patient transport, product code ILK 

(§ 890.5150(b)). 

II. Criteria for Exemption 

There are a number of factors FDA 

may consider to determine whether a 

510(k) is necessary to provide 

reasonable assurance of the safety and 

effectiveness of a class II device. These 

factors are discussed in the guidance the 

Agency issued on February 19, 1998, 

entitled ‘‘Procedures for Class II Device 

Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff’’ (available at http://

www.fda.gov/downloads/ 

MedicalDevices/DeviceRegulationand

Guidance/Guidance6Documents/ 

UCM080199.pdf). 

As discussed in the guidance 

document, FDA generally considers the 

following factors to determine whether 

a report under section 510(k) is 

necessary for class II devices: (1) The 

device does not have a significant 

history of false or misleading claims or 

of risks associated with inherent 

characteristics of the device; (2) 

characteristics of the device necessary 

for its safe and effective performance are 

well established; (3) changes in the 

device that could affect safety and 

effectiveness will either (a) be readily 

detectable by users by visual 

examination or other means such as 

routine testing, before causing harm or 

(b) not materially increase the risk of 

injury, incorrect diagnosis, or ineffective 


khammond on DSKJM1Z7X2PROD with NOTICES
31724 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 

treatment; and (4) any changes to the 

device would not be likely to result in 

a change in the device’s classification. 

FDA may also consider that, even when 

exempting devices, these devices would 

still be subject to the general limitations 

on exemptions. 

III. Proposed Class II Device 

Exemptions 

FDA has received the following 

petition requesting an exemption from 

premarket notification for a class II 

device: Sam DeMarco, Staff Regulatory 

Affairs Specialist, on behalf of Stryker 

Medical, 3800 E Centre Ave., Portage, 

MI 49002, for powered patient transport, 

all other powered patient transport, 

classified under § 890.5150(b). FDA 

seeks comment on the petition in 

accordance with section 510(m)(2) of 

the FD&C Act. 

IV. Paperwork Reduction Act of 1995 

While this notice contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this notice. The 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120. 

Dated: June 7, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12505 Filed 6–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Renal/ 

Urological Small Business Activities. 

Date: July 8, 2021. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Santanu Banerjee, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 2106, 

Bethesda, MD 20892, (301) 435–5947, 

banerjees5@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Speech, Language and 

Communication. 

Date: July 9, 2021. 

Time: 11:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Sara Louise Hargrave, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3170, 

Bethesda, MD 20892, (301) 443–7193, 

hargravesl@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: June 10, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–12510 Filed 6–14–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Investigator Initiated 

Extended Clinical Trial (R01); NIAID Clinical 

Trial Planning Grant (R34); NIAID Clinical 

Trial Implementation Cooperative Agreement 

(U01); NIAID SBIR Phase II Clinical Trial 

Implementation Cooperative Agreement 

(U44). 

Date: June 28, 2021. 

Time: 12:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Mario Cerritelli, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F58, Rockville, MD 

20852, 240–669–5199, cerritem@

mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Investigator Initiated 

Extended Clinical Trial (R01); NIAID Clinical 

Trial Planning Grant (R34); NIAID Clinical 

Trial Implementation Cooperative Agreement 

(U01); NIAID SBIR Phase II Clinical Trial 

Implementation Cooperative Agreement 

(U44). 

Date: June 29, 2021. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Mario Cerritelli, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F58, Rockville, MD 

20852, 240–669–5199, cerritem@

mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: June 9, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–12451 Filed 6–14–21; 8:45 am] 

BILLING CODE 4140–01–P 


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