31720 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 

states that the requirements for the 

MIECHV grants to tribes, tribal 

organizations, and urban Indian 

organizations are to be consistent, to the 

greatest extent practicable, with the 

requirements for grantees under the 

MIECHV program for states and 

jurisdictions. 

OCC, in collaboration with the Health 

Resources and Services Administration, 

Maternal and Child Health Bureau 

awarded grants for the Tribal MIECHV 

Program (Tribal Home Visiting) to 

support cooperative agreements to 

conduct community needs assessments; 

plan for and implement high-quality, 

culturally-relevant, evidence-based 

home visiting programs in at-risk tribal 

communities; establish, measure, and 

report on progress toward meeting 

performance measures in six 

legislatively-mandated benchmark 

areas; and conduct rigorous evaluation 

activities to build the knowledge base 

on home visiting among Native 

populations. 

After the first grant year, Tribal Home 

Visiting grantees must comply with the 

requirement to submit an Annual Report 

to the Secretary that should feature 

activities carried out under the program 

during the past reporting period, and a 

final report to the Secretary during the 

final year of their grant. To assist 

grantees with meeting these 

requirements, ACF created guidance for 

grantees to use when writing their 

reports. The guidance specifies that 

grantees must address the following: 

• Update on Home Visiting Program 

Goals and Objectives 

• Update on the Implementation of 

Home Visiting Program in Targeted 

Community(ies) 

• Progress toward Meeting Legislatively 

Mandated Benchmark Requirements 

• Update on Rigorous Evaluation 

Activities 

• Home Visiting Program Continuous 

Quality Improvement (CQI) Efforts 

• Update on dissemination activities 

• Administration of Home Visiting 

Program 

• Technical Assistance Needs 

Previously, the guidance included 

information about both the annual and 

the final reports from grantees. This 

extension request includes updates to 

the guidance to make it specific to just 

the annual reports. Guidance specific to 

the final report will be submitted for 

review and approval by OMB in the 

future. A comment period will 

accompany that request. 

Respondents: Tribal Home Visiting 

Managers (information collection does 

not include direct interaction with 

individuals or families that receive the 

services). 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual 

burden 

hours 

Annual Report to the Secretary ....................................................................... 23 1 25 575 

Estimated Total Annual Burden 

Hours: 575. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Title V of the Social Security 

Act, sections 511(e)(8)(A) and 511(h)(2)(A). 

John M. Sweet, Jr., 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–12464 Filed 6–14–21; 8:45 am] 

BILLING CODE 4184–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2319] 

Evaluation of Study Data Exchange 

Standards for Submission of Study 

Data to the Center for Veterinary 

Medicine; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is soliciting comments on the use of 

study data exchange standards from 

persons involved in study conduct, data 

collection, data management, and 

submission of animal study data 

intended to support the approval of new 

animal drug applications, abbreviated 

new animal drug applications, or 

applications for conditional approval. 

DATES: Submit either electronic or 

written comments on the notice by 

September 13, 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 September 13, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 13, 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 31721 

1Conditional approval allows a sponsor to begin 

marketing a new animal drug after demonstrating 

the safety of the product and that there is a 

reasonable expectation of effectiveness, while the 

sponsor continues to collect the evidence of 

effectiveness needed for the product to receive full 

approval under section 512 of the FD&C Act (21 

U.S.C. 360b) (i.e., substantial evidence of 

effectiveness). Conditional approval is valid for 1 

year and can be renewed by FDA annually for up 

to a total of 5 years, if the sponsor shows sufficient 

progress towards demonstrating substantial 

evidence of effectiveness. 

2https://www.fda.gov/industry/fda-resourcesdata-standards. 

3http://www.cdisc.org. 

• 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. FDA2020–N–2319 for ‘‘Evaluation of Study 

Data Exchange Standards for 

Submission of Study Data to the Center 

for Veterinary Medicine.’’ 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: 

Charles Andres, Center for Veterinary 

Medicine (HFV–180), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–402–0653, 

charles.andres@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

For new animal drug applications 

(NADAs), the FDA requires full reports 

of investigations that have been 

conducted to show a new animal drug 

is safe and effective for use (section 

512(b)(1)(A) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360b(b)(1)(A))). Additionally, section 

512(n)(1)(E) of the FD&C Act (21 U.S.C. 

360b(n)(1)(E)) requires that abbreviated 

applications for the approval of a new 

animal drug (ANADAs) contain 

information to show that the generic 

new animal drug is bioequivalent to the 

approved new animal drug. FDA also is 

authorized to grant conditional approval 

to certain new animal drugs. An 

application for conditional approval 

must contain full reports of 

investigations that have been conducted 

to show that the new animal drug is safe 

and that there is a reasonable 

expectation of effectiveness. (See 

section 571(a)(2)(B) of the FD&C Act (21 

U.S.C. 360ccc(a)(2)(B)).) 1 In addition to 

the reports of animal studies conducted 

to support the safety and effectiveness 

of a new animal drug, copies of the 

underlying study data are submitted to 

FDA’s Center for Veterinary Medicine 

(CVM). 

As part of our continued effort to 

modernize our information technology 

systems and improve efficiency, we 

have transitioned to an electronic data 

format for submission of study data for 

regulatory review. Currently, CVM does 

not require or suggest study data 

exchange standards for such 

submissions. Study data standards are 

sets of rules on how particular types of 

data should be structured, defined, 

formatted, or exchanged between 

computer systems. The lack of 

uniformity of submitted electronic data 

files and the inconsistent use of 

terminology across submissions 

impedes efficiency and complicates our 

efforts to display, evaluate, and validate 

the data using advanced review and 

analysis tools. The use of study data 

exchange standards would improve the 

clarity and consistency of our 

expectations regarding submission of 

electronic data files. Additionally, the 

conformance to standardized study data 

format is now being encouraged and 

implemented in other parts of the FDA.2

Study data exchange standards 

provide a consistent general framework 

for organizing study data, including 

templates for datasets, standard or 

controlled terminology for variables, 

and standard calculations for common 

variables. The Clinical Data Interchange 

Standards Consortium (CDISC) is an 

open, multidisciplinary, nonprofit 

organization that has established 

worldwide industry standards to 

support the electronic acquisition, 

exchange, submission, and archiving of 

clinical trial data and metadata for 

medical and biopharmaceutical product 

development.3 CDISC facilitates the 

development of study data exchange 

standards as part of a collaboration 

involving multiple member 

organizations, including FDA. Two 

study data exchange standards 

developed by CDISC that CVM is 

exploring for potential use are the 

Standard for Exchange of Nonclinical 

Data (SEND), a data model developed to 

support the exchange of nonclinical 

tabulated datasets for toxicology studies 

conducted in animals, and the Study 

Data Tabulation Model (SDTM), a model 

for exchange of human clinical study 

data. FDA accepts both SEND and 

SDTM study data exchange standards 

for use in regulatory submissions. 

We are inviting comments on the use 

of study data exchange standards from 

persons involved in study conduct, data 

collection, data management, and 

submission of animal study data 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


khammond on DSKJM1Z7X2PROD with NOTICES