Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 11301 

training for database staff on security 

and privacy protection. The guidance 

recommends that, among other 

considerations, such a genetic variant 

database would collect, store, and report 

data and conclusions in compliance 

with all applicable requirements 

regarding protected health information, 

patient privacy, research subject 

protections, and data security. In section 

V.A of the guidance, FDA discusses 

security and privacy of such data, 

stating that ‘‘[g]enetic variant database 

operations must be in compliance with 

all applicable federal laws and 

regulations (e.g., the Health Insurance 

Portability and Accountability Act, the 

Genetic Information Nondiscrimination 

Act, the Privacy Act, the Federal Policy 

for the Protection of Human Subjects 

(‘‘Common Rule’’), etc.) regarding 

protected health information, patient 

privacy, research involving human 

subjects, and data security, as 

applicable.’’ 

However, we believe the comment 

may misunderstand the subject of the 

information collection request. We are 

requesting extension of the OMB 

approval of the information collection 

associated with the guidance document, 

i.e., the application for recognition of a 

publicly accessible genetic variant 

database as a source of valid scientific 

evidence that could support the clinical 

validity of genetic and genomic-based 

tests in a premarket submission, as well 

as record maintenance and public 

disclosure related to such recognition. 

The application for recognition does not 

include submission of PII or PHI that 

may be contained in a genetic variant 

database. Rather, the application 

includes standard operating procedures 

and other documents related to the 

database’s handling of PII and PHI 

confidentiality and privacy, among 

other considerations. The information 

collected in the application for 

recognition is used to evaluate the 

database’s oversight and governance 

procedures to determine that, among 

other things, they are designed to ensure 

the protection of PII and PHI and 

provide appropriate training for 

database staff. 

We have not revised the information 

collection based on the comment. 

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 

Application for recognition of genetic database .................. 5 1 5 80 400 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Maintenance of recognition activities ................................... 5 1 5 20 100 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Public disclosure of policies, procedures, and conflicts of 

interest .............................................................................. 5 1 5 1 5 

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: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03729 Filed 2–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0031] 

Best Practices for Development and 

Application of Disease Progression 

Models; Public Workshop; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: One of the goals of the 

Prescription Drug User Fee Act of 2017 

(PDUFA VI), part of the FDA 

Reauthorization Act of 2017 (FDARA), 

is advancing model-informed drug 

development (MIDD). The ‘‘Best 

Practices for Development and 

Application of Disease Progression 

Models’’ workshop fulfills FDA’s 

performance commitment under PDUFA 

VI to hold a workshop. The Food and 

Drug Administration (FDA or Agency) is 

opening a docket to solicit public input 

on topics areas for an upcoming disease 

progression modeling workshop. The 

purpose of this public workshop is to 

discuss the best practices for developing 

disease progression models and their 

application to support drug 

development decisions; share 


khammond on DSKJM1Z7X2PROD with NOTICES
11302 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 

experiences and case studies that 

highlight the opportunities and 

limitations in the development and 

application of disease progression 

models including models for natural 

history of disease and clinical trial 

simulations; and discuss the knowledge 

gaps and research needed to advance 

the development and use of disease 

progression models. 

DATES: To ensure that the Agency 

considers your input, submit either 

electronic or written comments by 

March 26, 2021. 

ADDRESSES: FDA is establishing a docket 

for public comment on this workshop. 

The docket number is FDA–2021–N– 

0031. The docket will close on March 

26, 2021. Submit either electronic or 

written comments on this public 

workshop by March 26, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before March 26, 2021. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 26, 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. 

You may submit comments as 

follows: 

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– 

2021–N–0031 for ‘‘Best Practices for 

Development and Application of 

Disease Progression Models; Public 

Workshop; Request for Comments.’’ 

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: 

Maryanne Dingman, Office of Clinical 

Pharmacology, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–8777, or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under FDARA, FDA agreed, in 

accordance with section I of the PDUFA 

VI Performance Goals, ‘‘Ensuring the 

Effectiveness of the Human Drug 

Review, part J, Enhancing Regulatory 

Decision Tools to Support Drug 

Development and Review,’’ to hold 

several workshops to identify best 

practices for MIDD. The workshop 

entitled ‘‘Best Practices for Development 

and Application of Disease Progression 

Models,’’ to be held in 2021, fulfills 

FDA’s performance commitment under 

PDUFA VI. FDA is requesting comments 

from the public to help identify areas of 

interest to be discussed during the 

workshop given the wide range of 

approaches to data collection, 

aggregation modeling, model 

development, verification and 

validation, and potential applications in 

drug development and regulatory 

review. The outcome will help the 

Agency inform the public on current 

experience, emerging techniques, and 

limitations to streamline the drug model 

development and facilitate the decisionmaking process. 

II. Request for Information and 

Comments 

Interested persons are invited to 

provide detailed information and 

comments on areas of interest to discuss 

during the upcoming ‘‘Best Practices for 

Development and Application of 

Disease Progression Models ’’ workshop. 

FDA is interested in responses about 

best practice considerations including, 

but not limited to, the following: 

1. The development and application 

of different types of disease progression 

models (e.g., empirical, semimechanistic, and fully mechanistic or 

systems modeling). 


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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 11303 

2. Modeling natural history of disease, 

specifically methodological 

considerations and challenges in 

characterizing the natural relationship 

between pharmacodynamic markers and 

clinical outcomes. 

3. Clinical trial simulations based on 

disease progression/natural history 

models to support drug development 

and regulatory decisions. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03727 Filed 2–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4951] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 March 26, 

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 0910–0332. 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. 

Medical Devices; Humanitarian Use 

Devices—21 CFR Part 814 

OMB Control Number 0910–0332— 

Extension 

This collection of information 

implements the humanitarian use 

devices (HUDs) provision of section 

520(m) of the Federal Food, Drug, and 

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

360j(m)) and part 814, subpart H (21 

CFR part 814, subpart H). Under section 

520(m) of the FD&C Act, FDA is 

authorized to exempt an HUD from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act (21 U.S.C. 

360d and 360e) provided that the 

device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 

account the probable risks and benefits 

of currently available devices or 

alternative forms of treatment. 

Respondents may submit a 

humanitarian device exemption (HDE) 

application seeking exemption from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act as 

authorized by section 520(m)(2) of the 

FD&C Act. The information collected 

will assist FDA in making 

determinations on the following: (1) 

Whether to grant HUD designation of a 

medical device; (2) whether to exempt 

an HUD from the effectiveness 

requirements under sections 514 and 

515 of the FD&C Act, provided that the 

device meets requirements set forth 

under section 520(m) of the FD&C Act; 

and (3) whether to grant marketing 

approval(s) for the HUD. Failure to 

collect this information would prevent 

FDA from making a determination on 

the factors listed previously in this 

document. Further, the collected 

information would also enable FDA to 

determine whether the holder of an 

HUD is in compliance with the HUD 

provisions under section 520(m) of the 

FD&C Act. 

In the Federal Register of August 13, 

2020 (85 FR 49379), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although two comments 

were received, they were not responsive 

to the four collection of information 

topics solicited. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for HUD designation—814.102 ............................. 20 1 20 40 800 

HDE Application—814.104 .................................................. 4 1 4 328 1,312 

HDE Amendments and resubmitted HDEs—814.106 ......... 20 5 100 50 5,000 

HDE Supplements—814.108 ............................................... 116 1 116 80 9,280 

Notification of withdrawal of an HDE—814.116(e)(3) ......... 2 1 2 1 2 

Notification of withdrawal of institutional review board approval—814.124(b) ........................................................... 1 1 1 2 2 

Periodic reports—814.126(b)(1) .......................................... 50 1 50 120 6,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,396 

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


khammond on DSKJM1Z7X2PROD with NOTICES