11300 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 

1Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/usepublic-human-genetic-variant-databases-supportclinical-validity-genetic-and-genomic-based-vitro. 

2FDA acknowledges that many databases may not 

use the term ‘‘administrator’’ or may have a 

committee of individuals that oversee the database. 

Therefore, for the purpose of this guidance, a 

genetic variant database administrator is the entity 

or entities that oversee database operations. 

Our estimated burden for the 

information collection reflects an 

increase of 52 hours. We attribute this 

adjustment to an increase in the number 

of establishments and reprocessed 

SUDs. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03748 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–7012] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Use of Public 

Human Genetic Variant Databases To 

Support Clinical Validity for Genetic 

and Genomic-Based In Vitro 

Diagnostics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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 0910–0850. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Use of Public 

Human Genetic Variant Databases To 

Support Clinical Validity for Genetic 

and Genomic-Based In Vitro 

Diagnostics 

OMB Control Number 0910–0850— 

Extension 

Section 2011 of the 21st Century 

Cures Act of 2016 (Pub. L. 114–255) 

encourages the FDA to develop new 

approaches for addressing regulatory 

science issues as part of the Precision 

Medicine Initiative (PMI). 

In the Federal Register of April 13, 

2018 (83 FR 16110), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Use of Public Human Genetic 

Variant Databases to Support Clinical 

Validity for Genetic and Genomic-Based 

In Vitro Diagnostics; Guidance for 

Stakeholders and Food and Drug 

Administration Staff.’’ 1 The guidance 

describes one part of FDA’s PMI effort 

to create a flexible and adaptive 

regulatory approach to the oversight of 

next generation sequencing (NGS)-based 

tests. The goal of this effort is to help 

ensure patients receive accurate and 

meaningful test results, while promoting 

innovation in test development. The 

guidance describes how publicly 

accessible databases of human genetic 

variants can serve as sources of valid 

scientific evidence to support the 

clinical validity of genotype-phenotype 

relationships in FDA’s regulatory review 

of both NGS-based tests and genetic and 

genomic tests based on other 

technologies. Publicly accessible genetic 

databases may be useful to support the 

clinical validity of NGS tests as well as 

single gene or panel tests that use other 

technology. 

The guidance describes FDA’s 

considerations in determining whether a 

genetic variant database is a source of 

valid scientific evidence that could 

support the clinical validity of an NGSbased test. The guidance further 

outlines the process by which 

administrators 2 of genetic variant 

databases could voluntarily apply to 

FDA for recognition, and how FDA 

would review such applications and 

periodically reevaluate recognized 

databases. The guidance also 

recommends that, at the time of 

recognition, the database administrator 

make information regarding policies, 

procedures, and conflicts of interest 

publicly available and accessible on the 

genetic variant database’s website. 

Respondents are administrators of 

genetic databases. Our estimate of five 

respondents per year is based on the 

current number of databases that may 

meet FDA recommendations for 

recognition and seek such recognition. 

Based on our experience and the 

nature of the information, we estimate 

that it will take an average of 80 hours 

to complete and submit an application 

for recognition. We estimate that 

maintenance of recognition activities 

will take approximately one-fourth of 

that time (20 hours) annually. We 

estimate that it will take approximately 

1 hour to post the information on the 

website. 

In the Federal Register of September 

23, 2020 (85 FR 59801), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two 

comments. One comment was not 

relevant to the topic or information 

collection. A summary of the other 

comment and our response are as 

follows: 

(Comment) One comment expressed 

concerns and suggestions regarding the 

collection, storage, and security of 

personally identifiable information (PII) 

and protected health information (PHI). 

(Response) The guidance document 

‘‘Use of Public Human Genetic Variant 

Databases to Support Clinical Validity 

for Genetic and Genomic-Based In Vitro 

Diagnostics’’ describes, among other 

things, FDA’s considerations in 

determining whether a publicly 

accessible genetic variant database is a 

source of valid scientific evidence that 

could support the clinical validity of 

genetic and genomic-based tests in a 

premarket submission and outlines the 

process by which administrators of 

publicly accessible genetic variant 

databases could voluntarily apply to 

FDA for recognition, and how FDA 

would assess such applications and 

periodically reevaluate recognized 

databases. FDA recommends that 

genetic database administrators should 

identify the applicable laws and 

regulations to assure that any 

requirements are addressed and 

transparently documented. Genetic 

variant database administrators should 

also put in place adequate security 

measures to ensure the protection and 

privacy of PII and PHI and provide 


khammond on DSKJM1Z7X2PROD with NOTICES
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