11298 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Total 

burden 

(in hr) 

Residents, first responders, business 

owners, employees, customers.

Eligibility Screener ............................

Epi CASE Survey .............................

900 

1,000 

1 

1 

2/60 

15/60 

30 

250 

General Survey ................................ 800 1 25/60 333 

Residents .......................................... Household Survey ............................ 120 1 10/60 20 

Hospital staff ..................................... Hospital Survey ................................ 40 1 25/60 17 

Staff from state, local, or tribal health 

agencies.

Medical Chart Abstraction Form ...... 25 10 30/60 125 

Total ........................................... ........................................................... ........................ ........................ ........................ 775 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–03703 Filed 2–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0672] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prominent and 

Conspicuous Mark of Manufacturers 

on Single-Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 reprocessed, 

single-use device labeling. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 26, 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 April 26, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 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. 

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– 

2011–N–0672 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Prominent and Conspicuous Mark of 

Manufacturers on Single-Use Devices.’’ 

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:// 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 11299 

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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Prominent and Conspicuous Mark of 

Manufacturers on Single-Use Devices 

OMB Control Number 0910–0577— 

Extension 

Section 502 of the Federal Food, Drug, 

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

352), among other things, establishes 

requirements that the label or labeling of 

a medical device must meet so that it is 

not misbranded and subject to 

regulatory action. Section 301 of the 

Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250) amended section 502 of the FD&C 

Act to add paragraph (u) to require 

devices (both new and reprocessed) to 

bear prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

Section 2(c) of the Medical Device 

User Fee Stabilization Act of 2005 

(MDUFSA) (Pub. L. 109–43) amends 

section 502(u) of the FD&C Act by 

limiting the provision to reprocessed 

single-use devices (SUDs) and the 

manufacturers who reprocess them. 

Under the amended provision, if the 

original SUD or an attachment to it 

prominently and conspicuously bears 

the name of the manufacturer, then the 

reprocessor of the SUD is required to 

identify itself by name, abbreviation, or 

symbol in a prominent and conspicuous 

manner on the device or attachment to 

the device. If the original SUD does not 

prominently and conspicuously bear the 

name of the manufacturer, the 

manufacturer who reprocesses the SUD 

for reuse may identify itself using a 

detachable label that is intended to be 

affixed to the patient record. 

As directed by MDUFSA, FDA issued 

the guidance entitled ‘‘Compliance with 

Section 301 of the Medical Device User 

Fee and Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices’’ (https://www.fda.gov/media/ 

71187/download) to identify 

circumstances in which the name or 

symbol of the original SUD 

manufacturer is not prominent and 

conspicuous, as used in section 502(u) 

of the FD&C Act. However, the guidance 

does not contain additional information 

collections. 

The requirements of section 502(u) of 

the FD&C Act impose a minimal burden 

on industry. This section of the FD&C 

Act only requires the manufacturer, 

packer, or distributor of a device to 

include their name and address on the 

labeling of a device. This information is 

readily available to the establishment 

and easily supplied. From FDA’s 

Unified Registration and Listing System 

database, FDA estimates that there are 

175 establishments that distribute 

approximately 946 reprocessed SUDs. 

The majority of establishments (161) 

distribute an average of 2 SUDs per 

establishment. The remaining 14 

establishments distribute an average of 

45 SUDs per establishment. Each 

response is anticipated to take 0.1 hours 

(6 minutes). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

Type of respondent Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Establishments listing less than 10 SUDs ........................... 161 2 322 0.1 32 

Establishments listing 10 or more SUDs ............................. 14 45 630 0.1 63 

Total .............................................................................. ........................ ........................ ........................ ........................ 95 

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

2Totals may not sum due to rounding. 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


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