49542 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

assume wholesale distributors will 

expend 1 hour for each notification. 

Because the extent of distribution of 

any illegitimate product will vary, we 

assume a wide distribution for each 

illegitimate product for purposes of 

establishing our burden estimate. We 

estimate that, for each notification that 

a manufacturer or repackager makes to 

FDA, the manufacturer or repackager 

will notify approximately 30 trading 

partners (relying on the number of 

distributors). This formula results in 

approximately 3,000 notifications 

annually to trading partners of 

manufacturers and repackagers. This 

estimate includes the notifications by 

manufacturers and repackagers who 

have determined that an illegitimate 

product is in their possession or control, 

as well as notifications by 

manufacturers who have determined 

that a product poses a high risk of 

illegitimacy. 

We assume that a large wholesale 

distributor may have up to 4,500 trading 

partners, where a small wholesale 

distributor may have 200 trading 

partners, averaging approximately 

2,350. We had originally estimated that 

a wholesale distributor would notify all 

2,350 trading partners for each of the 

illegitimate products identified. 

However, as a result of our experience 

with the collection and informal 

feedback from industry, we have 

lowered our estimate to reflect that 138 

respondents will make 1,175 disclosures 

for a total of 162,150 disclosures 

annually and that each disclosure will 

require approximately 12 minutes, for a 

total of 32,430 hours annually. 

We estimate that a pharmacy 

purchases prescription drugs from an 

average of two wholesale distributors. 

Therefore, a pharmacy would notify 2 

trading partners for each of the 12 

illegitimate products identified. This 

estimate results in in approximately 24 

notifications annually to pharmacy 

trading partners. 

We estimate that the burden for 

notifying trading partners of an 

illegitimate product and the number of 

trading partners notified will be the 

same as the estimates for notification of 

termination. The estimated total burden 

hours to notify trading partners that the 

notification is terminated is 

approximately 33,035 hours annually. 

We assume a comparable amount of 

time is required to provide the 

information necessary for requesting to 

terminate a notification. The time 

required to investigate and resolve an 

illegitimate product notification will 

vary, but we assume that each 

notification will eventually be 

terminated. We assume that the number 

of requests for termination of a 

notification per year will be the same as 

the original number of notifications for 

a given year. The estimated total burden 

hours to make requests for termination 

of notifications to FDA is 250 hours 

annually. 

Based on communications we have 

had with trading partners and 

stakeholders since the 2013 enactment 

of the DSCSA, we estimate that 20 

trading partners or stakeholders will 

submit approximately 20 requests for a 

waiver, an exception, or an exemption. 

Also based on feedback from industry 

stakeholders, we estimate that 

respondents will expend an average of 

80 hours to prepare and submit each 

request and to submit any additional 

followup information that we may 

request. We estimate the total burden as 

approximately 1,600 hours. 

We estimate that we will receive from 

approximately one respondent 

approximately one notification or other 

information informing us that there has 

or has not been a material change in the 

circumstances that warranted the 

waiver, exception, or exemption and 

that each notification will require 

approximately 16 hours to prepare and 

submit to us. We estimate the total 

burden as approximately 16 hours. 

We estimate that we will receive 

approximately one renewal request from 

approximately one respondent and that 

each request will require approximately 

16 hours to prepare and submit to us. 

We estimate the total burden as 

approximately 16 hours. 

Our estimated burden for the 

information collection reflects an 

overall increase of 56,116 hours and a 

corresponding increase of 271,638 

responses annually. We attribute this 

adjustment to an increase in the number 

of illegitimate product notification 

submissions we received in the last 

couple of years and the number of such 

submissions we have received so far this 

fiscal year. 

Dated: August 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19061 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0536] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

User Fee Cover Sheet, Form FDA 3601 

and Device Facility User Fee Cover 

Sheet, Form FDA 3601a 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 October 4, 

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 0910–0511 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 Device User Fee Cover Sheet, 

Form FDA 3601 and Device Facility 

User Fee Cover Sheet, Form FDA 3601a 

OMB Control Number 0910–0511— 

Revision 

The Federal Food, Drug, and Cosmetic 

Act, as amended by the Medical Device 

User Fee and Modernization Act of 2002 

(Pub. L. 107–250), and the Medical 

Device User Fee Amendments of 2007 

(Title II of the Food and Drug 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49543 

Administration Amendments Act of 

2007), authorizes FDA to collect user 

fees for certain medical device 

applications. Under this authority, 

companies pay a fee for certain new 

medical device applications or 

supplements submitted to the Agency 

for review. Because the submission of 

user fees concurrently with applications 

and supplements is required, the review 

of an application cannot begin until the 

fee is submitted. Form FDA 3601, the 

‘‘Medical Device User Fee Cover Sheet,’’ 

is designed to provide the minimum 

necessary information to determine 

whether a fee is required for review of 

an application, to determine the amount 

of the fee required, and to account for 

and track user fees. The form provides 

a cross-reference between the fees 

submitted for an application with the 

actual submitted application by using a 

unique number tracking system. The 

information collected is used by FDA’s 

Center for Devices and Radiological 

Health and FDA’s Center for Biologics 

Evaluation and Research to initiate the 

administrative screening of new medical 

device applications and supplemental 

applications. 

We are revising the information 

collection to add Form FDA 3601a, the 

‘‘Device Facility User Fee Cover Sheet.’’ 

Owners or operators of places of 

business (also called establishments or 

facilities) that are involved in the 

production and distribution of medical 

devices intended for use in the United 

States are required to register annually 

with FDA, a process known as 

establishment registration (21 CFR part 

807, subparts A through D). (The 

information collection for medical 

device establishment registration and 

listing is approved under OMB control 

number 0910–0625.) All establishments 

required to register must pay a user fee. 

Form FDA 3601a, the ‘‘Device Facility 

User Fee Cover Sheet,’’ is designed to 

collect payments for the annual 

establishment registration fee for 

medical device establishments. 

The total number of annual responses 

for Form FDA 3601 is based on the 

average number of cover sheet 

submissions received by FDA in recent 

years. The number of received annual 

responses includes cover sheets for 

applications that were qualified for 

small businesses and fee waivers or 

reductions. The estimated hours per 

response are based on past FDA 

experience with the various cover sheet 

submissions and range from 5 to 30 

minutes. For this analysis, we estimate 

18 minutes per coversheet. 

The total number of annual responses 

for Form FDA 3601a is based on the 

average number of cover sheet 

submissions received by FDA in recent 

years. Based on past FDA experience 

with various cover sheet submissions, 

we estimate 10 minutes per response. 

In the Federal Register of June 12, 

2020 (85 FR 35939), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although two comments 

were received, only one was responsive 

to the four collection of information 

topics solicited. 

FDA’s response to the comment is 

that the establishment registration fee is 

not eligible for a reduced small business 

fee. This can be found on our website 

at: https://www.fda.gov/medicaldevices/how-study-and-market-yourdevice/device-registration-and-listing. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2

FDA Form No. Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

3601 ......................................................................... 6,182 1 6,182 0.30 (18 minutes) ...... 1,855 

3601a ....................................................................... 24,086 1 24,086 0.17 (10 minutes) ...... 4,095 

Total .................................................................. ........................ ........................ 30,268 .................................... 5,950 

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

2 Numbers have been rounded. 

Our estimated burden for the 

information collection reflects an 

overall increase of 4,036 hours and a 

corresponding increase of 23,889 

responses/records. We attribute these 

increases to two factors: We have 

revised the burden estimate to include 

Form FDA 3601a and we have adjusted 

the number of respondents for Form 

FDA 3601 to reflect our current data. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19113 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1857] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food, and Current 

Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 October 4, 

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 0910–0751. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 


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