49538 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

respect to establishing a mammography 

facilities certification program. The 

Committee shall advise the HHS 

Secretary and the Commissioner or 

designee on: 

(A) Developing appropriate quality 

standards and regulations for 

mammography facilities; 

(B) Developing appropriate standards 

and regulations for bodies accrediting 

mammography facilities under this 

program; 

(C) Developing regulations with 

respect to sanctions; 

(D) Developing procedures for 

monitoring compliance with standards; 

(E) Establishing a mechanism to 

investigate consumer complaints; 

(F) Reporting new developments 

concerning breast imaging which should 

be considered in the oversight of 

mammography facilities; 

(G) Determining whether there exists 

a shortage of mammography facilities in 

rural and health professional shortage 

areas and determining the effects of 

personnel on access to the services of 

such facilities in such areas; 

(H) Determining whether there will 

exist a sufficient number of medical 

physicists after October 1, 1999; and 

(I) Determining the costs and benefits 

of compliance with these requirements. 

The Committee shall consist of a core 

of 15 members, including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among physicians, practitioners, and 

other health professionals, whose 

clinical practice, research 

specialization, or professional expertise 

includes a significant focus on 

mammography. Members will be invited 

to serve for overlapping terms of up to 

4 years. Almost all members of this 

committee serve as Special Government 

Employees. The core of voting members 

shall include at least four individuals 

from among national breast cancer or 

consumer health organizations with 

expertise in mammography, and at least 

two practicing physicians who provide 

mammography services. In addition to 

the voting members, the Committee 

shall include two nonvoting industry 

representative members who have 

expertise in mammography equipment. 

The Committee may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/RadiationEmittingProducts/ 

NationalMammography

QualityAssuranceAdvisoryCommittee/ 

ucm520365.htm or by contacting the 

Designated Federal Officer (see FOR

FURTHER INFORMATION CONTACT). In light 

of the fact that no change has been made 

to the committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19108 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–2014–D–0609] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Drug Supply Chain 

Security Act Implementation 

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 information 

collection associated with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 2, 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 November 2, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 2, 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– 

2014–D–0609 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Drug 

Supply Chain Security Act 

Implementation.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49539 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Drug Supply Chain Security Act 

Implementation 

OMB Control Number 0910–0806— 

Revision 

This information collection helps to 

support implementation of section 582 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360eee–1). 

Enacted in 2013, the Drug Supply Chain 

Security Act (DSCSA) (Title II of Pub. L. 

113–54) amended section 582 of the 

FD&C Act and outlines steps to build an 

electronic, interoperable system to 

identify and trace certain prescription 

drugs as they are distributed in the 

United States. The DSCSA is intended 

to enhance FDA’s ability to help protect 

consumers from exposure to drugs that 

may be counterfeit, stolen, 

contaminated, or otherwise harmful. 

Respondents to the information 

collection are manufacturers, 

wholesalers, dispensers, and 

repackagers, as defined in section 581 of 

the FD&C Act (21 U.S.C. 360eee), of 

pharmaceutical drug products. 

To assist respondents with statutory 

requirements set forth in section 582 

pertaining to notifications of illegitimate 

products or products with a high risk of 

illegitimacy, we developed Form FDA 

3911 entitled ‘‘Drug Notification’’ along 

with the corresponding instructional 

document ‘‘INSTRUCTIONS FOR 

COMPLETION OF FORM FDA 3911— 

DRUG NOTIFICATION.’’ Form FDA 

3911 and the instructions are available 

from, and may be completed using, our 

website at https://www.fda.gov/drugs/ 

drug-supply-chain-security-act-dscsa/ 

drug-notifications-frequently-askedquestions. Form FDA 3911 is intended 

to facilitate notifications governed by 

section 582 by providing a uniform 

format for initial notifications, followup 

notifications, and requests for the 

termination of a notification. 

Section 582 of the FD&C Act also 

provides for FDA issuance of guidance 

documents to facilitate implementation 

of the DSCSA. To that end, we continue 

to develop guidance documents to assist 

respondents with information collection 

provisions set forth in section 582. The 

procedural guidance document entitled 

‘‘Drug Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification’’ (June 

2021; available at: https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/drug-supplychain-security-act-implementationidentification-suspect-product-andnotification) is intended to assist 

respondents in identifying suspect 

products, as defined at section 581, and 

with terminating notifications of 

illegitimate product or products with a 

high risk of illegitimacy. As explained 

in the guidance document, beginning 

January 1, 2015, certain trading partners 

(i.e., manufacturers, repackagers, 

wholesale distributors, or dispensers), 

upon determining that a product in their 

possession or control is a suspect 

product, must quarantine the product 

while they promptly conduct an 

investigation to determine whether the 

product is an illegitimate product, must 

notify FDA if they determine that the 

product is illegitimate product, and 

must notify certain trading partners of 

the illegitimate product as prescribed by 

section 582. Manufacturers must also 

notify FDA and certain immediate 

trading partners after determining that a 

product in their possession or control 

has a high risk of being illegitimate 

product. 

Similarly, we developed the draft 

guidance document ‘‘Waivers, 

Exceptions, and Exemptions From the 

Requirements of Section 582 of the 

Federal Food, Drug, and Cosmetic Act’’ 

(May 2018; available at: https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

waivers-exceptions-and-exemptionsrequirements-section-582-federal-fooddrug-and-cosmetic-act). The draft 

guidance explains Agency established 

processes by which: (1) A trading 

partner may request a waiver from 

certain requirements in section 582 if it 

would result in an undue economic 

hardship or for emergency medical 

reasons; (2) a manufacturer or 

repackager may request an exception to 


lotter on DSK11XQN23PROD with NOTICES1
49540 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

the section 582 requirements related to 

product identifiers if a product is 

packaged in a container too small or 

otherwise unable to accommodate a 

label with sufficient space to bear the 

required information; and (3) FDA may 

determine other products or 

transactions that shall be exempt from 

requirements of section 582. 

FDA has recently published the draft 

guidance document ‘‘Enhanced Drug 

Distribution Security at the Package 

Level Under the Drug Supply Chain 

Security Act’’ (June 2021; available at: 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security-act). The draft 

guidance clarifies the enhanced system 

requirements listed in section 582(g)(1) 

of the FD&C Act. This draft guidance 

also outlines and provides 

recommendations on the system 

attributes necessary for enabling the 

secure tracing of product at the package 

level, including allowing for the use of 

verification, inference, and aggregation, 

as necessary. FDA has also published a 

draft guidance document entitled 

‘‘DSCSA Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs: How to Exchange Product 

Tracing Information’’ (November 2014; 

available at: https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/dscsa-standardsinteroperable-exchange-informationtracing-certain-human-finishedprescription-drugs). This draft guidance 

establishes initial standards for the 

interoperable exchange of product 

tracing information, in paper or 

electronic format, for compliance with 

sections 582(a) through (e) of the FD&C 

Act. 

Two additional guidance documents 

help to further explain the statutory 

requirements of section 582. The 

‘‘Product Identifiers under the Drug 

Supply Chain Security Act—Questions 

and Answers’’ guidance for industry 

(June 2021; available at: https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

product-identifiers-under-drug-supplychain-security-act-questions-andanswers) is intended to address 

anticipated questions regarding product 

identifiers that are required under 

section 582 for packages and 

homogenous cases of certain drug 

products. The ‘‘Verification Systems 

Under the Drug Supply Chain Security 

Act for Certain Prescription Drugs’’ draft 

guidance (October 2018; available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/verification-systems-underdrug-supply-chain-security-act-certainprescription-drugs) provides 

recommendations for a robust 

verification system for the 

determination, quarantine, and 

investigation of suspect products, as 

well as the quarantine, notification, and 

disposition of illegitimate products. The 

guidance also addresses FDA’s 

recommendation that trading partners 

submit cleared product notifications. 

Finally, the guidance addresses the 

statutory requirements for verification, 

including verification of saleable 

returns, at the package level for product 

identifiers on packages and homogenous 

cases intended to be introduced in a 

transaction into commerce. 

FDA guidance documents are issued 

consistent with requirements found in 

section 582, as well as our Good 

Guidance Practice regulations found in 

21 CFR 10.115, which provide for 

public comment at any time. In 

addition, since enactment of the 

DSCSA, our Center for Drug Evaluation 

and Research has developed and 

continues to maintain a website 

communicating DSCSA implementation 

activity, including relevant resources at: 

https://www.fda.gov/drugs/drug-supplychain-integrity/drug-supply-chainsecurity-act-dscsa. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

time per 

response 

Total hours 

Manufacturers and Repackagers ......................................... 100 1 100 1 100 

Wholesale Distributors ......................................................... 138 1 138 1 138 

Dispenser ............................................................................. 12 1 12 1 12 

Total .............................................................................. ........................ ........................ 250 ........................ 250 

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

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN

ILLEGITIMATE PRODUCT 1

Type of respondent Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

disclosures 

Average 

time per 

disclosure 

Total hours 

Manufacturers and Repackagers ......................................... 100 30 3,000 * 0.20 600 

Wholesale Distributors ......................................................... 138 1,175 162,150 * 0.20 32,430 

Dispensers ........................................................................... 12 2 24 * 0.20 5 

Total .............................................................................. ........................ ........................ 165,174 ........................ 33,035 

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

* (12 minutes.) 


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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49541 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

time per 

response 

Total hours 

Manufacturers and Repackagers ......................................... 100 1 100 1 100 

Wholesale Distributors ......................................................... 138 1 138 1 138 

Dispensers ........................................................................... 12 1 12 1 12 

Total .............................................................................. ........................ ........................ 250 ........................ 250 

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

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN

ILLEGITIMATE PRODUCT TERMINATION 1

Type of respondent Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

disclosures 

Average 

time per 

disclosure 

Total hours 

Manufacturers and Repackagers ......................................... 100 30 3,000 * 0.20 600 

Wholesale Distributors ......................................................... 138 1,175 162,150 * 0.20 32,430 

Dispensers ........................................................................... 12 2 24 * 0.20 5 

Total .............................................................................. ........................ ........................ 165,174 ........................ 33,035 

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

* (12 minutes.) 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR REQUESTS FOR WAIVERS, EXCEPTIONS, OR EXEMPTIONS 1

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

time per 

response 

Total hours 

Requests to FDA for a Waiver, Exception, or Exemption ... 20 1 20 80 1,600 

Notifications to FDA of a Material Change in Circumstances Warranting the Waiver, Exception, or Exemption ............................................................................. 1 1 1 16 16 

Requests to FDA to Renew a Waiver, Exception, or Exemption ............................................................................. 1 1 1 16 16 

Total .............................................................................. ........................ ........................ 22 ........................ 1,632 

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

Based on illegitimate product 

notifications already received, we 

estimate a total of 250 respondents to 

the information collection. Our database 

for establishment and drug product 

listing suggests that many companies 

perform activities of both manufacturers 

and repackagers and therefore we have 

combined our estimated number of 

respondent manufacturers and 

repackagers. In addition, because 

statutory provisions specifically define 

‘‘dispensers’’ to include retail 

pharmacies, hospital pharmacies, and 

groups of chain pharmacies, our 

estimate of the number of dispensers is 

intended to reflect the overall estimated 

number of respondents we believe to be 

subject to the requirements under 

section 582(d) of the FD&C Act. Because 

manufacturers, repackagers, and 

wholesale distributors are collectively 

responsible for prescription drugs from 

the point of manufacturing through 

distribution in the drug supply chain, 

we assume that these three trading 

partners submit most notifications of 

illegitimate products. Upon evaluation 

of those notifications received in fiscal 

year (FY) 2020 and, thus far, in FY 2021, 

we assume those 250 respondents are 

comprised of 40 percent manufacturers 

(100), 55 percent wholesale distributors 

(138), and 5 percent pharmacies (12). 

We assume that annual notifications 

will vary from zero to two for 

manufacturers and repackagers, as well 

as from pharmacies, but that most of 

companies will make no notifications. 

Although our establishment and drug 

product listing database currently 

reflects approximately 1,400 

manufacturers and repackagers, we 

estimate only 100 manufacturers and 

repackagers will notify us of illegitimate 

products an average of one time per 

year. 

Relying on data from the National 

Association of Chain Drug Stores, the 

National Community Pharmacists 

Association, and the American Hospital 

Association, we assume there are 

approximately 67,000 pharmacy sites in 

the United States. Based on a review of 

data, we estimate 12 pharmacies will 

notify FDA of illegitimate product an 

average of 1 time per year. 

According to the Healthcare 

Distribution Alliance (formerly known 

as Healthcare Distribution Management 

Association), approximately 30 

wholesale distributors are responsible 

for over 90 percent of drug distributions. 

Based on sales, and because FDA is 

estimating that over 1,570 small 

wholesale distributors may be 

responsible for the remaining 10 percent 

of drug sales, we estimate that 

wholesale distributors will be 

responsible for making approximately 

an average of 1 notification per year to 

account for the estimated 138 

notifications that FDA will receive 

regarding illegitimate product. We 


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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 


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