34754 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Annual 

burden 

hours 

1301.6(a) ............................................................................ 3,020 1 0.70 2,114 2,114 

1302.12(k) .......................................................................... 1,054,720 1 .166 175,084 175,084 

1302.14(c) .......................................................................... 3,020 1 2.00 6,040 6,040 

1302.16(b) .......................................................................... 3,020 1 5.00 15,100 15,100 

1302.33(a)–(b) ................................................................... 1,054,720 1 1.00 1,054,720 1,054,720 

1302.33(c)(2) ...................................................................... 294,632 1 2.00 589,264 589,264 

1302.42(a)–(b) ................................................................... 1,054,720 1 0.66 696,115 696,115 

1302.42(e) .......................................................................... 3,020 1 0.50 1,510 1,510 

1302.47(b)(7)(iv) ................................................................ 3,020 1 0.50 1,510 1,510 

1302.53(b)–(d) ................................................................... 3,020 1 0.166 501 501 

1302.90(a) .......................................................................... 3,020 1 0.50 1,510 1,510 

1302.90(b)(1)(i)–(iv), (b)(4) ................................................ 79,509 1 0.33 26,238 26,238 

1302.93(a) .......................................................................... 26,503 1 0.25 6,626 6,626 

1302.94(a) .......................................................................... 3,020 1 0.166 501 501 

1302.101(a)(4), 1302.102(b)–(c) ........................................ 3,020 1 79.00 238,580 238,580 

1302.102(d)(3) ................................................................... 110 1 10.00 1,100 1,100 

1303.12 .............................................................................. 3,020 1 0.166 501 501 

1303.22–24 ........................................................................ 956,120 1 0.33 315,520 315,520 

1303.42–53 ........................................................................ 260 1 40.00 10,400 10,400 

1303.70(c) .......................................................................... 200 1 1.00 200 200 

1303.72(a)(3) ..................................................................... 3,020 1 2.00 6,040 6,040 

1304.13 .............................................................................. 75 1 60.00 4,500 4,500 

1304.15(a) .......................................................................... 400 1 0.25 100 100 

Estimated Total Annual Burden 

Hours: 3,153,774. 

Authority: 42 U.S.C. 9836A. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–14123 Filed 6–29–21; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1960] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; MedWatch: The 

Food and Drug Administration Medical 

Products Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 FDA’s 

MedWatch adverse experience reporting 

(AER) program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 30, 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 August 30, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 30, 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–N–1960 for ‘‘MedWatch: The FDA 

Medical Products Reporting Program.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34755 

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: 

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. 

MedWatch: The FDA Medical Products 

Reporting Program 

OMB Control Number 0910–0291— 

Extension 

This information collection supports 

FDA laws and regulations governing 

adverse event reports and product 

experience reports for FDA-regulated 

products. The Federal Food, Drug, and 

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

353b, 355, 360i, 360l, 379aa, and 393) 

and the Public Health Service Act (42 

U.S.C. 262) authorize FDA to collect 

adverse event reports and product 

experience reports from regulated 

industry and to monitor the safety of 

drugs, biologics, medical devices, and 

dietary supplements. These reporting 

and recordkeeping requirements are 

found in FDA regulations, discussed in 

Agency guidance, and included in 

Agency forms. Although there are no 

laws or regulations mandating 

postmarket reporting for medical foods, 

infant formula, cosmetics, or tobacco 

products, we encourage voluntary 

reporting of adverse experiences 

associated with these products. 

To facilitate both consumer and 

industry reporting of adverse events and 

experiences with FDA-regulated 

products, we developed the MedWatch 

program. The MedWatch program 

allows anyone to submit reports to FDA 

on adverse events, including injuries 

and/or deaths, as well as other product 

experiences associated with the 

products we regulate. While the 

MedWatch program provides for both 

paper-based and electronic reporting, 

this information collection covers 

paper-based reporting. Requirements 

regarding mandatory reporting of 

adverse events or product problems 

have been codified in parts 310, 314, 

329, 600, and 803 (21 CFR 310, 314, 

600, and 803), and specified in sections 

503B, 760, and 761 of the FD&C Act (21 

U.S.C. 353b, 379aa, and 379aa–1). 

Mandatory reporting of adverse events 

for human cells, tissues, and cellularand tissue-based products (HCT/Ps) 

have been codified in § 1271.350 (21 

CFR 1271.350). Other postmarketing 

reporting associated with requirements 

found in sections 201, 502, 505, and 701 

(21 U.S.C. 321, 352, 355, and 371) of the 

FD&C Act and applicable to certain drug 

products with and without approved 

applications are approved under OMB 

control number 0910–0230. 

Since 1993, mandatory adverse event 

reporting has been supplemented by 

voluntary reporting by healthcare 

professionals, patients, and consumers 

via the MedWatch reporting process. To 

carry out its responsibilities, the Agency 

needs to be informed when an adverse 

event, product problem, error with use 

of a human medical product, or 

evidence of therapeutic failure is 

suspected or identified in clinical use. 

When FDA receives this information 

from healthcare professionals, patients, 

or consumers, the report becomes data 

that will be used to assess and evaluate 

the risk associated with the product. 

FDA will take any necessary action to 

reduce, mitigate, or eliminate the 

public’s exposure to the risk through 

regulatory and public health 

interventions. 

To implement these reporting 

provisions for FDA-regulated products 

(except vaccines) during their postapproval and marketed lifetimes, we 

developed the following three forms, 

available for download from our website 

or upon request to the Agency: (1) Form 

FDA 3500 may be used for voluntary 

(i.e., not mandated by law or regulation) 

reporting by healthcare professionals; 

(2) Form FDA 3500A is used for 

mandatory reporting (i.e., required by 

law or regulation); and (3) Form FDA 

3500B, available in English and 

Spanish, is written in plain language 

and may be used for voluntary reporting 

(i.e., not mandated by law or regulation) 

by consumers (i.e., patients and their 

caregivers). Respondents to the 


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34756 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

information collection are healthcare 

professionals, medical care 

organizations and other user facilities 

(e.g., extended care facilities, 

ambulatory surgical centers), 

consumers, manufacturers of biological, 

food products including dietary 

supplements and special nutritional 

products (e.g., infant formula and 

medical foods), cosmetics, drug 

products or medical devices, and 

importers. 

Use of Form FDA 3500 (Voluntary 

Reporting) 

This voluntary version of the form 

may be used by healthcare professionals 

to submit all reports not mandated by 

Federal law or regulation. Individual 

healthcare professionals are not 

required by law or regulation to submit 

reports to the Agency or the 

manufacturer, with the exception of 

certain adverse events following 

immunization with vaccines as 

mandated by the National Childhood 

Vaccine Injury Act of 1986. Reports for 

vaccines are not submitted via 

MedWatch or MedWatch forms, but are 

submitted to the Vaccines Adverse 

Event Reporting System (VAERS; see 

http://vaers.hhs.gov), which is jointly 

administered by FDA and the Centers 

for Disease Control and Prevention. 

Hospitals are not required by Federal 

law or regulation to submit reports 

associated with drug products, 

biological products, or special 

nutritional products. However, hospitals 

and other user facilities are required by 

Federal law to report medical devicerelated deaths and serious injuries. 

Under Federal law and regulation 

(section 761(b)(1) of the FD&C Act), a 

dietary supplement manufacturer, 

packer, or distributor whose name 

appears on the label of a dietary 

supplement marketed in the United 

States is required to submit to FDA any 

serious adverse event report it receives 

regarding use of the dietary supplement 

in the United States. However, FDA 

bears the burden to gather and review 

evidence that a dietary supplement may 

be adulterated under section 402 of the 

FD&C Act after that product is 

marketed. Therefore, the Agency 

depends on the voluntary reporting by 

healthcare professionals and especially 

by consumers of suspected serious 

adverse events and product quality 

problems associated with the use of 

dietary supplements. All dietary 

supplement reports were originally 

received by the Agency on paper 

versions of Form FDA 3500 (by mail or 

fax). Today, electronic reports may be 

sent to the Agency via an online 

submission route called the Safety 

Reporting Portal at http://

www.safetyreporting.hhs.gov/. In that 

case, the Form FDA 3500 is not used. 

Form FDA 3500 may be used to report 

to the Agency adverse events, product 

problems, product use errors, and 

therapeutic failures. The form is 

provided in both paper and electronic 

formats. Reporters may mail or fax 

paper forms to the Agency. A fillable 

.pdf version of the form is available at 

https://www.accessdata.fda.gov/scripts/ 

medwatch/ or electronically submit a 

report via the MedWatch Online 

Voluntary Reporting Form at https://

www.accessdata.fda.gov/scripts/ 

medwatch/. Reporting is supported for 

drugs, non-vaccine biologicals, medical 

devices, food products, special 

nutritional products, cosmetics, and 

non-prescription human drug products 

marketed without an approved 

application. The paper form may also be 

used to submit reports about dietary 

supplements. Electronic reports for 

dietary supplements may be submitted 

to the Agency via an online submission 

route called the Safety Reporting Portal 

at http://www.safetyreporting.hhs.gov/. 

Electronic reports for tobacco products 

may be submitted to the Agency via the 

tobacco questionnaire within the online 

Safety Reporting Portal at http://

www.safetyreporting.hhs.gov/. 

Use of Form FDA 3500A—Mandatory 

Reporting 

Drug and Biological Products 

Sections 503B, 505(j), and 704 of the 

FD&C Act (21 U.S.C. 374) require that 

important safety information relating to 

all human prescription drug products be 

made available to FDA in the event it 

becomes necessary to take appropriate 

action to ensure protection of the public 

health. Mandatory reporting of adverse 

events for HCT/Ps is codified in 

§ 1271.350. Consistent with statutory 

requirements, information is required to 

be submitted electronically and 

therefore we account for most all reports 

under OMB control number 0910–0645, 

established to support electronic 

reporting to our MedWatch program. At 

the same time, regulations provided for 

waivers from the electronic submission 

requirements and we therefore account 

for paper-based reporting in this 

information collection. 

Medical Device Products 

Section 519 of the FD&C Act (21 

U.S.C. 360i) requires manufacturers and 

importers, of devices intended for 

human use to establish and maintain 

records, make reports, and provide 

information as the Secretary of Health 

and Human Services may by regulation 

reasonably require to assure that such 

devices are not adulterated or 

misbranded and to otherwise assure its 

safety and effectiveness. The Safe 

Medical Device Act of 1990, signed into 

law on November 28, 1990, amends 

section 519 of the FD&C Act. The 

amendment requires that user facilities 

such as hospitals, nursing homes, 

ambulatory surgical facilities, and 

outpatient treatment facilities report 

deaths related to medical devices to 

FDA and to the manufacturer, if known. 

Serious illnesses and injuries are to be 

reported to the manufacturer or to FDA 

if the manufacturer is not known. These 

statutory requirements regarding 

mandatory reporting have been codified 

by FDA under 21 CFR part 803 (part 

803). Part 803 mandates the use of the 

Form FDA 3500A for reporting to FDA 

on medical devices. While most 

reporting associated with medical 

device products is covered under OMB 

control number 0910–0437, we retain 

coverage for paper-based adverse 

experience report submissions in this 

collection. 

Dietary Supplements 

Section 502(x) in the FD&C Act 

implements the requirements of The 

Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act, which became law (Pub. 

L. 109–462) on December 22, 2006. 

These requirements apply to 

manufacturers, packers, and distributors 

of nonprescription human drug 

products marketed without an approved 

application. The law requires reports of 

serious adverse events to be submitted 

to the Agency by manufacturers of 

dietary supplements. Electronic reports 

for dietary supplements may be 

submitted using the Safety Reporting 

Portal at http://

www.safetyreporting.hhs.gov/. Paperbased dietary supplement reports may 

be submitted using the MedWatch Form 

FDA 3500A. 

Use of Form FDA 3500B—Consumer 

Voluntary Reporting 

This voluntary version of the form 

may be used by consumers, patients, or 

caregivers to submit reports not 

mandated by Federal law or regulation. 

Individual consumers, patients, or 

caregivers are not required by law or 

regulation to submit reports to the 

Agency or the manufacturer. FDA 

supports and encourages direct 

reporting to the Agency by consumers of 

suspected adverse events and other 

product problems associated with 

human medical products, food, dietary 

supplements, and cosmetic products 

and invite these respondents to visit our 


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Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34757 

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

report-problem-fda for more 

information. Since the inception of the 

MedWatch program in July 1993, the 

program has been promoting and 

facilitating voluntary reporting by both 

the public and healthcare professionals. 

FDA has further encouraged voluntary 

reporting by requiring inclusion of the 

MedWatch toll-free phone number or 

the MedWatch internet address on all 

outpatient drug prescriptions dispensed, 

as mandated by section 17 of the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109). 

Section 906 of the FDA Amendments 

Act amended section 502(n) of the 

FD&C Act, mandating that published 

direct-to-consumer advertisements for 

prescription drugs include the following 

statement printed in conspicuous text 

(this includes vaccine products): ‘‘You 

are encouraged to report negative side 

effects of prescription drugs to the FDA. 

Visit https://www.fda.gov/medwatch, or 

call 1–800–FDA–1088.’’ Most private 

vendors of consumer medication 

information, the drug product-specific 

instructions dispensed to consumers at 

outpatient pharmacies, remind patients 

to report ‘‘side effects’’ to FDA and 

provide contact information to permit 

MedWatch reporting. 

Since 2013, FDA has made available 

the 3500B form. Proposed during the 

previous authorization in 2012, the 

3500B form is a version of the 3500 form 

that is tailored for consumers and 

written in plain language in 

conformance with the Plain Writing Act 

of 2010 (https://www.govinfo.gov/ 

content/pkg/PLAW-111publ274/pdf/ 

PLAW-111publ274.pdf). The 3500B 

form evolved from several iterations of 

draft versions, with input from human 

factors experts, from other regulatory 

agencies and with extensive input from 

consumer advocacy groups and the 

public. Since 2019, the 3500B form has 

been available in Spanish at https://

www.fda.gov/safety/medwatch-fdasafety-information-and-adverse-eventreporting-program/reporting-seriousproblems-fda and available to upload 

electronically since 2021 at https://

www.accessdata.fda.gov/scripts/ 

medwatch/ 

index.cfm?action=reporting.spanish. 

Form FDA 3500B, may be used to 

report adverse events, product 

problems, product use errors and 

problems after switching from one 

product maker to another maker to the 

Agency. The form is provided in both 

paper and electronic formats. 

Respondents may submit reports by 

mail or fax paper forms to the Agency 

or electronically submit a report via the 

MedWatch Online Voluntary Reporting 

Form at https://

www.accessdata.fda.gov/scripts/ 

medwatch/. A fillable .pdf version of the 

form, available at http://www.fda.gov/ 

downloads/AboutFDA/ 

ReportsManualsForms/Forms/ 

UCM349464.pdf may be downloaded, 

completed, and mailed or faxed to the 

Agency. Reporting is supported for 

drugs, non-vaccine biologicals, medical 

devices, food products, special 

nutritional products, cosmetics, and 

non-prescription human drug products 

marketed without an approved 

application. The paper form may also be 

used to submit reports about dietary 

supplements. Electronic reports for 

dietary supplements may be submitted 

to the Agency via an online submission 

route called the Safety Reporting Portal 

at http://www.safetyreporting.hhs.gov/. 

Electronic reports for tobacco products 

may be submitted to the Agency via the 

tobacco questionnaire within the online 

Safety Reporting Portal at http://

www.safetyreporting.hhs.gov/. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center or 

21 CFR section 

and/or FDA form 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research/Center for Drug Evaluation and 

Research: Form 3500 ........................................................................................ 14,727 1 14,727 0.66 (40 

minutes) 

9,720 

Form 3500A(§§ 310.305, 314.80, 314.98, 600.80, and 1271.350) ...................... 599 98 58,702 1.21 71,029 

Form 3500A (§ 310.305 outsourcing facilities) ..................................................... 50 2 100 1.21 121 

Center for Devices and Radiological Health: Form 3500 ..................................... 5,233 1 5,233 0.66 (40 

minutes) 

3,454 

Form 3500A (part 803) ......................................................................................... 2,277 296 673,992 1.21 815,530 

Center for Food Safety and Applied Nutrition: Form 3500 ................................... 1,793 1 1,793 0.66 (40 

minutes) 

1,183 

Form 3500A .......................................................................................................... 1,659 1 1,659 1.21 2,007 

Center for Tobacco Products: Form 3500 ............................................................ 39 1 39 0.66 (40 

minutes) 

26 

All Centers: Form 3500B ...................................................................................... 13,750 1 13, 750 0.46 (28 

minutes) 

6,325 

Written requests for temporary waiver under § 329.100(c)(2) .............................. 1 1 1 1 1 

Total ............................................................................................................... ........................ ........................ ........................ ........................ 909,396 

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

We are retaining the currently 

approved burden estimates for the 

information collection. 

Dated: June 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13943 Filed 6–29–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–E–1340] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AXONICS SACRAL 

NEUROMODULATION SYSTEM 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for AXONICS SACRAL 

NEUROMODULATION SYSTEM and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 


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