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 


jbell on DSKJLSW7X2PROD with NOTICES
34758 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

of Commerce, for the extension of a 

patent which claims that medical 

device. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 30, 2021. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 27, 2021. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

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– 

2020–E–1340 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; AXONICS SACRAL 

NEUROMODULATION SYSTEM.’’ 

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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until FDA 

grants permission to market the device. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a medical device will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(3)(B). 

FDA has approved for marketing the 

medical device AXONICS SACRAL 

NEUROMODULATION SYSTEM. 

AXONICS SACRAL 

NEUROMODULATION SYSTEM is 

indicated for treatment of chronic fecal 

incontinence in patients who have 

failed or are not candidates for more 

conservative treatments. Subsequent to 

this approval, the USPTO received a 

patent term restoration application for 

AXONICS SACRAL 

NEUROMODULATION SYSTEM (U.S. 

Patent No. 7,331,499) from Alfred E. 

Mann Foundation for Scientific 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34759 

Research, and the USPTO requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated July 14, 

2020, FDA advised the USPTO that this 

medical device had undergone a 

regulatory review period and that the 

approval of AXONICS SACRAL 

NEUROMODULATION SYSTEM 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

AXONICS SACRAL 

NEUROMODULATION SYSTEM is 681 

days. Of this time, 494 days occurred 

during the testing phase of the 

regulatory review period, while 187 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption for this 

device, under section 520(g) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360j(g)), became 

effective: October 27, 2017. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) for human tests to 

begin, as required under section 520(g) 

of the FD&C Act, became effective 

October 27, 2017. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): March 4, 2019. 

The applicant claims March 1, 2019, as 

the date the premarket approval 

application (PMA) for AXONICS 

SACRAL NEUROMODULATION 

SYSTEM (PMA 190006) was initially 

submitted. However, FDA records 

indicate that PMA 190006 was 

submitted on March 4, 2019. 

3. The date the application was 

approved: September 6, 2019. FDA has 

verified the applicant’s claim that PMA 

190006 was approved on September 6, 

2019. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 434 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13972 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–2021–N–0515] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarketing 

Adverse Experience Reporting and 

Recordkeeping for Drug and Biological 

Products 

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 postmarketing 

reporting and recordkeeping of adverse 

experiences for drug and biological 

products. 

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.’’ 


jbell on DSKJLSW7X2PROD with NOTICES