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.’’ 


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34760 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0515 for ‘‘Postmarketing 

Adverse Experience Reporting and 

Recordkeeping for Drug and Biological 

Products.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

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. 

Postmarketing Adverse Experience 

Reporting and Recordkeeping for Drug 

and Biologics Products 

OMB Control Number 0910–0230— 

Extension 

This information collection supports 

statutory provisions set forth in the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) regarding the monitoring of 

FDA-regulated products. Specifically, 

FDA must be promptly informed of 

adverse experiences associated with the 

use of marketed drugs, including human 

drugs and biological products. 

Regulations in §§ 310.305 and 314.80 

(21 CFR 310.305 and 314.80) implement 

reporting and recordkeeping 

requirements that enable FDA to take 

action to protect the public health from 

adverse drug experiences. All applicants 

who have received marketing approval 

for drug products are required to report 

serious, unexpected adverse drug 

experiences (15-day ‘‘Alert reports’’), as 

well as followup reports (§ 314.80(c)(1)) 

to FDA. This includes reports of all 

foreign or domestic adverse experiences 

as well as those based on information 

from applicable scientific literature and 

certain reports from postmarketing 

studies. Section 314.80(c)(1)(iii) pertains 

to such reports submitted by 

nonapplicants. 

Under § 314.80(c)(2), applicants must 

provide periodic reports of adverse drug 

experiences. For the reporting interval, 

a periodic report includes reports of 

serious, expected adverse drug 

experiences, all nonserious adverse drug 

experiences, and an index of these 

reports; a narrative summary and 

analysis of adverse drug experiences; an 

analysis of the 15-day Alert reports 

submitted during the reporting interval; 

and a history of actions taken because 

of adverse drug experiences. Under 

§ 314.80(j), applicants must keep for 10 

years records of all adverse drug 

experience reports known to the 

applicant. 

For marketed prescription drug 

products without approved new drug 

applications (NDAs) or abbreviated new 

drug applications (ANDAs), 

manufacturers, packers, and distributors 

are required to report to FDA serious, 

unexpected adverse drug experiences as 

well as followup reports (§ 310.305(c)). 

Section 310.305(c)(5) pertains to the 

submission of followup reports to 

reports forwarded to the manufacturers, 

packers, and distributors by FDA. Under 

§ 310.305(g), each manufacturer, packer, 

and distributor shall maintain for 10 

years records of all adverse drug 

experiences required to be reported. 

Section 760 of the FD&C Act (21 

U.S.C. 379aa) also provides for 

mandatory safety reporting for over-thecounter (OTC) human drug products not 

subject to applications approved under 

section 505 of the FD&C Act (21 U.S.C. 

355) (NDAs or ANDAs). These 

requirements apply to all OTC drug 

products marketed without an approved 

application, including those marketed 

under the OTC Drug Monograph Review 

process (whether or not subject to a final 

monograph), those marketed outside the 

monograph system, and including those 

that have been discontinued from 

marketing but for which a report of an 

adverse event was received. Under 21 

CFR 329.100, respondents must submit 

reports according to section 760 of the 

FD&C Act in an electronic format. 

To assist respondents with 

implementation of section 760 of the 

FD&C Act, FDA developed the guidance 

for industry entitled ‘‘Postmarketing 

Adverse Event Reporting for 

Nonprescription Human Drug Products 


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Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34761 

Marketed Without an Approved 

Application,’’ available at https://

www.fda.gov/media/77193/download. 

The guidance document discusses what 

should be included in a serious adverse 

drug event report submitted under 

section 760(b)(1) of the FD&C Act, 

including how to submit these reports 

and followup reports under section 

760(c)(2) of the FD&C Act. 

Section 760(e) of the FD&C Act also 

requires that responsible persons 

maintain records of nonprescription 

drug adverse event reports, whether the 

event is serious or not, for a period of 

6 years. FDA’s guidance recommends 

that respondents maintain records of 

efforts to obtain the minimum data 

elements for a report of a serious 

adverse drug event and any followup 

reports. 

The primary purpose of FDA’s 

adverse drug experience reporting 

system is to enable identification of 

signals for potentially serious safety 

problems with marketed drugs. 

Although premarket testing discloses a 

general safety profile of a new drug’s 

comparatively common adverse effects, 

the larger and more diverse patient 

populations exposed to the marketed 

drug provide the opportunity to collect 

information on rare, latent, and longterm effects. Signals are obtained from 

a variety of sources, including reports 

from patients, treating physicians, 

foreign regulatory agencies, and clinical 

investigators. Information derived from 

the adverse drug experience reporting 

system contributes directly to increased 

public health protection because the 

information enables FDA to make 

important changes to the product’s 

labeling (such as adding a new 

warning), to make decisions about risk 

evaluation and mitigation strategies or 

the need for postmarketing studies or 

clinical trials and, when necessary, to 

initiate removal of a product from the 

market. 

In addition, this information 

collection includes an International 

Council for Harmonisation (ICH) 

guidance for industry entitled 

‘‘Providing Postmarketing Periodic 

Safety Reports in the ICH E2C(R2) 

Format (Periodic Benefit-Risk 

Evaluation Report),’’ available at https:// 

www.fda.gov/media/85520/download. 

The guidance describes the conditions 

under which applicants may use the 

ICH3 E2C(R2) Periodic Benefit-Risk 

Evaluation Report format for certain 

types of adverse event reporting. FDA 

regulations in §§ 314.80(c)(2) and 

600.80(c)(2) (21 CFR 600.80(c)(2)) 

require applicants to submit 

postmarketing periodic safety reports for 

each approved application. The reports 

must be submitted quarterly for the first 

3 years following the U.S. approval date 

and annually thereafter and must 

contain the information described in 

§§ 314.80(c)(2)(ii) and 600.80(c)(2)(ii) 

(the information collection associated 

with 21 CFR part 600—Biological 

Products, is approved under OMB 

control number 0910–0308). The 

Agency guidance assists respondents 

with satisfying the regulatory 

requirements in an alternative format, 

noting that the process differs 

depending on whether an applicable 

periodic safety update report (PSUR) 

waiver is in place. The information 

collection burden for waivers of a PSUR 

are currently approved in OMB control 

number 0910–0771; however, it is being 

consolidated with this information 

collection for administrative efficiency. 

Similarly, the information collection 

accounts for burden that may be 

applicable to the guidance document, 

‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During a 

Pandemic,’’ available at https://

www.fda.gov/media/72498/download. 

In response to the Coronavirus Disease 

2019 public health emergency, we 

revised the Agency guidance document, 

‘‘, to provide recommendations for 

recordkeeping applicable to any 

pandemic, not just influenza, including 

recommendations for planning, 

notification, and documentation for 

continuity of operations for firms that 

report postmarketing adverse events 

during any pandemic. 

Respondents to this collection of 

information are (1) manufacturers, 

packers, distributors, and applicants of 

FDA-regulated drug and biologic 

products; (2) manufacturers, packers, 

and distributors of marketed 

prescription drug products without an 

FDA-approved application; and (3) 

manufacturers, packers, and distributors 

of marketed nonprescription drug 

products, including OTC drug products 

marketed without an approved 

application, OTC drug products 

marketed under the OTC Drug 

Monograph Review process (whether 

subject to a final monograph or not), and 

drug products marketed outside the 

monograph system. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section or type 

of respondent and activity 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

310.305(c)(5) ........................................................................ 3 1 3 1 3 

314.80(c)(1)(iii) ..................................................................... 5 1 5 1 5 

314.80(c)(2) .......................................................................... 820 17.32 14,202 60 852,120 

Reports of serious adverse drug events (§ 329.100) .......... 285 690 196,650 6 1,179,900 

Applicants that have a PSUR waiver for an approved application ............................................................................ 55 3.4 187 1 187 

Applicants that do not have a PSUR waiver for an approved application ............................................................ 29 2.3 67 2 134 

Notifying FDA when normal reporting is not feasible .......... 350 1 350 8 2,800 

Total 2 ............................................................................ ........................ ........................ 211,464 ........................ 2,035,149 

1The reporting burden for §§ 310.305(c)(1), (2), and (3), and 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0645. 2The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. 


jbell on DSKJLSW7X2PROD with NOTICES
34762 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section or FD&C Act 

section and activity 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

310.305 ................................................................................ 25 1 25 16 400

314.80(j) ............................................................................... 325 2,025 658,240 16 10,531,840

Recordkeeping of nonprescription drug adverse event reports (Section 760(e)(1) of the FD&C Act) ...................... 300 885.6667 265,700 8 2,125,600 

Adding Adverse Event report planning to Continuity of Operations Plans ................................................................... 100 1 100 50 5,000 

Maintaining documentation of pandemic conditions and resultant high absenteeism ................................................. 350 1 350 8 2,800 

Maintaining records to identify what reports have been 

stored and when the reporting process was restored ..... 350 1 350 8 2,800 

Total 2 ............................................................................ ........................ ........................ 924,765 ........................ 12,668,440 

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

2There are maintenance costs of approximately $22,000 annually. 

The information collection reflects 

adjustments resulting in an overall 

decrease in burden hours and an 

increase in annual responses. We 

believe these adjustments reflect 

expected fluctuations in burden and 

invite comment on our assumptions. 

Dated: June 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13968 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–2184] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; FETROJA 

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 FETROJA 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 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) 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–2184 for Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; FETROJA. 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 


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