30958 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

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 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(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 OPTIMIZER. 

OPTIMIZER is indicated to improve 6- 

minute hall walk distance, quality of 

life, and functional status of New York 

Heart Association Class III heart failure 

patients who remain symptomatic 

despite guideline-directed medical 

therapy, are in normal sinus rhythm, are 

not indicated for Cardiac 

Resynchronization Therapy, and have a 

left ventricular ejection fraction ranging 

from 25 percent to 45 percent. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for OPTIMIZER (U.S. Patent 

Nos. 8,260,416 and 8,311,629) from 

Impulse Dynamics N.V., and the USPTO 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

November 9, 2020, FDA advised the 

USPTO that this medical device had 

undergone a regulatory review period 

and that the approval of OPTIMIZER 

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 

OPTIMIZER is 5,434 days. Of this time, 

5,236 days occurred during the testing 

phase of the regulatory review period, 

while 198 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: May 6, 2004. FDA has verified 

the applicant’s claim that the date the 

investigational device exemption for 

human tests to begin, as required under 

section 520(g) of the FD&C Act, became 

effective May 6, 2004. 

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): September 5, 2018. 

FDA has verified the applicant’s claim 

that the premarket approval application 

(PMA) for OPTIMIZER (PMA 180036) 

was initially submitted September 5, 

2018. 

3. The date the application was 

approved: March 21, 2019. FDA has 

verified the applicant’s claim that PMA 

180036 was approved on March 21, 

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 applications for patent extension, 

this applicant seeks 1,258 days or 1,293 

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 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12192 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0115] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry and Food and Drug 

Administration Staff—Class II Special 

Controls Guidance Document: 

Automated Blood Cell Separator 

Device Operating by Centrifugal or 

Filtration Principle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 July 12, 

2021. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 30959 

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 0910–0594. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Guidance for Industry and FDA Staff— 

Class II Special Controls Guidance 

Document: Automated Blood Cell 

Separator Device Operating by 

Centrifugal or Filtration Separation 

Principle 

OMB Control Number 0910–0594— 

Extension 

This information collection supports 

Agency regulations. Under the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), FDA may establish special 

controls, including performance 

standards, postmarket surveillance, 

patient registries, guidelines, and other 

appropriate actions it believes necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

The special control guidance serves as 

the special control for the automated 

blood cell separator device operating by 

centrifugal or filtration separation 

principle intended for the routine 

collection of blood and blood 

components (§ 864.9245 (21 CFR 

864.9245)). The guidance entitled 

‘‘Guidance for Industry and FDA Staff— 

Class II Special Controls Guidance 

Document: Automated Blood Cell 

Separator Device Operating by 

Centrifugal or Filtration Separation 

Principle’’ is available at https://

www.fda.gov/media/124263/download. 

For currently marketed products not 

approved under the premarket approval 

process, the manufacturer should file 

with FDA for 3 consecutive years an 

annual report on the anniversary date of 

the device reclassification from class III 

to class II or on the anniversary date of 

the 510(k) of the Federal Food, Drug, 

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

360(k)) clearance. Any subsequent 

change to the device requiring the 

submission of a premarket notification 

in accordance with section 510(k) of the 

FD&C Act should be included in the 

annual report. Also, a manufacturer of a 

device determined to be substantially 

equivalent to the centrifugal or 

filtration-based automated cell separator 

device intended for the routine 

collection of blood and blood 

components should comply with the 

same general and special controls. 

The annual report should include, at 

a minimum, a summary of anticipated 

and unanticipated adverse events that 

have occurred and that are not required 

to be reported by manufacturers under 

Medical Device Reporting (MDR) (part 

803 (21 CFR part 803)). The reporting of 

adverse device events summarized in an 

annual report will alert FDA to trends 

or clusters of events that might be a 

safety issue otherwise unreported under 

the MDR regulation. The report should 

also include any subsequent change to 

the preamendments class III device 

requiring a 30-day notice in accordance 

with 21 CFR 814.39(f). 

Reclassification of this device from 

class III to class II relieves 

manufacturers of the burden of 

complying with the premarket approval 

requirements of section 515 of the FD&C 

Act (21 U.S.C. 360e) and may permit 

small potential competitors to enter the 

marketplace by reducing the burden. 

Although the special control guidance 

recommends that manufacturers of these 

devices file with FDA an annual report 

for 3 consecutive years, this would be 

less burdensome than the current 

postapproval requirements under 21 

CFR part 814, subpart E, including the 

submission of periodic reports under 21 

CFR 814.84. 

Collecting or transfusing facilities, the 

intended users of the device, and the 

device manufacturers have certain 

responsibilities under the Federal 

regulations. For example, collecting or 

transfusing facilities are required to 

maintain records of any reports of 

complaints of adverse reactions (21 CFR 

606.170), while the device manufacturer 

is responsible for conducting an 

investigation of each event that is 

reasonably known to the manufacturer 

and evaluating the cause of the event 

(§ 803.50(b) (21 CFR 803.50(b)). In 

addition, manufacturers of medical 

devices are required to submit to FDA 

individual adverse event reports of 

death, serious injury, and malfunctions 

(§ 803.50). 

In the special control guidance 

document, FDA recommends that 

manufacturers include in their three 

annual reports a summary of adverse 

reactions maintained by the collecting 

or transfusing facility or similar reports 

of adverse events collected. 

In the Federal Register of February 

18, 2021 (86 FR 10108), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Annual Report ...................................................................... 3 1 3 5 15 

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

Based on FDA records, there are 

approximately three manufactures of 

automated blood cell separator devices. 

We estimate that the manufacturers will 

spend approximately 5 hours preparing 

and submitting the annual report. Based 

on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimates. 

Other burden hours required for 

§ 864.9245 are reported and approved 

under OMB control number 0910–0120 

(premarket notification submission 

510(k), 21 CFR part 807, subpart E), and 

OMB control number 0910–0437 (MDR, 

part 803). 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 


khammond on DSKJM1Z7X2PROD with NOTICES
30960 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

1The Animal Rule refers to FDA’s regulations for 

the approval of new drugs and biological products 

when human efficacy studies are not ethical or 

feasible (see 21 CFR 314.600–650 for drugs and 21 

CFR 601.90–95 for biologics). 

Dated: June 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12191 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0315] 

Electronic Study Data Submission; 

Data Standards; Support and 

Requirement Begin for Study Data 

Tabulation Model Version 1.8 With 

Standard for Exchange of Nonclinical 

Data Implementation Guide—Animal 

Rule Version 1.0; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document that appeared in the Federal 

Register on March 11, 2020. The 

document announced that FDA will 

begin supporting the Clinical Data 

Interchange Standards Consortium 

(CDISC) for Study Data Tabulation 

Model version 1.8 (SDTM v1.8), and 

CDISC Standard for Exchange of 

Nonclinical Data Implementation 

Guide—Animal Rule version 1.0 

(SENDIG–AR v1.0) on March 15, 2020, 

and that these new standards will be 

required in submissions to FDA 

effective March 15, 2022. The document 

omitted the 36-month implementation 

period for certain investigational new 

drugs applications (INDs) as required by 

the guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’ which is referenced in that 

document. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Chenoa Conley, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1117, 

Silver Spring, MD 20993–0002, 301– 

796–0035, email: cderdatastandards@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of March 11, 

2020 (85 FR 14205), in FR Doc. 2020– 

04898, the following corrections are 

made: 

1. On page 14205, in the second 

column, the first sentence of the 

SUMMARY is corrected to read: ‘‘The Food 

and Drug Administration (FDA or 

Agency) Center for Drug Evaluation and 

Research (CDER) is announcing that 

FDA will begin supporting the Clinical 

Data Interchange Standards Consortium 

(CDISC) for Study Data Tabulation 

Model version 1.8 (SDTM v1.8), and 

CDISC Standard for Exchange of 

Nonclinical Data Implementation 

Guide—Animal Rule version 1.0 

(SENDIG–AR v1.0) on March 15, 2020, 

and that these new standards will be 

required in submissions for studies that 

start after March 15, 2022 (for new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and 

biologics license applications (BLAs)), 

and in submissions for studies that start 

after March 15, 2023 (for certain 

investigational new drug applications 

(INDs)), that are submitted to CDER.’’ 

2. On page 14206, in the first column, 

the last sentence of the document is 

corrected to read as follows: ‘‘FDA will 

begin supporting SDTM v1.8 and 

SENDIG–AR v1.0 on March 15, 2020, 

and the use of these new standards will 

be required in Animal Rule 1

submissions for studies that start after 

March 15, 2022 (for NDAs, ANDAs, and 

BLAs), and in Animal Rule submissions 

for studies that start after March 15, 

2023 (for certain INDs), that are 

submitted to CDER.’’ 

Dated: June 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12198 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0362] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice for Finished 

Pharmaceuticals, Including Medical 

Gases, and Active Pharmaceutical 

Ingredients 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 July 12, 

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 0910–0139. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Current Good Manufacturing Practice 

for Finished Pharmaceuticals, 

Including Medical Gases, and Active 

Pharmaceutical Ingredients—21 CFR 

Parts 210 and 211 and 21 U.S.C 

351(a)(2)(B) 

OMB Control Number 0910–0139— 

Extension 

This information collection supports 

FDA regulations that govern the 

manufacture, processing, packing, or 

holding of finished pharmaceuticals, 

including medical gases, and active 

pharmaceutical ingredients (APIs). 

Under section 501(a)(2)(B) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C 351(a)(2)(B)), a 

drug is adulterated if the methods used 

in, or the facilities or controls used for 

its manufacture, processing, packing, or 

holding do not conform to or are not 

operated or administered in conformity 

with current good manufacturing 

practice (CGMP) regulations. FDA is 

responsible for enforcing the FD&C Act 

as well as related statutes, including the 

Public Health Service Act. Congress 

enacted these laws to ensure that 

covered products meet applicable 

requirements regarding the safety, 

identity and strength, and the quality 


khammond on DSKJM1Z7X2PROD with NOTICES