12474 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

action. Mr. Gurry received the proposal 

on September 22, 2020. He did not 

request a hearing within the timeframe 

prescribed by regulation and has, 

therefore, waived his opportunity for a 

hearing and any contentions concerning 

his debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Gurry has 

been convicted of a felony under 

Federal law for conduct otherwise 

relating to the regulation of a drug 

product under the FD&C Act. 

As a result of the foregoing finding, 

Mr. Gurry is permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application, effective (see 

DATES) (see sections 306(a)(2)(B) and 

(c)(2)(A)(ii) of the FD&C Act). Any 

person with an approved or pending 

drug product application who 

knowingly employs or retains as a 

consultant or contractor, or otherwise 

uses the services of Mr. Gurry in any 

capacity during his debarment, will be 

subject to civil money penalties (section 

307(a)(6) of the FD&C Act (21 U.S.C. 

335b(a)(6))). If Mr. Gurry provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment, he will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug application from Mr. Gurry during 

his period of debarment, other than in 

connection with an audit under section 

306 of the FD&C Act (section 

306(c)(1)(B) of the FD&C Act). Note that, 

for purposes of section 306 of the FD&C 

Act, a ‘‘drug product’’ is defined as a 

drug subject to regulation under section 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382) or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262) (section 201(dd) of 

the FD&C Act (21 U.S.C. 321(dd))). 

Any application by Mr. Gurry for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2020–N–1413 and sent to the 

Dockets Management Staff (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: February 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04374 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0104] 

PolyMedica Industries Inc., et al.; 

Proposal To Withdraw Approval of 

Three New Drug Applications; 

Opportunity for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is proposing to withdraw 

approval of three new drug applications 

(NDAs) and is announcing an 

opportunity for the NDA holders to 

request a hearing on this proposal. The 

basis for the proposal is that the NDA 

holders have repeatedly failed to file 

required annual reports for those NDAs. 

DATES: The NDA holders may submit a 

request for a hearing by April 2, 2021. 

Submit all data, information, and 

analyses upon which the request for a 

hearing relies by May 3, 2021. Submit 

electronic or written comments by May 

3, 2021. 

ADDRESSES: The request for a hearing 

may be submitted by the NDA holders 

by either of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments to 

submit your request for a hearing. 

Comments submitted electronically to 

https://www.regulations.gov, including 

any attachments to the request for a 

hearing, will be posted to the docket 

unchanged. 

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. 

• Because your request for a hearing 

will be made public, you are solely 

responsible for ensuring that your 

request 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. The request 

for a hearing must include the Docket 

No. FDA–2021–N–0104 for 

‘‘PolyMedica Industries Inc. et al.; 

Proposal to Withdraw Approval of 

Three New Drug Applications; 

Opportunity for a Hearing.’’ The request 

for a hearing will be placed in the 

docket and 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. 

The NDA holders may submit all data 

and analyses upon which the request for 

a hearing relies in the same manner as 

the request for a hearing except as 

follows: 

• Confidential Submissions—To 

submit any data analyses with 

confidential information that you do not 

wish to be made publicly available, 

submit your data and analyses only as 

a written/paper submission. You should 

submit two copies total of all data and 

analyses. 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 any decisions on 

this matter. 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 

or available at the Dockets Management 

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

Monday through Friday, 240–402–7500. 

Submit both copies to the Dockets 

Management Staff. Any information 

marked as ‘‘confidential’’ will not be 

disclosed except in accordance with 21 

CFR 10.20 and other applicable 

disclosure law. 

Comments Submitted by Other 

Interested Parties: For all comments 

submitted by other interested parties, 

submit comments as follows: 

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:// 


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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12475 

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– 

2021–N–0104 for ‘‘PolyMedica 

Industries Inc. et al.; Proposal to 

Withdraw Approval of Three New Drug 

Applications; Opportunity for a 

Hearing.’’ Received comments, those 

filed in a timely manner (see DATES), 

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: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holder of an approved NDA to market a 

new drug for human use is required to 

submit annual reports to FDA 

concerning its approved NDA under 

§§ 314.81 and 314.98 (21 CFR 314.81 

and 314.98). The holders of the 

approved NDAs listed in table 1 have 

repeatedly failed to submit the required 

annual reports and have not responded 

to the Agency’s request for submission 

of the reports. 

TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug NDA holder 

NDA 016401 ............ NEOPAP (acetaminophen) Suppositories, 120 milligrams 

(mg).

PolyMedica Industries Inc., 2 Constitution Way, Woburn, 

MA 01801. 

NDA 050266 ............ ACHROMYCIN (tetracycline hydrochloride (HCl)) Ophthalmic Ointment, 10 mg/gram.Storz Ophthalmics Inc. (subsidiary of American Cyanamid 

Co.), 401 North Middletown Rd., Pearl River, NY 10965. 

NDA 050268 ............ ACHROMYCIN (tetracycline HCl) Ophthalmic Suspension, 

1%.

Do. 

Therefore, notice is given to the 

holders of the approved NDAs listed in 

table 1 and to all other interested 

persons that the Director of CDER 

proposes to issue an order, under 

section 505(e) of the Federal Food, Drug, 

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

355(e)), withdrawing approval of the 

NDAs and all amendments and 

supplements thereto on the grounds that 

the NDA holders have failed to submit 

reports required under § 314.81. 

In accordance with section 505 of the 

FD&C Act and 21 CFR part 314, the 

NDA holders are hereby provided an 

opportunity for a hearing to show why 

the approval of the NDAs listed 

previously should not be withdrawn 

and an opportunity to raise, for 

administrative determination, all issues 

relating to the legal status of the drug 

products covered by these NDAs. 

An NDA holder who decides to seek 

a hearing must file the following: (1) A 

written notice of participation and 

request for a hearing (see DATES and 

ADDRESSES) and (2) the data, 

information, and analyses relied on to 

demonstrate that there is a genuine and 

substantial issue of fact that requires a 

hearing (see DATES and ADDRESSES). Any 

other interested person may also submit 

comments on this notice. The 

procedures and requirements governing 

this notice of opportunity for a hearing, 

notice of participation and request for a 

hearing, the information and analyses to 

justify a hearing, other comments, and 

a grant or denial of a hearing are 

contained in § 314.200 (21 CFR 314.200) 

and in 21 CFR part 12. 

The failure of an NDA holder to file 

a timely written notice of participation 

and request for a hearing, as required by 

§ 314.200, constitutes an election by that 


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12476 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

NDA holder not to avail itself of the 

opportunity for a hearing concerning 

CDER’s proposal to withdraw approval 

of the NDAs and constitutes a waiver of 

any contentions concerning the legal 

status of the drug products. FDA will 

then withdraw approval of the NDAs, 

and the drug products may not 

thereafter be lawfully introduced or 

delivered for introduction into interstate 

commerce. Any new drug product 

introduced or delivered for introduction 

into interstate commerce without an 

approved NDA is subject to regulatory 

action at any time. 

A request for a hearing may not rest 

upon mere allegations or denials but 

must present specific facts showing that 

there is a genuine and substantial issue 

of fact that requires a hearing. If a 

request for a hearing is not complete or 

is not supported, the Commissioner of 

Food and Drugs will enter summary 

judgment against the person who 

requests the hearing, making findings 

and conclusions, and denying a hearing. 

All paper submissions under this 

notice of opportunity for a hearing must 

be filed in two copies. Except for data 

and information prohibited from public 

disclosure under 21 U.S.C. 331(j) or 18 

U.S.C. 1905, the submissions may be 

seen at the Dockets Management Staff 

(see ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday, and will 

be posted to the docket at https://

www.regulations.gov. 

This notice is issued under section 

505(e) of the FD&C Act and under 

authority delegated to the Director of 

CDER by the Commissioner of Food and 

Drugs. 

Dated: February 25, 2021. 

Patrizia Cavazzoni, 

Acting Director, Center for Drug Evaluation 

and Research. 

[FR Doc. 2021–04344 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

054 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a publication containing 

modifications the Agency is making to 

the list of standards FDA recognizes for 

use in premarket reviews (FDA 

Recognized Consensus Standards). This 

publication, entitled ‘‘Modifications to 

the List of Recognized Standards, 

Recognition List Number: 054’’ 

(Recognition List Number: 054), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: Submit either electronic or 

written comments on the notice at any 

time. These modifications to the list of 

recognized standards are applicable 

March 3, 2021. 

ADDRESSES: You may submit comments 

on the current list of FDA Recognized 

Consensus Standards at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

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– 

2004–N–0451 for ‘‘Food and Drug 

Administration Modernization Act of 

1997: Modifications to the List of 

Recognized Standards, Recognition List 

Number: 054.’’ Received comments 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. FDA will 

consider any comments received in 

determining whether to amend the 

current listing of modifications to the 

list of recognized standards, Recognition 

List Number: 054. 

• 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. 

An electronic copy of Recognition List 

Number: 054 is available on the internet 

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


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