66280 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

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 human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, ADLYXIN 

(lixisenatide) indicated as an adjunct to 

diet and exercise to improve glycemic 

control in adults with type 2 diabetes 

mellitus. Subsequent to this approval, 

the USPTO received a patent term 

restoration application for ADLYXIN 

(U.S. Patent No. RE45313) from ZP 

Holding SPV K/S and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

October 16, 2017, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

ADLYXIN 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 

ADLYXIN is 5,500 days. Of this time, 

5,133 days occurred during the testing 

phase of the regulatory review period, 

while 367 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

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

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

355(i)) became effective: July 8, 2001. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

July 8, 2001. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b)of the FD&C Act: July 27, 2015. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

ADLYXIN (NDA 208471) was initially 

submitted on July 27, 2015. 

3. The date the application was 

approved: July 27, 2016. FDA has 

verified the applicant’s claim that NDA 

208471 was approved on July 27, 2016. 

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 1,826 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: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27805 Filed 12–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4428] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medicated Feed 

Mill License Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 the medicated 

feed mill licensing system. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 25, 2019. 

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 February 25, 

2019. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 25, 2019. 

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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 66281 

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– 

2018–N–4428 for ‘‘Medicated Feed Mill 

License Application.’’ 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. 

• 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10 a.m.–12 p.m., 

11601 Landsdown St., North Bethesda, 

MD 20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), 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. 

Medicated Feed Mill License 

Application—21 CFR Part 515—OMB 

Control Number 0910–0337—Extension 

Feed manufacturers that seek to 

manufacture feed using Category II, 

Type A medicated articles or 

manufacture certain liquid and freechoice feed, using Category I, Type A 

medicated articles that must follow 

proprietary formulas or specifications 

are required to obtain a facility license 

under section 512 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360b). Our regulations in part 

515 (21 CFR part 515) establish the 

procedures associated with applying for 

a facility license. We require that a 

manufacturer seeking a facility license 

submit a completed medicated feed mill 

license application using Form FDA 

3448 (21 CFR 515.10(b)). We use the 

information submitted to establish that 

the applicant has made the certifications 

required by section 512 of the FD&C 

Act, to register the mill, and to schedule 

a pre-approval inspection. 

We require the submission of a 

supplemental medicated feed mill 

license application for a change in 

facility ownership or a change in facility 

address (§ 515.11(b)). If a licensed 

facility is no longer manufacturing 

medicated animal feed under § 515.23, a 

manufacturer may request voluntary 

revocation of a medicated feed mill 

license. An applicant also has the right 

to file a request for hearing under 

§ 515.30(c) to give reasons why a 

medicated feed mill license should not 

be refused or revoked. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Medicated Feed Mill License Application using Form FDA 

3448 (515.10(b)).

14 1 14 0.25 (15 minutes).4 

Supplemental Feed Mill License Application using Form 

FDA 3448 (515.11(b)).

54 1 54 0.25 (15 minutes).14 

Voluntary Revocation of Medicated Feed Mill License 

(515.23).

29 1 29 0.25 (15 minutes).7 


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66282 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Filing a Request for a Hearing on Medicated Feed Mill License (515.30(c)).1 1 1 4 .................... 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 29 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section and activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Maintenance of Records for Approved Labeling for Each 

‘‘Type B’’ and ‘‘Type C’’ Feed (510.305).

837 1 837 0.03 (2 minutes).25 

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

These estimates are based on our 

experience with medicated feed mill 

license applications. We estimate that 

we will receive 14 medicated feed mill 

license applications, 54 supplemental 

applications, 29 requests for voluntary 

revocation, and that these submissions 

will take approximately 15 minutes per 

response, as shown in table 1, rows 1 

through 3. We estimate that preparing a 

request for a hearing under § 515.30(c) 

takes approximately 4 hours, as shown 

in table 1, row 4. In table 2, we estimate 

that 837 licensees will keep the records 

required by 21 CFR 510.305 expending 

a total of 25 hours annually. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 2 hours and a 

corresponding decrease of 56 responses/ 

records. We attribute this adjustment to 

a net decrease in the number of 

submissions we received over the last 

few years. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27812 Filed 12–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–3001] 

Modified Risk Tobacco Product 

Applications for IQOS System With 

Marlboro Heatsticks, IQOS System 

With Marlboro Smooth Menthol 

Heatsticks, and IQOS System With 

Marlboro Fresh Menthol Heatsticks 

Submitted by Philip Morris Products 

S.A.; Closing of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; closing of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

closing date for the period for public 

comment on modified risk tobacco 

product applications (MRTPAs) 

submitted by Philip Morris Products 

S.A. for its IQOS system products. FDA 

recently received amendments to these 

MRTPAs and has made them available 

for public comment. 

DATES: Submit either electronic or 

written comments by February 11, 2019 

to ensure FDA considers your comment 

before completing its review of the 

applications. 

ADDRESSES: You may 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://

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– 

2017–D–3001 for ‘‘Modified Risk 

Tobacco Product Applications for IQOS 

system with Marlboro Heatsticks, IQOS 

system with Marlboro Smooth Menthol 

Heatsticks, and IQOS system with 

Marlboro Fresh Menthol Heatsticks 

submitted by Philip Morris Products 


amozie on DSK3GDR082PROD with NOTICES1