Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2459 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section, activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures Average burden per disclosure Total hours 

558.6(b)(3)–(5) and (b)(7)-(9); required disclosures when a veterinarian issues a VFD.3,050 246 750,000 .125 (7 minutes) ............................... 93,750 

558.6(c)(8); required disclosure (acknowledgement letter) from one 

distributor to another.

1,000 5 5,000 .125 (7 minutes) ............................... 625 

Total ........................................... ........................ ........................ ........................ ........................................................... 94,375 

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

The VFD regulation also contains 

several labeling provisions that are 

exempt from OMB review and approval 

under the PRA because they are a 

‘‘public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)) and therefore do not 

constitute a ‘‘collection of information’’ 

under the PRA (44 U.S.C. 3501, et seq.). 

All labeling and advertising for VFD 

drugs, combination VFD drugs, and 

feeds containing VFD drugs or 

combination VFD drugs must 

prominently and conspicuously display 

the following cautionary statement: 

‘‘Caution: Federal law restricts 

medicated feed containing this 

veterinary feed directive (VFD) drug to 

use by or on the order of a licensed 

veterinarian’’ (§ 558.6(a)(6)). In addition, 

the veterinarian must ensure that the 

following statement is included on the 

VFD (§ 558.6(b)(3)(xiii)): ‘‘Use of feed 

containing this veterinary feed directive 

(VFD) drug in a manner other than as 

directed on the labeling (extralabel use) 

is not permitted.’’ 

The veterinarian may restrict VFD 

authorization to only include the VFD 

drug(s) cited on the VFD or such 

authorization may be expanded to allow 

the use of the cited VFD drug(s) along 

with one or more over-the-counter 

animal drugs in an approved, 

conditionally approved, or indexed 

combination VFD drug (§ 558.6(b)(6)). 

The veterinarian must affirm his or her 

intent regarding combination VFD drugs 

by including one of the following 

statements on the VFD: 

1. ‘‘This VFD only authorizes the use 

of the VFD drug(s) cited in this order 

and is not intended to authorize the use 

of such drug(s) in combination with any 

other animal drugs’’ (§ 558.6(b)(6)(i)). 

2. ‘‘This VFD authorizes the use of the 

VFD drug(s) cited in this order in the 

following FDA-approved, conditionally 

approved, or indexed combination(s) in 

medicated feed that contains the VFD 

drug(s) as a component.’’ (List specific 

approved, conditionally approved, or 

indexed combination medicated feeds 

following this statement. 

§ 558.6(b)(6)(ii).) 

3. ‘‘This VFD authorizes the use of the 

VFD drug(s) cited in this order in any 

FDA-approved, conditionally approved, 

or indexed combination(s) in medicated 

feed that contains the VFD drug(s) as a 

component’’ (§ 558.6(b)(6)(iii)). 

These labeling statements are not 

subject to review by OMB because, as 

stated previously, they are a ‘‘public 

disclosure of information originally 

supplied by the Federal government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)) and therefore do not 

constitute a ‘‘collection of information’’ 

under the PRA (44 U.S.C. 3501, et seq.). 

Our estimate of the annual burden for 

this information collection has not 

changed since the last OMB approval, 

which was associated with the June 3, 

2015, final rule. However, the one-time 

burdens that we included in our 

analysis of the June 3, 2015, final rule 

(80 FR 31708 at 31729 to 31732) are not 

included in our current estimate. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00676 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–3619] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AXUMIN 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for AXUMIN 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 (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 19, 2018. 

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 

July 16, 2018. 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 March 19, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 2018. 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://


ethrower on DSK3G9T082PROD with NOTICES
2460 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 

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– 

2016–E–3619 for ’’Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; AXUMIN.’’ 

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 § 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.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: 

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 human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

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 AXUMIN 

(fluciclovine F-18). AXUMIN is 

indicated for positron emission 

tomography imaging in men with 

suspected prostate cancer recurrence 

based on elevated blood prostate 

specific antigen levels following prior 

treatment. Subsequent to this approval, 

the USPTO received a patent term 

restoration application for AXUMIN 

(U.S. Patent No. 5,808,146) from Emory 

University, and the USPTO requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated December 1, 

2016, FDA advised the USPTO that this 

human drug product had undergone a 

regulatory review period and that the 

approval of AXUMIN 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 

AXUMIN is 4,006 days. Of this time, 

3,763 days occurred during the testing 

phase of the regulatory review period, 

while 243 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: June 10, 2005. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 10, 2005 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: September 28, 

2015. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for AXUMIN (NDA 208054) was 

initially submitted on September 28, 

2015. 

3. The date the application was 

approved: May 27, 2016. FDA has 

verified the applicant’s claim that NDA 

208054 was approved on May 27, 2016. 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2461 

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 5 years 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: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00684 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–ES–2017–N135; FF01EWFW00– 

FXES111601M000] 

Marine Mammal Protection Act; Stock 

Assessment Report for the Northern 

Sea Otter in Washington 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: In accordance with the 

Marine Mammal Protection Act of 1972, 

as amended, and its implementing 

regulations, we, the U.S. Fish and 

Wildlife Service, have developed a draft 

revised marine mammal stock 

assessment report for the northern sea 

otter stock in the State of Washington. 

We now make the draft stock 

assessment report available for public 

review and comment. 

DATES: We will consider comments that 

are received or postmarked on or before 

April 17, 2018. 

ADDRESSES: If you wish to review the 

draft revised stock assessment report for 

the northern sea otter stock in 

Washington, you may obtain a copy 

from our website at http://www.fws.gov/ 

wafwo. Alternatively, you may contact 

the Washington Fish and Wildlife 

Office, 510 Desmond Dr., Suite 102, 

Lacey, WA 98503 (telephone: 360–753– 

9440). If you wish to comment on the 

stock assessment report, you may 

submit your comments in writing by 

any one of the following methods: 

• U.S. mail: State Supervisor, at the 

above address; 

• Hand delivery: Washington Fish 

and Wildlife Office at the above address; 

• Fax: 360–753–9565; or 

• Email: fw1_waseaottersar@fws.gov. 

FOR FURTHER INFORMATION CONTACT: 

Deanna Lynch, at the above street 

address, by telephone (360–753–9545), 

or by email (deanna_lynch@fws.gov). 

Persons who use a telecommunications 

device for the deaf (TDD) may call the 

Federal Relay Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: We 

announce the availability for review and 

comment of a draft revised marine 

mammal stock assessment report (SAR) 

for the northern sea otter (Enhydra lutris 

kenyoni) stock in the State of 

Washington. 

Background 

Under the Marine Mammal Protection 

Act of 1972, as amended (MMPA; 16 

U.S.C. 1361 et seq.), and its 

implementing regulations in the Code of 

Federal Regulations (CFR) at 50 CFR 

part 18, the U.S. Fish and Wildlife 

Service (Service) regulates the taking; 

import; and, under certain conditions, 

possession; transportation; purchasing; 

selling; and offering for sale, purchase, 

or export, of marine mammals. One of 

the goals of the MMPA is to ensure that 

stocks of marine mammals occurring in 

waters under U.S. jurisdiction do not 

experience a level of human-caused 

mortality and serious injury that is 

likely to cause the stock to be reduced 

below its optimum sustainable 

population (OSP) level. OSP is defined 

under the MMPA as ‘‘the number of 

animals which will result in the 

maximum productivity of the 

population or the species, keeping in 

mind the carrying capacity of the habitat 

and the health of the ecosystem of 

which they form a constituent element’’ 

(16 U.S.C. 1362(9)). 

To help accomplish the goal of 

maintaining marine mammal stocks at 

their OSPs, section 117 of the MMPA 

requires the Service and the National 

Marine Fisheries Service (NMFS) to 

prepare a SAR for each marine mammal 

stock that occurs in waters under U.S. 

jurisdiction. A SAR must be based on 

the best scientific information available; 

therefore, we prepare it in consultation 

with established regional scientific 

review groups established under 117(d) 

of the MMPA. Each SAR must include: 

1. A description of the stock and its 

geographic range; 

2. A minimum population estimate, 

current and maximum net productivity rate, 

and current population trend; 

3. An estimate of the annual human-caused 

mortality and serious injury by source and, 

for a strategic stock, other factors that may be 

causing a decline or impeding recovery of the 

stock; 

4. A description of commercial fishery 

interactions; 

5. A categorization of the status of the 

stock; and 

6. An estimate of the potential biological 

removal (PBR) level. 

The MMPA defines the PBR as ‘‘the 

maximum number of animals, not 

including natural mortalities, that may 

be removed from a marine mammal 

stock while allowing that stock to reach 

or maintain its [OSP]’’ (16 U.S.C. 

1362(20)). The PBR is the product of the 

minimum population estimate of the 

stock (Nmin); one-half the maximum 

theoretical or estimated net productivity 

rate of the stock at a small population 

size (Rmax); and a recovery factor (Fr) of 

between 0.1 and 1.0, which is intended 

to compensate for uncertainty and 

unknown estimation errors. This can be 

written as: 

PBR = (Nmin)(1⁄2 of the Rmax)(Fr) 

Section 117 of the MMPA also 

requires the Service and NMFS to 

review the SARs (a) at least annually for 

stocks that are specified as strategic 

stocks, (b) at least annually for stocks for 

which significant new information is 

available, and (c) at least once every 3 

years for all other stocks. If our review 

of the status of a stock indicates that it 

has changed or may be more accurately 

determined, then the SAR must be 

revised accordingly. 

A strategic stock is defined in the 

MMPA as a marine mammal stock ‘‘(A) 

for which the level of direct humancaused mortality exceeds the [PBR] 

level; (B) which, based on the best 

available scientific information, is 


ethrower on DSK3G9T082PROD with NOTICES