67290 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

1https://www.fda.gov/downloads/ 

AnimalVeterinary/GuidanceCompliance

Enforcement/GuidanceforIndustry/UCM052387.pdf. 

countries. FDA has actively participated 

in the International Council for 

Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission and 

European Medicines Agency, 

International Federation for Animal 

Health—Europe; FDA; the U.S. 

Department of Agriculture; the U.S. 

Animal Health Institute; the Japanese 

Ministry of Agriculture, Forestry, and 

Fisheries; and the Japanese Veterinary 

Products Association. Six observers are 

eligible to participate in the VICH 

Steering Committee: One representative 

from the government of Australia/New 

Zealand, one representative from the 

industry in Australia/New Zealand, one 

representative from the government of 

Canada, one representative from the 

industry in Canada, one representative 

from the government of South Africa, 

and one representative from the 

industry in South Africa. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health. 

II. Draft Guidance for Industry on 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products in Climatic Zones III and IV 

The VICH Steering Committee held a 

meeting in June 2018 and agreed that 

the draft guidance document entitled 

‘‘Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products in Climatic Zones III and IV’’ 

(VICH GL58) should be made available 

for public comment. This draft guidance 

document is an annex to the VICH 

parent stability guidance, GFI #73/VICH 

GL3(R), ‘‘Stability Testing of New 

Veterinary Drug Substances and 

Medicinal Products (Revision),’’ 1 and 

provides guidance regarding the 

stability data package for a new 

veterinary drug substance and 

medicinal product to be included in a 

registration or application submitted 

within the regions in climatic zones III 

and IV. This guidance provides 

additional guidance on the storage 

conditions for stability testing in 

countries located in Climatic Zones III 

(hot and dry) and IVB (hot and very 

humid), which are not covered by GFI 

#73/VICH GL3(R). This draft guidance 

document seeks to exemplify the core 

stability data package for new veterinary 

drug substances and medicinal 

products, but leaves flexibility to 

encompass the variety of different 

practical situations that may be 

encountered due to specific scientific 

considerations and characteristics of the 

materials being evaluated. 

FDA and the VICH Expert Working 

Group will consider comments about 

the draft guidance document. 

III. Significance of Guidance 

This level 1 draft guidance, developed 

under the VICH process, is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

For example, the document has been 

designated ‘‘guidance’’ rather than 

‘‘guideline.’’ In addition, guidance 

documents do not include mandatory 

language such as ‘‘shall,’’ ‘‘must,’’ 

‘‘require,’’ or ‘‘requirement,’’ unless 

FDA is using these words to describe a 

statutory or regulatory requirement. 

The draft guidance, when finalized, 

will represent the current thinking of 

FDA on this topic. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: December 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–28219 Filed 12–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–E–6002] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RUBRACA 

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 RUBRACA 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 February 26, 2019. 

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 

June 26, 2019. 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 February 26, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 26, 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67291 

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–E–6002 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; RUBRACA.’’ 

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, RUBRACA 

(rucaparib). RUBRACA is indicated as 

monotherapy for the treatment of 

patients with deleterious BRCA 

mutation (germline and/or somatic) 

associated advanced ovarian cancer who 

have been treated with two or more 

chemotherapies. Select patients for 

therapy based on an FDA-approved 

companion diagnostic for RUBRACA. 

This indication is approved under 

accelerated approval based on objective 

response rate and duration of response. 

Continued approval for this indication 

may be contingent upon verification and 

description of clinical benefit in 

confirmatory trials. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

RUBRACA (U.S. Patent No. 6,495,541) 

from Agouron Pharmaceuticals, LLC 

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 RUBRACA 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 

RUBRACA is 2,644 days. Of this time, 

2,464 days occurred during the testing 

phase of the regulatory review period, 

while 180 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: September 25, 

2009. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on September 25, 2009. 


amozie on DSK3GDR082PROD with NOTICES1
67292 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: June 23, 2016. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

RUBRACA (NDA 209115) was initially 

submitted on June 23, 2016. 

3. The date the application was 

approved: December 19, 2016. FDA has 

verified the applicant’s claim that NDA 

209115 was approved on December 19, 

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 1,412 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 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–28217 Filed 12–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidance for 

Linaclotide; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

draft guidance for industry on generic 

linaclotide oral capsules, entitled ‘‘Draft 

Guidance on Linaclotide.’’ The draft 

guidance, when finalized, will provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for linaclotide oral capsules. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 26, 2019 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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– 

2007–D–0369 for ‘‘Draft Guidance on 

Linaclotide.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ will be publicly viewable 

at https://www.regulations.gov or at the 

Dockets Management Staff office 

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 


amozie on DSK3GDR082PROD with NOTICES1