Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19671 

approved under OMB control number 

0910–0756. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08364 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–E–0475] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ELVITEGRAVIR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ELVITEGRAVIR (as a component of 

STRIBILD) 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. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

petitions (two copies are required) and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Submit petitions electronically to http:// 

www.regulations.gov at Docket No. 

FDA–2013–S–0610. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of 

Management, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Hillandale Campus, Rm. 3180, 

Silver Spring, MD 20993, 301–796– 

7900. 

SUPPLEMENTARY INFORMATION: 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 ELVITEGRAVIR 

(as a component of STRIBILD 

(cobicistat/emtricitabine/

ELVITEGRAVIR/tenofovir disoproxil 

fumarate)). STRIBILD is indicated as a 

complete regimen for the treatment of 

HIV–1 infection in adults who are 

antiretroviral treatment-naive. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for ELVITEGRAVIR (as a 

component of STRIBILD) (U.S. Patent 

No. 7,176,220) from Japan Tobacco Inc., 

and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated July 10, 2013, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of STRIBILD represented the 

first permitted commercial marketing or 

use of the ELVITEGRAVIR product. 

Thereafter, the USPTO requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

ELVITEGRAVIR (as a component of 

STRIBILD) is 2,666 days. Of this time, 

2,360 days occurred during the testing 

phase of the regulatory review period, 

while 306 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 (the FD&C Act) (21 

U.S.C. 355(i)) became effective: May 12, 

2005. The applicant claims May 18, 

2005, as the date the investigational new 

drug application (IND) for 

ELVITEGRAVIR became effective. 

However, FDA records indicate that the 

IND effective date was May 12, 2005, 

which was the date the IND sponsor was 

notified that clinical trials may proceed. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: October 27, 

2011. The applicant claims October 26, 

2011, as the date the new drug 

application (NDA) for STRIBILD (NDA 

203–100) was initially submitted. 

However, FDA records indicate that 

NDA 203–100 was submitted on 

October 27, 2011. 

3. The date the application was 

approved: August 27, 2012. FDA has 

verified the applicant’s claim that NDA 

203–100 was approved on August 27, 

2012. 

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 1,021 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by June 12, 2015. 

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 

October 13, 2015. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written or electronic 

mstockstill on DSK4VPTVN1PROD with NOTICES

19672 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 

petitions. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. If you submit a written 

petition, two copies are required. A 

petition submitted electronically must 

be submitted to http://

www.regulations.gov, Docket No. FDA– 

2013–S–0610. Comments and petitions 

that have not been made publicly 

available on http://www.regulations.gov 

may be viewed in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08362 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0090] 

Balancing Premarket and Postmarket 

Data Collection for Devices Subject to 

Premarket Approval; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Balancing Premarket and Postmarket 

Data Collection for Devices Subject to 

Premarket Approval.’’ This guidance 

clarifies FDA’s current policy on 

balancing premarket and postmarket 

data collection during the Agency’s 

review of premarket approval 

applications (PMA). Specifically, this 

guidance outlines how FDA considers 

the role of postmarket information in 

determining the appropriate type and 

amount of data that should be collected 

in the premarket setting to support 

premarket approval, while still meeting 

the statutory standard of safety and 

effectiveness. FDA believes this 

guidance will improve patient access to 

safe and effective medical devices that 

are important to public health by 

improving the predictability, 

consistency, transparency, and 

efficiency of the premarket process. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Balancing 

Premarket and Postmarket Data 

Collection for Devices Subject to 

Premarket Approval’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Josephson, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5449, Silver Spring, 

MD 20993–0002, 301–796–5178; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has long applied postmarket 

controls as a way to reduce premarket 

data collection, where appropriate, 

while assuring that the statutory 

standard for approval of reasonable 

assurance of safety and effectiveness is 

still met. The right balance of premarket 

and postmarket data collection 

facilitates timely patient access to 

important new technology without 

undermining patient safety. 

In this guidance, FDA describes 

existing statutory requirements under 

the Federal Food, Drug, and Cosmetic 

Act, its implementing regulations, and 

FDA policies that support the policy on 

balancing premarket and postmarket 

data collection during review of PMAs. 

In addition, FDA clarifies how the 

Agency considers postmarket data as 

part of the benefit-risk framework 

described in FDA’s guidance ‘‘Factors to 

Consider When Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approval and De Novo 

Classifications,’’ issued on March 28, 

2012. This guidance provides a resource 

for industry and FDA staff on how FDA 

determines when it is appropriate for a 

sponsor of a PMA to collect some data 

(clinical or non-clinical) in the 

postmarket setting, rather than 

premarket. 

A draft of this guidance was made 

available in the Federal Register on 

April 23, 2014, and the comment period 

closed July 22, 2014. Changes between 

the draft and final versions of this 

guidance include an increased focus on 

patient outcomes and additional 

examples to help industry better 

understand when it may be appropriate 

to shift data collection from the 

premarket to postmarket setting. The 

final guidance also recognizes the 

potential for use of registry data to 

satisfy post-approval study 

requirements. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on balancing premarket 

and postmarket data collection for 

devices subject to premarket approval. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or from 

CBER at http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

Persons unable to download an 

electronic copy of ‘‘Balancing Premarket 

and Postmarket Data Collection for 

Devices Subject to Premarket Approval’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1833 to 

mstockstill on DSK4VPTVN1PROD with NOTICES