Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19669 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

Agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. Members of the ICH 

Steering Committee include the 

European Union; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor, and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; FDA; the Pharmaceutical 

Research and Manufacturers of America; 

Health Canada; Swissmedic; and the 

World Health Organization (as an 

Observer). The ICH process has 

achieved significant harmonization of 

the technical requirements for the 

approval of pharmaceuticals for human 

use in the ICH regions over the past two 

decades. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. (FDA has verified 

the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

II. Meeting Attendance and 

Participation 

A. Registration 

If you wish to attend the meeting, 

visit https://www.eventbrite.com/e/

international-conference-onharmonization-regional-public-meetingtickets-16183519342. Please register for 

the meeting by May 11, 2015. Seating 

may be limited, so early registration is 

recommended. Registration is free and 

will be on a first-come, first-served 

basis. However, FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration on the day of the meetings 

will be based on space availability. 

If you need special accommodations 

because of a disability, please contact 

Tracy Porter (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

B. Requests for Oral Presentations 

Interested persons may present data, 

information, or views orally or in 

writing on issues pending at the public 

meeting. Public oral presentations will 

be scheduled between approximately 

3:30 p.m. and 4 p.m. Time allotted for 

oral presentations may be limited to 5 

minutes. Those desiring to make oral 

presentations should notify Tracy Porter 

(see FOR FURTHER INFORMATION CONTACT) 

by May 11, 2015, and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present; the names and addresses, 

telephone number, fax, and email of 

proposed participants; and an 

indication of the approximate time 

requested to make their presentation. 

The agenda for the public meeting 

will be made available on the Internet 

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

NewsEvents/ucm439475.htm. 

III. Comments 

Interested persons may submit either 

electronic or written comments to the 

public docket (see ADDRESSES) by June 

14, 2015. 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. 

IV. Transcripts 

Please be advised that as soon as a 

meeting transcript is available, FDA will 

post it at http://www.fda.gov/Drugs/

NewsEvents/ucm439475.htm. 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08359 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–0363] 

Expedited Access for Premarket 

Approval and De Novo Medical 

Devices Intended for Unmet Medical 

Need for Life Threatening or 

Irreversibly Debilitating Diseases or 

Conditions; 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 or the Agency) is 

announcing the availability of the 

guidance entitled ‘‘Expedited Access for 

Premarket Approval and De Novo 

Medical Devices Intended for Unmet 

Medical Need for Life Threatening or 

Irreversibly Debilitating Diseases or 

Conditions.’’ This guidance outlines 

FDA’s new, voluntary program for 

certain medical devices that 

demonstrate the potential to address 

unmet medical needs for life threatening 

or irreversibly debilitating diseases or 

conditions and that are subject to 

premarket approval (PMA) applications 

or de novo classifications. FDA believes 

that the Expedited Access Pathway 

(EAP) program will help patients have 

more timely access to these medical 

devices by expediting their 

development, assessment, and review, 

while preserving the statutory standard 

of reasonable assurance of safety and 

effectiveness for premarket approval, 

consistent with the Agency’s mission to 

protect and promote public health. The 

document also discusses how the EAP 

program approaches the balance of 

premarket and postmarket data 

collection and incorporates a benefitrisk framework. The EAP program will 

become effective April 15, 2015. 

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 ‘‘Expedited Access 

for Premarket Approval and De Novo 

Medical Devices Intended for Unmet 

Medical Need for Life Threatening or 

mstockstill on DSK4VPTVN1PROD with NOTICES

19670 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 

Irreversibly Debilitating Diseases or 

Conditions’’ 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’s EAP program contains features 

from the Center for Devices and 

Radiological Health’s (CDRH’s) 

Innovation Pathway, piloted in 2011 to 

facilitate the development and expedite 

the review of breakthrough 

technologies. In addition, the EAP 

program is based in part on FDA’s 

experience with the Center for Drug 

Evaluation and Research and Center for 

Biologics Evaluation and Research 

programs that are intended to facilitate 

and expedite development and review 

of new drugs to address unmet medical 

needs in the treatment of serious or lifethreatening conditions (‘‘FDA drugexpedited programs’’). However, while 

the EAP program incorporates some 

features of the FDA drug-expedited 

programs, it is a separate and distinct 

program tailored to devices and 

intended to further speed the 

availability of certain safe and effective 

devices that address unmet public 

health needs. 

As part of the EAP program, FDA 

intends to provide more interactive 

communications during device 

development and more interactive 

review of Investigational Device 

Exemption applications, PMA 

applications, and requests for de novo 

review. This includes working with the 

sponsor to create a data development 

plan specific to the device, which 

would outline all data the sponsor 

intends to collect in support of device 

approval, and identifying what data 

would be collected premarket and 

postmarket. In addition, FDA intends to 

work interactively with the sponsor 

within the benefit-risk framework 

discussed in the FDA guidance, 

‘‘Factors to Consider When Making 

Benefit-Risk Determinations in Medical 

Device Premarket Approvals and De 

Novo Classifications,’’ issued on March 

28, 2012, and in accordance with 

statutory and regulatory requirements, 

to determine whether certain data may 

be collected in the postmarket setting 

rather than in the premarket setting for 

devices subject to PMAs. This guidance 

details the EAP process, which will only 

be utilized at the request of the sponsor 

and with FDA’s agreement. 

At the time of this document’s 

publication, FDA does not know 

whether the EAP program will require a 

significant increase in resources. FDA 

will devote as many resources to EAP as 

possible without adversely impacting 

our ability to meet our Medical Device 

User Fee Act commitments. Our 

experience with the Innovation Pathway 

showed that early and more extensive 

interactions with sponsors can consume 

a significant amount of manager and 

staff time. FDA plans to closely monitor 

implementation of EAP to determine 

whether we have sufficient resources to 

effectively implement the program. 

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 expanding the scope 

to include de novo requests, an 

increased focus on patient benefits, a 

clarification of how FDA will allocate 

resources to the EAP program, and a 

clarified explanation of the EAP 

designation process. FDA also provided 

more examples to help industry better 

understand in which cases EAP may be 

the most appropriate pathway to device 

approval. The final guidance also 

recognizes the potential for use of 

registry data to satisfy post-approval 

study requirements and adds an 

evaluation mechanism for the EAP 

program. 

The EAP program will become 

effective April 15, 2015. 

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 the Expedited 

Access PMA program. 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 

CDRH 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/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm. Persons unable to 

download an electronic copy of 

‘‘Expedited Access for Premarket 

Approval Medical Devices Intended for 

Unmet Medical Need for Life 

Threatening or Irreversibly Debilitating 

Diseases or Conditions’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1400007 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This 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 812 have been approved 

under OMB control number 0910–0078; 

the collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

part 822 have been approved under 

OMB control number 0910–0449; and 

the collections of information regarding 

‘‘Requests for Feedback on Medical 

Device Submissions’’ have been 

mstockstill on DSK4VPTVN1PROD with NOTICES

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