22526 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 

Testimonies may also be submitted to 

this email address: Paige.Hausburg@

acf.hhs.gov. Registration to attend the 

consultation can be done using this link: 

http://events.constantcontact.com/

register/event?llr=vt7m85dab&oeidk

=a07eau2syfc09b2fe8f. 

Please register by May 18, 2015, so 

that OCSE can include everyone 

registered in the building access system 

to assure their entry. OCSE is located in 

a federal building and the security 

protocol requires government 

identification. 

OCSE understands that resources are 

limited and travel may not be possible 

for some tribal leaders. In order to 

engage as many tribal leaders as 

possible, individuals who are unable to 

travel to Washington, DC, can connect 

to the meeting via a conference call. The 

call-in number is 1–866–642–2926, 

participant passcode is 1436048. The 

URL for the webinar is: http://

hhs.adobeconnect.com/drotribal/. To 

join by phone, please register using the 

link above. 

Dated: April 16, 2015. 

Donna Bonar, 

Deputy Commissioner, Office of Child 

Support Enforcement. 

[FR Doc. 2015–09351 Filed 4–21–15; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0432] 

Clinical Trial Endpoints for the 

Approval of Non-Small Cell Lung 

Cancer Drugs and Biologics; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

guidance for industry entitled ‘‘Clinical 

Trial Endpoints for the Approval of 

Non-Small Cell Lung Cancer Drugs and 

Biologics.’’ This guidance provides 

recommendations to applicants on 

endpoints for cancer clinical trials 

submitted to FDA to support 

effectiveness claims in new drug 

applications, biologics license 

applications, or supplemental 

applications for the treatment of nonsmall cell lung cancer. This guidance 

focuses on endpoints specifically for 

lung cancer trials to support drug 

approval or labeling claims. This 

guidance should speed the development 

and improve the quality of protocols 

submitted to FDA to support anticancer 

effectiveness claims. This guidance 

finalizes the draft guidance issued on 

June 17, 2011. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or 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 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Rajeshwari Sridhara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 3512, 

Silver Spring, MD 20993–0002, 301– 

796–1759; 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, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Clinical Trial Endpoints for the 

Approval of Non-Small Cell Lung 

Cancer Drugs and Biologics.’’ FDA is 

developing guidance on oncology 

endpoints through a process that 

includes public workshops of oncology 

experts and discussions before FDA’s 

Oncologic Drugs Advisory Committee. 

This guidance provides background 

information and general principles. The 

endpoints discussed in this guidance 

are for drugs to treat patients with 

existing non-small cell lung cancer. This 

guidance does not address endpoints for 

drugs to prevent or decrease the 

incidence of cancer. 

This guidance finalizes the draft 

guidance for industry entitled ‘‘Clinical 

Trial Endpoints for the Approval of 

Non-Small Cell Lung Cancer Drugs and 

Biologics’’ issued June 17, 2011 (76 FR 

35450). Comments received from 

industry, professional societies, and 

consumer groups on the draft guidance 

have been taken into consideration by 

FDA in finalizing this guidance and 

some of the changes are summarized 

here. Sections II.A. and III. have been 

clarified based on the comments 

received and FDA’s current thinking 

and practice regarding the magnitude of 

treatment effect based on progressionfree survival. Appendices C and D have 

also been clarified based on the 

comments received and FDA’s view on 

primary and sensitivity analyses of 

progression-free survival. The language 

in the guidance has been simplified to 

be concise. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on clinical trial 

endpoints for the approval of non-small 

cell lung cancer drugs and biologics. 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. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

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 parts 312, 314, 

and 601 have been approved under 

OMB control numbers 0910–0014, 

0910–0001, and 0910–0338, 

respectively. 

III. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22527 

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. 

Dated: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09303 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–M–1452, FDA– 

2014–M–1596, FDA–2014–M–1597, FDA– 

2014–M–1599, FDA–2014–M–1735, FDA– 

2014–M–1736, FDA–2014–M–2042, FDA– 

2014–M–2246, FDA–2014–M–2248, and 

FDA–2014–M–2376] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 when 

submitting a written request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the summaries of 

safety and effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with sections 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

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

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from October 1, 2014, through 

December 31, 2014. There were no 

denial actions during this period. The 

list provides the manufacturer’s name, 

the product’s generic name or the trade 

name, and the approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 

2014, THROUGH DECEMBER 31, 2014 

PMA No., Docket No. Applicant Trade name Approval date 

P040037/S060, FDA–2014–M–1452 ............... W.L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis, GORE 

VIABAHN Endoprosthesis with Heparin.

September 19, 2014. 

P070015/S122, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE V® and XIENCE nano® Everolimus 

Eluting Coronary Stent System.

October 3, 2014. 

P110019/S066, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE PRIME® and XIENCE PRIME LL 

Everlimus Eluting Coronary Stent System.

October 3, 2014. 

P130024, FDA–2014–M–1597 ......................... Lutonix, Inc ................. Lutonix 035 Drug Coated Balloon PTA Catheter.October 9, 2014. 

P110023/S007, FDA–2014–M–1599 ............... ev3, Inc ....................... EverFlexTM Self-Expanding Peripheral Stent 

System.

October 10, 2014. 

P120005/S018, FDA–2014–M–1735 ............... Dexcom, Inc ............... Dexcom G4TM PLATINUM Continuous Glucose Monitoring System.October 21, 2014. 

P130026, FDA–2014–M–1736 ......................... St. Jude Medical ........ TactiCath Quartz® Catheter and 

TactiSysQuartz® Equipment.

October 24, 2014. 

P120011, FDA–2014–M–2042 ......................... Ideal Implant, Inc ........ IDEAL IMPLANT® Saline-filled Breast Implant November 14, 2014. 

P130007, FDA–2014–M–2246 ......................... Animas Corp .............. Animas Vibe System ....................................... November 25, 2014. 

P140020, FDA–2014–M–2248 ......................... Myriad Genetic Laboratories, Inc.BRACAnalysis CDxTM .................................... December 19, 2014. 

P020012/S009, FDA–2014–M–2376 ............... Suneva Medical, Inc ... Bellafill ............................................................. December 23, 2014. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES