Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12499 

St. NW., Washington, DC 20005, 267– 

765–1029, Rasika.Kalamegham@

aacr.org. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

the ‘‘Complexities in Personalized 

Medicine: Harmonizing Companion 

Diagnostics Across a Class of Targeted 

Therapies’’ public workshop must 

register online by March 17, 2015, 5 

p.m. Registration will be handled 

through ASCO. Early registration is 

recommended because facilities are 

limited and, therefore, we may limit the 

number of participants from each 

organization. If time and space permits, 

onsite registration on the day of the 

public workshop will be provided 

beginning at 7 a.m. 

If you need special accommodations 

due to a disability, please contact 

Kaitlyn Antonelli (see Contact Persons), 

571–483–1606, Kaitlyn.Antonelli@

asco.org, no later than March 10, 2015. 

To register for the public workshop, 

please use the following Web site: 

https://www.surveymonkey.com/s/

FDACompanionDiagnostics2015. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, email, and telephone 

number. Those without Internet access 

should contact Kaitlyn Antonelli to 

register. Registrants will receive 

confirmation after they have been 

accepted. You will be notified if you are 

on a waiting list. 

Streaming Audiocast of the Public 

Workshop: This public workshop will 

also be audiocast. Persons interested in 

accessing the audiocast must register 

online using the following Web site: 

https://www.surveymonkey.com/s/

FDACompanionDiagnostics2015. 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. Early 

registration is recommended because 

audiocast connections are limited. 

Organizations are requested to register 

all participants but to view using one 

connection per location. After 

registration, participants will be sent 

technical system requirements and 

connection access information after 

March 19, 2015. 

Comments: FDA is holding this public 

workshop to obtain information on 

harmonization of companion 

diagnostics across a class of targeted 

therapies. To permit the widest possible 

opportunity to obtain public comment, 

FDA is soliciting either electronic or 

written comments on all aspects of the 

public workshop. The deadline for 

submitting comments related to this 

public workshop is April 23, 2015. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 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. 

Transcript: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available 

approximately 45 days after the public 

workshop on the Internet at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this public 

workshop from the posted events list.) 

SUPPLEMENTARY INFORMATION: Multiple 

manufacturers are developing 

therapeutic products that rely on a 

particular biomarker and that may 

require contemporaneous approval/

clearance of a companion diagnostic if 

biomarker detection or measurement is 

necessary for the safe and effective use 

of the therapeutic product. Therapeutic 

product developers working in the same 

target space can use different methods 

and measures for the biomarker, and 

then partner with various sponsors to 

implement distinct companion 

diagnostics. These development 

programs can lead to approval/clearance 

of multiple therapeutic productcompanion diagnostic pairs for a single 

class of therapeutic products. For 

example, understanding of the 

Programmed Death Ligand 1 (PD–1) 

checkpoint pathway underlies current 

development of multiple targeted 

therapies and potential companion 

diagnostics targeting and measuring PD– 

1 pathway biomarkers. Although the 

biomarker being detected/measured is 

the same (or closely related) within the 

drug class, there may be differences 

between the companion diagnostics in 

design and performance, such as use of 

different antibodies or different cut-off 

values leading to designation of 

different sets of marker-positive and 

marker-negative patients. 

Comparison of the results from 

different tests is not part of the 

companies’ development program for 

each drug/test pair. Likewise, 

differences in results from distinct tests 

are typically not examined for their 

effect on efficacy of products within the 

drug class. With no assurance that all 

the tests identify the populations most 

likely to respond to all of the drugs, 

problems may arise if various 

companion diagnostics for the same 

biomarker are used in clinical practice 

to direct treatment with all the targeted 

therapies in the drug class. Using 

multiple companion diagnostics to 

determine therapy for each patient is 

costly, inefficient, and challenging 

when dealing with a limited biological 

specimen. Even if it were practical, 

multiple testing might lead to 

suboptimal use of the drugs. Likewise, 

use of one companion diagnostic might 

not adequately inform the use of all of 

the targeted therapies. In such scenarios, 

where multiple targeted therapycompanion diagnostic pairs exist, 

patients may not be able to receive 

optimal care. FDA believes this is an 

important public health issue that is not 

easily resolved. Thus, FDA is convening 

this workshop in association with 

AACR and ASCO to foster a 

collaborative examination of the 

problem as it relates to various 

stakeholders and to identify potential 

solutions or paths to solutions for the 

problem. 

Dated: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05348 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

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12500 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Ancillary Study on 

IBD. 

Date: April 8, 2015. 

Time: 4:30 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Maria E. Davila-Bloom, 

Ph.D., Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 758, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7637, davila-bloomm@

extra.niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05311 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Infant 

Mortality; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Infant 

Mortality (ACIM). 

Dates and Times: 

March 26, 2015, 8:30 a.m.–5:30 p.m. 

March 27, 2015, 8:30 a.m.–3:30 p.m. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Status: The meeting is open to the 

public with attendance limited to space 

availability. For more details and 

registration, please visit the ACIM Web 

site: http://www.hrsa.gov/

advisorycommittees/mchbadvisory/

InfantMortality/index.html. 

Purpose: The Committee provides 

advice and recommendations to the 

Secretary of Health and Human Services 

on the following: Department of Health 

and Human Services’ programs that 

focus on reducing infant mortality and 

improving the health status of infants 

and pregnant women; and factors 

affecting the continuum of care with 

respect to maternal and child health 

care. The Committee focuses on 

outcomes following childbirth; 

strategies to coordinate myriad federal, 

state, local, and private programs and 

efforts that are designed to deal with the 

health and social problems impacting 

on infant mortality; and the 

implementation of the Healthy Start 

Program and Healthy People 2020 infant 

mortality objectives. 

Agenda: Topics that will be discussed 

include the following: HRSA Update; 

MCHB Update; Healthy Start Program 

Update; Updates from Partnering 

Agencies and Organizations; and, 

ACIM’s recommendations for the HHS 

National Strategy to Address Infant 

Mortality, specifically Strategy 4: 

Increase Health Equity and Reduce 

Disparities by Targeting Social 

Determinants of Health through both 

Investments in High-Risk, UnderResourced Communities and Major 

Initiatives to Address Poverty. Proposed 

agenda items are subject to change as 

priorities dictate. 

Time will be provided for public 

comments limited to 5 minutes each. 

Comments are to be submitted in 

writing no later than 5:00 p.m. (EST) on 

March 19, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring information regarding 

the Committee should contact Michael 

C. Lu, M.D., M.P.H., Executive 

Secretary, ACIM, Health Resources and 

Services Administration, Room 18 W, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, telephone: 

(301) 443–2170. 

Individuals who are submitting public 

comments or who have questions 

regarding the meeting and location 

should contact David S. de la Cruz, 

Ph.D., M.P.H., ACIM Designated Federal 

Official, HRSA, Maternal and Child 

Health Bureau, telephone: (301) 443– 

0543, or email: David.delaCruz@

hrsa.hhs.gov. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–05416 Filed 3–6–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0913] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; 513(g) Request for 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 8, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0705. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

513(g) Request for Information—(OMB 

Control Number 0910–0705)— 

(Extension) 

Section 513(g) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360c(g)) provides a means for 

obtaining the Agency’s views about the 

classification and regulatory 

requirements that may be applicable to 

a particular device. Section 513(g) 

provides that, within 60 days of the 

receipt of a written request of any 

person for information respecting the 

class in which a device has been 

classified or the requirements applicable 

to a device under the FD&C Act, the 

Secretary of Health and Human Services 

mstockstill on DSK4VPTVN1PROD with NOTICES