Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69497 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR 601.12 and Form FDA 356h 

have been approved under OMB control 

number 0910–0338; the collections of 

information in 21 CFR 607.26 and Form 

FDA 2830 have been approved under 

OMB control number 0910–0052; the 

collections of information in 21 CFR 

606.121, 606.170, and 610.40 have been 

approved under OMB control number 

0910–0116; and the collections of 

information in 21 CFR 600.14 have been 

approved under OMB control number 

0910–0458. 

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 guidance at either 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27521 Filed 11–20–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0502] 

Report on the Standardization of Risk 

Evaluation and Mitigation Strategies; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Report on the 

Standardization of Risk Evaluation and 

Mitigation Strategies’’ that appeared in 

the Federal Register of September 23, 

2014. The document misstated the name 

of an organization. This document 

corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Richard Currey, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6125, 

Silver Spring, MD 20993–0002, 301– 

796–3918, FAX: 301–595–7910, REMS_

Standardization@fda.hhs.gov; or Adam 

Kroetsch, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1192, Silver Spring, 

MD 20993–0002; 301–796–3842, FAX: 

301–847–8443, REMS_

Standardization@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 23, 2014 

(79 FR 56816), in FR Doc. 2014–22513, 

the following correction is made: 

1. On page 56817, in the third 

column, under ‘‘Draft Report Describing 

Findings Concerning REMS 

Standardization and Plans for Projects 

to Standardize REMS,’’ ‘‘Accreditation 

Commission for Education in Nursing’’ 

is corrected to read ‘‘American Nurses 

Credentialing Center.’’ 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27522 Filed 11–20–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Developing and Using Precision 

Therapies in the ‘‘Omics’’ Era: 

Generating and Interpreting Evidence 

for Rare Subsets; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing a public workshop entitled 

‘‘Developing and Using Precision 

Therapies in the ‘Omics’ Era: Generating 

and Interpreting Evidence for Rare 

Subsets.’’ This public workshop is being 

cosponsored with the Center for 

Translational and Regulatory Sciences 

at the University of Virginia (UVA). The 

goals of this public workshop are to 

facilitate discussion on current 

scientific approaches using rare subsets 

during drug development programs and 

to further seek input from multiple 

stakeholders on approaches to obtain 

evidence that inform the regulatory 

evaluation of therapeutic products in 

rare subsets of patients identified 

through in-vitro diagnostic testing when 

specific, controlled trials are not 

feasible. 

DATES: The public workshop will be 

held on December 12, 2014, from 9 a.m. 

to 5 p.m. Individuals who wish to 

attend the public workshop in person or 

via a live Webcast must register online 

by December 1, 2014, at: https://

www.signup4.net/Public/

ap.aspx?OID=130&EID=DEVE96E. 

Section II of this document provides 

attendance and registration information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Padmaja Mummaneni, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2164, 

Silver Spring, MD 20993–0002, 301– 

796–2027, email: 

padmaja.mummaneni@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Therapeutic products are increasingly 

targeted to patients who have molecular 

characteristics that are diagnostic of a 

particular subtype of disease, prognostic 

for better or worse outcomes, or 

predictive of treatment response. The 

advent of next-generation sequencing 

and other high throughput technologies 

has enabled the development of in-vitro 

diagnostic tests that are able to detect 

rare molecular variations, specifically in 

the patient, tumor, or microbial DNA 

sequence. FDA and UVA are 

cosponsoring an open public workshop 

among stakeholders in the 

pharmaceutical industry, 

representatives from academia, 

regulatory scientists, and other 

interested parties on the development 

and usage of diagnostic and therapeutic 

products that respectively have the 

potential to identify and treat patients 

with rare molecular characteristics. It is 

important for regulatory agencies, 

pharmaceutical and diagnostic 

industries, and the medical community, 

including payers, to have a mutual 

mstockstill on DSK4VPTVN1PROD with NOTICES