Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15217 

Dated: March 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06497 Filed 3–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1288] 

Electronic Submission of Lot 

Distribution Reports; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Electronic Submission of Lot 

Distribution Reports; Guidance for 

Industry.’’ The guidance document 

provides information and 

recommendations pertaining to the 

electronic submission of lot distribution 

reports for applicants with approved 

biologics license applications (BLAs). 

FDA recently published in the Federal 

Register a final rule requiring that, 

among other things, lot distribution 

reports be submitted to FDA in an 

electronic format that the Agency can 

process, review, and archive. The 

guidance announced in this notice 

finalizes the draft guidance entitled 

‘‘Guidance for Industry: Electronic 

Submission of Lot Distribution Reports’’ 

dated August 2014, and is intended to 

help licensed manufacturers of products 

distributed under an approved BLA 

(henceforth referred to as applicants) 

comply with the final rule. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002 or 

Division of Drug Information, Center for 

Drug Evaluation and Research (CDER), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 51, Rm. 

2201, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. 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: Lori 

J. Churchyard, 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; or Jared Lantzy, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 1116, 

Silver Spring, MD 20993, email: esub@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Electronic 

Submission of Lot Distribution Reports; 

Guidance for Industry.’’ The guidance 

provides information and 

recommendations pertaining to the 

electronic submission of lot distribution 

reports. The guidance provides 

information on how to electronically 

submit lot distribution reports for 

biological products under approved 

BLAs for which CBER or CDER has 

regulatory responsibility. The guidance 

does not apply to any other biological 

product. 

FDA published in the Federal 

Register of June 10, 2014 (79 FR 33072), 

a final rule requiring electronic 

submission of certain postmarketing 

submissions. Among other things, under 

this rule applicants are required to 

submit biological lot distribution reports 

to FDA in an electronic format that the 

Agency can process, review, and 

archive. The guidance is intended to 

help applicants subject to lot 

distribution reporting comply with the 

final rule. Along with other information, 

the guidance provides updated 

information about the following: (1) 

Structured Product Labeling standard 

and vocabulary for electronic 

submission of lot distribution reporting; 

(2) additional resources such as 

implementation guide, validation 

procedures and links with further 

information; and (3) procedures for 

requesting temporary waivers from the 

electronic submission requirement. 

In the Federal Register of August 29, 

2014 (79 FR 51576), FDA announced the 

availability of the draft guidance 

entitled ’’ Guidance for Industry: 

Electronic Submission of Lot 

Distribution Reports’’ dated August 

2014. FDA published a correction notice 

to correct the docket number in the 

Federal Register of September 16, 2014 

(79 FR 55497). FDA received a few 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. FDA is 

finalizing the draft guidance with only 

editorial changes. The guidance 

announced in this notice finalizes the 

draft guidance dated August 2014. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. 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 statutes 

and regulations. 

II. 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 600.81 and 600.90 have been 

approved under 0910–0308. 

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/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

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

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http://

www.regulations.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15218 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 

Dated: March 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06498 Filed 3–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of 

Theranostic Kits for mTOR Analogbased Chemotherapy 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR part 404, 

that the National Institutes of Health, 

Department of Health and Human 

Services, is contemplating the grant to 

ProVivoX, Inc., of an exclusive 

evaluation option license to practice the 

inventions embodied in the following 

US Patent, US Patent Application, and 

International Patent Application (and all 

foreign counterparts): US Provisional 

Patent Application Serial No. 61/

144,501, filed 14 January 2009, entitled: 

‘‘Ratio-based Biomarker of Survival 

Utilizing PTEN and Phospho-AKT’’ 

[HHS Reference No. E–025–2009/0–US– 

01]; International Application No. PCT/ 

US2010/020944, filed on 13 January 

2010, entitled: ‘‘Ratio-based Biomarkers 

and Methods of Use Thereof’’ [HHS 

Reference No. E–025–2009/0–PCT–02]; 

US Patent Application Serial No. 13/

144,474, filed 13 July 2011 [HHS 

Reference No. E–025–2009/0–US–02]; 

and Canadian Patent Application No. 

2,749,601, filed on 13 January 2010 

[HHS Reference No. E–025–2009/0–CA– 

05]. The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective exclusive evaluation 

option license territory may be United 

States and Canada, and the field of use 

may be limited to: 

a. ‘‘Exclusive use of the Licensed Patent 

Rights to develop an immunohistochemistry 

(IHC)- or tissue microarray-based test kit for 

use with human tissue samples and approved 

in the United States and Canada as a Class 

III medical device, such test kit to be 

distributed in commerce for the for the 

purpose of predicting survival, response to 

therapy, or cancer recurrence in breast cancer 

patients.’’ 

b. ‘‘Non-exclusive use of the Licensed 

Patent Rights to develop an 

immunohistochemistry (IHC)- or tissue 

microarray-based test kit for use with human 

tissue samples and for which the United 

States FDA issues an order, in the form of a 

letter, which finds Licensee’s kit to be a 

medical device substantially equivalent to 

one or more similar legally marketed devices, 

and states that the Licensee’s device can be 

marketed in the U.S. (i.e., 510(k) cleared), 

such test kit to be distributed in commerce 

for the purpose of predicting survival, 

response to therapy, or cancer recurrence in 

breast cancer patients.’’ 

Upon the expiration or termination of 

the exclusive evaluation option license, 

ProVivoX, Inc., will have the exclusive 

right to execute an exclusive 

commercialization license which will 

supersede and replace the exclusive 

evaluation option license with no 

greater field of use and territory than 

granted in the exclusive evaluation 

option license. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before April 

7, 2015 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive evaluation 

option license should be directed to: 

Patrick McCue, Ph.D., Licensing and 

Patenting Manager, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: (301) 435–5560; Facsimile: 

(301) 402–0220; Email: mccuepat@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

technology describes a method of 

identifying cancer patients that may 

benefit from mTOR analog-based 

chemotherapy or agents directed against 

the AKT pathway. 

The prospective exclusive evaluation 

license is being considered under the 

small business initiative launched on 1 

October 2011, and will comply with the 

terms and conditions of 35 U.S.C. 209 

and 37 CFR part 404. The prospective 

exclusive evaluation option license, and 

a subsequent exclusive 

commercialization license, may be 

granted unless the NIH receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR part 404 

within fifteen (15) days from the date of 

this published notice. 

Complete applications for a license in 

the field of use filed in response to this 

notice will be treated as objections to 

the grant of the contemplated exclusive 

evaluation option license. Comments 

and objections submitted to this notice 

will not be made available for public 

inspection and, to the extent permitted 

by law, will not be released under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: March 17, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–06487 Filed 3–20–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request Prevalence, 

Incidence, Epidemiology and 

Molecular Variants of HIV in Blood 

Donors in Brazil (NHLBI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the FR in 

Volume 79 on December 31, 2014 on 

page 78876 and allowed 60-days for 

public comment. One public comment 

was received that was a personal 

opinion regarding conducting research 

about the Brazil blood donation system. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Direct Comments To Omb: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: Desk Officer for NIH. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Simone Glynn, MD, Project 

Officer/ICD Contact, Two Rockledge 

mstockstill on DSK4VPTVN1PROD with NOTICES