Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices 9267 

Management Plan to Reduce Predation 

of Juvenile Salmonids in the Columbia 

River Estuary, Review Period Ends: 03/ 

16/2015, Contact: Robert Winters 503– 

808–4738. Revision to FR Notice 

Published 02/13/2015; Correction to 

Document Status should be Final EIS. 

Dated: February 17, 2015. 

Dawn Roberts, 

Management Analyst, NEPA Compliance 

Division, Office of Federal Activities. 

[FR Doc. 2015–03524 Filed 2–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–9922–98–Region 6] 

Underground Injection Control 

Program; Hazardous Waste Injection 

Restrictions; Petition for Exemption 

Reissuance—Class I Hazardous Waste 

Injection; Lucite International, Inc. 

Beaumont Site, Nederland, TX 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of a final decision on a 

no migration petition reissuance. 

SUMMARY: Notice is hereby given that a 

reissuance of an exemption to the land 

disposal Restrictions, under the 1984 

Hazardous and Solid Waste 

Amendments to the Resource 

Conservation and Recovery Act, has 

been granted to Lucite International, 

Inc. for two Class I hazardous injection 

wells located at their Beaumont site 

located in Nederland, TX. The company 

has adequately demonstrated to the 

satisfaction of the Environmental 

Protection Agency by the petition 

reissuance application and supporting 

documentation that, to a reasonable 

degree of certainty, there will be no 

migration of hazardous constituents 

from the injection zone for as long as the 

waste remains hazardous. This final 

decision allows the continued 

underground injection by Lucite, of the 

specific restricted hazardous wastes 

identified in this exemption reissuance, 

into Class I hazardous waste injection 

wells WDW–100 & 101 until December 

31, 2030, unless EPA moves to 

terminate this exemption. Additional 

conditions included in this final 

decision may be reviewed by contacting 

the Region 6 Ground Water/UIC Section. 

A public notice was issued December 

18, 2014. The public comment period 

closed on February 2, 2015. No 

comments were received. This decision 

constitutes final Agency action and 

there is no Administrative appeal. This 

decision may be reviewed/appealed in 

compliance with the Administrative 

Procedure Act. 

DATES: This action is effective as of 

February 5, 2015. 

ADDRESSES: Copies of the petition 

reissuance and all pertinent information 

relating thereto are on file at the 

following location: Environmental 

Protection Agency, Region 6, Water 

Quality Protection Division, Source 

Water Protection Branch (6WQ–S), 1445 

Ross Avenue, Dallas, Texas 75202–2733. 

FOR FURTHER INFORMATION CONTACT: 

Philip Dellinger, Chief Ground Water/

UIC Section, EPA—Region 6, telephone 

(214) 665–8324. 

Dated: February 5, 2015. 

William K. Honker, 

Director, Water Quality Protection Division. 

[FR Doc. 2015–03463 Filed 2–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL DEPOSIT INSURANCE 

CORPORATION 

Sunshine Act Meeting 

Pursuant to the provisions of the 

‘‘Government in the Sunshine Act’’ (5 

U.S.C. 552b), notice is hereby given that 

at 10:03 a.m. on Tuesday, February 17, 

2015, the Board of Directors of the 

Federal Deposit Insurance Corporation 

met in closed session to consider 

matters related to the Corporation’s 

supervision, corporate, and resolution 

activities. 

In calling the meeting, the Board 

determined, on motion of Vice 

Chairman Thomas M. Hoenig, seconded 

by Director Jeremiah O. Norton 

(Appointive), concurred in by Director 

Thomas J. Curry (Comptroller of the 

Currency), Director Richard Cordray 

(Director, Consumer Financial 

Protection Bureau), and Chairman 

Martin J. Gruenberg, that Corporation 

business required its consideration of 

the matters which were to be the subject 

of this meeting on less than seven days’ 

notice to the public; that no earlier 

notice of the meeting was practicable; 

that the public interest did not require 

consideration of the matters in a 

meeting open to public observation; and 

that the matters could be considered in 

a closed meeting by authority of 

subsections (c)(4), (c)(6), (c)(8), 

(c)(9)(A)(ii), and (c)(9)(B) of the 

‘‘Government in the Sunshine Act’’ (5 

U.S.C. 552b(c)(4), (c)(6), (c)(8), 

(c)(9)(A)(ii), and (c)(9)(B). 

The meeting was held by telephone. 

Dated: February 17, 2015. 

Federal Deposit Insurance Corporation. 

Robert E. Feldman, 

Executive Secretary. 

[FR Doc. 2015–03605 Filed 2–18–15; 4:15 pm] 

BILLING CODE 6714–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0349] 

Investigating and Reporting Adverse 

Reactions Related to Human Cells, 

Tissues, and Cellular and TissueBased Products; Draft 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 draft document entitled 

‘‘Investigating and Reporting Adverse 

Reactions Related to Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps) Regulated Solely 

Under Section 361 of the Public Health 

Service Act and 21 CFR part 1271’’ 

dated February 2015. The draft guidance 

document is intended to provide 

manufacturers of human cells, tissues, 

and cellular and tissue-based products 

(HCT/Ps) for which no premarket 

submissions are required because they 

are not also regulated as drugs, devices, 

and/or biological products, with 

recommendations for complying with 

the requirements for investigating and 

reporting adverse reactions involving 

communicable disease in recipients of 

these HCT/Ps. The draft guidance, when 

finalized, is intended to supplement 

section XXII of FDA’s guidance entitled 

‘‘Guidance for Industry: Current Good 

Tissue Practice (CGTP) and Additional 

Requirements for Manufacturers of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps)’’ dated 

December 2011 and supersede the 

guidance entitled ‘‘Guidance for 

Industry: MedWatch Form FDA 3500A: 

Mandatory Reporting of Adverse 

Reactions Related to Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ dated November 

2005. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by April 21, 2015. 


TKELLEY on DSK3SPTVN1PROD with NOTICES
9268 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices 

ADDRESSES: Submit written requests for 

single copies of the draft 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. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft 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 draft 

guidance document. 

Submit electronic comments on the 

draft 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Investigating 

and Reporting Adverse Reactions 

Related to Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps) Regulated Solely Under 

Section 361 of the Public Health Service 

Act and 21 CFR part 1271’’ dated 

February 2015. The draft guidance 

document is intended provide 

manufacturers of HCT/Ps, with 

recommendations for complying with 

the requirements for investigating and 

reporting adverse reactions involving 

communicable disease in recipients of 

HCT/Ps that are regulated solely under 

section 361 of the Public Health Service 

Act (42 U.S.C. 264) and 21 CFR part 

1271 (361 HCT/Ps). 

The draft guidance, when finalized, is 

intended to supplement section XXII of 

FDA’s guidance entitled ‘‘Guidance for 

Industry: Current Good Tissue Practice 

(CGTP) and Additional Requirements 

for Manufacturers of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ dated December 

2011 by providing additional 

recommendations specific to the 

responsibilities to investigate 

complaints of adverse reactions 

concerning 361 HCT/Ps under 

§§ 1271.160(b)(2), 1271.320 and 

1271.350(a)(1). 

The draft guidance, when finalized, is 

intended to supersede the guidance 

entitled ‘‘Guidance for Industry: 

MedWatch Form FDA 3500A: 

Mandatory Reporting of Adverse 

Reactions Related to Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ dated November 

2005. The guidance will provide 

updated information specific to 

reporting adverse reactions related to 

HCT/Ps to supplement the general 

instructions accompanying the 

MedWatch mandatory reporting form, 

Form FDA 3500A. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft 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 part 1271 have been 

approved under OMB control number 

0910–0543 and OMB control number 

0910–0291. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. 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 draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: February 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03490 Filed 2–19–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (HRSA) announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on this Information 

Collection Request must be received no 

later than April 21, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail to the 

HRSA Information Collection Clearance 

Officer, Room 10–29, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Radiation Exposure Screening and 

Education Program OMB No. 0915– 

xxxx—New. 

Abstract: The Radiation Exposure 

Screening and Education Program 

(RESEP) is authorized by section 417C 

of the Public Health Service Act (42 

U.S.C. 285a–9). The purpose of RESEP 

is to assist individuals who live (or 

lived) in areas where U.S. nuclear 

weapons testing occurred and who are 


TKELLEY on DSK3SPTVN1PROD with NOTICES