Modernizing the Regulatory System for Biotechnology Products; Notice of Second Public Meeting, 10858-10859 [2016-04583]

Download as PDF 10858 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices the review period for this PMN expires May 25, 2016. IV. What is EPA’s authority for taking this action? Section 5(c) of TSCA and 40 CFR 720.75(c) authorizes EPA to extend, for good cause, the 90-day PMN review period for additional periods not to exceed in the aggregate 90 days. For this PMN, EPA finds that there is good cause to extend the review period. Based on analysis, EPA may need to regulate this new chemical substance and the Agency needs an extension of the review period to further investigate potential risk, examine regulatory options, and prepare the necessary documents, should regulatory action be required. Authority: 15 U.S.C. 2601 et seq. Dated: February 25, 2016. Greg Schweer, Chief, New Chemicals Notice Management Branch, Office of Pollution Prevention and Toxics. [FR Doc. 2016–04597 Filed 3–1–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FDA–2015–N–3403; FRL–9943–08] Modernizing the Regulatory System for Biotechnology Products; Notice of Second Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: Under the auspices of the National Science and Technology Council, EPA, along with the Office of Science and Technology Policy (OSTP), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA) are holding a second public meeting related to the memorandum entitled, ‘‘Modernizing the Regulatory System for Biotechnology Products,’’ issued by the Executive Office of the President (EOP) in July 2015. The purpose of the second public meeting is to illustrate current federal roles and responsibilities regarding biotechnology products. The docket, FDA–2015–N–3403, established by FDA prior to the first public meeting will continue to be used for this interagency effort. DATES: The meeting will be held on March 9, 2016, from 9:30 a.m. to 1:00 p.m. To request accommodation of a disability, please immediately contact the person listed under FOR FURTHER INFORMATON CONTACT to give EPA as mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 much time as possible to process your request. ADDRESSES: The meeting will be held at the EPA Region 6 Office at 1445 Ross Avenue, Dallas, Texas 75202–2750. FOR FURTHER INFORMATION CONTACT: For general questions about the meeting, contact Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: BPPDFRNotices@epa.gov. For questions about the memorandum entitled, ‘‘Modernizing the Regulatory System for Biotechnology Products,’’ or related activities described in that memorandum, contact the National Science and Technology Council: Emerging Technologies Interagency Policy Coordination Committee, Office of Science and Technology Policy, Executive Office of the President, Eisenhower Executive Office Building, 1650 Pennsylvania Ave. Washington, DC 20504, 202–456–4444, online: https://www.whitehouse.gov/webform/ contact-emerging-technologiesinteragency-policy-coordinatingcommittee-national-science-and. SUPPLEMENTARY INFORMATION: The second public meeting will be held on March 9, 2016, from 9:30 a.m. to 1:00 p.m. at EPA’s Region 6 Office in Dallas, Texas. The second public meeting will be used to illustrate current federal roles and responsibilities regarding biotechnology products. The final meeting agenda will be placed in the docket [FDA–2015–N–3403] as soon as it is available. The third public meeting will be held on March 30, 2016, at the University of California’s Davis Conference Center in Davis, California and information about that meeting, including an agenda and information regarding how to register will be placed in the docket and on the USDA Web site prior to the meeting. I. Background Under the auspices of the National Science and Technology Council, EPA, FDA, USDA and OSTP (collectively referred to as ‘‘we’’ in this Federal Register document), held a public meeting on October 30, 2015, to discuss the Executive Office of the President (EOP) memorandum entitled, ‘‘Modernizing the Regulatory System for Biotechnology Products,’’ that was issued in July 2015. The purpose of the October 2015 meeting was to inform the public about the activities described in the July 2015 memorandum; invite oral comments from interested parties; and provide information about how to submit written comments, data, or other information to the docket. The October meeting was the first of three public engagement sessions on this topic. On February 1, 2016, we announced the dates and locations for the second and third public engagement sessions: (1) https://wcms.epa.gov/pesticides/ save-date-march-9-30-2016-publicmeetings-updating-coordinatedframework-regulation; (2) https:// www.fda.gov/NewsEvents/ MeetingsConferencesWorkshops/ ucm463783.htm; and (3) https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology/sa_stakeholder_ meetings/cf_meeting. III. Meeting Materials, Transcripts and Recorded Video PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 II. How can I participate in the March 9th meeting? To participate in person or by webinar via Adobe Connect, please register online at https://www.epa.gov/ regulation-biotechnology-under-tscaand-fifra/modernizing-regulatorysystem-biotechnology-products. Those registered will receive detailed instructions with their confirmations that explain how to access the meeting via webinar or in person. Any additional information and data submitted voluntarily to us will become part of the administrative record for this activity and will be accessible to the public in the docket [FDA–2015–N– 3403] at https://www.regulations.gov. The transcript of the proceedings from the public meeting will become part of the administrative record for this activity and will also be included in the docket. Please be advised that as soon as a transcript is available, it will be accessible in the docket at https:// www.regulations.gov. Transcripts and meeting materials may also be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will 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 FDA Division of Freedom of Information, 5630 Fishers Lane, Rm. 1035, Rockville, MD 20857. Additionally, we will live webcast and record the public meeting. Once the recorded video is available, it will be accessible on EPA’s YouTube Channel. E:\FR\FM\02MRN1.SGM 02MRN1 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices Dated: February 24, 2016. Mark A. Hartman, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. 2016–04583 Filed 3–1–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPAHQ–SFUND–2012–0104; FRL–9943– 10–OLEM] Proposed Information Collection Request; Comment Request; Brownfields Program— Accomplishment Reporting (Renewal) Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency is planning to submit an information collection request (ICR), ‘‘Brownfields Program— Accomplishment Reporting (Renewal)’’ (EPA ICR No. 2104.06, OMB Control No. 2050–0192) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through May 31, 2016. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. DATES: Comments must be submitted on or before May 2, 2016. ADDRESSES: Submit your comments, referencing Docket ID No. EPA–HQ– SFUND–2012–0104 online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460. EPA’s policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. FOR FURTHER INFORMATION CONTACT: Kelly Gorini, Office of Brownfields and Land Revitalization, (5105T), Environmental Protection Agency, 1200 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 566–1702; email address: gorini.kelly@ epa.gov. SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202–566–1744. For additional information about EPA’s public docket, visit https://www.epa.gov/ dockets. Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. Abstract: The Small Business Liability Relief and Brownfields Revitalization Act (Pub. L. 107–118) (‘‘the Brownfields Amendments’’) was signed into law on January 11, 2002. The Act amends the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended, and authorizes EPA to award cooperative agreements to states, tribes, local governments, and other eligible entities to assess and clean up brownfield sites. Under the Brownfields Amendments, a brownfields site means real property, the expansion, redevelopment, or reuse of which may be complicated by the presence or potential presence of a hazardous substance, pollutant, or PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 10859 contaminant. For funding purposes, EPA uses the term ‘‘brownfields property(ies)’’ synonymously with the term ‘‘brownfields sites.’’ The Brownfields Amendments authorize EPA to award several types of cooperative agreements to eligible entities on a competitive basis. Under subtitle A of the Small Business Liability Relief and Brownfields Revitalization Act, states, tribes, local governments, and other eligible entities can receive assessment cooperative agreements to inventory, characterize, assess, and conduct planning and community involvement related to brownfields properties; cleanup cooperative agreements to carry out cleanup activities at brownfields properties; cooperative agreements to capitalize revolving loan funds and provide subgrants for cleanup activities; area-wide planning cooperative agreements to develop revitalization plans for brownfields; and environmental workforce and development job training and placement programs. Under subtitle C of the Small Business Liability Relief and Brownfields Revitalization Act, states and tribes can receive cooperative agreements to establish and enhance their response programs through the four elements and meet the public record requirements under the statute. Cooperative agreement recipients (‘‘recipients’’) have general reporting and record keeping requirements as a condition of their cooperative agreement that result in burden. A portion of this reporting and record keeping burden is authorized under 2 CFR part 1500 and identified in the EPA’s general grants ICR (OMB Control Number 2030–0020). EPA requires Brownfields program recipients to maintain and report additional information to EPA on the uses and accomplishments associated with funded brownfields activities. EPA uses several forms to assist recipients in reporting the information and to ensure consistency of the information collected. EPA uses this information to meet Federal stewardship responsibilities to manage and track how program funds are being spent, to evaluate the performance of the Brownfields Cleanup and Land Revitalization Program, to meet the Agency’s reporting requirements under the Government Performance Results Act, and to report to Congress and other program stakeholders on the status and accomplishments of the program. Form numbers: EPA ICR No. 2104.06, OMB Control No. 2050–0192. Respondents/affected entities: State/ local/tribal governments; Non-Profits. E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10858-10859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04583]


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ENVIRONMENTAL PROTECTION AGENCY

[FDA-2015-N-3403; FRL-9943-08]


Modernizing the Regulatory System for Biotechnology Products; 
Notice of Second Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Under the auspices of the National Science and Technology 
Council, EPA, along with the Office of Science and Technology Policy 
(OSTP), the Food and Drug Administration (FDA), and the United States 
Department of Agriculture (USDA) are holding a second public meeting 
related to the memorandum entitled, ``Modernizing the Regulatory System 
for Biotechnology Products,'' issued by the Executive Office of the 
President (EOP) in July 2015. The purpose of the second public meeting 
is to illustrate current federal roles and responsibilities regarding 
biotechnology products. The docket, FDA-2015-N-3403, established by FDA 
prior to the first public meeting will continue to be used for this 
interagency effort.

DATES: The meeting will be held on March 9, 2016, from 9:30 a.m. to 
1:00 p.m.
    To request accommodation of a disability, please immediately 
contact the person listed under FOR FURTHER INFORMATON CONTACT to give 
EPA as much time as possible to process your request.

ADDRESSES: The meeting will be held at the EPA Region 6 Office at 1445 
Ross Avenue, Dallas, Texas 75202-2750.

FOR FURTHER INFORMATION CONTACT: For general questions about the 
meeting, contact Robert McNally, Biopesticides and Pollution Prevention 
Division (7511P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
BPPDFRNotices@epa.gov. For questions about the memorandum entitled, 
``Modernizing the Regulatory System for Biotechnology Products,'' or 
related activities described in that memorandum, contact the National 
Science and Technology Council: Emerging Technologies Interagency 
Policy Coordination Committee, Office of Science and Technology Policy, 
Executive Office of the President, Eisenhower Executive Office 
Building, 1650 Pennsylvania Ave. Washington, DC 20504, 202-456-4444, 
online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the auspices of the National Science and Technology Council, 
EPA, FDA, USDA and OSTP (collectively referred to as ``we'' in this 
Federal Register document), held a public meeting on October 30, 2015, 
to discuss the Executive Office of the President (EOP) memorandum 
entitled, ``Modernizing the Regulatory System for Biotechnology 
Products,'' that was issued in July 2015. The purpose of the October 
2015 meeting was to inform the public about the activities described in 
the July 2015 memorandum; invite oral comments from interested parties; 
and provide information about how to submit written comments, data, or 
other information to the docket. The October meeting was the first of 
three public engagement sessions on this topic.
    On February 1, 2016, we announced the dates and locations for the 
second and third public engagement sessions: (1) https://wcms.epa.gov/pesticides/save-date-march-9-30-2016-public-meetings-updating-coordinated-framework-regulation; (2) https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm463783.htm; and (3) https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_stakeholder_meetings/cf_meeting.
    The second public meeting will be held on March 9, 2016, from 9:30 
a.m. to 1:00 p.m. at EPA's Region 6 Office in Dallas, Texas. The second 
public meeting will be used to illustrate current federal roles and 
responsibilities regarding biotechnology products. The final meeting 
agenda will be placed in the docket [FDA-2015-N-3403] as soon as it is 
available.
    The third public meeting will be held on March 30, 2016, at the 
University of California's Davis Conference Center in Davis, California 
and information about that meeting, including an agenda and information 
regarding how to register will be placed in the docket and on the USDA 
Web site prior to the meeting.

II. How can I participate in the March 9th meeting?

    To participate in person or by webinar via Adobe Connect, please 
register online at https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/modernizing-regulatory-system-biotechnology-products.
    Those registered will receive detailed instructions with their 
confirmations that explain how to access the meeting via webinar or in 
person.

III. Meeting Materials, Transcripts and Recorded Video

    Any additional information and data submitted voluntarily to us 
will become part of the administrative record for this activity and 
will be accessible to the public in the docket [FDA-2015-N-3403] at 
https://www.regulations.gov. The transcript of the proceedings from the 
public meeting will become part of the administrative record for this 
activity and will also be included in the docket. Please be advised 
that as soon as a transcript is available, it will be accessible in the 
docket at https://www.regulations.gov.
    Transcripts and meeting materials may also be viewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will 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 
FDA Division of Freedom of Information, 5630 Fishers Lane, Rm. 1035, 
Rockville, MD 20857. Additionally, we will live webcast and record the 
public meeting. Once the recorded video is available, it will be 
accessible on EPA's YouTube Channel.


[[Page 10859]]


    Dated: February 24, 2016.
Mark A. Hartman,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
[FR Doc. 2016-04583 Filed 3-1-16; 8:45 am]
BILLING CODE 6560-50-P

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