81 FR 10858 - Modernizing the Regulatory System for Biotechnology Products; Notice of Second Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 41 (March 2, 2016)

Page Range		10858-10859
FR Document		2016-04583

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.

Federal Register, Volume 81 Issue 41 (Wednesday, March 2, 2016)

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10858-10859]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: 
[email protected]. 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) http://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 http://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 
http://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 http://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

10858 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices

the review period for this PMN expires much time as possible to process your The second public meeting will be
May 25, 2016. request. held on March 9, 2016, from 9:30 a.m.
IV. What is EPA’s authority for taking ADDRESSES: The meeting will be held at to 1:00 p.m. at EPA’s Region 6 Office in
this action? the EPA Region 6 Office at 1445 Ross Dallas, Texas. The second public
Avenue, Dallas, Texas 75202–2750. meeting will be used to illustrate
Section 5(c) of TSCA and 40 CFR FOR FURTHER INFORMATION CONTACT: For current federal roles and responsibilities
720.75(c) authorizes EPA to extend, for general questions about the meeting, regarding biotechnology products. The
good cause, the 90-day PMN review contact Robert McNally, Biopesticides final meeting agenda will be placed in
period for additional periods not to and Pollution Prevention Division the docket [FDA–2015–N–3403] as soon
exceed in the aggregate 90 days. For this (7511P), Office of Pesticide Programs, as it is available.
PMN, EPA finds that there is good cause Environmental Protection Agency, 1200
to extend the review period. Based on The third public meeting will be held
Pennsylvania Ave. NW., Washington, on March 30, 2016, at the University of
analysis, EPA may need to regulate this DC 20460–0001; main telephone
new chemical substance and the Agency California’s Davis Conference Center in
number: (703) 305–7090; email address:
needs an extension of the review period Davis, California and information about
BPPDFRNotices@epa.gov. For questions
to further investigate potential risk, about the memorandum entitled, that meeting, including an agenda and
examine regulatory options, and prepare ‘‘Modernizing the Regulatory System for information regarding how to register
the necessary documents, should Biotechnology Products,’’ or related will be placed in the docket and on the
regulatory action be required. activities described in that USDA Web site prior to the meeting.
Authority: 15 U.S.C. 2601 et seq. memorandum, contact the National II. How can I participate in the March
Dated: February 25, 2016. Science and Technology Council: 9th meeting?
Greg Schweer, Emerging Technologies Interagency
Chief, New Chemicals Notice Management Policy Coordination Committee, Office To participate in person or by webinar
Branch, Office of Pollution Prevention and of Science and Technology Policy, via Adobe Connect, please register
Toxics. Executive Office of the President, online at http://www.epa.gov/
[FR Doc. 2016–04597 Filed 3–1–16; 8:45 am] Eisenhower Executive Office Building, regulation-biotechnology-under-tsca-
BILLING CODE 6560–50–P
1650 Pennsylvania Ave. Washington, and-fifra/modernizing-regulatory-
DC 20504, 202–456–4444, online: system-biotechnology-products.
https://www.whitehouse.gov/webform/
Those registered will receive detailed
ENVIRONMENTAL PROTECTION contact-emerging-technologies-
interagency-policy-coordinating- instructions with their confirmations
AGENCY that explain how to access the meeting
committee-national-science-and.
[FDA–2015–N–3403; FRL–9943–08] via webinar or in person.
SUPPLEMENTARY INFORMATION:
Modernizing the Regulatory System for I. Background III. Meeting Materials, Transcripts and
Biotechnology Products; Notice of Recorded Video
Under the auspices of the National
Second Public Meeting
Science and Technology Council, EPA, Any additional information and data
AGENCY: Environmental Protection FDA, USDA and OSTP (collectively submitted voluntarily to us will become
Agency (EPA). referred to as ‘‘we’’ in this Federal part of the administrative record for this
ACTION: Notice. Register document), held a public activity and will be accessible to the
meeting on October 30, 2015, to discuss public in the docket [FDA–2015–N–
SUMMARY: Under the auspices of the the Executive Office of the President 3403] at http://www.regulations.gov.
National Science and Technology (EOP) memorandum entitled, The transcript of the proceedings from
Council, EPA, along with the Office of ‘‘Modernizing the Regulatory System for the public meeting will become part of
Science and Technology Policy (OSTP), Biotechnology Products,’’ that was the administrative record for this
the Food and Drug Administration issued in July 2015. The purpose of the
(FDA), and the United States activity and will also be included in the
October 2015 meeting was to inform the docket. Please be advised that as soon
Department of Agriculture (USDA) are public about the activities described in
holding a second public meeting related as a transcript is available, it will be
the July 2015 memorandum; invite oral
to the memorandum entitled, accessible in the docket at http://
comments from interested parties; and
‘‘Modernizing the Regulatory System for provide information about how to www.regulations.gov.
Biotechnology Products,’’ issued by the submit written comments, data, or other Transcripts and meeting materials
Executive Office of the President (EOP) information to the docket. The October may also be viewed at the Division of
in July 2015. The purpose of the second meeting was the first of three public Dockets Management (HFA–305), Food
public meeting is to illustrate current engagement sessions on this topic. and Drug Administration, 5630 Fishers
federal roles and responsibilities On February 1, 2016, we announced Lane, Rm. 1061, Rockville, MD 20852. A
regarding biotechnology products. The the dates and locations for the second transcript will be available in either
docket, FDA–2015–N–3403, established and third public engagement sessions: hardcopy or on CD–ROM, after
by FDA prior to the first public meeting (1) https://wcms.epa.gov/pesticides/ submission of a Freedom of Information
will continue to be used for this save-date-march-9-30-2016-public- request. Written requests are to be sent
interagency effort.
mstockstill on DSK4VPTVN1PROD with NOTICES

meetings-updating-coordinated- to the FDA Division of Freedom of
DATES: The meeting will be held on framework-regulation; (2) http:// Information, 5630 Fishers Lane, Rm.
March 9, 2016, from 9:30 a.m. to 1:00 www.fda.gov/NewsEvents/ 1035, Rockville, MD 20857.
p.m. MeetingsConferencesWorkshops/ Additionally, we will live webcast and
To request accommodation of a ucm463783.htm; and (3) https://
record the public meeting. Once the
disability, please immediately contact www.aphis.usda.gov/aphis/ourfocus/
recorded video is available, it will be
the person listed under FOR FURTHER biotechnology/sa_stakeholder_
accessible on EPA’s YouTube Channel.
INFORMATON CONTACT to give EPA as meetings/cf_meeting.

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Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices 10859

Dated: February 24, 2016. Pennsylvania Ave. NW., Washington, contaminant. For funding purposes,
Mark A. Hartman, DC 20460; telephone number: (202) EPA uses the term ‘‘brownfields
Acting Director, Biopesticides and Pollution 566–1702; email address: gorini.kelly@ property(ies)’’ synonymously with the
Prevention Division, Office of Pesticide epa.gov. term ‘‘brownfields sites.’’ The
Programs. Brownfields Amendments authorize
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–04583 Filed 3–1–16; 8:45 am] Supporting documents which explain in EPA to award several types of
BILLING CODE 6560–50–P detail the information that the EPA will cooperative agreements to eligible
be collecting are available in the public entities on a competitive basis.
docket for this ICR. The docket can be Under subtitle A of the Small
ENVIRONMENTAL PROTECTION viewed online at www.regulations.gov Business Liability Relief and
AGENCY or in person at the EPA Docket Center, Brownfields Revitalization Act, states,
[EPAHQ–SFUND–2012–0104; FRL–9943– WJC West, Room 3334, 1301 tribes, local governments, and other
10–OLEM] Constitution Ave. NW., Washington, eligible entities can receive assessment
DC. The telephone number for the cooperative agreements to inventory,
Proposed Information Collection Docket Center is 202–566–1744. For characterize, assess, and conduct
Request; Comment Request; additional information about EPA’s planning and community involvement
Brownfields Program— public docket, visit http://www.epa.gov/ related to brownfields properties;
Accomplishment Reporting (Renewal) dockets. cleanup cooperative agreements to carry
Pursuant to section 3506(c)(2)(A) of out cleanup activities at brownfields
AGENCY: Environmental Protection properties; cooperative agreements to
Agency (EPA). the PRA, EPA is soliciting comments
and information to enable it to: (i) capitalize revolving loan funds and
ACTION: Notice. provide subgrants for cleanup activities;
Evaluate whether the proposed
collection of information is necessary area-wide planning cooperative
SUMMARY: The Environmental Protection
for the proper performance of the agreements to develop revitalization
Agency is planning to submit an
functions of the Agency, including plans for brownfields; and
information collection request (ICR),
whether the information will have environmental workforce and
‘‘Brownfields Program—
practical utility; (ii) evaluate the development job training and placement
Accomplishment Reporting (Renewal)’’
accuracy of the Agency’s estimate of the programs. Under subtitle C of the Small
(EPA ICR No. 2104.06, OMB Control No.
burden of the proposed collection of Business Liability Relief and
2050–0192) to the Office of Management
information, including the validity of Brownfields Revitalization Act, states
and Budget (OMB) for review and
the methodology and assumptions used; and tribes can receive cooperative
approval in accordance with the
(iii) enhance the quality, utility, and agreements to establish and enhance
Paperwork Reduction Act (44 U.S.C.
clarity of the information to be their response programs through the
3501 et seq.). Before doing so, EPA is
collected; and (iv) minimize the burden four elements and meet the public
soliciting public comments on specific
of the collection of information on those record requirements under the statute.
aspects of the proposed information
who are to respond, including through Cooperative agreement recipients
collection as described below. This is a
the use of appropriate automated (‘‘recipients’’) have general reporting
proposed extension of the ICR, which is
electronic, mechanical, or other and record keeping requirements as a
currently approved through May 31,
technological collection techniques or condition of their cooperative agreement
2016. An Agency may not conduct or
other forms of information technology, that result in burden. A portion of this
sponsor and a person is not required to
e.g., permitting electronic submission of reporting and record keeping burden is
respond to a collection of information
responses. EPA will consider the authorized under 2 CFR part 1500 and
unless it displays a currently valid OMB
comments received and amend the ICR identified in the EPA’s general grants
control number.
as appropriate. The final ICR package ICR (OMB Control Number 2030–0020).
DATES: Comments must be submitted on EPA requires Brownfields program
will then be submitted to OMB for
or before May 2, 2016. recipients to maintain and report
review and approval. At that time, EPA
ADDRESSES: Submit your comments, will issue another Federal Register additional information to EPA on the
referencing Docket ID No. EPA–HQ– notice to announce the submission of uses and accomplishments associated
SFUND–2012–0104 online using the ICR to OMB and the opportunity to with funded brownfields activities. EPA
www.regulations.gov (our preferred submit additional comments to OMB. uses several forms to assist recipients in
method) or by mail to: EPA Docket Abstract: The Small Business Liability reporting the information and to ensure
Center, Environmental Protection Relief and Brownfields Revitalization consistency of the information
Agency, Mail Code 28221T, 1200 Act (Pub. L. 107–118) (‘‘the Brownfields collected. EPA uses this information to
Pennsylvania Ave. NW., Washington, Amendments’’) was signed into law on meet Federal stewardship
DC 20460. January 11, 2002. The Act amends the responsibilities to manage and track
EPA’s policy is that all comments Comprehensive Environmental how program funds are being spent, to
received will be included in the public Response, Compensation, and Liability evaluate the performance of the
docket without change including any Act (CERCLA), as amended, and Brownfields Cleanup and Land
personal information provided, unless authorizes EPA to award cooperative Revitalization Program, to meet the
the comment includes profanity, threats, agreements to states, tribes, local Agency’s reporting requirements under
information claimed to be Confidential the Government Performance Results
mstockstill on DSK4VPTVN1PROD with NOTICES

governments, and other eligible entities
Business Information (CBI) or other to assess and clean up brownfield sites. Act, and to report to Congress and other
information whose disclosure is Under the Brownfields Amendments, a program stakeholders on the status and
restricted by statute. brownfields site means real property, accomplishments of the program.
FOR FURTHER INFORMATION CONTACT: the expansion, redevelopment, or reuse Form numbers: EPA ICR No. 2104.06,
Kelly Gorini, Office of Brownfields and of which may be complicated by the OMB Control No. 2050–0192.
Land Revitalization, (5105T), presence or potential presence of a Respondents/affected entities: State/
Environmental Protection Agency, 1200 hazardous substance, pollutant, or local/tribal governments; Non-Profits.

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Document Created: 2018-02-02 15:04:05
Document Modified: 2018-02-02 15:04:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on March 9, 2016, from 9:30 a.m. to 1:00 p.m.
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-
FR Citation		81 FR 10858