44624 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 

4. Use of Funds 

An applicant that receives an award 

under this announcement is expected to 

manage assistance agreement funds 

efficiently and effectively, and make 

sufficient progress towards completing 

the project activities described in the 

work-plan in a timely manner. The 

assistance agreement will include terms 

and conditions related to implementing 

this requirement. 

REGIONAL STATE AND TRIBAL BROWNFIELDS CONTACTS

Region State Tribal 

1. CT, ME, MA, 

NH, RI, VT.

James Byrne, 5 Post Office Square, Suite 100 (OSRR07–2), 

Boston, MA 02109–3912, Phone (617) 918–1389 Fax (617) 

918–1294.

AmyJean McKeown, 5 Post Office Square, Suite 100 

(OSRR07–2), Boston, MA 02109–3912, Phone (617) 918– 

1248 Fax (617) 918–1294. 

2. NJ, NY, PR, 

VI.

John Struble, 290 Broadway, 18th Floor, New York, NY 

10007–1866, Phone (212) 637–4291 Fax (212) 637–3083.

Phillip Clappin, 290 Broadway, 18th Floor, New York, NY 

10007–1866, Phone (212) 637–4431 Fax (212) 637–3083. 

3. DE, DC, MD, 

PA, VA, WV.

Michael Taurino, 1650 Arch Street (3HS51), Philadelphia, PA 

19103, Phone (215) 814–3371 Fax (215) 814–3274.

4. AL, FL, GA, 

KY, MS, NC, 

SC, TN.

Cindy Nolan, 61 Forsyth Street SW., 10th Fl (9T25), Atlanta, 

GA 30303–8960, Phone (404) 562–8425 Fax (404) 562– 

8788.

Olga Perry, 61 Forsyth Street SW., 10th Fl (9T25), Atlanta, 

GA 30303–8960, Phone (404) 562–8534 Fax (404) 562– 

8788. 

5. IL, IN, MI, 

MN, OH, WI.

Jan Pels, 77 West Jackson Boulevard (SB–5J), Chicago, IL 

60604–3507, Phone (312) 886–3009 Fax (312) 692–2161.

Kirstin Kuenzi, 77 West Jackson Boulevard (SB–5J), Chicago, IL 60604–3507, Phone (312) 886–6015 Fax (312) 

697–2075. 

6. AR, LA, NM, 

OK, TX.

Amber Howard, 1445 Ross Avenue, Suite 1200 (6SF), Dallas, TX 75202–2733, Phone (214) 665–3172 Fax (214) 

665–6660.

Freda Hardaway, 1445 Ross Avenue, Suite 1200 (6SF), Dallas, TX 75202–2733, Phone (214) 665–8342 Fax (214) 

665–6660. 

7. IA, KS, MO, 

NE.

Susan Klein, 11201 Renner Boulevard (SUPRSTAR), 

Lenexa, KS 66219, Phone (913) 551–7786 Fax (913) 551– 

9786.

Jennifer Morris, 11201 Renner Boulevard (SUPRSTAR), 

Lenexa, KS 66219, Phone (913) 551–7341 Fax (913) 551– 

9341. 

8. CO, MT, ND, 

SD, UT, WY.

Christina Wilson, 1595 Wynkoop Street (EPR–AR), Denver, 

CO 80202–1129, Phone (303) 312–6706 Fax (303) 312– 

6065.

Melisa Devincenzi, 1595 Wynkoop Street (EPR–AR), Denver, 

CO 80202–1129, Phone (303) 312–6377 Fax (303) 312– 

6962. 

9. AZ, CA, HI, 

NV, AS, GU, 

MP.

Eugenia Chow, 75 Hawthorne St. (SFD–6–1), San Francisco, 

CA 94105, Phone (415) 972–3160 Fax (415) 947–3520.

Jose Garcia, Jr., 600 Wilshire Blvd, Suite 1460, Los Angeles, 

CA 90017, Phone (213) 244–1811 Fax (213) 244–1850. 

10. AK, ID, OR, 

WA.

Mary K. Goolie, 222 West 7th Avenue #19 (AOO), Anchorage, AK 99513 Phone (907) 271–3414 Fax (907) 271– 

3424.

Mary K. Goolie, 222 West 7th Avenue #19 (AOO), Anchorage, AK 99513 Phone (907) 271–3414 Fax (907) 271– 

3424. 

XI. Statutory and Executive Order 

Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

is therefore not subject to review under 

Executive Orders 12866 and 13563 (76 

FR 3821, January 21, 2011). Because this 

action is not subject to notice and 

comment requirements under the 

Administrative Procedures Act or any 

other statute, it is not subject to the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) or Sections 202 and 205 of the 

Unfunded Mandates Reform Act of 1999 

(UMRA) (Pub. L. 104–4). In addition, 

this action does not significantly or 

uniquely affect small governments. This 

action does not create new binding legal 

requirements that substantially and 

directly affect Tribes under Executive 

Order 13175 (63 FR 67249, November 9, 

2000). This action does not have 

significant Federalism implications 

under Executive Order 13132 (64 FR 

43255, August 10, 1999). Because this 

action has been exempted from review 

under Executive Order 12866, this 

action is not subject to Executive Order 

13211, entitled Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). This action does not 

involve technical standards; thus, the 

requirements of Section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. The 

Congressional Review Act, 5 U.S.C. 801 

et seq., generally provides that before 

certain actions may take effect, the 

agency promulgating the action must 

submit a report, which includes a copy 

of the action, to each House of the 

Congress and to the Comptroller General 

of the United States. Because this final 

action does not contain legally binding 

requirements, it is not subject to the 

Congressional Review Act. 

Dated: September 1, 2017. 

David R. Lloyd, 

Director, Office of Brownfields and Land 

Revitalization, Office of Land and Emergency 

Management. 

[FR Doc. 2017–20436 Filed 9–22–17; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The applications will also be 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44625 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than October 20, 

2017. 

A. Federal Reserve Bank of 

Minneapolis (Brendan S. Murrin, 

Assistant Vice President) 90 Hennepin 

Avenue, Minneapolis, Minnesota 

55480–0291: 

1. Full Service Insurance Agency, Inc., 

Buxton, North Dakota; to acquire 100 

percent of the voting shares of First and 

Farmers Bank Holding Company and 

thereby indirectly acquire shares of The 

First and Farmers Bank, both of 

Portland, North Dakota. 

Board of Governors of the Federal Reserve 

System, September 20, 2017. 

Yao-Chin Chao, 

Assistant Secretary of the Board. 

[FR Doc. 2017–20424 Filed 9–22–17; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4952] 

Food and Drug Administration Clinical 

Trial Requirements, Regulations, 

Compliance, and Good Clinical 

Practice; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

educational conference co-sponsored 

with the Society of Clinical Research 

Associates (SOCRA). The public 

workshop on FDA’s clinical trial 

requirements is designed to aid the 

clinical research professional’s 

understanding of the mission and 

authority of FDA and to facilitate 

interaction with FDA representatives. 

The program will focus on the 

relationships among FDA and clinical 

trial staff, investigators, and 

institutional review boards (IRBs). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices, 

and biologics; and inspections of 

clinical investigators, IRBs, and research 

sponsors. 

DATES: The public workshop will be 

held on November 15 and 16, 2017, 

from 8 a.m. to 5 p.m. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at the Wyndham Lake Buena 

Vista Resort, 1850 Hotel Plaza Blvd., 

Lake Buena Vista, FL 32830, 407–828– 

4444. 

FOR FURTHER INFORMATION CONTACT: Kim 

Prenter, Food and Drug Administration, 

15100 NW. 67th Ave., Suite 400, Miami 

Lakes, FL 33014, 305–816–1474, Fax: 

305–816–1536; or Society of Clinical 

Research Associates (SOCRA), 530 West 

Butler Ave., Suite 109, Chalfont, PA 

18914, 800–762–7292, Fax 215–822– 

8633, email: SoCRAmail@aol.com, Web 

site: https://www.socra.org. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The public 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

clinical investigations, informed 

consent, and inspections of clinical 

investigators and IRBs. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

Modernization Act of 1997 (21 U.S.C. 

393), which includes working closely 

with stakeholders and maximizing the 

availability and clarity of information to 

stakeholders and the public. The 

workshop also is consistent with the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

as outreach activities by Government 

agencies to small businesses. 

II. Topics for Discussion 

Topics for discussion include the 

following: (1) What FDA Expects in a 

Pharmaceutical Clinical Trial; (2) 

Adverse Event Reporting—Science, 

Regulation, Error and Safety; (3) Part 11 

Compliance—Electronic Signatures; (4) 

Informed Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

with FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working with FDA’s 

Center for Biologics Evaluation and 

Research; and (12) The Inspection Is 

Over—What Happens Next? Possible 

FDA Compliance Actions. 

III. Participating in the Public 

Workshop 

Registration: Attendees are 

responsible for their own 

accommodations. Please mention 

SOCRA to receive the hotel room rate of 

$129 plus applicable taxes (available 

until October 16, 2017, or until the 

SOCRA room block is filled). For 

additional registration and meeting 

information, visit https://

www.socra.org/ or https://

www.socra.org/conferences-andeducation/live-conferences/fda-clinicaltrial-requirements-regulationscompliance-and-gcp-conference/ 

register/. 

Registrations fees are as follows: $575 

for SOCRA members, $650 for nonmembers (includes membership), $450 

for Federal Government members, $525 

for Federal Government non-members, 

and fee waived for FDA Employees. 

The registration fee covers expenses 

including refreshments, lunch, 

materials, and speaker expenses. 

Registration for the conference is open 

through November 14, 2017. 

If you need special accommodations 

due to a disability, please contact Kim 

Prenter (see FOR FURTHER INFORMATION

CONTACT) at least 10 days in advance. 

Other Issues for Consideration: 

Extended periods of question and 

answer and discussion have been 

included in the program schedule. This 

program offers 13.3 hours of Continuing 

Medical Education (CME) and 

Continuing Nursing Education (CNE) 

credit. CME for Physicians: The Society 

of Clinical Research Associates is 

accredited by the Accreditation Council 

for Continuing Medical Education to 

provide continuing medical education 

for physicians. CNE for Nurses: The 

Society of Clinical Research Associates 

is accredited as a provider of continuing 

nursing education by the American 

Nurses Credentialing Center’s 

Commission on Accreditation. ANCC/ 

PSNA Provider Reference Number: 205– 

3–A–09. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES