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
44626 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 

Dated: September 19, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20375 Filed 9–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2015–M–4474, FDA– 

2016–M–1915, FDA–2016–M–1837, FDA– 

2016–M–1916, FDA–2016–M–1914, FDA– 

2016–M–1917, FDA–2016–M–2182, FDA– 

2016–M–2183, FDA–2016–M–2184, FDA– 

2016–M–2185, FDA–2016–M–2332, FDA– 

2016–M–2334, FDA–2016–M–2333, FDA– 

2016–M–2485, FDA–2016–M–2498, FDA– 

2016–M–2499, FDA–2016–M–2500, FDA– 

2016–M–2649, FDA–2016–M–2650, FDA– 

2016–M–2651, FDA–2016–M–2735, FDA– 

2016–M–2974, FDA–2016–M–2971, FDA– 

2016–M–1972, FDA–2016–M–2973, FDA– 

2016–M–2975, FDA–2016–M–3430, FDA– 

2016–M–3431, FDA–2016–M–3913, FDA– 

2016–M–3653, FDA–2016–M–3914, FDA– 

2016–M–3915, FDA–2016–M–4046, FDA– 

2016–M–4344, FDA–2016–M–4458, FDA– 

2016–M–4459, FDA–2016–M–4483, FDA– 

2016–M–4657, FDA–2016–M–4530, FDA– 

2016–M–4653, FDA–2017–M–0180, FDA– 

2017–M–0181, FDA–2017–M–0229, FDA– 

2017–M–0560, FDA–2017–M–0831, FDA– 

2017–M–0661, FDA–2017–M–0971, FDA– 

2017–M–2652, FDA–2017–M–1121, FDA– 

2017–M–1122, FDA–2017–M–1228, FDA– 

2017–M–1845, FDA–2017–M–1227, FDA– 

2017–M–1713, FDA–2017–M–1714, FDA– 

2017–M–1950, FDA–2017–M–2594, FDA– 

2017–M–2766, FDA–2017–M–2767, FDA– 

2017–M–2768, FDA–2017–M–3103, FDA– 

2017–M–3200, FDA–2017–M–3430, FDA– 

2017–M–3579, FDA–2017–M–3580, FDA– 

2017–M–3778, FDA–2017–M–3839, FDA– 

2017–M–3928, FDA–2017–M–3982, FDA– 

2017–M–3990, and FDA–2017–M–3983] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Dockets Management Staff. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2015–M–4474, FDA–2016–M–1915, 

FDA–2016–M–1837, FDA–2016–M– 

1916, FDA–2016–M–1914, FDA–2016– 

M–1917, FDA–2016–M–2182, FDA– 

2016–M–2183, FDA–2016–M–2184, 

FDA–2016–M–2185, FDA–2016–M– 

2332, FDA–2016–M–2334, FDA–2016– 

M–2333, FDA–2016–M–2485, FDA– 

2016–M–2498, FDA–2016–M–2499, 

FDA–2016–M–2500, FDA–2016–M– 

2649, FDA–2016–M–2650, FDA–2016– 

M–2651, FDA–2016–M–2735, FDA– 

2016–M–2974, FDA–2016–M–2971, 

FDA–2016–M–1972, FDA–2016–M– 

2973, FDA–2016–M–2975, FDA–2016– 

M–3430, FDA–2016–M–3431, FDA– 

2016–M–3913, FDA–2016–M–3653, 

FDA–2016–M–3914, FDA–2016–M– 

3915, FDA–2016–M–4046, FDA–2016– 

M–4344, FDA–2016–M–4458, FDA– 

2016–M–4459, FDA–2016–M–4483, 

FDA–2016–M–4657, FDA–2016–M– 

4530, FDA–2016–M–4653, FDA–2017– 

M–0180, FDA–2017–M–0181, FDA– 

2017–M–0229, FDA–2017–M–0560, 

FDA–2017–M–0831, FDA–2017–M– 

0661, FDA–2017–M–0971, FDA–2017– 

M–2652, FDA–2017–M–1121, FDA– 

2017–M–1122, FDA–2017–M–1228, 

FDA–2017–M–1845, FDA–2017–M– 

1227, FDA–2017–M–1713, FDA–2017– 

M–1714, FDA–2017–M–1950, FDA– 

2017–M–2594, FDA–2017–M–2766, 

FDA–2017–M–2767, FDA–2017–M– 

2768, FDA–2017–M–3103, FDA–2017– 

M–3200, FDA–2017–M–3430, FDA– 

2017–M–3579, FDA–2017–M–3580, 

FDA–2017–M–3778, FDA–2017–M– 

3839, FDA–2017–M–3928, FDA–2017– 

M–3982, FDA–2017–M–3990, and FDA– 

2017–M–3983 for ‘‘Medical Devices; 

Availability of Safety and Effectiveness 

Summaries for Premarket Approval 

Applications.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 


asabaliauskas on DSKBBXCHB2PROD with NOTICES