Federal Register / Vol. 82, No. 172 / Thursday, September 7, 2017 / Notices 42349 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisitions of Shares of a Bank or 

Bank Holding Company 

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire shares of a bank 

or bank holding company. The factors 

that are considered in acting on the 

notices are set forth in paragraph 7 of 

the Act (12 U.S.C. 1817(j)(7)). 

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the offices of the Board of Governors. 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than 

September 21, 2017. 

A. Federal Reserve Bank of Atlanta 

(Kathryn Haney, Director of 

Applications) 1000 Peachtree Street NE., 

Atlanta, Georgia 30309. Comments can 

also be sent electronically to 

Applications.Comments@atl.frb.org: 

1. Joseph Huntley Johnson III, 

Birmingham, Alabama, Lawrence Harris 

Johnson, Birmingham, Alabama, and 

James Hughes Johnson, Tuscaloosa, 

Alabama; to become part of the Johnson 

Family Control Group and thereby 

retain voting shares of SNB Holdings, 

Inc., Slocomb, Alabama, and its 

subsidiary Friend Bank, Slocomb, 

Alabama. 

Board of Governors of the Federal Reserve 

System, September 1, 2017. 

Ann Misback, 

Secretary of the Board. 

[FR Doc. 2017–19006 Filed 9–6–17; 8:45 am] 

BILLING CODE P 

FEDERAL RESERVE SYSTEM 

Notice of Proposals To Engage in or 

To Acquire Companies Engaged in 

Permissible Nonbanking Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y, (12 

CFR part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

inspection at the offices of the Board of 

Governors. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than September 21, 2017. 

A. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Stockmens Limited Partnership, 

Rapid City, South Dakota; to engage in 

investment advisory services, by 

acquiring a 24 percent interest in Rock 

Creek Advisors, LLC, Rapid City, South 

Dakota, and thereby engage in 

investment advisory services pursuant 

to section 225.28(b)(6) of Regulation Y. 

Board of Governors of the Federal Reserve 

System, September 1, 2017. 

Ann Misback, 

Secretary of the Board. 

[FR Doc. 2017–19007 Filed 9–6–17; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4386] 

Deviation Reporting for Human Cells, 

Tissues, and Cellular and TissueBased Products; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

document entitled ‘‘Deviation Reporting 

for Human Cells, Tissues, and Cellular 

and Tissue-Based Products Regulated 

Solely Under Section 361 of the Public 

Health Service Act and 21 CFR part 

1271; Guidance for Industry.’’ The 

guidance document provides 

establishments that manufacture nonreproductive human cells, tissues, and 

cellular and tissue-based products 

(HCT/Ps), regulated solely under the 

Public Health Service Act (PHS Act) and 

under FDA regulations, with 

recommendations and relevant 

examples for complying with the 

requirements to investigate and report 

HCT/P deviations. The guidance 

announced in this notice finalizes the 

draft guidance of the same title dated 

December 2015. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

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 No. FDA– 

2015–D–4386 for ‘‘Deviation Reporting 

for Human Cells, Tissues, and Cellular 

and Tissue-Based Products Regulated 

Solely Under Section 361 of the Public 

Health Service Act and 21 CFR part 

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42350 Federal Register / Vol. 82, No. 172 / Thursday, September 7, 2017 / Notices 

1271; Guidance for Industry.’’ 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 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

Submit written requests for single 

copies of the 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 guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, 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 document entitled ‘‘Deviation 

Reporting for Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

Regulated Solely Under Section 361 of 

the Public Health Service Act and 21 

CFR part 1271; Guidance for Industry.’’ 

The document provides establishments 

that manufacture HCT/Ps, regulated 

solely under section 361 of the PHS Act 

and the regulations under 21 CFR part 

1271, with recommendations and 

relevant examples for complying with 

the requirements under 21 CFR 

1271.350(b) to investigate and report 

HCT/P deviations. The examples 

provided in the guidance are intended 

to illustrate those HCT/P deviations that 

have been most frequently reported to 

FDA, CBER. 

The guidance does not apply to 

reproductive HCT/Ps or to HCT/Ps 

regulated under 21 CFR part 1270 and 

recovered before May 25, 2005. The 

guidance does not apply to healthcare 

professionals who implant, transplant, 

infuse, or transfer HCT/Ps into 

recipients. The guidance also does not 

apply to HCT/Ps that are regulated as 

drugs, devices, and/or biological 

products under section 351 of the PHS 

Act and/or the Federal Food, Drug, and 

Cosmetic Act, nor does it apply to 

investigational HCT/Ps subject to an 

investigational new drug application or 

an investigational device exemption. 

In the Federal Register of December 

24, 2015 (80 FR 80364), FDA announced 

the availability of the draft guidance of 

the same title dated December 2015. 

FDA received a few comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. A summary of changes 

includes additional examples and 

editorial changes to improve clarity. The 

guidance announced in this notice 

finalizes the draft guidance dated 

December 2015. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Deviation 

Reporting for Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

Regulated Solely Under section 361 of 

the Public Health Service Act and 21 

CFR part 1271.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This 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 

21 CFR part 1271 have been approved 

under OMB control number 0910–0543. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

https://www.fda.gov/

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: August 23, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18737 Filed 9–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Listing of Members of the 

National Institutes of Health’s Senior 

Executive Service 2017 Performance 

Review Board (PRB) 

SUMMARY: The National Institutes of 

Health (NIH) announces the persons 

who will serve on the National 

Institutes of Health’s Senior Executive 

Service 2017 Performance Review 

Board. 

FOR FURTHER INFORMATION CONTACT: For 

further information about the NIH 

Performance Review Board, contact the 

Office of Human Resources, Division of 

Senior and Scientific Executive 

Management, National Institutes of 

Health, Building 2, Room 5E18, 

Bethesda, Maryland 20892, telephone 

301–402–7999 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: This 

action is being taken in accordance with 

Title 5, U.S.C., Section 4314(c)(4), 

which requires that members of 

performance review boards be 

appointed in a manner to ensure 

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