Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41415 

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 14, 2017. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. James C. Volkert, individually and 

as trustee of the James C. Volkert 

Revocable Living Trust, the James C. 

Volkert Revocable Living Trust, Susan 

A. Volkert, Jacquelyn Volkert, and 

Michael Volkert, all of Montgomery, 

Illinois; as a group acting in concert to 

retain voting shares of Montgomery 

Bancshares, Inc., and thereby indirectly 

retain voting shares of Bank of 

Montgomery, both in Montgomery, 

Illinois. 

B. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Jeff Schumacher, Lincoln, 

Nebraska; to acquire voting shares of 

North Central Bancorp, Inc., and thereby 

indirectly acquire BankFirst, both in 

Norfolk, Nebraska. 

Board of Governors of the Federal Reserve 

System, August 25, 2017. 

Yao-Chin Chao, 

Assistant Secretary of the Board. 

[FR Doc. 2017–18445 Filed 8–30–17; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–17–0607] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) 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; (b) 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; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) 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; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

The National Violent Death Reporting 

System (NVDRS)(OMB Control Number 

0920–0607, expiration 10/31/2017)— 

Revision—National Center for Injury 

Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Violence is a public health problem. 

The World Health Organization has 

estimated that 804,000 suicides and 

475,000 homicides occurred in the year 

2012 worldwide. Violence in the United 

States is a particular problem for the 

young; suicide and homicide were 

among the top 4 leading causes of death 

for Americans 10–34 and 1–34 years of 

age in 2015, respectively. In 2002 

Congress approved the first 

appropriation to start the National 

Violent Death Reporting System 

(NVDRS). NVDRS is coordinated and 

funded at the federal level but is 

dependent on separate data collection 

efforts managed by the state health 

department (or their bona fide agent) in 

each state. 

NVDRS is an ongoing surveillance 

system that captures annual violent 

death counts and circumstances that 

precipitate each violent incident. Data 

on violent death is defined as a death 

resulting from the intentional use of 

physical force or power (e.g., threats or 

intimidation) against oneself, another 

person, or against a group or 

community. CDC aggregates deidentified data from each state into one 

large national database that is analyzed 

and released in annual reports and 

publications. Descriptive analyses such 

as frequencies and rates are employed. 

A restricted access database is available 

for researchers to request access to 

NVDRS data for analysis and a webbased query system is open for public 

use that allows for electronic querying 

of data. NVDRS generates public health 

surveillance information at the national, 

state, and local levels that is more 

detailed, useful, and timely. 

Government, state and local 

communities have used NVDRS data to 

develop and evaluate prevention 

programs and strategies. NVDRS is also 

used to understand magnitude, trends, 

and characteristics of violent death and 

what factors protect people or put them 

at risk for experiencing violence. 

This is a revision request for an 

additional three years to continue data 

collection efforts of the currently 

approved information collection project. 

The purpose of this revision is to (1) 

implement updates to the web-based 

system to improve performance, 

functionality, and accessibility; (2) add 

new data elements to the system and 

minimal revisions to the NVDRS coding 

manual; (3) modify burden hours to 

account for the increase in violent 

deaths in the U.S. since 2003; and (4) to 

decrease the number of funded 

reporting state health departments from 

58 to 56. 

The estimated annual burden hours 

are 34,250. There are no costs to 

respondents. 


sradovich on DSK3GMQ082PROD with NOTICES
41416 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Total number 

of responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Public Agencies .............................................. Retrieving and refile records .......................... 56 1,223 30/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–18512 Filed 8–30–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4565] 

Electronic Study Data Submission; 

Data Standards; Support for Version 

Update of the Medical Dictionary for 

Regulatory Activities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing support for the most current 

version of Medical Dictionary for 

Regulatory Activities (MedDRA), end of 

support for earlier versions of MedDRA, 

and an update to the FDA Data 

Standards Catalog (Catalog) for study 

data provided in new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), and investigational 

new drug applications (INDs) to the 

Center for Biologics Evaluation and 

Research (CBER) and the Center for 

Drug Evaluation and Research (CDER). 

DATES: Submit either electronic or 

written comments on this document at 

any time. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submission 

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– 

2017–N–4565 for ‘‘Electronic Study 

Data Submission; Data Standards; 

Support for Version Update of the 

Medical Dictionary for Regulatory 

Activities.’’ 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. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, 

cderdatastandards@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7268, 

Silver Spring, MD 20993–0002, 240– 

402–7911, stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 17, 2014, FDA published final 

guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Standardized Study Data’’ 

(eStudy Data) posted on FDA’s Study 

Data Standards Resources Web page at 

https://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The eStudy Data guidance 


sradovich on DSK3GMQ082PROD with NOTICES