tkelley on DSK3SPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Notices 

that the submission is written by an 

individual, for example, the comment is 

identified with the category ‘‘Individual 

Consumer’’ under the field entitled 

‘‘Category (Required),’’ on the ‘‘Your 

Information’’ page on http:// 

www.regulations.gov. For this docket, 

however, FDA will not be following this 

general practice. Instead, FDA will post 

on http://www.regulations.gov 

comments to this docket that have been 

submitted by individuals in their 

individual capacity. If you wish to 

submit any information under a claim of 

confidentiality, please refer to 21 CFR 

10.20. 

C. Information Identifying the Person 

Submitting the Comment 

Please note that your name, contact 

information, and other information 

identifying you will be posted on http:// 

www.regulations.gov if you include that 

information in the body of your 

comments. For electronic comments 

submitted to http:// 

www.regulations.gov, FDA will post the 

body of your comment on http:// 

www.regulations.gov along with your 

state/province and country (if 

provided), the name of your 

representative (if any), and the category 

identifying you (e.g., individual, 

consumer, academic, industry). For 

written submissions submitted to the 

Division of Dockets Management, FDA 

will post the body of your comments on 

http://www.regulations.gov, but you can 

put your name and/or contact 

information on a separate cover sheet 

and not in the body of your comments. 

Dated: August 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–19418 Filed 8–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1051] 

Modified Risk Tobacco Product 

Applications: Applications for 10 

Products Submitted by Swedish Match 

North America Inc.; Reopening of 

Comment Period; Correction 

AGENCY: Food and Drug Administration, 


HHS. 


ACTION: Notice; correction. 


SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of July 31, 2015 (80 FR 45661). 

The document reopened the period for 

public comment on modified risk 

tobacco product applications (MRTPAs) 

submitted by Swedish Match North 

America Inc. for 10 tobacco products 

and announced the availability for 

public comment of amendments to the 

MRTPAs. The document was published 

with an incorrect paragraph in the 

Comments section. This document 

corrects that error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy and Planning, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

3330, Silver Spring, MD 20993–0002, 

301–796–9115. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2015–18782, appearing in the Federal 

Register of Friday, July 31, 2015, the 

following correction is made: 

On page 45661, in the third column, 

the first paragraph of the Comments 

section is corrected to read: 

A. General Information About 

Submitting Comments 

Interested persons may submit either 

incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy, Planning, 

Legislation, and Analysis, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3330, 

Silver Spring, MD 20993–0002, 301– 

796–9115. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2015–18448, appearing on page 44973, 

in the Federal Register of Tuesday, July 

28, 2015, the following correction is 

made: 

On page 44973, in the first column, in 

the headings section of the document, 

‘‘[Docket No. FDA–2014–D–2537]’’ is 

corrected to read ‘‘FDA–2015–D–2537’’. 

Dated: August 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–19487 Filed 8–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

47493 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Designation of a Class of Employees 

for Addition to the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice of a 

decision to designate a class of 

employees from the Westinghouse 

Electric Corporation in Bloomfield, New 

Jersey, as an addition to the Special 

Exposure Cohort (SEC) under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

NIOSH, 1090 Tusculum Avenue, MS C– 

46, Cincinnati, OH 45226–1938, 

Telephone 1–877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

SUPPLEMENTARY INFORMATION: 

Authority: 42 U.S.C. 7384q(b). 42 U.S.C. 

7384l(14)(C). 

On July 31, 2015, as provided for 

under 42 U.S.C. 7384l(14)(C), the 

Secretary of HHS designated the 

following class of employees as an 

addition to the SEC: 

All Atomic Weapons Employees who 

worked at the facility owned by 

Westinghouse Electric Corp., in Bloomfield, 

New Jersey, during the period from February 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

B. Public Availability of Comments 

Received comments may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday, and will be posted to 

the docket at http:// 

www.regulations.gov. As a matter of 

Agency practice, FDA generally does 

not post comments submitted by 

individuals in their individual capacity 

on http://www.regulations.gov. This is 

determined by information indicating 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–2537] 

Request for Quality Metrics; Notice of 

Draft Guidance Availability and Public 

Meeting; Request for Comments; 

Correction 

AGENCY: Food and Drug Administration, 


HHS. 


ACTION: Notice; correction. 


SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of July 28, 2015 (80 FR 44973). 

The document published with an 
DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Notice of Service Delivery Area 

Designation for the Koi Nation of 

Northern California Formerly Known as 

the Lower Lake Rancheria 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This Notice advises the public 

that the Indian Health Service (IHS) 

proposes the geographic boundaries of 

the Service Delivery Area (SDA) for the 

reaffirmed Koi Nation of Northern 

California, formerly known as the Lower 

Lake Rancheria, California (Indian 

Entities Recognized and Eligible to 

Receive Services From the United States 

Bureau of Indian Affairs, 80 Federal 

Register 1942 Jan. 14, 2015). The Koi 

Nation’s Federal recognition was 

reaffirmed by the Assistant Secretary of 

Indian Affairs on December 29, 2000. 

The Koi Nation SDA is to be comprised 

of Lake and Sonoma Counties in the 

State of California. The counties listed 

are designated administratively as the 

SDA, to function as a Purchased/ 

Referred Care (PRC), formerly known as 

contract health services, SDA, for the 

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tkelley on DSK3SPTVN1PROD with NOTICES

47494 Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Notices 

1, 1958, through May 31, 1958, or during the 

period from June 1, 1959, through June 30, 

1959, for a number of work days aggregating 

at least 250 work days, occurring either 

solely under this employment, or in 

combination with work days within the 

parameters established for one or more other 

classes of employees included in the Special 

Exposure Cohort. 

This designation will become 

effective on August 27, 2015, unless 

Congress provides otherwise prior to the 

effective date. After this effective date, 

HHS will publish a notice in the 

Federal Register reporting the addition 

of this class to the SEC or the result of 

any provision by Congress regarding the 

decision by HHS to add the class to the 

SEC. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2015–19471 Filed 8–6–15; 8:45 am] 

BILLING CODE 4163–19–P 

purposes of operating a PRC program 

pursuant to the Indian SelfDetermination and Education 

Assistance Act (ISDEAA), Pub. L. 93– 

638. 

DATES: This notice is effective 30 days 

after date of publication in the Federal 

Register (FR). 

ADDRESSES: Comments may be mailed to 

Ms. Betty Gould, Regulations Officer, 

Indian Health Service, 801 Thompson 

Avenue, Suite 450, Rockville, Maryland 

20852. Comments will be made 

available for public inspection at this 

address from 8:30 a.m. to 5:00 p.m. 

Monday–Friday beginning 

approximately two weeks after 

publication of this notice. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Carl Harper, Director, Office of Resource 

Access and Partnerships, Indian Health 

Service, 801 Thompson Avenue, Suite 

360, Rockville, Maryland 20852. 

Telephone 301/443–2694 (This is not a 

free number). 

PLEMENTAL INFORMATION: The IHS 

ently provides services under 

ulations in effect on September 15, 

7 and IHS republished at 42 CFR 

 136, subparts A through C. Many of 

newly recognized/restored/ 

firmed Tribes do not have 

rvations and either Congress has 

slatively designated counties to 

e as SDAs or the Director, IHS, 

rcised reasonable administrative 

retion to designate SDAs to 

ctuate the intent of Congress for 

e Tribes. The Director, IHS, 

lished notice of the establishment of 

As in the June 21, 2007 FR Notice (72 

34262–01). The SDAs function as 

C SDAs for the purposes of operating 

RC program pursuant to the ISDEAA, 

. L. 93–638. Thus, the PRC SDA list 

orporates the SDAs that operate as 

C SDAs for newly recognized/ 

ored/reaffirmed Tribes. At 42 CFR 

 136 Subpart C, a PRC SDA is 

ned as the geographic area within 

ch PRC will be made available by 

IHS to members of an identified 

an community who reside in the 

. Residence within a PRC SDA by a 

son who is within the scope of the 

an health program, as set forth in 42 

R 136.12 creates no legal entitlement 

RC but only potential eligibility for 

services. Services needed but not 

available at an IHS/Tribal facility are 

provided under the PRC program 

depending on the availability of funds, 

the person’s relative medical priority, 

and the actual availability and 

accessibility of alternate resources in 

accordance with the regulations. 

As applicable to the Tribes, these 

regulations provide that, unless 

otherwise designated, a PRC SDA shall 

consist of a county which includes all 

or part of a reservation and any county 

or counties which have a common 

boundary with the reservation (42 CFR 

136.22(a)(6) (2014). On December 29, 

2000 the Assistant Secretary of Indian 

Affairs reaffirmed the Federal 

recognition of the Koi Nation (Tribe), 

formerly known as the Lower Lake 

Rancheria, and the government-togovernment relationship between the 

United States and the Tribe. The Koi 

Nation is located in Lake and Sonoma 

Counties in the State of California. After 

consultation with the Tribal governing 

body, the SDA for the Tribe was agreed 

upon. The purpose of this FR notice is 

to notify the public that the IHS now 

administratively designates Lake and 

Sonoma Counties as the Koi Nation’s 

SDA. 

Under 42 CFR 136.23 those otherwise 

eligible Indians who do not reside on a 

reservation but reside within a PRC SDA 

must be either members of the Tribe or 

maintain close economic and social ties 

with the Tribe. In this case, the Tribe 

estimated the eligible user population to 

be 72 enrolled Koi Nation members who 

are actively involved with the Tribe. 

The Koi Nation’s Tribal office is 

located in the city of Santa Rosa, 

Sonoma County, in the State of 

California. A significant number of the 

Koi Nation SDA eligible user population 

also resides in Lake County in the State 

of California. There are other Federally 

recognized Tribes in Lake and Sonoma 

Counties and both counties are 

currently part of other Tribes’ PRC SDA. 

The Koi Nation only seeks to provide 

health care services to its members who 

reside in Lake and Sonoma Counties. 

This notice does not contain reporting 

or recordkeeping requirements subject 

to prior approval by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1980. 

PURCHASED/REFERRED CARE SERVICE DELIVERY AREAS AND SERVICE DELIVERY AREAS 

Tribe/reservation County/state 

Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reserva- Pinal, AZ. 

tion, Arizona. 

Alabama-Coushatta Tribes of Texas ........................................................ Polk, TX.1 

Alaska ....................................................................................................... Entire State.2 

Arapahoe Tribe of the Wind River Reservation, Wyoming ...................... Hot Springs, WY, Fremont, WY, Sublette, WY.