Federal Register / Vol. 79, No. 158 / Friday, August 15, 2014 / Notices 48169 

All Atomic Weapons Employees who 

worked at the facility owned by Nuclear 

Metals, Inc. (or a subsequent owner) in West 

Concord, Massachusetts, during the period 

from January 1, 1980, through December 31, 

1990, 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 became effective on 

August 10, 2014. Therefore, beginning 

on August 10, 2014, members of this 

class of employees, defined as reported 

in this notice, became members of the 

SEC. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2014–19378 Filed 8–14–14; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

[CDC–2014–0013, Docket Number NIOSH– 

274] 

NIOSH Current Intelligence Bulletin: 

Promoting Health and Preventing Disease 

and Injury through Workplace Tobacco 

Policies 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of draft document for 

public comment. 

SUMMARY: The National Institute for 

Occupational Safety and Health of the 

Centers for Disease Control and 

Prevention announces the availability of 

a draft Current Intelligence Bulletin 

(CIB) entitled NIOSH Current 

Intelligence Bulletin: Promoting Health 

and Preventing Disease and Injury 

through Workplace Tobacco Policies for 

public comment. To view the notice and 

related materials, visit http://

www.regulations.gov and enter CDC– 

2014–0013 in the search field and click 

‘‘Search.’’ 

Public comment period: Comments 

must be received September 15, 2014. 

ADDRESSES: You may submit comments, 

identified by CDC–2014–0013 and 

Docket Number NIOSH–274, by either 

of the following two methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov Follow the 

instructions for submitting comments. 

• Mail: National Institute for 

Occupational Safety and Health, NIOSH 

Docket Office, 1090 Tusculum Avenue, 

MS C–34, Cincinnati, Ohio 45226–1998. 

Instructions: All information received 

in response to this notice must include 

the agency name and docket number 

[CDC–2014–0013; NIOSH–274]. All 

relevant comments received will be 

posted without change http://

www.regulations.gov, including any 

personal information provided. All 

electronic comments should be 

formatted as Microsoft Word. All 

information received in response to this 

notice will also be available for public 

examination and copying at the NIOSH 

Docket Office, 1150 Tusculum Avenue, 

Room 109, Cincinnati, OH 45226–1998. 

SUPPLEMENTARY INFORMATION: The 

purpose of the public review of the draft 

document is to help assure that the final 

version of the NIOSH Current 

Intelligence Bulletin meets current 

quality standards before it is 

disseminated. 

Overall Questions 

(1) Does the draft CIB provide useful 

information and recommendations? 

(2) Is it reasonably clear and 

comprehensible? 

(3) Does it include any technical 

errors or factual inaccuracies? 

(4) Are there any critical omissions? 

(5) Does it include any unnecessary 

information that should be deleted? 

(6) Are any of the conclusions 

inappropriate? 

(7) Are any of the recommendations 

inappropriate? 

Background: NIOSH has previously 

published two formal Current 

Intelligence Bulletins entirely devoted to 

the issue of tobacco use. The first—CIB 

31: Adverse Health Effects of Smoking 

and the Occupational Environment 

[DHEW (NIOSH) Publication Number 

79–122]—outlined several ways in 

which smoking interacts with other 

workplace exposures to increase risk of 

disease and injury among workers. That 

document recommended that smoking 

be curtailed in workplaces where those 

other hazards are present and that 

worker exposure to those other 

occupational hazards be controlled 

http://www.cdc.gov/niosh/docs/1970/

79122_31.html. The second—CIB 54: 

Environmental Tobacco Smoke in the 

Workplace; Lung Cancer and other 

Health Effects [DHHS (NIOSH) 

Publication No. 91–108]—focused on 

secondhand smoke in the workplace as 

a cause of cancer and cardiovascular 

disease. That document recommended 

eliminating tobacco smoking in the 

workplace as the best preventive 

approach http://www.cdc.gov/niosh/

docs/91–108/. 

NIOSH has prepared a current draft 

CIB: Promoting Health and Preventing 

Disease and Injury through Workplace 

Tobacco Policies for anticipated 

dissemination during the 50th 

anniversary year of the Surgeon 

General’s first report on the health 

consequences of smoking published in 

1964. The draft CIB reflects a ‘‘strategy 

integrating occupational safety and 

health protection with health promotion 

to prevent worker injury and illness and 

to advance health and well-being’’ [see 

http://www.cdc.gov/niosh/TWH/

totalhealth.html], embodied by NIOSH 

in a recently launched Total Worker 

HealthTM (TWHTM) Program. 

FOR FURTHER INFORMATION CONTACT: R.M. 

Castellan, NIOSH, Division of 

Respiratory Disease Studies, Mailstop 

H–2900, 1095 Willowdale Road, 

Morgantown, West Virginia 26505– 

2888. Phone: (304) 285–6117. 

Dated: August 7, 2014. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–19384 Filed 8–14–14; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–48] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 


emcdonald on DSK67QTVN1PROD with NOTICES
48170 Federal Register / Vol. 79, No. 158 / Friday, August 15, 2014 / Notices 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by September 15, 

2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–5806 or 

Email: OIRA_submission@omb.eop.gov . 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement of a previously 

approved collection; Title of 

Information Collection: Hospital 

Conditions of Participation and 

Supporting Regulations; Use: The 

information collection requirements 

described in this information collection 

request are needed to implement the 

Medicare and Medicaid conditions of 

participation (CoP) for 4,890 accredited 

and non-accredited hospitals and an 

additional 101 critical access hospitals 

(CAHs) that have distinct part 

psychiatric or rehabilitation units 

(DPUs). CAHs that have DPUs must 

comply with all of the hospital CoPs on 

these units. This package reflects the 

paperwork burden for a total of 4,991 

(that is, 4,890 hospitals and 101 CAHs 

which include 81 CAHs that have 

psychiatric DPUs and 20 CAHs that 

have rehabilitation DPUs). The 

information collection requirements for 

the remaining 1,183 CAHs have been 

reported in a separate package under 

CMS–10239. 

The CoPs and accompanying 

requirements specified in the 

supporting regulations are used by our 

surveyors as a basis for determining 

whether a hospital qualifies for a 

provider agreement under Medicare and 

Medicaid. CMS and the health care 

industry believe that the availability to 

the facility of the type of records and 

general content of records, which the 

supporting regulations specify, is 

standard medical practice and is 

necessary in order to ensure the wellbeing and safety of patients and 

professional treatment accountability. 

Subsequent to publication of the 60-day 

Federal Register notice (January 31, 

2014; 79 FR 5417), the burden has been 

recalculated. Form Number: CMS–R–48 

(OMB control number: 0938–0328); 

Frequency: Yearly; Affected Public: 

Private sector (business or other forprofits); Number of Respondents: 4,991; 

Total Annual Responses: 17,279,717; 

Total Annual Hours: 14,424,655. (For 

policy questions regarding this 

collection contact Scott Cooper at 410– 

786–9465.) 

Dated: August 11, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–19260 Filed 8–14–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1279] 

Pilot Program for Qualification of 

Medical Device Development Tools 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is soliciting 

proposals to participate in a pilot 

program for Medical Device 

Development Tools (MDDT) 

qualification (MDDT Pilot Program). 

Under the MDDT Pilot Program, FDA 

intends to work together with 

developers of tools that meet the criteria 

for the proposed program, to determine 

whether certain tools may be developed 

and qualified in order to facilitate more 

predictable, efficient, and transparent 

regulatory evaluation when MDDTs are 

used to generate valid scientific 

evidence for medical device premarket 

applications. 

DATES: FDA will begin accepting 

nominations for participation in the 

voluntary MDDT Pilot Program 

September 15, 2014. 

FOR FURTHER INFORMATION CONTACT: Joan 

Adams-White, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3650, Silver Spring, 

MD 20993–0002, 301–796–5421, 

Joannie.Adams-White@fda.hhs.gov; or 

Kathryn O’Callaghan, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3614, Silver Spring, 

MD 20993–0002, 301–796–6349, 

Kathryn.ocallaghan@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

14, 2013 (78 FR 68459), the Food and 

Drug Administration (FDA) announced 

the availability of the draft guidance 

entitled ‘‘Medical Device Development 

Tools’’ (http://www.fda.gov/

medicaldevices/

deviceregulationandguidance/

guidancedocuments/ucm374427.htm) 

(MDDT draft guidance). When finalized, 

the draft guidance will represent FDA’s 

current thinking on qualification of 

MDDTs for use in device development 

and evaluation. The proposed MDDT 

qualification process is intended to 

support the development of MDDTs— 

tools that manufacturers and FDA use to 

assess and measure the performance, 


emcdonald on DSK67QTVN1PROD with NOTICES