28926 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2014–0008] 

Vessel Sanitation Program: Annual 

Program Status Meeting; Request for 

comment 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS) 

ACTION: Notice of public meeting and 

request for comment 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) within 

the Department of Health and Human 

Services (HHS) announces the 2014 

annual Vessel Sanitation Program (VSP) 

public meeting. The annual meeting 

serves as a forum for HHS/CDC to 

update interested persons on work 

completed in 2013 and plans for future 

activities. HHS/CDC is also opening a 

public docket so that additional 

comment and materials may be 

submitted. The official record of this 

meeting will remain open for 30 days 

(through July 10, 2014) so that 

additional materials or comments may 

be submitted and made part of the 

record. 

DATES: Written comments must be 

received on or before July 10, 2014. 

The meeting will be held on June 10, 

2014, from 9:00 a.m. to 4:30 p.m. in the 

auditorium of the Port Everglades 

Administration Building, 1850 Eller 

Drive, Fort Lauderdale, FL 33316. 

Information regarding logistics is 

available on the VSP Web site (http://

www.cdc.gov/nceh/vsp/

2014annualmeeting.htm). 

Deadline for Requests for Special 

Accommodations: Persons wishing to 

participate in the public meeting who 

need special accommodations should 

contact CAPT Jaret Ames (vsp@cdc.gov 

or 954–356–6650 or 770–488–3141) by 

Monday, June 2, 2014. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2014– 

0008 by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Vessel Sanitation Program, 

Centers for Disease Control and 

Prevention, 4770 Buford Highway NE., 

MS F–58, Atlanta, Georgia 30341. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Jaret Ames, Vessel Sanitation 

Program, Centers for Disease Control 

and Prevention, 4770 Buford Highway 

NE., MS F–58, Atlanta, Georgia 30341, 

email: vsp@cdc.gov, phone: 954–356– 

6650 or 770–488–3141. 

SUPPLEMENTARY INFORMATION: 

The purpose of the meeting is to 

inform the public of VSP’s activities in 

assisting the cruise industry to prevent 

the introduction and spread of 

gastrointestinal (GI) illness to U.S. ports 

from ships under VSP’s jurisdiction 

(ships with 13 or more passengers and 

an itinerary that includes foreign and 

U.S. ports). 

The meeting will include a review of 

HHS/CDC’s public health support 

activities from 2013, provide 

perspective on VSP’s approach to vessel 

sanitation, and offer industry the 

opportunity to provide input regarding 

industry efforts to exceed VSP 

requirements. Presentations will clarify 

the roles and responsibilities of VSP, 

cruise line public health management, 

and shipyards constructing cruise ships. 

Presentations will also include 

initiatives for improved epidemiologic 

study of disease outbreaks and strategic 

approaches to public health risk 

reduction for 2015 and the future. 

Matters to be discussed: 

• VSP year in review—operational and 

construction inspections, budget, and 

vessel sanitation training 

• CDC Calicivirus Laboratory— 

norovirus projects 

• GI illness data and epidemiology 

projects—VSP review and progress 

report 

• Cruise line public health initiatives 

• CDC Quarantine—Border Health 

Services Branch Update, including 

surveillance 

• Shipyard construction—strengthening 

public health through engineering 

controls 

• Cruise Lines International 

Association—industry public health 

challenges and response 

Meeting Accessibility: The meeting is 

open to the public, but space is limited 

to availability. Visitors must present 

government-issued identification to pass 

through the vehicle port security 

checkpoint and enter the administration 

building. 

Advanced registration is encouraged; 

the meeting room can accommodate 

approximately 100 persons. Information 

regarding logistics is available on the 

VSP Web site (http://www.cdc.gov/

nceh/vsp/2014annualmeeting.htm). 

Attendees at the annual meeting 

normally include cruise ship industry 

officials, private sanitation consultants, 

and other interested parties. 

Dated: May 15, 2014. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2014–11597 Filed 5–19–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0092] 

Electronic Study Data Submission; 

Data Standards; Availability of 

Validation Rules for Standard for 

Exchange of Nonclinical Data 

Formatted Studies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Center for Drug 

Evaluation and Research (CDER), is 

announcing the availability of the 

Validation Rules for Standard for 

Exchange of Nonclinical Data (SEND) 

Formatted Studies document. CDER is 

making this document available to 

improve the standardization and quality 

of nonclinical data that are submitted to 

CDER as well as to improve the 

predictability of data quality and 

usefulness. 

FOR FURTHER INFORMATION CONTACT: 

Office of Strategic Programs, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1183, 

Silver Spring, MD 20993, email: edata@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

February 6, 2014, FDA issued a Federal 

Register notice (79 FR 7201) 

announcing the availability of a revised 

draft guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’. The revised draft guidance 

incorporates by reference a technical 

specifications document entitled ‘‘Study 

Data Technical Conformance Guide.’’ 

On February 6, 2014, FDA issued a 

Federal Register notice (79 FR 7204) 

announcing the availability of the Guide 

and an update to the Data Standards 

Catalog. The Guide is available at 

http://www.fda.gov/downloads/

ForIndustry/DataStandards/

StudyDataStandards/UCM384744.pdf. 


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