Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Notices 25695 

well as updates from approximately half 

of the NORA Sector Councils on their 

progress, priorities, and implementation 

plans to date, including the NORA 

Manufacturing, Public Safety, Services, 

and Wholesale and Retail Trade Sector 

Councils. Updates will also be given on 

the Mid-Decade Review of NORA, the 

NORA Symposium 2011, and at least 

one NIOSH Program that is working on 

several NORA priorities, e.g., the NIOSH 

Economics Program. After each update, 

there will be time to discuss partnership 

opportunities. 

Status: The meeting is open to the 

public, limited only by the capacities of 

the conference call and conference room 

facilities. There is limited space 

available in the meeting room (capacity 

34). Therefore, information to allow 

participation in the meeting through the 

Internet (to see the slides) and a 

teleconference call (capacity 50) will be 

provided to registered participants. 

Participants are encouraged to consider 

attending by this method. Each 

participant is requested to register for 

the free meeting by sending an e-mail to 

noracoordinator@cdc.gov containing the 

participant’s name, organization name, 

contact telephone number on the day of 

the meeting, and preference for 

participation by Web meeting 

(requirements include: Computer, 

Internet connection, and telephone, 

preferably with ‘mute’ capability) or in 

person. An e-mail confirming 

registration will include the details 

needed to participate in the Web 

meeting. Non-U.S. citizens are 

encouraged to participate in the Web 

meeting. Non-U.S. citizens who do not 

register to attend in person on or before 

June 6, 2011, will not be granted access 

to the meeting site and will not be able 

to attend the meeting in-person due to 

mandatory security clearance 

procedures at the Patriots Plaza facility. 

Background: NORA is a partnership 

program to stimulate innovative 

research in occupational safety and 

health leading to improved workplace 

practices. Unveiled in 1996, NORA has 

become a research framework for the 

nation. Diverse parties collaborate to 

identify the most critical issues in 

workplace safety and health. Partners 

then work together to develop goals and 

objectives for addressing those needs 

and to move the research results into 

practice. The NIOSH role is facilitator of 

the process. For more information about 

NORA, see http://www.cdc.gov/niosh/ 

nora/about.html. 

Since 2006, NORA has been 

structured according to industrial 

sectors. Ten major sector groups have 

been defined using the North American 

Industrial Classification System 

(NAICS). After receiving public input 

through the Web and town hall 

meetings, ten NORA Sector Councils 

have been working to define sectorspecific strategic plans for conducting 

research and moving the results into 

widespread practice. During 2008–10, 

most of these Councils posted draft 

strategic plans for public comment and 

eight have posted finalized National 

Sector Agendas after considering 

comments on the drafts. For the 

National Sector Agendas, see http:// 

www.cdc.gov/niosh/nora/. 

FOR FURTHER INFORMATION CONTACT: 

Sidney C. Soderholm, PhD, NORA 

Coordinator, e-mail 

noracoordinator@cdc.gov, telephone 

(202) 245–0665. 

Dated: April 27, 2011. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2011–10950 Filed 5–4–11; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2011–0004] 

Public Health Information Network 

(PHIN) Messaging Guide for Syndromic 

Surveillance 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS) is requesting 

public comment on the draft PHIN 

Messaging Guide for Syndromic 

Surveillance. The document translates 

the business requirement 

recommendations from the International 

Society for Disease Surveillance to 

technical specifications to support 

meaningful use of electronic health 

records for syndromic surveillance. 

Comments will be used to inform and 

finalize the Messaging Guide. 

DATES: Written comments must be 

received on or before June 20, 2011. See 

Addresses for instructions to submit 

comment. 

ADDRESSES: You may submit written 

comments to the following address: 

Public Health Informatics and 

Technology Program Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, NE., Mailstop E–76, 

Atlanta, Georgia 30329. Attn: PHIN 

Syndromic Surveillance Messaging 

Guide Comments (Docket No. CDC– 

2011–0004), 

You may also submit written 

comments electronically to http:// 

www.regulations.gov. Comments must 

be identified by Docket No. CDC–2011– 

0004. Please follow directions at http:// 

wwww.regulations.gov to submit 

comments. 

All relevant comments received will 

be posted publicly without change, 

including any personal or proprietary 

information provided. An electronic 

version of the draft is available to 

download at http://www.regulations.gov 

and http://www.cdc.gov/phin/library/ 

2011/guides/Syndromic_

Surveillance_Implementation_

Guide_Release_1_4.pdf. 

Written comments, identified by 

Docket No. CDC–2011–0004, will be 

available for public inspection Monday 

through Friday, except for legal 

holidays, from 9 a.m. until 5 p.m., 

Eastern Daylight Time, at 1600 Clifton 

Road, NE., Atlanta, Georgia 30333. 

Please call ahead to (404) 639–6100 and 

ask for a representative from the Public 

Health Informatics and Technology 

Program Office to schedule your visit. 

Comments may also be viewed at http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Nikolay Lipskiy, Centers for Disease 

Control and Prevention, Public Health 

Informatics and Technology Program 

Office; l600 Clifton Road, NE., Mailstop 

E–76, Atlanta, Georgia 30329, phone 

404–498–6100. 

SUPPLEMENTARY INFORMATION: The 

International Society for Disease 

Surveillance (ISDS), with the support of 

CDC, convened a Meaningful Use 

Workgroup to define current syndromic 

surveillance business standards and 

data requirements. The goal of the ISDS 

workgroup is to ensure that public 

health authorities, health care 

professionals, Electronic Health Record 

(EHR) technology developers, and the 

HHS Office of the National Coordinator 

for Health Information Technology have 

business standards that will best 

support meaningful use of EHRs for 

syndromic surveillance. The Final 

Recommendation from ISDS (available 

at http://www.syndromic.org/uploads/ 

files/ISDSRecommendation_FINAL.pdf) 

was published in early January 2011. As 

the ISDS workgroup developed 

recommendations, the CDC Public 

Health Informatics and Technology 

Program Office, worked to translate the 

business requirement recommendations 

to technical specifications. This notice 

announces a draft PHIN Messaging 


jlentini on DSKJ8SOYB1PROD with NOTICES
25696 Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Notices 

Guide for Syndromic Surveillance 

available for public comment at http:// 

www.regulations.gov and http:// 

www.cdc.gov/phin/library/2011/guides/

Syndromic_Surveillance_

Implementation_Guide_Release_1_4.pdf 

Dated: April 27, 2011. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2011–10949 Filed 5–4–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0322] 

Guidance for Industry on Dosage 

Delivery Devices for Orally Ingested 

OTC Liquid Drug Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Dosage Delivery Devices for 

Orally Ingested OTC Liquid Drug 

Products.’’ This document is intended to 

provide guidance to firms that are 

manufacturing, marketing, or 

distributing orally ingested over-thecounter (OTC) liquid drug products 

packaged with dosage delivery devices 

(e.g., calibrated cups, droppers, 

syringes, or spoons). FDA is issuing this 

guidance because of ongoing concerns 

about potentially serious accidental 

drug overdoses that can result from the 

use of dosage delivery devices with 

markings that are inconsistent or 

incompatible with the labeled dosage 

directions for orally ingested OTC liquid 

drug products. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Spencer Salis, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Building 51, rm. 5216, 

Silver Spring, MD 20993–0002, 301– 

796–3327. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Dosage 

Delivery Devices for Orally Ingested 

OTC Liquid Drug Products.’’ The 

Agency has determined that many orally 

ingested OTC liquid drug products in 

the marketplace are packaged with 

dosage delivery devices that bear 

markings that are inconsistent with the 

labeled dosage directions, contain 

superfluous markings, or are missing 

necessary markings. FDA is issuing this 

guidance because of ongoing concerns 

about potentially serious accidental 

drug overdoses that can result from the 

use of dosage delivery devices with 

markings that are inconsistent or 

incompatible with the labeled dosage 

directions for orally ingested OTC drug 

products. FDA recommends that dosage 

delivery devices be included for all 

orally ingested OTC drug products that 

are liquid formulations, that they should 

bear markings that are consistent with 

the labeled dosage directions, and that 

they should be labeled in a manner that 

attempts to ensure that they are used 

only with the products with which they 

are included. 

In the Federal Register of November 

5, 2009 (74 FR 57319), FDA announced 

the availability of a draft guidance for 

industry entitled ‘‘Dosage Delivery 

Devices for Over-the-Counter Liquid 

Drug Products.’’ The notice gave 

interested persons an opportunity to 

comment by February 2, 2010. We 

received a number of comments from 

individuals, firms, and consumer 

groups. We have carefully considered 

the comments and, where appropriate, 

have made corrections, added 

information, or clarified the information 

in the guidance in response to the 

comments or on our own initiative. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on dosage delivery 

devices for orally ingested OTC liquid 

drug products. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

Dated: April 28, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–10965 Filed 5–4–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Committee on Rural 

Health and Human Services; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

that the following committee will 

convene its sixty-seventh meeting. 

Name: National Advisory Committee on 

Rural Health and Human Services. 

Dates and Times: June 15, 2011, 9 a.m.– 

4:45 p.m., June 16, 2011, 9 a.m.–4:45 p.m., 

June 17, 2011, 8:45 a.m.–10:30 a.m. 

Place: Park Place Hotel, 300 East State 

Street, Traverse City, MI 49684. (231) 946– 

5000. 

Status: The meeting will be open to the 

public. 

Purpose: The National Advisory 

Committee on Rural Health and Human 

Services provides advice and 

recommendations of health and human 

services in rural areas. 

Agenda: Wednesday morning, at 9 a.m., 

the meeting will be called to order by the 

Chairperson of the Committee, the Honorable 

Ronnie Musgrove. The first three 

presentations will be overviews of rural 

Michigan and the relevant health indicators. 

The remainder of the day the Committee will 

hear presentations on two of the chosen 


jlentini on DSKJ8SOYB1PROD with NOTICES