Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Notices 16817 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2010–N–0001] 

2010 Scientific Meeting of the National 

Antimicrobial Resistance Monitoring 

System; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘2010 Scientific Meeting of the 

National Antimicrobial Resistance 

Monitoring System.’’ The topic to be 

discussed is the results from the 

National Antimicrobial Resistance 

Monitoring System (NARMS) and 

related antimicrobial resistance 

monitoring and research, including 

activities in other national programs. 

Date and Time: The public meeting 

will be held on July 15 and 16, 2010, 

from 8 a.m. to 5 p.m. 

Location: The public meeting will be 

held at Hyatt Regency-Atlanta hotel, 265 

Peachtree St. NE, Atlanta, GA 30303, 

404–577–1234, FAX: 404–588–4137. 

Contact Person: Joanne Kla, Center for 

Veterinary Medicine (HFV–12), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20857, 240–276– 

9129, e-mail: NARMSinternational

Meeting@fda.hhs.gov, FAX: 240–276– 

9115. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone and fax 

number, and e-mail address), and 

written material and requests to make 

oral presentations, to the contact person 

(see Contact Person) on or before July 7, 

2010. There is no registration fee for the 

public meeting. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public meeting will be provided on a 

space available basis beginning at 8 a.m. 

on the day of the meeting. 

If you need special accommodations 

due to a disability, please contact the 

Hyatt Regency-Atlanta hotel, (see 

Location) at least 7 days in advance. 

Interested persons may present data, 

information, or views, orally or in 

writing, on the topic of the discussion 

of the meeting. Written submissions 

may be made to the contact person on 

or before July 1, 2010, for distribution at 

the meeting. Oral presentations from the 

public during the open public comment 

period will be scheduled between 

approximately 4 p.m. and 5 p.m. on July 

16, 2010. Those desiring to make oral 

presentations should notify the contact 

person by July 1, 2010, and submit a 

brief statement of the general nature of 

information they wish to present and an 

indication of the approximate time 

requested to make their presentation. 

Time allotted for each presentation may 

be limited. The contact person will 

inform each speaker of their schedule 

prior to the meeting. 

Comments: Regardless of attendance 

at the public meeting, interested persons 

may submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified 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. The docket 

will remain open for written or 

electronic comments for 30 days 

following the meeting. 

Agenda: The meeting will address 

goals and challenges of monitoring 

antimicrobial susceptibility in 

foodborne bacteria, and present research 

on the microbiology and epidemiology 

of resistance. The agenda for the public 

meeting will be made available on the 

agency’s Web site at http:// 

www.fda.gov/AnimalVeterinary/ 

SafetyHealth/AntimicrobialResistance/ 

NationalAntimicrobialResistance

MonitoringSystem/ucm059135.htm. 

Transcripts: FDA will prepare a 

meeting transcript and make it available 

on the agency’s Web site (see Agenda) 

after the meeting. FDA anticipates that 

transcripts will be available 

approximately 30 business days after 

the meeting. The transcript will be 

available for public examination at the 

Division of Dockets Management (HFA– 

305), 5630 Fishers Lane, rm. 1061, 

Rockville, MD 20852, between 9 a.m. 

and 4 p.m., Monday through Friday. A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: March 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–7496 Filed 4–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting for Software Developers on 

the Technical Specifications for 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: This notice announces a 

meeting to discuss the technical 

specifications for AHRQ’s common 

definitions and reporting formats 

(Common Formats) Version 1.1 that 

allow for reporting of patient safety 

information to Patient Safety 

Organizations (PSOs). The Patient 

Safety and Quality Improvement Act of 

2005, 42 U.S.C. 299b–21 to b–26, 

(Patient Safety Act) provides for the 

formation of PSOs, which collect, 

aggregate, and analyze confidential 

information regarding the quality and 

safety of healthcare delivery. The 

Patient Safety Act (at 42 U.S.C. 299b– 

23) authorizes the collection of this 

information in a standardized manner, 

as explained in the related Patient 

Safety and Quality Improvement Final 

Rule, 42 CFR part 3 (Patient Safety 

Rule), published in the Federal Register 

on November 21, 2008: 73 FR 70731– 

70814. As authorized by the Secretary of 

HHS, AHRQ coordinates the 

development of the Common Formats 

that allow healthcare providers to 

voluntarily collect and submit 

standardized information regarding 

patient safety events. More information 

on the Common Formats Version 1.1, 

including the technical specifications, 

can be obtained through AHRQ’s PSO 

Web site: http://www.PSO.AHRQ.gov/ 

index.html. 

Technical specifications promote 

standardization by ensuring that data 

collected by PSOs and other entities are 

clinically and electronically 

comparable. This meeting is designed as 

an interactive forum where PSOs and 

software developers can provide input 

on these technical specifications for the 

Common Formats Version 1.1. AHRQ 

especially requests input from those 

entities which have implemented, or 

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16818 Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Notices 

plan to implement, the formats 

electronically. 

DATES: The meeting will be held from 10 

a.m. to 5 p.m. on May 5, 2010. 

ADDRESSES: The meeting will be held at 

the Hyatt Regency Baltimore, 300 Light 

Street, Baltimore, Maryland 21202. 

FOR FURTHER INFORMATION CONTACT: 

Susan Grinder, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427–1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; E-mail: 

PSO@AHRQ.hhs.gov. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Disability Management 

on (301) 827–4840, no later than April 

21, 2010. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, and other 

healthcare providers may voluntarily 

report information regarding patient 

safety events and quality of care. AHRQ 

develops and maintains the Common 

Formats to improve the safety and 

quality of healthcare delivery. AHRQ’s 

Common Formats Version 1.1 includes: 

Æ Descriptions of patient safety 

events and unsafe conditions to be 

reported (event descriptions), 

Æ Specifications for patient safety 

aggregate reports and individual event 

summaries, 

Æ Delineation of data elements to be 

collected for specific types of events, 

Æ A user’s guide and quick guide, and 

Æ Technical specifications for 

electronic data collection and reporting. 

This meeting will focus on 

presentation and discussion of these 

new technical specifications, which 

provide direction to software developers 

that plan to implement the Common 

Formats electronically. The technical 

specifications are a critical component 

that will allow for the aggregation of 

patient safety event data by 

standardizing the patient safety event 

information collected and specifying 

standard rules for data collection, as 

well as providing guidance for how and 

when to create data elements, their valid 

values, and conditional and go-to logic 

for the data elements. In addition to 

standardizing the information collected, 

they specify the data submission file 

format. 

The technical specifications consist of 

the following: 

Æ Data dictionary—defines data 

elements and their attributes (data 

element name, answer values, field 

length, guide for use, etc.) included in 

Common Formats Version 1.1; 

Æ Clinical document architecture 

(CDA) implementation guide—provides 

instructions for developing a Health 

Level Seven (HL7) CDA Extensible 

Markup Language (XML) file to transmit 

the Common Formats Patient Safety 

data from the PSO to the PPC using the 

Common Formats; 

Æ Validation rules and errors 

document-specifies and defines the 

validation rules that will be applied to 

the Common Formats data elements 

submitted to the PPC; 

Æ Common Formats flow charts— 

diagrams the valid paths to complete 

generic and event specific formats (a 

complete event report); 

Æ Local specifications—provides 

specifications for processing, linking 

and reporting on events and details 

specifications for reports; and 

Æ Metadata registry—includes 

descriptive facts about information 

contained in the data dictionary to 

illustrate how such data corresponds 

with similar data elements used by 

other Federal agencies and standards 

development organizations [e.g., HL–7, 

International Standards Organization 

(ISO)]. 

Agenda, Registration and Other 

Information About the Meeting 

On Wednesday, May 5, 2010, the 

meeting will convene at 10 a.m. with an 

overview of the Common Formats 

Version 1.1, including the technical 

specifications. Next, AHRQ staff and 

contractors who developed the formats 

will review the different components of 

the technical specifications. Throughout 

the meeting there will be interactive 

discussion to allow meeting participants 

not only to provide input, but also to 

respond to the input provided by others. 

A more specific proposed agenda will 

be posted before the meeting at https: 

//www.psoppc.org/web/patientsafety. 

AHRQ requests that interested 

persons register with the PSO Privacy 

Protection Center (PSO PPC) on the 

Internet at https://www.psoppc.org/web/ 

patientsafety to participate in the 

meeting. The contact at the PSO PPC is 

Lauren Richie who can be reached by 

telephone at (630) 792–5977 and by email at support@psoppc.org. Additional 

logistical information for the meeting is 

also available from the PSO PPC. The 

meeting space will accommodate 

approximately 130 participants. 

Interested persons are encouraged to 

register as soon as possible for the 

meeting. Non-registered individuals will 

be able to attend the meeting in person 

if space is available. 

We invite review of the technical 

specifications for Common Formats 

Version 1.1 prior to the meeting. The 

formats can be accessed through 

AHRQ’s PSO Web site at http:// 

www.pso.AHRQ.gov/formats/ 

commonfmt.htm. AHRQ is committed to 

continuing refinement of the Common 

Formats. AHRQ welcomes questions 

from prospective meeting participants 

and interested individuals on the 

technical specifications for Common 

Formats Version 1.1. These questions 

should be e-mailed to 

support@psoppc.org no later than April 

28, 2010. AHRQ will use the input 

received at this meeting as we continue 

to update and refine the Common 

Formats. 

A summary of the meeting will be 

provided to all meeting participants. If 

you are unable to participate in the 

meeting and would like a copy of the 

summary, please send an e-mail to 

support@psoppc.org and it will be sent 

as soon as it is available after the 

meeting. 

Dated: March 24, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–7049 Filed 4–1–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; NEI Training Grants. 

Date: April 21–22, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

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