50974 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices 

Complainant alleges that the goods 

were loaded on a Wan Hai Lines 

(Singapore) PTE Ltd. (‘‘Wan Hai’’) 

vessel, under a Wan Hai bill of lading 

naming Henan Huatai as Shipper, and 

Complainant as Consignee; and that the 

cargo arrived at the port of discharge, 

Long Beach, CA, mid-June 2008. 

Complainant further alleges that it paid 

the full amount of the ocean freight and 

other charges to Wan Hai. Complainant 

claims that Shipper, Henan Huatai, 

went out of business in June 2008, and 

Respondent, acting as a freight 

forwarder in China on behalf of the 

Shipper, is unlawfully holding the 

original bill of lading, alleging debts 

owed by Shipper to Respondent. 

Complainant alleges that 

Respondent’s refusal to provide the 

original bill of lading to Complainant, 

unless Complainant paid to Respondent 

the amount owed by the Shipper, 

constitutes an unreasonable regulation 

or practice related to the delivery of 

property in violation of 46 U.S.C. 

41102(c) (formerly § 10(d)(1) of the 

Shipping Act of 1984). Complainant 

claims injury in the form of demurrage 

charges in the amount of $16,944.00; 

loss of its funds held in an escrow 

account required by Wan Hai in the 

amount of $47,801.42; and liquidated 

damages imposed by Wal-Mart for lost 

sales in the amount $106,115.00; for a 

total of $170,860.42, with liquidated 

damages continuing to accrue. 

Complainant requests that the 

Commission issue as relief, an Order: (1) 

Compelling Respondent to answer the 

charges in the subject complaint, and 

scheduling a hearing in Washington, 

DC; (2) finding that Respondent’s 

activities were unlawful and in 

violation of the Shipping Act; (3) 

compelling Respondent to pay 

reparations of $170,860.42 plus interest, 

costs, and attorney’s fees; and (4) 

requiring Respondent to provide 

Complainant with the original bill of 

lading to allow Complainant to secure 

release of its escrow deposit from Wan 

Hai and stop other liquidated damages 

from accruing. Additionally, 

Complainant requests that the 

Commission issue further relief as it 

deems just and proper. 

This proceeding has been assigned to 

the Office of Administrative Law Judges. 

Hearing in this matter, if any is held, 

shall commence within the time 

limitations prescribed in 46 CFR 502.61, 

and only after consideration has been 

given by the parties and the presiding 

officer to the use of alternative forms of 

dispute resolution. The hearing shall 

include oral testimony and crossexamination in the discretion of the 

presiding officer only upon proper 

showing that there are genuine issues of 

material fact that cannot be resolved on 

the basis of sworn statements, affidavits, 

depositions, or other documents or that 

the nature of the matter in issue is such 

that an oral hearing and crossexamination are necessary for the 

development of an adequate record. 

Pursuant to the further terms of 46 CFR 

502.61, the initial decision of the 

presiding officer in this proceeding shall 

be issued by August 26, 2009, and the 

final decision of the Commission shall 

be issued by December 24, 2009. 

Karen V. Gregory, 

Assistant Secretary. 

[FR Doc. E8–20115 Filed 8–28–08; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), DHHS. 

ACTION: Notice of Availability—

Common Formats for Safety Data 

Collection and Event Reporting. 

SUMMARY: The Patient Safety and 

Quality Improvement Act of 2005 

(Patient Safety Act) provides for the 

formation of Patient Safety 

Organizations (PSOs), which would 

collect and analyze confidential 

information reported by healthcare 

providers. 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 Notice of Proposed 

Rulemaking published in the Federal 

Register on February 12, 2008: 73 FR 

8112–8183. As requested by the 

Secretary of DHHS, AHRQ has 

coordinated the development of a set of 

common definitions and reporting 

formats (Common Formats) which 

would facilitate the voluntary collection 

of patient safety data and reporting of 

this information to PSOs. The purpose 

of this notice is to announce the initial 

release of the Common Formats, Version 

0.1 Beta, and the process for 

development of future versions. 

DATES: Ongoing public input. 

ADDRESSES: The Common Formats can 

be accessed electronically at the 

following Web site of the Department of 

Health and Human Services: http:// 

www.pso.ahrq.gov/index.html. 

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: 

psoc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act establishes a 

framework by which doctors, hospitals, 

and other health care providers may 

voluntarily report information on a 

privileged and confidential basis 

regarding patient safety events and 

quality of care. The Patient Safety Act 

provides for voluntary formation of 

PSOs, which can be public or private 

organizations, that collect, aggregate, 

and analyze information regarding the 

quality and safety of care delivered in 

any healthcare setting. Information that 

is assembled and developed by 

providers and PSOs—called ‘‘patient 

safety work product’’—is privileged and 

confidential; it can be used to identify 

patient safety events and unsafe 

conditions that increase risks to 

patients. 

The Patient Safety Act requires PSOs, 

to the extent practical and appropriate, 

to collect patient safety work product 

from providers in a standardized 

manner in order to permit valid 

comparisons of similar cases among 

similar providers. 

One of the goals of the legislation is 

to allow aggregation of sufficient data to 

identify and address underlying causal 

factors of patient safety problems. In 

order to facilitate standardized data 

collection, the Secretary of DHHS 

requested AHRQ to coordinate the 

development of Common Formats for 

patient safety events. 

Definitions and other details about 

PSOs and patient safety work product 

have been prepared for publication at 42 

CFR Part 3; a Notice of Proposed 

Rulemaking was published in the 

Federal Register on February 12, 2008, 

as noted above, and a final regulation 

implementing the Patient Safety Act is 

under review. 

Definition of Common Formats 

The term Common Formats is used to 

describe technical requirements 

developed for the uniform collection 

and reporting of patient safety data, 

including all supporting material: 

• Descriptions of patient safety events 

and unsafe conditions to be reported, 

• Delineation of data elements to be 

collected for specific types of events, 

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Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices 50975 

• Examples of patient safety 

population reports, 

• A metadata registry with data 

element attributes and technical 

specifications, 

• Paper forms to allow immediate 

implementation, and 

• A users guide. 

Common Formats delineate 

definitional and reporting specifications 

that will allow healthcare providers to 

collect and submit standardized 

information regarding patient safety 

events. The Common Formats are not 

intended to replace any current 

mandatory reporting system, 

collaborative/voluntary reporting 

system, research related reporting 

system, or other reporting/recording 

systems. 

Scope of Common Formats 

The scope of Common Formats will 

apply to all patient safety concerns 

including: 

• Incidents—patient safety events 

that reached the patient, whether or not 

there was harm, 

• Near misses or close calls—patient 

safety events that did not reach the 

patient, and 

• Unsafe conditions. 

In the interest of supporting PSO data 

collection from the outset, AHRQ is 

releasing Version 0.1 Beta of the 

Common Formats, which have a defined 

focus on patient safety reporting for 

hospital inpatients. It should be noted, 

however, that the Patient Safety Act 

confers both privilege and 

confidentiality on all patient safety 

work product developed under the aegis 

of a PSO with respect to healthcare in 

any setting. AHRQ anticipates 

expanding future versions of the 

Common Formats to include other 

settings such as: Nursing homes and 

other bedded facilities; ambulatory 

surgery centers; other ambulatory care 

settings, including community health 

centers, rehabilitation centers, and 

hemodialysis centers; physician and 

practitioner offices; and retail 

establishments such as pharmacies. 

Common Formats Development 

AHRQ has established a process to 

develop Common Formats that: (1) Is 

evidence based; (2) harmonizes across 

governmental health agencies; (3) 

incorporates feedback from the private 

sector, including professional 

associations/organizations, those who 

use the formats, and the public; and (4) 

permits timely updating of these 

clinically-sensitive formats. It is 

planned that updated versions of the 

formats will be released annually by 

AHRQ as guidance. While the 

dvelopment and release of Common 

Formats is outside the scope of the 

regulations implementing the Patient 

Safety Act, AHRQ described its 

proposed development process in the 

Notice of Proposed Rulemaking 

referenced above and sought public 

comment. There were a significant 

number of strongly supportive 

comments about the process; there were 

no negative comments. 

In anticipation of the need for 

Common Formats, AHRQ began their 

development in 2005 by creating an 

inventory of functioning private and 

public sector patient safety reporting 

systems. This inventory provides an 

evidence base to inform construction of 

the Common Formats. The inventory 

now numbers 64 and includes many 

systems from the private sector, 

including prominent academic settings, 

hospital systems, and international 

reporting systems (e.g., from the United 

Kingdom and the Commonwealth of 

Australia). In addition, virtually all 

major Federal patient safety reporting 

systems are included, such as those 

from the Centers for Disease Control and 

Prevention (CDC), the Food and Drug 

Administration (FDA), the Department 

of Defense (DoD), and the Department of 

Veterans Affairs (VA). 

AHRQ convened an interagency 

Patient Safety Work Group (PSWG) to 

develop draft formats. Included in the 

PSWG are major health agencies within 

the Department—CDC, Centers for 

Medicare and Medicaid Services (CMS), 

FDA, Health Resources and Services 

Administration (HRSA), the Indian 

Health Service (IHS), the National 

Institutes of Health (NIH), the Office of 

the National Coordinator for Health 

Information Technology (ONC)—as well 

as the DoD and the VA. 

The PSWG reviewed the AHRQ 

inventory, created draft Common 

Format data sets, harmonized individual 

data elements where possible, and 

created new data elements where 

necessary. From February through May 

of 2008, the draft Common Formats 

underwent two pilot tests in a 

significant number of healthcare 

facilities within DoD, IHS, and VA. 

These pilot tests were designed to 

provide guidance to refine the draft 

formats prior to their release as Version 

0.1 Beta. The PSWG, acting as the focus 

for original development and continuing 

upgrading/maintenance will assure 

consistency of definitions/formats with 

those of relevant government agencies 

as refinement of the Common Formats 

continues. 

The PSWG aligned the formats, to the 

extent practicable, with World Health 

Organization (WHO) concepts, 

framework, and definitions contained in 

their draft International Classification 

for Patient Safety (ICPS). The ICPS is 

currently under development. 

AHRQ’s initial construction of 

Common Formats thus draws on 

information from systems in both the 

public and private sectors, but was 

completed by a work group comprising 

only Federal agencies. To allow for 

greater participation by the private 

sector in the subsequent development of 

the Common Formats, AHRQ has 

engaged the National Quality Forum 

(NQF) to solicit comments and advice to 

guide future versions, as described 

below. It should be noted that the 

Common Formats Version 0.1 Beta can 

be implemented now, using AHRQ 

paper forms and the users guide. Other 

supporting materials will be made 

available shortly via the AHRQ Web 

site. 

Commenting on Common Formats 

Version 0.1 Beta 

AHRQ is committed to continuing 

refinement of the Common Formats. The 

Agency is specifically interested in 

obtaining feedback from both the private 

and public sectors—particularly from 

those who use the Common Formats—

and it has established a process to 

receive initial feedback that will guide 

rapid improvement of the formats. 

AHRQ has contracted with the NQF, 

a non-profit organization focused on 

healthcare quality, to assist with 

gathering and analyzing feedback on the 

Common Formats. In this role, the NQF 

will assist AHRQ in updating future 

versions of the formats by: Soliciting 

public comments from providers, 

professional organizations, the general 

public, and PSOs; triaging comments in 

terms of immediacy of importance; 

setting priorities; and convening expert 

panel(s) to offer advice on suggested 

improvements to the formats. This 

process will be a continuing one, 

guiding periodic updates of the 

Common Formats and, most 

importantly, reflecting the feedback of 

those using the formats. This latter 

group, the users, will be the most 

sensitive to and aware of needed 

updates and improvements to the 

formats. 

Future Releases 

While AHRQ’s Version 0.1 Beta has 

been developed based on evidence, 

consensus of the PSWG, and results 

from initial testing, this version does not 

reflect the refinement that will come 

from large-scale use and repeated 

revision. We anticipate that we may get 

much helpful guidance from early users 

of the formats. For this reason, AHRQ 

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50976 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices 

plans to release a second version of the 

formats in six to nine months, or 

perhaps sooner, depending on the 

nature of initial feedback. Once the 

formats are stabilized, AHRQ plans to 

release new versions annually. The 

Agency will follow the same process for 

formats developed for other settings. 

AHRQ realizes that using Version 0.1 

Beta paper forms is not the optimal way 

to collect patient safety data. Over time, 

computer software (developed in the 

private sector) will make use of the 

formats much more efficient. However, 

because the Agency plans an early 

second release of the Common Formats, 

it cautions software developers to 

understand that the first release of the 

formats will likely be substantially 

enhanced. 

More information on the feedback 

process can be obtained through 

AHRQ’s PSO Web site: http:// 

www.pso.ahrq.gov/index.html. 

Dated: August 21, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E8–19910 Filed 8–28–08; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS-R–65] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this 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 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. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection Requirements in Final Peer 

Review Organizations Sanction 

Regulations—42 CFR 1004.4, 1004.50, 

1004.60, and 1004.70; Use: The Peer 

Review Improvement Act of 1982 

amended Title XI of the Social Security 

Act (the Act), creating the Utilization 

and Quality Control Peer Review 

Organization Program. Section 1156 of 

the Act imposes obligations on health 

care practitioners and others who 

furnish or order services or items under 

Medicare. This section also provides for 

sanction actions, if the Secretary 

determines that the obligations as stated 

by this section are not met. Quality 

Improvement Organizations (QIOs) are 

responsible for identifying violations. 

QIOs may allow practitioners or other 

entities, opportunities to submit 

relevant information before determining 

that a violation has occurred. The 

information collection requirements 

contained in this information collection 

request are used by the QIOs to collect 

the information necessary to make their 

decision. Form Number: CMS–R–65 

(OMB# 0938–0444); Frequency: 

Reporting—On occasion; Affected 

Public: Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 53; Total Annual 

Responses: 53; Total Annual Hours: 

14,310. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

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

PaperworkReductionActof1995, or 

e-mail your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by October 28, 2008: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ____, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: August 22, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–19975 Filed 8–28–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0313] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Request for 

Inspection Under the Inspection by 

Accredited Persons Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

29, 2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0569. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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