9214 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: January 29, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–03482 Filed 2–14–14; 8:45 am] 

BILLING CODE 4160–90–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), Department of 

Health and Human Services (HHS). 

ACTION: Notice of Availability—New 

Common Formats 

SUMMARY: As authorized by the 

Secretary of HHS, AHRQ coordinates 

the development of common definitions 

and reporting formats (Common 

Formats) for reporting patient safety 

events to Patient Safety Organizations 

(PSOs) and other entities. The purpose 

of this notice is to announce the 

availability of a new type of Common 

Formats for public review and 

comment—Common Formats for 

Surveillance—Hospital. 

DATES: Ongoing public input. 

ADDRESSES: The newly released 

Common Formats for Surveillance— 

Hospital—which includes modules 

entitled Generic Adverse Event 

Information, Blood or Blood Product, 

Delivery-Maternal, Delivery-Neonatal, 

Device or Medical/Surgical Supply 

Including Health Information 

Technology (HIT), Fall, Medications, 

Pressure Ulcer, Readmissions, Surgery 

or Anesthesia, Venous 

Thromboembolism, and Other 

Outcomes of Interest—can be accessed 

electronically at the following HHS Web 

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

index.html 

FOR FURTHER INFORMATION CONTACT: 

Glenn Egelman, M.D., 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; Email: PSO@

AHRQ.HHS.GOV. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety and Quality 

Improvement Act of 2005, 42 U.S.C. 

299b-21 to b-26, (Patient Safety Act) and 

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, provide 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. 299b24(b)(1)(F)) requires PSOs to collect 

information from providers in a 

standardized manner that permits valid 

comparisons of similar cases among 

similar providers, to the extent practical 

and appropriate. As explained in 42 

CFR 3.102(b)(1)(iii)(A)(1), one option for 

a PSO to satisfy this requirement is by 

certifying that it is using the Secretary’s 

published guidance for common formats 

and definitions in its collection of 

information from healthcare providers. 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, and other healthcare 

providers may assemble information 

regarding patient safety events and 

quality of care. Information that is 

assembled and developed by providers 

for reporting to PSOs and the 

information received and analyzed by 

PSOs—called patient safety work 

product—is privileged and confidential. 

Patient safety work product is used to 

conduct patient safety activities, which 

may include identifying events, patterns 

of care, and unsafe conditions that 

increase risks and hazards to patients. 

Definitions and other details about PSOs 

and patient safety work product are 

included in the Patient Safety Act and 

Patient Safety Rule which can be 

accessed electronically at: http://

www.PSO.AHRQ.gov/REGULATIONS/

REGULATIONS.htm. 

Definition of Common Formats 

The term Common Formats refers to 

the common definitions and reporting 

formats, specified by AHRQ, that 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 system; rather the formats are 

intended to enhance the ability of 

healthcare providers to report 

information that is standardized both 

clinically and electronically. 

In collaboration with the interagency 

Federal Patient Safety Workgroup 

(PSWG), the National Quality Forum 

(NQF) and the public, AHRQ has 

developed Common Formats for two 

settings of care—acute care hospitals 

and skilled nursing facilities—in order 

to facilitate standardized data 

collection. The scope of Common 

Formats applies 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—circumstances 

that increase the probability of a patient 

safety event. 

Until now, Common Formats have 

been designed to support only 

traditional event reporting. Common 

Formats for Surveillance—Hospital are 

designed to provide, through 

retrospective review of medical records, 

information that is complementary to 

that derived from event reporting 

systems. These formats will facilitate 

improved detection of events and 

calculation of adverse event rates in 

populations reviewed. 

Common Formats Development 

In anticipation of the need for 

Common Formats, AHRQ began their 

development by creating an inventory of 

functioning private and public sector 

patient safety reporting systems. This 

inventory provides an evidence base 

that informed construction of the 

Common Formats. The inventory 

includes many systems from the private 

sector, including academic settings, 

hospital systems, and international 

reporting systems (e.g., from the United 

Kingdom and the Commonwealth of 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices 9215 

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). 

Since February 2005, AHRQ has 

convened the PSWG to assist AHRQ 

with developing and maintaining the 

Common Formats. The PSWG includes 

major health agencies within HHS— 

CDC, Centers for Medicare and 

Medicaid Services, FDA, Health 

Resources and Services Administration, 

Indian Health Service, National 

Institutes of Health, National Library of 

Medicine, Office of the National 

Coordinator for Health Information 

Technology, Office of Public Health and 

Science, and Substance Abuse and 

Mental Health Services 

Administration—as well as the DoD and 

VA. 

When developing Common Formats, 

AHRQ first reviews existing patient 

safety event reporting systems from a 

variety of health care organizations. In 

collaboration with the PSWG and 

Federal subject matter experts, AHRQ 

drafts and releases beta versions of the 

Common Formats for public review and 

comment. The PSWG assists AHRQ 

with assuring the consistency of 

definitions/formats with those of 

relevant government agencies as 

refinement of the Common Formats 

continues. To the extent practicable, the 

Common Formats are also aligned with 

World Health Organization (WHO) 

concepts, framework, and definitions for 

patient safety. 

Commenting on Common Formats: 

Common Formats for Surveillance— 

Hospital 

To allow for greater participation by 

the private sector in the subsequent 

development of the Common Formats, 

AHRQ engaged the NQF, a non-profit 

organization focused on health care 

quality, to solicit comments and advice 

to guide the further refinement of the 

Common Formats. The NQF then 

convenes an expert panel to review the 

comments received and provide 

feedback. Based upon the expert panel’s 

feedback, AHRQ, in conjunction with 

the PSWG, revises and refines the 

Common Formats. 

The Agency is specifically interested 

in obtaining feedback from both the 

private and public sectors to guide the 

improvement of the formats. 

Information on how to comment and 

provide feedback on the Common 

Formats for Surveillance—Hospital is 

available at: http://

www.Qualityforum.ORG/projects/

commonformats.aspx. 

More information about the Common 

Formats can be obtained through 

AHRQ’s PSO Web site: http://

www.PSO.AHRQ.gov/index.html. 

Dated: February 6, 2014. 

Richard Kronick, 

Director. 

[FR Doc. 2014–03492 Filed 2–14–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0283] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Final Guidance for Industry on 

Chemistry, Manufacturing, and 

Controls Postapproval Manufacturing 

Changes To Be Documented in Annual 

Reports 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Final Guidance for Industry on 

Chemistry, Manufacturing, and Controls 

Postapproval Manufacturing Changes to 

be Documented in Annual Reports ’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

November 6, 2013; the Agency 

submitted a proposed collection of 

information entitled ‘‘Final Guidance 

for Industry on Chemistry, 

Manufacturing, and Controls 

Postapproval Manufacturing Changes to 

be Documented in Annual Reports’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0758. The 

approval expires on January 31, 2017. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: February 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–03350 Filed 2–14–14; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0795] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Medical Devices; Third Party Review 

Under the Food and Drug 

Administration Modernization Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Medical Devices; Third Party Review 

Under the Food and Drug 

Administration Modernization Act 

(FDAMA)’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 19, 2013, the Agency 

submitted a proposed collection of 

information entitled ‘‘Medical Devices; 

Third Party Review Under FDAMA’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0375. The 

approval expires on January 31, 2017. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: February 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–03354 Filed 2–14–14; 8:45 am] 

BILLING CODE 4160–01–P 


tkelley on DSK3SPTVN1PROD with NOTICES