7606 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

AHRQ convenes the PSWG to assist 

AHRQ with developing and maintaining 

the Common Formats. The PSWG 

includes major health agencies within 

HHS—the Centers for Disease Control 

and Prevention, Centers for Medicare 

and Medicaid Services, Food and Drug 

Administration, 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 

Department of Defense and Department 

of Veterans Affairs. 

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. 

Through a contract with AHRQ, the 

NQF solicits feedback on the initial and 

subsequent versions of the Common 

Formats from private sector 

organizations and individuals. The 

NQF, a nonprofit organization that 

focuses on health care quality, then 

convenes an expert panel to review the 

comments received and provide 

feedback to AHRQ. Based upon the 

expert panel’s feedback, AHRQ, in 

conjunction with the PSWG, further 

revises the Common Formats. 

The technical specifications promote 

standardization of collected patient 

safety event information by specifying 

rules for data collection and submission, 

as well as by providing guidance for 

how and when to create data elements, 

their valid values, conditional and go-to 

logic, and reports. These specifications 

will ensure that data collected by PSOs 

and other entities have comparable 

clinical meaning. 

The technical specifications also 

provide direction to software 

developers, so that the Common 

Formats can be implemented 

electronically, and to PSOs, so that the 

Common Formats can be submitted 

electronically to the PSO Privacy 

Protection Center (PSOPPC) for data deidentification and transmission to the 

Network of Patient Safety Databases 

(NPSD). 

Common Formats 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; 

Æ clinical document architecture 

(CDA) implementation guide—provides 

instructions for developing a file to 

transmit the Common Formats Patient 

Safety data from the PSO to the PSOPPC 

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 PSOPPC; 

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 

The 2015 meeting will be an 

interactive forum designed to allow 

meeting participants not only to provide 

input but also to respond to the input 

provided by others. The meeting agenda 

will include: An overview of Federal 

efforts related to the Common Formats; 

presentations and discussion of 

implementation of Common Formats 

Event Reporting—Hospital Versions 1.1 

and 1.2; and, a review of data 

submission both by PSOs and by 

vendors on behalf of PSOs. 

AHRQ requests that interested 

persons send an email to the PSOPPC at 

support@psoppc.ORG for registration 

information. The meeting space will 

accommodate approximately 150 

participants. Before the meeting, a 

detailed agenda and logistical 

information will be provided to 

registrants. Prior to the meeting, AHRQ 

invites review of the technical 

specifications for Common Formats 

which can be accessed through AHRQ’s 

PSO Web site at http://

www.pso.AHRQ.GOV/formats/

commonfmt.htm. 

Dated: February 3, 2015. 

Richard Kronick, 

Director. 

[FR Doc. 2015–02590 Filed 2–10–15; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Opportunity To Collaborate in the 

Evaluation of Simplified Nucleic Acid 

Tests for Detecting and Quantifying 

HIV 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS). 

ACTION: General notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS) announces an 

opportunity for industry and the public 

to collaborate on a project to evaluate 

simplified nucleic acid tests. HHS/CDC 

is interested in evaluating simplified 

nucleic acid tests that (1) can be used 

near a patient with rapid turn-around of 

results (2) can be used to aid in the 

diagnosis of HIV–1 infection, and (3) 

have the potential to be used in 

moderately complex and/or waived 

laboratories as defined under the 

Clinical Laboratory Improvement 

Amendment (CLIA) regulations. Tests of 

interest include those that use whole 

blood, serum, plasma, or dried blood 

spots. Performance will be evaluated 

relative to HHS/Food and Drug 

Administration (FDA)-approved 

qualitative and quantitative nucleic acid 

tests as well as antibody immunoassays. 

More than one collaborator may be 

selected. 

DATES: Formal proposals must be 

received on or before April 13, 2015. 

ADDRESSES: Formal proposals should be 

submitted to Division of HIV/AIDS 

Prevention, National Center for HIV/

AIDS, Viral Hepatitis, STD, and TB 

Prevention, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop E–46, Atlanta, Georgia 30329, 

Attn: Simplified Nucleic Acid Tests 

Evaluation Project. If you are interested 

in submitting a proposal, please send a 

letter of interest to Dr. Michele Owen at 

smo2@cdc.gov by March 13, 2015. The 

letter of interest is not considered a 

formal proposal and is not required; 

however, it is highly recommended, as 

it will assist CDC in planning for the 

review process. The formal proposal 

will still need to be submitted according 

to the instructions in this notice. 

FOR FURTHER INFORMATION CONTACT: 

Questions on the project should be 

addressed to: Laura Wesolowski, 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, and TB Prevention, 

Centers for Disease Control and 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7607 

Prevention, 1600 Clifton Road NE., 

Mailstop E–46, Atlanta, GA 30329, 

telephone: (404) 639–6007, email: lig7@

cdc.gov. 

Scientific questions should be 

addressed to Michele Owen, National 

Center for HIV/AIDS, Viral Hepatitis, 

STD, and TB Prevention, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., Mailstop A–25, 

Atlanta, GA 30329; Phone 404–639– 

1046, email smo2@cdc.gov. 

SUPPLEMENTARY INFORMATION: HHS/CDC 

seeks to collaborate with one or more 

companies that have developed a 

simplified nucleic acid test that can 

detect acute or established HIV–1 

infection. Acute HIV infection is the 

early infection period associated with 

high viral load that occurs before the 

development of HIV antibodies, and 

established infection is that which 

occurs once antibodies are detectable. 

The objective of the collaboration is 

timely collection of data to evaluate the 

performance characteristics of 

simplified nucleic acid tests when used 

in their intended applications. The 

evaluation will be conducted in phases. 

The first round of evaluation will be 

done on well characterized stored or 

mock laboratory specimens. Following 

the initial round of evaluation, a subset 

of tests with high performance will be 

evaluated with prospectively collected 

specimens. Only tests that are near 

production (i.e., not first generation 

prototypes) will be eligible for the 

collaboration. Companies that are 

interested in collaborating must be 

planning to produce a simplified 

nucleic acid test for distribution in the 

United States and to seek FDA approval 

for diagnostic or prognostic use (priority 

given to tests with both applications). 

Confidential proposals, preferably six 

pages or less (excluding appendices), 

are solicited from companies which 

have a product that is suitable for 

commercial distribution. This 

collaboration will have an expected 

duration of 1 to 6 years. 

Currently, nucleic acid testing 

conducted as part of HHS/CDC’s 

laboratory algorithm is associated with 

a delay in returning results because 

testing is often conducted in referral 

laboratories. Likewise, pooled nucleic 

acid testing causes delays due to the 

time required to create and break down 

pools in the event of a positive pool. 

Rapid identification of acute and 

established HIV–1 infection using a 

simplified nucleic acid test may have a 

significant impact on patients with 

positive test results obtaining care and 

services more quickly. Therapeutic 

monitoring could also be conducted 

more efficiently using a simplified 

nucleic acid test. 

For this project, preference may be 

given to manufacturers that have 

produced rapid nucleic acid tests that 

can aid in HIV–1 diagnosis, and be used 

for monitoring responses to therapy. 

Tests should be simple to use on 

unprocessed specimens (e.g., whole 

blood) or include specimen processing 

in the design of the test. Preference will 

also be given for tests that can be 

performed in 60 minutes or less, that 

have the potential to be designated 

moderately complex or waived under 

the Clinical Laboratory Improvement 

Amendments (CLIA), and that are 

capable of both qualitative and 

quantitative applications. 

HHS/CDC and Collaborator 

Responsibilities 

HHS/CDC’s role may include, but will 

not be limited to, the following: 

(1) Providing scientific and technical 

expertise needed for the research 

project; 

(2) Providing appropriate panels of 

specimens, and conducting the tests; 

(3) Planning and conducting research 

studies of the diagnostic tests and 

interpreting results; and 

(4) Publishing research results. 

HHS/CDC anticipates that the role of 

the successful collaborator(s) will 

include the following: 

(1) Providing tests and finalized 

protocols that can be used in the 

evaluation; and 

(2) Providing the CDC Division of 

HIV/AIDS Prevention access to 

necessary data about the diagnostic tests 

in support of the research activities. 

Selection Criteria 

Proposals submitted for consideration 

should address, as fully as possible and 

to the extent relevant to the proposal, 

each of the following: 

(1) Data available on the performance 

of the test in persons with acute and 

established HIV–1 infection. 

(2) Information on the technology 

used for the test and its basic operating 

principals for detecting HIV RNA and/ 

or DNA. 

(3) Information on: 

a. the time required to perform the 

test; 

b. whether the test is performed on 

whole blood, serum, plasma, or dried 

blood spots; and 

c. the steps involved in performing 

the test on each specimen type; 

(4) Information on the storage 

requirements and stability of the test. 

(5) Plans and capability of the 

company to seek HHS/FDA approval 

and whether the company intends to 

seek a diagnostic claim, a prognostic 

claim (for patient monitoring) or both. 

(6) Plans the company has for seeking 

CLIA waiver status, if FDA approved. 

Dated: February 6, 2015. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2015–02793 Filed 2–10–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10433] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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. 

DATES: Comments must be received by 

April 13, 2015. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 


tkelley on DSK3SPTVN1PROD with NOTICES