4724 Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Notices 

required by the CSTHEA to submit 

ingredient reports to HHS on an annual 

basis. The legislation also authorizes 

HHS to undertake research, and to 

report to Congress, as deemed 

appropriate, about the health effects of 

these ingredients. 

Respondents are not required to 

submit specific forms; however, they are 

required to meet reporting guidelines 

and to submit the ingredient report by 

chemical name and Chemical Abstract 

Service (CAS) Registration Number, 

consistent with accepted reporting 

practices for other companies currently 

required to report ingredients added to 

other consumer products. Typically, 

respondents submit a summary report to 

CDC with the ingredient information for 

multiple products, or a statement that 

there are no changes to their previously 

submitted ingredient report. 

Ingredient reports for new products 

are due at the time of first importation. 

Thereafter, ingredient reports are due 

annually on March 31. Information is 

submitted to OSH by mailing a written 

report on the respondent’s letterhead, by 

CD, three-inch floppy disk, or thumb 

drive. The information collection is 

subject to strict confidentiality 

provisions and electronic mail 

submissions are not accepted. Upon 

receipt and verification of the annual 

nicotine and ingredient report, OSH 

issues a Certificate of Compliance to the 

respondent. 

OMB approval is requested for three 

years. There are no changes to 

information collection procedures, the 

estimated burden per response, or the 

estimated number of respondents. The 

total estimated annualized burden hours 

are 22,269. There are no costs to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Smokeless Tobacco Manufacturers, Packagers, and Importers.SLT Nicotine and Ingredient and Report ....... 13 1 1,713 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–01649 Filed 1–28–14; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2014–0003] 

Draft Guideline—Centers for Disease 

Control and Prevention Draft Guideline 

for the Prevention of Surgical Site 

Infections 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS). 

ACTION: Notice of availability and 

request for public comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS) requests public 

comment on the Draft Guideline for the 

Prevention of Surgical Site Infections 

(SSIs) (draft Guideline). The Draft 

Guideline addresses new and updated 

strategies for the prevention of SSI in 

healthcare settings. This draft Guideline 

can be found at http://

www.regulations.gov Docket No. CDC– 

2014–0003. CDC is also publishing the 

supporting appendices that include 

primary evidence, study evaluation, and 

data evaluation tables that were used in 

developing the draft Guideline 

recommendations at http://

www.regulations.gov. 

The draft Guideline is designed for 

use by infection prevention staff, 

healthcare epidemiologists, 

administrators, nurses, and personnel 

responsible for developing, 

implementing, and evaluating infection 

prevention and control programs for 

healthcare settings across the 

continuum of care. The 

recommendations contained in the draft 

Guideline are based on a targeted 

systematic review of the best available 

evidence for specific topics related to 

the prevention of surgical site infections 

(SSI). 

DATES: Comments must be received on 

or before February 28, 2014. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2014– 

0003, by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Healthcare Quality 

Promotion, National Center for 

Emerging and Zoonotic Infectious 

Diseases, Centers for Disease Control 

and Prevention, Attn: Guideline for the 

Prevention of Surgical Site Infections, 

Docket No. CDC–2014–0003, 1600 

Clifton Road NE., Mailstop A07, 

Atlanta, Georgia 30333. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN. All relevant 

public comments received will be 

posted publicly to www.regulations.gov 

without change, including any personal 

or proprietary information provided. To 

download an electronic version of the 

draft Guideline and appendices, access 

http://www.regulations.gov. 

Written materials identified by Docket 

No. CDC–2014–0003 will be available 

during the comment period for public 

inspection Monday through Friday, 

except for legal holidays, 9 a.m. until 

4:30 p.m. Eastern Standard Time, at 

CDC Library, 1600 Clifton Road NE., 

Atlanta, Georgia 30333. Please call 

ahead to (404) 639–1717 and request a 

Library representative schedule your 

visit. All public comments will be 

reviewed and considered prior to 

finalizing the draft Guideline. 

FOR FURTHER INFORMATION CONTACT: Erin 

Stone, Division of Healthcare Quality 

Promotion, National Center for 

Emerging and Zoonotic Infectious 

Diseases, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop A–31, Atlanta, Georgia 30333; 

Telephone: (404) 639–4000. 

SUPPLEMENTARY INFORMATION: Since 

2010 CDC has collaborated with 

national partners, academicians, public 

and private health professionals, and 

other partners to create this draft 

Guideline. Additionally, CDC sought 

input in each phase of development 

from subject matter experts in surgery, 

infectious diseases, and orthopedics 

through a Guideline Expert Panel 

formed to develop the new draft 

Guideline. CDC also received input from 

the Healthcare Infection Control 

Practices Advisory Committee (HICPAC) 

throughout the development of the draft 

Guideline. HICPAC includes 

representatives from public health, 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Notices 4725 

infectious diseases, regulatory and other 

federal agencies, professional societies, 

and other stakeholders. This new draft 

Guideline will not be a federal rule or 

regulation. 

Dated: January 22, 2014. 

Stacey Hoffman, 

Acting Director, Division of Executive 

Secretariat Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–01674 Filed 1–28–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Influenza Diagnostic Testing and 

Reporting 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: General notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) located 

within the Department of Health and 

Human Services (HHS) is seeking to 

assess new technologies that improve 

rapid influenza diagnostic testing and 

supplement national laboratory-based 

surveillance for human influenza 

infections. In particular, the Influenza 

Division within the National Center for 

Immunization and Respiratory Diseases 

(NCIRD) at HHS/CDC proposes to 

evaluate new or improved point of care 

diagnostic tests for influenza virus 

detection that incorporate the capability 

to transmit influenza diagnostic test 

results electronically, such as through 

wireless communication technology, for 

more timely diagnosis of human 

influenza and/or other respiratory 

pathogen infections in outpatient/

ambulatory and emergency room 

healthcare practices. 

DATES: HHS/CDC will accept inquiries/ 

proposals until December 31, 2015. 

ADDRESSES: You may submit your 

inquiry/proposal by email: 

FluDiagnosticTests@cdc.gov. 

All information submitted to HHS/

CDC will be kept confidential as 

allowed by relevant federal law, 

including the Freedom of Information 

Act (5 U.S.C. 552) and the Trade Secrets 

Act (18 U.S.C. 1905). Responses are 

preferred in electronic format. CDC does 

not intend to publish the results of these 

evaluations. 

FOR FURTHER INFORMATION CONTACT: 

Influenza Division, Centers for Disease 

Control and Prevention. Email: 

FluDiagnosticTests@cdc.gov. 

SUPPLEMENTARY INFORMATION: HHS/CDC 

uses epidemiologic, laboratory, clinical, 

and biostatistical sciences to prevent 

and control vaccine preventable 

infectious diseases. HHS/CDC also 

conducts applied research in a variety of 

settings, and translates the findings of 

this research into public health practice. 

HHS/CDC/NCIRD Influenza Division 

has lead technical responsibility for 

research, development, and evaluation 

of diagnostic tools for influenza and 

application of these to national 

surveillance and epidemiologic studies 

of influenza. Improving influenza 

diagnostic testing is part of HHS/CDC/ 

NCIRD Influenza Division’s strategic 

plan and includes support of the 

development of expanded respiratory 

pathogen tests on existing test 

platforms; development of advanced 

sequence detection methods for 

identifying novel influenza strains with 

pandemic potential; rapid identification 

of antiviral resistant influenza strains; 

rapid identification of influenza 

immunological response to determine 

the presence or absence of circulating 

antibodies specific for influenza viruses; 

and the development and 

characterization of stable diagnostic 

reagents or reference material and 

controls, for application with existing 

diagnostic test systems on established 

platforms. 

HHS/CDC/NCIRD Influenza Division 

seeks to collaborate on evaluations of 

any new or improved diagnostic tests 

for the detection of human influenza 

viruses. The tests may range from high 

complexity molecular assays providing 

genetic sequence information to point of 

care type tests that facilitate more timely 

diagnosis of human influenza infections 

and/or other respiratory pathogen 

infections in ambulatory and emergency 

room healthcare practices. Assays 

should present sensitivity and 

specificity higher than currently 

available products. 

For commercial products with 

approval for use by the US Food and 

Drug Administration (FDA), HHS/CDC/ 

NCIRD Influenza Division is seeking to 

evaluate the potential supplementation 

of current national laboratory-based 

influenza surveillance data with 

influenza test result data that can be 

transmitted directly to a public health 

entity (state, local, or CDC) from the test 

platform electronically, such as through 

wireless technology. Direct test 

platform-based reporting capability has 

been newly established. Current 

surveillance incorporates data from 

healthcare provider offices and 

laboratories through manual or 

automated reporting functions; 

however, most of the current testing 

platforms do not have the capacity to 

directly transmit reports. Such reports 

represent a new data source and thus 

require evaluation and determination of 

appropriate data use agreements. 

HHS/CDC/NCIRD Influenza Division 

is also interested in collaborating with 

organizations working on validation of 

novel and improved respiratory 

specimen collection materials and 

methods that can enable reliable and 

consistent self-collection or collection 

by non-expert personnel. Data obtained 

from the evaluation can be compared 

through analytical assessments and be 

used by HHS/CDC in making 

recommendations and decisions for 

diagnosis of influenza in the health 

setting. Products may be evaluated at 

HHS/CDC and/or at collaborating 

laboratories and if appropriate, may be 

used in epidemiologic validation 

studies. 

Interested organizations that have 

candidate products are invited to 

approach the HHS/CDC/NCIRD 

Influenza Division to assess whether the 

available product(s) are at a sufficient 

stage of development and how HHS/

CDC can collaborate on evaluations and 

comparative analysis. 

Information To Submit 

At a minimum, submitted information 

should include the following for each 

candidate product: (a) Product package 

insert or detailed instructions for use; 

(b) Detailed information to determine if 

the product is calibrated to a recognized 

standard; (c) Preliminary data 

demonstrating suitability for validation 

studies and clinical trial data on 

sensitivity and specificity; (d) Whether 

the product is FDA approved; and (e) 

Statement of how HHS/CDC/NCIRD 

Influenza Division could collaborate on 

product evaluation or further 

development. 

Dated: January 22, 2014. 

Stacey Hoffman, 

Acting Director, Division of Executive 

Secretariat Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–01670 Filed 1–28–14; 8:45 am] 

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tkelley on DSK3SPTVN1PROD with NOTICES