7478 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 

effectiveness of messages for intended 

audiences. 

Data collection methods proposed for 

HMTS includes intercept interviews, 

telephone interviews, focus groups, 

online surveys, and cognitive 

interviews. In almost all instances, data 

will be collected by outside 

organizations under contract with CDC. 

For many years CDC programs have 

used HMTS to test and refine message 

concepts and test draft materials for 

clarity, salience, appeal, and 

persuasiveness to target audiences. 

Having this generic clearance available 

has enabled them to test their 

information and get critical health 

information out to the public quickly. 

Over the last three years, more than 20 

messages have been tested using this 

clearance. For example: Evaluation of 

Emergency Preparedness Materials for 

Limited English Proficient Spanish 

Speakers. Risk communication is a top 

priority in CDC’s anthrax preparedness 

activities. The Anthrax Management 

Team developed materials to provide 

LEP Spanish-speakers with information 

needed to increase the chances for 

survival in the event that bioterrorists 

attacked the U.S. using anthrax. Once 

refined, based on participant feedback, 

these materials will be used in creating 

additional public education materials to 

be utilized during an anthrax 

emergency. The lessons learned about 

communication with vulnerable 

populations have application to others 

who are seeking to improve 

communication during a domestic or 

global public health emergency. 

The Division of Diabetes Translation 

obtained OMB approval through HMTS 

for Testing of Brand Concepts, Messages 

and Materials for CDC’s National 

Diabetes Prevention Program (National 

DPP). Materials testing was conducted 

with multiple audiences, and provided 

the detailed level of feedback needed to 

make materials that resonate with each 

audience. Findings have also been used 

to inform the development and testing 

of a new brand for the National DPP 

which will be launched in 2015. 

The National Institute for 

Occupational Safety and Health 

(NIOSH) conducted a field study, 

Spanish Trench Safety CD–ROM, to 

determine the most effective way to 

disseminate trench safety information to 

Latino immigrant workers using 

computer-based training. Using results 

of this study, NIOSH produced the CD– 

ROM and are preparing to field test the 

product. As part of this project, a 

tutorial was also created for workers 

with limited computer literacy teaching 

them how to use the computer. The 

tutorial has been field tested and the 

English and Spanish versions will 

become NIOSH numbered publications. 

Over 12,000 respondents were 

queried and over 5,500 burden hours 

used during this time period. Because 

the availability of this ICR has been so 

critical to programs in disseminating 

their materials and information to the 

public in a timely manner, OADC is 

requesting a three year extension of this 

information collection. 

There is no cost to the respondents 

other than their time. The total 

estimated annualized burden hours are 

2,470. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Public Health Professionals, Health Care Providers, State and Local Public Health Officials, Emergency Responders, General 

Public.

Moderator’s Guides, Eligibility Screeners, 

Interview Guides, Opinion Surveys, Consent Forms.

18, 525 1 8/60 

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. 2015–02592 Filed 2–9–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Child Care Development Fund 

(CCDF)—Reporting Improper 

Payments—Instructions for States. 

OMB No.: 0970–0323. 

Description: Section 2 of the Improper 

Payments Act of 2002 provides for 

estimates and reports of improper 

payments by Federal agencies. Subpart 

K of 45 CFR, Part 98 will require States 

to prepare and submit a report of errors 

occurring in the administration of CCDF 

grant funds once every three years. 

The Office of Child Care (OCC) is 

completing the third 3-year cycle of case 

record reviews to meet the requirements 

for reporting under IPIA. The current 

forms and instructions expire 

September 30, 2015. OCC is submitting 

the information collection for renewal 

clearance with minor changes. 

Responders will now have additional 

guidance and clarification in the 

instructions and errors have been 

corrected. New language incorporates 

requirements from the 2014 Child Care 

and Development Fund Block Grant Act 

passed in November 2014. 

Respondents: State grantees, the 

District of Columbia, and Puerto Rico. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Sampling Decisions and Fieldwork Preparation Plan ..................................... 17 1 106 1802 

Record Review Worksheet .............................................................................. 17 276 6.33 29,700.36 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 7479 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

State Improper Authorizations for Payment Report ........................................ 17 1 639 10,863 

Corrective Action Plan ..................................................................................... 8 1 156 1248 

Estimated Total Annual Burden 

Hours: 43,613.36. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–02698 Filed 2–9–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0973] 

Complicated Intra-Abdominal 

Infections: Developing Drugs for 

Treatment; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Complicated Intra-Abdominal 

Infections: Developing Drugs for 

Treatment.’’ The purpose of this 

guidance is to assist sponsors in the 

clinical development of drugs for the 

treatment of complicated intraabdominal infections (cIAIs). 

Specifically, this guidance addresses 

FDA’s current thinking regarding the 

overall drug development program for 

the treatment of cIAIs, including clinical 

trial designs to support approval of 

drugs. This guidance finalizes the draft 

guidance of the same name issued 

October 1, 2012. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Joseph G. Toerner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Complicated Intra-Abdominal 

Infections: Developing Drugs for 

Treatment.’’ The purpose of this 

guidance is to assist sponsors in the 

development of drugs for the treatment 

of cIAIs. 

Intra-abdominal infections including 

cIAIs are common in clinical practice 

and comprise a wide variety of clinical 

presentations and differing sources of 

infection. Different bacterial pathogens 

are responsible for cIAI, including 

Gram-negative aerobic bacteria, Grampositive bacteria, and anaerobic 

bacteria, including mixed infections. 

This guidance describes the efficacy 

endpoint of clinical success as 

resolution of the baseline signs and 

symptoms attributable to cIAI. The 

guidance provides a scientific 

justification for a noninferiority margin. 

This guidance finalizes the draft 

guidance of the same name issued 

October 1, 2012. After consideration of 

comments received in response to the 

draft guidance, FDA updated the 

guidance to include clarifications about 

the primary efficacy endpoint and the 

use of prior nontrial antibacterial drugs. 

In addition, issuance of this guidance 

fulfills a portion of the requirements of 

Title VIII, section 804 of the Food and 

Drug Safety and Innovation Act of 2012 

(Pub. L. 112–144), which requires FDA 

to review and, as appropriate, revise not 

fewer than three guidance documents 

per year for the conduct of clinical trials 

with respect to antibacterial and 

antifungal drugs. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 


rljohnson on DSK3VPTVN1PROD with NOTICES