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
7480 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 

1This indication is protected by orphan drug 

exclusivity expiring on September 23, 2018. See the 

Orphan Drug Designations and Approvals database 

at http://www.accessdata.fda.gov/scripts/

opdlisting/oopd/index.cfm. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. 

Dated: February 4, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02591 Filed 2–9–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Arthritis Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Arthritis 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 17, 2015, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Answers to commonly asked 

questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Stephanie L. 

Begansky, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: AAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

biologics license application (BLA) 

125544 for CT–P13, a proposed 

biosimilar to Janssen Biotech Inc.’s 

REMICADE (infliximab), submitted by 

Celltrion, Inc. The proposed indications 

(uses) for this product are: (1) Reducing 

signs and symptoms and inducing and 

maintaining clinical remission in adult 

patients with moderately to severely 

active Crohn’s disease who have had an 

inadequate response to conventional 

therapy; (2) reducing the number of 

draining enterocutaneous and 

rectovaginal fistulas and maintaining 

fistula closure in adult patients with 

fistulizing Crohn’s disease; (3) reducing 

signs and symptoms and inducing and 

maintaining clinical remission in 

pediatric patients 6 years of age and 

older with moderately to severely active 

Crohn’s disease who have had an 

inadequate response to conventional 

therapy; (4) reducing signs and 

symptoms, inducing and maintaining 

clinical remission and mucosal healing, 

and eliminating corticosteroid use in 

adult patients with moderately to 

severely active ulcerative colitis who 

have had an inadequate response to 

conventional therapy; (5) reducing signs 

and symptoms and inducing and 

maintaining clinical remission in 

pediatric patients 6 years of age and 

older with moderately to severely active 

ulcerative colitis who have had an 

inadequate response to conventional 

therapy; 1 (6) in combination with 

methotrexate, reducing signs and 

symptoms, inhibiting the progression of 

structural damage, and improving 

physical function in patients with 

moderately to severely active 

rheumatoid arthritis; (7) reducing signs 

and symptoms in patients with active 

ankylosing spondylitis; (8) reducing 

signs and symptoms of active arthritis, 

inhibiting the progression of structural 

damage, and improving physical 

function in patients with psoriatic 

arthritis; and (9) treatment of adult 

patients with chronic severe (i.e., 

extensive and/or disabling) plaque 

psoriasis who are candidates for 

systemic therapy and when other 

systemic therapies are medically less 

appropriate. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 3, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

23, 2015. Time allotted for each 


rljohnson on DSK3VPTVN1PROD with NOTICES