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
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 7481 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 24, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Stephanie L. 

Begansky at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 5, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–02670 Filed 2–9–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than March 12, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

National Practitioner Data Bank for 

Adverse Information on Physicians and 

Other Health Care Practitioners—45 

CFR part 60 Regulations and Forms. 

OMB No. 0915–0126—Revision. 

Abstract: This is a request for a 

revision of OMB approval of the 

information collection contained in 

regulations found at 45 CFR part 60 

governing the National Practitioner Data 

Bank (NPDB) and the forms to be used 

in registering with, reporting 

information to, and requesting 

information from the NPDB. 

Administrative forms are also included 

to aid in monitoring compliance with 

federal reporting and querying 

requirements. Responsibility for NPDB 

implementation and operation resides 

in the Bureau of Health Workforce, 

Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

The intent of the NPDB is to improve 

the quality of health care by 

encouraging hospitals, state licensing 

boards, professional societies, and other 

entities providing health care services to 

identify and discipline those who 

engage in unprofessional behavior, and 

to restrict the ability of incompetent 

health care practitioners, providers, or 

suppliers to move from state to state 

without disclosure of previous 

damaging or incompetent performance. 

It also serves as a fraud and abuse 

clearinghouse for the reporting and 

disclosing of certain final adverse 

actions (excluding settlements in which 

no findings of liability have been made) 

taken against health care practitioners, 

providers, or suppliers by health plans, 

federal agencies, and state agencies. 

The reporting forms, request for 

information forms (query forms), and 

administrative forms (used to monitor 

compliance) are accessed, completed, 

and submitted to the NPDB 

electronically through the NPDB Web 

site at http://www.npdb.hrsa.gov/. All 

reporting and querying is performed 

through this secure Web site. 

Need and Proposed Use of the 

Information: The NPDB acts primarily 

as a flagging system; its principal 

purpose is to facilitate comprehensive 

review of practitioners’ professional 

credentials and background. 

Information is collected from, and 

disseminated to, eligible entities 

(entities that are entitled to query and/ 

or report to the NPDB as authorized in 

Title 45 part 60 of the Code of Federal 

Regulations) on the following: (1) 

Medical malpractice payments, (2) 

licensure actions taken by Boards of 

Medical Examiners, (3) state licensure 

and certification actions, (4) federal 

licensure and certification actions, (5) 

negative actions or findings taken by 

peer review organizations or private 

accreditation entities, (6) adverse 

actions taken against clinical privileges, 

(7) federal or state criminal convictions 

related to the delivery of a health care 

item or service, (8) civil judgments 

related to the delivery of a health care 

item or service, (9) exclusions from 

participation in federal or state health 

care programs, and (10) other 

adjudicated actions or decisions. It is 

intended that NPDB information should 

be considered with other relevant 

information in evaluating credentials of 

health care practitioners, providers, and 

suppliers. 

Likely Respondents: Eligible entities 

that are entitled to query and/or report 

to the NPDB as authorized in 

regulations found at 45 CFR part 60. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


rljohnson on DSK3VPTVN1PROD with NOTICES