Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20689 

3520). The collections of information 21 

CFR part 814, subparts B and E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information 21 CFR part 814, subpart H, 

have been approved under OMB control 

number 0910–0332; the collections of 

information 21 CFR part 820 have been 

approved under OMB control number 

0910–0073; the collections of 

information in FDA form 3601 have 

been approved under OMB control 

number 0910–0511; and the collections 

of information in FDA form 3602a have 

been approved under OMB control 

number 0910–0508. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. Always access an 

FDA guidance document by using 

FDA’s Web site listed previously to find 

the most current version of the 

guidance. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8886 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0044] 

Guidance for Industry on Influenza: 

Developing Drugs for Treatment and/or 

Prophylaxis; 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 ‘‘Influenza: Developing Drugs 

for Treatment and/or Prophylaxis.’’ This 

guidance is intended to assist sponsors 

in the clinical development of drugs and 

therapeutic biological products for the 

treatment and/or prophylaxis of illness 

caused by influenza viruses A and B, 

including both seasonal and pandemic 

varieties. This guidance finalizes the 

draft guidance issued February 20, 2009. 

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, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. 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: 

Jeffrey Murray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6360, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Influenza: Development of Drugs for 

Treatment and/or Prophylaxis.’’ Because 

of the public health implications of both 

epidemic and pandemic influenza, the 

variable nature of the disease, the 

limited therapeutic options, and 

challenges in studying new options, 

FDA is issuing guidance to assist 

sponsors in all phases of influenza drug 

development. 

This guidance addresses nonclinical 

development, early phases of clinical 

development, phase 3 protocol designs 

and endpoints for the treatment of both 

uncomplicated and serious influenza, 

and protocol designs for prevention of 

symptomatic influenza. Other issues 

that are addressed in this guidance 

include the role of animal data in an 

influenza drug development program, 

and considerations relating to the 

potential for emergency access to 

influenza drugs, including advance 

development of protocols for further 

exploration and verification of drug 

effects under epidemic and pandemic 

conditions. 

A draft notice of availability of this 

guidance was published for comment in 

the Federal Register of February 20, 

2009 (74 FR 7908). Comments we 

received on the draft guidance have 

been considered and the guidance has 

been revised as follows: (1) Clarification 

on the size of a safety database needed 

to support filing of a new drug 

application for the treatment of serious 

influenza; (2) elaboration on why 

virologic endpoints are not currently 

acceptable primary efficacy endpoints 

in phase 3 studies; (3) a 

recommendation for the inclusion of 

sensitive and specific assays (e.g., realtime polymerase chain reaction assay) 

for laboratory confirmation of influenza 

infection to assist in defining the 

infected population for analyses in 

influenza treatment trials; and (4) 

additional statements regarding 

proposals for potential emergency use 

authorizations of antiviral drugs for 

influenza. 

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 developing drugs 

for treatment and/or prophylaxis of 

influenza illness. 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. 

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 to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

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20690 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

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: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8817 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Preparation for International 

Conference on Harmonization Steering 

Committee and Expert Working Group 

Meetings in Cincinnati, OH; Regional 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Preparation for ICH Steering 

Committee and Expert Working Group 

Meetings in Cincinnati, Ohio’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Cincinnati, OH. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Group meetings in 

Cincinnati, OH, scheduled on June 11 

through 17, 2011, at which discussion of 

the topics underway and the future of 

ICH will continue. 

Date and Time: The public meeting 

will be held on May 19, 2011, from 2 

p.m. to 4 p.m. 

Location: The public meeting will be 

held at the Washington Theater room at 

the Hilton Washington DC/Rockville 

Hotel & Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: All participants must 

register with Kimberly Franklin, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, email: Kimberly.Franklin@fda.hhs.gov, or 

FAX: 301–595–7937. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material, and requests 

to make oral presentations to the contact 

person (see Contact Person) by May 16, 

2011. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Public oral presentations will 

be scheduled between approximately 

3:30 p.m. and 4 p.m. Time allotted for 

oral presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person (see Contact Person) by May 16, 

2011, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses, telephone 

number, fax, and email of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

If you need special accommodations 

due to a disability, please contact 

Kimberly Franklin (see Contact Person) 

at least 7 days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information, 12420 

Parklawn Dr., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan, and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

Agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor, and Welfare; the Japanese 

Pharmaceutical Manufactures 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. (FDA has verified 

the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

The agenda for the public meeting 

will be made available on the Internet 

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

NewsEvents/ucm248489.htm. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8816 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

International Consortium of 

Orthopedic Registries; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘International Consortium of 

Orthopedic Registries (ICOR).’’ The 

mstockstill on DSKH9S0YB1PROD with NOTICES