20688 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

314.71, 314.97 and 601.12; and the 

content and format of prescription drug 

labeling submitted under 21 CFR 201.56 

and 201.57. These collections of 

information are subject to review by 

OMB under the PRA act and are 

approved under OMB control numbers 

0910–0001, 0910–0338, and 0910–0572. 

Section V of the draft guidance refers to 

the guidance entitled ‘‘Formal Dispute 

Resolution: Appeals Above the Division 

Level,’’ which describes collections of 

information approved under OMB 

control number 0910–0430. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http:// 

www.regulations.gov. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8895 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–1998–D–0281] 

Guidance for Industry and Food and 

Drug Administration Staff; 30-Day 

Notices, 135-Day Premarket Approval 

Supplements and 75-Day Humanitarian 

Device Exemption Supplements for 

Manufacturing Method or Process 

Changes; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled ‘‘30- 

Day Notices, 135-Day Premarket 

Approval (PMA) Supplements and 75- 

Day Humanitarian Device Exemption 

(HDE) Supplements for Manufacturing 

Method or Process Changes.’’ This 

document provides guidance on the 

type of changes to an approved 

application that FDA believes may 

qualify for submission as 30-day 

notices, the type of information to 

submit in a 30-day notice, and the user 

fees associated with these submissions. 

The guidance document is immediately 

in effect, but it remains subject to 

comment in accordance with the 

Agency’s good guidance practices 

(GGP). 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4613, Silver Spring, 

MD 20993–0002; or to the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

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: 

For devices regulated by CDRH: 

Anastacia Bilek, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3656, Silver Spring, 

MD 20993–0002, 301–796–5588. 

For devices regulated by CBER: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘30-Day 

Notices, 135-Day Premarket Approval 

(PMA) Supplements and 75-Day 

Humanitarian Device Exemption (HDE) 

Supplements for Manufacturing Method 

or Process Changes.’’ This guidance is 

being issued consistent with FDA’s GGP 

regulation (§ 10.115 (21 CFR 10.115). 

This guidance is being implemented 

without prior public comment because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2)). The Agency 

made this determination because 

statutory provisions regarding medical 

device user fees under the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) (Pub. L. 110–85) are 

in effect and being implemented, and 

guidance is needed to help effect such 

implementation. Although this guidance 

is immediately in effect, it remains 

subject to comment in accordance with 

the Agency’s GGP regulation. 

The Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA) 

(Pub. L. 107–250) amended the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. et seq.) to 

authorize FDA to collect user fees for 

the review of certain premarket 

submissions (See section 708 of the 

FD&C Act (21 U.S.C. 379j).) FDAAA 

further amended the FD&C Act to 

extend FDA’s authority to collect 

medical device user fees through 

September 30, 2012, and added 30-day 

notices to the types of premarket 

submissions subject to user fees (21 

U.S.C. 379j(a)(2)(A)(vi)). For additional 

information on the MDUFMA, please 

see http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/

Overview/MedicalDeviceUser

FeeandModernizationActMDUFMA/

default.htm. 

This guidance supersedes the 

previous guidance document entitled 

‘‘30-Day Notices and 135-Day PMA 

Supplements for Manufacturing Method 

or Process Changes, Guidance for 

Industry and CDRH,’’ that published in 

the Federal Register of February 25, 

1998 (63 FR 9570). This guidance 

describes the user fees authorized, 

updates the previous guidance to clarify 

the process for submitting a 30-day 

notice, and provides additional 

information on the types of changes that 

may be submitted. The previous 

guidance did not include information 

on HDEs even though certain 

modifications to a manufacturing 

procedure or method of manufacture for 

HDEs are subject to the 30-day notice 

provisions. The current guidance 

includes this information. 

The guidance represents the Agency’s 

current thinking on 30-day notices, 135- 

day PMA supplements and 75-Day HDE 

supplements for manufacturing method 

or process changes. 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 statute 

and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

mstockstill on DSKH9S0YB1PROD with NOTICES

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. 

mstockstill on DSKH9S0YB1PROD with NOTICES