11554 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

1The regulation, CGMP guidance, and supportive 

information, including historical documents, are 

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

ApprovalProcess/Manufacturing/ucm085783.htm. 

2We update guidances periodically. To make sure 

you have the most recent version of a guidance, 

check FDA’s Drugs guidance Web page at: http:// 

www.fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/default.htm. 

Silver Spring, MD 20993–0002, 301– 

796–3416. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘FDA 

Oversight of PET Drug Products— 

Questions and Answers.’’ In 1997, 

Congress passed the Food and Drug 

Administration Modernization Act (the 

Modernization Act) (Pub. L. 105–115). 

Section 121 of the Modernization Act 

directed FDA to establish appropriate 

approval procedures and current good 

manufacturing practices (CGMP) for 

PET drugs. The procedures were 

finalized and an implementation 

timeline was instituted on December 10, 

2009, when FDA published regulations 

that described the minimum CGMP 

standards that each PET drug 

manufacturer is to follow during the 

production of a PET drug (see part 212 

(21 CFR part 212)).1 Under the 

requirements of section 121 of the 

Modernization Act, within 2 years 

following that publication date, a new 

drug application (NDA) or abbreviated 

new drug application (ANDA) must be 

submitted for any PET drug marketed 

for clinical use in the United States. 

Recognizing that many PET drug 

producers are unfamiliar with the drug 

approval process, FDA issued the 

guidance entitled PET Drug 

Applications—Content and Format for 

NDAs and ANDAs,2 and held a public 

meeting in March 2011 to assist 

applicants in preparing NDAs and 

ANDAs for the three most commonly 

used PET drugs. Numerous questions 

have been raised since that public 

meeting on all aspects of FDA oversight 

of PET drugs. This draft guidance is 

being issued to respond to the questions 

that have been submitted to date, and it 

will be revised periodically to respond 

to additional questions that have been 

submitted and are expected to be 

submitted in the future. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the FDA oversight of PET drugs. 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. 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. 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. 

III. Paperwork Reduction Act of 1995 

This draft 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. 3501–3520). The collections 

of information in 21 CFR part 314 were 

approved under OMB control numbers 

0910–0001 and 0910–0338; the 

collections of information in 21 CFR 

part 312 were approved under OMB 

control number 0910–0014; the 

collections of information in part 212 

were approved under OMB control 

number 0910–0667; the collections of 

information in 21 CFR parts 210 and 

211 were approved under 0910–0139; 

and the collections of information in 

21 CFR part 207 were approved under 

OMB control number 0910–0445. The 

draft guidance also refers to collections 

of information associated with 

submitting Form FDA 3397 

(Prescription Drug User Fee Cover 

Sheet), approved under OMB control 

number 0910–0297. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or 

http://www.regulations.gov. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4427 Filed 2–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0621] 

Final Decision on Withdrawal of Breast 

Cancer Indication for AVASTIN 

(Bevacizumab) Following Public 

Hearing; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the final decision 

withdrawing approval of the breast 

cancer indication for AVASTIN 

(Bevacizumab). The Commissioner of 

Food and Drugs (the Commissioner) 

issued the decision following a June 

2011 public hearing on a proposal to 

withdraw the approval. 

DATES: Withdrawal of AVASTIN’s breast 

cancer indication was effective 

November 18, 2011. 

ADDRESSES: Submit written requests for 

single copies of the decision 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. The 

final decision, hearing transcript, and 

other documents may be seen in the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1601, Rockville, 

MD 20852. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the decision and related 

documents. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Sickafuse, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–2320. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 22, 2008, FDA’s Center 

for Drug Evaluation and Research 

(CDER) approved a supplemental 

biologics license application (sBLA 

125085/91) submitted by Genentech, 

Inc. (Genentech), for the use of 

AVASTIN in combination with 

paclitaxel for patients who have not 

received chemotherapy for treatment of 

HER2-negative metastatic breast cancer 

(MBC). This approval was issued under 

the Agency’s accelerated approval 

regulations for biological products, 21 

CFR part 601, subpart E. Consistent with 

those regulations, the approval was 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11555 

subject to the requirement that the 

product be studied further to verify and 

describe its clinical benefit. On 

November 16, 2009, Genentech 

submitted the results of two clinical 

trials intended to satisfy this 

requirement. CDER determined that 

these trials failed to verify AVASTIN’s 

clinical benefit in the treatment of MBC 

and on December 16, 2010, issued a 

notice of opportunity for a hearing to 

Genentech proposing to withdraw 

approval of AVASTIN’s MBC 

indication. Genentech submitted a 

hearing request dated December 23, 

2010, followed by a submission of data 

and information on which it would rely 

at a hearing. The Agency granted 

Genentech’s hearing request and 

published a notice of hearing on May 

11, 2011 (76 FR 27332). The hearing was 

held on June 28 and 29, 2011. Following 

the hearing, on November 18, 2011, the 

Commissioner issued a final decision 

withdrawing approval of AVASTIN’s 

MBC indication. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the final decision at http:// 

www.fda.gov/downloads/NewsEvents/

Newsroom/UCM280546.pdf. The final 

decision, a transcript of the hearing, and 

other documents pertaining to the 

withdrawal of Avastin’s MBC indication 

are available at http://www.regulations.

gov under the docket number found in 

brackets in the heading of this 

document. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4424 Filed 2–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0605] 

Guidance for Institutional Review 

Boards, Clinical Investigators, and 

Sponsors: Institutional Review Board 

Continuing Review After Clinical 

Investigation Approval; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled, 

‘‘Guidance for IRBs, Clinical 

Investigators, and Sponsors: IRB 

Continuing Review after Clinical 

Investigation Approval.’’ The guidance 

announced in this document finalizes 

the draft guidance of the same title 

dated January 2010. This document also 

supersedes the Information Sheet, 

Continuing Review After Study 

Approval. The guidance is intended to 

assist institutional review boards (IRBs) 

in carrying out their continuing review 

responsibility by providing 

recommendations regarding the criteria, 

process, and frequency of continuing 

review to assure the protection of the 

rights and welfare of subjects in clinical 

investigations. 

DATES: Submit either electronic or 

written comments at any time. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research (CDER), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 51, Rm. 

2201, Silver Spring, MD 20993–0002 (1– 

888–463–6332 or 301–796–3400); or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448 (1–800–835– 

4709 or 301–827–1800); or 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 (1– 

800–638–2041 or 301–796–7100). Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. 

FOR FURTHER INFORMATION CONTACT: Sara 

Goldkind, Office of Good Clinical 

Practice, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 5129, Silver Spring, MD 20993– 

0002. 301–796–8342. 

SUPPLEMENTARY INFORMATION:

I. Background 

FDA is announcing the availability of 

a guidance entitled, ‘‘Guidance for IRBs, 

Clinical Investigators, and Sponsors: 

IRB Continuing Review after Clinical 

Investigation Approval.’’ This guidance 

is intended to assist IRBs in carrying out 

their continuing review responsibility 

under 21 CFR 56.108(a) and 56.109(f) by 

providing recommendations regarding 

the criteria, process, and frequency of 

continuing review to assure the 

protection of the rights and welfare of 

subjects in clinical investigations. The 

guidance should also help clinical 

investigators and sponsors better 

understand their responsibilities related 

to continuing review. This guidance 

supersedes the Information Sheet, 

‘‘Continuing Review After Study 

Approval’’ (September 1998, Office of 

Health Affairs, Food and Drug 

Administration). To enhance human 

subject protection and reduce regulatory 

burden, the Department of Health and 

Human Services, Office for Human 

Research Protections (OHRP) and FDA 

have been actively working to 

harmonize the Agencies’ regulatory 

requirements and guidance for human 

subject research. This guidance 

document was developed as a part of 

these efforts. 

In the Federal Register of January 13, 

2010 (75 FR 1790), FDA announced the 

availability of the draft guidance of the 

same title, dated January 2010. FDA 

received numerous comments on the 

draft guidance. All comments received 

during the comment period and 

questions received by Agency staff 

related to implementation of the 

regulations have been carefully 

reviewed and, where appropriate, 

incorporated into the guidance. Changes 

from the draft guidance include more 

detailed discussion about what should 

be submitted to assist the IRB in 

conducting continuing review, 

clarification of recommendations 

regarding submission of study-wide 

information for multi-site studies, 

discussion of the circumstances in 

which expedited review procedures 

may be used for continuing review, and 

revised guidance about how continuing 

review dates should be determined. In 

addition, FDA’s draft guidance, ‘‘IRB 

Continuing Review after Clinical 

Investigation Approval’’, did not 

address IRB approval of research with 

conditions. Subsequent to OHRP’s 

issuance of its guidance, ‘‘IRB Approval 

of Research with Conditions’’ 

(November 2010), FDA received 

multiple inquiries and comments 

recommending that FDA adopt the same 

policy. In response to these comments, 

FDA is including a discussion of IRB 

approval of research with conditions in 

the guidance. 

This guidance is part of the 

Information Sheet Guidance Initiative, 

announced in the Federal Register of 

February 3, 2006 (71 FR 5861), which 

describes FDA’s intention to update the 

process for developing, issuing, and 

making available guidances intended for 

IRBs, clinical investigators, and 


srobinson on DSK4SPTVN1PROD with NOTICES