Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11553 

document). We base this estimate on our 

experience with related contingency 

planning under the draft guidance for 

industry entitled: ‘‘Planning for the 

Effects of High Absenteeism to Ensure 

Availability of Medically Necessary 

Drug Products’’ (Absenteeism Draft 

Guidance) published in the Federal 

Register of January 8, 2010 (75 FR 

1060), and October 18, 2010 (75 FR 

63832), and the public comments we 

received on our burden estimate for that 

guidance. The Absenteeism Draft 

Guidance recommends that drug and 

biological product manufacturers 

develop written plans to maintain an 

adequate supply of medically necessary 

products during an emergency that 

results in high employee absenteeism. 

Although the draft guidance that is the 

subject of this Federal Register 

document is not related to employee 

absenteeism, the two guidance 

documents apply to a similar group of 

manufacturers and we believe the 

contingency plans recommended in 

both draft guidance documents will 

include similar elements. Accordingly, 

we believe the burden estimates from 

the Absenteeism Draft are relevant to 

this draft guidance. However, we 

specifically request comment on these 

contingency plan burden hour 

estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED REPORTING BURDEN 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Hours per 

response Total hours 

Voluntary Reporting Under Section IV of the Draft Guidance .................................................................................. 480 1 480 2 960 

Total .............................................................................. ........................ ........................ ........................ ........................ 960 

1There are no capital costs or operating and maintenance costs associated with this information collection. 

TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

Voluntary Contingency Plans Under Section VI of the Draft 

Guidance .......................................................................... 70 1 70 500 35,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 35,000 

1There are no capital costs or operating and maintenance costs associated with this information collection. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either written or electronic 

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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/ucm121568.htm, http:// 

www.fda.gov/cber/guidelines.htm, or 

http://www.regulations.gov. 

Dated: February 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4439 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–2012–D–0080] 

Draft Guidance on Food and Drug 

Administration Oversight of Positron 

Emission Tomography Drug 

Products—Questions and Answers; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘FDA Oversight of PET Drug Products— 

Questions and Answers.’’ The draft 

guidance provides questions and 

answers that address nearly all aspects 

of the FDA approval and surveillance 

processes, including application 

submission, review, compliance with 

good manufacturing practices, 

inspections, registration and listing, and 

user fees. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 29, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft guidance document. 

Submit electronic comments on the 

draft 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: 

Elizabeth Giaquinto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, rm. 6164, 


srobinson on DSK4SPTVN1PROD with NOTICES
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