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the draft guidance of the same title 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
11556 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

1Prior to the 2007 reauthorization of the Best 

Pharmaceuticals for Children Act (Pub. L. 107–109), 

the priority list included specific drugs instead of 

therapeutic areas. 

sponsors. Known as ‘‘Information 

Sheets,’’ these guidances have provided 

recommendations to IRBs, clinical 

investigators, and sponsors to help them 

fulfill their responsibilities to protect 

human subjects who participate in 

research regulated by the FDA. The 

Information Sheet Guidance Initiative is 

intended to ensure that the Information 

Sheets are updated, consistent with the 

FDA’s good guidance practices (GGPs). 

As part of the initiative, which will be 

ongoing, the Agency plans to rescind 

Information Sheets that are obsolete, 

revise and reissue guidances that 

address current issues, and develop new 

guidance documents as needed. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. 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. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.regulations.gov or 

http://www.fda.gov/ScienceResearch/ 

SpecialTopics/RunningClinicalTrials/ 

GuidancesInformationSheetsandNotices

/ucm113709.htm. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4425 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–2011–N–0918] 

Pediatric Studies of Meropenem 

Conducted in Accordance With 

Section 409I of the Public Health 

Service Act; Establishment of Public 

Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opening of a public docket to make 

available to the public a report of the 

pediatric studies of meropenem that 

were conducted in accordance with 

section 409I of the Public Health Service 

Act (PHS Act) and submitted to the 

Director of the National Institutes of 

Health (NIH) and the Commissioner of 

Food and Drugs. 

DATES: Submit either electronic or 

written comments by March 28, 2012. 

ADDRESSES: You may submit comments, 

identified by FDA–2011–N–0918, by 

any of the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Denise Pica-Branco, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6402, 

Silver Spring, MD 20993–0002, Email: 

denise.picabranco@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under 

section 409I of the PHS Act (42 U.S.C. 

284m), the Secretary of the Department 

of Health and Human Services (the 

Secretary) acting through the Director of 

the NIH, in consultation with FDA and 

experts in pediatric research, must 

develop, prioritize, and publish a list of 

priority needs in pediatric therapeutics, 

including drugs and indications that 

require study.1 For drugs and 

indications on this list, FDA, acting in 

consultation with NIH, is authorized to 

issue a written request to holders of a 

new drug application (NDA) or 

abbreviated new drug application 

(ANDA) for a drug for which pediatric 

studies are needed to provide safety and 

efficacy information for pediatric 

labeling. If the sponsors receiving the 

written request decline to conduct the 

studies or if FDA does not receive a 

response to the written request within 

30 days of the date the written request 

was issued, the Secretary, acting 

through the Director of NIH and in 

consultation with FDA, must publish a 

request for proposals to conduct the 

pediatric studies described in the 

written request and award funds to an 

entity with appropriate expertise for the 

conduct of the pediatric studies 

described in the written request. Upon 

completion of the pediatric studies, a 

study report that includes all data 

generated in connection with the 

studies must be submitted to FDA and 

NIH and placed in a public docket 

assigned by FDA. 

Meropenem, an antibiotic medication, 

is labeled for pediatric patients from 3 

months of age through adolescence as a 

single agent antimicrobial therapy for 

meningitis and complicated intraabdominal infections, and is a 

recommended option for monotherapy 

of high severity complicated intraabdominal infections in adults. Off-label 

use of meropenem in newborn and 

infant patients younger than 3 months 

of age is significant, despite the lack of 

adequate pharmacokinetic, dosing, 

tolerability, and safety data for this age 

group. 

On August 13, 2003, NIH published a 

Federal Register notice (68 FR 48402) 

announcing the addition of several 

drugs, including meropenem, to the 

priority list of drugs most in need of 


srobinson on DSK4SPTVN1PROD with NOTICES