Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 21783 

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 the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of May 19, 

1997 (62 FR 27470), FDA published a 

notice announcing the availability of the 

E2C guidance. In the Federal Register of 

February 5, 2004 (69 FR 5551), FDA also 

published the addendum to the E2C 

guidance to provide needed clarification 

and additional guidance. Since that 

time, the pharmacovigilance 

environment has evolved, prompting 

reassessment of the role of the periodic 

safety update report in the spectrum of 

safety documents submitted to 

regulatory authorities. This 

reassessment highlighted several factors 

that led to consensus for revising the 

E2C guidance and the addendum to the 

E2C guidance to enhance their 

usefulness in light of advances in the 

field. There has been significant 

progress in the technology and science 

of pharmacovigilance, including 

electronic submission of individual case 

safety reports to regulatory authorities, 

automated data mining techniques, 

more attention to benefit-risk 

evaluation, greater emphasis on 

proactive and documented risk 

management planning, and increasing 

recognition that meaningful evaluation 

of important new risk information 

should be undertaken in the context of 

a medicinal product’s benefits. 

In January 2012, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘E2C(R2) Periodic Benefit-Risk 

Evaluation Report’’ should be made 

available for public comment. The draft 

guidance is the product of the E2C(R2) 

Expert Working Group of the ICH. 

Comments about this draft will be 

considered by FDA and the E2C(R2) 

Expert Working Group. 

The draft guidance describes the 

format, content, and timing of a PBRER 

for an approved drug or biologic. The 

PBRER will serve as a common standard 

for periodic reporting on approved 

drugs or biologics among the ICH 

regions. Once this guidance is finalized, 

applicants can submit a waiver request 

for submission of the PBRER in the 

United States in place of a periodic 

adverse drug experience report for a 

new drug application, for an abbreviated 

new drug application, or for a biologics 

license application. The harmonized 

PBRER is intended to promote a 

consistent approach to periodic 

postmarket safety reporting among the 

ICH regions and to enhance efficiency 

by reducing the number of reports 

generated for submission to the 

regulatory authorities. 

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 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. The Paperwork Reduction Act of 

1995 

This draft guidance includes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3520). In 

accordance with the PRA, before 

publication of the final guidance 

document, FDA intends to solicit public 

comment and obtain OMB approval for 

any information collections 

recommended in this guidance that are 

new or that would represent material 

modifications to previously approved 

collections of information found in FDA 

regulations. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

regulations.gov, http://www.fda.gov/

Drugs/GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm. 

Dated: April 6, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8697 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0691] 

Guidance on Media Fills for Validation 

of Aseptic Preparations for Positron 

Emission Tomography Drugs; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Media Fills for Validation of Aseptic 

Preparations for Positron Emission 

Tomography (PET) Drugs.’’ This 

guidance is intended to help 

manufacturers of PET drugs meet the 

requirements for the Agency’s current 

good manufacturing practice regulations 

for PET drugs. 

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 

request. 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: 

Elizabeth Giaquinto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, Rm. 

6164, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3416. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Media Fills for 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
21784 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 

Validation of Aseptic Preparations for 

Positron Emission Tomography (PET) 

Drugs.’’ Most PET drugs are designed for 

parenteral administration and are 

produced by aseptic processing. The 

goal of aseptic processing is to make a 

product that is free of microorganisms 

and toxic microbial byproducts, such as 

bacterial endotoxins. The media fill is 

the performance of an aseptic 

manufacturing procedure using a sterile 

microbiological growth medium in 

place of the drug solution to test 

whether the aseptic procedures are 

adequate to prevent contamination 

during actual drug production. This 

guidance takes the form of questions 

and answers written specifically to help 

manufacturers comply with the 

Agency’s current good manufacturing 

practices for PET drugs (21 CFR part 

212) regarding media fills. 

A draft guidance of the same title was 

announced in the Federal Register on 

September 30, 2011 (76 FR 60847), and 

Docket No. FDA 2011–D–0691 was open 

for comments until December 29, 2011. 

We received comments from industry 

and professional societies. We have 

carefully considered, and where 

appropriate, we have made corrections, 

added information, or clarified the 

information in this guidance in response 

to the comments or on our own 

initiative. 

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 media fills and 

process simulations for 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 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 212 have been approved 

under OMB control number 0910–0667. 

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: April 6, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8702 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No FDA–2012–N–0001] 

Science Board to the Food and Drug 

Administration; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Science Board to 

the Food and Drug Administration 

(Science Board). 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex and 

technical issues, as well as emerging 

issues within the scientific community 

in industry and academia. Additionally, 

the Science Board provides advice to 

the Agency on keeping pace with 

technical and scientific evolutions in 

the fields of regulatory science, on 

formulating an appropriate research 

agenda, and on upgrading its scientific 

and research facilities to keep pace with 

these changes. It will also provide the 

means for critical review of Agencysponsored intramural and extramural 

scientific research programs. 

Date and Time: The meeting will be 

held on May 2, 2012, from 9 a.m. to 4 

p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993. For 

those unable to attend in person, the 

meeting will also be Web cast. The link 

for the Web cast is available at 

https://collaboration.fda.gov/ 

scienceboard/. Information regarding 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

CONTACT PERSON FOR MORE INFORMATION: 

Martha Monser, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4286, Silver Spring, 

MD 20993, 301–796–4627, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 

Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The Science Board will be 

provided with an overview of 

Georgetown University’s proposed 

programs under the Centers for 

Excellence in Regulatory Science and 

Innovation (CERSI) initiative. In 

addition, the Board will also hear about 

CERSI activities resulting from the 

Memorandum of Understanding 

between the National Center for 

Toxicological Research and the state of 

Arkansas. The Board will also be 

provided with an overview of ongoing 

genomic efforts at FDA as well as an 

update on Foods activities and an 

update regarding Scientific Computing 

efforts. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. 

Background material is available at 

http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES