21782 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 

2011/Front-of-Package-Nutrition-RatingSystems-and-Symbols-Promoting-HealthierChoices.aspx. 

8. Centers for Disease Control and 

Prevention, ‘‘2005–2006 National Health and 

Examination Survey Questionnaire, Diet 

Behavior and Nutrition section,’’ 

Unpublished results of questions DBQ.750 

and DBQ.780. Questionnaire available at 

http://www.cdc.gov/nchs/data/nhanes/

nhanes_05_06/sp_dbq_d.pdf. 

9. U.S. Food and Drug Administration, 

‘‘2008 Health and Diet Survey,’’ March 20, 

2010. Available at http://www.fda.gov/Food/ 

ScienceResearch/ResearchAreas/Consumer

Research/ucm193895.htm. 

10. Food Marketing Institute, ‘‘2009 U.S. 

Grocery Shopper Trends Survey,’’ 

Washington, DC 2009. 

11. Drichoutis, A.C., P. Lazaridis, and R.M. 

Nayga, ‘‘Consumers’ Use of Nutritional 

Labels: A Review of Research Studies and 

Issues,’’ Academy of Marketing Science 

Review, 2006(9), 2006. Available at http://

www.amsreview.org/articles/drichoutis09- 

2006.pdf. 

12. La ̈hteenma ̈ki, L., P. Lampila, K. 

Grunert, et. al, ‘‘Impact of Health-Related 

Claims on the Perception of Other Product 

Attributes,’’ Food Policy, 23: 230–239, 2010. 

13. Labiner-Wolfe, J., C.-T. J. Lin, and L. 

Verrill, ‘‘Effect of Low Carbohydrate Claims 

on Consumer Perceptions About Food 

Products’ Healthfulness and Helpfulness for 

Weight Management,’’ Journal of Nutrition 

Education and Behavior, 42(5): 315–320, 

2010. 

14. Roe, B., A.S. Levy, and B.M. Derby, 

‘‘The Impact of Health Claims on Consumer 

Search and Product Evaluation Outcomes: 

Evidence From FDA Experimental Data,’’ 

Journal of Public Policy and Marketing, 18(1): 

89–105, 1999. 

15. LeGault, L., M.B. Brandt, N. McCabe, 

et. al, ‘‘2000–2001 Food Label and Package 

Survey: An Update on Prevalence of 

Nutrition Labeling and Claims on Processed, 

Packaged Foods,’’ Journal of the American 

Dietetic Association, 104(6): 952–958, 2004. 

16. Kapsak, W.R., D. Schmidt, N.M. Childs, 

et. al, ‘‘Consumer Perceptions of Graded, 

Graphic and Text Label Presentations for 

Qualified Health Claims,’’ Critical Reviews in 

Food Science and Nutrition, 48: 248–256, 

2008. 

17. U.S. Food and Drug Administration, 

‘‘Health and Diet Survey: Dietary Guidelines 

Supplement—Report of Findings (2004 and 

2005), 2008. Available at http://www.fda.gov/ 

Food/ScienceResearch/ResearchAreas/

ConsumerResearch/ucm080331.htm. 

Dated: April 5, 2012. 

David Dorsey, 

Acting Association Commissioner for Policy 

and Planning. 

[FR Doc. 2012–8699 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–D–0315] 

International Conference on 

Harmonisation; Draft Guidance for 

Industry on E2C(R2) Periodic BenefitRisk Evaluation Report; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘E2C(R2) Periodic 

Benefit-Risk Evaluation Report.’’ The 

draft guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance updates and 

combines two ICH guidances, ‘‘E2C 

Clinical Safety Data Management: 

Periodic Safety Update Reports for 

Marketed Drugs’’ (E2C guidance) and 

‘‘Addendum to E2C Clinical Safety Data 

Management: Periodic Safety Update 

Reports for Marketed Drugs’’ 

(addendum to the E2C guidance). The 

draft guidance describes the format, 

content, and timing of a periodic 

benefit-risk evaluation report (PBRER) 

for an approved drug or biologic. 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. 

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 11, 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, 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. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. 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: 

Regarding the draft guidance: Andrea 

Feight, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4494, Silver Spring, 

MD 20993–0002, 301–796–0152; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 3506, 

Silver Spring, MD 20993–0002, 301– 

796–8377. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory Agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
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