Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 21779 

Estimated Total Annual Burden 

Hours: 330,000 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@acf.hhs.

gov. All requests should be identified by 

the title of the information collection. 

ACF specifically requests comments 

on: (a) Whether the proposed collection 

of information is necessary for the 

proper performance of the functions of 

the agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden information to be collected; and 

(d) ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–8589 Filed 4–10–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0221] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study on Consumer Responses to 

Labeling Statements on Food 

Packages 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by May 11, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–New and 

title ‘‘Experimental Study on Consumer 

Responses to Labeling Statements on 

Food Packages.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, II, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Experimental Study on Consumer 

Responses to Labeling Statements on 

Food Packages—(OMB Control Number 

0910–NEW) 

I. Background 

The Nutrition Labeling and Education 

Act requires almost all packaged foods 

to bear nutrition labeling in the form of 

the Nutrition Facts label. The law also 

allows manufacturers to provide other 

nutrition information on labels in the 

form of various types of statements, 

including claims, as long as such 

statements comply with the regulatory 

limits that govern the use of each type 

of statement. There are three types of 

claims that the food industry can 

voluntarily use on food labels: (1) 

Health claims, (2) nutrient content 

claims (e.g., ‘‘Low fat’’), and (3) 

structure/function claims (e.g., 

‘‘Calcium builds strong bones.’’). 

Although the different types of claims 

are regulated differently, they all must 

be truthful and not misleading (Ref. 1). 

With the increased public interest in 

identifying healthier foods, U.S. food 

processors have been adding nutritional 

information in the form of nutrition 

symbols to food labels in addition to 

claims. Examples of nutrition symbols 

that have been used or suggested 

include nutrient-specific disclosures 

(e.g., ‘‘Guideline Daily Amounts’’) (Ref. 

2), calorie declarations (Ref. 3), 

summary product rating (e.g., ‘‘Smart 

Spot’’) (Ref. 4), a hybrid summary 

indicator with nutrient-specific 

disclosure (e.g., ‘‘Sensible Solution: 

Good Source of Calcium, Good Sources 

of 8 Vitamins and Minerals’’) (Ref. 5), 

the Facts-Up-Front icon, with and 

without positive nutrients (Ref. 6), and 

the symbol recommended by the 

Institute of Medicine (Ref. 7). Claims 

related to non-nutritional product 

characteristics are also used in food 

labeling. The claims may feature, among 

other things, statements about how 

foods are grown or made (e.g., 

‘‘Organic’’ and ‘‘All Natural’’) or 

absence of a substance (e.g., ‘‘Glutenfree’’). 

Many consumers use claims and the 

Nutrition Facts label in food choice 

decisions (Refs. 8 through 10). While 

some products carry only a single 

labeling statement (e.g., either one claim 

or one symbol) on their packages, many 

products carry two or more labeling 

statements. In addition, on the same 

package the attributes of one statement 

may differ from those of other 

statements in terms of featured nutrient, 

type of claim, framing of statement, 

nature of statement, and presentation of 

statement. For example, a package may 

display one or more statements such as 

symbols relating to nutrition content, 

statements in words relating to the 

presence of certain nutrients, statements 

in words relating to the absence of other 

nutrients, statements in words 

describing the health benefits of 

consuming foods containing or not 

containing certain nutrients, and 

statements in words describing how the 

product was produced. Moreover, all of 

those symbols and statements are 

distributed in various places on the 

package in different font sizes and 

colors. 

There exists a large body of literature 

on the impacts of different types of 

labeling statements on consumer 

perceptions and choices of products 

(Refs. 11 and 12). The majority of the 

research, including the consumer 

research that the Agency has previously 

conducted (Refs. 13 and 14), has 

focused on single labeling statements by 

eliciting study participants’ reactions to 

variants of a given statement. An 

advantage of this research approach is 

that it helps isolate the effects of 

individual statements and avoid 

potential confounding effects caused by 

the presence of other statements. A 

disadvantage of this research approach, 

however, is that it does not necessarily 

reflect the labels consumers see in the 

marketplace. In particular, the existing 


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21780 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 

literature provides little information 

about how the coexistence of two or 

more different labeling statements 

affects product perceptions and choices. 

This information, however, is critical for 

understanding the roles played by 

labeling statements in dietary decisions. 

Research suggests consumer product 

perceptions and purchase decisions can 

be influenced by labeling statements 

and different labeling statements may 

have different influences (Refs. 11 

through 14). Therefore, FDA, as part of 

its effort to promote public health, 

proposes to use this study to explore 

consumer responses to food labels that 

bear multiple labeling statements. 

Specifically, the study plans to examine: 

(1) Consumer responses to food labels 

that exhibit various combinations of the 

number and type of statements, (2) 

whether and how consumer responses 

to one label characteristic may be 

affected by the other characteristic (i.e., 

the interactions between different 

characteristics of labeling statements), 

and (3) whether and how labeling 

statements affect consumers’ use of the 

Nutrition Facts label. 

The proposed collection of 

information is a controlled randomized 

experimental study. The study will use 

a 15-minute Web-based survey to collect 

information from 4,000 Englishspeaking adult members of an online 

consumer panel maintained by a 

contractor. The study will aim to 

produce a sample that reflects the U.S. 

Census on gender, education, age, and 

ethnicity/race. 

The study will randomly assign each 

of its participants to view two label 

images from a set of food labels that will 

be created for the study. These images 

will be systematically varied in the 

following aspects: (1) Number of 

statements (ranging from none to three); 

(2) featured nutrient and food product 

(fat—snack bar, sodium—chips, or 

fiber—breakfast cereal); (3) type of 

statement (text such as ‘‘Supports 

Cardiovascular Functioning’’ or graphic, 

specifically the Facts-Up-Front icons 

and one of the icon concepts proposed 

by the Institute of Medicine) (Refs. 13 

and 14); and (4) nature of featured 

product attribute (such as ‘‘Supports the 

Immune System’’ or ‘‘All Natural’’). 

With regard to claims, the study will 

focus on examples of nutrient content 

claims and structure/function claims 

that can be found on many food 

packages (Ref. 15). All label images will 

be mockups resembling food labels that 

may be found in the marketplace. 

Images will show product identity (e.g., 

tortilla chips) but not any real or 

fictitious brand name. The study will 

provide interested participants access to 

the Nutrition Facts label but not 

together with a product image. 

The survey will ask its participants to 

view label images and answer questions 

about their perceptions and reactions 

related to the viewed product and label. 

Product perceptions (e.g., healthfulness, 

potential health benefits, levels of 

nutrients, and taste) and label 

perceptions (e.g., helpfulness and 

credibility) will constitute the measures 

of responses in the experiment. To help 

understand the data, the survey will 

also collect information about 

participants’ background, such as 

familiarity with and consumption, 

purchase, and perception of the 

categories of food included in the study; 

awareness and knowledge of nutrients; 

dietary interests; motivation regarding 

label use and health literacy; and health 

status and demographic characteristics. 

The study is part of the Agency’s 

continuing effort to enable consumers to 

make informed dietary choices and 

construct healthful diets. Results of the 

study will be used primarily to enrich 

the Agency’s understanding of how 

multiple claims and other labeling 

statements on food packages may affect 

how consumers perceive a product or a 

label, which may in turn affect their 

dietary choices. Results of the study will 

not be used to develop population 

estimates. 

In the Federal Register of April 13, 

2011 (76 FR 20675), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. The Agency received four 

responses to the notice. One of the 

responses was outside of the scope of 

the proposed collection of information 

described in the 60-day notice and is 

not addressed here. The remaining three 

responses contained multiple 

comments. These comments, and the 

Agency’s responses, are discussed in the 

following paragraphs. 

(Comment 1) Two comments 

suggested that FDA provide mock 

stimuli for public comment prior to 

initiating the study. 

(Response) We appreciate the 

suggestion for the Agency to provide the 

experimental stimuli for public 

comment prior to initiating the study. 

Per the PRA, a copy of the proposed 

experimental stimuli is provided in the 

Appendix of the supporting document. 

(Comment 2) One comment suggested 

that the study include questions to 

probe how non-misleading nutrient 

content, health, and structure/function 

claims may improve consumers’ 

understanding of a product’s nutritional 

attributes. 

(Response) We agree and have 

included measures to assess how 

participants’ understanding of a 

product’s nutritional attributes may be 

affected by non-misleading claims. 

(Comment 3) Two comments 

expressed concerns about four questions 

proposed in the draft questionnaire. 

Two of the questions of concern asked 

if participants had ever heard or read 

that certain foods (unnamed) may help 

lower the risk of seven different types of 

health problems, such as cancer, 

diabetes, and others. The third and 

fourth questions of concern asked 

whether specific nutrients (e.g., 

calcium, potassium, etc.) or a particular 

food product, respectively, might help 

reduce the risk of the same health 

problems asked about in the other two 

questions. Both comments suggested 

that such questions would demonstrate 

that ‘‘consumers misinterpret structure 

function claims as health claims’’ and 

argued that such a demonstration would 

be inconsistent with the stated purpose 

of the information collection. 

(Response) FDA does not agree that 

the proposed questions on participants’ 

prior knowledge of foods’ health 

benefits and inferences from reading a 

label would bias the study toward 

health claims rather than structure/ 

function claims. Since label inferences 

can be affected by what consumers 

already know or believe about a food, 

the prior knowledge questions are 

included to help understand study 

participants’ reactions to labeling 

statements. The question about 

perceived health benefits of a product is 

one of the most important measures of 

label inferences. The Agency’s previous 

research has shown that consumer 

inferences of the health benefits of a 

product do not necessarily vary between 

types of labeling statements (i.e., health 

claims, structure/function claims, and 

nutrient content claims). Hence, this 

question is not expected to produce 

erroneous data with respect to 

inferences about structure/function 

claims. 

(Comment 4) One comment suggested 

that FDA consider including an 

experimental condition in which 

participants would view a label bearing 

up to three different labeling statements 

because consumers are routinely 

exposed to this amount of information 

on food packages. In the originally 

proposed design, FDA included label 

manipulations involving only up to two 

different labeling statements. 

(Response) We agree with the 

comment and have revised the study to 

include experimental conditions 

containing up to three labeling 

statements on a label. 

(Comment 5) One comment suggested 

including an assessment of how the 


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Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 21781 

various labeling statements affect 

whether participants intend to purchase 

the product or not. 

(Response) As we proposed in the 

draft questionnaire, we will include a 

question about purchase intention. 

(Comment 6) One commenter noted 

that prior research has shown that the 

appearance of packaging and statements 

on the front of the package can increase 

the likelihood of consumers using the 

Nutrition Facts label. 

(Response) FDA agrees that 

information about consumers’ use of the 

Nutrition Facts label is important and 

plans to record and analyze how likely 

the study’s participants are to consult 

the Nutrition Facts label when viewing 

claims and other statements on the front 

label of a product. 

(Comment 7) One comment 

questioned the relevance of asking 

participants to rate the safety or 

trustworthiness of a product based on 

the label information they view. 

(Response) Although the label content 

of a product may not be intended to 

influence consumer assumptions 

regarding the safety of a product, prior 

research has demonstrated that such 

influence may occur (Ref. 16). 

Therefore, it would be useful to 

understand whether similar reactions 

happen in a multiclaim context. 

Nevertheless, the products that the 

proposed study plans to include 

(breakfast cereal, chips, and snack bars) 

are generally not associated with safety 

issues that may lead to foodborne illness 

or other safety hazards. Therefore, the 

study will omit the proposed question 

on perceived product safety. On the 

other hand, the Agency has determined 

that it is still important and relevant to 

elicit study participants’ perceptions of 

the trustworthiness of various labeling 

statements (not foods, as stated in the 

comment), especially when these 

statements feature different nutrients or 

product benefits. Thus, the study will 

keep the proposed question on 

perceived trustworthiness of the label. 

(Comment 8) One comment suggested 

that the study ask about participants’ 

interest in nutrients for which there is 

concern of inadequate intake among 

Americans. The comment recommended 

replacing Vitamin D and omega-3 fatty 

acids for Vitamins A and C, as proposed 

in the previous draft questionnaire. 

(Response) We agree with the 

comment and have incorporated the 

suggestion in the revised questionnaire. 

(Comment 9) One comment suggested 

that a plausible distractor or wrong 

choice be included in the question 

about the nutrients participants try to 

limit or increase in their diet to test the 

validity of the responses. 

(Response) We disagree with the 

comment. Our previous surveys indicate 

respondents can provide valid 

responses to these questions (for 

example, Ref. 17). Furthermore, we are 

concerned that the validity of the 

responses would suffer if a distractor or 

wrong choice is included because 

participants may be confused by the 

presence of such options in the 

question. 

To help design and refine the 

questionnaire, FDA plans to conduct 

cognitive interviews by screening 72 

panelists in order to obtain 9 

participants in the interviews. Each 

screening is expected to take 5 minutes 

(0.083 hour), and each cognitive 

interview is expected to take 1 hour. 

The total for cognitive interview 

activities is 15 hours (6 hours + 9 

hours). Subsequently, we plan to 

conduct pretests of the questionnaire 

before it is administered in the study. 

We expect that 1,600 invitations, each 

taking 2 minutes (0.033 hour), will need 

to be sent to panelists to have 200 of 

them complete a 15-minute (0.25 hour) 

pretest. The total for the pretest 

activities is 103 hours (53 hours + 50 

hours). For the survey, we estimate that 

32,000 invitations, each taking 2 

minutes (0.033 hour) to complete, will 

need to be sent to the consumer panel 

to have 4,000 of its members complete 

a 15-minute (0.25 hour) questionnaire. 

The total for the survey activities is 

2,056 hours (1,056 hours + 1,000 hours). 

Thus, the total estimated burden is 

2,174 hours. FDA’s burden estimate is 

based on prior experience with research 

that is similar to this proposed study. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Cognitive interview screener ...................... 72 1 72 0.083 (5 minutes) 6 

Cognitive interview ..................................... 9 1 9 1 hour 9 

Pretest invitation ........................................ 1,600 1 1,600 0.033 (2 minutes) 53 

Pretest ........................................................ 200 1 200 0.25 (15 minutes) 50 

Survey invitation ......................................... 32,000 1 32,000 0.033 (2 minutes) 1,056 

Survey ........................................................ 4,000 1 4,000 0.25 (15 minutes) 1,000 

Total .................................................... ........................ ........................ ........................ .................................................. 2,174 

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

II. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. U.S. Food and Drug Administration, 

‘‘Claims That Can Be Made for Conventional 

Foods and Dietary Supplements,’’ September 

2003. Available at http://www.fda.gov/Food/ 

LabelingNutrition/LabelClaims/ucm111447.

htm. 

2. Kellogg’s, ‘‘How to Read a Nutrition 

Label,’’ 2010. Available at http://

www.kelloggs.com/en_US/the-benefits-ofcereal/how-to-read-a-nutrition-label.html. 

3. PepsiCo, ‘‘Nutrition Labeling,’’ 2010. 

Available at http://www.pepsico.com/

Purpose/Human-Sustainability/NutritionLabeling.html. 

4. Schmit, J., ‘‘PepsiCo Labels Some of Its 

Snacks ‘Smart,’ ’’ USA Today, September 2, 

2004. Available at http://www.usatoday.com/ 

money/industries/food/2004–09–02-smartspot_x.htm. 

5. Kraft Foods, ‘‘Sensible Solution,’’ 2010. 

Available at http://www.kraftrecipes.com/kf/ 

HealthyLiving/SensibleSolution/Sensible

Solution_Landing.aspx. 

6. FactsUpFront.org, ‘‘Facts Up Front,’’ 

2011. Available at http://factsupfront.com/. 

7. Institute of Medicine, ‘‘Front-of-Package 

Nutrition Rating Systems and Symbols: 

Promoting Healthier Choices,’’ 2011. 

Available at http://www.iom.edu/Reports/


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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 


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