Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11547 

Kimberly Lane, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–4549 Filed 2–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Advisory Board on Radiation and 

Worker Health (ABRWH or Advisory 

Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

The meeting scheduled to convene on 

February 28–29, 2012 was published in 

the Federal Register on February 16, 

2012, Volume 77, Number 32, Pages 

9254–9255. This notice was put on 

display for 12 days in advance of the 

meeting instead of the 15 calendar days 

required in accordance with section 

10(a)(2) of the Federal Advisory 

Committee Act (Pub. L. 92–463), and 

pursuant to the requirements of 42 CFR 

83.15(a). 

CONTACT PERSON FOR MORE INFORMATION: 

Theodore Katz, M.P.A., Executive 

Secretary, NIOSH, CDC, 1600 Clifton 

Road, NE., MS E–20, Atlanta, Georgia 

30333, Telephone: (513) 533–6800, toll 

free: 1–800–CDC–INFO, email: 

dcas@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 17, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–4569 Filed 2–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0320] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study on Consumer Responses to 

Whole Grain 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. 

DATES: Fax written comments on the 

collection of information by March 28, 

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 Whole Grain Labeling 

Statements on Food Packages.’’ Please 

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 Whole Grain Labeling 

Statements on Food Packages—(OMB 

Control Number 0910–New) 

I. Background 

The Nutrition Labeling and Education 

Act, which amended the Federal Food, 

Drug, and Cosmetic Act, requires most 

foods to bear nutrition labeling (i.e., the 

Nutrition Facts) and requires food labels 

that bear nutrient content claims and 

certain health messages to comply with 

specific requirements. There are three 

different types of claims (health claims, 

nutrient content claims, and structure/ 

function claims) that the food industry 

can voluntarily use on food labels. 

Although they are regulated differently, 

they all must be truthful and not 

misleading (Ref. 1). 

In the past 30 years, whole-grain 

consumption has been greatly promoted 

by government agencies and scientific 

communities as an important part of a 

healthy diet (Refs. 2 and 3). For 

example, the newly released ‘‘Dietary 

Guidelines for Americans 2010’’ 

recommends Americans eat fewer 

refined grains and consume more 

nutrient-dense whole grains instead 

(Ref. 4). At the same time, whole grain 

labeling statements, such as ‘‘Made 

With Whole Grain’’, on food products 

have also become more prevalent in 

recent years (Ref. 5). Given the variety 

of whole-grain statements on food 

products and the importance of whole 

grains in maintaining a healthy diet, it 

is important for policy makers to gain a 

better understanding of how consumers 

interpret these statements. 

Several studies indicate that 

consumers may have difficulties in 

understanding the meaning of whole 

grains or recognizing whole-grain foods 

(Refs. 6 to 8). Research also suggests 

consumer product perceptions and 

purchase decisions can be influenced by 

labeling statements, and different 

labeling statements may have different 

influences (Refs. 9 and 10). The majority 

of existing studies focus on whole grain 

intake or the relationships between 

whole grain and disease prevention. 

There is a lack of systematic 

investigation of consumers’ 

understanding of different whole-grain 

labeling statements. We are aware of at 

least one existing study related to the 

statements (Ref. 11). However, the study 

did not compare consumer reactions to 

various whole-grain statements. 

Therefore, FDA, as part of its effort to 

promote public health, plans to use the 

proposed study to explore and compare 

consumer responses to food labels that 

use whole-grain labeling statements. 

Specifically, the study plans to 

examine: (1) Consumer judgments about 

a food product including its nutritional 

attributes, overall healthiness, and 

health benefits; (2) consumer judgments 

about a labeling statement in terms of its 

credibility, helpfulness, and other 

attributes; (3) consumer interpretations 

of different terms and statements, such 

as ‘‘Made with Whole Grain’’, ‘‘MultiGrain’’, and ‘‘100% Whole Wheat’’; (4) 

consumer extrapolation of whole grain 

statements beyond the scope of the 

statements themselves (i.e., halo effects); 


srobinson on DSK4SPTVN1PROD with NOTICES
11548 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

and (5) how whole grain statements 

influence consumer use of the Nutrition 

Facts. 

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 2,700 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 

participant to view one label image from 

a set of food labels that will be created 

for the study and systematically varied 

in the (1) whole grain labeling 

statement; (2) featured product (e.g., 

bread, salty snacks, and breakfast bars); 

(3) access to the Nutrition Facts label; 

and (4) nutritional profile (differing by 

the amount of fiber and the ranking 

order of whole grain products on the 

ingredient list). With regard to claims, 

the study will focus on examples of 

whole grain statements that can be 

found on food packages. All label 

images will be mock-ups resembling 

food labels that may be found in the 

marketplace. Images will show product 

identity (e.g., bread) but not any real or 

fictitious brand name. The study will 

provide half of the participants access to 

the Nutrition Facts but not together with 

a product image (i.e., these participants 

can look at the Nutrition Facts if they 

choose to). The study will show the 

other half of the respondents a label in 

which the Nutrition Facts is located 

next to the product image. 

The survey will ask its participants to 

view label images and answer questions 

about their perceptions and reactions 

related to the product and claim. 

Product perceptions (e.g., healthiness, 

potential health benefits, levels of whole 

grains, and fiber amount) and label 

perceptions (e.g., helpfulness and 

credibility) will constitute the measures 

of response in the experiment. To help 

understand the data, the survey will 

also collect information about 

participants’ backgrounds, such as 

consumption and purchase patterns, 

awareness and knowledge of nutrients 

and substances, 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 enhance 

the Agency’s understanding of how 

whole grains claims and other related 

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 May 26, 

2011 (76 FR 30725), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received eight letters 

in response to the notice, each 

containing multiple comments. Several 

comments were generally supportive of 

FDA’s study. Additional comments 

were outside the scope of the four 

collection of information topics on 

which the notice solicits comments and 

will not be discussed in this document. 

The comments on the four collection of 

information topics, and the Agency’s 

responses, are discussed in the 

following paragraphs. 

(Comment 1) One comment 

questioned the necessity of the study 

given FDA’s many pressing 

responsibilities. The comment suggested 

that the ‘‘Dietary Guidelines for 

Americans 2005’’ and the prevalence of 

Whole Grain Stamps on products have 

increased consumer ability to 

understand the benefits of whole grains 

and to find and purchase them in stores. 

(Response) FDA disagrees with this 

comment. Research suggests that 

although consumers may be aware of 

the benefits of whole grain foods, they 

still have difficulties in understanding 

the meaning of whole grains or 

recognizing whole grain foods (Refs. 6 

through 8). Given the multitude of 

whole grain statements appearing in the 

marketplace and the importance of 

whole grains in maintaining a healthy 

diet, there is a genuine need for 

systematic investigation of how 

consumers interpret various whole-grain 

statements. 

(Comment 2) Several comments 

suggested improvements to the 

proposed survey instrument. One 

comment questioned whether the terms 

‘‘healthiness’’ and ‘‘nutritional 

qualities’’ should be equated to one 

another as in a proposed response item 

‘‘healthiness or nutritional qualities.’’ A 

few comments noted that the scales of 

the ranking questions need to be revised 

from a four or six point scale to a five 

point scale with a ‘‘neutral position’’ 

(e.g., neither agree nor disagree). Several 

comments questioned whether a ‘‘don’t 

know’’ choice should be included or 

omitted in several places. One comment 

suggested that the section on general 

knowledge of whole grains should be 

asked before questions on specific 

labels. One comment stated that the 

questions on evaluating the 

trustworthiness and helpfulness of the 

whole grain statement may be biased or 

leading because all the negative terms 

are placed on the left-hand side of the 

scale. Another comment stated that the 

perceptions of the claim statement may 

be confounded by product cues such as 

color and graphics. 

(Response) FDA has carefully 

reviewed the survey instrument and has 

incorporated all necessary clarifications 

and improvements in response to the 

comments. In terms of the perceived 

connection between ‘‘healthiness’’ and 

‘‘nutritional qualities,’’ FDA found in 

previous cognitive testing that some 

respondents understood nutritional 

qualities as an element of healthiness 

and equated the two concepts, as in 

‘‘healthiness or nutritional qualities.’’ 

The testing also found that this 

expression performed best in 

respondent comprehension and in 

conveying the intent of the item, which 

is the nutritional aspect of health. 

Therefore, we have decided to retain the 

expression ‘‘healthiness or nutritional 

qualities.’’ Regarding inclusion of a 

‘‘neutral’’ (neither agree nor disagree) 

response in the rating scales, research 

(e.g., Ref. 12) has suggested that such a 

response can be interpreted as a ‘‘don’t 

know’’ response by some respondents. 

Therefore, we have kept the six point 

rating scale and added a ‘‘don’t know’’ 

option. Questions whose response 

options purposefully omit a ‘‘don’t 

know’’ option will be further evaluated 

in the cognitive interviews to confirm 

that participants are able to select one 

of the provided choices. Regarding the 

order of the general knowledge and 

label response sections, we disagree 

with the suggestion and believe the 

suggested change would create more 

biases than the current order. We also 

disagree that claim perceptions may be 

biased because negative terms are 

placed on the left-hand side of the scale. 

Existing research has not produced 

consensus about whether placing 

negative or positive terms at the 

beginning of a scale is more likely to 

cause biases. More importantly, because 

this is an experimental study that 

employs random assignment, bias is 

irrelevant as we are mainly interested in 

quantitative differences in dependent 

measures between tested stimuli (e.g., 

claims). We agree that product cues may 

make it difficult to isolate the impact of 

whole grain claims. For this reason, the 

study has created mock-up labels that 

do not include real or fictitious brand 

names and only resemble, but are not 

identical to, real packages. Moreover, 

the study will compare responses to 

labels that differ only in the presence or 

absence of a claim, and in the claim 

language, but not in any other respect. 

(Comment 3) One comment suggested 

that FDA should clearly define in the 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11549 

study concepts such as ‘‘whole grains’’, 

‘‘foods made from whole grains’’, and 

‘‘whole grain food’’ when asking about 

whole grain consumption. 

(Response) We disagree with this 

suggestion. How consumers interpret 

these labeling statements is the core 

question that FDA is interested in 

answering and clear definitions would 

defeat this purpose. In the modified 

version of our questionnaire, we have 

provided specific examples of whole 

grain products (such as cereal or bread, 

pasta that are made with whole grains) 

when we ask participants about their 

whole grain consumption patterns. 

(Comment 4) One comment proposed 

revising a question in the survey that is 

intended to assess potential consumer 

confusion about the meaning of organic 

versus whole grain. The question we 

proposed asked participants to judge the 

likelihood that a product is organic 

based on the information shown on the 

experimental label stimuli. 

(Response) The question FDA 

originally proposed (how likely a 

product shown in the survey is organic) 

has been removed from the revised 

questionnaire. Instead, we have added a 

new question that asks whether 

respondents think the statement ‘‘All 

whole grain foods are organic’’ is true or 

false. 

(Comment 5) One comment stated 

that consumers do not understand 

‘‘ounce-equivalents’’ when trying to 

answer the whole grain consumption 

questions. The comment suggested 

using grams or servings as a 

measurement of whole grain, or other 

basic descriptions of amounts as 

included in the ‘‘Dietary Guidelines for 

Americans’’ or MyPlate (e.g., half of the 

grains you consume, half of a plate). 

(Response) We agree that consumers 

are probably more familiar with 

measurements expressed in servings or 

grams than with measurements 

expressed in ounce-equivalents and 

have replaced ounce-equivalents with 

servings or grams in the study. Also, we 

have removed the question about 

whether consumers are aware of the 

recommended amount of whole grains 

they should consume according to the 

Dietary Guidelines for Americans 

because respondents may not know 

details in the ‘‘Dietary Guidelines for 

Americans’’ or MyPlate. 

(Comment 6) One comment suggested 

that FDA should incorporate the three 

standards listed in the ‘‘Dietary 

Guidelines for Americans 2010’’ (‘‘look 

for 100% whole grain foods’’; ‘‘look for 

products using the FDA whole grain 

health claim’’; ‘‘look for products with 

at least 8 grams of whole grain’’) into the 

study to see whether consumers can use 

them to seek out whole grains. 

(Response) We agree that this 

information is useful and have included 

these standards in the study. We will 

examine how well respondents 

understand them and whether they can 

evaluate the amount of whole grain in 

a certain food based on the claim on the 

front of the food package and the 

Nutrition Facts and the ingredient list 

on the back. 

(Comment 7) One comment suggested 

that FDA add a variety of grains and 

more non-wheat-based foods (e.g., 

brown rice, oatmeal, and popcorn) to 

see if consumers understand these are 

whole grain foods. The same comment 

also suggested FDA include more foods 

lower in overall grain content than the 

three planned (bread, cereal, breakfast 

bars), as these are likely to be high in 

grain content. 

(Response) We agree with the 

comment and have included bread, salty 

snacks (instead of cereal), and breakfast 

bars in the study. 

(Comment 8) One comment suggested 

that FDA add more questions on 

participants’ consumption, purchases of 

the food categories studied, and health 

and nutrition attitude questions. The 

comment also suggested that FDA 

explore consumers’ understanding of 

whole grains relative to consumers’ 

understanding of other aspects of a 

healthy diet, such as consumption of 

leafy green vegetables or legumes. The 

comment stated that the information can 

help reveal whether consumer 

knowledge about dietary practices other 

than whole grain consumption might 

require greater Agency resources and 

attention. 

(Response) We have added questions 

on participants’ consumption and 

purchase of the food categories that will 

be studied (bread, breakfast bars, and 

salty snacks). Due to resource 

limitations, we will not be able to ask 

additional questions about participants’ 

understanding of other aspects of a 

healthy diet or expand the study to 

include a larger group of foods. 

(Comment 9) One comment suggested 

that, in addition to testing two 

nutritional profiles for a given product 

(one high in fiber amount and one low 

in fiber amount), the study should 

include at least one product that 

provides a good source of fiber. 

(Response) We agree that the 

suggested addition will increase our 

understanding of consumer reactions to 

products with various fiber contents. 

We have included three types of foods: 

Bread, breakfast bars, and salty snacks 

(instead of cereal), each with two 

nutritional profiles (one high in fiber 

amount and one low in fiber amount) in 

the study. Bread usually provides a 

good source of fiber. 

(Comment 10) One comment 

suggested that, because the focus of the 

proposed research is on interpretation of 

whole grain label statements, the data 

analysis should treat the label 

statements as fixed effects and the 

product categories and nutrition profiles 

as random effects. 

(Response) We will consider the need 

and appropriateness of the suggested 

analytic approach during data analysis. 

(Comment 11) Several comments 

urged FDA to provide graphics and 

revised instruments in the 30-day notice 

for public comment. 

(Response) We agree and have 

included these materials in the 

information collection request. 

(Comment 12) One comment 

encouraged FDA to revise its draft 

guidance to provide clear guidance to 

industry as to the types of claims that 

may be made about whole grains and 

also to limit whole grain claims to foods 

that provide at least a good source of 

fiber (10% Daily Value) for foods with 

a mid to large size Reference Amount 

Customarily Consumed (RACC), such as 

those associated with ready-to-eat 

cereals. 

(Response) The comment is outside of 

the scope of the proposed collection of 

information described in the 60-day 

notice and therefore is not addressed 

here. Nonetheless, the comment has 

been forwarded to the docket for the 

whole grain draft guidance. 

FDA estimates the burden of this 

collection of information as follows 

(Table 1). FDA plans to conduct 

cognitive interviews by screening 72 

panelists in order to obtain 9 

individuals for cognitive 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 screen 

1,152 individuals for pretest, each 

taking 2 minutes (0.033 hours), in order 

to have 576 of them complete a 15- 

minute (0.25 hours) pretest. The 576 

target responses are 376 more than the 

200 target responses described in the 60- 

day notice. The change is because we 

increased the number of our 

experimental conditions from 156 to 

288, and we wanted to ensure two 

responses per experimental condition 

(288 * 2). Thus, the total for the pretest 

activities is 182 hours (38 hours + 144 

hours). For the survey, we estimate that 

5,400 invitations, each taking 2 minutes 

(0.033 hours), will need to be sent to 

adult members of an online consumer 


srobinson on DSK4SPTVN1PROD with NOTICES
11550 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

panel to have 2,700 of them complete a 

15-minute (0.25 hours) questionnaire. 

The total for the survey activities is 855 

hours (180 hours + 675 hours). 

Therefore, the total estimated burden is 

1,052 hours. This estimate is 454 hours 

lower than the 1,506 hours described in 

the 60-day notice and reflects 15 fewer 

hours for pretest invitation, 533 fewer 

hours for survey invitation, and 94 more 

hours for the pretest, respectively. 

Recent experience by our contractor 

suggests that the Agency will not need 

to send as many invitations as originally 

estimated to achieve its target sample 

sizes in pretest and survey. FDA’s 

burden estimate is based on prior 

experience with research that is similar 

to this proposed study. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number 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 ....................... 1,152 1 1,152 0.033 (2 minutes) ..................... 38 

Pretest ...................................... 576 1 576 0.25 (15 minutes) ..................... 144 

Survey invitation ....................... 5,400 1 5,400 0.033 (2 minutes) ..................... 180 

Survey ....................................... 2,700 1 2,700 0.25 (15 minutes) ..................... 675 

Total ................................... ............................ ............................ ............................ ................................................... 1,052 

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

II. References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20857, under 

Docket No. FDA–2011–N–0320 and may 

be seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday. We have verified all Web site 

addresses, but we are not responsible for 

any subsequent changes to the Web sites 

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. Cleveland, L.E., A.J. Moshfegh, A.M. 

Albertson, et al., ‘‘Dietary Intake of Whole 

Grains,’’ Journal of the American College of 

Nutrition, vol. 19, pp. 331S–338S, 2000. 

3. Kantor, L.S., J.N. Variyam, J.E. 

Allshouse, et al., ‘‘Choose a Variety of Grains 

Daily, Especially Whole Grains: A Challenge 

for Consumers,’’ Journal of Nutrition, vol. 

131, pp. 473S–486S, 2001. 

4. U.S. Department of Agriculture and U.S. 

Department of Health and Human Services, 

‘‘Executive Summary of Dietary Guidelines 

for Americans, 2010,’’ January 2011, 

available at http://www.cnpp.usda.gov/

Publications/DietaryGuidelines/2010/

PolicyDoc/ExecSumm.pdf. 

5. Supermarket News, ‘‘Report: Whole 

Grains Gain Momentum,’’ September 17, 

2010, available at http://supermarketnews.

com/news/whole_grains_0917/#. 

6. Arvola, A., L. La ̈hteenma ̈ki, M. Dean, et 

al., ‘‘Consumers’ Beliefs About Whole and 

Refined Grain Products in the UK, Italy and 

Finland,’’ Journal of Cereal Science, vol. 46, 

pp. 197–206, 2007. 

7. Kantor, L.S., J.N. Variyam, J.E. 

Allshouse, et al., ‘‘Choose a Variety of Grains 

Daily, Especially Whole Grains: A Challenge 

for Consumers,’’ Journal of Nutrition, vol. 

131, pp. 473S–486S, 2001. 

8. Marquart, L., K.L. Wiemer, J.M. Jones, et 

al., ‘‘Whole Grain Health Claims in the USA 

and Other Efforts to Increase Whole-Grain 

Consumption,’’ Proceedings of the Nutrition 

Society, vol. 62, pp. 151–160, 2003. 

9. 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, vol. 10.9, 2006. 

10. Grunert, K.G. and J.M. Willis, ‘‘A 

Review of European Research on Consumer 

Response to Nutrition Information on Food 

Labels,’’ Journal of Public Health, vol. 15, 

pp. 384–399, 2007. 

11. Kellogg Company. ‘‘A Survey of 

Consumers’ Whole Grain & Fiber 

Consumption Behaviors, and the Perception 

of Whole Grain Foods as a Source of Dietary 

Fiber,’’ 2010. FDA Docket No. 2006–D–0298. 

July 2010, available at http://

www.regulations.gov/#!document

Detail;D=FDA–2006–D–0298–0016. 

12. Clark, L.A. and D. Watson, 

‘‘Constructing Validity: Basic Issues in 

Objective Scale Development,’’ Psychological 

Assessment, vol. 7(3), pp. 309–319, 1995. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4423 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–0140] 

Draft Guidance for Industry on 

Notification to Food and Drug 

Administration of Issues That May 

Result in a Prescription Drug 

Shortage; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Notification to FDA 

of Issues that May Result in a 

Prescription Drug or Biological Product 

Shortage.’’ This draft guidance relates to 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), which requires sole 

manufacturers to notify FDA of a 

discontinuance of certain drug products 

and to the President’s Executive Order 

13588 of October 31, 2011, directing 

FDA to use all available administrative 

tools to expand the Agency’s efforts to 

combat the problem of drug shortages. 

We are also requesting responsive 

comments from interested stakeholders 

on a specific question posed in this 

Federal Register document related to 

the draft guidance. 

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. 


srobinson on DSK4SPTVN1PROD with NOTICES