Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20677 

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. 

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 106 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 3,000 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

Portion of study Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Cognitive interview screener ................................................ 72 1 72 5/60 6 

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

Pretest invitation .................................................................. 1,600 1 1,600 2/60 53 

Pretest .................................................................................. 200 1 200 15/60 50 

Survey invitation ................................................................... 32,000 1 32,000 2/60 1,056 

Survey .................................................................................. 4,000 1 4,000 15/60 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 (see ADDRESSES) 

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. Nutrition at a Glance. 2010. 

Available at http:// 

www.kelloggnutrition.com/learn-aboutlabels/nutrition-at-a-glance.html. 

3. PepsiCo. Nutrition Labeling. 2010. 

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

Purpose/Human-Sustainability/ 

Nutrition-Labeling.html. 

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

Products ‘Smart,’’’ USA Today, 

September 2, 2004. Available at http:// 

www.usatoday.com/money/industries/ 

food/2004–09–02-smart-spot_x.htm. 

5. Kraft Foods. Sensible Solution. 2010. 

Available at http:// 

www.kraftrecipes.com/kf/HealthyLiving/ 

SensibleSolution/ 

SensibleSolution_Landing.aspx. 

6. 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 is 

available at http://www.cdc.gov/nchs/ 

data/nhanes/nhanes_05_06/ 

sp_dbq_d.pdf. 

7. U.S. Food and Drug Administration. 2008 

Health and Diet Survey. March 20, 2010. 

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

ScienceResearch/ResearchAreas/ 

ConsumerResearch/ucm193895.htm. 

8. Food Marketing Institute. 2009 U.S. 

Grocery Shopper Trends Survey. 

Washington, DC 2009. 

9. Drichoutis, A.C., Lazaridis, P. and Nayga, 

R.M., ‘‘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. 

10. La ̈hteenma ̈ki, L., Lampila, P.. Grunert, K., 

Boztug, Y., Ueland, ;., A ̊ stro ̈m, A. and 

Martinsdo ́ttir, E., ‘‘Impact of HealthRelated Claims on the Perception of 

Other Product Attributes,’’ Food Policy, 

23: 230–9. 2010. 

11. Labiner-Wolfe, J., Lin, C.-T. J. and Verrill 

L., ‘‘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. 

12. Roe, B., Levy, A.S., and Derby, B.M., ‘‘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. 

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

Adler, C., Brown, A.-M., and Brecher, S., 

‘‘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): 952–8, 2004. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8908 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0237] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Applications for 

Food and Drug Administration 

Approval To Market a New Drug; 

Postmarketing Reports; Reporting 

Information About Authorized Generic 

Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

mstockstill on DSKH9S0YB1PROD with NOTICES

20678 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the requirements for a New Drug 

Application (NDA) holder to notify the 

Agency if an authorized generic drug is 

marketed by clearly including this 

information in an easily accessible place 

in the annual report and by sending a 

copy of the relevant portion of the 

annual report to a central contact point 

in the Agency. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 13, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the OMB control number 

0910–0646. Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–3792, Elizabeth.Berbakos@ 

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Applications for Food and Drug 

Administration Approval To Market a 

New Drug; Postmarketing Reports; 

Reporting Information About 

Authorized Generic Drugs—21 CFR 

314.81(b)(2)—(OMB Control Number 

0910–0646—Extension) 

In the Federal Register of July 28, 

2009 (74 FR 37163), FDA published a 

final rule that required the holder of an 

NDA to notify the Agency if an 

authorized generic drug is marketed by 

clearly including this information in 

annual reports in an easily accessible 

place and by sending a copy of the 

relevant portion of the annual reports to 

a central contact point. We took this 

action as part of our implementation of 

the Food and Drug Administration 

Amendments Act, which requires that 

FDA publish a list of all authorized 

generic drugs included in an annual 

report after January 1, 1999, and that the 

Agency update the list quarterly. We 

initially published this list on June 27, 

2008, on the Internet and notified 

relevant Federal Agencies that the list 

was published, and we will continue to 

update it. 

During the past several years, FDA 

has been reviewing annual reports it has 

received under § 314.81(b)(2) (21 CFR 

314.81(b)(2)) to discern whether an 

authorized generic drug is being 

marketed by the NDA holder. Based on 

information learned from this review 

and based on the number of annual 

reports the Agency currently receives 

under § 314.81(b)(2), we estimate that 

we will receive approximately 400 

annual reports containing the 

information required under 

§ 314.81(b)(2)(ii)(b), for authorized 

generic drugs that were marketed during 

the time period covered by an annual 

report submitted after January 1, 1999. 

Based on the number of sponsors that 

currently submit annual reports, we 

estimate that approximately 60 sponsors 

will submit these 400 annual reports 

with authorized generics. As indicated 

in table 1 of this document, we are 

estimating that the same number of 

annual reports will be submitted each 

year from the same number of sponsors 

containing the information required 

under § 314.81(b)(2)(ii)(b), and that the 

same number of copies of that portion 

of each annual report containing the 

authorized generic drug information 

will be submitted from the same number 

of sponsors. Concerning the hours per 

response, based on our estimate of 40 

hours to prepare each annual report 

currently submitted under 

§ 314.81(b)(2), we estimate that sponsors 

will need approximately 1 hour to 

prepare the information required under 

§ 314.81(b)(2)(ii)(b) for each authorized 

generic drug that was marketed during 

the time period covered by an annual 

report submitted after January 1, 1999; 

approximately 15 minutes to prepare 

the information required under 

§ 314.81(b)(2)(ii)(b) for each subsequent 

annual report; and approximately 3 

minutes to submit to FDA a copy of that 

portion of each annual report containing 

the authorized generic drug information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 314.81(b)(2)(ii)(b) Number of 

respondents 

Number of 

reponses per 

respondent 

Total annual 

respondents 

Average 

burden per 

response 

(in hours) 

Total hours 

Authorized generic drug information on first marketed 

generics in an annual report under § 314.81(b)(2)(ii)(b) .. 60 6.7 400 1 400 

Authorized generic drug information submitted in each 

subsequent annual report ................................................ 60 6.7 400 15/60 100 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20679 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR 314.81(b)(2)(ii)(b) Number of 

respondents 

Number of 

reponses per 

respondent 

Total annual 

respondents 

Average 

burden per 

response 

(in hours) 

Total hours 

The submission of a copy of that portion of each annual 

report containing authorized generic drug information .... 60 6.7 400 3/60 20 

Total .............................................................................. ........................ ........................ ........................ ........................ 520 

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

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8820 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0157] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application Review 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed collection of information 

concerning requests by sponsors of 

investigational new drugs and 

applicants for new drug approvals or 

biologics licenses for fast track 

designation as provided in the guidance 

for industry on fast track drug 

development programs. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 13, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application 

Review—(OMB Control Number 0910– 

0389)—Extension 

Section 112(a) of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by adding 

section 506 (21 U.S.C. 356). The section 

authorizes FDA to take appropriate 

action to facilitate the development and 

expedite the review of new drugs, 

including biological products, intended 

to treat a serious or life-threatening 

condition and that demonstrate a 

potential to address an unmet medical 

need. Under section 112(b) of FDAMA, 

FDA issued guidance to industry on fast 

track policies and procedures outlined 

in section 506 of the FD&C Act. The 

guidance discusses collections of 

information that are specified under 

section 506 of the FD&C Act, other 

sections of the Public Health Service 

Act (the PHS Act), or implementing 

regulations. The guidance describes 

three general areas involving collection 

of information: (1) Fast track 

designation requests; (2) premeeting 

packages; and (3) requests to submit 

portions of an application. Of these, fast 

track designation requests and 

premeeting packages, in support of 

receiving a fast track program benefit, 

provide for additional collections of 

information not covered elsewhere in 

statute or regulation. Information in 

support of fast track designation or fast 

track program benefits that has 

previously been submitted to the 

Agency, may, in some cases, be 

incorporated into the request by 

referring to the information rather than 

resubmitting it. 

Under section 506(a)(1) of the FD&C 

Act, an applicant who seeks fast track 

designation is required to submit a 

request to the Agency showing that the 

product: (1) Is intended for a serious or 

life-threatening condition and (2) has 

the potential to address an unmet 

mstockstill on DSKH9S0YB1PROD with NOTICES