Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21381 

reading the news article, participants 

will complete a questionnaire assessing 

their emotional response, appraisals, 

attribution of responsibility, perceptions 

about the safety of the affected produce, 

intentions to grow, sell, or buy the 

affected produce, perceived probability 

of a repeat event, and a measure of their 

innate ability to effectively respond to 

the information in the article. 

To help design and refine the 

questionnaire, we will recruit 25 

participants in order to conduct 10 

cognitive interviews. We estimate 

cognitive interview recruitment will 

take 5 minutes (0.083 hours), for a total 

of 2 hours. The cognitive interviews are 

estimated at 1 hour per response for a 

total of 10 hours for the cognitive 

interview activities. We expect to send 

screeners to 800 members of a consumer 

panel, each taking 2 minutes (0.03 

hours) to complete, for a total of 24 

hours for the consumer panel screener 

activity. We also expect to administer 

360 screeners to growers and retailers, 

each taking 2 minutes (0.033 hours) to 

complete, for a total of 24 hours (11 + 

11 = 22). Twenty-four participants (20 

consumers, 2 growers, 2 retailers) will 

complete the pre-test. Each pre-test will 

take 10 minutes (0.17 hours) for a total 

of 5 hours for the pre-test activity. We 

estimate that 900 individuals (540 

consumers, 180 growers, and 180 

retailers) will complete the 

questionnaire for the experiment, each 

taking 10 minutes (0.17 hours) for a total 

of 153 hours for the experimental study 

activities. The estimated total hour 

burden of the collection of information 

is 215 hours. 

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) 2

Total hours 

Cognitive Interview Recruitment .......................................... 25 1 25 5/60 2 

Cognitive Interviews ............................................................. 10 1 10 1 10 

Consumer Panel Screener .................................................. 800 1 800 2/60 24 

Grower Screener .................................................................. 360 1 360 2/60 11 

Retailer Screener ................................................................. 360 1 360 2/60 11 

Pre-tests ............................................................................... 24 1 24 10/60 5 

Experiment ........................................................................... 900 1 900 10/60 153 

Total .............................................................................. ........................ ........................ ........................ ........................ 216 

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

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. 

II. References 

11. Olsen, S., L. MacKinon, et al., 

‘‘Surveillance for Foodborne Disease 

Outbreaks—United States, 1993 to1997,’’ 

Morbidity and Mortality Weekly Report 

49(SS01), pp. 1 through 51, 2000. 

2. FDA 101: Product Recalls—From First 

Alert to Effectiveness Checks, Available 

at http://www.fda.gov/ForConsumers/ 

ConsumerUpdates/ucm049070.htm. 

3. Calvin, L., ‘‘Outbreak Linked to Spinach 

Forces Reassessment of Food Safety 

Practices,’’ Amber Waves 5(3), pp. 24 

through 31, 2007. 

4. Lucier, G. and R. Dettmann, ‘‘Vegetables 

and Melons Outlook,’’ A Report From the 

United States Department of Agriculture, 

Economic Research Service, VGS–327, 

June 26, 2008. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9155 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0241] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ATRYN; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of March 21, 2011 (76 FR 

15323). The document announced the 

determination of the regulatory review 

period for ATRYN. The document was 

published with an incorrect docket 

number. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Office of Policy, Planning 

and Budget, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 3208, Silver Spring, 

MD 20993–0002, 301–796–9138. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2011–6509, appearing on page 15323, in 

the Federal Register of Monday, March 

21, 2011, the following correction is 

made: 

1. On page 15323, in the first column, 

in the Docket No. heading, ‘‘[Docket No. 

FDA–2010–E–0241]’’ is corrected to read 

‘‘[Docket No. FDA–2009–E–0241]’’. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9153 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 


srobinson on DSKHWCL6B1PROD with NOTICES
21382 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on Monday, May 16, 2011, from 

8 a.m. to 3 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel’s telephone number is 301–589– 

5200. 

Contact Person: Walter Ellenberg, 

Office of Pediatric Therapeutics, Office 

of the Commissioner, Food and Drug 

Administration, Bldg. 32, rm. 5154, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–0885, 

e-mail: Walter.Ellenberg@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). Please call 

the Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On May 16, 2011, the 

Pediatric Advisory Committee will meet 

to discuss pediatric-focused safety 

reviews, as mandated by the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109) and the Pediatric Research 

Equity Act (Pub. L. 110–85) for Bepreve 

(bepotastine besliate), Besivance 

(besifloxacin hydrochloride), Cetraxal 

(ciprofloxacin hydrochloride), Patanase 

Spray (olopatadine hydrochloride), 

Astepro Spray (azelastine 

hydrocholoride), Crestor (rosuvastatin 

calcium), Welchol (colesevelam 

hydrochloride), Intuniv (guanfacine), 

Lexapro (escitalopram oxalate), Actonel 

(risedronate), Hiberix [Haemophilus b 

Conjugate Vaccine (Tetanus Toxoid 

Conjugate)], and Valcyte 

(valganciclovir). The committee will 

also receive further followup on Topical 

Calcineurin Inhibitors: Elidel 

(pimecrolimus) and Protopic 

(tacrolimus). 

The Pediatric Advisory Committee 

will hear and discuss the 

recommendation of the Pediatric Ethics 

Subcommittee from its meeting on May 

11, 2011, regarding the Institutional 

Review Board process for clinical 

investigations that involve both an FDA 

regulated product and research 

involving children as subjects that is 

conducted or supported by HHS. The 

announcement of the May 11, 2011, 

Pediatric Ethics Subcommittee of the 

Pediatric Advisory Committee meeting 

can be found elsewhere in this issue of 

the Federal Register. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 2, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 25, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 26, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Walter 

Ellenberg at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9150 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0184] 

Pediatric Ethics Subcommittee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Pediatric 

Advisory Committee on FDA and 

certain Department of Health and 

Human Services regulatory issues. 

DATES: The meeting will be held on 

Wednesday, May 11, 2011, from 8 a.m. 

to 3 p.m. 

FDA is opening a docket to allow for 

additional public comments to be 

submitted to the Agency on the issues 

before the Pediatric Ethics 

Subcommittee. Submit either electronic 

or written comments by May 5, 2011. 

ADDRESSES: The meeting will be held at 

the North Marriott Hotel & Conference 

Center, 5701 Marinelli Rd., Bethesda, 

MD 20852. 

Submit electronic comments 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. 

Contact Person: Walter Ellenberg, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5154, 

Silver Spring, MD 20993–0002, 301– 

796–0885, or by e-mail: Walter.Ellenberg 

@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 


srobinson on DSKHWCL6B1PROD with NOTICES