Federal Register / Vol. 77, No. 59 / Tuesday, March 27, 2012 / Notices 18251 

study goals are to: (1) Measure 

consumer attitudes, beliefs, and 

intended behaviors related to cigarette 

smoking in response to graphic warning 

labels; (2) determine whether consumer 

responses to graphic warning labels 

differ across various groups based on 

smoking status, age, or other 

demographic variables; and (3) evaluate 

the relative effectiveness of various 

graphic images associated with each of 

the nine warning statements specified in 

the Tobacco Control Act for achieving 

each of the communication goals. The 

information collected from the study is 

necessary to inform the Agency’s efforts 

to implement the mandatory graphic 

warnings required by the Tobacco 

Control Act. 

The experimental study data will be 

collected from participants of an 

Internet panel of approximately 43,000 

people. Participation in the 

experimental study is voluntary. 

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 Total hours 

Pretest ................................................................................ 60 1 60 0 .5 30 

Screener ............................................................................. 15,000 1 15,000 0 .016 240 

Experimental Survey .......................................................... 5,400 1 5,400 0 .5 2,700 

Total ............................................................................ ........................ ........................ ........................ .......................... 2,970 

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

FDA’s burden estimate is based on 

prior experience with Internet panel 

experiments similar to the study 

proposed here. Sixty panel members 

will take part in a pretest of the study, 

estimated to last 30 minutes (0.5 hours), 

for a total of 30 hours. Approximately 

15,000 respondents will complete a 

screener to determine eligibility for 

participation in the study, estimated to 

take 1 minute (0.016 hours), for a total 

of 240 hours. Fifty-four hundred 

respondents will complete the full 

study, estimated to last 30 minutes, for 

a total of 2,700 hours. The total 

estimated burden is 2,970 hours (30 

hours plus 240 hours plus 2,700 hours). 

Dated: March 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7289 Filed 3–26–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Development of Animal Models of 

Pregnancy To Address Medical 

Countermeasures for Influenza in the 

‘‘At Risk’’ Population of Pregnant 

Women: Influenza as a Case Study; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration’s 

(FDA) Center for Drug Evaluation and 

Research and FDA’s National Center for 

Toxicological Research are announcing 

a 2-day public workshop entitled 

‘‘Development of Animal Models of 

Pregnancy To Address Medical 

Countermeasures for Influenza in the 

‘At Risk’ Population of Pregnant 

Women: Influenza as a Case Study.’’ 

The purpose of this workshop is to 

provide a forum to carefully consider 

scientific issues related to selecting 

animal models for use in evaluating 

medical influenza countermeasures 

(anti-influenza drugs) that may be given 

during pregnancy. Specifically, this 

workshop will address experimental 

design issues in selecting the most 

appropriate animal model that mimics 

human pregnancy. The goal is to use 

this model to evaluate how pregnancy 

changes the pharmacokinetics of antiinfluenza drugs in animals and compare 

those changes to the changes that are 

known to occur in human pregnancy. 

The data obtained from using this model 

may enhance the knowledge base 

needed to extrapolate the effects of 

pregnancy on other medical 

countermeasures. 

DATES: Date and Time: The public 

workshop will be held on April 30, 

2012, from 8:30 a.m. to 5 p.m., and on 

May 1, 2012, from 8:30 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Central 

Shared Use (CSU) Bldg. 2, rm. 2047, 

Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1, where routine 

security check procedures will be 

performed, a visitor badge will be 

issued, and an escort will be provided 

to the meeting room. Governmentissued identification will be needed. For 

additional information on parking and 

security, please refer to http://www.fda.

gov/AboutFDA/WorkingatFDA/

BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

Contact Person: For questions about 

the workshop, please contact Cindy de 

Sales, cindy@tepgevents.com, 240–316– 

3207. 

Registration: There is no fee to attend 

the public workshop, but attendees 

must register in advance. Space is 

limited, and registration will be on a 

first-come, first-served basis. Persons 

interested in attending this workshop 

must register online at http:// 

fda.contractmeetings.com before April 

16, 2012. Non-U.S. citizens are subject 

to additional security screening, and 

they should register as soon as possible. 

For those without Internet access, please 

contact Cindy de Sales (see Contact 

Person) to register. Onsite registration is 

not available. 

If you need special accommodations 

due to a disability, please contact Cindy 

de Sales (see Contact Person) at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: During 

seasonal and pandemic influenza 

outbreaks, pregnant women generally 

have greater morbidity and mortality 

than other adults. The data from the 

2009 H1N1 influenza pandemic 

suggested that pregnant women were at 

increased risk for medical 

complications. There is limited 

information regarding the efficacy, 

pharmacokinetics, optimal dosing, and 

side effects of anti-influenza drugs that 

may need to be used during pregnancy. 

The same is true for most drugs to treat 

diseases due to other infectious agents. 

The anti-influenza drugs have been 

selected for further study because the 

influenza virus can infect pregnant 

women, and oseltamivir, an antimstockstill on DSK4VPTVN1PROD with NOTICES

18252 Federal Register / Vol. 77, No. 59 / Tuesday, March 27, 2012 / Notices 

influenza drug of the neurominadase 

inhibitor class, was recommended for 

treatment of and/or for prophylaxis in 

pregnant women during the 2009 H1N1 

influenza pandemic. In addition, two 

clinical studies conducted in pregnant 

women provide some pharmacokinetic 

data for oseltamivir. 

This workshop is open to all 

interested parties. The target audience 

includes professionals in the scientific 

community interested in discussing the 

challenges of evaluating medical 

countermeasures for effective and safe 

use during pregnancy. 

The workshop will include plenary 

and breakout sessions on the scientific 

challenges in the development of animal 

models of pregnancy that can be used to 

address the safety and efficacy of 

medical countermeasures. Broad topics 

to be covered in the plenary sessions 

include: (1) The physiology and 

pharmacology of pregnancy as it relates 

to model development; (2) the role of 

animal models in evaluating medical 

countermeasures, including influenza 

therapies, that may be used during 

pregnancy; and (3) experimental design 

considerations. Topics of the breakout 

sessions will include: (1) Animal model 

selection, (2) design of the 

pharmacokinetic studies, and (3) 

additional issues in experimental 

design. 

Background information on the public 

workshop, registration information, the 

agenda, and other relevant information 

will be posted, as it becomes available, 

on the registration Web site at http:// 

fda.contractmeetings.com. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hard copy or 

on CD–ROM, after submission of a 

Freedom of Information request. Send 

written requests to the Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857. Send faxed requests to 301– 

827–9267. 

Dated: March 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7290 Filed 3–26–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Environmental 

Health Sciences Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Environmental Health Sciences Council. 

Date: May 22–23, 2012. 

Open: May 22, 2012, 8:30 a.m. to 5 p.m. 

Agenda: Discussion of program policies 

and issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Open: May 23, 2012, 8:30 a.m. to 9:30 a.m. 

Agenda: Discussion of program policies 

and issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T. W. Alexander Drive, Research 

Triangle Park, NC 27709. 

Closed: May 23, 2012, 9:45 a.m. to 12:30 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Contact Person: Gwen W. Collman, Ph.D., 

Director, Division of Extramural Research & 

Training, National Institutes of Health, Nat. 

Inst. of Environmental Health Sciences, 615 

Davis Dr., KEY615/3112, Research Triangle 

Park, NC 27709, (919) 541–4980, 

collman@niehs.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.niehs.nih.gov/dert/c-agenda.htm, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: March 20, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–7333 Filed 3–26–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI Conference Grants. 

Date: April 19–20, 2012. 

Time: 11 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Chang Sook Kim, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7179, Bethesda, MD 20892–7924, 301–435– 

0287, carolko@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Ancilliary Studies in Clinical Trials. 

mstockstill on DSK4VPTVN1PROD with NOTICES