Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 20037 

TABLE 1—ESTABLISHED LIST OF THE CHEMICALS AND CHEMICAL COMPOUNDS IDENTIFIED BY FDA AS HARMFUL AND

POTENTIALLY HARMFUL CONSTITUENTS IN TOBACCO PRODUCTS AND TOBACCO SMOKE—Continued 

Constituent 

Carcinogen (CA), 

respiratory toxicant (RT), 

cardiovascular toxicant 

(CT), reproductive or 

developmental toxicant 

(RDT), 

addictive (AD) 

Glu-P-2 (2-Aminodipyrido[1,2-a:3’,2’-d]imidazole) .......................................................................................................... CA 

Hydrazine ........................................................................................................................................................................ CA, RT 

Hydrogen cyanide ........................................................................................................................................................... RT, CT 

Indeno[1,2,3-cd]pyrene ................................................................................................................................................... CA 

IQ (2-Amino-3-methylimidazo[4,5-f]quinoline) ................................................................................................................ CA 

Isoprene .......................................................................................................................................................................... CA 

Lead ................................................................................................................................................................................ CA, CT, RDT 

MeA-a-C (2-Amino-3-methyl)-9H-pyrido[2,3-b]indole) .................................................................................................... CA 

Mercury ........................................................................................................................................................................... CA, RDT 

Methyl ethyl ketone ......................................................................................................................................................... RT 

5-Methylchrysene ............................................................................................................................................................ CA 

4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) .................................................................................................. CA 

Naphthalene .................................................................................................................................................................... CA, RT 

Nickel .............................................................................................................................................................................. CA, RT 

Nicotine ........................................................................................................................................................................... RDT, AD 

Nitrobenzene ................................................................................................................................................................... CA, RT, RDT 

Nitromethane .................................................................................................................................................................. CA 

2-Nitropropane ................................................................................................................................................................ CA 

N-Nitrosodiethanolamine (NDELA) ................................................................................................................................. CA 

N-Nitrosodiethylamine ..................................................................................................................................................... CA 

N-Nitrosodimethylamine (NDMA) ................................................................................................................................... CA 

N-Nitrosomethylethylamine ............................................................................................................................................. CA 

N-Nitrosomorpholine (NMOR) ........................................................................................................................................ CA 

N-Nitrosonornicotine (NNN) ............................................................................................................................................ CA 

N-Nitrosopiperidine (NPIP) ............................................................................................................................................. CA 

N-Nitrosopyrrolidine (NPYR) ........................................................................................................................................... CA 

N-Nitrososarcosine (NSAR) ............................................................................................................................................ CA 

Nornicotine ...................................................................................................................................................................... AD 

Phenol ............................................................................................................................................................................. RT, CT 

PhIP (2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine) .............................................................................................. CA 

Polonium-210 .................................................................................................................................................................. CA 

Propionaldehyde ............................................................................................................................................................. RT, CT 

Propylene oxide .............................................................................................................................................................. CA, RT 

Quinoline ......................................................................................................................................................................... CA 

Selenium ......................................................................................................................................................................... RT 

Styrene ............................................................................................................................................................................ CA 

o-Toluidine ...................................................................................................................................................................... CA 

Toluene ........................................................................................................................................................................... RT, RDT 

Trp-P-1 (3-Amino-1,4-dimethyl-5H-pyrido[4,3-b]indole) ................................................................................................. CA 

Trp-P-2 (1-Methyl-3-amino-5H-pyrido[4,3-b]indole ) ...................................................................................................... CA 

Uranium-235 ................................................................................................................................................................... CA, RT 

Uranium-238 ................................................................................................................................................................... CA, RT 

Vinyl acetate ................................................................................................................................................................... CA, RT 

Vinyl chloride .................................................................................................................................................................. CA 

Dated: March 23, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012-7727 Filed 3-30-12; 11:15 am] 

BILLING CODE 4160-01-P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Peripheral and Central Nervous 

System Drugs 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: Peripheral and 

Central Nervous System Drugs Advisory 

Committee. 

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 May 24, 2012, from 8:30 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

Building 31, the Great Room, White Oak 

Conference Center (Rm. 1503), 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

mstockstill on DSK4VPTVN1PROD with NOTICES

20038 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Glendolynn S. 

Johnson, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO31–2417, Silver Spring, MD 

20993–0002, (301) 796–9001, fax: (301) 

847–8533, email: PCNS@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), and follow 

the prompts to the desired center or 

product 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: The committee will discuss 

new drug application (NDA) 202737, for 

tafamidis meglumine capsules, 

proposed trade name VYNDAQEL, 

submitted by FoldRx Pharmaceuticals, 

Inc., a subsidiary of Pfizer, Inc. The 

proposed indication is for the treatment 

of transthyretin (TTR) familial amyloid 

polyneuropathy. 

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 10, 2012. 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 May 2, 

2012. 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 May 3, 2012. 

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 Glendolynn 

S. Johnson 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: March 29, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–7967 Filed 4–2–12; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOMELAND 

SECURITY 

[DHS Docket No. ICEB–2012–0002] 

RIN 1653–ZA04 

Employment Authorization for Syrian 

F–1 Nonimmigrant Students 

Experiencing Severe Economic 

Hardship as a Direct Result of Civil 

Unrest in Syria Since March 2011 

AGENCY: U.S. Immigration and Customs 

Enforcement; DHS. 

ACTION: Notice. 

SUMMARY: This notice announces that 

the Secretary of Homeland Security 

(Secretary) has suspended certain 

regulatory requirements for F–1 

nonimmigrant students whose country 

of citizenship is Syria and who are 

experiencing severe economic hardship 

as a direct result of the civil unrest in 

Syria since March 2011. The Secretary 

has determined that a suspension of 

certain regulatory requirements for 

Syrian citizens who are F–1 

nonimmigrant students is warranted 

because it will provide relief to these F– 

1 students so they may obtain 

employment authorization, work an 

increased number of hours while school 

is in session, and reduce their course 

load while continuing to maintain their 

F–1 student status. F–1 students who 

are granted employment authorization 

by means of this notice will be deemed 

to be engaged in a ‘‘full course of study’’ 

for the duration of their employment 

authorization, provided that they satisfy 

the minimum course load requirement 

described in this notice. 

DATES: This notice is effective April 3, 

2012 and will remain in effect until 

October 3, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Louis Farrell, Director, Student and 

Exchange Visitor Program; MS 5600, 

U.S. Immigration and Customs 

Enforcement, 500 12th Street SW., 

Washington, DC 20536–5600; (703) 603– 

3400. This is not a toll-free number. 

Program information can be found at 

http://www.ice.gov/sevis/. 

SUPPLEMENTARY INFORMATION: 

What action is DHS taking under this 

notice? 

The Secretary of Homeland Security 

(Secretary) is exercising her authority 

under 8 CFR 214.2(f)(9) to temporarily 

suspend the applicability of certain 

requirements governing on-campus and 

off-campus employment. F–1 students 

granted employment authorization by 

means of this notice will be deemed to 

be engaged in a ‘‘full course of study’’ 

for the duration of their employment 

authorization if they satisfy the 

minimum course load set forth in this 

notice. See 8 CFR 214.2(f)(6)(i)(F). 

Who is covered by this notice? 

This notice applies exclusively to F– 

1 students whose country of citizenship 

is Syria and who were lawfully present 

in the United States in F–1 

nonimmigrant status on April 3, 2012 

under section 101(a)(15)(F)(i) of the 

Immigration and Nationality Act (INA), 

8 U.S.C. 1101(a)(15)(F)(i) and (1) are 

enrolled in an institution that is Student 

and Exchange Visitor Program (SEVP) 

certified for enrollment for F–1 

students; (2) are currently maintaining 

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