4154 Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices 

(2) the accuracy of our 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. 

Food Labeling; Notification Procedures 

for Statements on Dietary 

Supplements—21 CFR 101.93 (OMB 

Control Number 0910–0331—Extension) 

Section 403(r)(6) of the FD&C Act (21 

U.S.C. 343(r)(6)) requires that FDA be 

notified by manufacturers, packers, and 

distributors of dietary supplements that 

they are marketing a dietary supplement 

product that bears on its label or in its 

labeling a statement provided for in 

section 403(r)(6) of the FD&C Act. 

Section 403(r)(6) of the FD&C Act 

requires that FDA be notified, with a 

submission about such statements, no 

later than 30 days after the first 

marketing of the dietary supplement. 

Information that is required in the 

submission includes: (1) The name and 

address of the manufacturer, packer, or 

distributor of the dietary supplement 

product; (2) the text of the statement 

that is being made; (3) the name of the 

dietary ingredient or supplement that is 

the subject of the statement; (4) the 

name of the dietary supplement 

(including the brand name); and (5) a 

signature of a responsible individual 

who can certify the accuracy of the 

information presented, and who must 

certify that the information contained in 

the notice is complete and accurate, and 

that the notifying firm has 

substantiation that the statement is 

truthful and not misleading. 

The procedural regulation for this 

program is codified at § 101.93 (21 CFR 

101.93). Section 101.93 provides 

submission procedures and identifies 

the information that must be included 

in order to meet the requirements of 

section 403 of the FD&C Act. 

Description of Respondents: 

Respondents to this collection of 

information include manufacturers, 

packers, or distributors of dietary 

supplements that bear section 403(r)(6) 

of the FD&C Act statements on their 

labels or labeling. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

101.93 .................................................................................. 2,200 1 2,200 0.75 1,650 

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

We believe that there will be minimal 

burden on the industry to generate 

information to meet the requirements of 

section 403 of the FD&C Act in 

submitting information regarding 

section 403(r)(6) of the FD&C Act 

statements on labels or in labeling of 

dietary supplements. We are requesting 

only information that is immediately 

available to the manufacturer, packer, or 

distributor of the dietary supplement 

that bears such a statement on its label 

or in its labeling. We estimate that, each 

year, approximately 2,200 firms will 

submit the information required by 

section 403 of the FD&C Act. We 

estimate that a firm will require 0.75 

hours to gather the information needed 

and prepare a submission, for a total of 

1,650 hours (2,200 × 0.75). This estimate 

is based on the average number of 

notification submissions received by us 

in the preceding 3 years. 

Dated: January 14, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–01031 Filed 1–17–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[DHS–2011–0108] 

RIN 1601–ZA11 

Identification of Foreign Countries 

Whose Nationals Are Eligible To 

Participate in the H–2A and H–2B 

Nonimmigrant Worker Programs 

AGENCY: Office of the Secretary, DHS. 

ACTION: Notice. 

SUMMARY: Under Department of 

Homeland Security (DHS) regulations, 

U.S. Citizenship and Immigration 

Services (USCIS) may approve petitions 

for H–2A and H–2B nonimmigrant 

status only for nationals of countries 

that the Secretary of Homeland Security, 

with the concurrence of the Secretary of 

State, has designated by notice 

published in the Federal Register. That 

notice must be renewed each year. This 

notice announces that the Secretary of 

Homeland Security, in consultation 

with the Secretary of State, is 

identifying 59 countries whose 

nationals are eligible to participate in 

the H–2A and H–2B programs for the 

coming year. The list published today 

includes one new addition: Grenada. 

DATES: Effective Date: This notice is 

effective January 18, 2013, and shall be 

without effect at the end of one year 

after January 18, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Francis Cissna, Office of Policy, 

Department of Homeland Security, 

Washington, DC 20528, (202) 447–3835. 

SUPPLEMENTARY INFORMATION: 

Background: Generally, USCIS may 

approve H–2A and H–2B petitions for 

nationals of only those countries that 

the Secretary of Homeland Security, 

with the concurrence of the Secretary of 

State, has designated as participating 

countries. Such designation must be 

published as a notice in the Federal 

Register and expires after one year. 

USCIS, however, may allow a national 

from a country not on the list to be 

named as a beneficiary of an H–2A or 

H–2B petition based on a determination 

that such participation is in the U.S. 

interest. See 8 CFR 214.2(h)(5)(i)(F) and 

8 CFR 214.2(h)(6)(i)(E). 

In designating countries to include on 

the list, the Secretary of Homeland 

Security, with the concurrence of the 

Secretary of State, will take into account 

factors including, but not limited to: (1) 

The country’s cooperation with respect 

to issuance of travel documents for 

citizens, subjects, nationals, and 

residents of that country who are subject 

to a final order of removal; (2) the 

number of final and unexecuted orders 

of removal against citizens, subjects, 

nationals, and residents of that country; 

(3) the number of orders of removal 

executed against citizens, subjects, 

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Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices 4155 

nationals, and residents of that country; 

and (4) such other factors as may serve 

the U.S. interest. See 8 CFR 

214.2(h)(5)(i)(F)(1)(i) and 8 CFR 

214.2(h)(6)(i)(E)(1). 

In December 2008, DHS published in 

the Federal Register two notices, 

‘‘Identification of Foreign Countries 

Whose Nationals Are Eligible to 

Participate in the H–2A Visa Program,’’ 

and ‘‘Identification of Foreign Countries 

Whose Nationals Are Eligible to 

Participate in the H–2B Visa Program,’’ 

which designated 28 countries whose 

nationals are eligible to participate in 

the H–2A and H–2B programs. See 73 

FR 77,043 (Dec. 18, 2008); 73 FR 77,729 

(Dec. 19, 2008). The notices ceased to 

have effect on January 17, 2010 and 

January 18, 2010, respectively. See 8 

CFR 214.2(h)(5)(i)(F)(2) and 8 CFR 

214.2(h)(6)(i)(E)(3). To allow for the 

continued operation of the H–2A and 

H–2B programs, the Secretary of 

Homeland Security, with the 

concurrence of the Secretary of State, 

has published subsequent notices on an 

annual basis. See 75 FR 2,879 (Jan. 19, 

2010) (adding 11 countries); 76 FR 2,915 

(Jan. 18, 2011) (removing Indonesia and 

adding 15 countries); 77 FR 2,558 (Jan. 

18, 2012) (adding five countries). 

The Secretary of Homeland Security 

has determined, with the concurrence of 

the Secretary of State, that the 58 

countries designated in the January 18, 

2012 notice continue to meet the 

standards identified in that notice for 

eligible countries and therefore should 

remain designated as countries whose 

nationals are eligible to participate in 

the H–2A and H–2B programs. Further, 

the Secretary of Homeland Security, 

with the concurrence of the Secretary of 

State, has determined to add Grenada to 

the list. This determination is made 

taking into account the four factors 

identified above. The Secretary of 

Homeland Security also considered 

other pertinent factors including, but 

not limited to, evidence of past usage of 

the H–2A and H–2B programs by 

nationals of the country to be added, as 

well as evidence relating to the 

economic impact on particular U.S. 

industries or regions resulting from the 

addition or continued non-inclusion of 

specific countries. 

Designation of Countries Whose 

Nationals Are Eligible To Participate in 

the H–2A and H–2B Nonimmigrant 

Worker Programs 

Pursuant to the authority provided to 

the Secretary of Homeland Security 

under sections 214(a)(1), 215(a)(1), and 

241 of the Immigration and Nationality 

Act (8 U.S.C. 1184(a)(1), 1185(a)(1), and 

1231), I am designating, with the 

concurrence of the Secretary of State, 

nationals from the following countries 

to be eligible to participate in the H–2A 

and H–2B nonimmigrant worker 

programs: 

Argentina 

Australia 

Barbados 

Belize 

Brazil 

Bulgaria 

Canada 

Chile 

Costa Rica 

Croatia 

Dominican Republic 

Ecuador 

El Salvador 

Estonia 

Ethiopia 

Fiji 

Grenada 

Guatemala 

Haiti 

Honduras 

Hungary 

Iceland 

Ireland 

Israel 

Jamaica 

Japan 

Kiribati 

Latvia 

Lithuania 

Macedonia 

Mexico 

Moldova 

Montenegro 

Nauru 

The Netherlands 

Nicaragua 

New Zealand 

Norway 

Papua New Guinea 

Peru 

The Philippines 

Poland 

Romania 

Samoa 

Serbia 

Slovakia 

Slovenia 

Solomon Islands 

South Africa 

South Korea 

Spain 

Switzerland 

Tonga 

Turkey 

Tuvalu 

Ukraine 

United Kingdom 

Uruguay 

Vanuatu 

This notice does not affect the status 

of aliens who currently hold valid H–2A 

or H–2B nonimmigrant status. Persons 

holding such status, however, will be 

affected by this notice at the time they 

seek an extension of stay in H–2 

classification, or a change of status (1) 

from another nonimmigrant status to H– 

2 status or (2) from one H–2 status to 

another. 

Nothing in this notice limits the 

authority of the Secretary of Homeland 

Security or her designee or any other 

federal agency to invoke against any 

foreign country or its nationals any 

other remedy, penalty, or enforcement 

action available by law. 

Janet Napolitano, 

Secretary. 

[FR Doc. 2013–00908 Filed 1–17–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Application for Foreign 

Trade Zone and/or Status Designation, 

and Application for Foreign Trade 

Zone Activity Permit 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 60-Day Notice and request for 

comments; Extension of an existing 

collection of information: 1651–0029. 

SUMMARY: As part of its continuing effort 

to reduce paperwork and respondent 

burden, CBP invites the general public 

and other Federal agencies to comment 

on an information collection 

requirement concerning the Application 

for Foreign Trade Zone Admission and/ 

or Status Designation, and Application 

for Foreign Trade Zone Activity Permit 

(CBP Forms 214, 214A, 214B, 214C and 

216). This request for comment is being 

made pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13). 

DATES: Written comments should be 

received on or before March 19, 2013 to 

be assured of consideration. 

ADDRESSES: Direct all written comments 

to U.S. Customs and Border Protection, 

Attn: Tracey Denning, Regulations and 

Rulings, Office of International Trade, 

799 9th Street NW., 5th Floor, 

Washington, DC 20229–1177. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Regulations and Rulings, Office of 

International Trade, 799 9th Street NW., 

5th Floor, Washington, DC 20229–1177, 

at 202–325–0265. 

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