[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14664-14667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73, 172, 173, 176, 177, 178, 184, and 189

[Docket No. FDA-2012-N-0010]


Food and Color Additives; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending certain 
regulations regarding food and color additives to correct minor errors 
(such as misspelled chemical names) and to update office names and 
addresses. This action is editorial in nature and is intended to 
improve the accuracy of the Agency's regulations.

DATES: This rule is effective March 7, 2013.

FOR FURTHER INFORMATION CONTACT:  Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1200.

SUPPLEMENTARY INFORMATION: We are making technical amendments to our 
regulations under 21 CFR parts 73, 172, 173, 176, 177, 178, 184, and 
189. In brief, these amendments are as follows:
     Correct misspelled chemical names in Sec. Sec.  73.3129, 
176.180, and 177.1210. For example, we are revising Sec.  73.3129 to 
replace ``Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-
sulphonatophenyl]amino]-9, 10-dihydro-9,10-dioxoanthracene-2-
sulphonate'' with ``Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-
2-sulfonatophenyl]amino]-9,10-dihydro-9.10-dioxoanthracene-2-
sulfonate'';
     Correct a table entry in Sec.  177.1500 regarding the 
melting point of certain nylon 12T resins; and
     Amend Sec. Sec.  172.712, 172.723, 172.809, 172.831, 
172.833, 172.886, 173.25, 173.45, 173.325, 173.368, 177.1350, 177.1360, 
177.1637, 177.2440, 177.2600, 178.1010, 178.3297, 184.1012, 184.1024, 
184.1034, 184.1063, 184.1259, 184.1316, 184.1415, 184.1583, 184.1595, 
184.1866, 184.1914, 184.1985, 189.110, and 189.180 to remove archaic or 
obsolete office names and replace them with the current Office name 
``Office of Food Additive Safety.'' Where appropriate, we also are 
updating the street address to reflect our present location at 5100 
Paint Branch Parkway, College Park, MD 20740, and contact information 
to reflect our new telephone number, 240-402-1200. The final rule 
contains no collection of information. Therefore, clearance by the 
Office of Management and Budget under the Paperwork Reduction Act of 
1995 is not required. Publication of this document constitutes final 
action of these changes under the Administrative Procedure Act (5 
U.S.C. 553). These amendments are merely correcting nonsubstantive 
errors. FDA, therefore, for good cause, finds under 5 U.S.C. 
553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.

List of Subjects

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

21 CFR Part 173

    Food additives.

21 CFR Parts 176, 177, and 178

    Food additives, Food packaging.

21 CFR Part 184

    Food additives, Substances generally recognized as safe.

21 CFR Part 189

    Food additives, Food packaging, Substances prohibited from use in 
human food.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR parts 73, 172, 173, 176, 177, 178, 184, and 189 are 
amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


0
2. Amend Sec.  73.3129 as follows:
0
a. Revise the section heading to read as set forth below.
0
b. In paragraph (a), remove ``disodium 1-amino-4-[[4-[(2-bromo-1-
oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-
dioxoanthracene-2-sulphonate'' and in its place add ``disodium 1-amino-
4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-
dihydro-9,10-dioxoanthracene-2-sulfonate''.


Sec.  73.3129  Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-
sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.

* * * * *

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
3. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.


Sec.  172.712  [Amended]

0
4. In Sec.  172.712, in paragraph (b), remove ``the Office of Premarket 
Approval, Center for Food Safety and Applied Nutrition, 5100 Paint 
Branch Pkwy., College Park, MD 20740'' and in its place add ``the 
Office of Food Additive Safety (HFS-200), Center for Food Safety and 
Applied Nutrition,

[[Page 14665]]

5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1200''.


Sec.  172.723  [Amended]

0
5. In Sec.  172.723, in paragraph (b)(1), remove ``Division of Petition 
Control (HFS-215), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 1110 Vermont Ave. NW., suite 1200, Washington, 
DC'' and in its place add ``Office of Food Additive Safety (HFS-200), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  172.809  [Amended]

0
6. In Sec.  172.809, in paragraph (b), remove ``Division of Petition 
Control (HFS-215), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  172.831  [Amended]

0
7. In Sec.  172.831, in paragraph (b), remove ``Division of Product 
Policy (HFS-206), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  172.833  [Amended]

0
8. In Sec.  172.833, in paragraph (b)(2), remove ``Office of Premarket 
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  172.886  [Amended]

0
9. In Sec.  172.886, in paragraph (c)(2)(iii), remove ``Office of 
Premarket Approval (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740'' and in its place add ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1200''.

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR 
HUMAN CONSUMPTION

0
10. The authority citation for 21 CFR part 173 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348.


Sec.  173.25  [Amended]

0
11. In Sec.  173.25, in paragraph (b)(2)(ii)(B), remove ``Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740'' and in its place add ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1200''.


Sec.  173.45  [Amended]

0
12. In Sec.  173.45, in paragraph (a), remove ``Division of Product 
Policy, Center for Food Safety and Applied Nutrition (HFS-205), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  173.325  [Amended]

0
13. In Sec.  173.325, in paragraph (h), remove ``Division of Petition 
Control (HFS-215), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  173.368  [Amended]

0
14. In Sec.  173.368, in paragraph (c), remove ``Office of Premarket 
Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

0
15. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.


Sec.  176.180  [Amended]

0
16. In Sec.  176.180, in the table in paragraph (b)(2), in the first 
column, remove ``Methyl napthalene sulfonic acid-formaldehyde 
condensate, sodium salt'' and in its place add ``Methyl naphthalene 
sulfonic acid-formaldehyde condensate, sodium salt''; and remove 
``Napthalene sulfonic acid-formaldehyde condensate, sodium salt'' and 
in its place add ``Naphthalene sulfonic acid-formaldehyde condensate, 
sodium salt''.

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

0
17. The authority citation for 21 CFR part 177 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.


Sec.  177.1210  [Amended]

0
18. In Sec.  177.1210, in table 1 in paragraph (b)(5), in the first 
column, remove ``Napthalene sulfonic acid-formaldehyde condensate, 
sodium salt'' and in its place add ``Naphthalene sulfonic acid-
formaldehyde condensate, sodium salt''; and remove ``Sodium salt of 
trisopropyl napthalenesulfonic acid'' and in its place add ``Sodium 
salt of trisopropyl naphthalenesulfonic acid''.


Sec.  177.1350  [Amended]

0
19. In Sec.  177.1350, in paragraph (b)(2), remove ``Division of 
Petition Control (HFS-215) Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740'' and in its place add ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1200''.


Sec.  177.1360  [Amended]

0
20. In Sec.  177.1360, in paragraph (d), remove ``Office of Premarket 
Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200)), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.

[[Page 14666]]

Sec.  177.1500  [Amended]

0
21. In Sec.  177.1500, in table 1 in paragraph (b), in the third column 
of the entry for ``11. Nylon 12T resins for use in contact with all 
types of food except those containing more than 8 percent alcohol,'' 
remove ``290-310'' and in its place add ``N/A''.


Sec.  177.1637  [Amended]

0
22. In Sec.  177.1637, in paragraph (b)(2), remove ``Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740'' and in its place add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  177.2440  [Amended]

0
23. In Sec.  177.2440, in paragraph (a)(3), remove ``Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, 1110 Vermont Ave. NW., Suite 1200, Washington, DC'' and in 
its place add ``Office of Food Additive Safety (HFS-200), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1200''.


Sec.  177.2600  [Amended]

0
24. In Sec.  177.2600, in paragraph (c)(4)(i), remove ``Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740'' and in its place add ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1200''.

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

0
25. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.


Sec.  178.1010  [Amended]

0
26. In Sec.  178.1010, in paragraph (c)(40), remove ``Division of 
Petition Control, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740'' and in its place add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  178.3297  [Amended]

0
27. Amend Sec.  178.3297 as follows:
0
a. In paragraph (c), remove ``Center for Food Safety and Applied 
Nutrition, (HFS-200) Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740,'' and in its place add ``Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1200''.
0
b. In paragraph (e), in the entry for ``High-purity furnace black,'' 
remove ``Office of Premarket Approval (HFS-200), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

0
28. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.


Sec.  184.1012  [Amended]

0
29. In Sec.  184.1012, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 1110 Vermont Ave. NW., Suite 1200, Washington, 
DC'' and in its place add ``Office Food Additive Safety (HFS-200), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  184.1024  [Amended]

0
30. In Sec.  184.1024, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.


Sec.  184.1034  [Amended]

0
31. In Sec.  184.1034, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.


Sec.  184.1063  [Amended]

0
32. In Sec.  184.1063, in paragraph (b)(8), remove ``Division of 
Petition Control, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740'' and in its place add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  184.1259  [Amended]

0
33. In Sec.  184.1259, in paragraph (b)(8), remove ``Division of Food 
and Color Additives, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740'' and in its place add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  184.1316  [Amended]

0
34. In Sec.  184.1316, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.


Sec.  184.1415  [Amended]

0
35. In Sec.  184.1415, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.


Sec.  184.1583  [Amended]

0
36. In Sec.  184.1583, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in

[[Page 14667]]

its place add ``Office of Food Additive Safety (HFS-200), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1200''.


Sec.  184.1595  [Amended]

0
37. In Sec.  184.1595, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.


Sec.  184.1866  [Amended]

0
38. In Sec.  184.1866, in paragraph (b), remove ``Office of Premarket 
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740'' and in its place add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  184.1914  [Amended]

0
39. In Sec.  184.1914, in paragraph (b), remove ``Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740'' and in its place add ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-1200''.


Sec.  184.1985  [Amended]

0
40. In Sec.  184.1985, in paragraph (b), remove ``Division of Petition 
Control (HFS-215), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 1110 Vermont Ave. NW., Suite 1200, Washington, 
DC'' and in its place add ``Office of Food Additive Safety (HFS-200), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.

PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

0
41. The authority citation for 21 CFR part 189 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371, 381.


Sec.  189.110  [Amended]

0
42. In Sec.  189.110, in paragraph (c), remove ``Division of Food and 
Color Additives, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740'' and in its place add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.


Sec.  189.180  [Amended]

0
43. In Sec.  189.180, in paragraph (c), remove ``Division of Food and 
Color Additives, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740'' and in its place add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1200''.

    Dated: February 1, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2013-04701 Filed 3-6-13; 8:45 am]
BILLING CODE 4160-01-P