[Federal Register Volume 88, Number 57 (Friday, March 24, 2023)]
[Rules and Regulations]
[Pages 17710-17725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 106, 170, 172, 173, 184, and 190

[Docket No. FDA-2022-N-2898]


Food Labeling, Infant Formula Requirements, Food Additives and 
Generally Recognized as Safe Substances, New Dietary Ingredient 
Notification; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending its 
regulations that pertain to food labeling, infant formula requirements, 
food additives, direct food substances affirmed as generally recognized 
as safe (GRAS), and new dietary ingredient (NDI) notifications. These 
amendments correct typographical errors, correct errors in sample 
labels, restore inadvertent omissions, and update office and 
organization names, addresses, and other references. This action is 
ministerial or editorial in nature.

DATES: This rule is effective on March 24, 2023.

FOR FURTHER INFORMATION CONTACT: 
    For further information about food labeling amendments, Mark 
Kantor, Office of Nutrition and Food Labeling (HFS-830), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1450.
    For further information about infant formula amendments, Carrie 
Assar, Office of Nutrition and Food Labeling (HFS-850), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1450.
    For further information about food additive and GRAS amendments, 
Annette McCarthy, Office of Food Additive Safety (HFS-205), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1200.
    For further information about NDI notification amendments, Laura 
Rich, Office of Dietary Supplement Programs (HFS-810), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-8152.
    For further information about the rule, Alexandra Jurewitz, Office 
of Regulations and Policy (HFS-024), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Food Labeling (21 CFR Part 101)

    In the Federal Register of May 27, 2016 (81 FR 33742), we published 
a final rule entitled ``Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels'' (the Nutrition Facts Label Final Rule). The 
Nutrition Facts Label Final Rule amended our labeling regulations for 
conventional foods and dietary supplements to provide updated nutrition 
information on the label to assist consumers in maintaining healthy 
dietary practices.
    In the Federal Register of December 21, 2018 (83 FR 65493), we 
issued a technical amendment pertaining to the Nutrition Facts label 
requirements. The technical amendments corrected errors that were made 
in sample labels, restored incorrect deletions, corrected the edition 
of a reference cited in the Nutrition Facts Label Final Rule, and 
corrected cross-references to other

[[Page 17711]]

regulations. However, certain errors remained, and so this rulemaking 
will provide additional corrections to sample labels and updates to 
office names.

B. Notification of an Adulterated or Misbranded Infant Formula (Sec.  
106.150 (21 CFR 106.150))

    In the Federal Register of February 10, 2014 (79 FR 7934), FDA 
published an interim final rule entitled ``Current Good Manufacturing 
Practices, Quality Control Procedures, Quality Factors, Notification 
Requirements, and Records and Reports, for Infant Formula'' (2014 
interim final rule). In the Federal Register of June 10, 2014 (79 FR 
33057), FDA issued a final rule, adopting, with some modifications, the 
2014 interim final rule where FDA established notification requirements 
for adulterated or misbranded infant formula. The 2014 interim final 
rule included an incorrect statutory citation in this provision, and so 
this rulemaking is intended to correct the citation.

C. Food Additives and GRAS Substances (21 CFR Parts 170, 172, 173, and 
184)

    Our regulations in parts 170, 172, 173, and 184 (21 CFR parts 170, 
172, 173, and 184) discuss the general principles for evaluating food 
additive safety, the use of food additives, and substances affirmed as 
GRAS. Our regulations reference office names and addresses that are no 
longer correct, reference an organization's name that is no longer 
correct, and include a potentially confusing reference to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act); consequently, this rulemaking 
will update names and addresses and clarify a reference to the FD&C 
Act.

D. Dietary Supplements (21 CFR Part 190)

    In the Federal Register of September 23, 1997 (62 FR 49886), FDA 
published a final rule entitled ``Premarket Notification for a New 
Dietary Ingredient.'' The final rule specifies the information a 
manufacturer or distributor must include in its premarket NDI 
notification and establishes the administrative procedures for these 
notifications. The regulation refers to an FDA office name and address 
that is no longer correct, and so this rulemaking will update the 
office name and address.

II. Description of the Technical Amendments

    We are making technical amendments to our regulations in parts 101, 
106, and 190 (21 CFR parts 101, 106, and 190) and parts 170, 172, 173, 
and 184. In general, part 101 pertains to food labeling, including the 
nutrition labeling of food. Part 106 pertains to current good 
manufacturing practice, quality control procedures, quality factors, 
records and reports, and notifications regarding infant formula. Part 
170 pertains to food additives while part 172 pertains to food 
additives permitted for direct addition to food for human consumption. 
Part 173 pertains to secondary food additives permitted in food for 
human consumption. Part 184 pertains to direct food substances affirmed 
as generally recognized as safe. Part 190 pertains to dietary 
supplements.

A. Food Labeling (Part 101)

    Since we published the technical amendments to the final rule in 
the Federal Register, we have become aware of additional changes or 
corrections that are needed to the Nutrition Facts label requirements. 
These changes or corrections are non-substantive; for example, Sec.  
101.9(d)(11) and (j)(5)(ii)(B) (21 CFR 101.9(d)(11) and (j)(5)(ii)(B)) 
show sample Nutrition Facts labels. In one case, the sample label 
included an extra word in the phrasing of a nutrient declaration. In 
the other case, the sample label included a number that did not comply 
with the rounding requirements for certain nutrients. The technical 
amendment revises the sample labels. We describe these and other 
changes to the Food Labeling regulations below.
1. Section 101.4 and Office Name Corrections
    Our regulations in 21 CFR 101.4 discuss the designation of food 
ingredients and state that certain references are available for 
examination at the ``Food and Drug Administration's Main Library.'' The 
technical amendment revises where the references are available for 
examination to be FDA's Dockets Management Staff.
2. Section 101.9(b)(7)(vi) and Addresses for Obtaining Reference 
Materials
    The Nutrition Facts Label Final Rule revised the name of the 
program office that is responsible for developing regulations and 
answering questions related to nutrition labeling, as well as for 
maintaining some references discussed throughout Sec.  101.9. The 
program office's former name was the Office of Nutritional Products, 
Labeling and Dietary Supplements, and the Nutrition Facts Label Final 
Rule changed the program office's name to the Office of Nutrition and 
Food Labeling. However, our regulations in Sec.  101.9(b)(7)(vi) 
continued to use the program office's former name. Therefore, this 
technical amendment revises Sec.  101.9(b)(7)(vi) by replacing ``Office 
of Nutritional Products, Labeling and Dietary Supplements'' with 
``Office of Nutrition and Food Labeling.''
3. Section 101.9(c)(8)(iv) and Units of Measure
    Our regulations in Sec.  101.9(c)(8)(iv) provide the Reference 
Daily Intakes (RDIs), nomenclature, and units of measure for various 
vitamins and minerals that are essential in human nutrition. The 
regulation lists the vitamins and minerals in a table, and footnotes to 
the table provide additional information. Footnote 3 discusses the 
units of measure that may be used for vitamin A. The footnote says, in 
part, that the abbreviation ``RAE'' stands for ``Retinol activity 
equivalents'' and that 1 microgram RAE equals 1 microgram retinol, ``2 
microgram supplemental [beta]-carotene'' or ``dietary 24 micrograms 
dietary [beta]-cryptoxanthin.'' The technical amendment replaces ``2 
microgram'' with ``2 micrograms'' and deletes the word ``dietary'' 
before ``24 micrograms.''
4. Section 101.9(d)(11)(iii) and the Tabular Format Label Illustration
    Our regulations in Sec.  101.9(d)(11)(iii) contain a sample 
Nutrition Facts label in a tabular format. However, the sample label 
contains the statement ``Includes 1g of Added Sugars.'' Under Sec.  
101.9(c)(6)(iii), however, the correct statement is ``Includes `X' g 
Added Sugars.'' Therefore, the technical amendment revises the sample 
label by removing the word ``of'' so that the statement reads 
``Includes 1g Added Sugars.''
5. Section 101.9(j)(5)(ii)(B) and ``Infants Through 12 Months of Age'' 
Label Illustration
    Our regulations in Sec.  101.9(j)(5)(ii)(B) contain a sample 
Nutrition Facts label for a food intended for infants through 12 months 
of age. The sample label declares the amount of sodium to be 74 mg. 
Under Sec.  101.9(c)(4), however, the amount of sodium declared on a 
Nutrition Facts label must be expressed to the nearest 5-milligram 
increment when the serving contains 5 to 140 milligrams of sodium. 
Therefore, the technical amendment provides a revised sample label 
correcting the amount of sodium from ``74mg'' to ``75mg.''
6. Section 101.9(j)(13)(i)(B), Footnote Requirements for Foods in Small 
Packages, and Minimum Type Size
    Our regulations in Sec.  101.9(j)(13)(i)(B) discuss requirements 
for foods in small

[[Page 17712]]

packages. The Nutrition Facts Label Final Rule revised Sec.  
101.9(j)(13)(i)(B) so that the Nutrition Facts label on small packages 
would not be required to bear a footnote explaining what the ``% Daily 
Value'' means and manufacturers could voluntarily include an 
abbreviated footnote of ``% DV = % Daily Value'' in a type size no 
smaller than 6 point. Additionally, these requirements include, among 
other things, the minimum type size for required information. The 
minimum type size is specified as ``no smaller than 6 point or all 
upper-case type of 1-16 inches.''
    The inclusion of the alternate footnote option was inadvertently 
omitted when changes to the same paragraph, as described in the Federal 
Register of December 1, 2014 (79 FR 71259), became effective on 
December 1, 2016. Consequently, we are restoring the alternate footnote 
option. The technical amendment also corrects the minimum type size, in 
inches, to ``\1/16\ inches'' rather than ``1-16 inches.''
7. Section 101.9(j)(13)(ii)(A)(1) and Tabular Display for Small 
Packages Label Illustration
    Our regulations in Sec.  101.9(j)(13)(ii)(A)(1) provide a sample 
label for the tabular display for small packages. The sample label 
included an asterisk (*) after the ``% DV'' heading but omitted any 
footnote or other explanation as to what the asterisk was referring. 
The sample label also included ``servings per container'' and ``serving 
size'' declarations that are not consistent with our rounding 
regulations in Sec.  101.9(b)(5)(i), which state that ``Cups shall be 
expressed in \1/4\- or \1/3\-cup increments.''
    Manufacturers may voluntarily include an abbreviated footnote ``% 
DV = % Daily Value'' for products in small packages, but because the 
sample label did not include the abbreviated footnote, the technical 
amendment removes the asterisk after the ``% DV'' heading in the sample 
label. The technical amendment also revises the serving size from ``\1/
6\ cup'' to ``\1/3\ cup'' and the servings per container from ``5 
servings per container'' to ``about 3 servings per container'' in the 
sample label.
8. Section 101.9(j)(13)(ii)(A)(2) and Linear Display for Small Packages 
Label Illustration
    Our regulations in Sec.  101.9(j)(13)(ii)(A)(2) provide a sample 
label for the linear display for small packages. The sample label 
included a ``% DV'' declaration of ``Potas. (5% DV).'' Under Sec.  
101.9(c)(8)(iii), however, the ``% DV'' for vitamins and minerals must 
be expressed to the nearest 2-percent increment up to and including the 
10-percent level. Therefore, the technical amendment changes ``Potas. 
(5% DV)'' to ``Potas. (6% DV)'' in the sample label.
9. Section 101.9(j)(13)(ii)(B) and Corrections to Abbreviation 
Instructions
    Our regulations in Sec.  101.9(j)(13)(ii)(B) allow for the use of 
``Vit.'' and ``Potas.'' as abbreviations for ``Vitamin'' and 
``Potassium,'' respectively, on the labels of small and intermediate-
sized packages. While our regulations in Sec.  101.9(d)(12) also show 
the use of these abbreviations on the standard vertical side-by-side 
label illustration, indicating that we intended to permit this use, we 
failed to state explicitly that these abbreviations are permitted on 
labels other than the labels of small and intermediate-sized packages. 
In addition, the regulations allow for the use of ``Total carb.'' as an 
abbreviation for ``Total carbohydrate'' on dual-column displays and 
refers to other requirements in Sec.  101.9 by their paragraph 
designations.
    The technical amendment revises Sec.  101.9(j)(13)(ii)(B) to 
clearly state that the use of ``Vit.'' and ``Potas.'' as abbreviations 
for ``Vitamin'' and ``Potassium,'' respectively, on the standard 
vertical side-by-side label display as shown in Sec.  101.9(d)(12), is 
permitted in addition to their use on the labels of small and 
intermediate-sized packages. The technical amendment also revises Sec.  
101.9(j)(13)(ii)(B) to include ``of this section'' at the end of the 
sentence pertaining to ``Total carbohydrate'' so that it refers to 
``paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this section.''
10. Section 101.45 and Office Name Correction
    Our regulations in 21 CFR 101.45 discuss the guidelines for 
voluntary nutrition labeling of raw fruits, vegetables, and fish and 
encourages submission of nutrient databases to the ``Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-800).'' The 
regulations also state that guidance is available from the ``FDA Office 
of Food Labeling.'' The technical amendment revises the office name to 
be ``Office of Nutrition and Food Labeling (HFS-800), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740.''
11. Section 101.80 and Office Name Correction
    Our regulations in 21 CFR 101.80 discuss dietary noncariogenic 
carbohydrate sweeteners and dental caries health claims. The 
regulations state that a reference is available for examination at the 
``Food and Drug Administration's Main Library.'' The technical 
amendment revises where the reference is available for examination to 
be FDA's Dockets Management Staff.
12. Section 101.81 and Office Name Correction
    Our regulations in 21 CFR 101.81 discuss soluble fiber from certain 
foods and risk of coronary heart disease health claims. The regulations 
state that certain references are available for examination at the 
``Food and Drug Administration's Main Library.'' The technical 
amendment revises where the references are available for examination to 
be FDA's Dockets Management Staff.
13. Section 101.83 and Office Name Correction
    Our regulations in 21 CFR 101.83 discuss plant sterol/stanol esters 
and risk of coronary heart disease health claims. The regulations state 
that certain references are available for examination at the ``Food and 
Drug Administration's Main Library.'' The technical amendment revises 
where the references are available for examination to be FDA's Dockets 
Management Staff.
14. Section 101.93 and Office Name Correction
    Our regulations in part 101, subpart F, discuss specific 
requirements for descriptive claims that are neither nutrient content 
claims nor health claims. In 21 CFR 101.93 the requirements for 
notifications for certain types of statements for dietary supplements 
are discussed and submissions are directed to the ``Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-810), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740.'' The 
technical amendment revises the office name to be ``Office of Dietary 
Supplement Programs (HFS-810),'' which reflects the office's current 
name.
15. Section 101.108 and Office Name Correction
    Our regulations in 21 CFR 101.108 discuss temporary exemptions for 
purposes of conducting authorized food labeling experiments. The 
regulation states that written proposals should be sent to the 
``Division of Dockets Management (HFA-305).'' The technical amendment 
revises the office name to be ``Dockets Management Staff (HFA-305).''

[[Page 17713]]

B. Notification of an Adulterated or Misbranded Infant Formula (Sec.  
106.150)

    Our regulations in Sec.  106.150(a)(1) state that a manufacturer 
must promptly notify us when the manufacturer has knowledge that 
reasonably supports the conclusion that an infant formula processed by 
that manufacturer and that has left an establishment controlled by the 
manufacturer may not provide the nutrients required by section 412(i) 
of the FD&C Act. The regulation was intended to provide a corresponding 
U.S. Code cite for section 412(i) of the FD&C Act and identifies the 
U.S. Code cite as 21 U.S.C. 350d(i). The U.S. Code citation should have 
been 21 U.S.C. 350a(i). Therefore, the technical amendment replaces 
``21 U.S.C. 350d(i)'' with ``21 U.S.C. 350a(i).''

C. Food Additives (Parts 170, 172, 173, and 184)

1. Sections 170.35, 170.38, and 170.39--Office Name Correction and 
Correction Regarding Dockets Management
    The regulations in Sec. Sec.  170.35(b)(1) and (b)(2), 170.38(b)(1) 
and (b)(2), and 170.39(e) and (g) (21 CFR 170.35(b)(1) and (b)(2), 
170.38(b)(1) and (b)(2), and 170.39(e) and (g)) state that data, 
information, comments, or other documents are on display or available 
at the ``Division of Dockets Management.'' The technical amendment 
revises these regulations to replace ``Division of Dockets Management'' 
with ``Dockets Management Staff'' to reflect the office's current name.
    Similarly, our regulations in Sec.  170.39(d), (e), and (h) refer 
to the ``Office of Premarket Approval.'' The technical amendment 
replaces ``Office of Premarket Approval'' with ``Office of Food 
Additive Safety'' to reflect the office's current name.
2. Sections 172.105, 172.133, 172.250, 172.859, 172.878, and 172.882--
Office Name and Contact Information Correction
    Our regulations in 21 CFR 172.105, 172.133, 172.250, 172.859, 
172.878, and 172.882 discuss the use of anoxomer, dimethyl carbonate, 
petroleum naphtha, sucrose fatty acid esters, white mineral oil, and 
synthetic isoparaffinic petroleum hydrocarbons as food additives, 
respectively, and state that certain references are available from the 
``Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740.'' The 
technical amendment replaces all instances of ``Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740'' with ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1200.'' We are making this change to include the name and contact 
information of the office where the references are available.
3. Section 172.155--Office Name, Contact Information, and Other Minor 
Corrections
    Our regulations in 21 CFR 172.155 discuss the use of natamycin 
(also known as pimaricin) as a food additive. Section 172.155(c) states 
that a reference is available from the ``Division of Product Policy 
(HFS-206)'' and provides the office's address. The regulation also 
states that this reference is available for examination at the ``Food 
and Drug Administration's Main Library.'' The technical amendment: (1) 
updates the associated address of where the reference is available to 
be ``Office of Food Additive Safety (HFS-200), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1200;'' and (2) revises where the 
reference is available for examination to be FDA's Dockets Management 
Staff.
4. Sections 172.167, 172.185, 172.320, 172.345, 172.379, 172.380, 
172.665, 172.712, 172.780, 172.810, 172.812, 172.831, 172.841, 172.862, 
and 172.867--Office Name and Contact Information Corrections
    Our regulations in 21 CFR 172.167, 172.185, 172.320, 172.345, 
172.379, 172.380, 172.665, 172.712, 172.780, 172.810, 172.812, 172.831, 
172.841, 172.862, and 172.867 discuss the use of silver nitrate and 
hydrogen peroxide solution, TBHQ, amino acids, folic acid (folacin), 
vitamin D2, vitamin D3, gellan gum, 1,3-butylene 
glycol, acacia (gum arabic), dioctyl sodium sulfosuccinate, glycine, 
sucralose, polydextrose, oleic acid derived from tall oil fatty acids, 
and olestra as food additives, respectively. The regulations state that 
certain references are available for examination at the ``Food and Drug 
Administration's Main Library.'' The technical amendment revises where 
the references are available for examination to be FDA's Dockets 
Management Staff.
5. Sections 172.723--Office Contact Information and Other Minor 
Corrections
    Our regulations in 21 CFR 172.723 discuss the use of epoxidized 
soybean oil as a food additive. The regulations state that certain 
references may be examined at either the ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1200'' or the ``Food and Drug Administration's Main Library, 10903 
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039.'' The technical amendment revises where the references are 
available for examination to be FDA's Docket Management Staff.
6. Sections 172.736, 172.803, and 172.869--Office Contact Information 
and Other Minor Corrections
    Our regulations in 21 CFR 172.736, 172.803, and 172.869 discuss the 
use of glycerides and polyglycides of hydrogenated vegetable oils, 
advantame, and sucrose oligoesters as food additives, respectively. The 
regulations state that certain references are available from either the 
``Office of Food Additive Safety, 5001 Campus Dr., College Park, MD 
20740,'' the ``Office of Food Additive Safety, Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740,'' or the ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5001 
Campus Dr., College Park, MD 20740'' and are available for examination 
at the ``Food and Drug Administration's Main Library.'' The technical 
amendment: (1) updates the associated address of where the references 
are available to be the ``Office of Food Additive Safety (HFS-200), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200;'' and (2) revises where the references are available for 
examination to be FDA's Dockets Management Staff.
7. Sections 172.785, 172.809, 172.829, and 172.833--Office Contact 
Information and Other Minor Corrections
    Our regulations in 21 CFR 172.785, 172.809, 172.829, and 172.833 
discuss the use of Listeria-specific bacteriophage preparation, 
curdlan, neotame, and sucrose acetate isobutyrate as food additives, 
respectively. The regulations state that specific references are 
available from either the ``Office of Food Additive Safety (HFS-200), 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039,'' the 
``Office of Food Additive Safety (HFS-200), Food and Drug 
Administration's Main Library,

[[Page 17714]]

10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 
20993,'' or the ``Office of Food Additive Safety (HFS-200), Food and 
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 
Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-402-1200'' and 
are available for examination at the ``Center for Food Safety and 
Applied Nutrition's Library'' or the ``Food and Drug Administration's 
Main Library.'' The technical amendment: (1) updates the associated 
address of where the references are available to be ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200;'' and (2) revises where the references are 
available for examination to be FDA's Dockets Management Staff.
8. Sections 172.800 and 172.886--Office Name, Contact Information, and 
Other Minor Corrections
    Our regulations in 21 CFR 172.800 and 172.886 discuss the use of 
acesulfame potassium and petroleum wax as food additives, respectively. 
The regulations state that certain references are available from the 
``Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740'' and are 
available for examination at the ``Food and Drug Administration's Main 
Library.'' The technical amendment: (1) updates the associated address 
of where the references are available to be ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1200;'' and (2) revises where the references are available for 
examination to be FDA's Dockets Management Staff.
9. Section 172.804--Office Name and Other Minor Corrections
    Our regulations in 21 CFR 172.804 discuss the use of aspartame as a 
food additive. The regulations discuss standards of identity 
established under ``section 401 of the act'' and, at paragraph (c)(2), 
states that a specific analytical method is available from the ``Office 
of Premarket Approval (HFS-200), Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993'' and are available for inspection at either the ``Center for 
Food Safety and Applied Nutrition's Library'' or the ``Food and Drug 
Administration's Main Library.'' The technical amendment: (1) revises 
``section 401 of the act'' to read as ``section 401 of the Federal 
Food, Drug, and Cosmetic Act'' to clarify which statute is being 
referenced; (2) replaces ``Office of Premarket Approval'' with ``Office 
of Food Additive Safety'' to reflect the office's current name; (3) 
updates the associated address for the Office of Food Additive Safety; 
and (4) revises where the reference is available for examination to be 
FDA's Dockets Management Staff.
10. Section 172.864--Office Name and Contact Information Corrections
    Our regulations in 21 CFR 172.864 discuss the use of synthetic 
fatty alcohols as a food additive. The regulation states that various 
analytical methods are either available from the ``Office of Food 
Additive Safety, 5001 Campus Dr., College Park, MD 20740'' or the 
``Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740.'' The 
regulation also states that these references are available for 
examination at the ``Food and Drug Administration's Main Library, 10903 
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039.''The technical amendment: (1) replaces ``Office of Food 
Additive Safety, 5001 Campus Dr., College Park, MD 20740'' with 
``Office of Food Additive Safety (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1200;'' (2) replaces ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' with ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday;'' and (3) replaces ``Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740'' with ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200.'' We are making this change to update the 
office address and contact information of the office where the 
references are available.
11. Sections 173.25, 173.45, 173.228, 173.280, 173.310, 173.325, 
173.356, 173.368, and 173.375--Office Name and Contact Information 
Corrections
    Our regulations in 21 CFR 173.25, 173.45, 173.228, 173.280, 
173.310, 173.325, 173.356, 173.368, and 173.375 discuss the use of ion-
exchange resins, polymaleic acid and its sodium salt, ethyl acetate, 
solvent extraction process for citric acid, boiler water additives, 
acidified sodium chlorite solutions, hydrogen peroxide, ozone, and 
cetylpyridinium chloride as secondary direct food additives, 
respectively, and state that certain references are available for 
examination from the ``Food and Drug Administration's Main Library.'' 
The technical amendment revises where the references are available for 
examination to be FDA's Dockets Management Staff.
12. Sections 173.60, 173.65, 173.73, and 173.400--Office Name and 
Contact Information Correction
    Our regulations in 21 CFR 173.60, 173.65, 173.73, and 173.400 
discuss the use of dimethylamine-epichlorohydrin copolymer, 
divinylbenzene copolymer, sodium polyacrylate, and 
dimethyldialkylammonium chloride as secondary direct food additives, 
respectively, and state that certain references are available from 
either the ``Center for Food Safety and Applied Nutrition (HFS-200), 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740'' 
or the ``Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740.'' The 
technical amendment replaces all instances of ``Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740'' or ``Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740'' with ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200.'' We are making this change to update the name and contact 
information of the office where the references are available.
13. Section 173.115--Office Contact Information Correction
    Our regulations in 21 CFR 173.115 discuss the use of alpha-
acetolactate decarboxylase ([alpha]-ALDC) enzyme preparation derived 
from a recombinant Bacillus subtilis as a secondary direct food 
additive. The regulations state that

[[Page 17715]]

certain references may be examined at the ``Center for Food Safety and 
Applied Nutrition, 5001 Campus Dr., College Park, MD 20740.'' The 
technical amendment revises where the references are available for 
examination to be FDA's Docket Management Staff.
14. Sections 173.160 and 173.165--Office Name, Contact Information, and 
Other Minor Corrections
    Our regulations in 21 CFR 173.160 and 173.165 discuss the use of 
Candida guilliermondii and Candida lipolytica as secondary direct food 
additives, respectively, and state that certain references are 
available from the ``Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 
20740'' and are available for examination at the ``Food and Drug 
Administration's Main Library.'' The technical amendment: (1) updates 
the associated address of where the references are available to be 
``Office of Food Additive Safety (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1200;'' and (2) revises where the 
references are available for examination to be FDA's Dockets Management 
Staff.
15. Sections 173.300, 173.340, and 173.357--Office Contact Information 
and Other Minor Corrections
    Our regulations in 21 CFR 173.300, 173.340, and 173.357 discuss the 
use of chlorine dioxide, defoaming agents, and materials used as fixing 
agents in the immobilization of enzyme preparations as secondary direct 
food additives, respectively, and state that certain references are 
available from the ``Office of Food Additive Safety (HFS-200), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740.'' The regulations also state 
that the references are available for examination at the ``Food and 
Drug Administration's Main Library.'' The technical amendment: (1) 
revises the office contact information to add the office's telephone 
number, ``240-402-1200,'' to the end; and (2) revises where the 
references are available for examination to be FDA's Dockets Management 
Staff.
16. Section 173.370--Office Name, Contact Information, and Other Minor 
Corrections
    Our regulations in 21 CFR 173,370 discuss the use of peroxyacids as 
secondary direct food additives. The regulation in Sec.  173.370(c) 
states that specific analytical methods can be obtained from the 
``Division of Petition Review'' or are available for examination at the 
``Food and Drug Administration's Main Library.'' The technical 
amendment: (1) updates the associated address of where the analytical 
methods can be obtained to be the ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200;'' and (2) revises where the analytical methods are available for 
examination to be FDA's Dockets Management Staff.
17. Part 184--Office Name and Contact Information Corrections
    Our regulations in part 184 discuss direct food substances affirmed 
as generally recognized as safe. Throughout part 184, the regulations 
state that certain references are available for examination at the 
``Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.'' 
The technical amendment revises where the references are available for 
examination to be ``Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday.''
18. Section 184.1538--Office Name Correction
    Our regulations in Sec.  184.1538 (21 CFR 184.1538) discuss nisin 
preparation as a specific substance affirmed as GRAS. The regulation in 
Sec.  184.1538(b) and (d) states that copies of a specific reference 
are available from the ``Division of Dockets Management.'' The 
technical amendment replaces ``Division of Dockets Management'' with 
``Dockets Management Staff'' to reflect the current name and contact 
information of the office from which the reference is available.

D. Dietary Supplements (Part 190)

    Our regulations in part 190, subpart B, discuss NDI notifications. 
The regulation in 21 CFR 190.6(a) discusses the requirement for 
premarket notification and directs submissions to the ``Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-820), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740.'' The 
technical amendment updates the address to ``Office of Dietary 
Supplement Programs (HFS-810), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740.'' This technical amendment reflects our current 
organizational structure with regard to dietary supplements.

III. The Administrative Procedure Act

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553). 
Under 5 U.S.C. 553(b)(3)(B) of the APA, an Agency may, for good cause, 
find (and incorporate the finding and a brief statement of reasons in 
the rules issued) that notice and public comment procedure on a rule is 
impracticable, unnecessary, or contrary to the public interest. We have 
determined that notice and public comment are unnecessary because these 
amendments only make technical or non-substantive changes, such as 
correcting sample labels, updating office or organization names, and 
updating addresses. For these reasons, we have determined that 
publishing a notice of proposed rulemaking and providing opportunity 
for public comment is unnecessary.
    In addition, FDA finds good cause for these amendments to become 
effective on the date of publication of this action. The APA allows an 
effective date less than 30 days after publication as provided by an 
Agency for good cause found and published with the rule (5 U.S.C. 
553(d)(3)). A delayed effective date is unnecessary in this case 
because the amendments do not impose any new regulatory requirements on 
affected parties. As a result, affected parties do not need time to 
prepare before the rule takes effect. Therefore, we find good cause for 
this correction to become effective on the date of publication of this 
action.

IV. Paperwork Reduction Act of 1995

    This 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.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has

[[Page 17716]]

determined that the rule does not contain policies that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, we conclude that the rule does not contain policies that 
have federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

VII. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

List of Subjects

21 CFR Part 101

    Food Labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 106

    Food grades and standards, Infants and children, Nutrition, 
Reporting and recordkeeping requirements.

21 CFR Part 170

    Administrative practice and procedure, Food additives, Reporting 
and recordkeeping requirements.

21 CFR Parts 172 and 190

    Food additives, Reporting and recordkeeping requirements.

21 CFR Parts 173 and 184

    Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
101, 106, 170, 172, 173, 184, and 190 are amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.


Sec.  101.4   [Amended]

0
2. In Sec.  101.4(h) introductory text and (h)(2), remove ``Food and 
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 
Third Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, 
add ``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  101.9   [Amended]

0
3. Amend Sec.  101.9 by:
0
a. In paragraph (b)(7)(vi), removing ``Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-800)'' and, in its place, adding 
``Office of Nutrition and Food Labeling (HFS-800)'';
0
b. In paragraph (c)(8)(iv), removing ``2 microgram'' and ``dietary 24 
micrograms dietary [beta]-cryptoxanthin'' in footnote 3 to the table 
and adding ``2 micrograms'' and ``24 micrograms dietary [beta]-
cryptoxanthin'' in their place, respectively;
0
c. In paragraph (d)(11)(iii), revising the sample label;
0
d. In paragraph (j)(5)(ii)(B), revising the sample label;
0
e. In paragraph (j)(13)(i) introductory text, adding a sentence at the 
end of the paragraph;
0
f. In paragraph (j)(13)(i)(B), removing ``\1/16\ inches'' and, in its 
place, adding ``\1/16\ inches'';
0
g. In paragraph (j)(13)(ii)(A)(1), revising the sample label;
0
h. In paragraph (j)(13)(ii)(A)(2), revising the sample label; and
0
i. In paragraph (j)(13)(ii)(B), revising the sentences that begin with 
``Total carbohydrate--Total carb'', ``Vitamin--Vit'' and ``Potassium--
Potas''.
    The revisions read as follows:


Sec.  101.9  

* * * * *
    (d) * * *
    (11) * * *
    (iii) * * *
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TR24MR23.011

    (j) * * *
    (5) * * *
    (ii) * * *
    (B) * * *

[[Page 17717]]

[GRAPHIC] [TIFF OMITTED] TR24MR23.012

    (13) * * *
    (i) * * * Foods in packages subject to requirements of paragraphs 
(j)(13)(ii)(A)(1) and (2) of this section do not require the 
information in paragraphs (d)(9) and (f)(5) related to the footnote, 
however the abbreviated footnote statement ``% DV = % Daily Value'' may 
be used.
* * * * *
    (ii) * * *
    (A) * * *
    (1) * * *
    [GRAPHIC] [TIFF OMITTED] TR24MR23.013
    
    (2) * * *

[[Page 17718]]

[GRAPHIC] [TIFF OMITTED] TR24MR23.014

BILLING CODE 4164-01-C
    (B) * * *
    Total carbohydrate--Total carb. This abbreviation can also be used 
on dual-column displays as shown in paragraphs (e)(5), (e)(6)(i), and 
(e)(6)(ii) of this section.
* * * * *
    Vitamin--Vit. This abbreviation can also be used on the standard 
vertical side-by-side display as shown in paragraph (d)(12) of this 
section.
    Potassium--Pot. This abbreviation can also be used on the standard 
vertical side-by-side display as shown in paragraph (d)(12) of this 
section.
* * * * *


Sec.  101.45   [Amended]

0
4. Amend Sec.  101.45 as follows:
0
a. In paragraph (b)(1) introductory text, remove ``Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-800)'' and, 
in its place, add ``Office of Nutrition and Food Labeling (HFS-800)''; 
and
0
b. In paragraph (b)(1)(i), remove ``FDA Office of Food Labeling'' and, 
in its place, add ``Office of Nutrition and Food Labeling (HFS-800), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740''.


Sec.  101.80   [Amended]

0
5. In Sec.  101.80(c)(2)(iii)(C), remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  101.81   [Amended]

0
6. In Sec.  101.81(c)(2)(ii)(A) introductory text, (c)(2)(ii)(A)(5), 
(c)(2)(ii)(B)(1), and (c)(2)(ii)(B)(2), remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  101.83   [Amended]

0
7. In Sec.  101.83(c)(2)(ii)(A)(2) and (c)(2)(ii)(B)(2), remove ``Food 
and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 
2, Third Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its 
place, add ``Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday''.


Sec.  101.93  [Amended]

0
8. In Sec.  101.93(a)(1), remove ``Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-810)'' and, in its place, add 
``Office of Dietary Supplement Programs (HFS-810)''.


Sec.  101.108  [Amended]

0
9. In Sec.  101.108(c), remove ``Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852'' and, in its place, add ``Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday 
through Friday''.

PART 106--INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD 
MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY 
FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS

0
10. The authority citation for part 106 continues to read as follows:

    Authority:  21 U.S.C. 321, 342, 350a, 371.


Sec.  106.150   [Amended]

0
11. In Sec.  106.150(a)(1), remove ``21 U.S.C. 350d(i)'' and, in its 
place, add ``21 U.S.C. 350a(i)''.

PART 170--FOOD ADDITIVES

0
12. The authority citation for part 170 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 346a, 348, 371.


Sec.  170.35   [Amended]

0
13. Amend Sec.  170.35 as follows:
0
a. In paragraph (b)(1), remove ``Division of Dockets Management'' and, 
in its place, add ``Dockets Management Staff''; and
0
b. In paragraph (b)(2), remove ``Division of Dockets Management'' and 
``Division of Dockets Management's office'', and, in their place, add 
``Dockets Management Staff'' and ``Dockets Management Staff's office'', 
respectively.


Sec.  170.38   [Amended]

0
14. Amend Sec.  170.38 as follows:
0
a. In paragraph (b)(1), remove ``Division of Dockets Management'' and, 
in its place, add ``Dockets Management Staff''; and
0
b. In paragraph (b)(2), remove ``Division of Dockets Management'' and 
``Division of Dockets Management's office'' and, in their place, add 
``Dockets Management Staff'' and ``Dockets Management Staff's office'', 
respectively.


Sec.  170.39   [Amended]

0
15. Amend Sec.  170.39 as follows:
0
a. In paragraph (d), remove ``Office of Premarket Approval'' and, in 
its place, add ``Office of Food Additive Safety'';
0
b. In paragraph (e), remove ``Division of Dockets Management'' wherever 
it appears and, in its place, add ``Dockets Management Staff'' and 
remove ``Office of Premarket Approval'' in the sixth sentence and, in 
its place, add ``Office of Food Additive Safety'';
0
c. In paragraph (g), remove ``Division of Dockets Management'' in the 
fifth

[[Page 17719]]

sentence and, in its place, add ``Dockets Management Staff''; and
0
d. In paragraph (h), remove ``Office of Premarket Approval'' in the 
first sentence and, in its place, add ``Office of Food Additive 
Safety''.

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

0
16. The authority citation for part 172 continues to read as follows:

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


Sec.  172.105   [Amended]

0
17. In Sec.  172.105(b)(1), (2), and (3), remove ``Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740'' where it appears and, in its 
place, add ``Office of Food Additive Safety (HFS-200), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1200''.


Sec.  172.133   [Amended]

0
18. In Sec.  172.133(a)(2), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), 5001 Campus Dr., 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, 5001 
Campus Dr., College Park, MD 20740, 240-402-1200''.


Sec.  172.155   [Amended]

0
19. In Sec.  172.155(c), in the third sentence, remove ``Division of 
Product Policy (HFS-206), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., 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, 5001 Campus Dr., College Park, MD 20740, 240-402-1200'' 
and remove ``Food and Drug Administration's Main Library, 10903 New 
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039'' and, in its place, add ``Dockets Management Staff (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through 
Friday''.


Sec.  172.167   [Amended]

0
20. Amend Sec.  172.167 as follows:
0
a. In paragraph (b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''; and
0
b. In paragraph (d)(2), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 301-436-2163'', and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''


Sec.  172.185   [Amended]

0
21. In Sec.  172.185(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.250   [Amended]

0
22. In Sec.  172.250(b)(3) footnote 1, remove ``Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 
Campus Dr., 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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  172.320   [Amended]

0
23. Amend Sec.  172.320 as follows:
0
a. In paragraph (g) introductory text, remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''; and
0
b. In paragraph (g)(2), remove ``FDA Main Library, 10903 New Hampshire 
Ave., Silver Spring, MD 20993'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''.


Sec.  172.345   [Amended]

0
24. In Sec.  172.345(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.379   [Amended]

0
25. In Sec.  172.379(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.380   [Amended]

0
26. In Sec.  172.380(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.665   [Amended]

0
27. In Sec.  172.665(d)(2), remove ``Food and Drug Administration's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''.


Sec.  172.712   [Amended]

0
28. In Sec.  172.712(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.723   [Amended]

0
29. Amend Sec.  172.723 as follows:
0
a. In paragraph (b)(1), remove ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr.,

[[Page 17720]]

College Park, MD 20740, 240-402-1200'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday'';
0
b. In paragraph (b)(3), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.736   [Amended]

0
30. Amend Sec.  172.736 as follows:
0
a. In paragraph (b)(1), remove ``Office of Food Additive Safety, 5001 
Campus Dr., 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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''; and
0
b. In paragraph (b)(1), (2), and (3), remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  172.780   [Amended]

0
31. In Sec.  172.780(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.785   [Amended]

0
32. In Sec.  172.785(b)(1), remove ``Office of Food Additive Safety 
(HFS-200), Food and Drug Administration's Main Library, 10903 New 
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039'' and, in its place, add ``Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200'' 
and remove ``Center for Food Safety and Applied Nutrition's Library, 
5001 Campus Dr., College Park MD 20740'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  172.800   [Amended]

0
33. Amend Sec.  172.800 as follows:
0
a. In paragraph (b)(1), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''; and
0
b. In paragraph (b)(2), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.803   [Amended]

0
34. In Sec.  172.803(b) introductory text, remove ``Office of Food 
Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, 5001 Campus Dr., 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, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1200'' and remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  172.804   [Amended]

0
35. Amend Sec.  172.804 as follows:
0
a. In the introductory text, remove ``of the act'' and, in its place, 
add ``of the Federal Food, Drug, and Cosmetic Act'';
0
b. In paragraph (b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''; and
0
c. In paragraph (c)(2), remove ``Office of Premarket Approval (HFS-
200), Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039'' 
and, in its place, add ``Office of Food Additive Safety (HFS-200), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200'', and remove ``Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740'' and, in its place, add ``Dockets Management Staff (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through 
Friday''.


Sec.  172.809   [Amended]

0
36. In Sec.  172.809(b), remove ``Office of Food Additive Safety (HFS-
200), Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-
402-1200'' and, in its place, add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200'' 
and remove ``Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740'' 
and, in its place, add ``Dockets Management Staff (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday''.


Sec.  172.810   [Amended]

0
37. In Sec.  172.810, in the introductory paragraph, remove ``Food and 
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 
Third Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, 
add ``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  172.812   [Amended]

0
38. In Sec.  172.812(a), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD

[[Page 17721]]

20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through 
Friday''.


Sec.  172.829   [Amended]

0
39. In Sec.  172.829(b) introductory text, remove ``Office of Food 
Additive Safety (HFS-200), Food and Drug Administration's Main Library, 
10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 
20993, 301-796-2039'' and, in its place, add ``Office of Food Additive 
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1200'' and remove ``Center for Food Safety and Applied Nutrition's 
Library, 5001 Campus Dr., Rm. 1C-100, College Park, MD 20740'' and, in 
its place, add ``Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday''.


Sec.  172.831   [Amended]

0
40. In Sec.  172.831(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.833   [Amended]

0
41. Amend Sec.  172.833 as follows:
0
a. In paragraph (b)(2), remove ``Office of Food Additive Safety (HFS-
200), Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-
402-1200'' and, in its place, add ``Office of Food Additive Safety 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200'' 
and remove ``Center for Food Safety and Applied Nutrition's Library, 
5001 Campus Dr., College Park, MD 20740'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''; and
0
b. In paragraph (b)(4), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.841   [Amended]

0
42. In Sec.  172.841(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  172.859   [Amended]

0
43. In Sec.  172.859, remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740'' wherever it appears and, in its place, add 
``Office of Food Additive Safety (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1200''.


Sec.  172.862   [Amended]

0
44. In Sec.  172.862(b)(1), remove ``Food and Drug Administration's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''.


Sec.  172.864   [Amended]

0
45. Amend Sec.  172.864 as follows:
0
a. In paragraph (a)(3), remove ``Office of Food Additive Safety, 5001 
Campus Dr., 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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200'' and remove ``Food and Drug Administration's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''; and
0
b. In paragraph (b)(3) footnote 1, remove ``Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus 
Dr., 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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  172.867   [Amended]

0
46. In Sec.  172.867(b), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.

0
47. In Sec.  172.869, revise the fourth sentence of paragraph (b) 
introductory text and paragraph (b)(1) to read as follows:


Sec.  172.869   Sucrose oligoesters.

* * * * *
    (b) * * * Copies may be examined at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday 
through Friday, or at the National Archives and Records Administration 
(NARA). * * *

----------------------------------------------------------------------------------------------------------------
                                                                                          Source for obtaining
           Specification                    Limit                 Method cited                   method
----------------------------------------------------------------------------------------------------------------
(1) Sucrose esters................  Not less than 90%....  ``Method for Analyzing the  Office of Food Additive
                                                            Purity of Sucrose Fatty     Safety (HFS-200), Center
                                                            Acid Esters,'' Chemical     for Food Safety and
                                                            Corp., June 17, 1998.       Applied Nutrition, Food
                                                                                        and Drug Administration,
                                                                                        5001 Campus Dr., College
                                                                                        Park, MD 20740, 240-402-
                                                                                        1200.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


[[Page 17722]]

* * * * *


Sec.  172.878  [Amended]

0
48. In Sec.  172.878(a)(3), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  172.882   [Amended]

0
49. In Sec.  172.882(a), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  172.886  [Amended]

0
50. Amend Sec.  172.886 as follows:
0
a. In paragraph (b) footnote 1, remove ``Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus 
Dr., 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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''; and
0
b. In paragraph (c)(2)(iii), remove ``Food and Drug Administration's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''.

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

0
51. The authority citation for part 173 continues to read as follows:

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


Sec.  173.25   [Amended]

0
52. In Sec.  173.25(b)(2)(ii)(B), remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  173.45   [Amended]

0
53. In Sec.  173.45(a), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  173.60   [Amended]

0
54. In Sec.  173.60(b)(3), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  173.65   [Amended]

0
55. In Sec.  173.65(b), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  173.73  [Amended]

0
56. In Sec.  173.73(a)(2), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.


Sec.  173.115   [Amended]

0
57. In Sec.  173.115(b)(3), remove ``Center for Food Safety and Applied 
Nutrition, 5001 Campus Dr., College Park, MD 20740'' and, in its place, 
add ``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  173.160  [Amended]

0
58. Amend Sec.  173.160 as follows:
0
a. In paragraph (b)(2), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''; and
0
b. In paragraph (d), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  173.165   [Amended]

0
59. Amend Sec.  173.165 as follows:
0
a. In paragraph (b)(2), remove ``Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 
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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''; and
0
b. In paragraph (d), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  173.228   [Amended]

0
60. In Sec.  173.228(a), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  173.280   [Amended]

0
61. In Sec.  173.280(c), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.

[[Page 17723]]

Sec.  173.300   [Amended]

0
62. In Sec.  173.300(a)(2), add ``, 240-402-1200'' after ``Office of 
Food Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740'' and remove ``Food and Drug Administration's Main Library, 
10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 
20994, 301-796-2039'' and, in its place, add ``Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday 
through Friday''.


Sec.  173.310   [Amended]

0
63. Amend Sec.  173.310 as follows:
0
a. In paragraph (f) introductory text, remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''; and
0
b. In paragraph (f)(1), remove ``FDA Main Library, 10903 New Hampshire 
Ave., Silver Spring, MD 20993'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''.


Sec.  173.325   [Amended]

0
64. In Sec.  173.325(h), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.

0
65. In Sec.  173.340, in the table to paragraph (a)(4), revise the 
entry for ``n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycol'' to 
read as follows:


Sec.  173.340   Defoaming agents.

* * * * *
    (a) * * *
    (4) * * *

------------------------------------------------------------------------
          Substances                           Limitations
------------------------------------------------------------------------
n-Butoxypoly(oxyethylene)-      Viscosity range, 4,850-5,350 Saybolt
 poly(oxypropylene)glycol.       Universal Seconds (SUS) at 37.8 [deg]C
                                 (100 [deg]F). The viscosity range is
                                 deteRmined by the method ``Viscosity
                                 DeteRmination of n-
                                 butoxypoly(oxyethylene)-
                                 poly(oxypropylene) glycol'' dated April
                                 26, 1995, developed by Union Carbide
                                 Corp., P.O. Box 670, Bound Brook, NJ
                                 08805, which is incorporated by
                                 reference in accordance with 5 U.S.C.
                                 552(a) and 1 CFR part 51. Copies of the
                                 material incorporated by reference are
                                 available from the Office of Food
                                 Additive Safety (HFS-200), Center for
                                 Food Safety and Applied Nutrition, Food
                                 and Drug Administration, 5001 Campus
                                 Dr., College Park, MD 20740, 240-402-
                                 1200, and may be examined at the
                                 Dockets Management Staff (HFA-305),
                                 Food and Drug Administration, 5630
                                 Fishers Lane, Rm. 1061, Rockville, MD
                                 20852, 240-402-7500, between 9 a.m. and
                                 4 p.m., Monday through Friday, or at
                                 the National Archives and Records
                                 Administration (NARA). For infoRmation
                                 on the availability of this material at
                                 NARA, call 202-741-6030, or go to:
                                 https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *


Sec.  173.356   [Amended]

0
66. In Sec.  173.356(a), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.

0
67. In Sec.  173.357, in the table to paragraph (a)(2), revise the 
entry for ``Polyethylenimine reaction product with 1,2-dichloroethane 
(CAS Reg. No. 68130-97-2)'' to read as follows:


Sec.  173.357   Materials used as fixing agents in the immobilization 
of enzyme preparations.

* * * * *
    (a) * * *
    (2) * * *

[[Page 17724]]



------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
 
                              * * * * * * *
Polyethylenimine reaction product with   May be used as a fixing
 1,2-dichloroethane (CAS Reg. No. 68130-  material in the immobilization
 97-2) is the reaction product of         of glucoamylase enzyme
 homopolymerization of ethylenimine in    preparations from Aspergillus
 aqueous hydrochloric acid at 100         niger for use in the
 [deg]C and of cross-linking with 1,2-    manufacture of beer.
 dichloroethane. The finished polymer    May be used as a fixing
 has an average molecular weight of       material in the immobilization
 50,000 to 70,000 as determined by gel    of:
 permeation chromatography. The          1. Glucose isomerase enzyme
 analytical method is entitled            preparations for use in the
 ``Methodology for Molecular Weight       manufacture of high fructose
 Detection of Polyethylenimine,'' which   corn syrup, in accordance with
 is incorporated by reference in          Sec.   184.1372 of this
 accordance with 5 U.S.C. 552(a) and 1    chapter.
 CFR part 51. Copies may be obtained     2. Glucoamylase enzyme
 from the Office of Food Additive         preparations from Aspergillus
 Safety (HFS-200), Center for Food        niger for use in the
 Safety and Applied Nutrition, 5001       manufacture of beer. Residual
 Campus Dr., College Park, MD 20740,      ethylenimine in the finished
 240-402-1200, and may be examined at     polyethylenimine polymer will
 the Dockets Management Staff (HFA-       be less than 1 part per
 305), Food and Drug Administration,      million as determined by gas
 5630 Fishers Lane, Rm. 1061,             chromatography-mass
 Rockville, MD 20852, 240-402-7500,       spectrometry. The residual
 between 9 a.m. and 4 p.m., Monday        ethylenimine is determined by
 through Friday, or at the National       an analytical method entitled
 Archives and Records Administration      ``Methodology for Ethylenimine
 (NARA). For information on the           Detection in
 availability of this material at NARA,   Polyethylenimine,'' which is
 call 202-741-6030, or go to: http://     incorporated by reference in
 www.archives.gov/federal_register/       accordance with 5 U.S.C.
 code_of_federal_regulations/             552(a) and 1 CFR part 51.
 ibr_locations.html.                      Residual 1,2-dichloroethane in
                                          the finished polyethylenimine
                                          polymer will be less than 1
                                          part per million as determined
                                          by gas chromatography. The
                                          residual 1,2-dichloroethane is
                                          determined by an analytical
                                          method entitled, ``Methodology
                                          for Ethylenedichloride
                                          Detection in
                                          Polyethylenimine,'' which is
                                          incorporated by reference in
                                          accordance with 5 U.S.C.
                                          552(a) and 1 CFR part 51.
                                          Copies may be obtained from
                                          the Office of Food Additive
                                          Safety (HFS-200), Center for
                                          Food Safety and Applied
                                          Nutrition, 5001 Campus Dr.,
                                          College Park, MD 20740, 240-
                                          402-7500, or may be examined
                                          at the Dockets Management
                                          Staff (HFA-305), Food and Drug
                                          Administration, 5630 Fishers
                                          Lane, Rm. 1061, Rockville, MD
                                          20852, 240-402-7500, between 9
                                          a.m. and 4 p.m., Monday
                                          through Friday, or at the
                                          National Archives and Records
                                          Administration (NARA). For
                                          information on the
                                          availability of this material
                                          at NARA, call 202-741-6030, or
                                          go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *


Sec.  173.368   [Amended]

0
68. In Sec.  173.368(c), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  173.370   [Amended]

0
69. In Sec.  173.370(c), remove ``Division of Petition Review, Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5001 Campus Dr., 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, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1200'' and remove ``Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039'' and, in its place add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  173.375   [Amended]

0
70. In Sec.  173.375(a), remove ``Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039'' and, in its place, add ``Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., 
Monday through Friday''.


Sec.  173.400  [Amended]

0
71. In Sec.  173.400(b) and (c)(2)(ii), remove ``Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 
Campus Dr., 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, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1200''.

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

0
72. The authority citation for part 184 continues to read as follows:

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

PART 184 [AMENDED]

0
73. In part 184, remove ``Food and Drug Administration's Main Library, 
10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 
20993, 301-796-2039'' wherever it appears and, in its place, add 
``Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday''.


Sec.  184.1538   [Amended]

0
74. Amend Sec.  184.1538 as follows:
0
a. In paragraph (b) introductory text, remove ``Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852'' and, in its place, add ``Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''; and
0
b. In paragraph (d), remove ``Division of Dockets Management (HFA-305), 
Food and Drug Administration, Rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857'' and, in its place, add ``Dockets

[[Page 17725]]

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 
p.m., Monday through Friday''.

PART 190--DIETARY SUPPLEMENTS

0
75. The authority citation for part 190 continues to read as follows:

    Authority: Secs. 201(ff), 301, 402, 413, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 
371).


Sec.  190.6   [Amended]

0
76. In Sec.  190.6(a), remove ``Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-820), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740'' and, in its place, add ``Office of Dietary 
Supplement Programs (HFS-810), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740''.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05418 Filed 3-23-23; 8:45 am]
BILLING CODE 4164-01-P


