[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