Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments, 17710-17725 [2023-05418]
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
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Masoud Afghan General Trading, Plot No. S31216 Jebel Ali Free Zone,
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88 FR [INSERT FEDERAL REGISTER PAGE
NUMBER] 3/24/2023.
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Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
of April 1, 2022, in section 232.11,
reinstate the definition of ‘‘Interactive
Data Financial Report’’ to read as
follows:
[FR Doc. 2023–06171 Filed 3–23–23; 8:45 am]
BILLING CODE 3510–33–P
§ 232.11
232.
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SECURITIES AND EXCHANGE
COMMISSION
17 CFR Part 230
General Rules and Regulations,
Securities Act of 1933
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
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In Title 17 of the Code of Federal
Regulations, Parts 200 to 239, revised as
of April 1, 2022, make the following
corrections:
§ 230.482
[Corrected]
1. Amend § 230.482 in paragraph (a)
by removing the note with the heading
‘‘Note to Paragraph (a)’’.
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Interactive Data Financial Report. The
term Interactive Data Financial Report
means the machine-readable computer
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[FR Doc. 2023–06293 Filed 3–23–23; 8:45 am]
BILLING CODE 0099–10–P
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]
§ 230.498
Food Labeling, Infant Formula
Requirements, Food Additives and
Generally Recognized as Safe
Substances, New Dietary Ingredient
Notification; Technical Amendments
[Corrected]
2. Amend § 230.498 in paragraph (f)(2)
by removing the phrase ‘‘a Notice under
§ 270.30e–3 of this chapter,’’ after
‘‘Summary Prospectus’’, and adding ‘‘a
Notice under § 270.30e–3 of this
chapter,’’ after the phrase ‘‘Statutory
Prospectuses,’’.
■
[FR Doc. 2023–06287 Filed 3–23–23; 8:45 am]
SECURITIES AND EXCHANGE
COMMISSION
17 CFR Part 232
Regulation S–T—General Rules and
Regulations for Electronic Filings
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 17 of the Code of Federal
Regulations, Parts 200 to 239, revised as
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AGENCY:
Food and Drug Administration,
HHS.
I. Background
ACTION:
A. Food Labeling (21 CFR Part 101)
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,
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
Final rule; technical
amendments.
SUMMARY:
BILLING CODE 0099–10–P
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Definition of terms used in part
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:
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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 (§ 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.
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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
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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 nonsubstantive; for example, § 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 § 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
§ 101.9(b)(7)(vi) continued to use the
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program office’s former name.
Therefore, this technical amendment
revises § 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 § 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 bcarotene’’ or ‘‘dietary 24 micrograms
dietary b-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 § 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
§ 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 § 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 § 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 § 101.9(j)(13)(i)(B)
discuss requirements for foods in small
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packages. The Nutrition Facts Label
Final Rule revised § 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.’’
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7. Section 101.9(j)(13)(ii)(A)(1) and
Tabular Display for Small Packages
Label Illustration
Our regulations in
§ 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 § 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
§ 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 § 101.9(c)(8)(iii), however,
the ‘‘% DV’’ for vitamins and minerals
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must be expressed to the nearest 2percent 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 § 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
§ 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 dualcolumn displays and refers to other
requirements in § 101.9 by their
paragraph designations.
The technical amendment revises
§ 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 § 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 § 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
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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).’’
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B. Notification of an Adulterated or
Misbranded Infant Formula (§ 106.150)
Our regulations in § 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)
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1. Sections 170.35, 170.38, and 170.39—
Office Name Correction and Correction
Regarding Dockets Management
The regulations in §§ 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
§ 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.,
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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
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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,
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
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.
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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
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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.
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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 (a-ALDC) enzyme
preparation derived from a recombinant
Bacillus subtilis as a secondary direct
food additive. The regulations state that
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
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.
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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 § 173.370(c) states that
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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 § 184.1538 (21 CFR
184.1538) discuss nisin preparation as a
specific substance affirmed as GRAS.
The regulation in § 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
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17715
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
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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
(j) * * *
(5) * * *
(ii) * * *
VerDate Sep<11>2014
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
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.
§ 101.4
[Amended]
2. In § 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’’.
■
§ 101.9
[Amended]
3. Amend § 101.9 by:
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)’’;
■ b. In paragraph (c)(8)(iv), removing ‘‘2
microgram’’ and ‘‘dietary 24 micrograms
dietary b-cryptoxanthin’’ in footnote 3
to the table and adding ‘‘2 micrograms’’
and ‘‘24 micrograms dietary bcryptoxanthin’’ in their place,
respectively;
■ c. In paragraph (d)(11)(iii), revising
the sample label;
■ d. In paragraph (j)(5)(ii)(B), revising
the sample label;
■ e. In paragraph (j)(13)(i) introductory
text, adding a sentence at the end of the
paragraph;
■ f. In paragraph (j)(13)(i)(B), removing
‘‘1⁄16 inches’’ and, in its place, adding
‘‘1⁄16 inches’’;
■ g. In paragraph (j)(13)(ii)(A)(1),
revising the sample label;
■ h. In paragraph (j)(13)(ii)(A)(2),
revising the sample label; and
■ 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:
■
■
§ 101.9
*
*
*
(d) * * *
(11) * * *
(iii) * * *
*
*
BILLING CODE 4164–01–P
(B) * * *
16:01 Mar 23, 2023
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Food Labeling, Nutrition, Reporting
and recordkeeping requirements.
21 CFR Part 106
Food grades and standards, Infants
and children, Nutrition, Reporting and
recordkeeping requirements.
Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
(ii) * * *
(A) * * *
(1) * * *
ER24MR23.013</GPH>
paragraphs (d)(9) and (f)(5) related to the
footnote, however the abbreviated
footnote statement ‘‘% DV = % Daily
Value’’ may be used.
*
*
*
*
*
(2) * * *
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16:01 Mar 23, 2023
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(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
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
(B) * * *
Total carbohydrate—Total carb. This
abbreviation can also be used on dualcolumn 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.
*
*
*
*
*
§ 101.45
[Amended]
4. Amend § 101.45 as follows:
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
■ 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’’.
■
■
§ 101.80
[Amended]
5. In § 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’’.
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■
§ 101.81
[Amended]
6. In § 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–
■
VerDate Sep<11>2014
16:01 Mar 23, 2023
Jkt 259001
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’’.
§ 106.150
§ 101.83
■
[Amended]
7. In § 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’’.
■
§ 101.93
[Amended]
8. In § 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)’’.
■
§ 101.108
[Amended]
9. In § 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
10. The authority citation for part 106
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 350a, 371.
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Frm 00040
Fmt 4700
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[Amended]
11. In § 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
12. The authority citation for part 170
continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 346a,
348, 371.
§ 170.35
[Amended]
13. Amend § 170.35 as follows:
a. In paragraph (b)(1), remove
‘‘Division of Dockets Management’’ and,
in its place, add ‘‘Dockets Management
Staff’’; and
■ 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.
■
■
§ 170.38
[Amended]
14. Amend § 170.38 as follows:
a. In paragraph (b)(1), remove
‘‘Division of Dockets Management’’ and,
in its place, add ‘‘Dockets Management
Staff’’; and
■ 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.
■
■
§ 170.39
[Amended]
15. Amend § 170.39 as follows:
a. In paragraph (d), remove ‘‘Office of
Premarket Approval’’ and, in its place,
add ‘‘Office of Food Additive Safety’’;
■ 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’’;
■ c. In paragraph (g), remove ‘‘Division
of Dockets Management’’ in the fifth
■
■
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sentence and, in its place, add ‘‘Dockets
Management Staff’’; and
■ 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
16. The authority citation for part 172
continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
§ 172.105
[Amended]
17. In § 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’’.
■
§ 172.133
[Amended]
18. In § 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’’.
■
§ 172.155
[Amended]
19. In § 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’’.
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■
§ 172.167
[Amended]
20. Amend § 172.167 as follows:
a. In paragraph (b), remove ‘‘Food and
Drug Administration’s Main Library,
■
■
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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
■ 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’’
§ 172.185
[Amended]
21. In § 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’’.
■
§ 172.250
[Amended]
22. In § 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’’.
■
§ 172.320
[Amended]
23. Amend § 172.320 as follows:
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
■ 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’’.
■
■
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§ 172.345
17719
[Amended]
24. In § 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’’.
■
§ 172.379
[Amended]
25. In § 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’’.
■
§ 172.380
[Amended]
26. In § 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’’.
■
§ 172.665
[Amended]
27. In § 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’’.
■
§ 172.712
[Amended]
28. In § 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’’.
■
§ 172.723
[Amended]
29. Amend § 172.723 as follows:
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.,
■
■
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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’’;
■ 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’’.
§ 172.736
[Amended]
30. Amend § 172.736 as follows:
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
■ 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’’.
■
■
§ 172.780
[Amended]
31. In § 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’’.
■
§ 172.785
[Amended]
32. In § 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
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■
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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’’.
§ 172.800
[Amended]
33. Amend § 172.800 as follows:
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
■ 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’’.
■
■
§ 172.803
[Amended]
34. In § 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’’.
■
§ 172.804
[Amended]
35. Amend § 172.804 as follows:
a. In the introductory text, remove ‘‘of
the act’’ and, in its place, add ‘‘of the
Federal Food, Drug, and Cosmetic Act’’;
■ 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.
■
■
PO 00000
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Fmt 4700
Sfmt 4700
and 4 p.m., Monday through Friday’’;
and
■ 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’’.
§ 172.809
[Amended]
36. In § 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’’.
■
§ 172.810
[Amended]
37. In § 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’’.
■
§ 172.812
[Amended]
38. In § 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
■
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20852, 240–402–7500, between 9 a.m.
and 4 p.m., Monday through Friday’’.
§ 172.829
[Amended]
39. In § 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’’.
■
§ 172.831
40. In § 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’’.
41. Amend § 172.833 as follows:
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
[Amended]
42. In § 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’’.
■
§ 172.859
[Amended]
43. In § 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’’.
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
■ 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’’.
■
[Amended]
■
■
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§ 172.841
[Amended]
■
§ 172.833
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500, between 9 a.m.
and 4 p.m., Monday through Friday’’;
and
■ 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’’.
§ 172.862
[Amended]
44. In § 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’’.
■
§ 172.864
[Amended]
45. Amend § 172.864 as follows:
a. In paragraph (a)(3), remove ‘‘Office
of Food Additive Safety, 5001 Campus
■
■
§ 172.867
[Amended]
46. In § 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’’.
■
47. In § 172.869, revise the fourth
sentence of paragraph (b) introductory
text and paragraph (b)(1) to read as
follows:
■
§ 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). * * *
Specification
Limit
Method cited
Source for obtaining method
(1) Sucrose esters .......
Not less than 90% .....
‘‘Method for Analyzing the Purity of Sucrose
Fatty Acid Esters,’’ Chemical Corp., June
17, 1998.
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.
*
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*
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*
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*
*
§ 172.878
Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
*
*
*
[Amended]
48. In § 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’’.
■
§ 172.882
[Amended]
49. In § 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’’.
■
§ 172.886
[Amended]
50. Amend § 172.886 as follows:
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
■ 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
Authority: 21 U.S.C. 321, 342, 348.
lotter on DSK11XQN23PROD with RULES1
[Amended]
52. In § 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,
■
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§ 173.45
[Amended]
53. In § 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’’.
■
§ 173.60
[Amended]
54. In § 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’’.
■
§ 173.65
[Amended]
55. In § 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’’.
■
§ 173.73
[Amended]
56. In § 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’’.
■
§ 173.115
51. The authority citation for part 173
continues to read as follows:
■
§ 173.25
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240–402–7500, between 9
a.m. and 4 p.m., Monday through
Friday’’.
[Amended]
57. In § 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’’.
■
§ 173.160
■
[Amended]
58. Amend § 173.160 as follows:
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
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
■ 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’’.
■
§ 173.165
[Amended]
59. Amend § 173.165 as follows:
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
■ 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’’.
■
■
§ 173.228
[Amended]
60. In § 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’’.
■
§ 173.280
[Amended]
61. In § 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’’.
■
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
§ 173.300
[Amended]
62. In § 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’’.
■
§ 173.310
■
[Amended]
63. Amend § 173.310 as follows:
§ 173.325
[Amended]
64. In § 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’’.
■ 65. In § 173.340, in the table to
paragraph (a)(4), revise the entry for ‘‘nButoxypoly(oxyethylene)poly(oxypropylene)glycol’’ to read as
follows:
■
§ 173.340
*
Defoaming agents.
*
*
(a) * * *
(4) * * *
*
*
Substances
Limitations
n-Butoxypoly(oxyethylene)- poly(oxypropylene)glycol .............
Viscosity range, 4,850–5,350 Saybolt Universal Seconds (SUS) at 37.8 °C (100
°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.
*
*
*
§ 173.356
*
*
*
*
*
[Amended]
66. In § 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),
■
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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
■ 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’’.
■
VerDate Sep<11>2014
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*
*
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’’.
■ 67. In § 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:
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
*
*
§ 173.357 Materials used as fixing agents
in the immobilization of enzyme
preparations.
*
*
*
(a) * * *
(2) * * *
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*
17724
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Substances
Limitations
*
*
*
*
*
*
*
Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg.
May be used as a fixing material in the immobilization of glucoamylase
No. 68130–97–2) is the reaction product of homopolymerization of
enzyme preparations from Aspergillus niger for use in the manufacethylenimine in aqueous hydrochloric acid at 100 °C and of crossture of beer.
linking with 1,2-dichloroethane. The finished polymer has an average May be used as a fixing material in the immobilization of:
molecular weight of 50,000 to 70,000 as determined by gel perme1. Glucose isomerase enzyme preparations for use in the manufacture
ation chromatography. The analytical method is entitled ‘‘Methodof high fructose corn syrup, in accordance with § 184.1372 of this
ology for Molecular Weight Detection of Polyethylenimine,’’ which is
chapter.
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
2. Glucoamylase enzyme preparations from Aspergillus niger for use in
CFR part 51. Copies may be obtained from the Office of Food Addithe manufacture of beer. Residual ethylenimine in the finished
tive Safety (HFS–200), Center for Food Safety and Applied Nutrition,
polyethylenimine polymer will be less than 1 part per million as de5001 Campus Dr., College Park, MD 20740, 240–402–1200, and
termined by gas chromatography-mass spectrometry. The residual
may be examined at the Dockets Management Staff (HFA–305),
ethylenimine is determined by an analytical method entitled ‘‘MethFood and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockodology for Ethylenimine Detection in Polyethylenimine,’’ which is inville, MD 20852, 240–402–7500, between 9 a.m. and 4 p.m., Moncorporated by reference in accordance with 5 U.S.C. 552(a) and 1
day through Friday, or at the National Archives and Records AdminCFR part 51. Residual 1,2-dichloroethane in the finished
istration (NARA). For information on the availability of this material at
polyethylenimine polymer will be less than 1 part per million as deNARA, call 202–741–6030, or go to: https://www.archives.gov/federal_
termined by gas chromatography. The residual 1,2-dichloroethane is
register/code_of_federal_regulations/ibr_locations.html.
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: https://www.archives.gov/federal_
register/code_of_federal_regulations/ibr_locations.html.
*
*
*
§ 173.368
*
*
*
*
[Amended]
68. In § 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’’.
[Amended]
69. In § 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
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■
VerDate Sep<11>2014
16:01 Mar 23, 2023
*
20852, 240–402–7500, between 9 a.m.
and 4 p.m., Monday through Friday’’.
*
■
§ 173.370
*
Jkt 259001
§ 173.375
70. In § 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’’.
[Amended]
71. In § 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
72. The authority citation for part 184
continues to read as follows:
■
PO 00000
*
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 184 [AMENDED]
[Amended]
■
§ 173.400
*
Frm 00046
Fmt 4700
Sfmt 4700
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’’.
■
§ 184.1538
[Amended]
74. Amend § 184.1538 as follows:
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
■ 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
■
■
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Rules and Regulations
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’’.
DEPARTMENT OF THE TREASURY
PART 190—DIETARY SUPPLEMENTS
Income Taxes
75. The authority citation for part 190
continues to read as follows:
CFR Correction
■
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).
§ 190.6
[Amended]
76. In § 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.
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 51
Environmental Criteria and Standards
BILLING CODE 0099–10–P
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 26 of the Code of Federal
Regulations, Part 1 (§§ 1.641–1.850),
revised as of April 1, 2022, amend
section 1.704–1T by adding paragraph
(b)(2)(iv)(g), reserved paragraphs
(b)(2)(iv)(h) through (s), paragraph
(b)(3), reserved paragraphs (b)(4)
through (6), paragraph (c), and reserved
paragraphs (d) through (e), to read as
follows:
§ 1.704–1T Partner’s distributive share
(temporary).
[FR Doc. 2023–06296 Filed 3–23–23; 8:45 am]
BILLING CODE 0099–10–P
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 24 of the Code of Federal
Regulations, Parts 0 to 199, revised as of
April 1, 2022, in section 51.201,
reinstate the definition of ‘‘Hazardous
substances’’ to read as follows:
Definitions.
*
*
*
*
*
Hazardous substances—means
petroleum products (petrochemicals)
and chemicals that can produce blast
overpressure or thermal radiation levels
in excess of the standards set forth in
§ 51.203. A specific list of hazardous
substance is found in appendix I to this
subpart.
*
*
*
*
*
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Part 19
Distilled Spirits Plants
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 27 of the Code of Federal
Regulations, Parts 1 to 39, revised as of
April 1, 2022, in section 19.230, in
paragraph (d), reinstate the text as the
third sentence to read as follows:
[FR Doc. 2023–06294 Filed 3–23–23; 8:45 am]
§ 19.230 Conditions requiring prepayment
of taxes.
BILLING CODE 0099–10–P
*
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*
*
Frm 00047
(d) * * * The proprietor must prepay
the tax to the extent that a withdrawal
would cause the outstanding tax
liability to exceed the limits of coverage
under the bond. * * *
*
*
*
*
*
[FR Doc. 2023–06295 Filed 3–23–23; 8:45 am]
*
*
*
*
(g) For further guidance, see § 1.704–
1(b)(2)(iv)(g) through (s).
(h) through (s) [Reserved]
(3) For further guidance, see § 1.704–
1(b)(3) through (6).
(4) through (6) [Reserved]
(c) For further guidance, see § 1.704–
1(c) through (e).
(d) through (e) [Reserved]
*
*
*
*
*
BILLING CODE 4164–01–P
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26 CFR Part 1
*
[FR Doc. 2023–05418 Filed 3–23–23; 8:45 am]
§ 51.201
Internal Revenue Service
17725
*
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*
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DEPARTMENT OF THE INTERIOR
Bureau of Safety and Environmental
Enforcement
30 CFR Part 250
[Docket ID: BSEE–2023–0001; 234E1700D2;
ETISF0000.EAQ000 EEEE500000]
RIN 1014–AA58
Oil and Gas and Sulfur Operations on
the Outer Continental Shelf—Civil
Penalty Inflation Adjustment
Bureau of Safety and
Environmental Enforcement, Interior.
ACTION: Final rule.
AGENCY:
This final rule adjusts the
level of the maximum daily civil
monetary penalty contained in the
Bureau of Safety and Environmental
Enforcement (BSEE) regulations for
violations of the Outer Continental Shelf
Lands Act (OCSLA), in accordance with
the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (FCPIA of 2015) and Office of
Management and Budget (OMB)
guidance. The civil penalty inflation
adjustment, using a 1.07745 multiplier,
accounts for one year of inflation based
on the Consumer Price Index for all
Urban Consumers (CPI–U) spanning
from October 2021 to October 2022.
DATES: This rule is effective on March
24, 2023.
FOR FURTHER INFORMATION CONTACT:
Janine Marie Tobias, Safety and
Enforcement Division, Bureau of Safety
and Environmental Enforcement, (202)
208–4657 or by email: regs@bsee.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Legal Authority
The OCSLA, at 43 U.S.C. 1350(b)(1),
directs the Secretary of the Interior
(Secretary) to adjust the OCSLA
maximum daily civil penalty amount at
least once every three years to reflect
any increase in the CPI–U to account for
inflation. On November 2, 2015, the
President signed into law the FCPIA of
2015 (Sec. 701 of Pub. L. No. 114–74),
which required Federal agencies to
adjust the level of civil monetary
penalties found in their regulations with
an initial ‘‘catch-up’’ adjustment
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]]>Agencies
[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: https:// 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: https://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
