83 FR 4423 - Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 21 (January 31, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 21 (January 31, 2018)
| Page Range | 4423-4423 | |
| FR Document | 2018-01912 |
[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)] [Rules and Regulations] [Page 4423] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01912] [[Page 4423]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2016-C-2767] Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; confirmation of effective date. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum. DATES: Effective date of final rule published in the Federal Register of November 7, 2017 (82 FR 51554) confirmed: December 8, 2017. ADDRESSES: For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the ``Search'' box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1071. SUPPLEMENTARY INFORMATION: In the Federal Register of November 7, 2017 (82 FR 51554), we amended the color additive regulations to add Sec. 73.70, ``Calcium carbonate,'' (21 CFR 73.70) to provide for the safe use of calcium carbonate to color soft and hard candies and mints, and in inks used on the surface of chewing gum, except that it may not be used to color chocolate for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), unless added color is authorized by such standards. We gave interested persons until December 7, 2017, to file objections or requests for a hearing. We explained that to file an objection, among other things, persons must specify with particularity the provision(s) to which they object. We also explained that if a person who properly submits an objection wants a hearing, he or she must specifically request a hearing and that failure to do so will constitute a waiver of the right to a hearing (82 FR 51554 at 51557). We received two comments regarding our decision to amend the color additive regulations to provide for the safe use of calcium carbonate to color soft and hard candies and mints, and in inks used on the surface of chewing gum. Neither comment, however, specified with particularity the provision(s) of the regulation to which they objected nor specifically requested a hearing. Therefore, we find that the effective date of the final rule that published in the Federal Register of November 7, 2017, should be confirmed. List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Foods, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, we are giving notice that no objections or requests for a hearing were filed in response to the November 7, 2017, final rule. Accordingly, the amendments issued thereby became effective December 8, 2017. Dated: January 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01912 Filed 1-30-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Rules and Regulations 4423
DEPARTMENT OF HEALTH AND they object. We also explained that if a DATES: In accordance with the
HUMAN SERVICES person who properly submits an Congressional Review Act, this rule is
objection wants a hearing, he or she effective on April 2, 2018.
Food and Drug Administration must specifically request a hearing and FOR FURTHER INFORMATION CONTACT: Rob
that failure to do so will constitute a Schlicht, Office of the Comptroller,
21 CFR Part 73 waiver of the right to a hearing (82 FR Bureau of Consular Affairs, Department
[Docket No. FDA–2016–C–2767] 51554 at 51557). of State; phone: 202–485–6685, telefax:
We received two comments regarding 202–485–6826; email: fees@state.gov.
Listing of Color Additives Exempt our decision to amend the color additive SUPPLEMENTARY INFORMATION: For the
From Certification; Calcium Carbonate; regulations to provide for the safe use of complete explanation of the background
Confirmation of Effective Date calcium carbonate to color soft and hard of this rule, including the rationale for
candies and mints, and in inks used on the change, the authority of the
AGENCY: Food and Drug Administration, the surface of chewing gum. Neither
HHS. Department of State (‘‘Department’’) to
comment, however, specified with make the fee changes in question, and
ACTION: Final rule; confirmation of particularity the provision(s) of the an explanation of the study that
effective date. regulation to which they objected nor produced the fee amounts, consult the
specifically requested a hearing. prior public notices cited in the
SUMMARY: The Food and Drug
Therefore, we find that the effective date ‘‘Background’’ section below.
Administration (FDA or we) is
of the final rule that published in the
confirming the effective date of Background
Federal Register of November 7, 2017,
December 8, 2017, for the final rule that
should be confirmed. The Department published an interim
appeared in the Federal Register of
November 7, 2017, and that amended List of Subjects in 21 CFR Part 73 final rule in the Federal Register, 80 FR
the color additive regulations to provide 53704, on September 8, 2015, amending
Color additives, Cosmetics, Drugs, sections of 22 CFR part 22. Specifically,
for the safe use of calcium carbonate to Foods, Medical devices.
color hard and soft candy, mints, and in the rule amended the Schedule of Fees
inks used on the surface of chewing Therefore, under the Federal Food, for Consular Services and provided 60
gum. Drug, and Cosmetic Act (21 U.S.C. 321, days for comments from the public.
341, 342, 343, 348, 351, 352, 355, 361, During this 60-day comment period, 15
DATES: Effective date of final rule 362, 371, 379e) and under authority comments were received by mail, email,
published in the Federal Register of delegated to the Commissioner of Food and through the submission process at
November 7, 2017 (82 FR 51554) and Drugs, we are giving notice that no regulations.gov.
confirmed: December 8, 2017. objections or requests for a hearing were This rule establishes the following
ADDRESSES: For access to the docket to filed in response to the November 7, fees for the categories below:
read background documents or 2017, final rule. Accordingly, the —Administrative Processing of Request
comments received, go to https:// amendments issued thereby became for Certificate of Loss of Nationality
www.regulations.gov and insert the effective December 8, 2017. (CLN) $2,350
docket number found in brackets in the Dated: January 24, 2018. —Passport Book Application Fee (age 16
heading of this final rule into the and older) from $70 to $50
Leslie Kux,
‘‘Search’’ box and follow the prompts, —Passport Book Application Fee (under
and/or go to the Dockets Management Associate Commissioner for Policy.
age 16) from $40 to $20
Staff, 5630 Fishers Lane, Rm. 1061, [FR Doc. 2018–01912 Filed 1–30–18; 8:45 am]
—Passport Security Surcharge from $40
Rockville, MD 20852. BILLING CODE 4164–01–P
to $60
FOR FURTHER INFORMATION CONTACT: The original publication of the
Judith Kidwell, Center for Food Safety interim final rule included an incorrect
and Applied Nutrition, Food and Drug DEPARTMENT OF STATE effective date of September 23, 2015, for
Administration, 5001 Campus Dr., the above changes in the Passport Book
College Park, MD 20740, 240–402–1071. 22 CFR Part 22 Application fees and Passport Security
SUPPLEMENTARY INFORMATION: In the Surcharge. That date subsequently was
Federal Register of November 7, 2017 [Public Notice 9450] corrected. See 80 FR 55242. The correct
(82 FR 51554), we amended the color effective date is reflected herein; it is
additive regulations to add § 73.70, RIN 1400–AD71
September 26, 2015.
‘‘Calcium carbonate,’’ (21 CFR 73.70) to Schedule of Fees for Consular
provide for the safe use of calcium Analysis of Comments
Services, Department of State and
carbonate to color soft and hard candies Overseas Embassies and Consulates In the 60-day period since the
and mints, and in inks used on the publication of the interim final rule, 15
surface of chewing gum, except that it AGENCY: Department of State. comments were received. Twelve of the
may not be used to color chocolate for ACTION: Final rule. comments were about the
which standards of identity have been Administrative Processing of Request
issued under section 401 of the Federal SUMMARY: This rule finalizes the interim for CLN fee. The other three comments
Food, Drug, and Cosmetic Act (21 U.S.C. final rule published in the Federal were about Executive Branch fees or
341), unless added color is authorized Register on September 8, 2015. U.S. citizenship.
sradovich on DSK3GMQ082PROD with RULES
by such standards. Specifically, the rule implemented Many of the comments suggested that
We gave interested persons until changes to the Schedule of Fees for the fee for Administrative Processing of
December 7, 2017, to file objections or Consular Services (‘‘Schedule’’) for Request for CLN creates a barrier to
requests for a hearing. We explained certain passport and citizenship services expatriation. Most asserted that the fee
that to file an objection, among other fees. This rulemaking addresses public is excessive and that many individuals
things, persons must specify with comments and adopts as final the will be unable to pay it. However, one
particularity the provision(s) to which changes to these fees. comment expressed support for
VerDate Sep<11>2014 16:53 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\31JAR1.SGM 31JAR1](https://thefederalregister.org/doc/83_FR_4444/page/1.svg)
Document Created: 2018-01-31 00:57:58
Document Modified: 2018-01-31 00:57:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; confirmation of effective date. | |
| Dates | Effective date of final rule published in the Federal Register of November 7, 2017 (82 FR 51554) confirmed: December 8, 2017. | |
| Contact | Judith Kidwell, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1071. | |
| FR Citation | 83 FR 4423 | |
| CFR Associated | Color Additives; Cosmetics; Drugs; Foods and Medical Devices |
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