82 FR 7648 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 13 (January 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 13 (January 23, 2017)
| Page Range | 7648-7649 | |
| FR Document | 2017-00534 |
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)] [Rules and Regulations] [Pages 7648-7649] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00534] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 73 and 74 [Docket No. FDA-2016-F-0821] Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; 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 2, 2016, for the final rule that appeared in the Federal Register of November 1, 2016, and that amended the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs). We are taking this action to ensure clarity that the effective date in the final rule remains December 2, 2016. DATES: Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016. FOR FURTHER INFORMATION CONTACT: Laura A. Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1275. SUPPLEMENTARY INFORMATION: In the Federal Register of November 1, 2016 (81 FR 75689), we amended the color additive regulations in Sec. 73.3126 (21 CFR 73.3126) and Sec. 74.3045 (21 CFR 74.3045) to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for IOLs. The preamble to the final rule stated that persons who would be adversely affected by one or more provisions in the final rule could file electronic or written objections (81 FR 75689 at 75691). We also stated that the effective date of the final rule would be on December 2, 2016, unless a person properly files an objection or request for a hearing to review any provisions in the final rule (81 FR 75689). We explained that, to file an objection, a person must, among other things, specify with particularity the provision(s) of the regulation to which they object and the grounds for the objection (81 FR 75689 at 75691). Within each objection, a person also must specifically state whether he/she requests a hearing. We received no objections or requests for a hearing on the final rule that met these requirements. We received five general comments, including one that disagreed with the rule, but the comments did not meet the requirements to be considered an objection under 21 CFR 12.22(a)(3). Therefore, we find that the effective date of the final rule that published in the Federal Register of November 1, 2016, should be confirmed. List of Subjects 21 CFR Part 73 Color additives, Cosmetics, Drugs, Medical devices. [[Page 7649]] 21 CFR Part 74 Color additives, Cosmetics, Drugs. 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, and redelegated to the Director, Office of Food Additive Safety, we are giving notice that no objections or requests for a hearing were filed in response to the November 1, 2016, final rule. Accordingly, the amendments issued thereby became effective December 2, 2016. Dated: January 9, 2017. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2017-00534 Filed 1-19-17; 8:45 am] BILLING CODE 4164-01-P
![7648 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Rules and Regulations
Dated: January 5, 2017. In FR Doc. 2016–24873 appearing on SUMMARY: The Food and Drug
Pamela M. Bush, page 71369 in the Federal Register of Administration (FDA or we) is
Commission Secretary. Monday, October 17, the following confirming the effective date of
[FR Doc. 2017–00413 Filed 1–19–17; 8:45 am] corrections are made: December 2, 2016, for the final rule that
appeared in the Federal Register of
BILLING CODE 6360–01–P Corrections November 1, 2016, and that amended
1. On page 71369, in the third the color additive regulations to provide
column, redesignate amendatory for the safe use of titanium dioxide and
SOCIAL SECURITY ADMINISTRATION
instructions 6 through 9 as 7 through 10 [phthalocyaninato (2-)] copper to color
20 CFR Part 404 and add new amendatory instruction 6 orientation marks for intraocular lenses
to read as follows: (IOLs). We are taking this action to
[Docket No. SSA–2014–0016] ensure clarity that the effective date in
■ 6. Amend § 404.1592f by revising
RIN 0960–AH66 paragraph (a) to read as follows: the final rule remains December 2, 2016.
DATES: Effective date of final rule
Unsuccessful Work Attempts and § 404.1592f How do we determine published in the Federal Register of
Expedited Reinstatement Eligibility; reinstated benefits?
November 1, 2016 (81 FR 75689),
Correction (a) If you meet the requirements for confirmed: December 2, 2016.
reinstatement under § 404.1592c(a), we FOR FURTHER INFORMATION CONTACT:
AGENCY: Social Security Administration. will then consider in which month to
ACTION: Final rules; correction. Laura A. Dye, Center for Food Safety
reinstate your entitlement. We will and Applied Nutrition (HFS–265), Food
SUMMARY: We published a document in reinstate your entitlement with the and Drug Administration, 5001 Campus
the Federal Register revising our rules earliest month, in the 12-month period Dr., College Park, MD 20740–3835, 240–
on October 17, 2016. That document that ends with the month before you 402–1275.
inadvertently omitted a corresponding filed your request for reinstatement, that SUPPLEMENTARY INFORMATION: In the
technical change to § 404.1592f(a) when you would have met all of the Federal Register of November 1, 2016
§ 404.1592c(a) was amended with the requirements under § 404.1592c(a) if (81 FR 75689), we amended the color
final rule publication. By making this you had filed your request for additive regulations in § 73.3126 (21
technical correction we will also need to reinstatement in that month. Otherwise, CFR 73.3126) and § 74.3045 (21 CFR
redesignate the amendatory instructions you will be entitled to reinstated 74.3045) to provide for the safe use of
to incorporate the missing section benefits beginning with the month in titanium dioxide and [phthalocyaninato
changes to § 404.1592f(a). This which you filed your request for such (2-)] copper to color orientation marks
document corrects the final regulation benefits if you did not perform for IOLs.
by making these technical corrections. substantial gainful activity in that The preamble to the final rule stated
month. If you performed substantial that persons who would be adversely
DATES: The corrections are effective
gainful activity in the month of filing, affected by one or more provisions in
April 17, 2017.
but are no longer able to perform the final rule could file electronic or
FOR FURTHER INFORMATION CONTACT:
substantial gainful activity, we will written objections (81 FR 75689 at
Kristine Erwin-Tribbitt, Office of reinstate your benefits with the month
Retirement and Disability Policy, Office 75691). We also stated that the effective
after the month you filed your request date of the final rule would be on
of Research, Demonstration, and for reinstatement. We cannot reinstate
Employment Support, Social Security December 2, 2016, unless a person
your entitlement for any month prior to properly files an objection or request for
Administration, 6401 Security January 2001.
Boulevard, Robert Ball Building 3–A– a hearing to review any provisions in
26, Baltimore, MD 21235–6401, (410) * * * * * the final rule (81 FR 75689). We
965–3353. For information on eligibility explained that, to file an objection, a
Carolyn W. Colvin,
or filing for benefits, call our national person must, among other things,
Acting Commissioner of Social Security. specify with particularity the
toll-free number, 1–800–772–1213 or [FR Doc. 2017–00076 Filed 1–19–17; 8:45 am]
TTY 1–800–325–0778, or visit our provision(s) of the regulation to which
Internet site, Social Security Online, at
BILLING CODE 4191–02–P they object and the grounds for the
http://www.socialsecurity.gov. objection (81 FR 75689 at 75691).
Within each objection, a person also
SUPPLEMENTARY INFORMATION: We
DEPARTMENT OF HEALTH AND must specifically state whether he/she
published a final rule in the Federal HUMAN SERVICES requests a hearing. We received no
Register of October 17, 2016 (81 FR
objections or requests for a hearing on
71367) titled, Unsuccessful Work Food and Drug Administration the final rule that met these
Attempts and Expedited Reinstatement
requirements. We received five general
Eligibility. The final rule, among other 21 CFR Parts 73 and 74 comments, including one that disagreed
things, amended 20 CFR parts 404 and
[Docket No. FDA–2016–F–0821] with the rule, but the comments did not
416. We inadvertently omitted a
meet the requirements to be considered
corresponding technical change to Listing of Color Additives Exempt an objection under 21 CFR 12.22(a)(3).
§ 404.1592f(a) when § 404.1592c(a) was From Certification; Titanium Dioxide Therefore, we find that the effective date
amended with the final rule publication. and Listing of Color Additives Subject of the final rule that published in the
This document amends and corrects the
mstockstill on DSK3G9T082PROD with RULES
to Certification; [Phthalocyaninato (2-)] Federal Register of November 1, 2016,
final regulation. Copper; Confirmation of Effective Date should be confirmed.
(Catalog of Federal Domestic Assistance
Program Nos. 9601, Social Security— AGENCY: Food and Drug Administration, List of Subjects
Disability Insurance; 96.006, Supplemental HHS. 21 CFR Part 73
Security Income; 96.008, Social Security— ACTION: Final rule; confirmation of
Work Incentives Planning and Assistance Color additives, Cosmetics, Drugs,
effective date.
Program.) Medical devices.
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![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Rules and Regulations 7649
21 CFR Part 74 Improvements Act of 2015 and Office of penalties and to further the policy goals
Color additives, Cosmetics, Drugs. Management and Budget (OMB) of the underlying statutes.
guidance. The Office of Management and Budget
Therefore, under the Federal Food, (OMB) issued guidance for Federal
Drug, and Cosmetic Act (21 U.S.C. 321, DATES: This rule is effective on January agencies on calculating the catch-up
341, 342, 343, 348, 351, 352, 355, 361, 23, 2017. adjustment. See February 24, 2016,
362, 371, 379e) and under authority FOR FURTHER INFORMATION CONTACT: Memorandum for the Heads of
delegated to the Commissioner of Food Elizabeth Appel, Director, Office of Executive Departments and Agencies,
and Drugs, and redelegated to the Regulatory Affairs and Collaborative from Shaun Donovan, Director, Office of
Director, Office of Food Additive Safety, Action, Office of the Assistant Management and Budget, re:
we are giving notice that no objections Secretary—Indian Affairs; telephone Implementation of the Federal Civil
or requests for a hearing were filed in (202) 273–4680, elizabeth.appel@ Penalties Inflation Adjustment Act
response to the November 1, 2016, final bia.gov. Improvements Act of 2015 (M–16–06).
rule. Accordingly, the amendments Under the guidance, the Department
issued thereby became effective SUPPLEMENTARY INFORMATION:
identified applicable civil monetary
December 2, 2016. I. Background penalties and calculated the catch-up
Dated: January 9, 2017. II. Calculation of Annual Adjustments adjustment. A civil monetary penalty is
Dennis M. Keefe, III. Procedural Requirements any assessment with a dollar amount
A. Regulatory Planning and Review (E.O.
Director, Office of Food Additive Safety, 12866)
that is levied for a violation of a Federal
Center for Food Safety and Applied Nutrition. B. Regulatory Flexibility Act civil statute or regulation, and is
[FR Doc. 2017–00534 Filed 1–19–17; 8:45 am] C. Small Business Regulatory Enforcement assessed or enforceable through a civil
BILLING CODE 4164–01–P Fairness Act action in Federal court or an
D. Unfunded Mandates Reform Act administrative proceeding. A civil
E. Takings (E.O. 12630) monetary penalty does not include a
F. Federalism (E.O. 13132) penalty levied for violation of a criminal
DEPARTMENT OF THE INTERIOR G. Civil Justice Reform (E.O. 12988) statute, or fees for services, licenses,
H. Consultation With Indian Tribes (E.O. permits, or other regulatory review. The
Bureau of Indian Affairs 13175)
I. Paperwork Reduction Act
calculated catch-up adjustment is based
25 CFR Parts 140, 141, 211, 213, 225, J. National Environmental Policy Act on the percent change between the
226, 227, 243, and 249 K. Effects on the Energy Supply (E.O. Consumer Price Index for all Urban
13211) Consumers (CPI0–U) for the month of
[178A2100DD/AAKC001030/
L. Clarity of This Regulation October in the year of the previous
A0A501010.999900253G]
M. Administrative Procedure Act adjustment (or in the year of
RIN 1076–AF35 establishment, if no adjustment has
I. Background
been made) and the October 2015 CPI–
Civil Penalties Inflation Adjustments; On November 2, 2015, the President U.
Annual Adjustments signed into law the Federal Civil The Bureau issued an interim final
AGENCY: Bureau of Indian Affairs, Penalties Inflation Adjustment Act rule providing for calculated catch-up
Interior. Improvements Act of 2015 (Sec. 701 of adjustments on June 30, 2016 (81 FR
ACTION: Final rule. Pub. L. 114–74) (‘‘the Act’’). The Act 42478) and requesting comments post-
requires Federal agencies to adjust the promulgation. The Bureau issued a final
SUMMARY: This rule provides for annual level of civil monetary penalties with an rule affirming the catch-up adjustments
adjustments to the level of civil initial ‘‘catch-up’’ adjustment through set forth in the interim final rule on
monetary penalties contained in Bureau rulemaking and then make subsequent December 2, 2016 (81 FR 86953). The
of Indian Affairs (Bureau) regulations to annual adjustments for inflation. The final rule adjusted the following civil
account for inflation under the Federal purpose of these adjustments is to monetary penalties, effective on August
Civil Penalties Inflation Adjustment Act maintain the deterrent effect of civil 1, 2016:
Catchup
Current Adjusted
CFR citation Description of penalty adjustment
penalty penalty
multiplier
25 CFR 140.3 ......... Penalty for trading in Indian country without a license ............................................ $500 2.50000 $1,250
25 CFR 141.50 ....... Penalty for trading on Navajo, Hopi or Zuni reservations without a license ........... 500 2.50000 1,250
25 CFR 211.55 ....... Penalty for violation of leases of Tribal land for mineral development, violation of 1,000 1.50245 1,502
part 211, or failure to comply with a notice of noncompliance or cessation
order.
25 CFR 213.37 ....... Penalty for failure of lessee to comply with lease of restricted lands of members 500 2.50000 1,250
of the Five Civilized Tribes in Oklahoma for mining, operating regulations at
part 213, or orders.
25 CFR 225.37 ....... Penalty for violation of minerals agreement, regulations at part 225, other appli- 1,000 1.59089 1,591
cable laws or regulations, or failure to comply with a notice of noncompliance
or cessation order.
mstockstill on DSK3G9T082PROD with RULES
25 CFR 226.42 ....... Penalty for violation of lease of Osage reservation lands for oil and gas mining or 500 1.78156 891
regulations at part 226, or noncompliance with the Superintendent’s order.
25 CFR 226.43(a) ... Penalty per day for failure to obtain permission to start operations ........................ 50 1.78156 89
25 CFR 226.43(b) ... Penalty per day for failure to file records ................................................................. 50 1.78156 89
25 CFR 226.43(c) ... Penalty for each well and tank battery for failure to mark wells and tank batteries 50 1.78156 89
25 CFR 226.43(d) ... Penalty each day after operations are commenced for failure to construct and 50 1.78156 89
maintain pits.
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Document Created: 2017-01-20 01:29:38
Document Modified: 2017-01-20 01:29:38
| 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 1, 2016 (81 FR 75689), confirmed: December 2, 2016. | |
| Contact | Laura A. Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1275. | |
| FR Citation | 82 FR 7648 | |
| CFR Citation | 21
CFR
73 21 CFR 74 | |
| CFR Associated | Color Additives; Cosmetics; Drugs and Medical Devices |
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