82 FR 43845 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 181 (September 20, 2017)

Page Range		43845-43846
FR Document		2017-20050

The Food and Drug Administration (FDA or we) is confirming the effective date of August 3, 2017, for the final rule that appeared in the Federal Register of July 3, 2017, and that amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice.

Federal Register, Volume 82 Issue 181 (Wednesday, September 20, 2017)

[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Rules and Regulations]
[Pages 43845-43846]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-C-2570]


Listing of Color Additives Exempt From Certification; Spirulina 
Extract; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of August 3, 2017, for the final rule that appeared in 
the Federal Register of July 3, 2017, and that amended the color 
additive regulations to provide for the expanded safe use of spirulina 
extract to seasonally color hard-boiled shell eggs at levels consistent 
with good manufacturing practice.

DATES: Effective date of final rule published in the Federal Register 
of July 3, 2017 (82 FR 30731), confirmed: August 3, 2017.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1075.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 3, 2017 (82 
FR 30731), we amended the color additive regulations in Sec.  73.530 
Spirulina extract (21 CFR 73.530) to provide for the expanded safe use 
of spirulina extract to seasonally color the shells of hard-boiled 
eggs.
    We gave interested persons until August 2, 2017, to file objections 
or requests for a hearing. We received no objections or requests for a 
hearing on the final rule. Therefore, we find that the effective date 
of the final rule that published in the Federal Register of July 3, 
2017, should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

0
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 July 3, 2017, final rule. Accordingly, the 
amendments issued thereby became effective August 3, 2017.


[[Page 43846]]


    Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20050 Filed 9-19-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Rules and Regulations 43845

As a result of the lack of funding, federalism assessment under Executive DEPARTMENT OF HEALTH AND
NTIA began the orderly shutdown of the Order 13132. HUMAN SERVICES
PTFP thereafter. NTIA has not
processed applications or awarded any Regulatory Flexibility Act Food and Drug Administration
additional grants under the PTFP since The Chief Counsel for Regulation of
that time. NTIA has continued to 21 CFR Part 73
the Department of Commerce certified
monitor PTFP grants it awarded before to the Chief Counsel for Advocacy of the [Docket No. FDA–2016–C–2570]
Fiscal Year 2011 to ensure taxpayer
Small Business Administration that the
funds have been utilized in the most Listing of Color Additives Exempt
repeal of regulations governing the
responsible and efficient manner. From Certification; Spirulina Extract;
PTFP would not have a significant
II. Comments impact on a substantial number of small Confirmation of Effective Date
On July 18, 2017, NTIA published a entities in accordance with section AGENCY: Food and Drug Administration,
Notice of Proposed Rulemaking (NPRM) 605(b) of the Regulatory Flexibility Act HHS.
in the Federal Register seeking (5 U.S.C. 605(b)). NTIA received no ACTION: Final rule; confirmation of
comment on its proposed repeal of comments on the certification, which effective date.
regulations governing the PTFP. NTIA remains unchanged.
did not receive any comments in SUMMARY: The Food and Drug
Paperwork Reduction Act Administration (FDA or we) is
response to the NPRM.
confirming the effective date of August
III. Repeal of Regulations for the Public The repeal of the regulations
3, 2017, for the final rule that appeared
Telecommunications Facilities Program governing the PTFP contains no
in the Federal Register of July 3, 2017,
collections of information. Therefore, and that amended the color additive
Congress authorized NTIA to establish
clearance by the Office of Management regulations to provide for the expanded
regulations ‘‘as may be necessary to
and Budget (OMB) under the Paperwork safe use of spirulina extract to
carry out’’ the PTFP.6 Due to the lack of
funding for seven years and no Reduction Act of 1995 is not required. seasonally color hard-boiled shell eggs
prospective funding for the PTFP, the In 2013, OMB approved NTIA’s requests at levels consistent with good
regulations governing the PTFP are to discontinue the following collections manufacturing practice.
unnecessary and obsolete. If these associated with the regulations DATES: Effective date of final rule
regulations are not removed, it may governing the PTFP: OMB Control published in the Federal Register of
suggest that the program is still active Numbers 0660–0003, 0660–0001, and July 3, 2017 (82 FR 30731), confirmed:
and may cause confusion regarding the 0605–0001; consequently, NTIA has no August 3, 2017.
status of the program. Accordingly, active collections associated with its FOR FURTHER INFORMATION CONTACT:
NTIA is repealing its regulations regulations governing the PTFP. Molly A. Harry, Center for Food Safety
governing the PTFP. and Applied Nutrition, Food and Drug
Lists of Subjects in 15 CFR Part 2301
Administrative Procedure Act Administration, 5001 Campus Dr.,
Administrative procedure, Grant College Park, MD 20740, 240–402–1075.
The Final Rule relates solely to the programs-communications, Reporting SUPPLEMENTARY INFORMATION: In the
repeal of grant program processes, and, and recordkeeping requirements,
as such, is not subject to the Federal Register of July 3, 2017 (82 FR
Telecommunications. 30731), we amended the color additive
requirements of the Administrative
Procedure Act, 5 U.S.C. 553(a)(2). ■ For the reasons stated above, and regulations in § 73.530 Spirulina extract
under the authority of 47 U.S.C. 390– (21 CFR 73.530) to provide for the
Congressional Review Act expanded safe use of spirulina extract to
393 and 397–399b, NTIA is removing
It has been determined that this final seasonally color the shells of hard-
and reserving 15 CFR part 2301.
rule is not major under 5 U.S.C. 801 et boiled eggs.
seq. PART 2301—[REMOVED AND We gave interested persons until
August 2, 2017, to file objections or
Executive Order 12866 RESERVED]
requests for a hearing. We received no
The repeal of the regulations objections or requests for a hearing on
Dated: September 15, 2017.
governing the PTFP is not a significant the final rule. Therefore, we find that
Leonard Bechtel, the effective date of the final rule that
regulatory action as defined by
Executive Order 12866. Director of Administration and Chief published in the Federal Register of
Financial Officer, performing the non- July 3, 2017, should be confirmed.
Executive Order 13132 exclusive duties of the Assistant Secretary
for Communications and Information, List of Subjects in 21 CFR Part 73
The repeal of the regulations
governing the PTFP does not contain National Telecommunications and Color additives, Cosmetics, Drugs,
Information Administration. Medical devices.
policies with federalism implications
sufficient to warrant preparation of a [FR Doc. 2017–20012 Filed 9–19–17; 8:45 am]
■ Therefore, under the Federal Food,
BILLING CODE 3510–60–P Drug, and Cosmetic Act (21 U.S.C. 321,
Construction’ ’’). In the 2014 appropriation, 341, 342, 343, 348, 351, 352, 355, 361,
Congress rescinded $8.5 million from the NTIA 362, 371, 379e) and under authority
sradovich on DSKBBY8HB2PROD with RULES

PTFP account. Consolidated Appropriations Act,
2014, Pub. L. 113–76, sec. 524(a) (Jan. 17, 2014) delegated to the Commissioner of Food
(‘‘Of the unobligated balances available for and Drugs, we are giving notice that no
‘Department of Commerce, National objections or requests for a hearing were
Telecommunications and Information filed in response to the July 3, 2017,
Administration, Public Telecommunications
Facilities, Planning and Construction,’ $8,500,000 is final rule. Accordingly, the amendments
hereby rescinded’’). issued thereby became effective August
6 47 U.S.C. 392(e). 3, 2017.

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43846 Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Rules and Regulations

Dated: September 14, 2017. whose disclosure is restricted by statute. comment from April 6, 2013, to May 8,
Anna K. Abram, Multimedia submissions (audio, video, 2013. One comment was received and
Deputy Commissioner for Policy, Planning, etc.) must be accompanied by a written adequately addressed in the final SIP
Legislation, and Analysis. comment. The written comment is submission. The amended submission
[FR Doc. 2017–20050 Filed 9–19–17; 8:45 am] considered the official comment and was placed on public comment January
BILLING CODE 4164–01–P should include discussion of all points 12, 2017, to February 15, 2017. No
you wish to make. The EPA will comments were received. These
generally not consider comments or submissions also satisfied the
ENVIRONMENTAL PROTECTION comment contents located outside of the completeness criteria of 40 CFR part 51,
AGENCY primary submission (i.e. on the web, appendix V. In addition, as explained
cloud, or other file sharing system). For above and in more detail in the
40 CFR Part 52 additional submission methods, the full technical support document which is
EPA public comment policy, part of this docket, the revisions meets
[EPA–R07–OAR–2017–0208; FRL–9967–93– information about CBI or multimedia the substantive SIP requirements of the
Region 7] submissions, and general guidance on CAA, including section 110 and
Approval of Implementation Plans; making effective comments, please visit implementing regulations.
State of Iowa; Elements of the https://www2.epa.gov/dockets/
III. What action is EPA taking?
Infrastructure SIP Requirements for commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: EPA is approving elements of the July
the 2010 Nitrogen Dioxide National 23, 2013, (received July 29, 2013)
Ambient Air Quality Standard (NAAQS) Heather Hamilton, Air Planning and
Development Branch, U.S. infrastructure SIP submission from the
AGENCY: Environmental Protection Environmental Protection Agency, State of Iowa, which addresses the
Agency (EPA). Region 7, 11201 Renner Boulevard, requirements of CAA sections 110(a)(1)
Lenexa, KS 66219 at (913) 551–7039, or and (2) as applicable to the 2010 NO2
ACTION: Direct final rule.
by email at hamilton.heather@epa.gov. NAAQS. As stated above, EPA is
SUMMARY: The Environmental Protection SUPPLEMENTARY INFORMATION:
approving the following elements of
Agency (EPA) is taking direct final Throughout this document ‘‘we,’’ ‘‘us,’’ section 110(a)(2): (A), (B), (C), (D)(i)(I)—
action to approve elements of a State and ‘‘our’’ refer to EPA. This section significant contribution to
Implementation Plan (SIP) submission, provides additional information by nonattainment (prong 1), interfering
and an amended SIP submission from addressing the following: with maintenance of the NAAQS (prong
the State of Iowa for the 2010 Nitrogen 2) and (D)(i)(II)—prevent significant
I. What is being addressed in this document? deterioration of air quality (prong 3),
Dioxide (NO2) National Ambient Air II. Have the requirements for approval of a
Quality Standard (NAAQS). and (D)(ii), (E) through (H), and (J)
SIP revision been met?
Infrastructure SIPs address the III. What action is EPA taking? through (M). The March 1, 2017, SIP
applicable requirements of Clean Air IV. Statutory and Executive Order Reviews amendment, revised 110(a)(2)(D)(i)(I).
Act (CAA) section 110, which requires Details of the submission are addressed
I. What is being addressed in this in the TSD, included as part of the
that each state adopt and submit a SIP document?
for the implementation, maintenance, docket, to discuss this approval action.
and enforcement of each new or revised EPA is approving elements of the EPA is not taking action on section
NAAQS promulgated by the EPA. These 2010 NO2 NAAQS infrastructure SIP 110(a)(2)(I). Section 110(a)(2)(I) requires
SIPs are commonly referred to as submission from the State of Iowa that in the case of a plan or plan
‘‘infrastructure’’ SIPs. The infrastructure received on July 29, 2013, and an revision for areas designated as
requirements are designed to ensure that amended SIP submission received on nonattainment areas, states must meet
the structural components of each March 9, 2017. Specifically, EPA is applicable requirements of part D of the
state’s air quality management program approving the following elements of CAA, relating to SIP requirements for
are adequate to meet the state’s section 110(a)(2): (A), (B), (C), (D)(i)(I)— designated nonattainment areas. EPA
responsibilities under the CAA. significant contribution to does not expect infrastructure SIP
nonattainment (prong 1), interfering submissions to address element (I). The
DATES: This direct final rule will be specific SIP submissions for designated
with maintenance of the NAAQS (prong
effective November 20, 2017, without nonattainment areas, as required under
2) and (D)(i)(II)—prevent of significant
further notice, unless EPA receives CAA title I, part D, are subject to
deterioration of air quality (prong 3),
adverse comment by October 20, 2017. different submission schedules than
and (D)(ii), (E) through (H), and (J)
If EPA receives adverse comment, we those for section 110 infrastructure
through (M). EPA is not acting on the
will publish a timely withdrawal of the elements. EPA will take action on part
elements of section 110(a)(2)(D)(i)(II)—
direct final rule in the Federal Register D attainment plan SIP submissions
protection of visibility (prong 4), and
informing the public that the rule will through a separate rulemaking governed
110(a)(2)(I).
not take effect. A Technical Support Document (TSD) by the requirements for nonattainment
ADDRESSES: Submit your comments, is included as part of this docket to areas, as described in part D.
identified by Docket ID No. EPA–R07– discuss the details of this action, EPA is not taking action on section
OAR–2017–0208, to https:// including analysis of how the SIP meets 110(a)(2)(D)(i)(II), prong 4.
www.regulations.gov. Follow the online the applicable 110 requirements for We are publishing this direct final
instructions for submitting comments. infrastructure SIPs. rule without a prior proposed rule
sradovich on DSKBBY8HB2PROD with RULES

Once submitted, comments cannot be because we view this as a
edited or removed from Regulations.gov. II. Have the requirements for approval noncontroversial action and anticipate
EPA may publish any comment received of a SIP revision been met? no adverse comment. However, in the
to its public docket. Do not submit The state submission has met the ‘‘Proposed Rules’’ section of this
electronically any information you public notice requirements for SIP Federal Register, we are publishing a
consider to be Confidential Business submissions in accordance with 40 CFR separate document that will serve as the
Information (CBI) or other information 51.102. The state initiated public proposed rule to approve the SIP

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Document Created: 2018-10-24 14:21:11
Document Modified: 2018-10-24 14:21:11

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 July 3, 2017 (82 FR 30731), confirmed: August 3, 2017.
Contact		Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.
FR Citation		82 FR 43845
CFR Associated		Color Additives; Cosmetics; Drugs and Medical Devices

82 FR 43845 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 181 (September 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration