82 FR 12067 - Use of Ozone-Depleting Substances

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 38 (February 28, 2017)

Page Range		12067-12068
FR Document		2017-03866

In accordance with a determination by the Director of the Office of Management and Budget (OMB) that the direct final rule (``Use of Ozone Depleting Substances'') published on October 26, 2016, is excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action confirms the effective date of February 23, 2017, for the direct final rule.

Federal Register, Volume 82 Issue 38 (Tuesday, February 28, 2017)

[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Rules and Regulations]
[Pages 12067-12068]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03866]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2015-N-1355]
RIN 0910-AH36


Use of Ozone-Depleting Substances

AGENCY: Food and Drug Administration, HHS.

[[Page 12068]]


ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: In accordance with a determination by the Director of the 
Office of Management and Budget (OMB) that the direct final rule (``Use 
of Ozone Depleting Substances'') published on October 26, 2016, is 
excluded from the memorandum of January 20, 2017, from the Assistant to 
the President and Chief of Staff, entitled ``Regulatory Freeze Pending 
Review,'' this action confirms the effective date of February 23, 2017, 
for the direct final rule.

DATES: The effective date of the direct final rule that published on 
October 26, 2016, at 81 FR 74298, is confirmed to be February 23, 2017.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, 
[email protected].

SUPPLEMENTARY INFORMATION: On October 26, 2016, the Food and Drug 
Administration (FDA or Agency) issued a direct final rule amending the 
regulation on uses of ozone-depleting substances (ODSs), including 
chlorofluorocarbons, to remove the designations for sterile aerosol 
talc administered intrapleurally by thoracoscopy for human use and 
metered-dose atropine sulfate aerosol human drugs administered by oral 
inhalation as ``essential uses'' under the Clean Air Act. FDA took this 
action because alternative products that do not use ODSs are now 
available, and because these products are no longer being marketed in 
versions that contain ODSs. FDA did not receive any significant adverse 
comments regarding the direct final rule, which was published with an 
effective date of February 23, 2017.
    A memorandum of January 20, 2017 (82 FR 8346), from the Assistant 
to the President and Chief of Staff, entitled ``Regulatory Freeze 
Pending Review,'' directed the heads of Executive Departments and 
Agencies to temporarily postpone for 60 days from the date of the 
memorandum the effective dates of all regulations that had been 
published in the Federal Register but had not yet taken effect, for the 
purpose of ``reviewing questions of fact, law, and policy they raise.'' 
The memorandum also stated that the Director of OMB may exclude certain 
regulations if they ``affect critical health, safety, financial, or 
national security matters, or for some other reason.'' Pursuant to the 
memorandum, the Director of OMB has excluded the direct final rule that 
published on October 26, 2016, at 81 FR 74298, from the directive to 
delay the effective date of certain regulations. The Department, 
therefore, confirms that the effective date of the direct final rule is 
February 23, 2017.

    Dated: February 22, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-03866 Filed 2-27-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 38 / Tuesday, February 28, 2017 / Rules and Regulations 12067

ASW TX E5 Alice, TX [Amended] radius of Possum Kingdom Airport and 504 1 of Regulation D 2 under the
Alice International Airport, TX within 4 miles each side of the 031° bearing Securities Act of 1933.
(Lat. 27°44′27″ N., long. 98°01′37″ W.) from the airport extending from the 7.0-mile
Orange Grove NALF, TX radius to 10.9 miles northeast of the airport, List of Subjects in 17 CFR Part 230
(Lat. 27°53′49″ N., long. 98°02′37″ W.) and within 4 miles each side of the 210°
Reporting and recordkeeping
Navy Orange Grove TACAN bearing from the airport extending from the
7.0-mile radius to 10.9 miles southwest of the requirements, Securities.
(Lat. 27°53′43″ N., long. 98°02′33″ W.)
Kingsville, Kleberg County Airport, TX airport. Text of the Amendments
(Lat. 27°33′03″ N., long. 98°01′51″ W.) * * * * * For the reasons set out above, title 17,
That airspace extending upward from 700
feet above the surface within a 7.5-mile ASW TX E5 Hamilton, TX [Amended] chapter II of the Code of Federal
radius of Alice International Airport, and Hamilton Municipal Airport, TX Regulations is amended as follows:
within 2 miles each side of the 135° bearing (Lat. 31°39′57″ N., long. 98°08′55″ W.)
from Alice International Airport extending That airspace extending upward from 700 PART 230—GENERAL RULES AND
from the 7.5-mile radius to 9.8 miles feet above the surface within a 6.5-mile REGULATIONS, SECURITIES ACT OF
southeast of the airport, and within a 7.2- radius of Hamilton Municipal Airport, and 1933
mile radius of the Orange Grove NALF, and within 2 miles each side of the 009° bearing
within 1.6 miles each side of the 129° radial from the airport extending from the 6.5-mile ■ 1. The general authority citation for
of the Navy Orange Grove TACAN extending radius to 9.4 miles north of the airport, and part 230 continues to read as follows:
from the 7.2-mile radius of the Orange Grove within 2 miles each side of the 189° bearing
NALF to 11 miles southeast of the Orange Authority: 15 U.S.C. 77b, 77b note, 77c,
from the airport extending from the 6.5-mile 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z–3, 77sss,
Grove NALF, and within 1.5 miles each side radius to 10.3 miles south of the airport.
of the 320° radial of the Navy Orange Grove 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o–7 note,
TACAN extending from the 7.2-mile radius Issued in Fort Worth, Texas, on February 78t, 78w, 78ll(d), 78mm, 80a–8, 80a–24, 80a–
of the Orange Grove NALF to 9.7 miles 8, 2017. 28, 80a–29, 80a–30, and 80a–37, and Pub. L.
northwest of the Orange Grove NALF, and Walter Tweedy, 112–106, sec. 201(a), sec. 401, 126 Stat. 313
within a 6.6-mile radius of Kleberg County (2012), unless otherwise noted.
Acting Manager, Operations Support Group,
Airport, and within 4.0 miles each side of the ATO Central Service Center. * * * * *
320° bearing from the Kleberg County Airport
[FR Doc. 2017–03835 Filed 2–27–17; 8:45 am] ■ 2. Amend § 230.504 by revising
from the 6.6-mile radius to 10.3 miles
northwest of the airport, excluding that BILLING CODE 4910–13–P paragraph (b)(2) to read as follows:
airspace within the Corpus Christi, TX, Class § 230.504 Exemption for limited offerings
E airspace area. and sales of securities not exceeding
* * * * * $5,000,000.
SECURITIES AND EXCHANGE
ASW TX E5 Bay City, TX [Amended] * * * * *
COMMISSION
Bay City Municipal Airport, TX (b) * * *
(Lat. 28°58′24″ N., long. 95°51′48″ W.) 17 CFR Part 230 (2) The aggregate offering price for an
That airspace extending upward from 700 offering of securities under this
feet above the surface within a 6.5-mile § 230.504, as defined in § 230.501(c),
[Release Nos. 33–10238A; 34–79161A; File
radius of Bay City Municipal Airport. No. S7–22–15]
shall not exceed $5,000,000, less the
* * * * * aggregate offering price for all securities
sold within the twelve months before
ASW TX E5 Brenham, TX [Amended] RIN 3235–AL80 the start of and during the offering of
Brenham Municipal Airport, TX securities under this § 230.504 or in
(Lat. 30°13′11″ N., long. 96°22′28″ W.) Exemptions To Facilitate Intrastate and
violation of section 5(a) of the Securities
That airspace extending upward from 700 Regional Securities Offerings
Act.
feet above the surface within a 6.5-mile AGENCY: Securities and Exchange
radius of Brenham Municipal Airport.
* * * * *
Commission. Dated: February 22, 2017.
* * * * *
ACTION: Final rule; technical correction. Brent J. Fields,
ASW TX E5 Burnet, TX [Amended]
SUMMARY: This document makes a Secretary.
Burnet Municipal Airport-Kate Craddock
technical correction to one of the final [FR Doc. 2017–03848 Filed 2–27–17; 8:45 am]
Field, TX
(Lat. 30°44′20″ N., long. 98°14′19″ W.) regulations (SEC Rel. No. 33–10238) BILLING CODE 8011–01–P

That airspace extending upward from 700 published in the Federal Register on
feet above the surface within a 6.6-mile November 21, 2016 (81 FR 83494).
radius of Burnet Municipal Airport-Kate Specifically, the amendments to Rule DEPARTMENT OF HEALTH AND
Craddock Field. 504 of Regulation D under the Securities HUMAN SERVICES
* * * * * Act of 1933 inadvertently omitted the
word ‘‘or’’ from the last sentence of the Food and Drug Administration
ASW TX E5 Falfurrias, TX [Amended]
rule; this correction is reflected in the
Brooks County Airport, TX text of the amendments below. 21 CFR Part 2
(Lat. 27°12′22″ N., long. 98°07′16″ W.)
DATES: This correction is effective [Docket No. FDA–2015–N–1355]
That airspace extending upward from 700
feet above the surface within a 6.6-mile February 28, 2017.
RIN 0910–AH36
FOR FURTHER INFORMATION CONTACT:
pmangrum on DSK3GDR082PROD with RULES

radius of Brooks County Airport.
* * * * * Anthony G. Barone, Special Counsel, or Use of Ozone-Depleting Substances
Jenny Riegel, Special Counsel, Division
ASW TX E5 Graford, TX [Amended] AGENCY: Food and Drug Administration,
of Corporation Finance, at (202) 551–
Possum Kingdom Airport, TX 3460. HHS.
(Lat. 32°55′24″ N., long. 98°26′13″ W.)
That airspace extending upward from 700 SUPPLEMENTARY INFORMATION: We are 1 17 CFR 230.504.
feet above the surface within a 7.0-mile making a technical correction to Rule 2 17 CFR 230.500 through 230.508.

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12068 Federal Register / Vol. 82, No. 38 / Tuesday, February 28, 2017 / Rules and Regulations

ACTION: Direct final rule; confirmation of Pursuant to the memorandum, the II. Calculation of Annual Adjustment
effective date. Director of OMB has excluded the direct On December 16, 2016, OMB issued
final rule that published on October 26, guidance to agencies to calculate the
SUMMARY: In accordance with a 2016, at 81 FR 74298, from the directive
determination by the Director of the annual adjustment. See Memorandum
to delay the effective date of certain for the Heads of Executive Departments
Office of Management and Budget regulations. The Department, therefore,
(OMB) that the direct final rule (‘‘Use of and Agencies, from Shaun Donovan,
confirms that the effective date of the Director, Office of Management and
Ozone Depleting Substances’’) direct final rule is February 23, 2017.
published on October 26, 2016, is Budget, Subject: Implementation of the
excluded from the memorandum of Dated: February 22, 2017. 2017 annual adjustment pursuant to the
January 20, 2017, from the Assistant to Thomas E. Price, Federal Civil Penalties Inflation
the President and Chief of Staff, entitled Secretary. Adjustment Act Improvements Act of
‘‘Regulatory Freeze Pending Review,’’ [FR Doc. 2017–03866 Filed 2–27–17; 8:45 am] 2015. According to OMB, the cost-of-
this action confirms the effective date of BILLING CODE 4164–01–P
living adjustment multiplier for 2017,
February 23, 2017, for the direct final based on the Consumer Price Index
rule. (CPI–U) for the month of October 2016,
not seasonally adjusted, is 1.01636.
DATES: The effective date of the direct
DEPARTMENT OF THE INTERIOR Pursuant to this guidance, the
final rule that published on October 26,
Commission has calculated the annual
2016, at 81 FR 74298, is confirmed to be
National Indian Gaming Commission adjustment level of the civil monetary
February 23, 2017.
penalty contained in 25 CFR 575.4
FOR FURTHER INFORMATION CONTACT: (‘‘The Chairman may assess a civil fine,
25 CFR Part 575
Daniel Orr, Center for Drug Evaluation not to exceed $49,467 per violation,
and Research, Food and Drug Annual Adjustment of Civil Monetary against a tribe, management contractor,
Administration, 10903 New Hampshire Penalty To Reflect Inflation or individual operating Indian gaming
Ave., Bldg. 51, Rm. 6246, Silver Spring, for each notice of violation . . .’’). The
MD 20993, 240–402–0979, AGENCY: National Indian Gaming 2017 adjusted level of the civil
daniel.orr@fda.hhs.gov. Commission, Department of the Interior. monetary penalty is $50,276 ($49,467 ×
SUPPLEMENTARY INFORMATION: On ACTION: Final rule. 1.01636).
October 26, 2016, the Food and Drug
SUMMARY: In compliance with the III. Regulatory Matters
Administration (FDA or Agency) issued
a direct final rule amending the Federal Civil Penalties Inflation Regulatory Planning and Review
regulation on uses of ozone-depleting Adjustment Act Improvements Act of
This final rule is not a significant rule
substances (ODSs), including 2015 (the Act) and Office of
under Executive Order 12866.
chlorofluorocarbons, to remove the Management and Budget (OMB)
(1) This rule will not have an effect of
designations for sterile aerosol talc guidance, the National Indian Gaming
$100 million or more on the economy or
administered intrapleurally by Commission (NIGC or Commission) is
will not adversely affect, in a material
thoracoscopy for human use and amending its civil monetary penalty
way, the economy, productivity,
metered-dose atropine sulfate aerosol rule to reflect an annual adjustment for
competition, jobs, the environment,
human drugs administered by oral inflation in order to improve the
public health or safety, or state, local, or
inhalation as ‘‘essential uses’’ under the penalty’s effectiveness and maintain its
tribal governments or communities.
Clean Air Act. FDA took this action deterrent effect. The Act provides that (2) This rule will not create a serious
because alternative products that do not the new penalty level must apply to inconsistency or otherwise interfere
use ODSs are now available, and penalties assessed after the effective with an action taken or planned by
because these products are no longer date of the increase, including when the another agency.
being marketed in versions that contain penalties whose associated violation (3) This rule does not involve
ODSs. FDA did not receive any predate the increase. entitlements, grants, user fees, or loan
significant adverse comments regarding DATES: This final rule is effective programs or the rights or obligations of
the direct final rule, which was February 28, 2017. recipients.
published with an effective date of (4) This regulatory change does not
FOR FURTHER INFORMATION CONTACT:
February 23, 2017. raise novel legal or policy issues.
A memorandum of January 20, 2017 Contact Armando J. Acosta, Senior
(82 FR 8346), from the Assistant to the Attorney, Office of General Counsel, Regulatory Flexibility Act
President and Chief of Staff, entitled National Indian Gaming Commission, at
The Commission certifies that this
‘‘Regulatory Freeze Pending Review,’’ (202) 632–7003; fax (202) 632–7066 (not
rule will not have a significant
directed the heads of Executive toll-free numbers).
economic effect on a substantial number
Departments and Agencies to SUPPLEMENTARY INFORMATION: of small entities under the Regulatory
temporarily postpone for 60 days from Flexibility Act (5 U.S.C. 601 et seq.)
I. Background
the date of the memorandum the because the rule makes annual
effective dates of all regulations that had On November 2, 2015, the President adjustments for inflation.
been published in the Federal Register signed into law the Federal Civil
but had not yet taken effect, for the Penalties Inflation Adjustment Act Small Business Regulatory Enforcement
pmangrum on DSK3GDR082PROD with RULES

purpose of ‘‘reviewing questions of fact, Improvements Act of 2015 (Sec. 701 of Fairness Act
law, and policy they raise.’’ The Pub. L. 114–74). Beginning in 2017, the This final rule is not a major rule
memorandum also stated that the Act requires agencies to make annual under 5 U.S.C. 804(2), the Small
Director of OMB may exclude certain inflationary adjustments to their civil Business Regulatory Enforcement
regulations if they ‘‘affect critical health, monetary penalties by January 15th of Fairness Act. It will not result in the
safety, financial, or national security each year, in accordance with yearly expenditure by state, local, or tribal
matters, or for some other reason.’’ OMB guidance. governments, in the aggregate, or by the

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Document Created: 2017-02-27 23:53:41
Document Modified: 2017-02-27 23:53:41

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		Direct final rule; confirmation of effective date.
Dates		The effective date of the direct final rule that published on October 26, 2016, at 81 FR 74298, is confirmed to be February 23, 2017.
Contact		Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, [email protected]
FR Citation		82 FR 12067
RIN Number		0910-AH36

82 FR 12067 - Use of Ozone-Depleting Substances

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 38 (February 28, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration