83 FR 13105 - Revision of Organization; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

Page Range		13105-13106
FR Document		2018-06065

The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.

Federal Register, Volume 83 Issue 59 (Tuesday, March 27, 2018)

[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Rules and Regulations]
[Pages 13105-13106]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

[Docket No. FDA-2018-N-0011]


Revision of Organization; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
its regulations to reflect organizational change for the Office of 
Regulatory Policy, Center for Drug Evaluation and Research (CDER), 
Office of Medical Products and Tobacco. FDA is taking this action to 
ensure accuracy and clarity in the Agency's regulations.

DATES: This rule is effective March 27, 2018.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 5.1100 to update the 
organizational information for the Office of Regulatory Policy, CDER, 
Office of Medical Products and Tobacco.
    Publication of this document constitutes final action on this 
change under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because this 
amendment to the regulations provides only a technical change to update 
the

[[Page 13106]]

organizational information for the Office of Regulatory Policy, CDER, 
Office of Medical Products and Tobacco.

List of Subjects in 21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
5 is amended as follows:

PART 5--ORGANIZATION

0
1. The authority citation for part 5 continues to read as follows:

    Authority:  5 U.S.C. 552; 21 U.S.C. 301-397.


Sec.  5.1100   [Amended]

0
2. In Sec.  5.1100, under the heading ``OFFICE OF MEDICAL PRODUCTS AND 
TOBACCO'', under ``Office of Regulatory Policy.'', under ``Division of 
Regulatory Policy III.'', add the words ``Division of Regulatory Policy 
IV.''.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06065 Filed 3-26-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Rules and Regulations 13105

conditions will remain strong. Inflation these final amendments to Regulation D. § 204.10 Payment of interest on balances.
on a 12-month basis is expected to move The rate increases for IORR and IOER * * * * *
up in coming months and to stabilize that are reflected in the final (b) * * *
around the Committee’s 2 percent amendments to Regulation D were made (5) The rates for IORR and IOER are:
objective over the medium term. Near- with a view towards accommodating
term risks to the economic outlook commerce and business and with regard Rate
appear roughly balanced, but the to their bearing upon the general credit (%)
Committee is monitoring inflation situation of the country. Notice and
IORR ..................................... 1.75
developments closely. public comment would prevent the IOER ..................................... 1.75
In view of realized and expected labor Board’s action from being effective as
market conditions and inflation, the promptly as necessary in the public
Committee decided to raise the target * * * * *
interest, and would not otherwise serve
range for the federal funds rate to 11⁄2 to any useful purpose. Notice, public
13⁄4 percent. The stance of monetary By order of the Board of Governors of the
comment, and a delayed effective date
policy remains accommodative, thereby Federal Reserve System, March 22, 2018.
would create uncertainty about the
supporting strong labor market Ann E. Misback,
finality and effectiveness of the Board’s
conditions and a sustained return to 2 action and undermine the effectiveness Secretary of the Board.
percent inflation. A Federal Reserve of that action. Accordingly, the Board [FR Doc. 2018–06124 Filed 3–26–18; 8:45 am]
Implementation note released has determined that good cause exists to BILLING CODE 6210–01–P
simultaneously with the announcement dispense with the notice, public
stated that: comment, and delayed effective date
The Board of Governors of the Federal procedures of the APA with respect to DEPARTMENT OF HEALTH AND
Reserve System voted unanimously to raise these final amendments to Regulation D. HUMAN SERVICES
the interest rate paid on required and excess
reserve balances to 1.75 percent, effective IV. Regulatory Flexibility Analysis Food and Drug Administration
March 22, 2018. The Regulatory Flexibility Act
As a result, the Board is amending (‘‘RFA’’) does not apply to a rulemaking 21 CFR Part 5
§ 204.10(b)(5) of Regulation D to change where a general notice of proposed [Docket No. FDA–2018–N–0011]
IORR to 1.75 percent and IOER to 1.75 rulemaking is not required.10 As noted
percent. previously, the Board has determined Revision of Organization; Technical
that it is unnecessary and contrary to Amendment
III. Administrative Procedure Act
the public interest to publish a general
In general, the Administrative notice of proposed rulemaking for this AGENCY: Food and Drug Administration,
Procedure Act (‘‘APA’’) 7 imposes three final rule. Accordingly, the RFA’s HHS.
principal requirements when an agency requirements relating to an initial and Final rule; technical
ACTION:
promulgates legislative rules (rules final regulatory flexibility analysis do amendment.
made pursuant to congressionally not apply.
delegated authority): (1) Publication SUMMARY: The Food and Drug
with adequate notice of a proposed rule; V. Paperwork Reduction Act Administration (FDA or Agency) is
(2) followed by a meaningful In accordance with the Paperwork amending its regulations to reflect
opportunity for the public to comment Reduction Act (‘‘PRA’’) of 1995,11 the organizational change for the Office of
on the rule’s content; and (3) Board reviewed the final rule under the Regulatory Policy, Center for Drug
publication of the final rule not less authority delegated to the Board by the Evaluation and Research (CDER), Office
than 30 days before its effective date. Office of Management and Budget. The of Medical Products and Tobacco. FDA
The APA provides that notice and final rule contains no requirements is taking this action to ensure accuracy
comment procedures do not apply if the subject to the PRA. and clarity in the Agency’s regulations.
agency for good cause finds them to be DATES: This rule is effective March 27,
‘‘unnecessary, impracticable, or contrary List of Subjects in 12 CFR Part 204
2018.
to the public interest.’’ 8 Section 553(d) Banks, Banking, Reporting and FOR FURTHER INFORMATION CONTACT:
of the APA also provides that recordkeeping requirements. Florine Purdie, Center for Drug
publication at least 30 days prior to a For the reasons set forth in the Evaluation and Research, Food and
rule’s effective date is not required for preamble, the Board amends 12 CFR Drug Administration, 10903 New
(1) a substantive rule which grants or part 204 as follows: Hampshire Ave. Bldg. 51, Rm. 6248,
recognizes an exemption or relieves a Silver Spring, MD 20993–0002, 301–
restriction; (2) interpretive rules and PART 204—RESERVE
796–3601.
statements of policy; or (3) a rule for REQUIREMENTS OF DEPOSITORY
which the agency finds of good cause INSTITUTIONS (REGULATION D) SUPPLEMENTARY INFORMATION: FDA is
for shortened notice and publishes its amending 21 CFR 5.1100 to update the
reasoning with the rule.9 ■ 1. The authority citation for part 204 organizational information for the Office
The Board has determined that good continues to read as follows: of Regulatory Policy, CDER, Office of
cause exists for finding that the notice, Authority: 12 U.S.C. 248(a), 248(c), 461, Medical Products and Tobacco.
public comment, and delayed effective 601, 611, and 3105. Publication of this document
date provisions of the APA are constitutes final action on this change
amozie on DSK30RV082PROD with RULES

■ 2. Section 204.10 is amended by
unnecessary, impracticable, or contrary revising paragraph (b)(5) to read as under the Administrative Procedure Act
to the public interest with respect to follows: (5 U.S.C. 553). FDA has determined that
notice and public comment are
75 U.S.C. 551 et seq. 10 5 U.S.C. 603 and 604. unnecessary because this amendment to
85 U.S.C. 553(b)(3)(A). 11 44 U.S.C. 3506; see 5 CFR part 1320, appendix the regulations provides only a
9 5 U.S.C. 553(d). A.1. technical change to update the

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Document Created: 2018-03-27 01:26:35
Document Modified: 2018-03-27 01:26:35

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; technical amendment.
Dates		This rule is effective March 27, 2018.
Contact		Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601.
FR Citation		83 FR 13105
CFR Associated		Authority Delegations (government Agencies); Imports and Organization and Functions (government Agencies)

83 FR 13105 - Revision of Organization; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration