Regulatory Clean Up Initiative

Cited as:85 FR 72899
Court:Centers For Medicare & Medicaid Services, Children And Families Administration, Inspector General Office
Publication Date:16 Nov 2020
Record Number:2020-21774
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.
Rules and Regulations Federal Register
72899
Vol. 85, No. 221
Monday, November 16, 2020
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
2 CFR Part 376
42 CFR Parts 23, 51c, 52i, 56, 57, 63,
and 124
45 CFR Parts 3, 63, and 75
48 CFR Parts 302 and 326
[Docket Number HHS–OS–2020–0015]
RIN 0991–AC19
Food and Drug Administration
21 CFR Parts 1, 5, 12, 14, 25, 81, 133,
172, 178, 184, 201, 310, 369, 501, and
582
Centers for Medicare & Medicaid
Services
42 CFR Parts 411, 412, 422, 423, 426,
440, 441, 447, 482, and 485
Office of Inspector General
42 CFR Parts 1004 and 1008
Administration for Children and
Families
45 CFR Parts 305, 307, 1324, 1325,
1326, and 1328
Regulatory Clean Up Initiative
AGENCY
: Office of the Assistant
Secretary for Administration (ASA),
HHS.
ACTION
: Final rule.
SUMMARY
: The U.S Department of Health
and Human Services (HHS) is amending
its regulations to make miscellaneous
corrections, including correcting
references to other regulations,
misspellings and other typographical
errors. This document is necessary to
inform the public of these non-
substantive changes to HHS’s
regulations.
DATES
: This rule is effective as of
December 16, 2020.
FOR FURTHER INFORMATION CONTACT
:
Douglas Cheung, Ph.D., ReImagine
Transformation Management Office,
Immediate Office of the Secretary,
email: douglas.cheung@hhs.gov; and
RegCleanUp@hhs.gov.
SUPPLEMENTARY INFORMATION
:
I. Introduction
HHS is committed to advancing its
mission in part through strong
regulatory stewardship, including
regularly reviewing and modernizing its
regulations, in accordance with the
principles, inter alia, established in
Executive Order 13563 (Jan. 18, 2011).
Section 6 of E.O. 13563 (76 FR 3821)
guides the process of the retrospective
review of existing regulations by
agencies. While retrospective regulatory
review and reform has until now been
a largely manual process, new
technologies exist that can support
policy subject matter experts (SMEs) in
their efforts to review large amounts of
regulatory text. As part of HHS’s
pioneering efforts to pilot the use of
Artificial Intelligence (AI) and other
advanced analyses, HHS recently
applied AI and Natural Language
Processing (NLP) technology to support
and accelerate SME reviews in
cognizant divisions of HHS of
unstructured text in the Code of Federal
Regulations (CFR), facilitating the
identification of opportunities to
improve HHS’s regulations.
In conjunction with, and following
validation by, human SMEs, this AI-
augmented analysis indicated that HHS
has a number of ‘‘incorrect citations,’’ in
which a current regulation cites a
regulation that may have moved or may
no longer exist. In response to these
findings, HHS is amending the
identified ‘‘incorrect citations.’’ The
amendments detailed in this rule correct
these citations, remove erroneous
language, or correct misspellings and
other typographical errors.
II. Background
HHS is committed to the
Administration’s vision of reducing
regulatory burden and modernizing the
CFR. Executive Order 13771 (Jan. 30,
2017) (82 FR 9339) and E.O. 13563 both
emphasize the importance of
retrospectively reviewing existing
regulations in order to achieve these
objectives. In particular, section 6 of
E.O. 13563 asks agencies to ‘‘consider
how best to promote retrospective
analyses of rules that may be outmoded
. . .’’ (76 FR 3822). HHS has continued
to execute regulatory reform through
new and innovative methods. In the
past, regulatory analysis and reform has
been a largely manual process, limited
by each expert’s experience with a
particular subset of agency regulations,
and it has been labor-intensive and
time-consuming to find regulatory
reform opportunities through this
manual review. In addition, unless a
portfolio of minor changes can occur
through a consolidated regulatory
vehicle, it is often administratively
impractical to implement many results
of retrospective review; this relative
infeasibility of implementation may in
turn discourage the identification and
correction of many small but valuable
refinements to existing regulations.
However, HHS has piloted a new
method of regulatory analysis, using an
AI-driven tool that analyzed HHS’s
regulations using NLP as applied to the
regulatory text in the CFR. This NLP
analysis is designed to accelerate and
augment expert review, by highlighting
‘‘candidate’’ provisions that could be
outmoded, allowing HHS SMEs to focus
on these provisions as potential areas of
opportunity for modernization. The NLP
analysis revealed numerous reform
opportunities, including instances
where a regulation citation is now
incorrect. Combined with the policy
expertise of HHS SMEs, this NLP
analysis method has yielded promising
results towards reforming and
modernizing regulations at HHS. The
revisions outlined in this rule represent
a portion of the results from this effort,
and are focused on administrative, non-
substantive changes that will clean up
HHS’s regulations. For efficiency, a
consolidated regulatory vehicle is being
used to implement these numerous non-
substantive changes across multiple
HHS regulations. Future uses of these
technologies to promote comprehensive
and systematic retrospective review will
continue to algorithmically refine
identification of potentially
‘‘outmoded’’ regulations and will seek
algorithmic characterization of other
regulatory targets of E.O. 13563—
regulations which are ‘‘ineffective,
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insufficient, or excessively
burdensome’’, as candidates for SME
review and potential reform.
III. Summary of Changes
2 CFR Part 376
Deletion. In 2 CFR 376.10, this rule
removes the incorrect references to 3
CFR 1986 Comp., p. 189 and 3 CFR 1989
Comp., p. 235 as these references no
longer exist. Although 3 CFR 1986 and
3 CFR 1989 are referenced as sources for
Executive Order 12549 ‘‘Debarment and
Suspension’’ (signed February 18, 1986)
and Executive Order 12689 ‘‘Debarment
and Suspension (signed august 18,
1989), removal of these references
ensure consistency with 2 CFR 276.10
as currently written.
21 CFR Part 1
Correct Reference. In 21 CFR
1.24(a)(6)(ii) and (8)(ii), this rule
removes the incorrect reference 21 CFR
101.105 and replaces it with the correct
reference 21 CFR 101.7 as 21 CFR
101.105 was redesignated in 2016 as
part of a technical amendment (81 FR
59130).
21 CFR Part 5
Correct an Omission. In 21 CFR
5.1100, a footnote ‘‘*’’ next to the
‘‘Office of Chief Counsel,’’ that had
appeared in earlier editions and was
inadvertently omitted, should be
inserted to read as it had in prior
editions, as follows: ‘‘*The Office of the
Chief Counsel (also known as the Food
and Drug Division, Office of the General
Counsel, Department of Health and
Human Services), while
administratively within the Office of the
Commissioner, is part of the Office of
the General Counsel of the Department
of Health and Human Services.’’
Correct an Omission. In 21 CFR
5.1105, a footnote ‘‘*’’ next to the
‘‘Office of Chief Counsel,’’ that had
appeared in earlier editions and was
inadvertently omitted, should be
inserted to read as it had in prior
editions, as follows: ‘‘*The Office of the
Chief Counsel (also known as the Food
and Drug Division, Office of the General
Counsel, Department of Health and
Human Services), while
administratively within the Office of the
Commissioner, is part of the Office of
the General Counsel of the Department
of Health and Human Services.’’
21 CFR Part 12
Deletion. In 21 CFR 12.21(a)(2), this
rule deletes the phrase ‘‘514.2 for
applications for animal feeds’’ as 21
CFR 514.2 was removed in 1999 (64 FR
63195) to provide for feed mill licensing
in accordance with the Animal Drug
Availability Act (ADAA) of 1996.
21 CFR Part 14
Correct Reference. In 21 CFR
14.7(b), this rule removes the incorrect
reference 45 CFR 5.34 and replaces it
with the correct reference 45 CFR 5.61—
45 CFR 5.64 (subpart F Appeals) as 45
CFR 5.34 was removed when the
Freedom of Information regulations
were reorganized in 2016 (81 FR 74930).
21 CFR Part 25
Deletion. This rule deletes and
reserves 21 CFR 25.33(a)(7), which reads
‘‘(7) Approval of a drug for use in
animal feeds if such drug has been
approved under § 514.2 or 514.9 of this
chapter for other uses,’’ as 21 CFR 514.2
and 21 CFR 514.9 were removed in 1999
(64 FR 63195) to provide for feed mill
licensing in accordance with the Animal
Drug Availability Act (ADAA) of 1996.
21 CFR Part 81
Deletion. In 21 CFR 81.30(s)(2), this
rule deletes the sentence ‘‘Ingested drug
lip products, however, are regulated for
use in 74.1308 and 74.1309’’ in order to
remove the incorrect references to 21
CFR 74.1308 and 21 CFR 74.1309. This
language is no longer needed because 21
CFR 74.1308 and 21 CFR 74.1309 were
removed in 1988 (53 FR 26766).
Deletion. This rule deletes 21 CFR
81.32. This language is no longer
needed because it cross-references a
section, 21 CFR 81.25, that was removed
in 1988 (53 FR 33110).
21 CFR Part 133
Deletion. This rule deletes 21 CFR
133.116(d), which reads ‘‘(d) Low
sodium cheddar cheese is subject to
§ 105.69 of this chapter’’ as 21 CFR
105.69 was revoked in 1996 (61 FR
27771).
Deletion. This rule deletes 21 CFR
133.121(f) which reads ‘‘(f) Low sodium
colby cheese is subject to § 105.69 of
this chapter’’ as 21 CFR 105.69 was
revoked in 1996 (61 FR 27771).
21 CFR Part 172
Deletion. In 21 CFR 172.840(c)(13),
this rule deletes ‘‘and 133.131’’ as this
section was revoked in 1996 (61 FR
58991) after FDA determined that lowfat
cottage cheese was more appropriately
covered by the general standard in 21
CFR 130.10.
21 CFR Part 178
Correct Reference. In 21 CFR
178.3730, this rule removes the
incorrect references to 21 CFR 193.390,
21 CFR 561.310, and 21 CFR 561.340
and replaces them with the correct
references 40 CFR 180.127 and 40 CFR
180.128. This change reflects a
renumbering of the CFR in 1988 (53 FR
24666) and a consolidation of certain
tolerance regulations in 2000 (65 FR
33703).
Deletion. In 21 CFR 178.3730, this
rule removes the incorrect reference to
21 CFR 193.60 as this rule was
renumbered in 1988 (53 FR 24666) and
revoked in 1989 (54 FR 43424).
21 CFR Part 184
Correct Reference. In 21 CFR
184.1097, this rule removes the
incorrect reference to 9 CFR 318.7 and
replaces it with the correct reference 9
CFR 424.21. This change reflects a
renumbering of the CFR in 1999 (64 FR
72168).
Correct Reference. In 21 CFR
184.1143, this rule removes the
incorrect reference to 21 CFR 170.1 and
replaces it with the correct reference 21
CFR 170.3(n)(22) as the definition for
‘‘gelatins and puddings’’ was moved in
1977 (42 FR 14302).
Correct Reference. In 21 CFR
184.1924(c)(1), this rule removes the
incorrect reference to 27 CFR 2.5 and
replaces it with the correct reference 27
CFR 1.10 as the definition reference was
moved in 1996 (61 FR 26096) and
moved again in 1999 (64 FR 49985).
21 CFR Part 201
Deletion. This rule removes a clause
in 21 CFR 201.317(c) that cross-
references 21 CFR 310.500, which was
revoked in 2002 (67 FR 42992, 42997).
21 CFR Part 310
Deletion. This rule removes 21 CFR
310.303 as it concerns procedures to list
a drug in 21 CFR 310.304, which was
revoked as obsolete or no longer
necessary to achieve public health goals
in 1996 (61 FR 29476, 29477).
21 CFR Part 369
Correct Reference. In 21 CFR 369.3,
this rule removes the incorrect reference
to 21 CFR 369.22, which was removed
in 2002 (67 FR 4904, 4907).
21 CFR Part 501
Deletion. In 21 CFR 501.105(t), this
rule removes the incorrect reference to
21 CFR 564.14(b) as 21 CFR part 564
was removed in 1999 (64 FR 4293) as an
unnecessary regulation.
21 CFR Part 582
Correct Reference. In 21 CFR
582.99, this rule removes the incorrect
references to 40 CFR 180.1001(c) and (d)
and replaces them with the correct
references of 40 CFR 180.910 and 40
CFR 180.920 as these references were
renumbered in 2004 (69 FR 23113).
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42 CFR Part 23
Correct Reference. This rule amends
§ 23.9 to remove the phrase ‘‘the most
recent ‘CSA Income Poverty Guidelines’
(45 CFR 1060.2) issued by the
Community Services Administration;’’
and replace it with ‘‘the poverty
guidelines updated periodically in the
Federal Register by the U.S. Department
of Health and Human Services under
the authority of 42 U.S.C. 9902(2);’’. The
Secretary of HHS is required to update
the poverty guidelines at least annually,
adjusting them based on the Consumer
Price Index for All Urban Consumers. 45
CFR 1060.2 no longer exists; rather,
updates are published at least annually
in the Federal Register.
42 CFR Part 51c
Correct Reference. Section
51c.107(5) is amended to remove the
phrase ‘‘the most recent ‘CSA Income
Poverty Guidelines’ (45 CFR 1060.2)
issued by the Community Services
Administration;’’ and replace it with
‘‘the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2);’’. The Secretary of
HHS is required to update the poverty
guidelines at least annually, adjusting
them based on the Consumer Price
Index for All Urban Consumers. 45 CFR
1060.2 no longer exists; rather, updates
are published at least annually in the
Federal Register.
Correct Reference. Section 51c.303
is amended to remove the phrase ‘‘the
most recent ‘CSA Income Poverty
Guidelines’ (45 CFR 1060.2) issued by
the Community Services
Administration;’’ and replace it with
‘‘the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2);’’. The Secretary of
HHS is required to update the poverty
guidelines at least annually, adjusting
them based on the Consumer Price
Index for All Urban Consumers. 45 CFR
1060.2 no longer exists; rather, updates
are published at least annually in the
Federal Register.
42 CFR Part 52i
Correct Reference. In § 52i.11b, this
rule removes the incorrect reference to
45 CFR 74.53 and replaces it with the
correct reference 45 CFR 75.361. This
change reflects an update to the
referenced citation.
Correct Reference. In § 52i.11c, this
rule removes the incorrect reference to
45 CFR 74.53e and replaces it with the
correct reference 45 CFR 75.364. This
change reflects an update to the
referenced citation.
Correct Reference. In § 52i.11d, this
rule removes the incorrect reference to
45 CFR 74.52 and replaces it with the
correct reference 45 CFR 75.341. This
change reflects an update to the
referenced citation.
42 CFR Part 56
Correct Reference. Section 56.108 is
amended to remove the phrase ‘‘the
most recent ‘CSA Income Poverty
Guidelines’ (45 CFR 1060.2) issued by
the Community Services
Administration;’’ and replace it with
‘‘the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2);’’. The Secretary of
HHS is required to update the poverty
guidelines at least annually, adjusting
them based on the Consumer Price
Index for All Urban Consumers. 45 CFR
1060.2 no longer exists; rather, updates
are published at least annually in the
Federal Register.
Correct Reference. Section 56.303 is
amended to remove the phrase ‘‘the
most recent ‘CSA Income Poverty
Guidelines’ (45 CFR 1060.2) issued by
the Community Services
Administration;’’ and replace it with
‘‘the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2);’’. The Secretary of
HHS is required to update the poverty
guidelines at least annually, adjusting
them based on the Consumer Price
Index for All Urban Consumers. 45 CFR
1060.2 no longer exists; rather, updates
are published at least annually in the
Federal Register.
42 CFR Part 57
Deletion. Section 57.1505 is
amended to remove the incorrect
reference to 57.110 as it no longer exists.
42 CFR Part 63
Correct Reference. In § 63.2, this
rule removes the incorrect reference to
50.102 and replaces it with the correct
reference 42 CFR part 93.103. This rule
also amends the language to remove the
outdated phrase ‘‘misconduct of
science’’ and replaces it with the
correct, current terminology ‘‘research
misconduct’’.
Revised Nomenclature. In § 63.9(b),
this rule removes the outdated phrase
‘‘misconduct of science’’ and replaces it
with the correct, current terminology
‘‘research misconduct’’.
42 CFR Part 124
Correct Reference. In § 124.511, this
rule removes the incorrect reference to
42 CFR 125.510 as this regulation no
longer exists.
Correct Reference. In § 124.602, this
rule removes the incorrect reference to
42 CFR 53.1 as it is no longer necessary.
This citation references Title VI of the
Public Health Service Act, which was
repealed in 1979 and has not received
Congressional funding since the late
1980’s.
42 CFR Part 411
Correct Reference. In § 411.353(d),
this rule removes the incorrect reference
to § 1003.101 and replaces it with the
correct reference § 1003.110. This
change is necessary as HHS OIG re-
designated the section referenced in this
citation in a December 7, 2016
regulation (81 FR 88334). The December
7, 2016 regulation made no substantive
changes to this provision.
42 CFR Part 412
Correct Reference. In § 412.42, this
rule removes all incorrect references to
§ 405.310 and replaces them with the
correct references § 411.15. These
changes are necessary as § 405.310 was
renumbered in the early 1980’s, and the
reference needs to be updated
accordingly.
42 CFR Part 422
Correct Reference. In § 422.304(f),
this rule removes the incorrect reference
to § 495.220 and replaces it with the
correct reference § 495.204. The
Medicare and Medicaid Programs;
Electronic Health Record Incentive
Program final rule (75 FR 44314),
published July 28, 2010, states that 42
CFR 422.304 would be amended to add
a new paragraph (f), which would ‘‘act
as a cross-reference to MA EHR
incentive payment rules in subpart C of
part 495 of this chapter’’ (75 FR 44481).
Section 422.304(f), as added by the July
28, 2010 final rule, erroneously
references § 495.220. This citation was
incorrect at the time final rule was
adopted; the regulations subpart C of
part 495 do not include a § 495.220.
Section 422.304(f) should instead have
cross-referenced § 495.204 (‘‘Incentive
payments to qualifying MA
organizations for MA–EPs and MA-
affiliated eligible hospitals’’).
Correct Reference. In § 422.322(b),
this rule removes the incorrect reference
to 413.86(d) and replaces it with the
correct reference § 413.76. Medicare
Program; Changes to the Hospital
Inpatient Prospective Payment Systems
and Fiscal Year 2005 Rates; Final Rule
(69 FR 48916), published on August 11,
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2004 states that § 413.86(d) would be
redesignated into nine separate sections
(§ §413.75, 413.76, 413.77, 413.78,
413.79, 413.80, 413.81, 413.82, and
413.83). Section 422.322 of ‘‘The
Medicare Program; Establishment of the
Medicare Advantage Program; Final
Rule (70 FR 4729), published Jan 28,
2005, incorrectly cited § 413.86(d)
which existed before the Final Rule 69
FR 48916 split the section into nine
separate sections. Section 422.322(b)
should have cross-referenced § 413.76
(Direct GME payments: Calculation of
payments for GME costs) in place of
§ 413.86(d).
Correct Reference. In
§ 422.324(b)(2), this rule removes the
incorrect reference to § 413.86(b) and
replaces it with the correct reference
§ 413.75(b). In a final rule published on
August 11, 2004, § 413.86 was removed
because the size of the section had
grown too voluminous. The contents of
the section were redesignated into nine
individual sections (§ §413.75 through
413.83). At that time however, the
agency failed to update this reference to
the section in § 422.324(b)(2).
Correct Reference. In
§ 422.1094(b)(2), this rule removes the
incorrect reference to § 422.858 and
replaces it with the correct reference
§ 422.1088. Subpart T (consisting of
§ §422.1000 through 422.1094) was
added to part 422 on December 5, 2007
(72 FR 68727). The reference to
§ 423.858 was a typographical error in
that document as that section did not
exist at that time and was not otherwise
mentioned in the document. The change
is necessary to make this technical
correction.
42 CFR Part 423
Correct Reference. In
§ 423.1094(b)(2), this rule removes the
incorrect reference to § 423.858 and
replaces it with the correct reference
§ 423.1088. Subpart T (consisting of
§ §423.1000 through 423.1094), was
added on December 5, 2007 (72 FR
68736). At that time, the reference to
§ 423.858 in §423.1094 was a
typographical error in that document as
that section did not exist at that time
and was not otherwise mentioned in the
document adding subpart T. The change
is necessary to make this technical
correction.
Correct Reference. In
§ 423.2330(c)(3), this rule removes the
incorrect reference to § 423.2306(b)(4)
and replaces it with the correct
reference § 423.2315(b)(4). Subpart W
(consisting of 423.2300 through
423.2345) was added to part 423 on
April 12, 2012 (71 FR 22172). In that
document, the reference to § 423.2306
was a typographical error as that section
did not exist at that time and was not
included in the subpart being added.
The change is necessary to make this
technical correction.
42 CFR Part 426
Correct Reference. In § 426.110,
paragraph 1 of the definition of
‘‘Proprietary data and Privileged
information’’, this rule removes the
incorrect reference to 45 CFR 5.65 and
replaces it with the correct reference 45
CFR 5.31(d) and (e). This reference has
been included in § 426.110 since it was
adopted on November 7, 2003 (68 FR
63716), however, on October 28, 2016
(81 FR 74939), the Department
published a final rule revising part 5.
That revision moved the substantive
text which had been in § 5.65 to 45 CFR
5.31(d) and (e). This change is necessary
to make this technical correction.
42 CFR Part 440
Correct Reference. In § 440.20(b)
introductory text, this rule removes the
incorrect reference to § 481.1 and
replaces it with the correct reference
§ 491.2. There is no citation §481.1 in
the CFR. § 491.2 defines Nurse
Practitioners and Physician Assistants
for Rural Health Clinics and is the
appropriate reference for § 440.20(b).
42 CFR Part 441
Correct Reference. In § 441.17(a)(1),
(a)(4), and (b), this rule removes the
incorrect references to § 405.1316,
§ 405.1128(a), and §405.1316(f),
respectively, and replaces them with the
correct reference ‘‘part 493 of this
chapter’’. These citations have been
rescinded and updated under Medicare
regulations but the corresponding
Medicaid regulations that reference
them were not updated.
Correct Reference. In § 441.18(c)
introductory text, this rule removes the
incorrect reference to § 441.169 and
replaces it with the correct reference
§ 440.169. This reference was correct in
the October 1, 2008 edition on the CFR,
however on June 30, 2009 at 74 FR
31196, CMS revised paragraph (c) and
this amendment contained a
typographical error that resulted in this
reference being incorrectly changed.
42 CFR Part 447
Correct Reference. In § 447.299(c),
this rule removes the incorrect reference
to § 455.204 and replaces it with the
correct reference ‘‘§ 455.304 of this
chapter’’. The current reference is a
typographical error and does not exist.
This change is necessary to make this
technical correction.
42 CFR Part 482
Correct Reference. In 42 CFR
482.27(b)(3)(iii) and 482.27(b)(4)(iii),
this rule removes the incorrect
references to 21 CFR 610.48 as, effective
December 28, 2015, the FDA issued a
final rule that removed and reserved 21
CFR 610.48 in its entirety, along with
any reference to this requirement in the
FDA’s other requirements. This rule also
revises the remaining text of our
provisions at 42 CFR 482.27(b)(3)(iii)
and 482.27(b)(4)(iii), which contained
references to 21 CFR 610.48(b)(3) and
610.48(c)(2), respectively.
42 CFR Part 485
Correct Reference. In
§ 485.639(c)(1)(vii), this rule removes
the incorrect reference to 42 CFR 413.86
as it no longer exists and adds in its
place, a reference to § §413.76 through
413.83. In a previous group of technical
amendments (FY 2005 IPPS final rule)
(69 FR 49234), CMS redesignated the
contents of § 413.86 as § § 413.75
through 413.83. They also updated
cross-references to § 413.86 that were
located in various sections under 42
CFR parts 400 through 499. They
inadvertently did not capture all of the
needed cross-reference changes.
42 CFR Part 1004
Correct Reference. In § 1004.40, this
rule removes the incorrect reference to
476.139 and replaces it with the correct
reference 480.139. This non-substantive
technical change is necessary to
reference the correct regulation section
that was moved.
42 CFR Part 1008
Correct Reference. In § 1008.36, this
rule removes the incorrect reference to
45 CFR 5.65 and replaces it with the
correct reference 45 CFR 5.41. This non-
substantive technical change is
necessary to reference the correct
regulation section that was moved.
45 CFR Part 3
Correct Reference. In § 3.1, this rule
removes the incorrect reference to 40
United States Code section 318 or 318d
and replaces it with the correct
reference U.S. Public Law 107–296,
Homeland Security Act of 2002. This
amendment reflects a change in the
referenced statutory authority.
Correct Reference. In § 3.2(f), this
rule removes the incorrect reference to
Article 27, Sec. 36 in row 5 the table
and replaces it with the correct
reference Criminal Law, Sec. 4–202;
removes the incorrect reference to
Article 27, Sec. 36B in row 6 of the table
and replaces it with the correct
reference Sec. 4–202; removes the
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incorrect reference to Article 27, Sec.
36B in row 7 of the table and replaces
it with the correct reference Criminal
Law, Sec. 4–204; removed the incorrect
reference to Article 27, Sec. 122 in row
8 of the table and replaces it with the
correct reference Criminal Law, Sec. 6–
409; removes the incorrect reference to
Article 27, Secs. 240, 245 in row 9 of the
table and replaces it with the correct
reference Criminal Law, Sec. 12–102.
These changes update the citations in
the referenced Maryland codes.
Correct Reference. In § 3.5, this rule
removes the incorrect reference to 41
CFR 101–45.304 and replaces it with the
correct reference 41 CFR part 102–41;
removes the incorrect reference to 41
CFR part 101–48 and replaces it with
the correct reference 41 CFR 102;
removed the incorrect reference to 41
CFR 101–48.305 and replaces it with the
correct reference 41 CFR 102–41. These
changes reflect updates to the
referenced General Services
Administration regulations.
Correct Reference. In § 3.61, this
rule removes the incorrect reference to
40 United States Code section 318 or
318d and replaces it with the correct
reference U.S. Public Law 107–296,
Homeland Security Act of 2002. This
amendment reflects a change in the
referenced statutory authority.
45 CFR Part 63
Correct Reference. In § 63.1, this
rule removes the incorrect reference to
41 CFR 3–1.53 (which was not
implemented into a final rule and is
obsolete) and replaces it with the correct
reference 45 CFR 75.201(a), and
removes the incorrect reference to 41
CFR Chapters 1 and 3 (which is obsolete
and has been replaced by the Federal
Acquisition Regulations System (FAR)
at 48 CFR) and replaces it with the
correct reference 48 CFR Chapter 3.
45 CFR Part 75
Correct Reference. In § 75.372, this
rule removes the incorrect reference to
45 CFR 75.390 and replaces it with the
correct reference 45 CFR 75.386, so that
the sentence now reads ‘‘the
requirements of 75.381 and 75.386’’.
The current citation of ‘‘the
requirements of 75.381 through 75.390’’
is no longer accurate as § §75.382
through 75.485 and § §75.387 through
75.390 are now reserved.
45 CFR Part 305
Correct Reference. Section 305.0 is
amended in the beginning of the last
sentence by replacing ‘‘Sections 305.40
through 305.42 . . .’’ with ‘‘Sections
305.40, 305.42 . . .’’ which removes the
first instance of ‘‘through’’ in the
sentence and replaces with a comma.
This change is not substantive and
clarifies the sentence.
45 CFR Part 307
Correct Reference. In § 307.5(d)(3),
this rule removes the incorrect reference
to 45 CFR 305.99 and replaces it with
the correct reference 45 CFR 305.66.
This change is not substantive and is
necessary to make this technical
correction.
45 CFR Part 1324
Correct Reference. In § 1324.11, this
rule removes the incorrect reference to
45 CFR 1327.13(e) and replaces it with
the correct reference 45 CFR 1324.13(e);
removes two incorrect references to 45
CFR 1327.19(b)(5) and replaces them
with the correct reference 1324.19(b)(5)
through (8); removes the incorrect
reference to 45 CFR 1327.21 and
replaces it with the correct reference 45
CFR 1324.21. 45 CFR 1327 was moved
to 45 CFR 1324 in 2016 by 81 FR 35644
reflecting the Administration for
Community Living’s 2012
reorganization in a single subchapter of
the regulations. The text of statutes was
not completely updated to align with
this final rule.
Correct Reference. In § 1324.15, this
rule removes the incorrect reference to
45 CFR 1327.13(e) and replaces it with
the correct reference 1324.13(e);
removes the incorrect reference to 45
CFR 1327.13(g) and replaces it with the
correct reference 45 CFR 1324.13(g);
removes the incorrect reference to 45
CFR 1327.13(c)(2) and replaces it with
the correct reference 1324.13(c)(2). 45
CFR 1327 was moved to 45 CFR 1324
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In
§ 1324.19(b)(6), this rule removes the
incorrect reference to 45 CFR
1327.11(e)(3) and replaces it with the
correct reference 45 CFR 1324.11(e)(3).
45 CFR 1327 was moved to 45 CFR 1324
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In
§ 1324.19(b)(7), this rule removes the
incorrect reference to 45 CFR
1327.11(e)(3) and replaces it with the
correct reference 45 CFR 1324.11(e)(3).
45 CFR 1327 was moved to 45 CFR 1324
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In
§ 1324.19(b)(8), this rule removes the
incorrect reference to 45 CFR
1327.11(e)(3) and replaces it with the
correct reference 45 CFR 1324.11(e)(3).
45 CFR 1327 was moved to 45 CFR 1324
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Deletion. In § 1324.21(b)(3), this
rule amends the language ‘‘(3) Where a
State agency is unable to adequately
remove or remedy a conflict, it shall
carry out the Ombudsman program by
contract or other arrangement with a
public agency or nonprofit private
organization, pursuant to section
712(a)(4) of the Act. The State agency
may not enter into a contract or other
arrangement to carry out the
Ombudsman program if the other entity,
and may not operate the Office directly
if it’’ to remove the erroneous phrase ‘‘if
the other entity.’’ 45 CFR 1324.21(b)(3)
contains a grammatical typo. The earlier
version at Federal Register Number
2015–01914, July 1, 2016 was referred to
identify the correct grammatical
language.
45 CFR Part 1325
Correct Reference. In § 1325.4, this
rule removes the incorrect reference to
45 CFR 1386.30 and replaces it with the
correct reference 45 CFR 1326.30(f). 45
CFR 1386 was moved to 45 CFR 1326
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
45 CFR Part 1326
Correct Heading. In 45 CFR 1326,
this rule removes the incorrect heading
of ‘‘Formula Grant Program’’ and
replaces it with the correct heading
‘‘Developmental Disabilities Formula
Grant Programs’’. This heading was
changed in 2016 by 81 FR 35644
reflecting the Administration for
Community Living’s 2012
reorganization in a single subchapter of
the regulations. The text of statutes was
not completely updated to align with
this final rule.
Correct Reference. In § 1326.103,
this rule removes the incorrect reference
to 45 CFR 1386.90 and replaces it with
the correct reference 45 CFR 1326.90. 45
CFR 1386 was moved to 45 CFR 1326
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in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In § 1326.112,
this rule removes the incorrect reference
to 45 CFR 1386.84 and replaces it with
the correct reference 45 CFR 1326.84. 45
CFR 1386 was moved to 45 CFR 1326
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In § 1326.93, this
rule removes the incorrect reference to
45 CFR 1386.94 and replaces it with the
correct reference 45 CFR 1326.94. 45
CFR 1386 was moved to 45 CFR 1326
in 2016 by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
45 CFR Part 1328
Correct Reference. In § 1328.2, this
rule removes the incorrect reference to
45 CFR 1385.3 and replaces it with the
correct reference 45 CFR 1325.3;
removes the incorrect reference to 45
CFR 1388.3 and replaces it with the
correct reference 45 CFR 1328.3; and
removes the incorrect reference to 45
CFR 1388.4 and replaces it with the
correct reference to 45 CFR 1328.4. 45
CFR 1385 was moved to 45 CFR 1325
and 45 CFR 1388 was moved to 45 CFR
1328 in 2016 by 81 FR 35644 reflecting
the Administration for Community
Living’s 2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In § 1328.3, this
rule removes the incorrect reference to
45 CFR 1388.2 and replaces it with the
correct reference 45 CFR 1328.2. 45 CFR
1388 was moved to 45 CFR 1386 in 2016
by 81 FR 35644 reflecting the
Administration for Community Living’s
2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
Correct Reference. In § 1328.5, this
rule removes the incorrect reference to
45 CFR 1385.3 and replaces it with the
correct reference 45 CFR 1325.3;
removes the incorrect reference to 45
CFR 1388.2 and replaces it with the
correct reference 45 CFR 1328.2;
removes the incorrect reference to 45
CFR 1388.3 and replaces it with the
correct reference to 45 CFR 1328.3. 45
CFR 1385 was moved to 45 CFR 1325
and 45 CFR 1388 was moved to 45 CFR
1328 in 2016 by 81 FR 35644 reflecting
the Administration for Community
Living’s 2012 reorganization in a single
subchapter of the regulations. The text
of statutes was not completely updated
to align with this final rule.
48 CFR Part 302
Correct Reference. In § 302.101, this
rule removes the incorrect reference to
48 CFR 301.604 and replaces it with the
correct reference PGI Part 301.604.
48 CFR Part 326
Correct Reference. In § 326.603(d),
this rule removes the incorrect reference
to ‘326.2’ and replaces it with ‘326.6’.
This change is not substantive as it only
reflects the renumbering of the reference
and the content has not been changed.
IV. Rulemaking Procedure
Under the Administrative Procedure
Act (5 U.S.C. 553(b)), an agency may
waive publication in the Federal
Register of a notice of proposed
rulemaking and opportunity for
comment requirements if it finds, for
good cause, that they are impractical,
unnecessary, or contrary to the public
interest. As authorized by 5 U.S.C.
553(b)(3)(B), HHS finds good cause to
waive notice and opportunity for
comment on these amendments, as
notice and opportunity for comment are
unnecessary. These amendments will
have no substantive impact and are of
an administrative nature as they deal
with correcting incorrect references and
misspellings. HHS is exercising its
authority under 5 U.S.C. 553(b)(3)(B) to
publish these amendments as a final
rule. The amendments are effective 30
days after date of publication in the
Federal Register. These amendments do
not require action by any person or
entity regulated by HHS, and do not
change the substantive responsibilities
of any person or entity regulated by
HHS.
V. Executive Orders 12866, 13563,
13771, and 13777
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity).
Section 3(f) of Executive Order 12866
defines a ‘‘significant regulatory action’’
as ‘‘any regulatory action that is likely
to result in a rule that may: (1) Have an
annual effect on the economy of $100
million or more or adversely affect in a
material way the economy, a sector of
the economy, productivity, competition,
jobs, the environment, public health or
safety or State, local, or tribal
governments or communities; (2) Create
a serious inconsistency or otherwise
interfere with an action taken or
planned by another agency; (3)
Materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) Raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in th[e]
Executive Order.’’
A regulatory impact analysis must be
prepared for major rules with
economically significant effects ($100
million or more in any 1 year). HHS
submits that this final rule is not
economically significant as measured by
the $100 million threshold, and hence
not a major rule under the
Congressional Review Act. This rule has
not been designated as a significant
regulatory action as defined by
Executive Order 12866. As such, it has
not been reviewed by the Office of
Management and Budget.
Executive Order 13771, titled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017. It has been
determined that this rule is not
significant and thus is exempt from
regulatory or deregulatory action for the
purposes of Executive Order 13771.
On February 24, 2017, the President
issued Executive Order 13777 titled
‘‘Enforcing the Regulatory Reform
Agenda’’. As required by Section 3 of
the Executive Order, HHS established a
Regulatory Reform Task Force (HHS
Task Force) to review existing
regulations and make recommendations
regarding their repeal, replacement, or
modification. It has been determined
that this rule is not significant and thus
is exempt for the purposes of Executive
Order 13777.
VI. Regulatory Flexibility Act
This action will not have a significant
impact on a substantial number of small
entities. Therefore, the regulatory
flexibility analysis provided for under
the Regulatory Flexibility Act is not
required.
VII. Paperwork Reduction Act
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
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VIII. Federalism
We have analyzed this final rule in
accordance with the principles set forth
in E.O. 13132. We have determined that
the rule does not contain policies that
have substantial direct effects on the
States, on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the Executive
Order and, consequently, a federalism
summary impact statement is not
required.
List of Subjects
2 CFR Part 376
Administrative practice and
procedure, Grant programs, Reporting
and recordkeeping requirements.
21 CFR Part 1
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
21 CFR Part 5
Authority delegations (Government
agencies), Imports, Organization and
functions (Government agencies).
21 CFR Part 12
Administrative practice and
procedure.
21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
21 CFR Part 25
Environmental impact statements,
Foreign relations, Reporting and
recordkeeping requirements.
21 CFR Part 81
Color additives, Cosmetics, Drugs.
21 CFR Part 133
Cheese, Food grades and standards,
Food labeling.
21 CFR Part 172
Food Additives, Reporting and
recordkeeping requirements.
21 CFR Part 178
Food additives, Food packaging.
21 CFR Part 184
Food Additives.
21 CFR Part 201
Drugs, Labeling, Reporting and
recordkeeping requirements.
21 CFR Part 310
Administrative practice and
procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping
requirements.
21 CFR Part 369
Labeling, Medical devices, Over-the-
counter drugs.
21 CFR Part 501
Animal foods, Packaging and
containers, Reporting and recordkeeping
requirements.
21 CFR Part 582
Animal feeds, Animal foods, Food
additives.
42 CFR Part 23
Government employees, Health
professions, Loan programs-health,
Manpower, Reporting and
recordkeeping requirements.
42 CFR Part 51c
Grant programs-health, Health care,
Health facilities, Reporting and
recordkeeping requirements.
42 CFR Part 52i
Grant programs-health, Medical
research.
42 CFR Part 56
Grant programs-health, Health care,
Health facilities, Migrant labor,
Reporting and recordkeeping
requirements.
42 CFR Part 57
Aged, Education of disadvantaged,
Educational facilities, Educational study
programs, Grant programs-education,
Grant programs-health, Health facilities,
Health professions, Loan programs-
health, Medical and dental schools,
Reporting and recordkeeping
requirements, Scholarships and
fellowships, Student aid.
42 CFR Part 63
Grant programs-health, Health
professions, Libraries, Manpower
training programs, Student aid.
42 CFR Part 124
Grant programs-health, Health
facilities, Reporting and recordkeeping
requirements.
42 CFR Part 411
Diseases, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 412
Administrative practice and
procedure, Health facilities, Medicare,
Puerto Rico, Reporting and
recordkeeping requirements.
42 CFR Part 422
Administrative practice and
procedure, Health facilities, Health
maintenance organizations (HMO),
Medicare, Penalties, Privacy, Reporting
and recordkeeping requirements.
42 CFR Part 423
Administrative practice and
procedure, Emergency medical services,
Health facilities, Health maintenance
organizations (HMO), Health
professionals, Medicare, Penalties,
Privacy, Reporting and recordkeeping
requirements.
42 CFR Part 426
Administrative practice and
procedure, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 440
Grant programs-health, Medicaid.
42 CFR Part 441
Aged, Family planning, Grant
programs-health, Infants and children,
Medicaid, Penalties, Reporting and
recordkeeping requirements.
42 CFR Part 447
Accounting, Administrative practice
and procedure, Drugs, Grant programs-
health, Health facilities, Health
professions, Medicaid, Reporting and
recordkeeping requirements, Rural
areas.
42 CFR Part 482
Grant programs-health, Hospitals,
Medicaid, Medicare, Reporting and
recordkeeping requirement.
42 CFR Part 485
Grant programs-health, Health
facilities, Medicaid, Privacy, Reporting
and recordkeeping requirements.
42 CFR Part 1004
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, Peer Review
Organization (PRO), Penalties,
Reporting and recordkeeping
requirements.
42 CFR Part 1008
Administrative practice and
procedure, Medicaid, Medicare,
Reporting and recordkeeping
requirements.
45 CFR Part 3
Federal buildings and facilities,
Penalties, Traffic regulations.
45 CFR Part 63
Grant programs-communications,
Grant programs-education, Grant
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1
The Office of the Chief Counsel (also known as
the Food and Drug Division, Office of the General
Counsel, Department of Health and Human
Services), while administratively within the Office
of the Commissioner, is part of the Office of the
General Counsel of the Department of Health and
Human Services.
programs-health, Grant programs-social
programs, Research,
Telecommunications.
45 CFR Part 75
Accounting, Administrative practice
and procedure, Adult education, Aged,
Agriculture, American Samoa, Bilingual
education, Blind, Business and
industry, Civil rights, Colleges and
universities, Communications,
Community development, Community
facilities, Copyright, Credit, Cultural
exchange programs, Educational
facilities, Educational research,
Education, Education of disadvantaged,
Education of individuals with
disabilities, Educational study
programs, Electric power, Electric
power rates, Electric utilities,
Elementary and secondary education,
Energy conservation, Equal educational
opportunity, Federally affected areas,
Government contracts, Grant programs,
Grant programs-agriculture, Grant
programs-business, Grant programs-
communications, Grant programs-
education, Grant programs-energy,
Grant programs-health, Grant programs-
housing and community development,
Grant programs-social programs, Grants
administration, Guam, Home
improvement, Homeless, Hospitals,
Housing, Human research subjects,
Indians, Indians-education, Infants and
children, Insurance, Intergovernmental
relations, International organizations,
Inventions and patents, Loan programs,
Loan programs social programs, Loan
programs-agriculture, Loan programs-
business, Loan programs-
communications, Loan programs-
energy, Loan programs-health, Loan
programs-housing and community
development, Manpower training
programs, Migrant labor, Mortgage
insurance, Nonprofit organizations,
Northern Mariana Islands, Pacific
Islands Trust Territories, Privacy,
Renewable Energy, Reporting and
recordkeeping requirements, Rural
areas, Scholarships and fellowships,
School construction, Schools, Science
and technology, Securities, Small
businesses, State and local governments,
Student aid, Teachers,
Telecommunications, Telephone, Urban
areas, Veterans, Virgin Islands,
Vocational education, Vocational
rehabilitation, Waste treatment and
disposal, Water pollution control, Water
resources, Water supply, Watersheds,
Women.
45 CFR Part 305
Accounting, Child support, Grant
programs-social programs, Reporting
and recordkeeping requirements.
45 CFR Part 307
Child support, Computer technology,
Grant programs-social programs,
Reporting and recordkeeping
requirements.
45 CFR Parts 1324, 1325, 1326, and
1328
Administrative practice and
procedure, Aged, Colleges and
universities, Grant programs-Education,
Grant programs-Indians, Grant
programs-social programs, Indians,
Individuals with disabilities, Legal
services, Long term care, Nutrition,
Research, Reporting and recordkeeping
requirements.
48 CFR Parts 302 and 326
Government procurement.
For reasons described in the
preamble, the Department of Health and
Human Services amends 2 CFR part
376; 21 CFR parts 1, 5, 12, 14, 25, 81,
133, 172, 178, 184, 201, 310, 369, 501,
and 582; 42 CFR parts 23, 51c, 52i, 56,
57, 63, 124, 411, 412, 422, 423, 426, 440,
441, 447, 482, 485, 1004, and 1008; 45
CFR parts 3, 63, 75, 305, 307, 1324,
1325, 1326, and 1328; and 48 CFR parts
302 and 326 as follows:
Title 2—Grants and Agreements
PART 376—NONPROCUREMENT
DEBARMENT AND SUSPENSION
1. The authority citation for part 376
continues to read as follows:
Authority: 5 U.S.C. 301; 31 U.S.C. 6101
(note); E.O. 12689, 3 CFR, 1989 Comp., p.
235; E.O. 12549, 3 CFR, 1986 Comp., p. 198;
E.O. 11738, 3 CFR, 1973 Comp., p. 799.
§ 376.10 [Amended]
2. Amend § 376.10 as follows:
a. Remove the reference ‘‘(3 CFR 1986
Comp., p. 189)’’; and
b. Remove the reference ‘‘(3 CFR 1989
Comp., p. 235)’’.
Title 21—Food and Drugs
PART 1—GENERAL ENFORCEMENT
REGULATIONS
3. The authority citation for part 1
continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454,
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b,
360ccc, 360ccc–1, 360ccc–2, 362, 371, 373,
374, 379j–31, 381, 382, 384a, 384b, 384d,
387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243,
262, 264, 271; Pub. L. 107–188, 116 Stat. 594,
668–69; Pub. L. 111–353, 124 Stat. 3885,
3889.
§ 1.24 [Amended]
4. Amend § 1.24(a)(6)(ii) and (8)(ii) by
removing the reference ‘‘§ 101.105(j)’’
and adding in its place the reference
‘‘§ 101.7’’.
PART 5—ORGANIZATION
5. The authority citation for part 5
continues to read as follows:
Authority: 5 U.S.C. 552; 21 U.S.C. 301–
397.
§ 5.1100 [Amended]
6. Amend § 5.1100 by
§ 5.1105 [Amended]
7. Revise § 5.1105 to read as follows:
§ 5.1105 Chief Counsel, Food and Drug
Administration.
The Office of the Chief Counsel’s
mailing address is White Oak Bldg. 1,
10903 New Hampshire Ave., Silver
Spring, MD 20993.
1
PART 12—FORMAL EVIDENTIARY
PUBLIC HEARING
8. The authority citation for part 12
continues to read as follows:
Authority: 21 U.S.C. 141–149, 321–393,
467f, 679, 821, 1034; 42 U.S.C. 201, 262,
263b-263n, 264; 15 U.S.C. 1451–1461; 5
U.S.C. 551–558, 701–721; 28 U.S.C. 2112.
§ 12.21 [Amended]
9. Amend § 12.21(a)(2) by removing
the phrase ‘‘514.2 for applications for
animal feeds’’.
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
10. The authority citation for part 14
continues to read as follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155; Pub. L. 113–54.
§ 14.7 Amended]
11. Amend § 14.7(b) by removing ‘‘45
CFR 5.34’’ and add in its place ‘‘45 CFR
5.61—and 45 CFR 5.64’’.
PART 25—ENVIRONMENTAL IMPACT
CONSIDERATIONS
12. The authority citation for part 25
continues to read as follows:
Authority: 21 U.S.C. 321–393; 42 U.S.C.
262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR
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1500–1508; E.O. 11514, 35 FR 4247, 3 CFR,
1971 Comp., p. 531–533 as amended by E.O.
11991, 42 FR 26967, 3 CFR, 1978 Comp., p.
123–124; E.O. 12114, 44 FR 1957, 3 CFR,
1980 Comp., p. 356–360.
§ 25.33 [Amended]
13. Amend § 25.33 by removing
paragraph (a)(7).
14. Amend § 25.33 by revising
paragraph (a)(5) and (6) to read as
follows:
§ 25.33 Animal drugs.
* * * * *
(a) * * *
(5) A change of sponsor; or
(6) A previously approved animal
drug to be contained in medicated feed
blocks under § 510.455 of this chapter or
as a liquid feed supplement under
§ 558.5 of this chapter.
* * * * *
PART 81—GENERAL SPECIFICATIONS
AND GENERAL RESTRICTIONS FOR
PROVISIONAL COLOR ADDITIVES
FOR USE IN FOODS, DRUGS, AND
COSMETICS
15. The authority citation for part 81
continues to read as follows:
Authority: 21 U.S.C. 371, 379e, 379e note.
§ 81.30 [Amended]
16. Amend § 81.30(s)(2) by removing
the last sentence.
§ 81.32 [Removed]
17. Remove § 81.32.
PART 133—CHEESES AND RELATED
CHEESE PRODUCTS
18. The authority citation for part 133
continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348,
371, 379e.
§ 133.116 [Amended]
19. Remove § 133.116(d).
§ 133.121 Amended]
20. Remove § 133.121(f).
PART 172—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
21. The authority citation for part 172
continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
22. Revise § 172.840(c)(13) to read as
follows:
§ 172.840 Polysorbate 80.
* * * * *
(c) * * *
(13) As a defoaming agent in the
preparation of the creaming mixture for
cottage cheese as identified in § 133.128
of this chapter, whereby the amount of
the additive does not exceed .008
percent by weight of the finished
product.
* * * * *
PART 178—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
23. The authority citation for part 178
continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
24. Revise § 178.3730 to read as
follows:
§ 178.3730 Piperonyl butoxide and
pyrethrins as components of bags.
Piperonyl butoxide in combination
with pyrethrins may be safely used for
insect control on bags that are intended
for use in contact with dried feed or
dried food in compliance with 40 CFR
180.127 and 40 CFR 180.128.
PART 184—DIRECT FOOD
SUBSTANCES AFFIRMED AS
GENERALLY RECOGNIZED AS SAFE
25. The authority citation for part 184
continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
26. Revise § 184.1097(c)(2) to read as
follows:
§ 184.1097 Tannic acid.
* * * * *
(c) * * *
(2) Tannic acid may be used in
rendered animal fat in accordance with
9 CFR 424.21.
* * * * *
27. Revise § 184.1143(d) to read as
follows:
§ 184.1143 Ammonium sulfate.
* * * * *
(d) The ingredient is used in food at
levels not to exceed good manufacturing
practice in accordance with
§ 184.1(b)(1). Current good
manufacturing practice results in a
maximum level, as served, of 0.15
percent for baked goods as defined in
§ 170.3(n)(1) of this chapter and 0.1
percent for gelatins and puddings as
defined in § 170.3(n)(22) of this chapter.
* * * * *
28. Revise § 184.1924(c)(1) to read as
follows:
§ 184.1924 Urease enzyme preparation
from Lactobacillus fermentum.
* * * * *
(c) * * *
(1) The ingredient is used in wine, as
defined in 27 CFR 1.10 and 4.10, as an
enzyme as defined in § 170.3(o)(9) of
this chapter to convert urea to ammonia
and carbon dioxide.
* * * * *
PART 201—LABELING
29. The authority citation for part 201
continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 358, 360, 360b, 360gg–360ss, 371,
374, 379e; 42 U.S.C. 216, 241, 262, 264.
30. Revise § 201.317(c) to read as
follows:
§ 201.317 Digitalis and related cardiotonic
drugs for human use in oral dosage forms;
required warning.
* * * * *
(c) This section does not apply to
digoxin products for oral use.
PART 310—NEW DRUGS
31. The authority citation for part 310
continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360hh–360ss, 361(a),
371, 374, 375, 379e, 379k–l; 42 U.S.C. 216,
241, 242(a), 262.
§ 310.303 [Removed]
32. Remove § 310.303.
PART 369—INTERPETATIVE
STATEMENT RE WARNINGS ON
DRUGS AND DEVICES FOR OVER-
THE-COUNTER SALE
33. The authority citation for part 369
continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 371.
34. Revise § 369.3 to read as follows:
§ 369.3 Warnings required on drugs
exempted from prescription-dispensing
requirements of section 503(b)(1)(C).
Drugs exempted from prescription-
dispensing requirements under section
503(b)(1)(C) of the act are subject to the
labeling requirements prescribed in
§ 310.201(a) of this chapter. Although,
for convenience, warning and caution
statements for a number of the drugs
named in § 310.201 of this chapter
(cross-referenced in the text of this part)
are included in subpart B of this part,
the inclusion of such drugs in §§ 369.20
or 369.21 in no way affects the
requirements for compliance with
§ 310.201(a) of this chapter, or the
provisions of an effective application
pursuant to section 505(b) of the act.
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PART 501—ANIMAL FOOD LABELING
35. The authority citation for part 501
continues to read as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371.
36. Amend § 501.105, by revising the
introductory text of paragraph (t) to read
as follows:
§ 501.105 Declaration of net quantity of
contents when exempt.
* * * * *
(t) Where the declaration of net
quantity of contents is in terms of net
weight and/or drained weight or volume
and does not accurately reflect the
actual quantity of the contents or the
product falls below the applicable
standard of fill of container because of
equipment malfunction or otherwise
unintentional product variation, and the
label conforms in all other respects to
the requirements of this chapter, the
mislabeled food product may be sold by
the manufacturer or processor directly
to institutions operated by Federal, State
or local governments: Provided, That:
* * * * *
PART 582—SUBSTANCES
GENERALLY RECOGNIZED AS SAFE
37. The authority citation for part 582
continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
38. Revise § 582.99 to read as follows:
§ 582.99 Adjuvants for pesticide
chemicals.
Adjuvants, identified and used in
accordance with 40 CFR 180.910 and
180.920, which are added to pesticide
use dilutions by a grower or applicator
prior to application to the raw
agricultural commodity, are exempt
from the requirement of tolerances
under section 409 of the act.
Title 42—Public Health
PART 23—NATIONAL HEALTH
SERVICE CORPS
39. The authority citation for part 23
currently reads as follows:
Authority: 42 U.S.C. 254f, 254f–1, 254g,
254h, 254h–1, 254p(c), and 254n(e)(1).
§ 23.9 [Amended]
40. Revise § 23.9(c)(1) to read as
follows:
§ 23.9 What must an entity to which
National Health Service Corps personnel
are assigned (i.e., a National Health Service
Corps site) charge for the provision of
health services by assigned personnel?
* * * * *
(c)(1) No charge or a nominal charge
will be made for health services
provided by assigned National Health
Service Corps personnel to individuals
within the health manpower shortage
area with annual incomes at or below
the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2). However, no
individual will be denied health
services based upon inability to pay for
the services. Any individual who has an
annual income above the poverty
guidelines but whose income does not
exceed 200 percent of the poverty
guidelines, will receive health services
at a nominal charge. However, charges
will be made for services to the extent
that payment will be made by a third
party which is authorized or under legal
obligation to pay the charges.
* * * * *
PART 51c—GRANTS FOR
COMMUNITY HEALTH SERVICES
41. The authority citation for part 51c
continues to read as follows:
Authority: 42 U.S.C. 216, 254c.
§ 51c.107 [Amended]
42. Amend § 51c.107(b)(5) by
removing ‘the most recent CSA Income
Poverty Guidelines’ (45 CFR 1060.2)
issued by the Community Services
Administration;’’ and adding in its place
‘‘the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2);’’.
§ 51c.303 [Amended]
43. Amend § 51c.303(f) by removing
the phrase ‘‘the most recent ‘CSA
Poverty Income Guidelines’ (45 CFR
1060.2)’’ and adding in its place ‘‘the
poverty guidelines updated periodically
in the Federal Register by the U.S.
Department of Health and Human
Services under the authority of 42
U.S.C. 9902(2);’’.
PART 52i—NATIONAL INSTITUTE ON
MINORITY HEALTH AND HEALTH
DISPARITIES RESEARCH
ENDOWMENT PROGRAMS
44. The authority citation for part 52i
continues to read as follows:
Authority: 42 U.S.C. 216, 285t–285t–1.
§ 52i.11 [Amended]
45. Amend § 52i.11 by:
a. In paragraph (b), removing the
reference ‘‘74.53’’ and adding in its
place the reference ‘‘75.361’’.
b. In paragraph(c), removing the
reference ‘‘74.53e’’ and adding in its
place the reference ‘‘75.364’’.
c. In paragraph (d), removing the
reference ‘‘74.52’’ and adding in its
place the reference ‘‘75.341’’.
PART 56—GRANTS FOR MIGRANT
HEALTH SERVICES
46. The authority citation for part 56
continues to read as follows:
Authority: U.S.C. 216, 247d.
§ 56.108 [Amended]
47. Amend § 56.108 by removing the
phrase ‘‘the most recent ‘CSA Income
Poverty Guidelines’ (45 CFR 1060.2)
issued by the Community Services
Administration;’’ and replacing it with
‘‘the poverty guidelines updated
periodically in the Federal Register by
the U.S. Department of Health and
Human Services under the authority of
42 U.S.C. 9902(2);’’.
§ 56.303 [Amended]
48. Amend § 56.303(f) by removing
the phrase ‘‘the most recent ‘CSA
Poverty Income Guidelines’ (45 CFR
1060.2)’’ and adding in its place ‘‘the
poverty guidelines updated periodically
in the Federal Register by the U.S.
Department of Health and Human
Services under the authority of 42
U.S.C. 9902(2);’’.
§ 56.603 [Amended]
49. Amend § 56.603 by removing the
phrase ‘‘the most recent ‘CSA Poverty
Income Guidelines (45 CFR 1060.2) ’’
and adding in its place ‘‘the poverty
guidelines updated periodically in the
Federal Register by the U.S. Department
of Health and Human Services under
the authority of 42 U.S.C. 9902(2);’’.
PART 57—GRANTS FOR
CONSTRUCTION OF TEACHING
FACILITIES, EDUCATIONAL
IMPROVEMENTS, SCHOLARSHIPS
AND STUDENT LOANS
50. The authority citation for part 57
continues to read as follows:
Authority: 42 U.S.C. 293g.
§ 57.1505 [Amended]
51. Amend § 57.1505(a)(1) by
removing the reference ‘‘57.110’’.
PART 63—TRAINEESHIPS
52. The authority citation for part 63
continues to read as follows:
Authority: 42 U.S.C. 216, 282(b)(13),
284(b)(1)(C), 285a–2(b)(3), 286b–3, 287c–
21(a).
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§ 63.2 [Amended]
53. Amend § 63.2 by removing the
reference ‘‘50.102’’ and adding in its
place the reference ‘‘93.103’’.
§ 63.2 [Amended]
54. Amend § 63.2 by removing the
phrase ‘‘Misconduct in science’’ and
adding in its place ‘‘research
misconduct’’.
§ 63.9 [Amended]
55. Amend § 63.9(b) by removing the
phrase ‘‘misconduct in science’’ and
add in its place ‘‘research misconduct’’.
PART 124—MEDICAL FACILITY
CONSTRUCTION AND
MODERNIZATION
56. The authority citation for part 124
continues to read as follows:
Authority: 42 U.S.C. 216, 300o–1, 300r,
unless otherwise noted.
§ 124.511 [Amended]
57. Amend § 124.511 by removing the
reference ‘‘125.510’’.
§ 124.602 [Amended]
58. Amend § 124.602 by removing the
reference ‘‘42 CFR 53.1(d)’’.
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
59. The authority citation for part 411
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395w–101
through 1395w–152, 1395hh, and 1395nn.
§ 411.353 [Amended]
60. Amend § 411.353(d) by removing
the reference ‘‘§ 1003.101 of this title’’
and adding in its place the reference
‘‘§ 1003.110’’.
PART 412—PROSPECTIVE PAYMENT
SYSTEMS FOR INPATIENT HOSPITAL
SERVICES
61. The authority citation for part 412
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh.
§ 412.42 [Amended]
62. Amend § 412.42 as follows:
a. In paragraph (b)(2)(i), remove the
reference ‘‘§ 405.310(g)’’ and add in its
place ‘‘§ 411.15(g)’’;
b. In paragraph (b)(2)(ii), remove the
reference ‘‘§ 405.310(k)’’ and add in its
place ‘‘§ 411.15(k)’’; and
c. In paragraph (b)(2)(iii), remove the
reference ‘‘§ 405.310(m)’’ and add in its
place ‘‘§ 411.15(m)’’.
PART 422—MEDICARE ADVANTAGE
PROGRAM
63. The authority citation for part 422
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh.
§ 422.304 [Amended]
64. Amend § 422.304(f) by removing
the reference ‘‘§ 495.220’’ and adding in
its place ‘‘§ 495.204’’.
§ 422.322 [Amended]
65. Amend § 422.322(b) by removing
the reference ‘‘413.86(d)’’ and adding in
its place ‘‘413.76’’.
§ 422.324 [Amended]
66. Amend § 422.324(b)(2) by
removing the reference ‘‘§ 413.86(b)’’
and adding in its place ‘‘§ 413.75(b)’’.
§ 422.1094 [Amended]
67. Amend § 422.1094(b)(2) by
removing the reference ‘‘422.858’’ and
adding in its place the reference
‘‘§ 423.1088 of this chapter’’.
PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
68. The authority citation for part 423
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395w–101
through 1395w–152, 1395hh.
§ 423.1094 [Amended]
69. Amend § 423.1094(b)(2) by
removing the reference ‘‘423.858’’ and
adding in its place the reference
‘‘§ 423.1088’’.
§ 423.2330 [Amended]
70. Amend § 423.2330(c)(3) by
removing the reference
‘‘§ 423.2306(b)(4) of this subpart’’ and
adding in its place the reference
‘‘§ 423.2315(b)(4)’’.
PART 426—REVIEW OF NATIONAL
COVERAGE DETERMINATIONS AND
LOCAL COVERAGE
DETERMINATIONS
71. The authority citation for part 426
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh.
§ 426.110 [Amended]
72. Amend § 426.110 in paragraph 1
of the definition of ‘‘Proprietary data
and Privileged information’’ by
removing the reference ‘‘45 CFR 5.65’’
and adding in its place ‘‘45 CFR 5.31(d)
and (e)’’.
PART 440—SERVICES: GENERAL
PROVISIONS
73. The authority citation for part 440
continues to read as follows:
Authority: 42 U.S.C. 1302.
§ 440.20 [Amended]
74. Amend § 440.20(b) introductory
text by removing the reference ‘‘§ 481.1’’
and adding in its place ‘‘§ 491.2’’.
PART 441—SERVICES:
REQUIREMENTS AND LIMITS
APPLICABLE TO SPECIFIC SERVICES
75. The authority citation for part 441
continues to read as follows:
Authority: 42 U.S.C. 1302.
§ 441.17 [Amended]
76. Amend § 441.17 as follows:
a. In paragraph (a)(1), remove the
reference ‘‘§ 405.1316’’ and add in its
place the reference ‘‘part 493’’;
b. In paragraph (a)(4), remove the
reference ‘‘‘‘§ 405.1128(a)’’ and add in
its place the reference ‘‘part 493’’; and
c. In paragraph (b), remove the
reference ‘‘§ 405.1316(f)(2) and (3)’’ and
add in its place the reference ‘‘part 493
of this chapter’’.
§ 441.18 [Amended]
77. Amend § 441.18(c) introductory
text by removing the reference
‘‘§ 441.169’’ and adding in its place
‘‘§ 440.169’’.
PART 447—PAYMENTS FOR
SERVICES
78. The authority citation for part 447
continues to read as follows:
Authority: 42 U.S.C. 1302, 1396r–8.
§ 447.299 [Amended]
79. Amend § 447.299(c) introductory
text by removing the reference
‘‘§ 455.204’’ and adding in its place
‘‘§ 455.304 of this chapter’’.
PART 482—CONDITIONS OF
PARTICIPATION FOR HOSPITALS
80. The authority citation for part 482
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, 1395rr,
1395lll, unless otherwise noted.
§ 482.27 [Amended]
81. Amend § 482.27 as follows:
a. In paragraph (b)(3)(iii), remove the
phrase ‘‘, as set forth at 21 CFR
610.48(b)(3)’’; and
b. In paragraph (b)(4)(iii), remove the
reference ‘‘21 CFR 610.46(b)(2),
610.47(b)(2), and 610.48(c)(2)’’ and add
in its place the reference ‘‘21 CFR
610.46(b)(2) and 610.47(b)(2)’’.
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PART 485—CONDITIONS OF
PARTICIPATION: SPECIALIZED
PROVIDERS
82. The authority citation for part 485
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395(hh).
§ 485.639 [Amended]
83. Amend § 485.639(c)(1)(vii) by
removing the reference ‘‘§ 413.86’’ and
adding in its place the reference
‘‘§§ 413.76 through 413.83’’.
PART 1004—IMPOSITION OF
SANCTIONS ON HEALTH CARE
PRACTITIONERS AND PROVIDERS OF
HEALTH CARE SERVICES BY A
QUALITY IMPROVEMENT
ORGANIZATION
84. The authority citation for part
1004 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320c–5.
§ 1004.40 [Amended]
85. Amend § 1004.40 by removing the
reference ‘‘476.139’’ and adding in its
place ‘‘480.139’’.
PART 1008—ADVISORY OPINIONS BY
THE OIG
86. The authority citation for part
1008 continues to read as follows:
Authority: 42 U.S.C. 1320a–7d(b).
§ 1008.36 [Amended]
87. Amend § 1008.36 by removing the
reference ‘‘45 CFR 5.65’’ and adding in
its place ‘‘45 CFR 5.41’’.
Tile 45—Public Welfare
PART 3—CONDUCT OF PERSONS
AND TRAFFIC ON THE NATIONAL
INSTITUTES OF HEALTH FEDERAL
ENCLAVE
88. The authority citation for part 3
continues to read as follows:
Authority: 40 U.S.C. 318–318d. 486;
Delegation of Authority, 33 FR 604.
§ 3.1 [Amended]
89. In § 3.1, in the definition of
‘‘Police officer’’, remove the reference
‘‘40 United States Code section 318 or
318d’’ and add in its place ‘‘U.S. Public
Law 107–296, Homeland Security Act of
2002’’.
§ 3.2 [Amended]
90. In § 3.2, revise the table in
paragraph (f) to read as follows:
§ 3.2 Applicability.
* * * * *
(f) * * *
Subject Maryland code annotated Provides generally Maximum penalty
1. Pedestrian right-of-way ........ Transportation, Sec. 21–502 .. Pedestrians have the right-of-way in cross-
walks and certain other areas. Subject to
certain limitations.
Imprisonment 2 months and/
or $500 fine.
Sec. 21–511 ........................... Blind, partially blind, or hearing impaired pe-
destrians have the right-of-way at any
crossing or intersection. Subject to certain
limitations.
$500 fine.
2. Drivers to exercise due care Transportation, Sec. 21–504 .. Drivers shall exercise due care to avoid col-
liding with pedestrians, children and inca-
pacitated individuals.
$500 fine.
3. Driving while intoxicated,
under the influence of alco-
hol and/or a drug or con-
trolled substance.
Transportation, Sec. 21–902 .. Prohibits .......................................................... Sec. 21–902(a) (driving while
intoxicated, first offense):
Imprisonment 1 year and/or
$1,000 fine.
Sec. 21–902 (b), (c), (d) (driv-
ing under the influence): Im-
prisonment 2 months and/or
$500 fine.
4. Unattended motor vehicles .. Transportation, Sec. 21–1101 Prohibits leaving motor vehicles unattended
unless certain precautions are taken. $500 fine.
5. Carrying or wearing certain
concealed weapons (other
than handguns) or openly
with intent to injure.
Sec. 4–202 ............................. Prohibits, except for law enforcement per-
sonnel or as a reasonable precaution
against apprehended danger.
Imprisonment 3 years or
$1,000 fine.
6. Unlawful wearing, carrying,
or transporting a handgun,
whether concealed or openly.
Sec. 4–202 ............................. Prohibits except by law enforcement per-
sonnel or with permit. First offense and no prior re-
lated offense: Imprisonment
3 years and/or $2,500 fine.
7. Use of handgun or conceal-
able antique firearm in com-
mission of felony or crime of
violence.
Sec. 4–204 ............................. Prohibits .......................................................... Imprisonment 20 years.
8. Disturbance of the peace ..... Sec. 6–409 ............................. Prohibits acting in a disorderly manner in
public places. Imprisonment 30 days and/or
$500 fine.
9. Gambling .............................. Sec. 12–102 ........................... Prohibits betting, wagering and gambling,
and certain games of chance (does not
apply to vending or purchasing lottery tick-
ets authorized under State law in accord-
ance with approved procedures).
Sec. 240: Imprisonment one
year and/or $1,000 fine.
Sec. 245: Imprisonment 2
years and/or $100 fine.
§ 3.5 [Amended]
91. In § 3.5:
a. Removing the reference ‘‘41 CFR
part 101–48’’ and adding in its place
‘‘41 CFR 102’’.
b. Removing the ‘‘41 CFR 101–45.304’’
and 101–48.305’’ and add in their place
‘‘41 CFR part ‘‘102–41’’.
§ 3.61 [Amended]
92. Amend § 3.61 by removing the
reference ‘‘40 U.S.C. 318c’’ and adding
in its place the reference ‘‘U.S. Public
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Law 107–296, Homeland Security Act of
2002’’.
PART 63—GRANT PROGRAMS
ADMINISTERED BY THE OFFICE OF
THE ASSISTANT SECRETARY FOR
PLANNING AND EVALUATION
93. The authority citation for part 63
continues to read as follows:
Authority: Sec. 602, Community Services
Act (42 U.S.C. 2942); sec. 1110, Social
Security Act (42 U.S.C. 1310).
§ 63.1 Amended]
94. Amend § 63.1 by:
a. Removing ‘‘41 CFR 3–1.53’’ and
adding in its place ‘‘45 CFR 75.201(a)’’.
b. Removing ‘‘41 CFR Chapters 1 and
3’’ and adding in its place ‘‘CFR Title
48, Chapter 3’’.
PART 75—UNIFORM ADMINISTRATIVE
REQUIREMENTS, COST PRINCIPLES,
AND AUDIT REQUIREMENTS FOR HHS
AWARDS
95. The authority citation for part 75
continues to read as follows:
Authority: 5 U.S.C. 301.
§ 75.372 [Amended]
96. Amend § 75.372 by removing
‘‘through 75.390’’ and adding in its
place ‘‘and 75.386’’.
PART 305—PROGRAM
PERFORMANCE MEASURES,
STANDARDS, FINANCIAL
INCENTIVES, AND PENALTIES
97. The authority citation for part 305
continues to read as follows:
Authority: 42 U.S.C. 609(a)(8), 652(a)(4),
652(g), 658a, 1302.
§ 305.0 [Amended]
98. Amend § 305.0 by removing
‘‘Sections 305.40 through 305.42 ’’ with
‘‘Sections 305.40, 305.42’’.
PART 307—COMPUTERIZED
SUPPORT ENFORCEMENT SYSTEMS
99. The authority citation for part 307
continues to read as follows:
Authority: 42 U.S.C. 652–658, 664, 666–
669A, 1302.
§ 307.5 [Amended]
100. Amend § 307.5(d)(3) by removing
the reference ‘‘305.99’’ and adding in its
place ‘‘305.66’’.
PART 1324—ALLOTMENTS FOR
VULNERABLE ELDER RIGHTS
PROTECTION ACTIVITIES
101. The authority citation for part
1324 continues to read as follows:
Authority: 42 U.S.C. 3001 et seq.
§ 1324.11 [Amended]
102. Amend § 1324.11 by:
a. Removing the reference
‘‘1327.13(e)’’ and adding in its place
‘‘1324.13(e)’’.
b. Removing all references
‘‘1327.19(b)(5) through (8)’’ and adding
in their places ‘‘1324.19(b)(5) through
(8)’’.
c.
d. Removing the reference ‘‘1327.21’’
and adding in its place ‘‘1324.21’’.
§ 1324.15 [Amended]
103. Amend § 1324.15 by:
a. Removing the reference
‘‘1327.13(e)’’ and adding in its place
‘‘1324.13(e)’’.
b. Removing the reference
‘‘1327.13(g)’’ and adding in its place
‘‘1324.13(g)’’.
c. Removing the reference
‘‘1327.13(c)(2)’’ and adding in its place
‘‘1324.13(c)(2)’’.
§ 1324.19 [Amended]
104. Amend § 1324.19 by removing
the reference ‘‘1327.11(e)(3)’’ wherever
it appears and adding in its place
‘‘1324.11(e)(3)’’.
§ 1324.21 [Amended]
105. Amend § 1324.21(b)(3) by
removing the phrase ‘‘if the other
entity’’.
PART 1325—REQUIREMENTS
APPLICABLE TO THE
DEVELOPMENTAL DISABILITIES
PROGRAM
106. The authority citation for part
1325 continues to read as follows:
Authority: 42 U.S.C. 15001 et seq.
§ 1325.4 [Amended]
107. Amend § 1325.4 by removing the
reference ‘‘45 CFR 1386.30(f)’’ and
adding in its place ‘‘45 CFR 1326.30(f)’’.
PART 1326—DEVELOPMENTAL
DISABILITIES FORMULA GRANT
PROGRAMS
108. The authority citation for part
1326 continues to read as follows:
Authority: 42 U.S.C. 15001 et seq.
109. Revise the part heading to read as
set forth above.
§ 1326.103 [Amended]
110. Amend § 1326.103 by removing
the reference ‘‘1386.90’’ and adding in
its place ‘‘1326.90’’.
§ 1326.93 [Amended]
111. Amend § 1326.93 by removing
the reference ‘‘1386.94’’ and adding in
its place ‘‘1326.94’’.
§ 1326.112 [Amended]
112. Amend § 1326.112 by removing
the reference ‘‘1386.84’’ and adding in
its place ‘‘1326.84’’.
PART 1328—THE NATIONAL
NETWORK OF UNIVERSITY CENTERS
FOR EXCELLENCE IN
DEVELOPMENTAL DISABILITIES,
EDUCATION, RESEARCH, AND
SERVICE
113. The authority citation for part
1328 continues to read as follows:
Authority: 42 U.S.C. 15001 et seq.
§ 1328.2 [Amended]
114. Amend § 1328.2 by:
a. Removing the reference ‘‘1385.3’’
and adding in its place ‘‘1325.3’’.
b. Removing the reference ‘‘1388.3’’
and adding in its place ‘‘1328.3’’.
c. Removing the reference ‘‘1388.4’’
and adding in its place ‘‘1328.4’’.
§ 1328.3 [Amended]
115. Amend § 1328.3 by removing the
reference ‘‘1388.2’’ and adding in its
place ‘‘1328.2’’.
§ 1328.5 [Amended]
116. Amend § 1328.5 by:
a. Removing the reference ‘‘1385.3’’
and adding in its place ‘‘1325.3’’.
b. Removing the reference ‘‘1388.2’’
and adding in its place ‘‘45 CFR
1328.2’’.
c. Removing the reference
‘‘1388.2(a)(1) and (2)’’ and adding in its
place ‘‘1328.2(a)(1) and (2)’’.
d. Removing the reference ‘‘1388.3’’
and adding in its place ‘‘1328.3’’.
Title 48—Federal Acquisition
Regulations System
PART 302—DEFINITIONS OF WORDS
AND TERMS
117. The authority citation for part
302 continues to read as follows:
Authority: 5 U.S.C. 301; 40 U.S.C. 121
(c)(2).
§ 302.101 [Amended]
118. Amend § 302.101 by removing
the reference ‘‘301.604’’ and adding in
its place ‘‘PGI Part 301.604’’
PART 326—OTHER SOCIOECONOMIC
PROGRAMS
119. The authority for part 326
continues to read as follows:
Authority: 5 U.S.C. 301, 40 U.S.C.
121(c)(2).
§ 326.603 [Amended]
120. Amend § 326.603(d) by removing
the reference ‘‘326.2’’ and adding in its
place ‘‘326.6’’.
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Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Rules and Regulations
Dated: September 25, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020–21774 Filed 11–13–20; 8:45 am]
BILLING CODE 4151–17–P
DEPARTMENT OF AGRICULTURE
Office of the Secretary
2 CFR Parts 415 and 416
Rural Utilities Service
7 CFR Part 1780
National Institute of Food and
Agriculture
7 CFR Part 3430
Department of Agriculture Regulations
for Grants and Agreements; Update of
Citations
AGENCY
: Office of the Secretary, Rural
Utilities Service, National Institute of
Food and Agriculture, and Office of the
Chief Financial Officer, Department of
Agriculture.
ACTION
: Final rule.
SUMMARY
: The Office of Management
and Budget (OMB) revised sections of
its Guidance for Grants and Agreements
in August 2020. This final rule amends
the regulations of several United States
Department of Agriculture agencies to
reflect the revised OMB guidance and
make technical corrections to the
Department’s grants and agreements
regulations.
DATES
: Effective November 16, 2020.
FOR FURTHER INFORMATION CONTACT
:
Tyson Whitney, Office of the Chief
Financial Officer, Director,
Transparency and Accountability
Reporting Division, United States
Department of Agriculture, 1400
Independence Avenue SW, Washington,
DC 20250–9011, 202–720–8978,
tyson.whitney@usda.gov.
SUPPLEMENTARY INFORMATION
: The
regulations in 2 CFR chapter IV set forth
the United States Department of
Agriculture’s (USDA) regulations for
grants and agreements. In a final rule
published December 19, 2014 (79 FR
75982), USDA’s Office of the Chief
Financial Officer adopted 2 CFR part
200, along with an agency-specific
addendum in a new 2 CFR part 400. The
regulations in 2 CFR parts 415, 416, 418,
and 422 were established. The
regulations in 2 CFR chapter IV updated
and replaced provisions that had
previously been found in 7 CFR parts
3015, 3016, 3018, 3019, 3022, and 3052.
The regulations of several USDA
agencies in title 7 refer to and cite the
grants and agreements regulations.
Following the publication of the various
final rules establishing the regulations
in 2 CFR chapter IV, those agencies
updated their regulations so that they
referred to the new grants and
agreements regulations in title 2 rather
than the predecessor regulations in title
7. As a result of the August 13, 2020,
publication of the Office of Management
and Budget’s ‘‘Guidance for Grants and
Agreements’’ (85 FR 49506), we have
identified a number of instances where
technical corrections are necessary. This
final rule makes those technical
corrections where needed.
Effective Date
This rule relates to internal agency
management and makes various
nonsubstantive changes to the
regulations in titles 2 and 7 of the Code
of Federal Regulations to make technical
corrections to the Department’s grants
and agreements regulations.
Accordingly, notice and other public
procedure on this rule are unnecessary
and contrary to the public interest.
Therefore, pursuant to 5 U.S.C. 553,
notice of proposed rulemaking and
opportunity to comment are not
required and this rule may be made
effective less than 30 days after
publication in the Federal Register.
Further, since this rule relates to
internal agency management, it is
exempt from the provisions of Executive
Orders 12866, 12988, and 13771.
Finally, this action is not a rule as
defined by the Regulatory Flexibility
Act (5 U.S.C. 501) and, thus, is exempt
from the provisions of that Act.
Paperwork Reduction Act
This final rule contains no new
reporting, recordkeeping, or third-party
disclosure requirements under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
List of Subjects
2 CFR Parts 415 and 416
Accounting, Administrative practice
and procedure, Agriculture, Auditing,
Business and industry, Colleges and
universities, Community development,
Cost principles, Economic development,
Government contracts, Grants
administration, Grant programs, Grant
programs—housing and community
development, Hospitals, Indians, Loan
programs—agriculture, Nonprofit
organizations, Reporting and
recordkeeping requirements, Rural
areas, State and local governments.
7 CFR Part 1780
Community development,
Community facilities, Grant programs—
housing and community development,
Loan programs—housing and
community development, Reporting and
recordkeeping requirements, Rural
areas, Waste treatment and disposal,
Water supply, Watersheds.
7 CFR Part 3430
Administrative practice and
procedure, Agriculture research,
Education, Federal assistance.
Accordingly, 2 CFR parts 415 and 416
and 7 CFR parts 1780 and 3430 are
amended as follows:
Title 2—[Amended]
PART 415—GENERAL PROGRAM
ADMINISTRATIVE REGULATIONS
1. The authority citation for part 415
is revised to read as follows:
Authority: 5 U.S.C. 301; 31 U.S.C. 901–
903; 7 CFR 2.28.
2. In § 415.1, paragraphs (a)(1) and
(b)(10) are revised to read as follows:
§ 415.1 Competition in the awarding of
discretionary grants and cooperative
agreements.
(a) * * *
(1) Potential applicants must be
invited to submit proposals through
publications such as the Federal
Register, OMB-designated
governmentwide website as described in
2 CFR 200.204, professional trade
journals, agency or program handbooks,
the Assistance Listings, or any other
appropriate means of solicitation. In so
doing, awarding agencies should
consider the broadest dissemination of
project solicitations in order to reach the
highest number of potential applicants.
* * * * *
(b) * * *
(10) The Assistance Listings number
and title.
* * * * *
PART 416—GENERAL PROGRAM
ADMINISTRATIVE REGULATIONS FOR
GRANTS AND COOPERATIVE
AGREEMENTS TO STATE AND LOCAL
GOVERNMENTS
3. The authority citation for part 416
is revised to read as follows:
Authority: 5 U.S.C. 301; 31 U.S.C. 901–
903; 7 CFR 2.28.
§ 416.1 [Amended]
4. Section 416.1 is amended as
follows:
a. In paragraph (a), by removing the
citation ‘‘2 CFR 200.101(e)(4) through
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