Document ID: FDA-2020-Z-2200-0001
Agency: fda
Document Type: Rule
Title: Regulatory Clean Up Initiative
Posted Date: 2020-11-16T05:00Z

[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Rules and Regulations]
[Pages 72899-72912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21774]

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 Rules and Regulations
                                                 Federal Register
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 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 
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  Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / 
Rules and Regulations  

[[Page 72899]]

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 da88bfbd99b6bfbbb48faa9ab2b2a9f4bdb5ac.

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,

[[Page 72900]]

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 Sec.  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 Sec.  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 Sec.  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).

[[Page 72901]]

42 CFR Part 23

     Correct Reference. This rule amends Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  124.511, this rule removes the 
incorrect reference to 42 CFR 125.510 as this regulation no longer 
exists.
     Correct Reference. In Sec.  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 Sec.  411.353(d), this rule removes 
the incorrect reference to Sec.  1003.101 and replaces it with the 
correct reference Sec.  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 Sec.  412.42, this rule removes all 
incorrect references to Sec.  405.310 and replaces them with the 
correct references Sec.  411.15. These changes are necessary as Sec.  
405.310 was renumbered in the early 1980's, and the reference needs to 
be updated accordingly.

42 CFR Part 422

     Correct Reference. In Sec.  422.304(f), this rule removes 
the incorrect reference to Sec.  495.220 and replaces it with the 
correct reference Sec.  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 Sec.  495.220. This citation was incorrect 
at the time final rule was adopted; the regulations subpart C of part 
495 do not include a Sec.  495.220. Section 422.304(f) should instead 
have cross-referenced Sec.  495.204 (``Incentive payments to qualifying 
MA organizations for MA-EPs and MA-affiliated eligible hospitals'').
     Correct Reference. In Sec.  422.322(b), this rule removes 
the incorrect reference to 413.86(d) and replaces it with the correct 
reference Sec.  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,

[[Page 72902]]

2004 states that Sec.  413.86(d) would be redesignated into nine 
separate sections (Sec.  Sec.  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 Sec.  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 
Sec.  413.76 (Direct GME payments: Calculation of payments for GME 
costs) in place of Sec.  413.86(d).
     Correct Reference. In Sec.  422.324(b)(2), this rule 
removes the incorrect reference to Sec.  413.86(b) and replaces it with 
the correct reference Sec.  413.75(b). In a final rule published on 
August 11, 2004, Sec.  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 (Sec.  Sec.  413.75 through 
413.83). At that time however, the agency failed to update this 
reference to the section in Sec.  422.324(b)(2).
     Correct Reference. In Sec.  422.1094(b)(2), this rule 
removes the incorrect reference to Sec.  422.858 and replaces it with 
the correct reference Sec.  422.1088. Subpart T (consisting of Sec.  
Sec.  422.1000 through 422.1094) was added to part 422 on December 5, 
2007 (72 FR 68727). The reference to Sec.  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 Sec.  423.1094(b)(2), this rule 
removes the incorrect reference to Sec.  423.858 and replaces it with 
the correct reference Sec.  423.1088. Subpart T (consisting of Sec.  
Sec.  423.1000 through 423.1094), was added on December 5, 2007 (72 FR 
68736). At that time, the reference to Sec.  423.858 in Sec.  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 Sec.  423.2330(c)(3), this rule 
removes the incorrect reference to Sec.  423.2306(b)(4) and replaces it 
with the correct reference Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  440.20(b) introductory text, 
this rule removes the incorrect reference to Sec.  481.1 and replaces 
it with the correct reference Sec.  491.2. There is no citation Sec.  
481.1 in the CFR. Sec.  491.2 defines Nurse Practitioners and Physician 
Assistants for Rural Health Clinics and is the appropriate reference 
for Sec.  440.20(b).

42 CFR Part 441

     Correct Reference. In Sec.  441.17(a)(1), (a)(4), and (b), 
this rule removes the incorrect references to Sec.  405.1316, Sec.  
405.1128(a), and Sec.  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 Sec.  441.18(c) introductory text, 
this rule removes the incorrect reference to Sec.  441.169 and replaces 
it with the correct reference Sec.  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 Sec.  447.299(c), this rule removes 
the incorrect reference to Sec.  455.204 and replaces it with the 
correct reference ``Sec.  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 Sec.  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 Sec.  Sec.  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 Sec.  413.86 as 
Sec.  Sec.  413.75 through 413.83. They also updated cross-references 
to Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 72903]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
Sec.  75.382 through 75.485 and Sec.  Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 72904]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.

[[Page 72905]]

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

[[Page 72906]]

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

0
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.

Sec.  376.10  [Amended]

0
2. Amend Sec.  376.10 as follows:
0
a. Remove the reference ``(3 CFR 1986 Comp., p. 189)''; and
0
b. Remove the reference ``(3 CFR 1989 Comp., p. 235)''.

Title 21--Food and Drugs

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
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.

Sec.  1.24  [Amended]

0
4. Amend Sec.  1.24(a)(6)(ii) and (8)(ii) by removing the reference 
``Sec.  101.105(j)'' and adding in its place the reference ``Sec.  
101.7''.

PART 5--ORGANIZATION

0
5. 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
6. Amend Sec.  5.1100 by

Sec.  5.1105  [Amended]

0
7. Revise Sec.  5.1105 to read as follows:

Sec.  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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

0
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.

Sec.  12.21  [Amended]

0
9. Amend Sec.  12.21(a)(2) by removing the phrase ``514.2 for 
applications for animal feeds''.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
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.

Sec.  14.7  Amended]

0
11. Amend Sec.  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

0
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

[[Page 72907]]

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.

Sec.  25.33  [Amended]

0
13. Amend Sec.  25.33 by removing paragraph (a)(7).

0
14. Amend Sec.  25.33 by revising paragraph (a)(5) and (6) to read as 
follows:

Sec.  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 Sec.  510.455 of this chapter or as a liquid feed 
supplement under Sec.  558.5 of this chapter.
* * * * *

PART 81--GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR 
PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

0
15. The authority citation for part 81 continues to read as follows:

    Authority:  21 U.S.C. 371, 379e, 379e note.

Sec.  81.30  [Amended]

0
16. Amend Sec.  81.30(s)(2) by removing the last sentence.

Sec.  81.32   [Removed]

0
17. Remove Sec.  81.32.

PART 133--CHEESES AND RELATED CHEESE PRODUCTS

0
18. The authority citation for part 133 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

Sec.  133.116  [Amended]

0
19. Remove Sec.  133.116(d).

Sec.  133.121   Amended]

0
20. Remove Sec.  133.121(f).

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
21. The authority citation for part 172 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
22. Revise Sec.  172.840(c)(13) to read as follows:

Sec.  172.840  Polysorbate 80.

* * * * *
    (c) * * *
    (13) As a defoaming agent in the preparation of the creaming 
mixture for cottage cheese as identified in Sec.  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

0
23. The authority citation for part 178 continues to read as follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.

0
24. Revise Sec.  178.3730 to read as follows:

Sec.  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

0
25. The authority citation for part 184 continues to read as follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.

0
26. Revise Sec.  184.1097(c)(2) to read as follows:

Sec.  184.1097  Tannic acid.

* * * * *
    (c) * * *
    (2) Tannic acid may be used in rendered animal fat in accordance 
with 9 CFR 424.21.
* * * * *

0
27. Revise Sec.  184.1143(d) to read as follows:

Sec.  184.1143  Ammonium sulfate.

* * * * *
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec.  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 Sec.  170.3(n)(1) of this 
chapter and 0.1 percent for gelatins and puddings as defined in Sec.  
170.3(n)(22) of this chapter.
* * * * *

0
28. Revise Sec.  184.1924(c)(1) to read as follows:

Sec.  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 Sec.  170.3(o)(9) of this chapter to 
convert urea to ammonia and carbon dioxide.
* * * * *

PART 201--LABELING

0
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.

0
30. Revise Sec.  201.317(c) to read as follows:

Sec.  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

0
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.

Sec.  310.303  [Removed]

0
32. Remove Sec.  310.303.

PART 369--INTERPETATIVE STATEMENT RE WARNINGS ON DRUGS AND DEVICES 
FOR OVER-THE-COUNTER SALE

0
33. The authority citation for part 369 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371.

0
34. Revise Sec.  369.3 to read as follows:

Sec.  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 Sec.  310.201(a) of this chapter. Although, 
for convenience, warning and caution statements for a number of the 
drugs named in Sec.  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 Sec. Sec.  369.20 or 369.21 in no way 
affects the requirements for compliance with Sec.  310.201(a) of this 
chapter, or the provisions of an effective application pursuant to 
section 505(b) of the act.

[[Page 72908]]

PART 501--ANIMAL FOOD LABELING

0
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.

0
36. Amend Sec.  501.105, by revising the introductory text of paragraph 
(t) to read as follows:

Sec.  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

0
37. The authority citation for part 582 continues to read as follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.

0
38. Revise Sec.  582.99 to read as follows:

Sec.  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

0
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).

Sec.  23.9  [Amended]

0
40. Revise Sec.  23.9(c)(1) to read as follows:

Sec.  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

0
41. The authority citation for part 51c continues to read as follows:

    Authority:  42 U.S.C. 216, 254c.

Sec.  51c.107  [Amended]

0
42. Amend Sec.  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);''.

Sec.  51c.303  [Amended]

0
43. Amend Sec.  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

0
44. The authority citation for part 52i continues to read as follows:

    Authority:  42 U.S.C. 216, 285t-285t-1.

Sec.  52i.11  [Amended]

0
45. Amend Sec.  52i.11 by:
0
a. In paragraph (b), removing the reference ``74.53'' and adding in its 
place the reference ``75.361''.
0
b. In paragraph(c), removing the reference ``74.53e'' and adding in its 
place the reference ``75.364''.
0
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

0
46. The authority citation for part 56 continues to read as follows:

    Authority:  U.S.C. 216, 247d.

Sec.  56.108  [Amended]

0
47. Amend Sec.  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);''.

Sec.  56.303  [Amended]

0
48. Amend Sec.  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);''.

Sec.  56.603  [Amended]

0
49. Amend Sec.  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

0
50. The authority citation for part 57 continues to read as follows:

    Authority: 42 U.S.C. 293g.

Sec.  57.1505  [Amended]

0
51. Amend Sec.  57.1505(a)(1) by removing the reference ``57.110''.

PART 63--TRAINEESHIPS

0
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).

[[Page 72909]]

Sec.  63.2  [Amended]

0
53. Amend Sec.  63.2 by removing the reference ``50.102'' and adding in 
its place the reference ``93.103''.

 Sec.  63.2   [Amended]

0
54. Amend Sec.  63.2 by removing the phrase ``Misconduct in science'' 
and adding in its place ``research misconduct''.

Sec.  63.9  [Amended]

0
55. Amend Sec.  63.9(b) by removing the phrase ``misconduct in 
science'' and add in its place ``research misconduct''.

PART 124--MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION

0
56. The authority citation for part 124 continues to read as follows:

    Authority:  42 U.S.C. 216, 300o-1, 300r, unless otherwise noted.

Sec.  124.511  [Amended]

0
57. Amend Sec.  124.511 by removing the reference ``125.510''.

Sec.  124.602  [Amended]

0
58. Amend Sec.  124.602 by removing the reference ``42 CFR 53.1(d)''.

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
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.

Sec.  411.353  [Amended]

0
60. Amend Sec.  411.353(d) by removing the reference ``Sec.  1003.101 
of this title'' and adding in its place the reference ``Sec.  
1003.110''.

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

0
61. The authority citation for part 412 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395hh.

Sec.  412.42  [Amended]

0
62. Amend Sec.  412.42 as follows:
0
a. In paragraph (b)(2)(i), remove the reference ``Sec.  405.310(g)'' 
and add in its place ``Sec.  411.15(g)'';
0
b. In paragraph (b)(2)(ii), remove the reference ``Sec.  405.310(k)'' 
and add in its place ``Sec.  411.15(k)''; and
0
c. In paragraph (b)(2)(iii), remove the reference ``Sec.  405.310(m)'' 
and add in its place ``Sec.  411.15(m)''.

PART 422--MEDICARE ADVANTAGE PROGRAM

0
63. The authority citation for part 422 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395hh.

Sec.  422.304  [Amended]

0
64. Amend Sec.  422.304(f) by removing the reference ``Sec.  495.220'' 
and adding in its place ``Sec.  495.204''.

Sec.  422.322  [Amended]

0
65. Amend Sec.  422.322(b) by removing the reference ``413.86(d)'' and 
adding in its place ``413.76''.

Sec.  422.324  [Amended]

0
66. Amend Sec.  422.324(b)(2) by removing the reference ``Sec.  
413.86(b)'' and adding in its place ``Sec.  413.75(b)''.

Sec.  422.1094  [Amended]

0
67. Amend Sec.  422.1094(b)(2) by removing the reference ``422.858'' 
and adding in its place the reference ``Sec.  423.1088 of this 
chapter''.

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
68. The authority citation for part 423 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh.

Sec.  423.1094   [Amended]

0
69. Amend Sec.  423.1094(b)(2) by removing the reference ``423.858'' 
and adding in its place the reference ``Sec.  423.1088''.

Sec.  423.2330  [Amended]

0
70. Amend Sec.  423.2330(c)(3) by removing the reference ``Sec.  
423.2306(b)(4) of this subpart'' and adding in its place the reference 
``Sec.  423.2315(b)(4)''.

PART 426--REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL 
COVERAGE DETERMINATIONS

0
71. The authority citation for part 426 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395hh.

Sec.  426.110  [Amended]

0
72. Amend Sec.  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

0
73. The authority citation for part 440 continues to read as follows:

    Authority:  42 U.S.C. 1302.

Sec.  440.20  [Amended]

0
74. Amend Sec.  440.20(b) introductory text by removing the reference 
``Sec.  481.1'' and adding in its place ``Sec.  491.2''.

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

0
75. The authority citation for part 441 continues to read as follows:

    Authority: 42 U.S.C. 1302.

Sec.  441.17  [Amended]

0
76. Amend Sec.  441.17 as follows:
0
a. In paragraph (a)(1), remove the reference ``Sec.  405.1316'' and add 
in its place the reference ``part 493'';
0
b. In paragraph (a)(4), remove the reference ````Sec.  405.1128(a)'' 
and add in its place the reference ``part 493''; and
0
c. In paragraph (b), remove the reference ``Sec.  405.1316(f)(2) and 
(3)'' and add in its place the reference ``part 493 of this chapter''.

Sec.  441.18  [Amended]

0
77. Amend Sec.  441.18(c) introductory text by removing the reference 
``Sec.  441.169'' and adding in its place ``Sec.  440.169''.

PART 447--PAYMENTS FOR SERVICES

0
78. The authority citation for part 447 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1396r-8.

Sec.  447.299  [Amended]

0
79. Amend Sec.  447.299(c) introductory text by removing the reference 
``Sec.  455.204'' and adding in its place ``Sec.  455.304 of this 
chapter''.

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
80. The authority citation for part 482 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395hh, 1395rr, 1395lll, unless 
otherwise noted.

Sec.  482.27  [Amended]

0
81. Amend Sec.  482.27 as follows:
0
a. In paragraph (b)(3)(iii), remove the phrase ``, as set forth at 21 
CFR 610.48(b)(3)''; and
0
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)''.

[[Page 72910]]

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
82. The authority citation for part 485 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395(hh).

Sec.  485.639  [Amended]

0
83. Amend Sec.  485.639(c)(1)(vii) by removing the reference ``Sec.  
413.86'' and adding in its place the reference ``Sec. Sec.  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

0
84. The authority citation for part 1004 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1320c-5.

Sec.  1004.40  [Amended]

0
85. Amend Sec.  1004.40 by removing the reference ``476.139'' and 
adding in its place ``480.139''.

PART 1008--ADVISORY OPINIONS BY THE OIG

0
86. The authority citation for part 1008 continues to read as follows:

    Authority:  42 U.S.C. 1320a-7d(b).

Sec.  1008.36  [Amended]

0
87. Amend Sec.  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

0
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.

Sec.  3.1  [Amended]

0
89. In Sec.  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''.

Sec.  3.2  [Amended]

0
90. In Sec.  3.2, revise the table in paragraph (f) to read as follows:

Sec.  3.2   Applicability.

* * * * *
    (f) * * *

----------------------------------------------------------------------------------------------------------------
               Subject                 Maryland code annotated     Provides generally        Maximum penalty
----------------------------------------------------------------------------------------------------------------
1. Pedestrian right-of-way...........  Transportation, Sec. 21- Pedestrians have the     Imprisonment 2 months
                                        502.                     right-of-way in          and/or $500 fine.
                                                                 crosswalks and certain
                                                                 other areas. Subject
                                                                 to certain limitations.
                                       Sec. 21-511............  Blind, partially blind,  $500 fine.
                                                                 or hearing impaired
                                                                 pedestrians have the
                                                                 right-of-way at any
                                                                 crossing or
                                                                 intersection. Subject
                                                                 to certain limitations.
2. Drivers to exercise due care......  Transportation, Sec. 21- Drivers shall exercise   $500 fine.
                                        504.                     due care to avoid
                                                                 colliding with
                                                                 pedestrians, children
                                                                 and incapacitated
                                                                 individuals.
3. Driving while intoxicated, under    Transportation, Sec. 21- Prohibits..............  Sec. 21-902(a) (driving
 the influence of alcohol and/or a      902.                                              while intoxicated,
 drug or controlled substance.                                                            first offense):
                                                                                          Imprisonment 1 year
                                                                                          and/or $1,000 fine.
                                                                                         Sec. 21-902 (b), (c),
                                                                                          (d) (driving under the
                                                                                          influence):
                                                                                          Imprisonment 2 months
                                                                                          and/or $500 fine.
4. Unattended motor vehicles.........  Transportation, Sec. 21- Prohibits leaving motor  $500 fine.
                                        1101.                    vehicles unattended
                                                                 unless certain
                                                                 precautions are taken.
5. Carrying or wearing certain         Sec. 4-202.............  Prohibits, except for    Imprisonment 3 years or
 concealed weapons (other than                                   law enforcement          $1,000 fine.
 handguns) or openly with intent to                              personnel or as a
 injure.                                                         reasonable precaution
                                                                 against apprehended
                                                                 danger.
6. Unlawful wearing, carrying, or      Sec. 4-202.............  Prohibits except by law  First offense and no
 transporting a handgun, whether                                 enforcement personnel    prior related offense:
 concealed or openly.                                            or with permit.          Imprisonment 3 years
                                                                                          and/or $2,500 fine.
7. Use of handgun or concealable       Sec. 4-204.............  Prohibits..............  Imprisonment 20 years.
 antique firearm in commission of
 felony or crime of violence.
8. Disturbance of the peace..........  Sec. 6-409.............  Prohibits acting in a    Imprisonment 30 days
                                                                 disorderly manner in     and/or $500 fine.
                                                                 public places.
9. Gambling..........................  Sec. 12-102............  Prohibits betting,       Sec. 240: Imprisonment
                                                                 wagering and gambling,   one year and/or $1,000
                                                                 and certain games of     fine. Sec. 245:
                                                                 chance (does not apply   Imprisonment 2 years
                                                                 to vending or            and/or $100 fine.
                                                                 purchasing lottery
                                                                 tickets authorized
                                                                 under State law in
                                                                 accordance with
                                                                 approved procedures).
----------------------------------------------------------------------------------------------------------------

Sec.  3.5  [Amended]

0
91. In Sec.  3.5:
0
a. Removing the reference ``41 CFR part 101-48'' and adding in its 
place ``41 CFR 102''.
0
b. Removing the ``41 CFR 101-45.304'' and 101-48.305'' and add in their 
place ``41 CFR part ``102-41''.

Sec.  3.61  [Amended]

0
92. Amend Sec.  3.61 by removing the reference ``40 U.S.C. 318c'' and 
adding in its place the reference ``U.S. Public

[[Page 72911]]

Law 107-296, Homeland Security Act of 2002''.

PART 63--GRANT PROGRAMS ADMINISTERED BY THE OFFICE OF THE ASSISTANT 
SECRETARY FOR PLANNING AND EVALUATION

0
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).

Sec.  63.1  Amended]

0
94. Amend Sec.  63.1 by:
0
a. Removing ``41 CFR 3-1.53'' and adding in its place ``45 CFR 
75.201(a)''.
0
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

0
95. The authority citation for part 75 continues to read as follows:

    Authority: 5 U.S.C. 301.

Sec.  75.372   [Amended]

0
96. Amend Sec.  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

0
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.

Sec.  305.0  [Amended]

0
98. Amend Sec.  305.0 by removing ``Sections 305.40 through 305.42 '' 
with ``Sections 305.40, 305.42''.

PART 307--COMPUTERIZED SUPPORT ENFORCEMENT SYSTEMS

0
99. The authority citation for part 307 continues to read as follows:

    Authority:  42 U.S.C. 652-658, 664, 666-669A, 1302.

Sec.  307.5   [Amended]

0
100. Amend Sec.  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

0
101. The authority citation for part 1324 continues to read as follows:

    Authority:  42 U.S.C. 3001 et seq.

Sec.  1324.11   [Amended]

0
102. Amend Sec.  1324.11 by:
0
a. Removing the reference ``1327.13(e)'' and adding in its place 
``1324.13(e)''.
0
b. Removing all references ``1327.19(b)(5) through (8)'' and adding in 
their places ``1324.19(b)(5) through (8)''.
0
c.
0
d. Removing the reference ``1327.21'' and adding in its place 
``1324.21''.

Sec.  1324.15   [Amended]

0
103. Amend Sec.  1324.15 by:
0
a. Removing the reference ``1327.13(e)'' and adding in its place 
``1324.13(e)''.
0
b. Removing the reference ``1327.13(g)'' and adding in its place 
``1324.13(g)''.
0
c. Removing the reference ``1327.13(c)(2)'' and adding in its place 
``1324.13(c)(2)''.

Sec.  1324.19   [Amended]

0
104. Amend Sec.  1324.19 by removing the reference ``1327.11(e)(3)'' 
wherever it appears and adding in its place ``1324.11(e)(3)''.

Sec.  1324.21   [Amended]

0
105. Amend Sec.  1324.21(b)(3) by removing the phrase ``if the other 
entity''.

PART 1325--REQUIREMENTS APPLICABLE TO THE DEVELOPMENTAL 
DISABILITIES PROGRAM

0
106. The authority citation for part 1325 continues to read as follows:

    Authority: 42 U.S.C. 15001 et seq.

Sec.  1325.4  [Amended]

0
107. Amend Sec.  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

0
108. The authority citation for part 1326 continues to read as follows:

    Authority: 42 U.S.C. 15001 et seq.

0
109. Revise the part heading to read as set forth above.

Sec.  1326.103  [Amended]

0
110. Amend Sec.  1326.103 by removing the reference ``1386.90'' and 
adding in its place ``1326.90''.

Sec.  1326.93  [Amended]

0
111. Amend Sec.  1326.93 by removing the reference ``1386.94'' and 
adding in its place ``1326.94''.

Sec.  1326.112   [Amended]

0
112. Amend Sec.  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

0
113. The authority citation for part 1328 continues to read as follows:

    Authority: 42 U.S.C. 15001 et seq.

Sec.  1328.2   [Amended]

0
114. Amend Sec.  1328.2 by:
0
a. Removing the reference ``1385.3'' and adding in its place 
``1325.3''.
0
b. Removing the reference ``1388.3'' and adding in its place 
``1328.3''.
0
c. Removing the reference ``1388.4'' and adding in its place 
``1328.4''.

Sec.  1328.3   [Amended]

0
115. Amend Sec.  1328.3 by removing the reference ``1388.2'' and adding 
in its place ``1328.2''.

Sec.  1328.5   [Amended]

0
116. Amend Sec.  1328.5 by:
0
a. Removing the reference ``1385.3'' and adding in its place 
``1325.3''.
0
b. Removing the reference ``1388.2'' and adding in its place ``45 CFR 
1328.2''.
0
c. Removing the reference ``1388.2(a)(1) and (2)'' and adding in its 
place ``1328.2(a)(1) and (2)''.
0
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

0
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).

Sec.  302.101  [Amended]

0
118. Amend Sec.  302.101 by removing the reference ``301.604'' and 
adding in its place ``PGI Part 301.604''

PART 326--OTHER SOCIOECONOMIC PROGRAMS

0
119. The authority for part 326 continues to read as follows:

    Authority: 5 U.S.C. 301, 40 U.S.C. 121(c)(2).

Sec.  326.603  [Amended]

0
120. Amend Sec.  326.603(d) by removing the reference ``326.2'' and 
adding in its place ``326.6''.

[[Page 72912]]

    Dated: September 25, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020-21774 Filed 11-13-20; 8:45 am]
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