Document

Regulatory Clean Up Initiative

The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspe...

Department of Health and Human Services
Office of the Secretary
Food and Drug Administration
Centers for Medicare & Medicaid Services
Office of Inspector General
Administration for Children and Families
  1. 2 CFR Part 376
  2. 42 CFR Parts 23, 51c, 52i, 56, 57, 63, and 124
  3. 45 CFR Parts 3, 63, and 75
  4. 48 CFR Parts 302 and 326
  5. [Docket Number HHS-OS-2020-0015]
  6. RIN 0991-AC19
  7. 21 CFR Parts 1, 5, 12, 14, 25, 81, 133, 172, 178, 184, 201, 310, 369, 501, and 582
  8. 42 CFR Parts 411, 412, 422, 423, 426, 440, 441, 447, 482, and 485
  9. 42 CFR Parts 1004 and 1008
  10. 45 CFR Parts 305, 307, 1324, 1325, 1326, and 1328

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: ; and .

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, ( printed page 72900) insufficient, or excessively burdensome”, as candidates for SME review and potential reform.

III. Summary of Changes

2 CFR Part 376

21 CFR Part 1

21 CFR Part 5

21 CFR Part 12

21 CFR Part 14

21 CFR Part 25

21 CFR Part 81

21 CFR Part 133

21 CFR Part 172

21 CFR Part 178

21 CFR Part 184

21 CFR Part 201

21 CFR Part 310

21 CFR Part 369

21 CFR Part 501

21 CFR Part 582

42 CFR Part 23

42 CFR Part 51c

42 CFR Part 52i

42 CFR Part 56

42 CFR Part 57

42 CFR Part 63

42 CFR Part 124

42 CFR Part 411

42 CFR Part 412

42 CFR Part 422

42 CFR Part 423

42 CFR Part 426

42 CFR Part 440

42 CFR Part 441

42 CFR Part 447

42 CFR Part 482

42 CFR Part 485

42 CFR Part 1004

42 CFR Part 1008

45 CFR Part 3

45 CFR Part 63

45 CFR Part 75

45 CFR Part 305

45 CFR Part 307

45 CFR Part 1324

45 CFR Part 1325

45 CFR Part 1326

45 CFR Part 1328

48 CFR Part 302

48 CFR Part 326

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. ( printed 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 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.

[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.

[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.

[Amended]

6. Amend § 5.1100 by

[Amended]

7. Revise § 5.1105 to read as follows:

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.

[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.

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 ( printed 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.

[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:

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.

[Amended]

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

[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.

[Amended]

19. Remove § 133.116(d).

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:

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:

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:

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:

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:

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:

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.

[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:

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.

( printed page 72908)

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:

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:

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).

[Amended]

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

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.

[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);”.

[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.

[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.

[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);”.

[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);”.

[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.

[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).

( printed page 72909)
[Amended]

53. Amend § 63.2 by removing the reference “50.102” and adding in its place the reference “93.103”.

[Amended]

54. Amend § 63.2 by removing the phrase “Misconduct in science” and adding in its place “research misconduct”.

[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.

[Amended]

57. Amend § 124.511 by removing the reference “125.510”.

[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.

[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.

[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.

[Amended]

64. Amend § 422.304(f) by removing the reference “§ 495.220” and adding in its place “§ 495.204”.

[Amended]

65. Amend § 422.322(b) by removing the reference “413.86(d)” and adding in its place “413.76”.

[Amended]

66. Amend § 422.324(b)(2) by removing the reference “§ 413.86(b)” and adding in its place “§ 413.75(b)”.

[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.

[Amended]

69. Amend § 423.1094(b)(2) by removing the reference “423.858” and adding in its place the reference “§ 423.1088”.

[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.

[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.

[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.

[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”.

[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.

[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.

[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)”.

( printed page 72910)

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).

[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.

[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).

[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.

[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”.

[Amended]

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

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 crosswalks and certain other areas. Subject to certain limitations Imprisonment 2 months and/or $500 fine.
Sec. 21-511 Blind, partially blind, or hearing impaired pedestrians 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 colliding with pedestrians, children and incapacitated individuals $500 fine.
3. Driving while intoxicated, under the influence of alcohol and/or a drug or controlled 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) (driving under the influence): Imprisonment 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 personnel 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 personnel or with permit First offense and no prior related offense: Imprisonment 3 years and/or $2,500 fine.
7. Use of handgun or concealable antique firearm in commission 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 tickets authorized under State law in accordance with approved procedures) Sec. 240: Imprisonment one year and/or $1,000 fine. Sec. 245: Imprisonment 2 years and/or $100 fine.
[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”.

[Amended]

92. Amend § 3.61 by removing the reference “ 40 U.S.C. 318c” and adding in its place the reference “U.S. Public ( printed 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

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).

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.

[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.

[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.

[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.

[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”.

[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)”.

[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)”.

[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.

[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.

[Amended]

110. Amend § 1326.103 by removing the reference “1386.90” and adding in its place “1326.90”.

[Amended]

111. Amend § 1326.93 by removing the reference “1386.94” and adding in its place “1326.94”.

[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.

[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”.

[Amended]

115. Amend § 1328.3 by removing the reference “1388.2” and adding in its place “1328.2”.

[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).

[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).

[Amended]

120. Amend § 326.603(d) by removing the reference “326.2” and adding in its place “326.6”.

( printed page 72912)

Dated: September 25, 2020.

Alex M. Azar II,

Secretary.

Footnotes

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.

Back to Citation

[FR Doc. 2020-21774 Filed 11-13-20; 8:45 am]

BILLING CODE 4151-17-P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

85 FR 72899

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Regulatory Clean Up Initiative,” thefederalregister.org (November 16, 2020), https://thefederalregister.org/documents/2020-21774/regulatory-clean-up-initiative.