[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Rules and Regulations]
[Pages 45063-45068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14716]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2023-N-0963]


Nomenclature Change for Dockets Management; Technical Amendment

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to reflect a change in the name of Division of Dockets 
Management to Dockets Management Staff and information regarding 
copies. This action is editorial in nature and is intended to improve 
the accuracy of the Agency's regulations.

DATES: This rule is effective July 14, 2023.

FOR FURTHER INFORMATION CONTACT: Karen Malvin, Dockets Management 
Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR chapter I to update 
Dockets Management Staff's name change and information regarding 
copies.
    Publication of this document constitutes final action on the 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because this 
amendment to the regulations provides only a technical change to update 
the organizational information for Dockets Management Staff.

List of Subjects

21 CFR Part 3

    Administrative practice and procedure, Biologics, Drugs, Medical 
devices.

21 CFR Part 5

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

21 CFR Part 7

    Administrative practice and procedure, Consumer protection, 
Reporting and recordkeeping requirements.

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Parts 12, 13, and 15

    Administrative practice and procedure.

21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

21 CFR Part 17

    Administrative practice and procedure, Penalties.

21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and 
recordkeeping requirements.

21 CFR Part 60

    Administrative practice and procedure, Drugs, Food additives, 
Inventions and patents, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 100

    Administrative practice and procedure, Food labeling, Food 
packaging, Foods, Intergovernmental relations.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 109

    Food packaging, Foods, Polychlorinated biphenyls (PCBs).

21 CFR Part 165

    Beverages, Bottled water, Food grades and standards.

21 CFR Part 170

    Administrative practice and procedure, Food additives, Reporting 
and recordkeeping requirements.

21 CFR Part 184

    Food additives.

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

    Administrative practice and procedure, Confidential business

[[Page 45064]]

information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 328

    Alcohol and alcoholic beverages, Labeling, Over-the-counter drugs.

21 CFR Part 330

    Over-the-counter drugs.

21 CFR Parts 341, 350, and 355

    Labeling, Over-the-counter drugs.

21 CFR Part 369

    Labeling, Medical devices, Over-the-counter drugs.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCBs).

21 CFR Part 509

    Animal foods, Packaging and containers, Polychlorinated biphenyls 
(PCBs).

21 CFR Parts 514 and 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information; Reporting and recordkeeping requirements.

21 CFR Part 570

    Animal feeds, Animal foods, Food additives.

21 CFR Part 573

    Animal feeds, Food additives.

21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

21 CFR Part 740

    Cosmetics, Labeling.

21 CFR Part 808

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 830

    Administrative practice and procedure, Labeling, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

21 CFR Part 861

    Administrative practice and procedure, Medical devices, Reporting 
and recordkeeping requirements.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements, X-rays.

21 CFR Part 1010

    Administrative practice and procedure, Electronic products, 
Exports, Radiation protection.

21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supplies.

21 CFR Part 1250

    Air carriers, Foods, Maritime carriers, Motor carriers, Public 
health, Railroads, Water supplies.

21 CFR Part 1271

    Biologics, Communicable diseases, Drugs, HIV/AIDS, Human cells and 
tissue-based products, Medical devices, Reporting and recordkeeping 
requirements.

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

PART 3--PRODUCT JURISDICTION

0
1. The authority citation for part 3 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-
360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 
262, 264.


Sec.  3.5  [Amended]

0
2. In Sec.  3.5, amend paragraph (a)(1) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 5--ORGANIZATION

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

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


Sec.  5.1110  [Amended]

0
4. In Sec.  5.1110, amend paragraph (a) by removing ``Division of 
Dockets Management'' wherever it appears and adding in its place 
``Dockets Management Staff''.

PART 7--ENFORCEMENT POLICY

0
5. The authority citation for part 7 continues to read as follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 
264.


Sec.  7.42  [Amended]

0
6. In Sec.  7.42, amend paragraph (b)(3) introductory text by removing 
``Division of Dockets Management'' and adding in its place ``Dockets 
Management Staff''.

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURE

0
7. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.


0
8. In part 10, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.


0
9. In Sec.  10.30, revise paragraph (b)(2) to read as follows:


Sec.  10.30  Citizen petition.

* * * * *
    (b) * * *
    (2) Mail, delivery services, or other non-electronic submissions. A 
petition (including any attachments), that is not electronically 
submitted under paragraph (b)(1) of this section, must be submitted in 
accordance with paragraph (b)(3) of this section and Sec.  10.20 and 
delivered to this address: Dockets Management Staff, Department of 
Health and Human Services, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852. Submit two copies (original and 
redacted version) for confidential petitions. Otherwise, only one copy 
is necessary.
* * * * *

PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

0
10. 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.

0
11. In part 12, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

[[Page 45065]]


0
12. In Sec.  12.80, revise paragraph (a) to read as follows:


Sec.  12.80  Filing and service of submissions.

    (a) Submissions, including pleadings in a hearing, are to be filed 
with Dockets Management Staff under Sec.  10.20 of this chapter except 
that two copies need be submitted (original and redacted version) for 
confidential petitions. Otherwise, only one copy is necessary. To 
determine compliance with filing deadlines in a hearing, a submission 
is considered submitted on the date it is actually received by Dockets 
Management Staff. When this part allows a response to a submission and 
prescribes a period of time for the filing of the response, an 
additional 3 days are allowed for the filing of the response if the 
submission is served by mail.
* * * * *

PART 13--PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

0
13. The authority citation for part 13 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b-263n, 264.

0
14. In part 13, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
15. 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.

0
16. In part 14, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 15--PUBLIC HEARING BEFORE THE COMMISSIONER

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

    Authority:  5 U.S.C. 553; 15 U.S.C. 1451-1461; 21 U.S.C. 141-
149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 
262, 263b-263n, 264.

0
18. In part 15, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

17--CIVIL MONEY PENALTIES HEARINGS

0
19. The authority citation for part 17 is revised to read as follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
20. In part 17, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

0
21. In Sec.  17.31, revise paragraph (a)(1) to read as follows:


Sec.  17.31  Form, filing, and service of papers.

    (a) * * *
    (1) Documents filed with Dockets Management Staff (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, shall include two copies (original and redacted version) for 
confidential petitions. Otherwise, only one copy is necessary.
* * * * *

PART 20--PUBLIC INFORMATION

0
22. The authority citation for part 20 continues to read as follows:

    Authority:  5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 
21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u--300u-5, 300aa-1.


Sec.  20.120  [Amended]

0
23. In Sec.  20.120, amend paragraphs (c) introductory text and (c)(3) 
by removing ``Division of Dockets Management's'' and adding in its 
place ``Dockets Management Staff's''.

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
24. 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 parts 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 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 
Comp., p. 356-360.

0
25. In part 25, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 60--PATENT TERM RESTORATION

0
26. The authority citation for part 60 continues to read as follows:

    Authority:  21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 
156; 42 U.S.C. 262.

0
27. In part 60, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 100--GENERAL

0
28. The authority citation for part 100 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 337, 342, 343, 348, 371.


Sec.  100.1  [Amended]

0
29. In Sec.  100.1, amend paragraphs (d)(3) and (f)(3) and (4) by 
removing ``Division of Dockets Management'' wherever it appears and 
adding in its place ``Dockets Management Staff''.

PART 109--UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION 
AND FOOD-PACKAGING MATERIAL

0
30. The authority citation for part 109 continues to read as follows:

    Authority:  21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.

0
31. In part 109, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 165--BEVERAGES

0
32. The authority citation for part 165 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.


Sec.  165.110  [Amended]

0
33. In Sec.  165.110, amend paragraph (b)(4)(iii)(F) introductory text 
by removing ``Division of Dockets Management'' and adding in its place 
``Dockets Management Staff''.

PART 201--LABELING

0
34. The authority citation for part 201 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 
360, 360b, 360ccc, 360ccc-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 
U.S.C. 216, 241, 262, 264.


Sec.  201.63  [Amended]

0
35. In Sec.  201.63, amend paragraph (d) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
36. The authority citation for part 312 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 
42 U.S.C. 262.

0
37. In part 312, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
38. The authority citation for part 314 continues to read as follows:


[[Page 45066]]


    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 
356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.

0
39. In part 314, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 328--OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL 
INGESTION THAT CONTAIN ALCOHOL

0
40. The authority citation for part 328 is revised to read as follows:

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


Sec.  328.10  [Amended]

0
41. In Sec.  328.10, amend paragraph (e) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY 
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

0
42. The authority citation for part 330 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, 
371.

0
43. In part 330, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC 
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

0
44. The authority citation for part 341 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.


Sec.  341.85  [Amended]

0
45. In Sec.  341.85, amend paragraph (c)(4) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 350--ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN 
USE

0
46. The authority citation for part 350 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.


Sec.  350.60  [Amended]

0
47. In Sec.  350.60, remove ``Dockets Management Branch'' and add in 
its place ``Dockets Management Staff''.

PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

0
48. The authority citation for part 355 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.


Sec.  355.70  [Amended]

0
49. In Sec.  355.70, amend paragraph (a) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 369--INTERPRETIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES 
FOR OVER-THE-COUNTER SALE

0
50. The authority citation for part 369 is revised to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.


Sec.  369.21  [Amended]

0
51. In Sec.  369.21, remove ``Division of Dockets Management'' and add 
in its place ``Dockets Management Staff''.

 PART 500--GENERAL

0
52. The authority citation for part 500 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.


Sec.  500.80  [Amended]

0
53. In Sec.  500.80, amend paragraph (a) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 509--UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-
PACKAGING MATERIAL

0
54. The authority citation for part 509 continues to read as follows:

    Authority:  21 U.S.C. 336, 342, 346, 346a, 348, 371.

0
55. In part 509, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
56. The authority citation for part 514 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 
360ccc, 371, 379e, 381.


Sec.  514.200  [Amended]

0
57. In Sec.  514.200, amend paragraph (c)(1) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
58. The authority citation for part 516 continues to read as follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.


Sec.  516.28  [Amended]

0
59. In Sec.  516.28, amend the introductory text by removing ``Division 
of Dockets Management'' and adding ``Dockets Management Staff'' in its 
place.

PART 570--FOOD ADDITIVES

0
60. The authority citation for part 570 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 346a, 348, 371.

0
61. In part 570, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.


Sec.  570.35  [Amended]

0
62. In Sec.  570.35, amend paragraph (b)(2) by removing ``Division of 
Dockets Management's'' and adding in its place ``Dockets Management 
Staff's''.

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF 
ANIMALS

0
63. The authority citation for part 573 continues to read as follows:

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


Sec.  573.460  [Amended]

0
64. In Sec.  573.460, amend paragraphs (a)(1)(i) and (a)(2)(i) by 
removing ``Division of Dockets Management'' and adding in its place 
``Dockets Management Staff''.

PART 601--LICENSING

0
65. The authority citation for part 601 continues to read as follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 
(21 U.S.C. 355 note).


Sec.  601.51  [Amended]

0
66. In Sec.  601.51, amend paragraph (d)(2) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 740--COSMETIC PRODUCT WARNING STATEMENTS

0
67. The authority citation for part 740 is revised to read as follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 356b, 360, 360c-

[[Page 45067]]

360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 
264; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).


Sec.  740.2  [Amended]

0
68. In Sec.  740.2, amend paragraph (b) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL 
MEDICAL DEVICE REQUIREMENTS

0
69. The authority citation for part 808 continues to read as follows:

    Authority:  21 U.S.C. 360j, 360k, 371.
    Section 808.1 also issued under Sec. 709, Public Law 115-52, 131 
Stat. 1065-67.

0
70. In part 808, revise all references to ``Division of Dockets 
Management'' to read ``Dockets Management Staff''.

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
71. The authority citation for part 814 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.


Sec.  814.9  [Amended]

0
72. In Sec.  814.9, amend paragraph (d)(2) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 830--UNIQUE DEVICE IDENTIFICATION

0
73. The authority citation for part 830 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 
371.


Sec.  830.10  [Amended]

0
74. In Sec.  830.10, amend paragraph (a) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
75. The authority citation for part 860 continues to read as follows:

    Authority:  21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 
360j, 371, 374.


Sec.  860.5  [Amended]

0
76. In Sec.  860.5, amend paragraphs (c)(2) and (d)(2) by removing 
``Division of Dockets Management'' and adding in its place ``Dockets 
Management Staff''.

PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

0
77. The authority citation for part 861 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 
374; 42 U.S.C. 262, 264.


Sec.  861.38  [Amended]

0
78. In Sec.  861.38, amend paragraph (c) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 895--BANNED DEVICES

0
79. The authority citation for part 895 continues to read as follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.


Sec.  895.21  [Amended]

0
80. In Sec.  895.21, amend paragraph (d)(8) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 900--MAMMOGRAPHY

0
81. The authority citation for part 900 continues to read as follows:

    Authority:  21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.


Sec.  900.18  [Amended]

0
82. In Sec.  900.18, amend paragraphs (d)(2) and (4) by removing 
``Division of Dockets Management'' and adding in its place ``Dockets 
Management Staff''.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
83. The authority citation for part 1010 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 
371, 381.


Sec.  1010.4  [Amended]

0
84. In Sec.  1010.4, amend paragraph (c)(3) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

0
85. In Sec.  1010.5, revise paragraph (c) introductory text to read as 
follows:


Sec.  1010.5  Exemptions for products intended for United States 
Government use.

* * * * *
    (c) Application for exemption. If you are submitting an application 
for exemption, or for amendment or extension thereof, you must submit 
two copies (original and redacted version) for confidential petitions 
to Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one 
copy is necessary. For an exemption under the criteria prescribed in 
paragraph (a)(1) of this section, the application shall include the 
information prescribed in paragraphs (c)(1) through (13) of this 
section. For an exemption under the criteria prescribed in paragraph 
(a)(2) of this section, the application shall include the information 
prescribed in paragraphs (c)(3) through (13) of this section. An 
application for exemption, or for amendment or extension thereof, and 
correspondence relating to such application shall be made available for 
public disclosure in Dockets Management Staff, except for confidential 
or proprietary information submitted in accordance with part 20 of this 
chapter. Information classified for reasons of national security shall 
not be included in the application. Except as indicated in this 
paragraph (c), the application for exemption shall include the 
following:
* * * * *

PART 1240--CONTROL OF COMMUNICABLE DISEASES

0
86. The authority citation for part 1240 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 264, 271.


Sec.  1240.62  [Amended]

0
87. In Sec.  1240.62, amend paragraph (d) by removing ``Division of 
Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 1250--INTERSTATE CONVEYANCE SANITATION

0
88. The authority citation for part 1250 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 264, 271.


Sec.  1250.51  [Amended]

0
89. In Sec.  1250.51, amend paragraph (f)(4)(ii) by removing ``Division 
of Dockets Management'' and adding in its place ``Dockets Management 
Staff''.

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS

0
90. The authority citation for part 1271 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.


Sec.  1271.37  [Amended]

0
91. In Sec.  1271.37, amend paragraph (a) introductory text by removing 
``Division of Dockets Management'' and adding in its place ``Dockets 
Management Staff''.


[[Page 45068]]


    Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14716 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P


