Rule2023-14716
Nomenclature Change for Dockets Management; Technical Amendment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 14, 2023
Effective
July 14, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 134 (Friday, July 14, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14716]
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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
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</html>Indexed from Federal Register on July 14, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.