# [Amended]
**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**
Administrative practice and procedure, Biologics, Drugs, Medical devices.
Authority delegations (Government agencies), Imports, Organization and functions (Government agencies).
Administrative practice and procedure, Consumer protection, Reporting and recordkeeping requirements.
Administrative practice and procedure, News media.
Administrative practice and procedure.
Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection.
Administrative practice and procedure, Penalties.
Confidential business information, Courts, Freedom of information, Government employees.
Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements.
Administrative practice and procedure, Drugs, Food additives, Inventions and patents, Medical devices, Reporting and recordkeeping requirements.
Administrative practice and procedure, Food labeling, Food packaging, Foods, Intergovernmental relations.
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Food packaging, Foods, Polychlorinated biphenyls (PCBs).
Beverages, Bottled water, Food grades and standards.
Administrative practice and procedure, Food additives, Reporting and recordkeeping requirements.
Food additives.
Drugs, Labeling, Reporting and recordkeeping requirements.
Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements, Safety.
Administrative practice and procedure, Confidential business information, Drugs, Reporting and recordkeeping requirements.
Alcohol and alcoholic beverages, Labeling, Over-the-counter drugs.
Over-the-counter drugs.
Labeling, Over-the-counter drugs.
Labeling, Medical devices, Over-the-counter drugs.
Animal drugs, Animal feeds, Cancer, Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).
Animal foods, Packaging and containers, Polychlorinated biphenyls (PCBs).
Administrative practice and procedure, Animal drugs, Confidential business information; Reporting and recordkeeping requirements.
Animal feeds, Animal foods, Food additives.
Animal feeds, Food additives.
Administrative practice and procedure, Biologics, Confidential business information.
Cosmetics, Labeling.
Imports, Medical devices, Reporting and recordkeeping requirements.
Health records, Medical devices, Medical research, Reporting and recordkeeping requirements.
Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements.
Administrative practice and procedure, Labeling, Medical devices, Reporting and recordkeeping requirements.
Administrative practice and procedure, Medical devices.
Administrative practice and procedure, Medical devices, Reporting and recordkeeping requirements.
Administrative practice and procedure, Labeling, Medical devices.
Electronic products, Health facilities, Medical devices, Radiation protection, Reporting and recordkeeping requirements, X-rays.
Administrative practice and procedure, Electronic products, Exports, Radiation protection.
Communicable diseases, Public health, Travel restrictions, Water supplies.
Air carriers, Foods, Maritime carriers, Motor carriers, Public health, Railroads, Water supplies.
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**
**21 CFR Part 3**
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.
§ 3.5
**21 CFR Part 3**
2. In § 3.5, amend paragraph (a)(1) by removing “Division of Dockets Management” and adding in its place “Dockets Management Staff”.
**PART 5—ORGANIZATION**
**21 CFR Part 5**
3. The authority citation for part 5 continues to read as follows:
**Authority:**
5 U.S.C. 552; 21 U.S.C. 301-397.
§ 5.1110
**21 CFR Part 5**
4. In § 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**
**21 CFR Part 7**
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.
§ 7.42
**21 CFR Part 7**
6. In § 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**
**21 CFR Part 10**
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.
**21 CFR Part 10**
8. In part 10, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**21 CFR Part 10**
9. In § 10.30, revise paragraph (b)(2) to read as follows:
§ 10.30
(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 § 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**
**21 CFR Part 12**
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.
**21 CFR Part 12**
11. In part 12, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**21 CFR Part 12**
12. In § 12.80, revise paragraph (a) to read as follows:
§ 12.80
(a) Submissions, including pleadings in a hearing, are to be filed with Dockets Management Staff under § 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**
**21 CFR Part 13**
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.
**21 CFR Part 13**
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**
**21 CFR Part 14**
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.
**21 CFR Part 14**
16. In part 14, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**PART 15—PUBLIC HEARING BEFORE THE COMMISSIONER**
**21 CFR Part 15**
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.
**21 CFR Part 15**
18. In part 15, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**17—CIVIL MONEY PENALTIES HEARINGS**
**21 CFR Part 17**
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.
**21 CFR Part 17**
20. In part 17, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**21 CFR Part 17**
21. In § 17.31, revise paragraph (a)(1) to read as follows:
§ 17.31
(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**
**21 CFR Part 20**
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.
§ 20.120
**21 CFR Part 20**
23. In § 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**
**21 CFR Part 25**
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.
**21 CFR Part 25**
25. In part 25, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**PART 60—PATENT TERM RESTORATION**
**21 CFR Part 60**
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.
**21 CFR Part 60**
27. In part 60, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**PART 100—GENERAL**
**21 CFR Part 100**
28. The authority citation for part 100 continues to read as follows:
**Authority:**
21 U.S.C. 321, 331, 337, 342, 343, 348, 371.
§ 100.1
**21 CFR Part 100**
29. In § 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**
**21 CFR Part 109**
30. The authority citation for part 109 continues to read as follows:
**Authority:**
21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.
**21 CFR Part 109**
31. In part 109, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**PART 165—BEVERAGES**
**21 CFR Part 165**
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.
§ 165.110
**21 CFR Part 165**
33. In § 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**
**21 CFR Part 201**
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.
§ 201.63
**21 CFR Part 201**
35. In § 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**
**21 CFR Part 312**
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.
**21 CFR Part 312**
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**
**21 CFR Part 314**
38. The authority citation for part 314 continues to read as follows:
**Authority:**
21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.
**21 CFR Part 314**
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**
**21 CFR Part 328**
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.
§ 328.10
**21 CFR Part 328**
41. In § 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**
**21 CFR Part 330**
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.
**21 CFR Part 330**
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**
**21 CFR Part 341**
44. The authority citation for part 341 continues to read as follows:
**Authority:**
21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
§ 341.85
**21 CFR Part 341**
45. In § 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**
**21 CFR Part 350**
46. The authority citation for part 350 continues to read as follows:
**Authority:**
21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
§ 350.60
**21 CFR Part 350**
47. In § 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**
**21 CFR Part 355**
48. The authority citation for part 355 continues to read as follows:
**Authority:**
21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
§ 355.70
**21 CFR Part 355**
49. In § 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**
**21 CFR Part 369**
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.
§ 369.21
**21 CFR Part 369**
51. In § 369.21, remove “Division of Dockets Management” and add in its place “Dockets Management Staff”.
**PART 500—GENERAL**
**21 CFR Part 500**
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.
§ 500.80
**21 CFR Part 500**
53. In § 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**
**21 CFR Part 509**
54. The authority citation for part 509 continues to read as follows:
**Authority:**
21 U.S.C. 336, 342, 346, 346a, 348, 371.
**21 CFR Part 509**
55. In part 509, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**PART 514—NEW ANIMAL DRUG APPLICATIONS**
**21 CFR Part 514**
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.
§ 514.200
**21 CFR Part 514**
57. In § 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**
**21 CFR Part 516**
58. The authority citation for part 516 continues to read as follows:
**Authority:**
21 U.S.C. 360ccc-1, 360ccc-2, 371.
§ 516.28
**21 CFR Part 516**
59. In § 516.28, amend the introductory text by removing “Division of Dockets Management” and adding “Dockets Management Staff” in its place.
**PART 570—FOOD ADDITIVES**
**21 CFR Part 570**
60. The authority citation for part 570 continues to read as follows:
**Authority:**
21 U.S.C. 321, 341, 342, 346a, 348, 371.
**21 CFR Part 570**
61. In part 570, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
§ 570.35
**21 CFR Part 570**
62. In § 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**
**21 CFR Part 573**
63. The authority citation for part 573 continues to read as follows:
**Authority:**
21 U.S.C. 321, 342, 348.
§ 573.460
**21 CFR Part 573**
64. In § 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**
**21 CFR Part 601**
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).
§ 601.51
**21 CFR Part 601**
66. In § 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**
**21 CFR Part 740**
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- 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).
§ 740.2
**21 CFR Part 740**
68. In § 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**
**21 CFR Part 808**
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.
**21 CFR Part 808**
70. In part 808, revise all references to “Division of Dockets Management” to read “Dockets Management Staff”.
**PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES**
**21 CFR Part 814**
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.
§ 814.9
**21 CFR Part 814**
72. In § 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**
**21 CFR Part 830**
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.
§ 830.10
**21 CFR Part 830**
74. In § 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**
**21 CFR Part 860**
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.
§ 860.5
**21 CFR Part 860**
76. In § 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**
**21 CFR Part 861**
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.
§ 861.38
**21 CFR Part 861**
78. In § 861.38, amend paragraph (c) by removing “Division of Dockets Management” and adding in its place “Dockets Management Staff”.
**PART 895—BANNED DEVICES**
**21 CFR Part 895**
79. The authority citation for part 895 continues to read as follows:
**Authority:**
21 U.S.C. 352, 360f, 360h, 360i, 371.
§ 895.21
**21 CFR Part 895**
80. In § 895.21, amend paragraph (d)(8) by removing “Division of Dockets Management” and adding in its place “Dockets Management Staff”.
**PART 900—MAMMOGRAPHY**
**21 CFR Part 900**
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.
§ 900.18
**21 CFR Part 900**
82. In § 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**
**21 CFR Part 1010**
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.
§ 1010.4
**21 CFR Part 1010**
84. In § 1010.4, amend paragraph (c)(3) by removing “Division of Dockets Management” and adding in its place “Dockets Management Staff”.
**21 CFR Part 1010**
85. In § 1010.5, revise paragraph (c) introductory text to read as follows:
§ 1010.5
(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**
**21 CFR Part 1240**
86. The authority citation for part 1240 continues to read as follows:
**Authority:**
42 U.S.C. 216, 243, 264, 271.
§ 1240.62
**21 CFR Part 1240**
87. In § 1240.62, amend paragraph (d) by removing “Division of Dockets Management” and adding in its place “Dockets Management Staff”.
**PART 1250—INTERSTATE CONVEYANCE SANITATION**
**21 CFR Part 1250**
88. The authority citation for part 1250 continues to read as follows:
**Authority:**
42 U.S.C. 216, 243, 264, 271.
§ 1250.51
**21 CFR Part 1250**
89. In § 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**
**21 CFR Part 1271**
90. The authority citation for part 1271 continues to read as follows:
**Authority:**
42 U.S.C. 216, 243, 263a, 264, 271.
§ 1271.37
**21 CFR Part 1271**
91. In § 1271.37, amend paragraph (a) introductory text by removing “Division of Dockets Management” and adding in its place “Dockets Management Staff”.
Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.