Nomenclature Change for Dockets Management; Technical Amendment, 45063-45068 [2023-14716]
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Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Rules and Regulations
Bend, OR, KBDN, VOR RWY 16, Amdt 11
Florence, SC, KFLO, ILS OR LOC RWY 9,
Amdt 13
Florence, SC, KFLO, RNAV (GPS) RWY 1,
Amdt 1
Florence, SC, KFLO, RNAV (GPS) RWY 9,
Amdt 1
Florence, SC, KFLO, RNAV (GPS) RWY 19,
Amdt 1
Florence, SC, KFLO, RNAV (GPS) RWY 27,
Amdt 1
Sumter, SC, KSMS, ILS OR LOC RWY 23,
Amdt 2
Sumter, SC, KSMS, Takeoff Minimums and
Obstacle DP, Amdt 1A
Seattle, WA, KBFI, RNAV (GPS) Y RWY 14R,
Orig
Seattle, WA, KBFI, RNAV (GPS) Y RWY 14R,
Amdt 1A, CANCELED
Seattle, WA, KBFI, RNAV (GPS) Y RWY 32L,
Orig
Seattle, WA, KBFI, RNAV (RNP) Z RWY 14R,
Orig
Seattle, WA, KBFI, RNAV (RNP) Z RWY 14R,
Amdt 1A, CANCELED
Seattle, WA, KBFI, RNAV (RNP) Z RWY 32L,
Orig
Rescinded: On June 21, 2023 (88 FR
40081), the FAA published an Amendment
in Docket No. 31490, Amdt No. 4063, to part
97 of the Federal Aviation Regulations under
§§ 97.23, 97.29, and 97.33. The following
entries for Northway, AK, San Francisco, CA,
and Cross Keys, NJ, effective August 10,
2023, are hereby rescinded in their entirety:
Northway, AK, PAOR, RNAV (GPS) RWY 6,
Amdt 1
Northway, AK, PAOR, RNAV (GPS) RWY 24,
Amdt 2
San Francisco, CA, KSFO, GLS RWY 19L,
Amdt 1
San Francisco, CA, KSFO, GLS RWY 19R,
Amdt 1
Cross Keys, NJ, 17N, VOR OR GPS RWY 9,
Amdt 6B, CANCELED
[FR Doc. 2023–14932 Filed 7–13–23; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0963]
Nomenclature Change for Dockets
Management; Technical Amendment
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; technical
amendment.
AGENCY:
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.
SUMMARY:
21 CFR Part 3
Administrative practice and
procedure, Biologics, Drugs, Medical
devices.
16 CFR Parts 0, 1, 2, 3 and 4
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Rules of Practice
In rule document 2023–12630
beginning on page 42872 in the issue of
Wednesday, July 5, 2023, make the
following corrections:
On page 42872, in the third column,
under DATES, in the first and fourth lines
‘‘June 5, 2023’’ should read ‘‘July 5,
2023’’.
[FR Doc. C1–2023–12630 Filed 7–13–23; 8:45 am]
BILLING CODE 0099–10–D
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21 CFR Parts 12, 13, and 15
Administrative practice and
procedure.
21 CFR Part 14
21 CFR Chapter I
List of Subjects
FEDERAL TRADE COMMISSION
45063
21 CFR Part 5
Authority delegations (Government
agencies), Imports, Organization and
functions (Government agencies).
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 7
Administrative practice and
procedure, Consumer protection,
Reporting and recordkeeping
requirements.
21 CFR Part 312
21 CFR Part 10
Administrative practice and
procedure, News media.
21 CFR Part 314
PO 00000
Frm 00009
Fmt 4700
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Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
Administrative practice and
procedure, Confidential business
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21 CFR Part 860
§ 5.1110
21 CFR Part 328
Administrative practice and
procedure, Medical devices.
■
Alcohol and alcoholic beverages,
Labeling, Over-the-counter drugs.
21 CFR Part 861
information, Drugs, Reporting and
recordkeeping requirements.
Administrative practice and
procedure, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 330
Over-the-counter drugs.
Administrative practice and
procedure, Labeling, Medical devices.
Labeling, Over-the-counter drugs.
21 CFR Part 369
Labeling, Medical devices, Over-thecounter 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 601
Administrative practice and
procedure, Biologics, Confidential
business information.
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.
Cosmetics, Labeling.
Air carriers, Foods, Maritime carriers,
Motor carriers, Public health, Railroads,
Water supplies.
PART 3—PRODUCT JURISDICTION
Imports, Medical devices, Reporting
and recordkeeping requirements.
■
1. The authority citation for part 3
continues to read as follows:
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
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.
21 CFR Part 814
§ 3.5
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.
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[Amended]
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
3. The authority citation for part 5
continues to read as follows:
■
Authority: 5 U.S.C. 552; 21 U.S.C. 301–
397.
PO 00000
Frm 00010
Fmt 4700
[Amended]
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
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.
8. In part 10, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
9. In § 10.30, revise paragraph (b)(2) to
read as follows:
■
§ 10.30
21 CFR Part 808
21 CFR Part 812
Authority: 21 U.S.C. 321–393; 42 U.S.C.
241, 262, 263b–263n, 264.
■
21 CFR Part 1250
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:
21 CFR Part 740
5. The authority citation for part 7
continues to read as follows:
§ 7.42
Electronic products, Health facilities,
Medical devices, Radiation protection,
Reporting and recordkeeping
requirements, X-rays.
Biologics, Communicable diseases,
Drugs, HIV/AIDS, Human cells and
tissue-based products, Medical devices,
Reporting and recordkeeping
requirements.
Animal feeds, Food additives.
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21 CFR Part 900
21 CFR Part 1271
21 CFR Part 573
PART 7—ENFORCEMENT POLICY
■
21 CFR Part 895
21 CFR Parts 341, 350, and 355
[Amended]
4. In § 5.1110, amend paragraph (a) by
removing ‘‘Division of Dockets
Management’’ wherever it appears and
adding in its place ‘‘Dockets
Management Staff’’.
Sfmt 4700
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 § 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
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.
11. In part 12, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
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12. In § 12.80, revise paragraph (a) 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.
§ 12.80
■
■
Filing and service of submissions.
(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
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.
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
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.
16. In part 14, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
PART 15—PUBLIC HEARING BEFORE
THE COMMISSIONER
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.
18. In part 15, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
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■
17—CIVIL MONEY PENALTIES
HEARINGS
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§ 17.31
Authority: 21 U.S.C. 321, 331, 337, 342,
343, 348, 371.
§ 100.1
[Amended]
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’’.
■
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
PART 109—UNAVOIDABLE
CONTAMINANTS IN FOOD FOR
HUMAN CONSUMPTION AND FOOD–
PACKAGING MATERIAL
30. The authority citation for part 109
continues to read as follows:
■
Authority: 21 U.S.C. 321, 336, 342, 346,
346a, 348, 371.
31. In part 109, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
■
22. The authority citation for part 20
continues to read as follows:
PART 165—BEVERAGES
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
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
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.
25. In part 25, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
PART 60—PATENT TERM
RESTORATION
Authority: 21 U.S.C. 348, 355, 360e, 360j,
371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.
27. In part 60, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
28. The authority citation for part 100
continues to read as follows:
■
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Fmt 4700
Authority: 21 U.S.C. 321, 341, 343, 343–
1, 348, 349, 371, 379e.
Sfmt 4700
[Amended]
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
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
[Amended]
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
36. The authority citation for part 312
continues to read as follows:
■
26. The authority citation for part 60
continues to read as follows:
■
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32. The authority citation for part 165
continues to read as follows:
§ 165.110
[Amended]
PART 100—GENERAL
19. The authority citation for part 17
is revised to read as follows:
■
20. In part 17, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■ 21. In § 17.31, revise paragraph (a)(1)
to read as follows:
45065
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360bbb, 371; 42 U.S.C. 262.
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
38. The authority citation for part 314
continues to read as follows:
■
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Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Rules and Regulations
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 355a, 355f, 356, 356a, 356b, 356c,
356e, 360cc, 371, 374, 379e, 379k–1.
PART 355—ANTICARIES DRUG
PRODUCTS FOR OVER–THE–
COUNTER HUMAN USE
39. In part 314, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
■
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
PART 328—OVER–THE–COUNTER
DRUG PRODUCTS INTENDED FOR
ORAL INGESTION THAT CONTAIN
ALCOHOL
§ 355.70
[Amended]
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.
[Amended]
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
[Amended]
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
50. The authority citation for part 369
is revised to read as follows:
■
■
60. The authority citation for part 570
continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 346a,
348, 371.
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
61. In part 570, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
§ 369.21
§ 570.35
[Amended]
51. In § 369.21, remove ‘‘Division of
Dockets Management’’ and add in its
place ‘‘Dockets Management Staff’’.
■
PART 500—GENERAL
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 360fff-6, 371.
■
43. In part 330, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
Authority: 21 U.S.C. 321, 331, 342, 343,
348, 351, 352, 353, 360b, 371, 379e.
52. The authority citation for part 500
continues to read as follows:
§ 500.80
[Amended]
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
63. The authority citation for part 573
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
[Amended]
53. In § 500.80, amend paragraph (a)
by removing ‘‘Division of Dockets
Management’’ and adding in its place
‘‘Dockets Management Staff’’.
■
§ 573.460
[Amended]
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’’.
■
44. The authority citation for part 341
continues to read as follows:
PART 509—UNAVOIDABLE
CONTAMINANTS IN ANIMAL FOOD
AND FOOD–PACKAGING MATERIAL
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
■
54. The authority citation for part 509
continues to read as follows:
■
Authority: 21 U.S.C. 336, 342, 346, 346a,
348, 371.
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).
■
§ 341.85
[Amended]
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
55. In part 509, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
PART 514—NEW ANIMAL DRUG
APPLICATIONS
56. The authority citation for part 514
continues to read as follows:
■
46. The authority citation for part 350
continues to read as follows:
■
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§ 516.28
■
42. The authority citation for part 330
continues to read as follows:
PART 341—COLD, COUGH, ALLERGY,
BRONCHODILATOR, AND
ANTIASTHMATIC DRUG PRODUCTS
FOR OVER–THE–COUNTER HUMAN
USE
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
PART 369—INTERPRETIVE
STATEMENTS RE WARNINGS ON
DRUGS AND DEVICES FOR OVER–
THE–COUNTER SALE
■
■
58. The authority citation for part 516
continues to read as follows:
■
■
49. In § 355.70, amend paragraph (a)
by removing ‘‘Division of Dockets
Management’’ and adding in its place
‘‘Dockets Management Staff’’.
■
■
§ 328.10
48. The authority citation for part 355
continues to read as follows:
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
§ 350.60
[Amended]
15:54 Jul 13, 2023
§ 514.200
[Amended]
57. In § 514.200, amend paragraph
(c)(1) by removing ‘‘Division of Dockets
Management’’ and adding in its place
‘‘Dockets Management Staff’’.
■
47. In § 350.60, remove ‘‘Dockets
Management Branch’’ and add in its
place ‘‘Dockets Management Staff’’.
■
VerDate Sep<11>2014
Authority: 21 U.S.C. 321, 331, 351, 352,
354, 356a, 360b, 360ccc, 371, 379e, 381.
Jkt 259001
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PART 601—LICENSING
65. The authority citation for part 601
continues to read as follows:
§ 601.51
[Amended]
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
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–
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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).
PART 861—PROCEDURES FOR
PERFORMANCE STANDARDS
DEVELOPMENT
§ 740.2
■
77. The authority citation for part 861
continues to read as follows:
[Amended]
68. In § 740.2, amend paragraph (b) by
removing ‘‘Division of Dockets
Management’’ and adding in its place
‘‘Dockets Management Staff’’.
■
Authority: 21 U.S.C. 351, 352, 360c, 360d,
360gg–360ss, 371, 374; 42 U.S.C. 262, 264.
§ 861.38
[Amended]
78. In § 861.38, amend paragraph (c)
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
PART 895—BANNED DEVICES
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.
Authority: 21 U.S.C. 352, 360f, 360h, 360i,
371.
■
70. In part 808, revise all references to
‘‘Division of Dockets Management’’ to
read ‘‘Dockets Management Staff’’.
■
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
79. The authority citation for part 895
continues to read as follows:
§ 895.21
PART 900—MAMMOGRAPHY
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.
Authority: 21 U.S.C. 360i, 360nn, 374(e);
42 U.S.C. 263b.
§ 814.9
§ 900.18
■
[Amended]
81. The authority citation for part 900
continues to read as follows:
[Amended]
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
PART 1010—PERFORMANCE
STANDARDS FOR ELECTRONIC
PRODUCTS: GENERAL
■
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
82. In § 900.18, amend paragraphs
(d)(2) and (4) by removing ‘‘Division of
Dockets Management’’ and adding in its
place ‘‘Dockets Management Staff’’.
83. The authority citation for part
1010 continues to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360, 360e360j, 360hh-360ss, 371, 381.
[Amended]
§ 1010.4
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
75. The authority citation for part 860
continues to read as follows:
■
lotter on DSK11XQN23PROD with RULES1
[Amended]
80. In § 895.21, amend paragraph
(d)(8) by removing ‘‘Division of Dockets
Management’’ and adding in its place
‘‘Dockets Management Staff’’.
■
Authority: 21 U.S.C. 321(h), 353(g), 360c,
360d, 360e, 360i, 360j, 371, 374.
§ 860.5
[Amended]
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’’.
■
VerDate Sep<11>2014
15:54 Jul 13, 2023
Jkt 259001
[Amended]
84. In § 1010.4, amend paragraph
(c)(3) by removing ‘‘Division of Dockets
Management’’ and adding in its place
‘‘Dockets Management Staff’’.
■ 85. In § 1010.5, revise paragraph (c)
introductory text to read as follows:
§ 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
Frm 00013
Fmt 4700
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
86. The authority citation for part
1240 continues to read as follows:
■
Authority: 42 U.S.C. 216, 243, 264, 271.
§ 1240.62
[Amended]
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
88. The authority citation for part
1250 continues to read as follows:
■
Authority: 42 U.S.C. 216, 243, 264, 271.
§ 1250.51
[Amended]
89. In § 1250.51, amend paragraph
(f)(4)(ii) by removing ‘‘Division of
Dockets Management’’ and adding in its
place ‘‘Dockets Management Staff’’.
■
■
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45067
Sfmt 4700
PART 1271—HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE–BASED
PRODUCTS
90. The authority citation for part
1271 continues to read as follows:
■
Authority: 42 U.S.C. 216, 243, 263a, 264,
271.
§ 1271.37
[Amended]
91. In § 1271.37, amend paragraph (a)
introductory text by removing ‘‘Division
of Dockets Management’’ and adding in
its place ‘‘Dockets Management Staff’’.
■
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45068
Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Rules and Regulations
Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
II Why is the Department promulgating
this Final Rule?
[FR Doc. 2023–14716 Filed 7–13–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
22 CFR Parts 41 and 42
[Public Notice: 12080]
RIN 1400–AF53
Visas: Nonimmigrant Visas; Immigrant
Visas
Department of State.
Final rule.
AGENCY:
ACTION:
The Department of State
(Department) amends its regulations
governing nonimmigrant and immigrant
visas to update classification symbols
and descriptions for certain immigrant
and nonimmigrant visas.
DATES: This final rule is effective on
September 12, 2023.
FOR FURTHER INFORMATION CONTACT:
Andrea Lage, Acting Senior Regulatory
Coordinator, Visa Services, Bureau of
Consular Affairs, 600 19th St. NW,
Washington, DC 20522, (202) 485–7586,
VisaRegs@state.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
lotter on DSK11XQN23PROD with RULES1
I. What changes to 22 CFR 41.12, 41.84,
and 42.11 does this Final Rule make?
The Department is amending 22 CFR
41.12 to include classification symbols
and related descriptions for the CW–1,
CW–2, E–2C, and T–6 visa
classifications. The Department is also
amending 22 CFR 42.11 to include
classification symbols and related
descriptions for surviving spouses and
children, as described in Section 403(a)
of the Emergency Security
Supplemental Appropriations Act, 2021
(‘‘ESSAA’’), Public Law 117–31, 135
Stat. 309, as well as classification
symbols and related descriptions for
EB–5 immigrant visas initiated by the
EB–5 Reform and Integrity Act of 2022,
Division BB of the Consolidated
Appropriations Act, 2022, Public Law
117–103 (‘‘EB–5 Reform and Integrity
Act’’). The changes in the classification
descriptions under this Final Rule will
have no impact on who may qualify for
such a visa; as such, this Final Rule will
not practically impact any current
applicant for any visa. This rule also
makes technical corrections to the
classification symbols for visa
classifications to ensure the accurate
inclusion of all active immigrant visa
classifications.
VerDate Sep<11>2014
15:54 Jul 13, 2023
Jkt 259001
A. T Visas, Victims of Trafficking in
Persons
The Trafficking Victims Protection
Reauthorization Act of 2008, Public Law
106–386 amended Section
101(a)(15)(T)(ii)(III) of the INA to
include parents and unmarried siblings
under the age of 18 whose eligibility for
T derivative classification is not tied to
the age of the principal applicant, but
rather to their present danger of
retaliation as a result of the principal’s
escape from trafficking or cooperation
with law enforcement, as determined by
U.S. Citizenship and Immigration
Services. These derivatives receive T–4
and T–5 visa classifications.
Additionally, Section 1221 of the
Violence Against Women
Reauthorization Act of 2013, Public Law
113–4, amended Section
101(a)(15)(T)(ii)(III) of the INA by
adding the T–6 derivative classification,
which is available to an eligible adult or
minor child of a T–1 principal
applicant’s derivative family member, if
such derivative’s adult or minor child
themself faces a present danger of
retaliation as a result of the principal’s
escape from trafficking or cooperation
with law enforcement.
Classification symbols in existing
regulations at 22 CFR 41.12 do not
reflect the 2013 expansion of eligibility
for the adult or minor child of a
derivative beneficiary, and to address
this, this rule amends 22 CFR 41.12 to
add the T–6 classification symbol and
description. This rule also adds details
to existing descriptions of the T–4 and
T–5 visa classification to better reflect
the statutory criteria. The rule further
amends 22 CFR 41.84 to reflect the
current language more closely in INA
section 101(a)(15)(T)(ii) which describes
the family members who may qualify for
T nonimmigrant status as certain
accompanying or following-to-join
derivative family members of a
principal T–1 nonimmigrant. These
classification codes are consistent with
those used by the Department of
Homeland Security.
B. CW Visas—Commonwealth of
Northern Mariana Islands (CNMI)
Transitional Workers
Section 6 of the Covenant to Establish
a Commonwealth of the Northern
Mariana Islands in Political Union with
the United States of America, Public
Law 94–241, as amended by Section
702(a) of the Consolidated Natural
Resources Act of 2008, Public Law 110–
229, provides for nonimmigrant visas
for certain CNMI transitional workers,
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Fmt 4700
Sfmt 4700
investors, and their spouses and
children. The Department classifies
CNMI transitional workers as CW–1,
spouses, or children of a CW–1 as a
CW–2, and CNMI investors and their
spouses or children as E–2C. This rule
adds these nonimmigrant visa
classifications to 22 CFR 41.12. These
classification codes are consistent with
those used by the Department of
Homeland Security.
C. SS1 Classification—Surviving
Spouses and Children of United States
Government Employees Abroad
Section 403(a) of the ESSAA amended
INA Section 101(a)(27)(D), 8 U.S.C.
1101(a)(27)(D), to change the definition
of a special immigrant to include ‘‘the
surviving spouse or child of an
employee of the United States
Government abroad: Provided, [t]hat the
employee performed faithful service for
a total of not less than 15 years or was
killed in the line of duty.’’ The
Department classifies each surviving
spouse and child of an employee of the
United States Government abroad as an
SS1. While this Final Rule does not
address the parameters under which a
noncitizen may qualify for issuance of
an SS1 immigrant visa, this rule adds
these special immigrant visa
classifications to 22 CFR 42.11.
D. EB–5 Program Changes
The EB–5 Reform and Integrity Act
made substantial changes to Section
203(b)(5) of the INA, 8 U.S.C. 1153(b)(5).
The EB–5 Reform and Integrity Act sets
forth an allocation of visas to qualified
immigrant investors who invest in new
commercial enterprises and satisfy
applicable job creation requirements.
Certain percentages of these visas are
reserved for investors in rural areas,
investors in areas designated by the
Department of Homeland Security
(DHS) as high unemployment areas, and
investors in infrastructure projects.
The EB–5 Reform and Integrity Act
repealed the former Regional Center
Program under section 610 of Public
Law 102–395 and authorized a new
Regional Center Program. As a result of
the new legislation, the Visa Office is
adding new EB–5 classification
symbols. An investor in a non-regional
center for an unreserved visa is
classified as NU–1 and the spouse and
children of an NU–1 applicant are
classified as an NU–2 and NU–3,
respectively. An investor in a regional
center for an unreserved visa is
classified as an RU–1 applicant, and the
spouse and children of an RU–1
applicant are classified as an RU–2 and
RU–3, respectively. An applicant for a
reserved visa who is an investor in a
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]]>Agencies
[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
