[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7148]


[Federal Register: March 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5, 7, 10, 12, 25, 60, 101, 109, 184, 314, 330, 500, 
509, 520, 522, 524, 558, 808, 1010, 1030, 1240, and 1250


Foods and Drugs; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to correct the address for FDA's Dockets Management Branch. 
A notice announcing the new address for the Dockets Management Branch 
was published in the Federal Register of June 10, 1991 (56 FR 26688). 
This action is being taken to improve the accuracy of the regulations.

EFFECTIVE DATE: March 28, 1994.

FOR FURTHER INFORMATION CONTACT: Robin Thomas Johnson, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 10, 1991 (56 
FR 26688), FDA announced the relocation of the Dockets Management 
Branch, effective June 14, 1991, and listed its new address as the 
``Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr. Rockville, MD 20857.'' In this document, 
FDA is amending certain portions of its regulations to reflect the 
correct address.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.

List of Subjects

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 Part 12

    Administrative practice and procedure.

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 101

    Food Labeling, Reporting and recordkeeping requirements.

21 CFR Part 109

    Food packaging, Foods, Polychlorinated biphenyls (PCB's).

21 CFR Part 184

    Food ingredients.

21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 330

    Over-the-counter drugs.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated 
biphenyls (PCB's).

21 CFR Part 509

    Animal foods, Packaging and containers, Polychlorinated biphenyls 
(PCB's).

21 CFR Part 520

    Animal drugs.

21 CFR Part 522

    Animal drugs.

21 CFR Part 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

21 CFR Part 808

    Intergovernmental relations, Medical devices.

21 CFR Part 1010

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

21 CFR Part 1030

    Electronic products, Microwave ovens, Radiation protection.

21 CFR Part 1240

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

21 CFR Part 1250

    Air carriers, Foods, Maritime carriers, Motor carriers, Public 
health, Railroads, Water supply.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
5, 7, 10, 12, 25, 60, 101, 109, 184, 314, 330, 500, 509, 520, 522, 524, 
558, 808, 1010, 1030, 1240, and 1250 are amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    1. The authority citation for 21 CFR part 5 continues to read as 
follows:

    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
secs. 301, 302, 303, 307, 310, 311, 351, 352, 361, 362, 1701-1706, 
2101, 2125, 2127, 2128 of the Public Health Service Act (42 U.S.C. 
241, 242, 242a, 242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 
300aa-1, 300aa-25, 300aa-27, 300aa-28); 42 U.S.C. 1395y, 3246b, 
4332, 4831(a), 10007-10008; E.O. 11490, 11921, and 12591; secs. 312, 
313, 314, of the National Childhood Vaccine Injury Act of 1986, Pub. 
L. 99-660 (42 U.S.C. 300aa-1 note).

Sec.  5.110  [Amended]

    2. Section 5.110 FDA Public Information Offices is amended in 
paragraph (a) by removing ``Room 4-62, Parklawn Building, 5600 Fishers 
Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 7--ENFORCEMENT POLICY

    3. The authority citation for 21 CFR part 7 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-393); secs. 301, 351, 354-360F, 361 of the Public 
Health Service Act (42 U.S.C. 241, 262, 263b-263n, 264).

Sec.  7.42  [Amended]

    4. Section 7.42 Recall strategy is amended in paragraph (b)(3) by 
removing ``Room 4-62, 5600 Fishers Lane,'' and adding in its place 
``rm. 1-23, 12420 Parklawn Dr.,''.

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    5. The authority citation for 21 CFR part 10 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-394); 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 
1034; secs. 2, 351, 354, 361 of the Public Health Service Act (42 
U.S.C. 201, 262, 263b, 264); secs. 2-12 of the Fair Packaging and 
Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. 551-558, 701-706; 28 
U.S.C. 2112.

Sec. 10.3  [Amended]

    6. Section 10.3 Definitions is amended in paragraph (a) in the 
definition for ``Dockets Management Branch'' by removing ``Room 4-62, 
5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn 
Dr.,''.


Sec. 10.20  [Amended]

    7. Section 10.20 Submission of documents to Dockets Management 
Branch; computation of time; availability for public disclosure is 
amended in paragraph (f) by removing ``Room 4-62, 5600 Fishers Lane,'' 
and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 10.30  [Amended]

    8. Section 10.30 Citizen petition is amended in paragraph (b) by 
removing ``Room 4-62, 5600 Fishers Lane,'' and adding in its place 
``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 10.33  [Amended]

    9. Section 10.33 Administrative reconsideration of action is 
amended in paragraph (b) by removing ``Room 4-62, 5600 Fishers Lane,'' 
and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 10.35  [Amended]

    10. Section 10.35 Administrative stay of action is amended in 
paragraph (b) by removing ``Room 4-62, 5600 Fishers Lane,'' and adding 
in its place ``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 10.85  [Amended]

    11. Section 10.85 Advisory opinions is amended in paragraph (b) by 
removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 
1-23, 12420 Parklawn Dr.,''.

PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

    12. The authority citation for 21 CFR part 12 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-393); 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 
1034; secs. 2, 351, 354-360F, 361 of the Public Health Service Act 
(42 U.S.C. 201, 262, 263b-263n, 264); secs. 2-12 of the Fair 
Packaging and Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. 551-558, 
701-706; 28 U.S.C. 2112.

Sec. 12.45  [Amended]

    13. Section 12.45 Notice of participation is amended in paragraph 
(a) by removing ``Room 4-62, 5600 Fishers Lane,'' and adding in its 
place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

    14. The authority citation for 21 CFR part 25 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-393); secs. 351, 354-361 of the Public Health 
Service Act (42 U.S.C. 262, 263b-264); 42 U.S.C. 4321, 4332; 40 CFR 
parts 1500-1508; E.O. 11514 as amended by E.O. 11991; E.O. 12114.

Sec. 25.42  [Amended]

    15. Section 25.42 Actions for which an environmental impact 
statement is prepared is amended in paragraph (b)(3)(v) by removing 
``5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 
Parklawn Dr.,''.

PART 60--PATENT TERM RESTORATION

    16. The authority citation for 21 CFR part 60 continues to read as 
follows:

    Authority:  Secs. 409, 505, 507, 515, 520, 701, 706 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348, 355, 357, 360e, 
360j, 371, 376); sec. 351 of the Public Health Service Act (42 
U.S.C. 262); 35 U.S.C. 156.

Sec. 60.20  [Amended]

    17. Section 60.20 FDA action on regulatory review period 
determinations is amended in paragraph (b) by removing ``Rm. 4-62, 5600 
Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn 
Dr.,''.


Sec. 60.24  [Amended]

    18. Section 60.24 Revision of regulatory review period 
determinations is amended in the introductory text of paragraph (a) by 
removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 
1-23, 12420 Parklawn Dr.,''.


Sec. 60.26  [Amended]

    19. Section 60.26 Final action on regulatory review period 
determinations is amended in paragraph (b)(2) by removing ``Rm. 4-62, 
5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn 
Dr.,''.

PART 101--FOOD LABELING

    20. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority:  Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

Sec. 101.108  [Amended]

    21. Section 101.108 Temporary exemptions for purposes of conducting 
authorized food labeling experiments is amended in paragraph (c) by 
removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 
1-23, 12420 Parklawn Dr.,''.

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

    22. The authority citation for 21 CFR part 109 continues to read as 
follows:

    Authority: Secs. 201, 306, 402, 406, 408, 409, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 336, 342, 346, 
346a, 348, 371).

Sec. 109.30  [Amended]

    23. Section 109.30 Tolerances for polychlorinated biphenyls (PCB's) 
is amended in paragraph (b) by removing ``Room 4-62, Parklawn Building, 
5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn 
Dr.,''; in paragraphs (c) and (d) by removing ``Rm. 4-62, 5600 Fishers 
Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,'' the 
three times it appears.

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    24. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

Sec. 184.1538  [Amended]

    25. Section 184.1538 Nisin preparation is amended in paragraphs (b) 
and (d) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its 
place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 201--LABELING

    26. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508, 
510, 512, 530-542, 701, 704, 721, of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 
360, 360b, 360gg-360ss, 371, 374, 379e); secs. 215, 301, 351, 361 of 
the Public Health Service Act (42 U.S.C. 216, 241, 262, 264).

Sec. 201.63  [Amended]

    27. Section 201.63 Pregnancy-nursing warning is amended in 
paragraph (d) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding 
in its place ``rm. 1-23, 12420 Parklawn Dr.,''.

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

    28. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority:  Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701, 
704, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 
331, 351, 352, 353, 355, 356, 357, 371, 374, 379e).

Sec. 314.200  [Amended]

    29. Section 314.200 Notice of opportunity for hearing; notice of 
participation and request for hearing; grant or denial of hearing is 
amended in paragraph (c)(1) by removing ``Rm. 4-62,'' and adding in its 
place ``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 314.300  [Amended]

    30. Section 314.300 Procedure for the issuance, amendment, or 
repeal of regulations is amended in paragraph (b)(4) by removing ``Rm. 
4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 
Parklawn Dr.,''.

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

    31. The authority citation for 21 CFR part 330 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371).

Sec. 330.1  [Amended]

    32. Section 330.1 General conditions for general recognition as 
safe, effective and not misbranded is amended in paragraph (g) by 
removing ``Room 4-62, Parklawn Building, 5600 Fishers Lane,'' and 
adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 500--GENERAL

    33. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512, 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 
342, 343, 348, 351, 352, 353, 360b, 371).

Sec. 500.80  [Amended]

    34. Section 500.80 Scope of this subpart is amended in paragraph 
(a) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its 
place ``rm. 1-23, 12420 Parklawn Dr.,''.

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

    35. The authority citation for 21 CFR part 509 continues to read as 
follows:

    Authority: Secs. 306, 402, 406, 408, 409, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 336, 342, 346, 346a, 348, 
371).

Sec. 509.30  [Amended]

    36. Section 509.30 Temporary tolerances for polychlorinated 
biphenyls (PCB'S) is amended in paragraph (b) by removing ``Room 4-62, 
Parklawn Building, 5600 Fishers Lane,'' and adding in its place ``rm. 
1-23, 12420 Parklawn Dr.,''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    37. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 520.2640  [Amended]

    38. Section 520.2640 Tylosin is amended in paragraph (a) by 
removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 
1-23, 12420 Parklawn Dr.,''.

PART 522--IMPLANTATION OR INJECTIBLE DOSAGE FORM NEW ANIMAL DRUGS

    39. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 522.2640a  [Amended]

    40. Section 522.2640a Tylosin injection is amended in paragraph (a) 
by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place 
``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 522.2640b  [Amended]

    41. Section 522.2640b Tylosin tartrate for injection is amended in 
paragraph (a) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding 
in its place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    42. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 524.2640  [Amended]

    43. Section 524.2640 Tylosin, neomycin eye powder is amended in 
paragraph (a) by removing ``Rm. 4-62, 5600 Fishers Lane'' and adding in 
its place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    44. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.625  [Amended]

    45. Section 558.625 Tylosin is amended in paragraph (a) by removing 
``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 
12420 Parklawn Dr.,''.

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

    46. The authority citation for 21 CFR part 808 continues to read as 
follows:

    Authority: Secs. 521, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360k, 371).

Sec. 808.20   [Amended]

    47. Section 808.20 Application is amended in paragraph (b) by 
removing ``Rm. 4-62, Parklawn Building, 5600 Fishers Lane,'' and adding 
in its place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

    48. The authority citation for 21 CFR part 1010 continues to read 
as follows:

    Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 
371, 381); secs. 354-360F of the Public Health Service Act (42 
U.S.C. 263b-263n).

Sec. 1010.4   [Amended]

    49. Section 1010.4 Variances is amended in the introductory text of 
paragraph (b) by removing ``Rm. 4-62, Parklawn Building, 5600 Fishers 
Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.


Sec. 1010.5  [Amended]

    50. Section 1010.5 Exemptions for products intended for United 
States Government use is amended in the introductory text of paragraph 
(c) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its 
place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY 
EMITTING PRODUCTS

    51. The authority citation for 21 CFR part 1030 continues to read 
as follows:

    Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 
371, 381); secs. 354-360F of the Public Health Service Act (42 
U.S.C. 263b-263n).


Sec. 1030.10  [Amended]

    52. Section 1030.10 Microwave ovens is amended in paragraph 
(c)(6)(iv) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in 
its place ``rm. 1-23, 12420 Parklawn Dr.,''.

PART 1240--CONTROL OF COMMUNICABLE DISEASES

    53. The authority citation for 21 CFR part 1240 continues to read 
as follows:

    Authority: Secs. 215, 311, 361, 368 of the Public Health Service 
Act (42 U.S.C. 216, 243, 264, 271).

Sec. 1240.62  [Amended]

    54. Section 1240.62 Turtles intrastate and interstate requirements 
is amended in paragraph (e) by removing ``Room 4-62, Parklawn Building, 
5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn 
Dr.,''.

PART 1250--INTERSTATE CONVEYANCE SANITATION

    55. The authority citation for 21 CFR part 1250 continues to read 
as follows:

    Authority: Secs. 215, 311, 361, 368 of the Public Health Service 
Act (42 U.S.C. 216, 243, 264, 271).

Sec. 1250.51  [Amended]

    56. Section 1250.51 Railroad conveyances; discharge of wastes is 
amended in paragraph (f)(4)(ii) by removing ``Room 4-62, Parklawn 
Building, 5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 
12420 Parklawn Dr.,''.

    Dated: March 22, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-7148 Filed 3-25-94; 8:45 am]
BILLING CODE 4160-01-F