Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10819 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 510, 

520, and 522 are amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for part 510 

continues to read as follows: 

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

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entries for 

‘‘Alaco, Inc.’’, ‘‘OXIS International, 

Inc.’’, ‘‘RSR Laboratories, Inc.’’, and 

‘‘Walco International, Inc.’’; and in the 

table in paragraph (c)(2), remove the 

entries for ‘‘024991’’, ‘‘049185’’, 

‘‘058670’’, and ‘‘064146’’. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for part 520 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. Revise § 520.260 to read as follows: 

§ 520.260 n-Butyl chloride. 

(a) Specifications. Each capsule 

contains 221, 442, 884, or 1,768 

milligrams (mg); or 4.42 grams of nbutyl chloride. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter: 

(1) No. 023851 for capsules containing 

221, 442, 884, or 1,768 mg, or 4.42 

grams (g); and 

(2) No. 054771 for capsules containing 

221 mg. 

(c) Conditions of use in dogs—(1) 

Amount. Administer capsules orally 

based on body weight as follows: 

(i) Capsules containing 221 mg: Under 

5 pounds, 1 capsule per 11⁄4 pounds of 

body weight. 

(ii) Capsules containing 442 mg: 

Under 5 pounds, 1 capsule per 21⁄2

pounds of body weight. 

(iii) Capsules containing 884 mg: 

(A) Under 5 pounds, 1 capsule; 

(B) 5 to 10 pounds, 2 capsules; 

(C) 10 to 20 pounds, 3 capsules; 

(D) 20 to 40 pounds, 4 capsules; 

(E) Over 40 pounds, 5 capsules. 

(iv) Capsules containing 1,768 mg: 

Dogs weighing 5 to 10 pounds, 1 

capsule. 

(v) Capsules containing 4.42 g: Dogs 

weighing 40 pounds or over, 1 capsule. 

(2) Indications for use. For the 

removal of ascarids (Toxocara canis and 

Toxascaris leonina) and hookworms 

(Ancylostoma caninum, Ancylostoma 

braziliense, and Uncinaria 

stenocephala) from dogs. 

(3) Limitations. Dogs should not be 

fed for 18 to 24 hours before being given 

the drug. Administration of the drug 

should be followed in 1⁄2 to 1 hour with 

a mild cathartic. Normal feeding may be 

resumed 4 to 8 hours after treatment. 

Animals subject to reinfection may be 

retreated in 2 weeks. A veterinarian 

should be consulted before using in 

severely debilitated dogs. 

§ 520.580 [Amended] 

■ 5. In § 520.580, in paragraph (b)(1), 

remove ‘‘Nos. 017135, 023851, and 

058670’’ and in its place add ‘‘Nos. 

017135 and 023851’’. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 6. The authority citation for part 522 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 522.84 [Removed] 

■ 7. Remove § 522.84. 

§ 522.518 [Removed] 

■ 8. Remove § 522.518. 

§ 522.1620 [Removed] 

■ 9. Remove § 522.1620. 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03251 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, and 522 

[Docket No. FDA–2019–N–5405] 

New Animal Drugs; Withdrawal of 

Approval of New Animal Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of seven new animal drug 

applications (NADAs) from multiple 

holders of these applications. The basis 

for the withdrawals is that the holders 

of these applications have repeatedly 

failed to file required annual reports for 

the applications. 

DATES: Withdrawal of approval is 

effective February 23, 2021. 

FOR FURTHER INFORMATION CONTACT: 

David Alterman, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5720, 

david.alterman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holders of approved applications to 

market new animal drugs are required to 

submit annual reports to FDA 

concerning each of their approved 

applications in accordance with 

§ 514.80 (21 CFR 514.80). 

In the Federal Register of January 8, 

2020 (85 FR 919), FDA published a 

notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of seven NADAs 

because the sponsors had failed to 

submit the required annual reports for 

these applications. The holders of these 

applications did not respond to the 

NOOH. Failure to file a written notice 

of participation and request for a 

hearing as required by § 514.200(b) (21 

CFR 514.200(b)) constitutes an election 

by the applicant not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and a waiver of any 

contentions concerning the legal status 

of the drug products. Therefore, 

approval of the seven applications listed 

in table 1 is being withdrawn. 

TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Trade name 

(drug) Sponsor 

031–971 ............. CUPRATE (cupric glycinate) .................................................... Walco International, Inc., 15 West Putnam, Porterville, CA 

93257. 

10820 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 

1 37 CFR 202.4; see 17 U.S.C. 408(c)(1). 

2 37 CFR 202.4(c)–(k). 3 84 FR 22762 (May 20, 2019). 

TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN—Continued 

Application No. Trade name 

(drug) Sponsor 

045–863 ............. PALOSEIN (orgotein) ............................................................... OXIS International, Inc., 6040 N. Cutter Circle, suite 317, 

Portland, OR 97217–3935. 

046–922 ............. SERGEANTS SURE SHOT (n-butyl chloride) Capsules ........ ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, 

NE 68105. 

046–923 ............. SERGEANTS (n-butyl chloride) Puppy Worm Capsules ......... ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, 

NE 68105. 

065–067 ............. Tetracycline Hydrochloride Tablets .......................................... Premo Pharmaceutical Laboratories, Inc., 111 Leuning St., 

South Hackensack, NJ 07606. 

140–850 ............. ELITE (dichlorophene and toluene) Dog and Cat Wormer ..... RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620. 

141–107 ............. BAPTEN for Injection (+-aminopropionitrile fumarate) ............ Alaco, Inc., 1500 North Wilmot Rd., suite 290–C, Tucson, AZ 

85712. 

The Commissioner of Food and Drugs 

(the Commissioner), under section 

512(e)(2)(A) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

360b(e)(2)(A)), finds that the holders of 

the applications listed in this document 

have repeatedly failed to submit reports 

required by § 514.80. In addition, under 

§ 514.200(b), the Commissioner finds 

that the holders of the applications have 

waived any contentions concerning the 

legal status of the drug products. 

Therefore, under these findings, 

approval of the applications listed in 

this document, and all amendments and 

supplements thereto, is hereby 

withdrawn, effective February 23, 2021. 

Elsewhere in this issue of the Federal 

Register, FDA is amending the animal 

drug regulations to reflect the 

withdrawal of approval of these 

applications. 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03250 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

LIBRARY OF CONGRESS 

Copyright Office 

37 CFR Parts 201 and 202 

[Docket No. 2019–4] 

Group Registration of Works on an 

Album of Music 

AGENCY: U.S. Copyright Office, Library 

of Congress. 

ACTION: Final rule. 

SUMMARY: The U.S. Copyright Office is 

creating a new group registration option 

for musical works, sound recordings, 

and certain other works contained on an 

album. This option will permit the 

registration of a group of musical works 

or a group of sound recordings 

distributed together, regardless of 

whether such distribution occurs via 

physical or digital media. The final rule 

generally adopts the provisions set forth 

in the May 2019 notice of proposed 

rulemaking in this proceeding, with 

certain updates to reflect the planned 

implementation of new online 

applications for this option. 

DATES: Effective March 26, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Regan A. Smith, General Counsel and 

Associate Register of Copyrights, by 

email at regans@copyright.gov; Robert 

Kasunic, Associate Register of 

Copyrights and Director of Registration 

Policy and Practice, by email at rkas@

copyright.gov; or John R. Riley, 

Assistant General Counsel, by email at 

jril@copyright.gov. Each can be 

contacted by telephone at 202–707– 

8350. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Copyright Act authorizes the 

Register of Copyrights to specify by 

regulation the administrative classes of 

works available for the purpose of 

seeking a registration and the nature of 

the deposits required for each class. In 

addition, Congress gave the Register the 

discretion to allow registration of groups 

of related works with one application 

and one filing fee, a procedure known 

as ‘‘group registration.’’ 1 Pursuant to 

this authority, the Register has issued 

regulations permitting the Office to 

issue group registrations for certain 

types of works, including for groups of 

newspapers, unpublished works, 

newsletters and serials, unpublished 

and published photographs, 

contributions to periodicals, secure test 

items, and short online literary works.2

On May 20, 2019, the Office 

published a Notice of Proposed 

Rulemaking (‘‘NPRM’’) proposing to 

create a new group registration option 

for musical works, sound recordings, 

and associated literary, pictorial, and 

graphic works contained on an album. 

This option is referred to as ‘‘Group 

Registration of Works on an Album of 

Music,’’ or ‘‘GRAM.’’ 3 The proposed 

rule would allow an applicant to 

register up to twenty musical works and 

twenty sound recordings, i.e., forty total 

works, if the works were fixed in the 

same phonorecord, if the works were 

created by the same author or had at 

least one common author, and if the 

claimant for each work in the group was 

the same. The proposed rule also would 

permit the registration of associated 

literary, pictorial, and graphic works in 

the album, such as cover art, liner notes, 

or posters. To exercise this option, the 

Office proposed that applicants would 

be required to submit their claims 

through the online copyright 

registration system using the Standard 

Application. 

The Office received thirteen 

comments in response to the NPRM, 

eleven from individuals, one from the 

National Music Publishers Association 

(‘‘NMPA’’), and a joint comment by the 

American Association of Independent 

Music (‘‘A2IM’’) and the Recording 

Industry Association of America 

(‘‘RIAA’’). Each commenter supported 

the Office’s proposal to create the new 

group registration option, though some 

suggested various amendments to the 

proposed rule, including removing the 

proposed limit on the number of works 

that may be included in each claim and 

clarifying who could be listed as a 

claimant of a work in a GRAM 

registration. 

Having reviewed and carefully 

considered the submitted comments, the 

Office now issues a final rule that 

generally follows the proposed rule, 

with some modifications. First, the rule 

requires claims under this option to be 

submitted using a new online