New Animal Drugs; Approval of New Animal Drug Applications, 17061-17065 [2021-06704]
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Rules and Regulations
207.13, 207.49, and 207.53 (21 CFR
207.1, 207.3, 207.13, 207.49, and
207.53) by replacing all cross-references
to ‘‘§ 207.1(b)’’ with ‘‘§ 207.1’’.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 207
[Docket No. FDA–2005–N–0464]
RIN 0910–AA49
Requirements for Foreign and
Domestic Establishment Registration
and Listing for Human Drugs,
Including Drugs That Are Regulated
Under a Biologics License Application,
and Animal Drugs; Corrections
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; correcting
amendments.
AGENCY:
On August 31, 2016, the Food
and Drug Administration (FDA or
Agency) published an amended final
rule that listed inaccurate crossreferences to FDA’s drug establishment
registration and drug listing regulations.
This document corrects the inaccurate
cross-references used in the final
regulations.
SUMMARY:
DATES:
This rule is effective April 1,
2021.
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3521.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 31,
2016 (81 FR 60170), FDA published the
final rule entitled ‘‘Requirements for
Foreign and Domestic Establishment
Registration and Listing for Human
Drugs, Including Drugs That Are
Regulated Under a Biologics License
Application, and Animal Drugs.’’ That
final rule amended current regulations
in part 207 (21 CFR part 207)
concerning who must register
establishments and list human drugs,
human drugs that are also biological
products, and animal drugs.
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II. Description of the Technical
Amendments
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List of Subjects in 21 CFR Part 207
Drugs, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, 21 CFR part
207 is amended as follows:
PART 207—REQUIREMENTS FOR
FOREIGN AND DOMESTIC
ESTABLISHMENT REGISTRATION
AND LISTING FOR HUMAN DRUGS,
INCLUDING DRUGS THAT ARE
REGULATED UNDER A BIOLOGICS
LICENSE APPLICATION, AND ANIMAL
DRUGS, AND THE NATIONAL DRUG
CODE
1. The authority citation for part 207
continues to read as follows:
■
FDA is amending its regulations in
part 207 to correct inaccurate crossreferences used in the August 31, 2016,
final rule. This document amends the
Agency’s regulations in part 207
through minor technical amendments to
update references in §§ 207.1, 207.3,
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III. Notice and Public Comment
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(APA) (5 U.S.C. 553). Section 553 of the
APA exempts ‘‘rules of agency
organization, procedure, or practice’’
from proposed rulemaking (i.e., notice
and comment rulemaking) (5 U.S.C.
553(b)(3)(A)). Rules are also exempt
when an Agency finds ‘‘good cause’’
that notice and comment rulemaking
procedures would be ‘‘impracticable,
unnecessary, or contrary to the public
interest’’ (5 U.S.C. 553(b)(3)(B).)
FDA has determined that this
rulemaking meets the notice and
comment exemption requirements in 5
U.S.C. 553(b)(3)(A) and (B). FDA’s
revisions make only technical changes
to correct inaccurate cross-references.
FDA does not believe public comment
is necessary for these minor revisions.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
and published with the rule’’ (5 U.S.C.
553(d)(3)). A delayed effective date is
unnecessary in this case because the
amendments do not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
cause for the amendments to become
effective on the date of publication of
this action.
Authority: 21 U.S.C. 321, 331, 351, 352,
355, 360, 360b, 371, 374, 381, 393; 42 U.S.C.
262, 264, 271.
§ 207.1
[Amended]
2. Amend § 207.1 in the definition of
Bulk drug substance by removing
■
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17061
‘‘§ 207.1(b)’’ and adding in its place
‘‘this section’’.
§ 207.3
[Amended]
3. Amend § 207.3 by removing
‘‘§ 207.1(b)’’ and adding in its place
‘‘§ 207.1’’.
■
§ 207.13
[Amended]
4. Amend § 207.13(l)(1) by removing
‘‘§ 207.1(b)’’ and adding in its place
‘‘§ 207.1’’.
■
§ 207.49
[Amended]
5. Amend § 207.49(a)(15)(i),
(a)(15)(ii)(A) and (B), and (a)(15)(iii)(A)
and (B) by removing ‘‘§ 207.1(b)’’ and
adding in its place ‘‘§ 207.1’’.
■
§ 207.53
[Amended]
6. Amend § 207.53(d)(1), (d)(2)(i) and
(ii), and (d)(3)(i) and (ii) by removing
‘‘§ 207.1(b)’’ and adding in its place
‘‘§ 207.1’’.
■
Dated: March 25, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–06677 Filed 3–31–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 528,
and 558
[Docket No. FDA–2020–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications
Food and Drug Administration,
Department of Health and Human
Services.
ACTION: Final rule; technical
amendments.
AGENCY:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during October,
November, and December 2020. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve the accuracy and
readability of the regulations.
DATES: This rule is effective April 1,
2021.
SUMMARY:
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
October, November, and December
2020, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents may be
seen in the office of the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500. Persons
with access to the internet may obtain
these documents at the CVM FOIA
Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2020
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Approval date
File No.
Sponsor
Product
name
Species
ELURA
(capromorelin
oral solution).
CYCLAVANCE
(cyclosporine oral
solution)
USP
MODIFIED.
STELFONTA
(tigilanol
tiglate injection).
Dogs and cats .......
TZED
(tiletamine and
zolazepam for injection).
pPL657
rDNA
construct
in domestic
pigs.
Dogs ......................
SELASPOT
(selamectin) Topical Solution.
October 16, 2020 ............
141–536
Elanco US Inc., 2500
Innovation Way,
Greenfield, IN 46140.
October 29, 2020 ............
200–692
Virbac AH, Inc., P.O.
Box 162059, Fort
Worth, TX 76161.
November 16, 2020 ........
141–541
QBiotics Group Ltd.,
Suite 3A, Level 1,
165 Moggill Rd.,
Taringa, Queensland
4068, Australia.
November 25, 2020 ........
200–557
Dechra Veterinary
Products LLC, 7015
College Blvd., Suite
525, Overland Park,
KS 66211.
December 14, 2020 ........
141–542
December 16, 2020 ........
200–696
Revivicor, Inc., a wholly
owned subsidiary of
United Therapeutics
Corp., 1700 Kraft Dr.,
Suite 2400,
Blacksburg, VA
24060.
Bimeda Animal Health
Ltd., 1B The Herbert
Building, The Park,
Carrickmines, Dublin
18, Ireland.
As provided in the regulatory text, the
animal drug regulations are amended to
reflect these approval actions. As they
are now the sponsor of an approved
application, QBiotics Group Ltd. and
Revivicor, Inc. will be added to the list
of sponsors of approved applications in
21 CFR 510.600(c).
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FOI Summary.
Original approval for
the treatment of nonmetastatic cutaneous
mast cell tumors and
non-metastatic subcutaneous mast cell
tumors located at or
distal to the elbow or
the hock in dogs.
Supplemental approval
for an intravenous
route.
FOI Summary.
Swine .....................
Original approval for an
intentional genomic
alteration in domestic
pigs.
FOI Summary.
Dogs and cats .......
Original approval as a
generic copy of
NADA 141–152.
FOI Summary.
Dogs ......................
Dogs ......................
FDA is making the following
amendments to improve the accuracy,
consistency, and readability of the
animal drug regulations:
• 21 CFR 558.128 is amended to
reflect the sponsors of approved
conditions of use for chlortetracycline
in beef cattle.
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Public
documents
Original approval for
management of
weight loss in cats
with chronic kidney
disease.
Original approval as a
generic copy of
NADA 141–218.
II. Technical Amendments
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Effect of the action
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FOI Summary.
FOI Summary.
• 21 CFR 558.342 is amended to
reformat special considerations for
labeling and manufacture of
melengestrol medicated feeds.
• Typographical errors are being
corrected wherever they have been
found.
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Rules and Regulations
III. Legal Authority
This rule sets forth technical
amendments to the regulations to codify
recent actions on approved new animal
drug applications and corrections to
improve the accuracy of the regulations,
and as such does not impose any burden
on regulated entities. This rule is issued
under section 512(i) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of the
conditions of use of an approved or
conditionally approved new animal
drug and the name and address of the
drug′s sponsor in a ‘‘notice, which upon
publication shall be effective as a
regulation.’’ A notice published
pursuant to section 512(i) is not subject
to the notice-and-comment rulemaking
requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See
section 512(i) of the FD&C Act; 21 CFR
10.40(e)(3); S. Rep. 90–1308, at 5 (1968).
This document does not meet the
definition of ‘‘rule’’ in 5 U.S.C.
804(3)(A) because it is a ‘‘rule of
particular applicability.’’ Therefore, it is
not subject to the congressional review
requirements in 5 U.S.C. 801–808.
Likewise, this is not a rule subject to
Executive Order 12866, which defines a
rule as ‘‘an agency statement of general
applicability and future effect, which
the agency intends to have the force and
effect of law, that is designed to
implement, interpret, or prescribe law
or policy or to describe the procedure or
practice requirements of an agency.’’
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, 522, 524, 528, and 558 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.
2. In § 510.600:
a. In the table in paragraph (c)(1), add
entries for ‘‘QBiotics Group Ltd.’’ and
‘‘Revivicor, Inc.’’ in alphabetical order;
and
■ b. In the table in paragraph (c)(2), add
entries for ‘‘086132’’ and ‘‘086134’’ in
numerical order.
The additions read as follows:
■
■
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, 524, and 528
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
*
*
*
(c) * * *
(1) * * *
*
*
Drug
labeler code
Firm name and address
*
*
*
*
*
*
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia ......................................................
*
*
*
*
*
*
*
Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060 .......
*
*
*
*
*
*
*
086132
086134
*
(2) * * *
Drug
labeler code
Firm name and address
*
*
*
*
*
*
*
086132 .................................. QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia
086134 .................................. Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg,
VA 24060
*
*
*
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. In § 520.292, revise paragraphs (a)
and (c) to read as follows:
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■
Capromorelin.
(a) Specifications. Each milliliter of
solution contains:
(1) 30 milligrams (mg) capromorelin;
or
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*
(2) 20 mg capromorelin.
*
*
*
*
(c) Conditions of use—(1) Dogs. Use
product described in paragraph (a)(1) of
this section as follows:
(i) Amount. Administer 3 mg/kg once
daily by mouth.
(ii) Indications for use. For appetite
stimulation in dogs.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats. Use product described in
paragraph (a)(2) of this section as
follows:
*
■
§ 520.292
*
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*
*
(i) Amount. Administer 2 mg/kg once
daily by mouth.
(ii) Indications for use. For
management of weight loss in cats with
chronic kidney disease.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
5. In § 520.522, add paragraph (b)(3) to
read as follows:
■
§ 520.522
*
Cyclosporine.
*
*
(b) * * *
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*
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Rules and Regulations
§ 528.2001 pPL657 recombinant
deoxyribonucleic acid construct.
(2) No. 051311 for use as in
paragraphs (c)(1)(i)(A), (c)(1)(ii)(A),
(c)(1)(iii), and (c)(2) of this section.
*
*
*
*
*
(3) No. 051311 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(1) of this
section.
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
9. The authority citation for part 524
continues to read as follows:
■
6. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Authority: 21 U.S.C. 360b.
■
§ 522.2450
■
Tigilanol.
(a) Specifications. Each milliliter (mL)
of solution contains 1 milligram
tigilanol tiglate.
(b) Sponsor. See No. 086132 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer as an intratumoral
injection at a dose of 0.5 mL per cubic
centimeter of tumor volume.
(2) Indications for use. For the
treatment of non-metastatic cutaneous
mast cell tumors and non-metastatic
subcutaneous mast cell tumors located
at or distal to the elbow or the hock in
dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
8. In § 522.2470, revise paragraphs
(b)(1) and (2) to read as follows:
■
§ 522.2470
injection.
Tiletamine and zolazepam for
*
*
*
*
*
(b) * * *
(1) Nos. 026637 and 054771 for use as
in paragraph (c) of this section.
Combination
in
grams/
ton
Chlortetracycline
amount
*
(xv) 350
mg/
head/
day.
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...............
■
*
§ 524.2098
*
13. The authority citation for part 558
continues to read as follows:
■
14. In § 558.128, revise paragraph
(e)(4)(xv) to read as follows:
■
11. The authority citation for part 528
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
§ 558.128
*
12 Add § 528.2001 to read as follows:
Chlortetracycline.
*
*
(e) * * *
(4) * * *
*
*
Limitations
*
*
1. Beef cattle: For control of bacterial pneumonia associated with
shipping fever complex caused
by Pasteurella spp. susceptible
to chlortetracycline.
2. Beef cattle (under 700 lb): For
control of active infection of
anaplasmosis caused by A.
marginale susceptible to chlortetracycline.
*
*
*
Withdrawal periods: To sponsor No. 054771 under NADAs 046–699
and 049–287, No. 066104 under NADA 092–286, and No. 069254
under NADA 048–480: Withdraw 48 hours prior to slaughter. To
sponsor No. 069254 under NADA 138–935 and ANADA 200–510:
Zero withdrawal period.
Withdrawal periods: To sponsor No. 054771 under NADAs 046–699
and 049–287, No. 066104 under NADA 092–286, and No. 069254
under NADA 048–480: Withdraw 48 hours prior to slaughter. To
sponsor No. 054771 under NADA 048–761 and No. 069254 under
NADA 138–935 and ANADA 200–510: Zero withdrawal period.
*
*
15:54 Mar 31, 2021
*
a. Revise paragraphs (d)(3) through
(6); and
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Sponsor
*
■
15. In § 558.342:
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PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc-1, 371.
PART 528—NEW ANIMAL DRUGS IN
GENETICALLY ENGINEERED
ANIMALS
*
*
Selamectin.
(a) Specifications. Each milliliter
contains 60 or 120 milligrams (mg) of
selamectin.
(b) Sponsors. See Nos. 054771,
055529, 061133, and 061651 in
§ 510.600(c) of this chapter.
(c) * * *
(1) Amount. Administer topically 2.7
mg of selamectin per pound (6 mg per
kilogram) of body weight.
*
*
*
*
*
Indications for use
*
*
10. In § 524.2098:
a. Revise paragraphs (a) and (b);
■ b. Remove paragraph (c) and
redesignate paragraph (d) as paragraph
(c); and
■ c. Revise newly redesignated
paragraph (c)(1).
The revisions read as follows:
■
7. Add § 522.2450 to read as follows:
(a) Specifications. pPL657 in the
glycoprotein galactosyltransferase
alpha-1,3 (GGTA1) gene in domestic
pigs.
(b) Sponsor. See No. 086134 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Intended
use. pPL657 rDNA construct in the
glycoprotein galactosyltransferase
alpha-1,3 gene (GGTA1) in the lineage
of domestic pigs (Sus scrofa domesticus)
hemizygous and homozygous for the
intentional genomic alteration resulting
in undetectable endogenous galactose
alpha-1,3-galactose sugar residues on
biological derivatives of domestic pigs
homozygous for the intentional genomic
alteration lineage that are intended to be
used as sources of food or human
therapeutics including excipients,
devices, drugs, or biological products.
(2) Limitations. Pigs of this lineage
(possessing the intentional genomic
alteration (pPL657 rDNA construct))
should not be treated with
aminoglycoside drugs and must only be
housed in physically contained facilities
specified in the approved application.
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*
■
*
054771
066104
069254
054771
066104
069254
*
b. Remove paragraphs (d)(7) and (8).
The revisions read as follows:
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Rules and Regulations
§ 558.342
Melengestrol.
SUPPLEMENTARY INFORMATION:
*
*
*
*
*
(d) * * *
(3) Liquid or dry combination Type B
or C medicated feeds containing
melengestrol acetate and lasalocid must
be labeled in accordance with
§ 558.311(d).
(4) Liquid or dry combination Type B
or C medicated feeds containing
melengestrol acetate and monensin
must be labeled in accordance with
§ 558.355(d).
(5) Liquid combination Type B or C
medicated feeds containing
melengestrol acetate and tylosin must be
manufactured in accordance with
§ 558.625(d).
(6) Liquid melengestrol acetate may
not be mixed with oxytetracycline in a
common liquid feed supplement.
*
*
*
*
*
Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06704 Filed 3–31–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 821
[Docket No. FDA–2021–N–0246]
Medical Devices; Technical
Amendments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; technical
amendments.
AGENCY:
The Food and Drug
Administration (FDA, the Agency, or
we) is amending its medical device
regulations to make an editorial
nonsubstantive change and replace a
reference to an obsolete office with
updated information. The rule does not
impose any new regulatory
requirements on affected parties. This
action is editorial in nature and is
intended to improve the accuracy of the
Agency’s regulations.
DATES: This rule is effective April 1,
2021.
FOR FURTHER INFORMATION CONTACT:
Madhusoodana Nambiar, Office of
Policy, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993–0002, 301–
796–5837.
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SUMMARY:
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I. Background
FDA’s Center for Devices and
Radiological Health (CDRH) has
reorganized to create an agile
infrastructure that can adapt to future
organizational, regulatory, and scientific
needs (84 FR 22854, May 20, 2019; 85
FR 18439, April 2, 2020). The newly
formed Office of Product Evaluation and
Quality (OPEQ) combined the former
Office of Compliance, the Office of
Device Evaluation, the Office of
Surveillance and Biometrics, and the
Office of In Vitro Diagnostics and
Radiological Health, with a focus on a
Total Product Lifecycle (TPLC)
approach to medical device oversight.
Within OPEQ there are Offices of Health
Technology that focus on the TPLC
review of specific types of medical
devices as well as cross-cutting offices
focusing on specific policy and
programmatic needs including the
Office of Regulatory Programs and the
Office of Clinical Evidence and
Analysis. As part of this technical
amendment, we are making changes to
correct a reference to an obsolete office
and to correctly identify the positions
with authority to make decisions on
exemptions and variances from tracking
orders. This change is nonsubstantive
and editorial in nature.
II. Description of the Technical
Amendments
The regulations specified in this rule
have been revised to make a nonsubstantive editorial change to correct
‘‘Director of the Office of Regulatory
Program’’ to ‘‘Director or Principal
Deputy Director of the Office of Product
Evaluation and Quality’’ and replace a
reference to ‘‘Director, Office of
Compliance’’ with ‘‘Director or Deputy
Directors, CDRH, or the Director or
Principal Deputy Director of the Office
of Product Evaluation and Quality.’’ The
rule does not impose any new
regulatory requirements on affected
parties. The amendments are editorial in
nature and should not be construed as
modifying any substantive standards or
requirements.
III. Notice and Public Comment
Publication of this document
constitutes final action of these changes
under the Administrative Procedure Act
(5 U.S.C. 553). Section 553 of the
Administrative Procedure Act (APA)
exempts ‘‘rules of agency organization,
procedure, or practice’’ from proposed
rulemaking (i.e., notice and comment
rulemaking) (5 U.S.C. 553(b)(3)(A)).
Rules are also exempt when an Agency
finds ‘‘good cause’’ that notice and
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
17065
comment rulemaking procedures would
be ‘‘impracticable, unnecessary, or
contrary to the public interest’’ (5 U.S.C.
553(b)(3)(B)).
FDA has determined that this
rulemaking meets the notice and
comment exemption requirements in 5
U.S.C. 553(b)(3)(A) and (B). FDA’s
revisions make technical or nonsubstantive changes that pertain solely
to the CDRH reorganization and do not
alter any substantive standard. FDA
does not believe public comment is
necessary for these minor revisions.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because
the amendments do not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
cause for the amendments to become
effective on the date of publication of
this action.
List of Subjects in 21 CFR Part 821
Imports, Medical devices, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, 21 CFR part
821 is amended as follows.
PART 821—MEDICAL DEVICE
TRACKING REQUIREMENTS
1. The authority citation for part 821
continues to read as follows:
■
Authority: 21 U.S.C. 331, 351, 352, 360,
360e, 360h, 360i, 371, 374.
2. In § 821.2, revise paragraphs (b)
introductory text and (c) to read as
follows:
■
§ 821.2
Exemptions and variances.
*
*
*
*
*
(b) A request for an exemption or
variance shall be submitted in the form
of a petition under § 10.30 of this
chapter and shall comply with the
requirements set out therein, except that
a response shall be issued in 90 days.
The Director or Deputy Directors,
CDRH, or the Director or Principal
Deputy Director of the Office of Product
Evaluation and Quality, CDRH, shall
issue responses to requests under this
section. The petition shall also contain
the following:
*
*
*
*
*
(c) An exemption or variance is not
effective until the Director or Deputy
Directors, CDRH, or the Director or
Principal Deputy Director of the Office
of Product Evaluation and Quality,
E:\FR\FM\01APR1.SGM
01APR1
]]>Agencies
[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Rules and Regulations]
[Pages 17061-17065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06704]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 528, and 558
[Docket No. FDA-2020-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications
AGENCY: Food and Drug Administration, Department of Health and Human
Services.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during October, November, and December 2020. FDA
is informing the public of the availability of summaries of the basis
of approval and of environmental review documents, where applicable.
The animal drug regulations are also being amended to improve the
accuracy and readability of the regulations.
DATES: This rule is effective April 1, 2021.
[[Page 17062]]
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
2020, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 16, 2020................. 141-536 Elanco US Inc., ELURA Dogs and cats............. Original approval FOI Summary.
2500 Innovation (capromorelin for management
Way, Greenfield, oral solution). of weight loss
IN 46140. in cats with
chronic kidney
disease.
October 29, 2020................. 200-692 Virbac AH, Inc., CYCLAVANCE Dogs...................... Original approval FOI Summary.
P.O. Box 162059, (cyclosporine as a generic
Fort Worth, TX oral solution) copy of NADA 141-
76161. USP MODIFIED. 218.
November 16, 2020................ 141-541 QBiotics Group STELFONTA Dogs...................... Original approval FOI Summary.
Ltd., Suite 3A, (tigilanol for the
Level 1, 165 tiglate treatment of non-
Moggill Rd., injection). metastatic
Taringa, cutaneous mast
Queensland 4068, cell tumors and
Australia. non-metastatic
subcutaneous
mast cell tumors
located at or
distal to the
elbow or the
hock in dogs.
November 25, 2020................ 200-557 Dechra Veterinary TZED (tiletamine Dogs...................... Supplemental FOI Summary.
Products LLC, and zolazepam approval for an
7015 College for injection). intravenous
Blvd., Suite 525, route.
Overland Park, KS
66211.
December 14, 2020................ 141-542 Revivicor, Inc., a pPL657 rDNA Swine..................... Original approval FOI Summary.
wholly owned construct in for an
subsidiary of domestic pigs. intentional
United genomic
Therapeutics alteration in
Corp., 1700 Kraft domestic pigs.
Dr., Suite 2400,
Blacksburg, VA
24060.
December 16, 2020................ 200-696 Bimeda Animal SELASPOT Dogs and cats............. Original approval FOI Summary.
Health Ltd., 1B (selamectin) as a generic
The Herbert Topical Solution. copy of NADA 141-
Building, The 152.
Park,
Carrickmines,
Dublin 18,
Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
As provided in the regulatory text, the animal drug regulations are
amended to reflect these approval actions. As they are now the sponsor
of an approved application, QBiotics Group Ltd. and Revivicor, Inc.
will be added to the list of sponsors of approved applications in 21
CFR 510.600(c).
II. Technical Amendments
FDA is making the following amendments to improve the accuracy,
consistency, and readability of the animal drug regulations:
21 CFR 558.128 is amended to reflect the sponsors of
approved conditions of use for chlortetracycline in beef cattle.
21 CFR 558.342 is amended to reformat special
considerations for labeling and manufacture of melengestrol medicated
feeds.
Typographical errors are being corrected wherever they
have been found.
[[Page 17063]]
III. Legal Authority
This rule sets forth technical amendments to the regulations to
codify recent actions on approved new animal drug applications and
corrections to improve the accuracy of the regulations, and as such
does not impose any burden on regulated entities. This rule is issued
under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360b(i)), which requires Federal Register publication
of the conditions of use of an approved or conditionally approved new
animal drug and the name and address of the drug's sponsor in a
``notice, which upon publication shall be effective as a regulation.''
A notice published pursuant to section 512(i) is not subject to the
notice-and-comment rulemaking requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act;
21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).
This document does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a ``rule of particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive
Order 12866, which defines a rule as ``an agency statement of general
applicability and future effect, which the agency intends to have the
force and effect of law, that is designed to implement, interpret, or
prescribe law or policy or to describe the procedure or practice
requirements of an agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 528
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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, 522, 524, 528, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
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.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1), add entries for ``QBiotics Group
Ltd.'' and ``Revivicor, Inc.'' in alphabetical order; and
0
b. In the table in paragraph (c)(2), add entries for ``086132'' and
``086134'' in numerical order.
The additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., 086132
Taringa, Queensland 4068, Australia....................
* * * * * * *
Revivicor, Inc., a wholly owned subsidiary of United 086134
Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
Blacksburg, VA 24060...................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
086132....................... QBiotics Group Ltd., Suite 3A, Level 1,
165 Moggill Rd., Taringa, Queensland
4068, Australia
086134....................... Revivicor, Inc., a wholly owned
subsidiary of United Therapeutics Corp.,
1700 Kraft Dr., Suite 2400, Blacksburg,
VA 24060
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.292, revise paragraphs (a) and (c) to read as follows:
Sec. 520.292 Capromorelin.
(a) Specifications. Each milliliter of solution contains:
(1) 30 milligrams (mg) capromorelin; or
(2) 20 mg capromorelin.
* * * * *
(c) Conditions of use--(1) Dogs. Use product described in paragraph
(a)(1) of this section as follows:
(i) Amount. Administer 3 mg/kg once daily by mouth.
(ii) Indications for use. For appetite stimulation in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats. Use product described in paragraph (a)(2) of this section
as follows:
(i) Amount. Administer 2 mg/kg once daily by mouth.
(ii) Indications for use. For management of weight loss in cats
with chronic kidney disease.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
5. In Sec. 520.522, add paragraph (b)(3) to read as follows:
Sec. 520.522 Cyclosporine.
* * * * *
(b) * * *
[[Page 17064]]
(3) No. 051311 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(1) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. Add Sec. 522.2450 to read as follows:
Sec. 522.2450 Tigilanol.
(a) Specifications. Each milliliter (mL) of solution contains 1
milligram tigilanol tiglate.
(b) Sponsor. See No. 086132 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer as an
intratumoral injection at a dose of 0.5 mL per cubic centimeter of
tumor volume.
(2) Indications for use. For the treatment of non-metastatic
cutaneous mast cell tumors and non-metastatic subcutaneous mast cell
tumors located at or distal to the elbow or the hock in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
8. In Sec. 522.2470, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) * * *
(1) Nos. 026637 and 054771 for use as in paragraph (c) of this
section.
(2) No. 051311 for use as in paragraphs (c)(1)(i)(A),
(c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
10. In Sec. 524.2098:
0
a. Revise paragraphs (a) and (b);
0
b. Remove paragraph (c) and redesignate paragraph (d) as paragraph (c);
and
0
c. Revise newly redesignated paragraph (c)(1).
The revisions read as follows:
Sec. 524.2098 Selamectin.
(a) Specifications. Each milliliter contains 60 or 120 milligrams
(mg) of selamectin.
(b) Sponsors. See Nos. 054771, 055529, 061133, and 061651 in Sec.
510.600(c) of this chapter.
(c) * * *
(1) Amount. Administer topically 2.7 mg of selamectin per pound (6
mg per kilogram) of body weight.
* * * * *
PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
0
11. The authority citation for part 528 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
12 Add Sec. 528.2001 to read as follows:
Sec. 528.2001 pPL657 recombinant deoxyribonucleic acid construct.
(a) Specifications. pPL657 in the glycoprotein
galactosyltransferase alpha-1,3 (GGTA1) gene in domestic pigs.
(b) Sponsor. See No. 086134 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Intended use. pPL657 rDNA construct in
the glycoprotein galactosyltransferase alpha-1,3 gene (GGTA1) in the
lineage of domestic pigs (Sus scrofa domesticus) hemizygous and
homozygous for the intentional genomic alteration resulting in
undetectable endogenous galactose alpha-1,3-galactose sugar residues on
biological derivatives of domestic pigs homozygous for the intentional
genomic alteration lineage that are intended to be used as sources of
food or human therapeutics including excipients, devices, drugs, or
biological products.
(2) Limitations. Pigs of this lineage (possessing the intentional
genomic alteration (pPL657 rDNA construct)) should not be treated with
aminoglycoside drugs and must only be housed in physically contained
facilities specified in the approved application.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
13. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
14. In Sec. 558.128, revise paragraph (e)(4)(xv) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Chlortetracycline amount ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(xv) 350 mg/head/day................ 1. Beef cattle: For control Withdrawal periods: To sponsor No. 054771 under 054771
of bacterial pneumonia NADAs 046-699 and 049-287, No. 066104 under 066104
associated with shipping NADA 092-286, and No. 069254 under NADA 048- 069254
fever complex caused by 480: Withdraw 48 hours prior to slaughter. To
Pasteurella spp. sponsor No. 069254 under NADA 138-935 and
susceptible to ANADA 200-510: Zero withdrawal period.
chlortetracycline.
2. Beef cattle (under 700 Withdrawal periods: To sponsor No. 054771 under 054771
lb): For control of active NADAs 046-699 and 049-287, No. 066104 under 066104
infection of anaplasmosis NADA 092-286, and No. 069254 under NADA 048- 069254
caused by A. marginale 480: Withdraw 48 hours prior to slaughter. To
susceptible to sponsor No. 054771 under NADA 048-761 and No.
chlortetracycline. 069254 under NADA 138-935 and ANADA 200-510:
Zero withdrawal period.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
15. In Sec. 558.342:
0
a. Revise paragraphs (d)(3) through (6); and
0
b. Remove paragraphs (d)(7) and (8).
The revisions read as follows:
[[Page 17065]]
Sec. 558.342 Melengestrol.
* * * * *
(d) * * *
(3) Liquid or dry combination Type B or C medicated feeds
containing melengestrol acetate and lasalocid must be labeled in
accordance with Sec. 558.311(d).
(4) Liquid or dry combination Type B or C medicated feeds
containing melengestrol acetate and monensin must be labeled in
accordance with Sec. 558.355(d).
(5) Liquid combination Type B or C medicated feeds containing
melengestrol acetate and tylosin must be manufactured in accordance
with Sec. 558.625(d).
(6) Liquid melengestrol acetate may not be mixed with
oxytetracycline in a common liquid feed supplement.
* * * * *
Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06704 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P
