[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Rules and Regulations]
[Page 79064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32591]
[[Page 79064]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Change of Sponsor; Zinc Gluconate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for a new animal drug
application (NADA) for zinc gluconate injectable solution from
Technology Transfer, Inc., to Ark Sciences, Inc.
DATES: This rule is effective December 21, 2011.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, (240) 276-8300, email:
[email protected].
SUPPLEMENTARY INFORMATION: Technology Transfer, Inc., 33 East Broadway,
suite 190, Columbia, MO 65203 has informed FDA that it has transferred
ownership of, and all rights and interest in, NADA 141-217 for
NEUTERSOL (zinc gluconate) Injectable Solution to Ark Sciences, Inc.,
1101 East 33rd St., suite B304, Baltimore, MD 21218. Accordingly, the
Agency is amending the regulations in 21 CFR 522.2690 to reflect the
transfer of ownership.
Following this change of sponsorship, Technology Transfer, Inc., is
no longer the sponsor of an approved application. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to remove the entries for
this firm.
In addition, Ark Sciences, Inc., is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, Sec. 510.600 is being amended to add entries for this
sponsor.
This rule 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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR 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, in the table in paragraph (c)(1), remove the entry
for ``Technology Transfer, Inc.''; alphabetically add a new entry for
``Ark Sciences, Inc.''; and in the table in paragraph (c)(2), remove
the entry for ``067647''; and in numerical sequence add a new entry for
``076175'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
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* * * * *
Ark Sciences, Inc., 1101 East 33rd St., suite B304, 076175
Baltimore, MD 21218.......................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
076175............................ Ark Sciences, Inc., 1101 East 33rd
St., suite B304, Baltimore, MD
21218.
* * * * *
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.2690 [Amended]
0
4. In paragraph (b) of Sec. 522.2690, remove ``067647'' and in its
place add ``076175''.
Dated: December 8, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-32591 Filed 12-20-11; 8:45 am]
BILLING CODE 4160-01-P