72 FR 246 pgs. 72920-72921 - New Animal Drugs; Change of Sponsor's Name
Type: RULEVolume: 72Number: 246Pages: 72920 - 72921
FR document: [FR Doc. E7-24974 Filed 12-21-07; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Name
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.
DATES:
This rule is effective December 26, 2007.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: david.newkirk@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
Altana, Inc., 60 Baylis Rd., Melville, NY 11747, has informed FDA that it has changed its name to Nycomed US, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes.
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 in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
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 part 510 is amended as follows:
PART 510-NEW ANIMAL DRUGS
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.
2. In § 510.600 in the table in paragraph (c)(1), remove the entry for "Altana, Inc." and alphabetically add a new entry for "Nycomed US, Inc."; and in the table in paragraph (c)(2), revise the entry for "025463" to read as follows:
§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(c) * * *
(1) * * *
| Firm name and address | Drug labeler code |
|---|---|
| ***** | |
| Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747 | 025463 |
| ***** | |
(2) * * *
| Drug labeler code | Firm name and address |
|---|---|
| ***** | |
| 025463 | Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747 |
| ***** | |
Dated: December 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24974 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S