[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Rules and Regulations]
[Pages 45157-45158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15763]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529


Certain Other Dosage Form New Animal Drugs; Formalin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by B.L. Mitchell, Inc. The ANADA provides for 
the use of formalin in a water bath for the control of certain external 
parasites on finfish and shrimp and for the control of certain fungi on 
finfish eggs.

DATES: This rule is effective August 13, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, 
MS 38756, filed ANADA 200-414 that provides for use of Formacide-B 
(formalin) in a water bath for the control of certain external 
parasites on finfish and shrimp and for the control of certain fungi on 
finfish eggs. B.L. Mitchell, Inc.'s Formacide-B is approved as a 
generic copy of Parasite-S, sponsored by Western Chemical, Inc., under 
NADA 140-989. The ANADA is approved as of July 17, 2007, and the 
regulations are amended in Sec.  529.1030 to reflect the approval.
    In addition, B.L. Mitchell, Inc., has not been previously listed in 
the animal drug regulations as a sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this 
firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug

[[Page 45158]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 529

    Animal drugs.

0
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 
529 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) alphabetically 
add a new entry for ``B.L. Mitchell, Inc.''; and in the table in 
paragraph (c)(2) numerically add a new entry for ``067188'' to read as 
follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland,  067188
 MS 38756.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
067188                       B.L. Mitchell, Inc., 103 Hwy. 82 E.,
                              Leland, MS 38756
                                * * * * *
------------------------------------------------------------------------

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec.  529.1030  [Amended]

0
4. In paragraph (b)(1) of Sec.  529.1030, remove ``Nos. 049968 and 
050378'' and add in its place ``Nos. 049968, 050378, and 067188''.

    Dated: August 1, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-15763 Filed 8-10-07; 8:45 am]
BILLING CODE 4160-01-S