[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Rules and Regulations]
[Pages 43043-43045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20444]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 101, 102, 105, 112, 113, 116, and 124

[Docket No. 97-117-1]


Viruses, Serums, Toxins, and Analogous Products and Patent Term 
Restoration; Nonsubstantive Technical Changes

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending our regulations regarding veterinary 
biological products to reflect the transfer of the Animal and Plant 
Health Inspection Service's veterinary biologics functions to the 
Veterinary Services program area and to update the addresses provided 
for staffs within the Center for Veterinary Biologics. We are also 
making several nonsubstantive changes to the regulations to correct 
errors, omissions, or inconsistencies.

EFFECTIVE DATE: August 9, 1999.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Special 
Assistant to the Deputy Administrator, VS, APHIS, 4700 River Road Unit 
148, Riverdale, MD 20737-1231; (301) 734-8245.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR parts 101 through 118 (referred to below 
as the regulations) contain provisions implementing the Virus-Serum-
Toxin Act, as amended (21 U.S.C. 151-159). The regulations in 9 CFR 
part 124 contain procedural requirements for patent extensions for 
veterinary biologics under 35 U.S.C. 156. We have made several 
nonsubstantive technical changes to those regulations to update their 
provisions and correct errors, omissions, or inconsistencies. As part 
of this rule, we have made the following changes:
    1. We have amended the addresses throughout the regulations to 
reflect the current organizational affiliation of the Center for 
Veterinary Biologics (CVB) staff within the Animal and Plant Health 
Inspection Service and the relocation of most of the CVB's Licensing 
and Policy Development staff to new offices in Ames, IA.
    2. In part 101, we have amended the definition of regulations to 
reflect the 1987 addition of part 118 and the definition of Virus-
Serum-Toxin Act to reflect the 1987 amendments to that act.
    3. We have amended Sec. 113.35(f) so that it refers to the labeling 
requirements that are set forth in Sec. 112.7(g). That paragraph had 
incorrectly stated that those requirements were in Sec. 112.7(h).
    4. In Secs. 113.327 and 113.452, information was missing from the 
tables found in each section. In the table in Sec. 113.327, the words 
``or less'' were not included after each of the numbers provided in the 
column titled ``Failures for satisfactory serials'' and the words ``or 
more'' were not included after each of the numbers provided in the 
column titled ``Failures for unsatisfactory serials.'' In Sec. 113.452, 
the numbers indicating which stage of testing (i.e., 1 or 2) and the 
number of vaccinates in each stage (40) were missing from the table 
despite the presence of titled columns for each set of numbers. We have 
corrected both tables in this rule.
    5. In Secs. 113.331 and 113.332, we have removed the word ``log'' 
from where it appeared incorrectly before the numbers 100.7 
and 100.2.
    6. Paragraph (a) of Sec. 113.451 referred to the National Bureau of 
Standards. We have updated the reference to reflect that agency's 
current name, the National Institute of Standards and Technology.
    7. Paragraph (b) of Sec. 124.1 refers to the Patent and Trademark 
Office (PTO) regulations concerning patent term extension. We have 
updated the citation provided for those PTO regulations to

[[Page 43044]]

reflect the 1995 addition of two sections to ``Subpart F--Extension of 
Patent Term'' (37 CFR 1.710 through 1.791).
    8. In Secs. 124.32 and 124.43, we have removed outdated references 
to the ``Assistant Secretary for Marketing and Inspection Services'' 
and have replaced them with the current title, ``Under Secretary for 
Marketing and Regulatory Programs.''
    This rule relates to internal agency management and includes 
technical amendments. Therefore, pursuant to 5 U.S.C. 553, notice of 
proposed rulemaking and opportunity to comment thereon are not 
required, and this rule may be made effective less than 30 days after 
publication in the Federal Register. Further, since this rule relates 
to internal agency management and includes technical corrections, it is 
exempt from the provisions of Executive Order 12866 and Executive Order 
12988. Finally, this subject is not a rule as defined by Public Law 96-
354, the Regulatory Flexibility Act, and thus, is exempt from the 
provisions of that Act.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects

9 CFR Part 101

    Animal biologics.

9 CFR Part 102

    Animal biologics, Reporting and recordkeeping requirements.

9 CFR Part 105

    Animal biologics.

9 CFR Part 112

    Animal biologics, Exports, Imports, Labeling, Packaging and 
containers, Reporting and recordkeeping requirements.

9 CFR Part 113

    Animal biologics, Exports, Imports, Reporting and recordkeeping 
requirements.

9 CFR Part 116

    Animal biologics, Reporting and recordkeeping requirements.

9 CFR Part 124

    Animal biologics, Patents.

    Accordingly, we are amending 9 CFR parts 101, 102, 105, 112, 113, 
116, and 124 as follows:

PART 101--DEFINITIONS

    1. The authority citation for part 101 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    2. In Sec. 101.2, the definitions of Regulations and Virus-Serum-
Toxin Act are revised to read as follows:


Sec. 101.2  Administrative Terminology.

* * * * *
    Regulations. The provisions in parts 101 through 118 of this 
subchapter.
* * * * *
    Virus-Serum-Toxin Act. The Act of March 4, 1913, 37 Stat. 832-833; 
as amended December 23, 1985, Public Law 99-198, 99 Stat. 1654-1655; 
and as further amended September 28, 1988, Public Law 100-449, 102 
Stat. 1868; 21 U.S.C. 151-159.
* * * * *

PART 102--LICENSES FOR BIOLOGICAL PRODUCTS

    3. The authority citation for part 102 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).


Sec. 102.5  [Amended]

    4. In Sec. 102.5(e), in the second sentence, remove the words 
``Animal and Plant Health Inspection Service, Biotechnology, Biologics, 
and Environmental Protection, Veterinary Biologics, 4700 River Road 
Unit 148, Riverdale, Maryland 20737-1237'' and add, in their place, the 
words ``Director, Center for Veterinary Biologics, Licensing and Policy 
Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197''.

PART 105--SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL 
LICENSES OR PERMITS

    5. The authority citation for part 105 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).


Sec. 105.1  [Amended]

    6. In Sec. 105.1(a)(1), remove the number ``117'' and add, in its 
place, the number ``118''.

PART 112--PACKAGING AND LABELING

    7. The authority citation for part 112 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).


Sec. 112.5  [Amended]

    8. In Sec. 112.5(d)(2)(ii), in the first sentence, remove the words 
``Two-or-three part'' and add, in their place, the words ``Two-or 
three-part''.


Sec. 112.6  [Amended]

    9. In Sec. 112.6(c), introductory text, in the fourth sentence, 
remove the words ``more then'' and add, in their place, the words 
``more than''.

PART 113--STANDARD REQUIREMENTS

    10. The authority citation for part 113 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).


Sec. 113.35  [Amended]

    11. In Sec. 113.35(f), remove the citation ``Sec. 112.7(h)'' and 
add, in its place, the citation ``Sec. 112.7(g)''.


Sec. 113.70  [Amended]

    12. Section 113.70 is amended as follows:
    a. In the introductory text, at the end of the first sentence, 
remove the words ``Pasteurella Multocida'' and add, in their place, the 
words ``Pasteurella multocida''.
    b. In paragraph (b)(1) remove the words ``Pasteurella Multocida'' 
and add, in their place, the words ``Pasteurella multocida''.
    c. In paragraph (b)(3) remove the words ``Pasteurella multocida'' 
and add, in their place, the words ``Pasteurella multocida''.


Sec. 113.113  [Amended]

    13. Section 113.113 is amended as follows:
    a. In paragraph (a)(2), in the third sentence, remove the words 
``the Deputy Director, VBFO, 223 South Walnut Avenue, Ames, Iowa 
50010'' and add, in their place, the words ``Director, Center for 
Veterinary Biologics, Inspection and Compliance, 510 South 17th Street, 
Suite 104, Ames, IA 50010-8197''.
    b. In paragraph (a)(3), in the second sentence, remove the words 
``the Deputy Director, VBFO, 223 South Walnut Avenue, Ames, Iowa 
50010'' and add, in their place, the words ``Director, Center for 
Veterinary Biologics, Inspection and Compliance, 510 South 17th Street, 
Suite 104, Ames, IA 50010-8197''.
    c. In paragraph (c)(2)(iv)(A) in the second sentence, remove the 
words ``Animal and Plant Health Inspection Service, Biotechnology, 
Biologics, and Environmental Protection, Veterinary Biologics, 4700 
River Road Unit 148, Riverdale, Maryland 20737-1237'' and add, in their 
place, the words ``Director, Center for Veterinary Biologics,

[[Page 43045]]

Licensing and Policy Development, 510 South 17th Street, Suite 104, 
Ames, IA 50010-8197''.
    d. In paragraph (c)(2)(iv)(B), at the beginning of the first 
sentence, remove the words ``Bulk of'' and add, in their place, the 
words ``Bulk or''.
    14. In Sec. 113.327(d)(2)(ii), the table is revised to read as 
follows:


Sec. 113.327  Bronchitis Vaccine.

* * * * *
    (d) * * *
    (2) * * *
    (ii) * * *

                                                Cumulative Totals
----------------------------------------------------------------------------------------------------------------
                                            Number
                  Stage                       of        Failures for satisfactory    Failures for unsatisfactory
                                           chickens              serials                       serials
----------------------------------------------------------------------------------------------------------------
1........................................        25  2 or less.....................  4 or more.
2........................................        50  5 or less.....................  6 or more.
----------------------------------------------------------------------------------------------------------------

* * * * *


Sec. 113.331  [Amended]

    15. In Sec. 113.331(d)(3), in the second sentence, remove the word 
``log'' both times it appears, and add the word ``times'' after the 
number ``100.7''.


Sec. 113.332  [Amended]

    16. In Sec. 113.332(d)(3), in the second sentence, add the word 
``times'' after the number ``100.7 `` and remove the word 
``log'' before the number ``102.0''.


Sec. 113.451  [Amended]

    17. In Sec. 113.451, in the introductory text of paragraph (a), 
remove the words ``Bureau of Standards'' and add the words ``Institute 
of Standards and Technology'' in their place.
    18. In Sec. 113.452(b)(4), the table is revised to read as follows:


Sec. 113.452  Erysipelothrix Rhusiopathiae Antibody.

* * * * *
    (b) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                              Cumulative total
                                       Number of      Cumulative       Cumulative total     number of deaths for
               Stage                  vaccinates       number of     number of deaths for    an unsatisfactory
                                                      vaccinates     a satisfactory test            test
----------------------------------------------------------------------------------------------------------------
1.................................              40              40  6 or less............  11 or more.
2.................................              40              80  12 or less...........  13 or more.
----------------------------------------------------------------------------------------------------------------

PART 116--RECORDS AND REPORTS

    19. The authority citation for part 116 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    20. In Sec. 116.5, paragraph (b) is revised to read as follows:


Sec. 116.5  Reports.

* * * * *
    (b) If, at any time, there are indications that raise questions 
regarding the purity, safety, potency, or efficacy of a product, or if 
it appears that there may be a problem regarding the preparation, 
testing, or distribution of a product, the licensee, permittee, or 
foreign manufacturer must immediately notify the Animal and Plant 
Health Inspection Service concerning the circumstances and the action 
taken, if any. Notification may be made by mail to Director, Center for 
Veterinary Biologics, Inspection and Compliance, 510 South 17th Street, 
Suite 104, Ames, IA 50010-8197; by electronic mail to [email protected]; by 
fax to (515) 232-7120; or by telephone to (515) 232-5785.
* * * * *

PART 124--PATENT TERM RESTORATION

    21. The authority citation for part 124 continues to read as 
follows:

    Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.2(m).


Sec. 124.1  [Amended]

    22. In Sec. 124.1(b), remove the number ``1.785'' and add the 
number ``1.791'' in its place.


Sec. 124.22  [Amended]

    23. In Sec. 124.22, in the introductory text of paragraph (a), 
remove the words ``the Animal and Plant Health Inspection Service, 
Biotechnology, Biologics, and Environmental Protection, Veterinary 
Biologics, 4700 River Road Unit 148, Riverdale, Maryland 20737-1237'' 
and add, in their place, the words ``Director, Center for Veterinary 
Biologics, Licensing and Policy Development, 510 South 17th Street, 
Suite 104, Ames, IA 50010-8197''.


Sec. 124.32  [Amended]

    24. In Sec. 124.32(a), in the first sentence, remove the words 
``Assistant Secretary for Marketing and Inspection Services'' and add, 
in their place, the words ``Under Secretary for Marketing and 
Regulatory Programs''.


Sec. 124.40  [Amended]

    25. In Sec. 124.40(b)(3), remove the words ``Animal and Plant 
Health Inspection Service, Biotechnology, Biologics, and Environmental 
Protection, Veterinary Biologics, 4700 River Road Unit 148, Riverdale, 
Maryland 20737-1237'' and add, in their place, the words ``Director, 
Center for Veterinary Biologics, Licensing and Policy Development, 510 
South 17th Street, Suite 104, Ames, IA 50010-8197''.


Sec. 124.43  [Amended]

    26. In Sec. 124.43, in the first sentence, remove the words 
``Assistant Secretary for Marketing and Inspection Services'' and add, 
in their place, the words ``Under Secretary for Marketing and 
Regulatory Programs''.

    Done in Washington, DC, this 4th day of August 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-20444 Filed 8-6-99; 8:45 am]
BILLING CODE 3410-34-U