[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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