80 FR 59725 - Notice of Request for Approval of an Information Collection; Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 191 (October 2, 2015)

Page Range		59725-59725
FR Document		2015-25078

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval of a new information collection concerning packaging and labeling for products approved in accordance with the Virus-Serum-Toxin Act.

Federal Register, Volume 80 Issue 191 (Friday, October 2, 2015)

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Page 59725]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-25078]

[[Page 59725]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0066]

Notice of Request for Approval of an Information Collection;
Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: New information collection; comment request.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant Health Inspection Service's
intention to request approval of a new information collection
concerning packaging and labeling for products approved in accordance
with the Virus-Serum-Toxin Act.

DATES: We will consider all comments that we receive on or before
December 1, 2015.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0066.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2015-0066, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0066 or in our reading room, which is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: For information on packaging and
labeling requirements for products approved under the Virus-Serum-Toxin
Act, contact Dr. Donna L. Malloy, Section Leader, Operational Support,
Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS,
APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 851-
3426. For copies of more detailed information on the information
collection, contact Ms. Kimberly Hardy, APHIS' Information Collection
Coordinator, at (301) 851-2727.

SUPPLEMENTARY INFORMATION: Title: Viruses, Serums, Toxins, and
Analogous Products; Packaging and Labeling.
OMB Control Number: 0579-XXXX.
Type of Request: Approval of a new information collection.
Abstract: Under the Virus-Serum-Toxin Act (the Act, 21 U.S.C. 151-
159) and regulations issued under the Act, the Animal and Plant Health
Inspection Service (APHIS) grants licenses or permits for biological
products which are pure, safe, potent, and efficacious when used
according to label instructions.
The regulations in 9 CFR part 112, ``Packaging and Labeling''
(referred to below as the regulations), prescribe requirements for the
packaging and labeling of veterinary biological products including
requirements applicable to final container labels, carton labels, and
enclosures. The main purpose of the regulations in part 112 is to
regulate the packaging and labeling of veterinary biologics in a
comprehensive manner, which includes ensuring that labeling provides
adequate instructions for the proper use of the product, including
vaccination schedules, warnings, and cautions. Complete labeling
(either on the product or accompanying the product) must be reviewed
and approved by APHIS in accordance with the regulations in part 112
prior to their use.
On January 13, 2011, we published in the Federal Register (76 FR
2268-2277, Docket No. APHIS-2008-0008) a proposal \1\ to amend the
regulations to make veterinary biologics labeling requirements more
consistent with current science and veterinary practice. Among other
things, for labels for export, we proposed to require licensees and
permitees to complete, and submit to APHIS, the Transmittal of Labels
and Circulars or Outlines form (APHIS Form 2015), maintain label
records, and for labels that do not comply with APHIS regulations for
packaging and labeling, to provide written authorization statements
from foreign veterinary officials of the importing country stating that
the labels for export comply with the requirements of their country
(importing country).
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\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0008.
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When we listed the above information collection activities in the
proposed rule, we inadvertently did not obtain approval from the Office
of Management and Budget (OMB). By this notice, we are asking OMB to
approve our use of this information collection for 3 years and to
assign an OMB control number.
The purpose of this notice is to solicit comments from the public
(as well as affected agencies) concerning our information collection.
These comments will help us:
(1) Evaluate whether the collection of information is necessary for
the proper performance of the functions of the Agency, including
whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
collection of information, including the validity of the methodology
and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, through use, as appropriate, of automated,
electronic, mechanical, and other collection technologies; e.g.,
permitting electronic submission of responses.
Estimate of burden: The public reporting burden for this collection
of information is estimated to average 0.1058 hours per response.
Respondents: Foreign veterinary authorities and U.S. importers and
exporters of veterinary biological products.
Estimated annual number of respondents: 200.
Estimated annual number of responses per respondent: 8.5.
Estimated annual number of responses: 1,700.
Estimated total annual burden on respondents: 180 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.

Done in Washington, DC, this 28th day of September 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-25078 Filed 10-1-15; 8:45 am]
BILLING CODE 3410-34-P

Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59725

DEPARTMENT OF AGRICULTURE SUPPLEMENTARY INFORMATION: Title: The purpose of this notice is to solicit
Viruses, Serums, Toxins, and Analogous comments from the public (as well as
Animal and Plant Health Inspection Products; Packaging and Labeling. affected agencies) concerning our
Service OMB Control Number: 0579–XXXX. information collection. These comments
Type of Request: Approval of a new will help us:
[Docket No. APHIS–2015–0066]
information collection. (1) Evaluate whether the collection of
Notice of Request for Approval of an Abstract: Under the Virus-Serum- information is necessary for the proper
Information Collection; Viruses, Toxin Act (the Act, 21 U.S.C. 151–159) performance of the functions of the
Serums, Toxins, and Analogous and regulations issued under the Act, Agency, including whether the
Products; Packaging and Labeling the Animal and Plant Health Inspection information will have practical utility;
Service (APHIS) grants licenses or (2) Evaluate the accuracy of our
AGENCY: Animal and Plant Health permits for biological products which estimate of the burden of the collection
Inspection Service, USDA. are pure, safe, potent, and efficacious of information, including the validity of
ACTION: New information collection; when used according to label the methodology and assumptions used;
comment request. instructions. (3) Enhance the quality, utility, and
The regulations in 9 CFR part 112, clarity of the information to be
SUMMARY: In accordance with the ‘‘Packaging and Labeling’’ (referred to collected; and
Paperwork Reduction Act of 1995, this below as the regulations), prescribe (4) Minimize the burden of the
notice announces the Animal and Plant requirements for the packaging and collection of information on those who
Health Inspection Service’s intention to labeling of veterinary biological are to respond, through use, as
request approval of a new information products including requirements appropriate, of automated, electronic,
collection concerning packaging and applicable to final container labels, mechanical, and other collection
labeling for products approved in carton labels, and enclosures. The main technologies; e.g., permitting electronic
accordance with the Virus-Serum-Toxin purpose of the regulations in part 112 is submission of responses.
Act. to regulate the packaging and labeling of Estimate of burden: The public
DATES: We will consider all comments veterinary biologics in a comprehensive reporting burden for this collection of
that we receive on or before December manner, which includes ensuring that information is estimated to average
1, 2015. labeling provides adequate instructions 0.1058 hours per response.
Respondents: Foreign veterinary
ADDRESSES: You may submit comments for the proper use of the product,
authorities and U.S. importers and
by either of the following methods: including vaccination schedules,
exporters of veterinary biological
• Federal eRulemaking Portal: Go to warnings, and cautions. Complete
products.
http://www.regulations.gov/#!docket labeling (either on the product or Estimated annual number of
Detail;D=APHIS–2015–0066. accompanying the product) must be respondents: 200.
• Postal Mail/Commercial Delivery: reviewed and approved by APHIS in Estimated annual number of
Send your comment to Docket No. accordance with the regulations in part responses per respondent: 8.5.
APHIS–2015–0066, Regulatory Analysis 112 prior to their use. Estimated annual number of
and Development, PPD, APHIS, Station On January 13, 2011, we published in responses: 1,700.
3A–03.8, 4700 River Road Unit 118, the Federal Register (76 FR 2268–2277, Estimated total annual burden on
Riverdale, MD 20737–1238. Docket No. APHIS–2008–0008) a respondents: 180 hours. (Due to
Supporting documents and any proposal 1 to amend the regulations to averaging, the total annual burden hours
comments we receive on this docket make veterinary biologics labeling may not equal the product of the annual
may be viewed at http:// requirements more consistent with number of responses multiplied by the
www.regulations.gov/#!docketDetail;D= current science and veterinary practice. reporting burden per response.)
APHIS–2015–0066 or in our reading Among other things, for labels for All responses to this notice will be
room, which is located in room 1141 of export, we proposed to require licensees summarized and included in the request
the USDA South Building, 14th Street and permitees to complete, and submit for OMB approval. All comments will
and Independence Avenue SW., to APHIS, the Transmittal of Labels and also become a matter of public record.
Washington, DC. Normal reading room Circulars or Outlines form (APHIS Form Done in Washington, DC, this 28th day of
hours are 8 a.m. to 4:30 p.m., Monday 2015), maintain label records, and for September 2015.
through Friday, except holidays. To be labels that do not comply with APHIS Kevin Shea,
sure someone is there to help you, regulations for packaging and labeling, Administrator, Animal and Plant Health
please call (202) 799–7039 before to provide written authorization Inspection Service.
coming. statements from foreign veterinary [FR Doc. 2015–25078 Filed 10–1–15; 8:45 am]
officials of the importing country stating
FOR FURTHER INFORMATION CONTACT: For BILLING CODE 3410–34–P
that the labels for export comply with
information on packaging and labeling
the requirements of their country
requirements for products approved
(importing country). DEPARTMENT OF AGRICULTURE
under the Virus-Serum-Toxin Act, When we listed the above information
contact Dr. Donna L. Malloy, Section collection activities in the proposed
Leader, Operational Support, Center for Farm Service Agency
rule, we inadvertently did not obtain
Veterinary Biologics Policy, Evaluation, approval from the Office of Management Agency Information Collection
mstockstill on DSK4VPTVN1PROD with NOTICES

and Licensing, VS, APHIS, 4700 River and Budget (OMB). By this notice, we Activities: Proposed Collection;
Road Unit 148, Riverdale, MD 20737– are asking OMB to approve our use of Comment Request; Generic Clearance
1231; (301) 851–3426. For copies of this information collection for 3 years for the Collection of Qualitative
more detailed information on the and to assign an OMB control number. Feedback on Agency Service Delivery
information collection, contact Ms.
Kimberly Hardy, APHIS’ Information 1 To view the proposed rule and the comments
AGENCY: Farm Service Agency, USDA.
Collection Coordinator, at (301) 851– we received, go to http://www.regulations.gov/# ACTION:30-Day notice of submission of
2727. !docketDetail;D=APHIS-2008-0008. information collection approval from

VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1

Document Created: 2015-12-15 08:45:27
Document Modified: 2015-12-15 08:45:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		New information collection; comment request.
Dates		We will consider all comments that we receive on or before December 1, 2015.
Contact		For information on packaging and labeling requirements for products approved under the Virus-Serum-Toxin Act, contact Dr. Donna L. Malloy, Section Leader, Operational Support, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 851- 3426. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
FR Citation		80 FR 59725

80 FR 59725 - Notice of Request for Approval of an Information Collection; Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 191 (October 2, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service