80 FR 53475 - VSTA Records and Reports Specific to International Standards for Pharmacovigilance

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 172 (September 4, 2015)

Page Range		53475-53478
FR Document		2015-21997

We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.

Federal Register, Volume 80 Issue 172 (Friday, September 4, 2015)

[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Proposed Rules]
[Pages 53475-53478]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-21997]

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Proposed Rules
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 /
Proposed Rules

[[Page 53475]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 101 and 116

[Docket No. APHIS-2014-0063]
RIN 0579-AE11

VSTA Records and Reports Specific to International Standards for
Pharmacovigilance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal and reproposal.

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SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act
regulations concerning records and reports. This change would require
veterinary biologics licensees and permittees to record and submit
reports concerning adverse events associated with the use of biological
products they produce or distribute. The information that must be
included in the adverse event reports submitted to the Animal and Plant
Health Inspection Service would be provided in separate guidance
documents. This proposed rule replaces a previously published proposed
rule, which we are withdrawing as part of this document.

DATES: We will consider all comments that we receive on or before
November 3, 2015.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0063.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2014-0063, 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-2014-
0063 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: 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.

SUPPLEMENTARY INFORMATION:

Background

The Virus-Serum-Toxin Act regulations in 9 CFR part 116 (referred
to below as the regulations) contain requirements for maintaining
detailed records of information necessary to give a complete accounting
of all the activities within a veterinary biologics establishment.
These records include records and reports for unfavorable or unintended
events that occur in animals after the use of a biological product.
Specifically, the regulations in Sec. 116.1, paragraph (a) state
that such reports must include, but are not limited to, the items
enumerated in the regulations, including inventory and disposition
records, (Sec. 116.2), information concerning product development and
preparation and market suspension and recalls (Sec. 116.5), animal
records (Sec. 116.6), and test records (Sec. 116.7).
In Sec. 116.5, paragraph (b) states that 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 (APHIS) concerning the
circumstances and the action taken, if any.
However, the regulations in Sec. 116.1 do not explicitly require
licensees and permittees to maintain records of adverse events
associated with the use of veterinary biologics, nor do the regulations
in Sec. 116.5 provide specific guidance in determining whether an
adverse event should be considered an indication that raises questions
regarding the purity, safety, potency, efficacy, preparation, testing,
or distribution (PSPEPTD) of such product. Consequently, each
veterinary biologics manufacturer makes an independent determination
concerning (1) whether an adverse event report raises PSPEPTD questions
and (2) when and in what manner such report of the adverse event will
be provided to APHIS.
To limit the harm to animals posed by unsatisfactory veterinary
biologics, APHIS must rely on adverse event reports provided by
veterinary biologics licensees and permittees. However, without any
explicit guidance as to the form those reports should take, licensees
and permittees are using nonstandardized methods to record and submit
reports regarding adverse events to APHIS. Similarly, without explicit
reporting requirements concerning adverse events, reports that may
signal problems concerning the use of veterinary biological products
are not all being submitted to APHIS in a timely manner.
The changes we are proposing are also consistent with guidelines
set out by the International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH).
VICH is a unique project conducted under the World Organization for
Animal Health, that brings together the regulatory authorities of the
European Union, Japan, and the United States and representatives from
the animal health industry in the three regions. Regulatory authorities
and industry experts from Australia, Canada, and New Zealand
participate as observers.
The purpose of VICH is to harmonize technical requirements for
veterinary medicinal products (both pharmaceuticals and biologics). As
a VICH member, APHIS provides expertise on veterinary biological
products and participates in efforts to enhance harmonization. Both
APHIS and the animal health industry are committed to seek
scientifically based harmonized technical requirements for the
development and use of veterinary biological products. VICH Guideline
GL42 specifically addresses data

[[Page 53476]]

elements for submission of adverse event reports.\1\
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\1\ The VICH pharmacovigilance guidelines can be accessed at
http://www.vichsec.org/guidelines/pharmacovigilance.html.
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By amending our regulations based on VICH pharmacovigilance
guidelines we would be integrating into our regulations internationally
accepted practices that would enhance the safety and efficacy of
veterinary biologics in the United States. Furthermore, our consistency
with these international guidelines would enhance the ability of the
U.S. biologics industry to export their products.
We have previously undertaken rulemaking to address the problems
described above and to bring our reporting and recordkeeping
requirements into closer alignment with the VICH guidelines.
Specifically, on August 17, 2005, we published in the Federal Register
(70 FR 48325-48329, Docket No. 00-071-2) a proposed rule \2\ to amend
the regulations concerning records and reports to require veterinary
biologics licensees and permittees to record and submit reports to
APHIS concerning adverse events associated with the use of veterinary
biological products that they produce or distribute. The proposed rule
would have required veterinary biologics licensees and permittees to
report to APHIS the number of doses of each licensed product that they
distribute. The proposed rule also would have amended the regulations
in 9 CFR part 101 to provide definitions for the terms adverse event
and adverse event report.
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\2\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/#!docketDetail;D=APHIS-2005-0071.
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We solicited comments on our proposal for 60 days ending on October
17, 2005. We received seven comments by that date. The comments were
from industry associations, manufacturers of veterinary biologics, and
a software company that specializes in pharmacovigilance. Four of these
commenters expressed conceptual support for the proposed rule, but were
concerned that parts of the proposed regulations were overly broad or
ambiguous and would increase the regulatory burden on the industry and
possibly compromise confidential business information. One commenter
was skeptical of the need for the rule. The remaining commenters
neither supported nor opposed the rule but instead either asked for
clarification or suggested wording that they believed would provide
greater clarity.
In response to these comments, we believe it is necessary to
clarify those provisions that could be subject to multiple
interpretations and to provide more specifics concerning the
information that should be included in adverse event reports associated
with the use of veterinary biologics that are submitted to the Agency.
Therefore, we are withdrawing the August 17, 2005, proposed rule and
are replacing it with the proposed changes described in this document.
The proposed recordkeeping and reporting requirements regarding adverse
events that would apply to each licensee, permittee, and foreign
establishment that prepares and distributes biological products are
described below.

Definitions

The regulations in 9 CFR part 101 contain definitions of terms used
in the regulations concerning veterinary biologics. The proposed
changes to part 116 of the regulations would make it necessary for us
to add definitions for two terms used in the proposed regulations to
Sec. 101.2. We would define adverse event as ``any observation in
animals, whether or not the cause of the event is known, that is
unfavorable and unintended, and that occurs after any use (as indicated
on the label or any off-label use) of a biological product, including
events related to a suspected lack of expected efficacy. For products
intended to diagnose disease, adverse events refer to a failure in
product performance that hinders an expected discovery of the correct
diagnosis.'' We would define adverse event report as ``any
communication concerning the occurrence of an adverse event from an
identifiable first-hand reporter which includes at least the following
information: An identifiable reporter; an identifiable animal; an
identifiable biologic product; and one or more adverse events.''

Adverse Event Records

We are proposing to add a new Sec. 116.9 to provide requirements
for adverse event records and reports. First, we would require that
licensees and permittees maintain a detailed record for every adverse
event report the licensee or permittee receives that is associated with
the use of biological products they produce or distribute. APHIS will
provide guidance on the information to be included in the reports on
our Web site, based on the recommendations in the VICH Guideline GL42,
which addresses data elements for submission of adverse event reports.
We will release guidance documents as a final rule is being
implemented, and we will make the documents available on our Web site
in draft form for public comment.
Second, we would require that licensees and permittees compile a
report of all adverse events reports they receive and submit that
report to the APHIS at regular intervals. Specifically, we would
require that these reports be submitted immediately 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. If the licensee or permittee determines the adverse event
report to be product-related, serious, and unexpected, the report would
have to be submitted to APHIS within 15 business days of the date the
report was first received. All other adverse event reports would have
to be submitted within 90 calendar days of the date the report was
first received.

Completion of Records

The regulations in Sec. Sec. 116.1(a)(3) and 116.8 provide that
all records (other than disposition records) required under part 116
shall be completed by the licensee, permittee, or foreign manufacturer
before any portion of a serial of any product may be marketed in the
United States or exported. We are proposing to amend those provisions
to also allow adverse event records to be excluded from the list of
records that must be completed before a product may be marketed or
exported. Like disposition records, adverse event records could not be
expected to have been completed prior to the marketing or exportation
of a product.
If this proposed rule is adopted as a final rule, there would be an
18-month implementation period to allow licensees and permittees
sufficient time to bring their recordkeeping and reporting into
compliance with the new reporting and recordkeeping requirements.

Miscellaneous

We would also make several minor, nonsubstantive changes to the
regulations to improve their clarity.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866 and, therefore, has not been
reviewed by the Office of Management and Budget.
In accordance with 5 U.S.C. 603, we have performed an initial
regulatory flexibility analysis, which is summarized below, regarding
the economic effects of this rule on small entities. The full analysis
may be viewed on the Regulations.gov Web site

[[Page 53477]]

(see ADDRESSES above for instructions for accessing Regulations.gov) or
obtained from the person listed under FOR FURTHER INFORMATION CONTACT.
The proposed rule would affect all of the approximately 314 U.S.
veterinary biologics manufacturers, including permittees. All the
affected entities would have to take at least some additional action--
even if that additional action involved sending a negative affirmation
report to APHIS annually.
The Small Business Administration (SBA) standard for establishments
primarily engaged in manufacturing vaccines, toxoids, blood fractions,
and culture media of plant or animal origin (NAICS 325414) is 500
employees or fewer. It is reasonable to assume that most are small in
size, under the SBA standards. This assumption is based on composite
data for providers of the same and similar services in the United
States. In 2012, there were 314 U.S. establishments in NAICS 325414 \3\
with a total employment of 40,411. The average number of employees per
firm in 2012 was 128. Similarly, in 2012, there were 235 U.S.
establishments in NAICS 325413, a classification comprised of
establishments primarily engaged in manufacturing in-vitro diagnostic
substances, including biological substances. The average number of
employees per firm in 2012 was 108.\4\
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\3\ http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=325414.
\4\ http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=325413.
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The proposed rule has the potential to benefit animals and their
owners, to the extent that it allows APHIS to act quickly to limit the
harm to animals posed by unsatisfactory veterinary biologics. For
animal owners, the monetary benefits are difficult to estimate, because
they would depend on several factors that are currently unknown--the
significance, or gravity, of the harm that would be avoided with the
rule in effect, and the number, and value, of animals that would avoid
harm with the rule in effect. For some animal owners, especially those
with large numbers of high value animals, the potential monetary
benefits could be significant. This proposed rule clarifies reporting
requirements. Manufacturer costs to comply with the proposed rule are
expected be minimal in most cases. By revising our regulations based on
VICH pharmacovigilance guidelines we will be applying an international
standard to the industry which will enhance the safety and efficacy of
veterinary biologics in the United States. Furthermore, our compliance
with this international standard will enhance the ability of the
biologics industry to export their products.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect.
This rule would not preempt any State or local laws, regulations, or
policies where they are necessary to address local disease conditions
or eradication programs. However, where safety, efficacy, purity, and
potency of biological products are concerned, it is the Agency's intent
to occupy the field. This includes, but is not limited to, the
regulation of labeling. Under the Act, Congress clearly intended that
there be national uniformity in the regulation of these products. There
are no administrative proceedings which must be exhausted prior to a
judicial challenge to the regulations under this rule.

Executive Order 13175

This rule does not significantly or uniquely affect the communities
of Indian tribal governments. The rule does not impose any mandate on
tribal governments or impose any duties on these entities. Thus, no
further action is required under Executive Order 13175.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. APHIS-
2014-0063. Please send a copy of your comments to: (1) APHIS, using one
of the methods described under ADDRESSES at the beginning of this
document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th
Street and Independence Avenue SW., Washington, DC 20250.
This proposed rule would require veterinary biologics licensees and
permittees to record and submit reports to APHIS concerning adverse
events associated with the use of biological products they produce or
distribute. APHIS would provide guidance as to the information to be
included in these reports. The reports would also be required to be
maintained for a specified amount of time.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, 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 information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 0.33 hours per response.
Respondents: U.S. importers and exporters of veterinary biological
products, shippers of veterinary biological products, State veterinary
authorities, and operators of establishments that produce or test
veterinary biological products or that engage in product research and
development.
Estimated annual number of respondents: 9,999.
Estimated annual number of responses per respondent: 1.59.
Estimated annual number of responses: 15,996.
Estimated total annual burden on respondents: 5,280 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.)
Copies of this information collection can be obtained from Ms.
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301)
851-2727.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to

[[Page 53478]]

compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Ms. Kimberly
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

Lists of Subjects

9 CFR Part 101

Animal biologics.

9 CFR Part 116

Animal biologics, Reporting and recordkeeping requirements.

Accordingly, we propose to amend 9 CFR parts 101 and 116 as
follows:

PART 101--DEFINITIONS

0
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 371.4.

0
2. Section 101.2 is amended by adding definitions for adverse event and
adverse event report in alphabetical order to read as follows:

Sec. 101.2 Administrative terminology.

* * * * *
Adverse event. Any observation in animals, whether or not the cause
of the event is known, that is unfavorable and unintended, and that
occurs after any use (as indicated on the label or any off-label use)
of a biological product, including events related to a suspected lack
of expected efficacy. For products intended to diagnose disease,
adverse events refer to a failure in product performance that hinders
an expected discovery of the correct diagnosis.
Adverse event report. Any communication concerning the occurrence
of an adverse event from an identifiable first-hand reporter which
includes the following information:
(1) An identifiable reporter;
(2) An identifiable animal;
(3) An identifiable biologic product; and
(4) One or more adverse events.
* * * * *

PART 116--RECORDS AND REPORTS

0
3. 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 371.4.

0
4. In Sec. 116.1, paragraph (a)(3) is revised to read as follows:

Sec. 116.1 Applicability and general considerations.

(a) * * *
(3) Records (other than disposition records and adverse event
records) required by this part must be completed by the licensee,
permittee, or foreign manufacturer, as the case may be, before any
portion of a serial of any product may be marketed in the United States
or exported.
* * * * *
0
5. Section 116.8 is revised to read as follows:

Sec. 116.8 Completion and retention of records.

All records (other than disposition records and adverse event
records) required by this part must be completed by the licensee,
permittee, or foreign manufacturer before any portion of a serial of
any product may be marketed in the United States or exported. All
records must be retained at the licensed or foreign establishment or
permittee's place of business for a period of 2 years after the
expiration date of a product or longer as may be required by the
Administrator.
0
6. Section 116.9 is added to read as follows:

Sec. 116.9 Recording and reporting adverse events.

(a) Licensees and permittees must maintain a detailed record for
every adverse event report the licensee or permittee receives for any
biological product it produces or distributes. These records shall be
maintained for a period of 3 years after the date the adverse event
report is received. The adverse event report form and guidance on how
to complete it, including guidance specific to the various information
blocks on the form, is available on the APHIS Web site at [ADDRESS TO
BE ADDED IN FINAL RULE] or by writing to APHIS at [POSTAL ADDRESS TO BE
ADDED IN FINAL RULE].
(b) A report of all adverse events reports received by a licensee
or permittee must be compiled and submitted to the Animal and Plant
Health Inspection Service. The frequency of report submission is as
follows:
(1) Immediate notification is required 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.
(2) Adverse event reports determined by the licensee or permittee
to be product-related, serious, and unexpected must be reported within
15 business days of the date the report was first received.
(3) All other adverse event reports must be reported within 90
calendar days of the date the report was first received.

Done in Washington, DC, this 31st day of August 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-21997 Filed 9-3-15; 8:45 am]
BILLING CODE 3410-34-P

53475

Proposed Rules Federal Register
Vol. 80, No. 172

Friday, September 4, 2015

This section of the FEDERAL REGISTER in our reading Room, which is located indication that raises questions
contains notices to the public of the proposed in Room 1141 of the USDA South regarding the purity, safety, potency,
issuance of rules and regulations. The Building, 14th Street and Independence efficacy, preparation, testing, or
purpose of these notices is to give interested Avenue SW., Washington, DC. Normal distribution (PSPEPTD) of such product.
persons an opportunity to participate in the reading room hours are 8 a.m. to 4:30
rule making prior to the adoption of the final Consequently, each veterinary biologics
rules.
p.m., Monday through Friday, except manufacturer makes an independent
holidays. To be sure someone is there to determination concerning (1) whether
help you, please call (202) 799–7039 an adverse event report raises PSPEPTD
DEPARTMENT OF AGRICULTURE before coming. questions and (2) when and in what
FOR FURTHER INFORMATION CONTACT: Dr. manner such report of the adverse event
Animal and Plant Health Inspection Donna L. Malloy, Section Leader, will be provided to APHIS.
Service Operational Support, Center for
Veterinary Biologics Policy, Evaluation, To limit the harm to animals posed by
9 CFR Parts 101 and 116 and Licensing, VS, APHIS, 4700 River unsatisfactory veterinary biologics,
Road Unit 148, Riverdale, MD 20737– APHIS must rely on adverse event
[Docket No. APHIS–2014–0063] reports provided by veterinary biologics
1231; (301) 851–3426.
RIN 0579–AE11
SUPPLEMENTARY INFORMATION:
licensees and permittees. However,
without any explicit guidance as to the
VSTA Records and Reports Specific to Background form those reports should take,
International Standards for licensees and permittees are using
The Virus-Serum-Toxin Act
Pharmacovigilance nonstandardized methods to record and
regulations in 9 CFR part 116 (referred
AGENCY: Animal and Plant Health to below as the regulations) contain submit reports regarding adverse events
Inspection Service, USDA. requirements for maintaining detailed to APHIS. Similarly, without explicit
ACTION: Proposed rule; withdrawal and records of information necessary to give reporting requirements concerning
reproposal. a complete accounting of all the adverse events, reports that may signal
activities within a veterinary biologics problems concerning the use of
SUMMARY: We are proposing to amend establishment. These records include veterinary biological products are not all
the Virus-Serum-Toxin Act regulations records and reports for unfavorable or being submitted to APHIS in a timely
concerning records and reports. This unintended events that occur in animals manner.
change would require veterinary after the use of a biological product.
biologics licensees and permittees to Specifically, the regulations in The changes we are proposing are also
record and submit reports concerning § 116.1, paragraph (a) state that such consistent with guidelines set out by the
adverse events associated with the use reports must include, but are not limited International Cooperation on
of biological products they produce or to, the items enumerated in the Harmonization of Technical
distribute. The information that must be regulations, including inventory and Requirements for Registration of
included in the adverse event reports disposition records, (§ 116.2), Veterinary Medicinal Products (VICH).
submitted to the Animal and Plant information concerning product VICH is a unique project conducted
Health Inspection Service would be development and preparation and under the World Organization for
provided in separate guidance market suspension and recalls (§ 116.5), Animal Health, that brings together the
documents. This proposed rule replaces animal records (§ 116.6), and test regulatory authorities of the European
a previously published proposed rule, records (§ 116.7). Union, Japan, and the United States and
which we are withdrawing as part of In § 116.5, paragraph (b) states that if representatives from the animal health
this document. at any time there are indications that industry in the three regions. Regulatory
DATES: We will consider all comments raise questions regarding the purity, authorities and industry experts from
that we receive on or before November safety, potency, or efficacy of a product, Australia, Canada, and New Zealand
3, 2015. or if it appears that there may be a participate as observers.
ADDRESSES: You may submit comments problem regarding the preparation,
testing, or distribution of a product, the The purpose of VICH is to harmonize
by either of the following methods: technical requirements for veterinary
• Federal eRulemaking Portal: Go to licensee, permittee, or foreign
manufacturer must immediately notify medicinal products (both
http://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0063. the Animal and Plant Health Inspection pharmaceuticals and biologics). As a
• Postal Mail/Commercial Delivery: Service (APHIS) concerning the VICH member, APHIS provides
Send your comment to Docket No. circumstances and the action taken, if expertise on veterinary biological
APHIS–2014–0063, Regulatory Analysis any. products and participates in efforts to
rmajette on DSK2VPTVN1PROD with PROPOSALS

and Development, PPD, APHIS, Station However, the regulations in § 116.1 do enhance harmonization. Both APHIS
3A–03.8, 4700 River Road Unit 118, not explicitly require licensees and and the animal health industry are
Riverdale, MD 20737–1238. permittees to maintain records of committed to seek scientifically based
Supporting documents and any adverse events associated with the use harmonized technical requirements for
comments we receive on this docket of veterinary biologics, nor do the the development and use of veterinary
may be viewed at http:// regulations in § 116.5 provide specific biological products. VICH Guideline
www.regulations.gov/ guidance in determining whether an GL42 specifically addresses data
#!docketDetail;D=APHIS-2014-0063 or adverse event should be considered an

VerDate Sep<11>2014 13:58 Sep 03, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\04SEP1.SGM 04SEP1

Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Proposed Rules 53477

(see ADDRESSES above for instructions veterinary biologics in the United permittees to record and submit reports
for accessing Regulations.gov) or States. Furthermore, our compliance to APHIS concerning adverse events
obtained from the person listed under with this international standard will associated with the use of biological
FOR FURTHER INFORMATION CONTACT. enhance the ability of the biologics products they produce or distribute.
The proposed rule would affect all of industry to export their products. APHIS would provide guidance as to
the approximately 314 U.S. veterinary the information to be included in these
biologics manufacturers, including Executive Order 12372
reports. The reports would also be
permittees. All the affected entities This program/activity is listed in the required to be maintained for a specified
would have to take at least some Catalog of Federal Domestic Assistance amount of time.
additional action—even if that under No. 10.025 and is subject to We are soliciting comments from the
additional action involved sending a Executive Order 12372, which requires public (as well as affected agencies)
negative affirmation report to APHIS intergovernmental consultation with concerning our proposed information
annually. State and local officials. (See 2 CFR collection and recordkeeping
The Small Business Administration chapter IV.) requirements. These comments will
(SBA) standard for establishments help us:
primarily engaged in manufacturing Executive Order 12988
(1) Evaluate whether the proposed
vaccines, toxoids, blood fractions, and This proposed rule has been reviewed information collection is necessary for
culture media of plant or animal origin under Executive Order 12988, Civil the proper performance of our agency’s
(NAICS 325414) is 500 employees or Justice Reform. It is not intended to functions, including whether the
fewer. It is reasonable to assume that have retroactive effect. This rule would information will have practical utility;
most are small in size, under the SBA not preempt any State or local laws, (2) Evaluate the accuracy of our
standards. This assumption is based on regulations, or policies where they are estimate of the burden of the proposed
composite data for providers of the same necessary to address local disease information collection, including the
and similar services in the United conditions or eradication programs. validity of the methodology and
States. In 2012, there were 314 U.S. However, where safety, efficacy, purity, assumptions used;
establishments in NAICS 325414 3 with and potency of biological products are (3) Enhance the quality, utility, and
a total employment of 40,411. The concerned, it is the Agency’s intent to clarity of the information to be
average number of employees per firm occupy the field. This includes, but is collected; and
in 2012 was 128. Similarly, in 2012, not limited to, the regulation of labeling. (4) Minimize the burden of the
there were 235 U.S. establishments in Under the Act, Congress clearly information collection on those who are
NAICS 325413, a classification intended that there be national to respond (such as through the use of
comprised of establishments primarily uniformity in the regulation of these appropriate automated, electronic,
engaged in manufacturing in-vitro products. There are no administrative mechanical, or other technological
diagnostic substances, including proceedings which must be exhausted collection techniques or other forms of
biological substances. The average prior to a judicial challenge to the information technology; e.g., permitting
number of employees per firm in 2012 regulations under this rule. electronic submission of responses).
was 108.4 Estimate of burden: Public reporting
The proposed rule has the potential to Executive Order 13175
burden for this collection of information
benefit animals and their owners, to the This rule does not significantly or is estimated to average 0.33 hours per
extent that it allows APHIS to act uniquely affect the communities of response.
quickly to limit the harm to animals Indian tribal governments. The rule Respondents: U.S. importers and
posed by unsatisfactory veterinary does not impose any mandate on tribal exporters of veterinary biological
biologics. For animal owners, the governments or impose any duties on products, shippers of veterinary
monetary benefits are difficult to these entities. Thus, no further action is biological products, State veterinary
estimate, because they would depend on required under Executive Order 13175. authorities, and operators of
several factors that are currently establishments that produce or test
unknown—the significance, or gravity, Paperwork Reduction Act
veterinary biological products or that
of the harm that would be avoided with In accordance with section 3507(d) of engage in product research and
the rule in effect, and the number, and the Paperwork Reduction Act of 1995 development.
value, of animals that would avoid harm (44 U.S.C. 3501 et seq.), the information Estimated annual number of
with the rule in effect. For some animal collection or recordkeeping respondents: 9,999.
owners, especially those with large requirements included in this proposed Estimated annual number of
numbers of high value animals, the rule have been submitted for approval to responses per respondent: 1.59.
potential monetary benefits could be the Office of Management and Budget Estimated annual number of
significant. This proposed rule clarifies (OMB). Please send written comments responses: 15,996.
reporting requirements. Manufacturer to the Office of Information and Estimated total annual burden on
costs to comply with the proposed rule Regulatory Affairs, OMB, Attention: respondents: 5,280 hours. (Due to
are expected be minimal in most cases. Desk Officer for APHIS, Washington, DC averaging, the total annual burden hours
By revising our regulations based on 20503. Please state that your comments may not equal the product of the annual
VICH pharmacovigilance guidelines we refer to Docket No. APHIS–2014–0063. number of responses multiplied by the
will be applying an international Please send a copy of your comments to: reporting burden per response.)
rmajette on DSK2VPTVN1PROD with PROPOSALS

standard to the industry which will (1) APHIS, using one of the methods Copies of this information collection
enhance the safety and efficacy of described under ADDRESSES at the can be obtained from Ms. Kimberly
beginning of this document, and (2) Hardy, APHIS’ Information Collection
3 http://thedataweb.rm.census.gov/TheDataWeb_
Clearance Officer, OCIO, USDA, Room Coordinator, at (301) 851–2727.
HotReport2/econsnapshot/2012/
snapshot.hrml?NAICS=325414.
404–W, 14th Street and Independence
Avenue SW., Washington, DC 20250. E-Government Act Compliance
4 http://thedataweb.rm.census.gov/TheDataWeb_

HotReport2/econsnapshot/2012/ This proposed rule would require The Animal and Plant Health
snapshot.hrml?NAICS=325413. veterinary biologics licensees and Inspection Service is committed to

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Document Created: 2015-12-15 09:58:02
Document Modified: 2015-12-15 09:58:02

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		Proposed Rules
Action		Proposed rule; withdrawal and reproposal.
Dates		We will consider all comments that we receive on or before November 3, 2015.
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.
FR Citation		80 FR 53475
RIN Number		0579-AE11
CFR Citation		9 CFR 101 9 CFR 116
CFR Associated		Animal Biologics and Reporting and Recordkeeping Requirements

80 FR 53475 - VSTA Records and Reports Specific to International Standards for Pharmacovigilance

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 172 (September 4, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service