22832 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 

1To view the proposed rule, supporting 

document, and the comments we received, go to 

http://www.regulations.gov/#!docketDetail;D

=APHIS-2014-0063. 

2The VICH pharmacovigilance guidelines can be 

accessed at http://www.vichsec.org/guidelines/ 

pharmacovigilance.html. 

the FOR FURTHER INFORMATION CONTACT

section. 

List of Subjects in 7 CFR Part 900 

Administrative practice and 

procedure, Freedom of information, 

Marketing agreements, Reporting and 

recordkeeping requirements. 

For the reasons set forth above, 7 CFR 

part 900 is amended as follows: 

PART 900—GENERAL REGULATIONS 

■ 1. The authority citation for part 900 

continues to read as follows: 

Authority: 7 U.S.C. 601–674 and 7 U.S.C. 

7401. 

■ 2. Add § 900.83 to subpart E read as 

follows: 

§ 900.83 Conducting Meetings via 

Electronic Communication or Otherwise. 

Notwithstanding any other provisions 

of a marketing order in this part, 

administrative bodies of fruit, vegetable, 

and specialty crop marketing orders, 

and their committees/subcommittees 

may, upon due notice to all members 

and the public: 

(a) Conduct meetings by any means of 

communication available, electronic or 

otherwise, that effectively assembles 

members and the public, and facilitates 

open communication. 

(b) Vote by any means of 

communication available, electronic or 

otherwise; Provided, That votes cast are 

verifiable and that quorum and other 

procedural requirements of each 

respective marketing order are met. 

(c) With the approval of the Secretary, 

each administrative body may prescribe 

any additional procedures necessary to 

carry out the objectives of paragraphs (a) 

and (b) of this section. 

Dated: May 11, 2018. 

Bruce Summers, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2018–10487 Filed 5–16–18; 8:45 am] 

BILLING CODE 3410–02–P 

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: Final rule. 

SUMMARY: We are amending the VirusSerum-Toxin Act regulations 

concerning records and reports. This 

change requires 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 (APHIS) will 

be provided in separate guidance 

documents. These records and reports 

will help ensure that APHIS can provide 

complete and accurate information to 

consumers regarding adverse reactions 

or other problems associated with the 

use of licensed biological products. 

DATES: Effective June 18, 2018. 

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. 

On September 4, 2015, we published 

in the Federal Register (80 FR 53475– 

53478, Docket No. APHIS–2014–0063) a 

proposal 1 to amend the regulations by 

establishing definitions for the terms 

adverse event and adverse event report 

and by providing requirements for 

adverse event records and reports. The 

changes we proposed are 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, the Animal and Plant 

Health Inspection Service (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: 

Pharmacovigilance: Data Elements for 

Submission of Adverse Events Reports 

specifically addresses the information 

that should be included when 

submitting adverse event reports.2

We solicited comments concerning 

our proposal for 60 days ending 

November 3, 2015. We received four 

comments by that date. They were from 

industry associations, a manufacturer of 

veterinary biologics, and a private 

citizen. The commenters were generally 

supportive of the proposed rule but 

asked some questions and raised some 

concerns about the provisions. These 

comments are discussed below by topic. 

General Comments 

One commenter stated that the 

current system for detecting safety 

issues with products has historically 

worked well. The commenter did not 

believe there have been significant 

safety issues that have not been detected 

in a timely fashion. 

APHIS agrees with the commenter 

that the existing system has worked 

well. However, we believe that this rule 

will significantly improve the existing 

system by enhancing our ability to 

monitor the observed performance of 

veterinary biologics. For example, 

currently each veterinary biologics 

manufacturer makes an independent 

determination concerning whether an 

adverse event report raises questions 

regarding purity, safety, potency, 

efficacy, preparation, testing, or 

distribution, and when and in what 

manner such a report of the adverse 

event will be provided to APHIS. Thus, 

without explicit reporting requirements 

concerning adverse events, reports that 

may signal problems concerning the use 

of veterinary biological products may 

not all be submitted to APHIS or may 

not be submitted in a timely manner. 


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Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 22833 

Another objective of this rule is to 

implement VICH guidelines pertaining 

to international standards specific for 

pharmacovigilance, which may enhance 

the ability of the biologics industry to 

export their products. 

One commenter noted that the only 

VICH guideline specifically referenced 

in the proposed rule is VICH GL42. The 

commenter stated that where the final 

rule, guidance documents, or APHIS 

practice touches upon the subject matter 

in the VICH guidelines, APHIS should 

look to all the VICH guidelines to 

harmonize definitions and practices to 

the furthest extent possible. The 

commenter specifically mentioned 

VICH GL24, Pharmacovigilance of 

Veterinary Medicinal Products: 

Management of Adverse Event Reports 

as one which APHIS should consider 

when establishing future regulations or 

guidelines. 

APHIS agrees that consistency with 

all relevant VICH guidelines is 

important. In the proposed rule, we 

referenced GL42 because we were 

proposing to add definitions to 9 CFR 

part 101 which are consistent with 

definitions found in this guideline. In 

future actions, however, we will 

reference all VICH guidelines regarding 

pharmacovigilance. We will also review 

all VICH guidelines associated with 

pharmacovigilance and consider them 

when developing future guidance 

documents, and will provide an 

opportunity for the industry to review 

and comment on any such documents. 

One commenter stated that this rule 

should not be implemented until APHIS 

has the capability to receive 

submissions electronically. The 

commenter further stated that in 

establishing this capability APHIS 

should utilize the VICH Guidelines for 

the Electronic Standards for Transfer of 

Data, and Data Elements for Submission 

of Adverse Event Reports (VICH GL42, 

30, and 35). 

APHIS agrees on the importance of 

electronic submission and we will 

prioritize the development of an 

electronic submission portal. However 

we do not agree that this rule should not 

be implemented until we have the 

capacity to receive electronic 

submissions. As noted above by another 

commenter, the current system for 

detecting safety signals with products 

has historically worked well. APHIS 

has, and will continue to have, the 

capability to receive adverse event 

information by phone, fax, email, etc. It 

is important to implement this rule in 

order to clarify specific reporting 

requirements and to harmonize with 

international standards. Since we 

already receive adverse event reports, 

we do not believe it is necessary to wait 

for the development of an electronic 

submission portal. 

One commenter stated that the same 

adverse event may be reported 

separately by two or more parties, such 

as the veterinarian and animal owner. 

The commenter stated that APHIS 

should ensure that it has the capability 

to detect any duplicate reports. 

We agree with the commenter and 

will work to develop internal systems to 

detect duplicate reports. 

One commenter recommended that 

APHIS engage the industry in 

substantial discussion relative to the 

method and process it will use for signal 

detection and trend analysis and signal 

assessment and management. The 

commenter stated that government and 

industry have the same goal of 

marketing pure, potent, safe, and 

effective products and industry is open 

to maintaining a partnership in signal 

detection, trend analysis, and risk 

management. 

APHIS agrees with the commenter 

and will continue to engage with 

industry as future guidance is 

developed. 

One commenter asked for clarification 

of APHIS expectations on the 

maintenance of pharmacovigilance data 

and practices when a facility is 

inspected. 

Proposed § 116.9(a) provides that 

records must be maintained for 3 years 

after the date that the adverse event 

report is received. 

One commenter asked for clarification 

on the aspects of the adverse event data 

that will be subject to the Freedom of 

Information Act (FOIA) and/or routinely 

made available on the APHIS website. 

The commenter stated that they 

expected that FOIA requests for this 

data will be received and that this data 

has tremendous potential for misuse. 

The commenter strongly suggested that 

if the data is made available on the 

APHIS website, information should also 

be provided about the limitations on 

interpreting the data. 

In general, if APHIS receives a FOIA 

request for publicly available 

information, we do not need to supply 

the information to the requester. 

Instead, we provide guidance on where 

the information is available and how 

often it is updated. If the FOIA request 

is for specific data that is not available 

publicly, then we are mandated to 

supply the information in its entirety 

without redaction. If it is information 

owned by a biologics manufacturer, 

then APHIS will send the FOIA request 

and responsive records to the 

manufacturer for review and redaction, 

if the responsive records contain 

confidential business information or 

trade secrets. 

Because the adverse event reports we 

receive are voluntary, APHIS has not yet 

made summary reports available to the 

public. We are aware that the number of 

adverse event reports received are a very 

small percentage of what is occurring in 

the field. After mandatory adverse event 

reporting is implemented, APHIS will 

make summary reports publicly 

available on the APHIS website. APHIS 

is working to determine the specifics on 

how often those reports are published 

and what explanatory information is 

included. 

Though we have not finalized a 

process to manage this data publicly, we 

do agree with the commenter about the 

limitations on interpreting the data 

when made public. For example, 

comparing products by the prevalence 

of adverse event cases reported can be 

misleading if one does not consider the 

number of animals exposed for each 

respective product. Prior to 

implementing the process for public 

disclosure of the data, we will explore 

the method that best serves all 

veterinary biologics stakeholders. 

Included in this will be the review and 

consideration of how the Food and Drug 

Administration handles their 

pharmacovigilance data. 

One commenter recommended that 

APHIS remove the adverse event 

reporting restrictions on the licenses for 

conditionally licensed products. The 

commenter also recommended that 

APHIS engage with State veterinarians 

and inform them that adverse events 

will be made public and that the 

industry should not be required by the 

State to provide additional reports. 

APHIS intends to engage with State 

veterinarians and other public groups to 

advise them of the availability of 

adverse event reports on the APHIS 

website. However, we will not remove 

adverse reporting restrictions on 

licenses because there may be specific 

issues associated with a product that 

require clarification on the license. 

One commenter noted that the 

definition of an adverse event for 

diagnostic products includes ‘‘failure in 

product performance.’’ The commenter 

stated that most customer reports of 

problems can either be traced to 

technical errors, or cannot be replicated 

with the product itself. The commenter 

further stated that unverified reports 

should not be the basis of adverse event 

reports to APHIS. The commenter stated 

that it is fairly straightforward to verify 

a problem with kit performance, and it 

seems appropriate that this be part of 

the determination that an adverse event 

has occurred. 


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22834 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 

The commenter is correct that for 

diagnostic kits a ‘‘failure in product 

performance’’ refers to a verified failure 

of the product itself, and would not 

include reports associated with 

equipment failure or technical errors. 

We will clarify this in guidance 

documents. 

In the proposed rule, we estimated 

that each report would require 0.33 

hours to generate and submit. One 

commenter stated that this estimate is 

too low. The commenter stated that any 

formal communication with a regulatory 

agency requires fact-checking and 

review, which add to the time required 

to generate the report. The commenter 

stated that they believe that a minimum 

of two full-time equivalent hours would 

be required for a simple report, with 4 

to 6 hours being a likely average for all 

reports. 

APHIS recognizes the variability in 

the time that it will take to gather, 

review, assess, and report adverse event 

cases to the agency. For example, the 

type of product (vaccine, diagnostic test 

kits, etc.) can have a significant 

influence in the respective time 

required to process a case. The reporting 

time would also vary depending on 

whether a licensee/permittee submits 

cases individually or batches multiple 

ones in a single submission. Therefore, 

considering the variability of processing 

adverse event reports for licensees/ 

permittees, we would agree that a more 

accurate estimate of burden would be a 

range of 1 to 3 hours. 

Definitions 

One commenter stated that the 

proposed definition of adverse event 

should align with the definition in VICH 

GL24. 

VICH GL24, which refers to all 

veterinary medicinal products (VMP), 

defines an adverse event as ‘‘any 

observation in animals, whether or not 

considered to be product-related, that is 

unfavorable and unintended and that 

occurs after any use of VMP (off-label 

and on-label uses). Included are events 

related to a suspected lack of expected 

efficacy according to approved labeling 

or noxious reactions in humans after 

being exposed to VMP(s).’’ 

We proposed to define an 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 offlabel 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. 

APHIS believes that the two definitions 

are generally consistent and that the 

APHIS definition is appropriate for the 

regulation of veterinary biological 

products as compared to the regulation 

of all other veterinary medicinal 

products. 

One commenter stated that the 

definition of adverse event report in 

VICH GL24 requires a ‘‘direct 

communication’’ while the proposed 

APHIS definition referred to ‘‘any 

communication.’’ The commenter stated 

APHIS should use the words ‘‘direct 

communication’’ because this language 

would trigger reporting based upon 

reliable information; and specifically 

would not trigger reporting simply 

because the licensee became aware of, 

for example, an unsubstantiated blog 

post or anti-product activity on the 

internet. 

APHIS agrees with the commenter. 

We have amended the definition of 

adverse event report to read ‘‘direct 

communication’’ instead of ‘‘any 

communication’’. 

One commenter noted that an adverse 

event report is defined as a 

communication received by a firm 

regarding an adverse event and which 

includes several pieces of information, 

including an ‘‘identifiable animal.’’ The 

commenter stated that test kits for 

diseases of livestock and poultry are 

most often used in laboratories, not at 

the location of the animals. The 

commenter further stated that 

laboratories would only rarely have 

access to individual animal 

identification devices in the normal 

course of their work. The commenter 

stated that if the intent of the rule is that 

all information listed must be available 

before a report to APHIS is required, 

that could greatly limit the number of 

reports. The commenter asked for 

clarification of the intent of the rule in 

this regard. 

APHIS agrees that this could be 

clearer. In cases where specific 

information regarding an animal 

identity is not readily available, we 

consider the species for which the 

product was used to be the minimum 

information for an ‘‘identifiable 

animal.’’ 

Frequency of Reporting 

One commenter noted that the terms 

serious adverse event and unexpected 

adverse event, which appear in VICH 

GL24, were not defined in the proposed 

rule. The commenter stated that those 

terms should not be considered factors 

that determine frequency of reporting. 

APHIS intends to define these terms 

in guidance documents that will be 

made available for review and comment 

by the industry and public before they 

are finalized. APHIS will work with the 

industry to develop guidance on these 

topics as the need arises. 

One commenter asked for clarification 

that APHIS is seeking spontaneous 

reports of adverse events, and not the 

results that could occur in clinical trials 

or other studies that would already be 

reported to APHIS in a study report, or 

adverse events that may be reported in 

the literature. 

The commenter is correct. Adverse 

event reports should address events that 

occur in field use of the product, not the 

results of clinical trials. 

One commenter stated that, in 

§ 116.9(b)(1), ‘‘immediate’’ should be 

interpreted to mean ‘‘within 3 business 

days’’ to be consistent with Veterinary 

Services Memorandum 800.57 ‘‘Market 

Suspensions.’’ The commenter stated 

that this would allow time for 

preliminary investigation. The 

commenter also stated that APHIS 

should replace the term ‘‘immediate’’ 

with ‘‘3 business days’’ in this section, 

as well as in § 116.5(b). 

APHIS agrees that it is practical to 

interpret ‘‘immediately’’ as ‘‘within 3 

business days’’ and will clarify this in 

guidance documents, which will be 

needed to establish a consistent 

application to the interpretation of a 

serious event. The requirement in 

§ 116.9(b)(1) is consistent with the 

established requirement in § 116.5(b), so 

we are making no changes to either 

paragraph. 

One commenter recommended that 

APHIS eliminate the 15 business day 

reporting requirement and any use of 

the concepts of ‘‘product-related’’, 

‘‘serious’’, and ‘‘expected’’ for case 

management timelines. The commenter 

stated that even if these are eliminated, 

APHIS would still receive those adverse 

event reports that impact the purity, 

potency, safety, or efficacy of the 

product on a 3 business day basis, and 

its ability to react very quickly to the 

most urgent situations would not be 

compromised. The commenter 

suggested that all other reports be 

submitted on the 90 calendar day 

requirement, which would provide 

sufficient time for a thorough 

investigation. A second commenter 

stated that a 90 day reporting period is 

too brief a period of time to submit 

reports; many of which will have 

nothing to report. The commenter 

suggested changes in the length of the 

reporting period over time 

APHIS agrees with the first 

commenter that serious and unexpected 

adverse events will be reported 

immediately within 3 business days and 


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Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 22835 

as such the requirement of 15 business 

days is not necessary. We have amended 

§ 116.9(b)(2) to remove the 15 day 

reporting requirement. Adverse event 

reports will continue to be received 

immediately or within 90 calendar days. 

We have also amended § 116.9(b) to 

require that adverse event reports 

determined to be product-related, 

serious, and unexpected will be 

reported immediately and that other 

reports will be received within 90 days. 

We will also clarify that ‘‘immediately’’ 

means ‘‘within 3 business days’’ in 

guidance documents. We do not agree 

with the second commenter regarding 

the need for the 90 day reporting period, 

with changes in the length of the 

reporting period changing over time. 

Since we have removed the 15 day 

reporting period, the 90 day period will 

need to remain as a standard time. 

However, as pharmacovigilance data is 

accumulated APHIS will consider 

exemptions and will clarify in future 

guidance documents. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. 

Executive Orders 12866 and 13771 and 

Regulatory Flexibility Act 

This final 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. This rule is 

not an Executive Order 13771 regulatory 

action because this rule is not 

significant under Executive Order 

12866. 

In accordance with 5 U.S.C. 604, we 

have performed a final regulatory 

flexibility analysis, which is 

summarized below, regarding the 

economic effects of this rule on small 

entities. Copies of the full analysis are 

available on the Regulations.gov website 

(see footnote 1 in this document for a 

link to Regulations.gov) or by contacting 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

We are amending the Virus-SerumToxin 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 

type of information that must be 

included in the adverse event reports 

submitted to APHIS would be provided 

in separate guidance documents. 

We are taking this action in order to 

limit the harm to animals due to adverse 

events related to a product’s purity, 

safety, potency, efficacy, preparation, 

testing, or distribution. Current 

regulations may hinder APHIS from 

taking expeditious action in cases where 

veterinary biologics are unsatisfactory. 

For animal owners, the monetary 

benefits of the proposal are difficult to 

estimate because they would depend on 

unknowable factors—the significance or 

gravity of the harm that would be 

avoided with the rule in effect, and the 

number and value of animals thereby 

protected. Manufacturer costs to comply 

with the proposed rule are expected be 

minimal; most establishments that 

would be affected already maintain 

recordkeeping systems for adverse event 

reports that capture most if not all of the 

information that would be required. 

Most of the establishments that would 

be affected by the proposed rule are 

small entities. 

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 final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. This rule will 

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 final rule, 

which were filed under 0579–0209, 

have been submitted for approval to the 

Office of Management and Budget 

(OMB). When OMB notifies us of its 

decision, if approval is denied, we will 

publish a document in the Federal 

Register providing notice of what action 

we plan to take. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

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 rule, please contact Ms. Kimberly 

Hardy, APHIS’ Information Collection 

Coordinator, at (301) 851–2483. 

Lists of Subjects 

9 CFR Part 101 

Animal biologics. 

9 CFR Part 116 

Animal biologics, Reporting and 

recordkeeping requirements. 

Accordingly, we are amending 9 CFR 

parts 101 and 116 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 371.4. 

■ 2. Section 101.2 is amended by adding 

definitions for Adverse event and 

Adverse event report in alphabetical 

order to read as follows: 

§ 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 offlabel 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. Direct 

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 


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22836 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 

(4) One or more adverse events. 

* * * * * 

PART 116—RECORDS AND REPORTS 

■ 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. 

■ 4. In § 116.1, paragraph (a)(3) is 

revised to read as follows: 

§ 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. 

* * * * * 

■ 5. Section 116.8 is revised to read as 

follows: 

§ 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. 

(Approved by the Office of Management and 

Budget under control number 0579–0013) 

■ 6. Section 116.9 is added to read as 

follows: 

§ 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 website at 

https://www.aphis.usda.gov/aphis/ 

ourfocus/animalhealth/veterinarybiologics or by writing to APHIS Center 

for Veterinary Biologics, 1920 Dayton 

Avenue, P.O. Box 844, Ames, Iowa 

50010. 

(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 also be reported 

immediately. 

(3) All other adverse event reports 

must be reported within 90 calendar 

days of the date the report was first 

received. 

(Approved by the Office of Management and 

Budget under control number 0579–0209) 

Done in Washington, DC, this 11th day of 

May 2018. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2018–10540 Filed 5–16–18; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2018–0443; Product 

Identifier 2018–NE–14–AD; Amendment 39– 

19286; AD 2018–10–11] 

RIN 2120–AA64 

Airworthiness Directives; CFM 

International S.A. Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are superseding 

Airworthiness Directive (AD) 2018–09– 

10 for all CFM International S.A. (CFM) 

Model CFM56–7B engines. AD 2018– 

09–10 required initial and repetitive 

inspections of the concave and convex 

sides of the fan blade dovetail to detect 

cracking and replacement of any blades 

found cracked. This AD requires the 

same initial and repetitive inspections 

but revises the compliance time for the 

initial inspections of certain higher-risk 

fan blades. This AD was prompted by a 

recent engine failure due to a fractured 

fan blade that resulted in the engine 

inlet cowl disintegrating and debris 

penetrating the fuselage, causing a loss 

of pressurization, and prompting an 

emergency descent. We are issuing this 

AD to address the unsafe condition on 

these products. 

DATES: This AD is effective June 1, 2018. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of June 1, 2018. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain other publication listed in 

this AD as of May 14, 2018 (83 FR 

19176, May 2, 2018). 

We must receive any comments on 

this AD by July 2, 2018. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

For service information identified in 

this final rule, contact CFM 

International Inc., Aviation Operations 

Center, 1 Neumann Way, M/D Room 

285, Cincinnati, OH 45125; phone: 877– 

432–3272; fax: 877–432–3329; email: 

aviation.fleetsupport@ge.com. You may 

view this service information at the 

FAA, Engine and Propeller Standards 

Branch, 1200 District Avenue, 

Burlington, MA. For information on the 

availability of this material at the FAA, 

call 781–238–7759. It is also available 

on the internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2018– 

0443. 

Examining the AD Docket 

You may examine the AD docket on 

the internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2018– 

0443; or in person at Docket Operations 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The AD docket contains this final rule, 

the regulatory evaluation, any 

comments received, and other 

information. The street address for 

Docket Operations (phone: 800–647– 


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