81 FR 78499 - Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 81, Issue 216 (November 8, 2016)
Animal and Plant Health Inspection Service
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78499-78500 | |
| FR Document | 2016-26936 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Rules and Regulations] [Pages 78499-78500] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26936] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 112 [Docket No. APHIS-2008-0008] RIN 0579-AD19 Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: In a final rule published in the Federal Register on August 30, 2016, and effective on October 31, 2016, we amended the Virus- Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with current science and veterinary practice. However, we inadvertently removed a requirement for an indications statement that should appear on final container labels, carton labels, and enclosures. This document corrects that error. DATES: Effective November 8, 2016. FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737; (301) 851-2352. SUPPLEMENTARY INFORMATION: In a final rule \1\ that was published in the Federal Register on August 30, 2016 (81 FR 59427, Docket No. APHIS- 2008-0008), and effective on October 31, 2016, we amended the Virus- Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with current science and veterinary practice. Among other things, in 9 CFR part 112, we amended Sec. 112.2(a)(5) to clarify that ``full instructions for the [[Page 78500]] proper use of the product'' refers to vaccination schedules, revaccination schedules (if necessary), indications for use, target species, recommended age for vaccination, vaccination route(s), and product license restrictions prescribed by the Animal and Plant Health Inspection Service that have a bearing on product use. However, when we made that change, we inadvertently removed a requirement for an indications statement to appear on final container labels, carton labels, and enclosures. Therefore, we are amending Sec. 112.2(a) to re-establish the requirement for an indications statement. --------------------------------------------------------------------------- \1\ To view the final rule and supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0008. --------------------------------------------------------------------------- List of Subjects in 9 CFR Part 112 Animal biologics, Exports, Imports, Labeling, packaging and containers, Reporting and recordkeeping requirements. Accordingly, we are amending 9 CFR part 112 as follows: PART 112--PACKAGING AND LABELING 0 1. The authority citation for part 112 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. 0 2. Section 112.2 is amended by adding paragraph (a)(12) to read as follows: Sec. 112.2 Final container label, carton label, and enclosure. (a) * * * (12) An indications statement to read, ``This product has been shown to be effective for the vaccination of healthy (insert name of species) __ weeks of age or older against __.'' Provided, That in the case of very small final container labels or carton, a statement as to where such information is to be found, such as ``See enclosure for complete directions,'' ``Full directions on carton,'' or comparable statement. * * * * * Done in Washington, DC, this 2nd day of November 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2016-26936 Filed 11-7-16; 8:45 am] BILLING CODE 3410-34-P
![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Rules and Regulations 78499
(3) Crediting service. An employee’s (F) Credit up to 30 calendar days for credit is also given for service between
creditable service must total at least 3 time off the rolls that follow involuntary January 1, 1980, and September 25,
years, under the following conditions: separation without personal cause of 1980. Otherwise, service in the District
(i) Work schedule. (A) Full-time employees who are eligible for a of Columbia Government on or after
service, and part-time service on or after noncompetitive appointment based on January 1, 1980, is not creditable as
July 1, 1962, are counted as calendar an interchange agreement with another intervening service; and
time from the date of appointment to merit system under § 6.7 of this chapter, (H) Performed overseas by family
date of separation. provided the person is employed in the members, as defined by § 315.608 of this
(B) Intermittent service on or after competitive service under the agreement chapter.
July 1, 1962, is counted as 1 day for during the period of his or her * * * * *
each day an employee is in pay status, eligibility. [FR Doc. 2016–26888 Filed 11–7–16; 8:45 am]
regardless of the number of hours for (G) Credit periods of nonpay status BILLING CODE 6325–39–P
which the employee is actually paid on incident to an assignment to a State,
a given day. Agencies should consult local, or Indian tribal government,
the ‘‘260-Day Work Year Chart’’ in institution of higher education, or other DEPARTMENT OF AGRICULTURE
OPM’s Guide to Processing Personnel eligible organization provided the
Actions to convert intermittent days employee returns to a creditable Animal and Plant Health Inspection
worked to calendar time. The service appointment pursuant to an agreement Service
requirement may not be satisfied in less established under subchapter VI of
than 3 years of calendar time. chapter 33, title 5, U.S.C., and part 334 9 CFR Part 112
(ii) Nonpay status on the rolls and of this chapter.
time off the rolls. An agency may not (iii) Restoration based on [Docket No. APHIS–2008–0008]
credit periods of nonpay status and time unwarranted or improper actions. Based RIN 0579–AD19
off the rolls except as follows: on a finding made on or after March 30,
(A) Credit the first 30 calendar days 1966, that a furlough, suspension, or Viruses, Serums, Toxins, and
of each period of nonpay status on the separation was unwarranted or Analogous Products; Packaging and
rolls during full-time employment, or improper, an employee restored to duty Labeling
during part-time employment on or after receives full calendar time credit for the
July 1, 1962. On this same basis, a AGENCY: Animal and Plant Health
period of furlough, suspension, or
seasonal employee receives credit for Inspection Service, USDA.
separation for which he or she is eligible
the first 30 calendar days of each period ACTION: Final rule; technical
to receive back pay. If the employee is
of nonduty/nonpay status. Nonpay restored to duty at a date later than the amendment.
status in excess of 30 days is not original adverse action, credit for
creditable. SUMMARY: In a final rule published in
intervening periods of nonpay status is the Federal Register on August 30,
(B) Credit periods of nonpay status given in accordance with other
and time off the rolls incident to entry 2016, and effective on October 31, 2016,
provisions of this subsection. If the we amended the Virus-Serum-Toxin Act
into and return from military service employee had been properly separated
and return from defense transfer, regulations to make veterinary biologics
from the rolls of the agency before a labeling requirements more consistent
provided the person is reemployed in finding was made that the adverse
Federal service during the period of his with current science and veterinary
action was unwarranted or improper, practice. However, we inadvertently
or her statutory or regulatory restoration the correction and additional service
or reemployment rights. removed a requirement for an
credit given the employee may not indications statement that should
(C) Credit periods of nonpay status
extend beyond the date of the proper appear on final container labels, carton
and time off the rolls incident to transfer
separation. labels, and enclosures. This document
to and return from an international (iv) Intervening service. Certain types
organization, provided the person is corrects that error.
of service that ordinarily are not
reemployed in Federal service under DATES: Effective November 8, 2016.
creditable are counted when they
subpart C of part 352 of this chapter. intervene between two periods of FOR FURTHER INFORMATION CONTACT: Dr.
(D) Credit periods of nonpay status Donna Malloy, Operational Support
creditable service. Under these
during which an employee was eligible Section, Center for Veterinary Biologics,
conditions, credit each period of
to receive continuation of pay or injury Policy, Evaluation, and Licensing, VS,
service:
compensation from the Office of (A) In the excepted service of the APHIS, 4700 River Road, Unit 148,
Workers’ Compensation Programs. Also Federal executive branch, including Riverdale, MD 20737; (301) 851–2352.
credit periods of time off the rolls employment in nonappropriated fund SUPPLEMENTARY INFORMATION: In a final
during which an employee was eligible positions in or under any Federal rule 1 that was published in the Federal
to receive injury compensation from the agency; Register on August 30, 2016 (81 FR
Office of Workers’ Compensation (B) Under temporary, term, or other 59427, Docket No. APHIS–2008–0008),
Programs, provided the person is nonpermanent employment in the and effective on October 31, 2016, we
reemployed under part 353 of this Federal competitive service; amended the Virus-Serum-Toxin Act
chapter. (C) In the Senior Executive Service; regulations to make veterinary biologics
(E) Credit up to 30 calendar days for (D) In the Federal legislative branch; labeling requirements more consistent
time off the rolls that follows separation (E) In the Federal judicial branch; with current science and veterinary
by reduction in force of employees who (F) In the armed forces; practice. Among other things, in 9 CFR
Lhorne on DSK30JT082PROD with RULES
are eligible for entry on the (G) In the District of Columbia
part 112, we amended § 112.2(a)(5) to
reemployment priority list under Government through December 31,
clarify that ‘‘full instructions for the
subpart B of part 330 of this chapter, 1979. For an employee on the District
provided the person is reemployed in rolls on December 31, 1979, who 1 To view the final rule and supporting
Federal service during the period of his converted on January 1, 1980, to the documents, go to http://www.regulations.gov/
or her reemployment priority. District independent personnel system, #!docketDetail;D=APHIS-2008-0008.
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![78500 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Rules and Regulations
proper use of the product’’ refers to DEPARTMENT OF HEALTH AND III. Comments on the Proposed Rule and FDA
vaccination schedules, revaccination HUMAN SERVICES Responses
A. Introduction
schedules (if necessary), indications for
Food and Drug Administration B. Scope of the Proposed Rule (§ 10.31)
use, target species, recommended age C. Certification and Verification
for vaccination, vaccination route(s), Requirements
and product license restrictions 21 CFR Part 10 D. Nonretroactivity of the Rule
prescribed by the Animal and Plant [Docket No. FDA–2011–N–0697] E. Additional Comments
Health Inspection Service that have a IV. Legal Authority
RIN 0910–AG26 V. Analysis of Environmental Impact
bearing on product use. However, when VI. Economic Analysis of Impacts
we made that change, we inadvertently Amendments to Regulations on Citizen A. Introduction and Summary
removed a requirement for an Petitions, Petitions for Stay of Action, B. Summary of Final Regulatory Impacts
indications statement to appear on final and Submission of Documents to Analysis
container labels, carton labels, and Dockets VII. Paperwork Reduction Act of 1995
enclosures. Therefore, we are amending VIII. Federalism
AGENCY: Food and Drug Administration, IX. References
§ 112.2(a) to re-establish the HHS.
requirement for an indications Executive Summary
ACTION: Final rule.
statement. Purpose of the Rule
SUMMARY: The Food and Drug
List of Subjects in 9 CFR Part 112 This rule establishes new regulations
Administration (FDA, the Agency, or
we) is amending certain regulations implementing section 505(q) of the
Animal biologics, Exports, Imports, FD&C Act (21 U.S.C. 355(q)) as enacted
Labeling, packaging and containers, relating to citizen petitions, petitions for
stay of action (PSAs), and the by FDAAA (Pub. L. 110–85) and
Reporting and recordkeeping amended by FDASIA (Pub. L. 112–144).
requirements. submission of documents to the Agency.
In particular, the final rule establishes Section 505(q) of the FD&C Act governs
Accordingly, we are amending 9 CFR new regulations to implement certain the manner in which FDA handles
part 112 as follows: provisions of the Federal Food, Drug, certain citizen petitions and PSAs that
and Cosmetic Act (the FD&C Act), ask the Agency to take any form of
PART 112—PACKAGING AND which concern certain citizen petitions action related to an ANDA, a 505(b)(2)
LABELING and PSAs that involve a request for FDA application, or an application submitted
to take any form of action relating to a under section 351(k) of the PHS Act
■ 1. The authority citation for part 112 pending abbreviated new drug (351(k) application) (42 U.S.C. 262(k)).
continues to read as follows: application (ANDA), 505(b)(2) Section 505(q) of the FD&C Act specifies
application, or certain applications that FDA must not delay approval of a
Authority: 21 U.S.C. 151–159; 7 CFR 2.22, pending application because of any
submitted under the Public Health
2.80, and 371.4. request to take any form of action
Service Act (PHS Act). We are making
■ 2. Section 112.2 is amended by adding these changes to implement provisions relating to the application, unless the
paragraph (a)(12) to read as follows: of the Food and Drug Administration request is in writing and in a citizen
Amendments Act of 2007 (FDAAA) and petition or a PSA, and the Agency
§ 112.2 Final container label, carton label, the Food and Drug Administration determines, upon reviewing the
and enclosure. Safety and Innovation Act (FDASIA). petition, that a delay is necessary to
DATES: This rule is effective January 9, protect the public health. Section 505(q)
(a) * * * of the FD&C Act also requires that all
2017.
(12) An indications statement to read, submitters of a petition (or PSA) include
ADDRESSES: For access to the docket to
‘‘This product has been shown to be with their submission a verbatim
read background documents or
effective for the vaccination of healthy certification statement specifying the
comments received, go to http://
(insert name of species) __ weeks of age www.regulations.gov and insert the date on which the information relied on
or older against __.’’ Provided, That in docket number (FDA–2011–N–0697) in the petition first became known.
the case of very small final container into the ‘‘Search’’ box and follow the Similarly, section 505(q) of the FD&C
labels or carton, a statement as to where prompts and/or go to the Division of Act requires that the submitters of a
such information is to be found, such as Dockets Management, 5630 Fishers supplement or a comment to a petition
‘‘See enclosure for complete directions,’’ Lane, Rm. 1061, Rockville, MD 20852. include with their submission a
‘‘Full directions on carton,’’ or verbatim verification statement
FOR FURTHER INFORMATION CONTACT:
comparable statement. specifying the date on which the
Darren Eicken, Center for Drug information relied on in their
* * * * * Evaluation and Research, Food and submission first became known. By
Done in Washington, DC, this 2nd day of
Drug Administration, 10903 New enacting section 505(q) of the FD&C Act,
November 2016. Hampshire Ave., Bldg. 51, Rm. 6206, Congress indicated a desire to ensure
Silver Spring, MD, 20993–0002, 240– that petitions not be used to improperly
Kevin Shea,
402–0978. delay approval of ANDAs, 505(b)(2)
Administrator, Animal and Plant Health SUPPLEMENTARY INFORMATION:
Inspection Service. applications, or 351(k) applications.
[FR Doc. 2016–26936 Filed 11–7–16; 8:45 am] Table of Contents This rule clarifies the requirements of
section 505(q) of the FD&C Act.
Lhorne on DSK30JT082PROD with RULES
BILLING CODE 3410–34–P Executive Summary
I. Background Summary of the Major Provisions of the
II. Overview of the Final Rule, Including Rule
Significant Changes to the Proposed Rule
A. Overview This rule amends FDA’s regulations
B. Significant Changes to the Proposed on general administrative procedures in
Rule part 10 (21 CFR part 10).
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Document Created: 2018-02-14 08:23:43
Document Modified: 2018-02-14 08:23:43
| 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 | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | Effective November 8, 2016. | |
| Contact | Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737; (301) 851-2352. | |
| FR Citation | 81 FR 78499 | |
| RIN Number | 0579-AD19 | |
| CFR Associated | Animal Biologics; Exports; Imports; Labeling; Packaging and Containers and Reporting and Recordkeeping Requirements |
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