81_FR_25410 81 FR 25328 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction

81 FR 25328 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 82 (April 28, 2016)

Page Range25328-25328
FR Document2016-09865

The Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524.

Federal Register, Volume 81 Issue 82 (Thursday, April 28, 2016)
[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Rules and Regulations]
[Page 25328]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2016-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Changes of Sponsorship; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment; correcting amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) published a document in 
the Federal Register of April 18, 2016 (81 FR 22520), amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during January and February 2016. That rule 
included two amendatory instructions that cited incorrect sections of 
21 CFR part 524.

DATES: Effective: April 28, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
[email protected].

SUPPLEMENTARY INFORMATION: In FR Doc. 2016-08827, appearing on page 
22520 in the Federal Register of Monday, April 18, 2016, the following 
corrections are made:
    On page 22524, in the third column, remove amendatory instructions 
35 and 36.

List of Subjects in 21 CFR Part 524

    Animal drugs.

    Accordingly, 21 CFR part 524 is corrected by making the following 
correcting amendments:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.


Sec.  524.1193  [Amended]

0
2. In paragraph (b)(2) of Sec.  524.1193, remove ``000859'' and in its 
place add ``016592''.


Sec.  524.1484k  [Amended]

0
3. In Sec.  524.1484k, revise the section heading to read: Neomycin and 
prednisolone suspension.

    Dated: April 22, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-09865 Filed 4-27-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                  25328              Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Rules and Regulations

                                                  and regulations of a country whose food                 application-related actions for new                    ACTION:   Final regulations.
                                                  safety system FDA has officially                        animal drug applications (NADAs) and
                                                  recognized as comparable or determined                  abbreviated new animal drug                            SUMMARY:   This document contains final
                                                  to be equivalent to that of the United                  applications (ANADAs) during January                   regulations relating to the penalty under
                                                  States).                                                and February 2016. That rule included                  section 6708 of the Internal Revenue
                                                     (iv) If your foreign supplier is a shell             two amendatory instructions that cited                 Code for failing to make available lists
                                                  egg producer that is not subject to the                 incorrect sections of 21 CFR part 524.                 of advisees with respect to reportable
                                                  requirements of part 118 of this chapter                DATES: Effective: April 28, 2016.
                                                                                                                                                                 transactions. Section 6708 imposes a
                                                  because it has fewer than 3,000 laying                                                                         penalty upon material advisors for
                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                  hens and you choose to comply with the                                                                         failing to make available to the
                                                                                                          George K. Haibel, Center for Veterinary
                                                  requirements in this section, you must                                                                         Secretary, upon written request, the list
                                                                                                          Medicine (HFV–6), Food and Drug
                                                  obtain written assurance, before                                                                               required to be maintained by section
                                                                                                          Administration, 7519 Standish Pl.,
                                                  importing the shell eggs and at least                                                                          6112 of the Internal Revenue Code
                                                                                                          Rockville, MD 20855, 240–402–5689,
                                                  every 2 years thereafter, that the shell                                                                       within 20 business days after the date of
                                                                                                          george.haibel@fda.hhs.gov.
                                                  egg producer acknowledges that its food                                                                        such request. The final regulations
                                                                                                          SUPPLEMENTARY INFORMATION: In FR Doc.                  primarily affect individuals and entities
                                                  is subject to section 402 of the Federal                2016–08827, appearing on page 22520
                                                  Food, Drug, and Cosmetic Act (or, when                                                                         who are material advisors, as defined in
                                                                                                          in the Federal Register of Monday,                     section 6111 of the Internal Revenue
                                                  applicable, that its food is subject to                 April 18, 2016, the following corrections
                                                  relevant laws and regulations of a                                                                             Code.
                                                                                                          are made:
                                                  country whose food safety system FDA                      On page 22524, in the third column,                  DATES:  Effective Date: These regulations
                                                  has officially recognized as comparable                 remove amendatory instructions 35 and                  are effective on April 28, 2016.
                                                  or determined to be equivalent to that of               36.                                                      Applicability Date: For date of
                                                  the United States).                                                                                            applicability see § 301.6708–1(i).
                                                  *      *      *     *     *                             List of Subjects in 21 CFR Part 524
                                                                                                                                                                 FOR FURTHER INFORMATION CONTACT:
                                                     (c) * * *                                              Animal drugs.                                        Hilary March, (202) 317–5406 (not a
                                                     (1) * * *                                              Accordingly, 21 CFR part 524 is                      toll-free number).
                                                     (i) Except as specified in paragraph                 corrected by making the following                      SUPPLEMENTARY INFORMATION:
                                                  (c)(1)(iii) of this section, in approving               correcting amendments:
                                                  your foreign suppliers, you must                                                                               Paperwork Reduction Act
                                                  evaluate the applicable FDA food safety                 PART 524—OPHTHALMIC AND                                   The collection of information
                                                  regulations and information relevant to                 TOPICAL DOSAGE FORM NEW                                contained in these final regulations has
                                                  the foreign supplier’s compliance with                  ANIMAL DRUGS                                           been reviewed and approved by the
                                                  those regulations, including whether the                                                                       Office of Management and Budget in
                                                  foreign supplier is the subject of an FDA               ■ 1. The authority citation for part 524
                                                                                                          continues to read as follows:                          accordance with the Paperwork
                                                  warning letter, import alert, or other                                                                         Reduction Act of 1995 (44 U.S.C.
                                                  FDA compliance action related to food                       Authority: 21 U.S.C. 360b.                         3507(d)) under control number 1545–
                                                  safety, and document the evaluation.                                                                           2245.
                                                                                                          § 524.1193        [Amended]
                                                  * * *                                                                                                             The collection of information in the
                                                  *      *      *     *     *                             ■  2. In paragraph (b)(2) of § 524.1193,               final regulations is in § 301.6708–
                                                                                                          remove ‘‘000859’’ and in its place add                 1(c)(3)(ii). This information is required
                                                    Dated: April 21, 2016.                                ‘‘016592’’.
                                                  Leslie Kux,                                                                                                    for the IRS to determine whether good
                                                                                                          § 524.1484k       [Amended]                            cause exists to allow a person affected
                                                  Associate Commissioner for Policy.
                                                                                                          ■ 3. In § 524.1484k, revise the section                by these regulations an extension of the
                                                  [FR Doc. 2016–09784 Filed 4–27–16; 8:45 am]
                                                                                                          heading to read: Neomycin and                          legislatively established 20-business-day
                                                  BILLING CODE 4164–01–P
                                                                                                          prednisolone suspension.                               period to furnish a lawfully requested
                                                                                                                                                                 list to the IRS. The collection of
                                                                                                            Dated: April 22, 2016.                               information is voluntary to obtain a
                                                  DEPARTMENT OF HEALTH AND                                Tracey Forfa,                                          benefit. The likely respondents are
                                                  HUMAN SERVICES                                          Acting Director, Center for Veterinary                 persons (individuals and entities) who
                                                                                                          Medicine.                                              qualify as material advisors, as defined
                                                  Food and Drug Administration
                                                                                                          [FR Doc. 2016–09865 Filed 4–27–16; 8:45 am]            in section 6111, who are unable to
                                                  21 CFR Part 524                                         BILLING CODE 4164–01–P                                 respond to a valid and statutorily
                                                                                                                                                                 authorized section 6112 list request
                                                  [Docket No. FDA–2016–N–0002]                                                                                   within the statutory period of time
                                                                                                          DEPARTMENT OF THE TREASURY                             provided by section 6708.
                                                  New Animal Drugs; Approval of New                                                                                 An agency may not conduct or
                                                  Animal Drug Applications; Changes of                    Internal Revenue Service                               sponsor, and a person is not required to
                                                  Sponsorship; Correction                                                                                        respond to, a collection of information
                                                  AGENCY:    Food and Drug Administration,                26 CFR Part 301                                        unless it displays a valid control
                                                  HHS.                                                    [TD 9764]                                              number.
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                        Final rule; technical
                                                  ACTION:                                                                                                           Books and records relating to a
                                                                                                          RIN 1545–BF39                                          collection of information must be
                                                  amendment; correcting amendments.
                                                                                                                                                                 retained as long as their contents might
                                                                                                          Section 6708 Failure To Maintain List
                                                  SUMMARY:   The Food and Drug                                                                                   become material in the administration
                                                                                                          of Advisees With Respect to
                                                  Administration (FDA) published a                                                                               of any internal revenue law. Generally,
                                                                                                          Reportable Transactions
                                                  document in the Federal Register of                                                                            tax returns and tax return information
                                                  April 18, 2016 (81 FR 22520), amending                  AGENCY: Internal Revenue Service (IRS),                are confidential, as required by section
                                                  the animal drug regulations to reflect                  Treasury.                                              6103 of the Internal Revenue Code.


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Document Created: 2016-04-28 01:05:12
Document Modified: 2016-04-28 01:05:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment; correcting amendments.
DatesEffective: April 28, 2016.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation81 FR 25328 

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