81_FR_63231 81 FR 63053 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine

81 FR 63053 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 178 (September 14, 2016)

Page Range63053-63054
FR Document2016-21985

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.

Federal Register, Volume 81 Issue 178 (Wednesday, September 14, 2016) 
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Rules and Regulations]
[Pages 63053-63054]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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


New Animal Drugs for Use in Animal Feeds; Chlortetracycline and 
Sulfamethazine; Chlortetracycline, Procaine Penicillin, and 
Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the withdrawal of approval of those parts 
of a new animal drug application (NADA) for a 3-way, fixed-ratio, 
combination drug Type A medicated article that pertain to use of the 
procaine penicillin component for production indications in swine and 
to reflect the reformulation of the Type A medicated article as a 2-
way, fixed-ratio, combination drug product without penicillin.

DATES: This rule is effective September 14, 2016.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0817, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmgate LLC (Pharmgate), 1015 Ashes Dr., 
Suite 102, Wilmington, NC 28405 has requested that FDA withdraw 
approval of those parts of NADA 138-934 for PENNCHLOR SP 500 
(chlortetracycline, procaine penicillin, and sulfamethazine) Type A 
medicated article that pertain to use of the procaine penicillin 
component for the production indications of growth promotion and 
increased feed efficiency in swine. Pharmgate requested voluntary 
withdrawal of approval of these indications for use because PENNCHLOR 
SP 500 Type A medicated article is no longer manufactured.
    With the withdrawal of approval of the production indications for 
procaine penicillin, the product approved under NADA 138-934 was 
reformulated as PENNCHLOR S 40/40 (chlortetracycline and 
sulfamethazine) Type A Medicated Article, a 2-way, fixed-ratio, 
combination drug Type A medicated article that does not contain 
penicillin procaine and is not labeled for production indications.

[[Page 63054]]

    The Agency has determined under 21 CFR 25.33(a) that this action is 
categorically excluded from the requirement to submit an environmental 
assessment or an environmental impact statement because it is of a type 
that does not individually or cumulatively have a significant effect on 
the human environment.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that the approval of those parts of NADA 138-934 pertaining to the 
procaine penicillin component indications for growth promotion and 
increased feed efficiency in swine is withdrawn, effective September 
14, 2016. As provided for in the regulatory text of this document, the 
animal drug regulations are amended to reflect this partial withdrawal 
of approval and subsequent product reformulation.
    NADA 138-934 was identified as being affected by guidance for 
industry (GFI) #213 ``New Animal Drugs and New Animal Drug Combination 
Products Administered in or on Medicated Feed or Drinking Water of 
Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions with GFI #209,'' December 
2013.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director of the Center for Veterinary Medicine, 21 
CFR part 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


Sec.  558.140  [Amended]

0
2. In Sec.  558.140, in paragraph (b)(2), remove ``No. 054771'' and in 
its place add ``Nos. 054771 and 069254''.


Sec.  558.145  [Amended]

0
3. In Sec.  558.145, remove and reserve paragraph (a)(2).

    Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-21985 Filed 9-13-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations 63053 Boeing commented that the load when fractured, the glass breaks into DEPARTMENT OF HEALTH AND conditions in special condition no. 4, in small pieces with relatively dull edges. HUMAN SERVICES Notice no. 25–16–03–SC, which The glass component installation must corresponds to special condition no. 3 retain all glass fragments to minimize Food and Drug Administration in this document, should include all the danger from flying glass shards or flight and landing loads, rather than pieces. The applicant must demonstrate 21 CFR Part 558 only emergency landing. These special this characteristic by impact and [Docket No. FDA–2016–N–0002] conditions are in addition to the load puncture testing, and testing to failure. requirements in the certification basis The applicant may conduct this test New Animal Drugs for Use in Animal for the glass installation, rather than in Feeds; Chlortetracycline and with or without any glass coating that lieu of the load requirements. Thus, is Sulfamethazine; Chlortetracycline, may be utilized in the design. it not necessary to repeat that all of Procaine Penicillin, and these loads apply to this installation. 2. Strength—In addition to meeting Sulfamethazine The emergency-landing load condition the load requirements for all flight and is not normally applied to installations landing loads, including any of the AGENCY: Food and Drug Administration, of this type, but for the use of large glass applicable emergency-landing HHS. in the cabin, we determined that this conditions in subparts C & D of 14 CFR ACTION: Final rule. additional safety standard is necessary. part 25, the glass components that are We made no changes to special located such that they are not protected SUMMARY: The Food and Drug condition number 3 in response to the from contact with cabin occupants must Administration (FDA) is amending the Boeing comments. animal drug regulations to reflect the not fail due to abusive loading, such as These special conditions contain the withdrawal of approval of those parts of impact from occupants stumbling into, additional safety standards that the a new animal drug application (NADA) leaning against, sitting on, or performing for a 3-way, fixed-ratio, combination Administrator considers necessary to other intentional or unintentional establish a level of safety equivalent to drug Type A medicated article that forceful contact with the glass pertain to use of the procaine penicillin that established by the existing component. The applicant must assess airworthiness standards. component for production indications the effect of design details such as in swine and to reflect the reformulation Applicability geometric discontinuities or surface of the Type A medicated article as a As discussed above, these special finish, including but not limited to 2-way, fixed-ratio, combination drug conditions are applicable to Boeing embossing and etching. product without penicillin. Model 737–700 airplanes modified by 3. Retention—The glass component, DATES: This rule is effective September Lufthansa. Should Lufthansa apply at a as installed in the airplane, must not 14, 2016. later date for a supplemental type come free of its restraint or mounting FOR FURTHER INFORMATION CONTACT: certificate to modify any other model system in the event of an emergency Cindy L. Burnsteel, Center for included on Type Certificate No. landing, considering both the Veterinary Medicine (HFV–130), Food A16WE to incorporate the same novel or directional loading and resulting and Drug Administration, 7500 Standish unusual design feature, these special rebound conditions. The applicant must Pl., Rockville, MD 20855, 240–402– conditions would apply to that model as assess the effect of design details such 0817, email: cindy.burnsteel@ well. as geometric discontinuities or surface fda.hhs.gov. Conclusion finish, including but not limited to SUPPLEMENTARY INFORMATION: Pharmgate This action affects only certain novel embossing and etching. LLC (Pharmgate), 1015 Ashes Dr., Suite or unusual design features on one model 4. Instruction for Continued 102, Wilmington, NC 28405 has series of airplane. It is not a rule of Airworthiness—The instructions for requested that FDA withdraw approval general applicability and affects only continued airworthiness must reflect the of those parts of NADA 138–934 for the applicant who applied to the FAA glass-panel fastening method used, and PENNCHLOR SP 500 (chlortetracycline, for approval of these features on the must ensure the reliability of the procaine penicillin, and sulfamethazine) airplane. methods used (e.g., life limit of Type A medicated article that pertain to use of the procaine penicillin List of Subjects in 14 CFR Part 25 adhesives, or clamp connection). component for the production Inspection methods and intervals must Aircraft, Aviation safety, Reporting indications of growth promotion and and recordkeeping requirements. be defined based upon adhesion data increased feed efficiency in swine. from the manufacturer of the adhesive, Pharmgate requested voluntary ■ The authority citation for these or actual adhesion test data, if withdrawal of approval of these special conditions is as follows: necessary. indications for use because Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704. Issued in Renton, Washington, on PENNCHLOR SP 500 Type A medicated September 7, 2016. article is no longer manufactured. The Special Conditions With the withdrawal of approval of Michael Kaszycki, Accordingly, pursuant to the Assistant Manager, Transport Airplane the production indications for procaine authority delegated to me by the Directorate, Aircraft Certification Service. penicillin, the product approved under asabaliauskas on DSK3SPTVN1PROD with RULES Administrator, the following special [FR Doc. 2016–22048 Filed 9–13–16; 8:45 am] NADA 138–934 was reformulated as conditions are issued as part of the type PENNCHLOR S 40/40 (chlortetracycline BILLING CODE 4910–13–P certification basis for Boeing Model and sulfamethazine) Type A Medicated 737–700 airplanes modified by Article, a 2-way, fixed-ratio, Lufthansa. combination drug Type A medicated 1. Material Fragmentation—The article that does not contain penicillin applicant must use tempered or procaine and is not labeled for otherwise treated glass to ensure that, production indications. VerDate Sep<11>2014 20:49 Sep 13, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\14SER1.SGM 14SER1

63054 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations The Agency has determined under 21 Dated: September 6, 2016. I. Executive Summary CFR 25.33(a) that this action is William T. Flynn, A. Purpose of the Regulatory Action categorically excluded from the Acting Director, Center for Veterinary requirement to submit an environmental Medicine. Both HUD and the courts have long assessment or an environmental impact [FR Doc. 2016–21985 Filed 9–13–16; 8:45 am] recognized that Title VIII of the Civil statement because it is of a type that BILLING CODE 4164–01–P Rights Act of 1968, as amended, (42 does not individually or cumulatively U.S.C. 3601 et seq.) (Fair Housing Act or have a significant effect on the human Act) prohibits harassment in housing environment. and housing-related transactions DEPARTMENT OF HOUSING AND because of race, color, religion, sex, Elsewhere in this issue of the Federal URBAN DEVELOPMENT national origin, disability,1 and familial Register, FDA gave notice that the status, just as Title VII of the Civil approval of those parts of NADA 138– 24 CFR Part 100 Rights Act of 1964 (42 U.S.C. 2000e et 934 pertaining to the procaine penicillin seq.) (Title VII) prohibits such component indications for growth [Docket No. FR–5248–F–02] harassment in employment. But no promotion and increased feed efficiency standards had been formalized for in swine is withdrawn, effective RIN 2529–AA94 assessing claims of harassment under September 14, 2016. As provided for in the Fair Housing Act. Courts have often the regulatory text of this document, the Quid Pro Quo and Hostile Environment Harassment and Liability for applied standards first adopted under animal drug regulations are amended to Title VII to evaluate claims of reflect this partial withdrawal of Discriminatory Housing Practices Under the Fair Housing Act harassment under the Fair Housing Act, approval and subsequent product but there are differences between the reformulation. AGENCY: Office of the Assistant Fair Housing Act and Title VII, and NADA 138–934 was identified as Secretary for Fair Housing and Equal between harassment in the workplace being affected by guidance for industry Opportunity, HUD. and harassment in or around one’s (GFI) #213 ‘‘New Animal Drugs and ACTION: Final rule. home, that warrant this rulemaking. New Animal Drug Combination This rule formalizes standards for Products Administered in or on SUMMARY: This final rule amends HUD’s evaluating claims of quid pro quo and Medicated Feed or Drinking Water of fair housing regulations to formalize hostile environment harassment in the Food-Producing Animals: standards for use in investigations and housing context. The rule does so by Recommendations for Drug Sponsors for adjudications involving allegations of defining ‘‘quid pro quo harassment’’ and Voluntarily Aligning Product Use harassment on the basis of race, color, ‘‘hostile environment harassment’’ as Conditions with GFI #209,’’ December religion, national origin, sex, familial conduct prohibited under the Fair 2013. status, or disability. The rule specifies Housing Act, and by specifying the This rule does not meet the definition how HUD will evaluate complaints of standards to be used to evaluate of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because quid pro quo (‘‘this for that’’) whether particular conduct creates a it is a rule of ‘‘particular applicability.’’ harassment and hostile environment quid pro quo or hostile environment in Therefore, it is not subject to the harassment under the Fair Housing Act. violation of the Act. Such standards will It will also provide for uniform apply both in administrative congressional review requirements in 5 treatment of Fair Housing Act claims adjudications and in cases brought in U.S.C. 801–808. raising allegations of quid pro quo and federal and state courts under the Fair List of Subjects in 21 CFR Part 558 hostile environment harassment in Housing Act. This rule also adds to judicial and administrative forums. This HUD’s existing Fair Housing Act Animal drugs, Animal feeds. regulations illustrations of rule defines ‘‘quid pro quo’’ and Therefore, under the Federal Food, ‘‘hostile environment harassment,’’ as discriminatory housing practices that Drug, and Cosmetic Act and under prohibited under the Fair Housing Act, may constitute illegal quid pro quo and authority delegated to the Commissioner and provides illustrations of hostile environment harassment. of Food and Drugs and redelegated to discriminatory housing practices that By establishing consistent standards the Director of the Center for Veterinary constitute such harassment. In addition, for evaluating claims of quid pro quo Medicine, 21 CFR part 558 is amended this rule clarifies the operation of and hostile environment harassment, as follows: traditional principles of direct and this rule provides guidance to providers vicarious liability in the Fair Housing of housing or housing-related services PART 558—NEW ANIMAL DRUGS FOR Act context. seeking to ensure that their properties or USE IN ANIMAL FEEDS businesses are free of unlawful DATES: Effective date: October 14, 2016. harassment. The rule also provides FOR FURTHER INFORMATION CONTACT: clarity to victims of harassment and ■ 1. The authority citation for part 558 Lynn Grosso, Acting Deputy Assistant their representatives regarding how to continues to read as follows: Secretary for Enforcement and assess potential claims of illegal Authority: 21 U.S.C. 354, 360b, 360ccc, Programs, Office of Fair Housing and harassment under the Fair Housing Act. 360ccc–1, 371. Equal Opportunity, Department of In addition, this final rule clarifies § 558.140 [Amended] Housing and Urban Development, 451 when housing providers and other asabaliauskas on DSK3SPTVN1PROD with RULES 7th Street SW., Room 5204, Washington entities or individuals covered by the ■ 2. In § 558.140, in paragraph (b)(2), DC 20410–2000; telephone number 202– Fair Housing Act may be held directly remove ‘‘No. 054771’’ and in its place 402–5361 (this is not a toll-free or vicariously liable under the Act for add ‘‘Nos. 054771 and 069254’’. number). Persons with hearing or speech impairments may contact this 1 This rule uses the term ‘‘disability’’ to refer to § 558.145 [Amended] what the Fair Housing Act and its implementing number via TTY by calling the toll-free regulations refer to as ‘‘handicap.’’ Both terms have ■ 3. In § 558.145, remove and reserve Federal Relay Service at 800–877–8339. the same legal meaning. See Bragdon v. Abbott, 524 paragraph (a)(2). SUPPLEMENTARY INFORMATION: U.S. 624, 631 (1998). VerDate Sep<11>2014 20:49 Sep 13, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\14SER1.SGM 14SER1


Document Created: 2016-09-14 02:27:05
Document Modified: 2016-09-14 02:27:05
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.
DatesThis rule is effective September 14, 2016.
ContactCindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0817, email: [email protected]
FR Citation81 FR 63053 
CFR AssociatedAnimal Drugs and Animal Feeds
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