80 FR 79474 - New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 245 (December 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 245 (December 22, 2015)
| Page Range | 79474-79476 | |
| FR Document | 2015-32000 |
[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)] [Rules and Regulations] [Pages 79474-79476] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32000] [[Page 79474]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2015-N-0002] New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review. DATES: This rule is effective December 22, 2015. FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0589, email: [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003 (68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of the Drug Efficacy Study Implementation (DESI) program, the Center for Veterinary Medicine (CVM) announced the effective conditions of use for several drug products and use combinations that were listed in 21 CFR 558.15. CVM proposed to withdraw the NADAs for those products or use combinations lacking substantial evidence of effectiveness following a 90-day opportunity to supplement the NADAs with labeling conforming to the relevant findings of effectiveness. In response to that notice of opportunity for a hearing (NOOH), Pennfield Oil Co. (Pennfield), 14040 Industrial Rd., Omaha, NE 68144, filed a hearing request for its approved, non-DESI finalized NADA 141- 137 for a bacitracin methylenedisalicylate Type A medicated article. In March 2015, Pennfield transferred sponsorship of NADA 141-137 to Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate) (80 FR 13226, March 13, 2015). Subsequently, Pharmgate filed a supplement to NADA 141-137 for PENNITRACIN MD 50G (bacitracin Type A medicated article) with labeling conforming to the findings of effectiveness in the 2003 NOOH. In addition, the submitted labeling included indications for use approved by FDA that were not subject to DESI findings of effectiveness (34 FR 7906, May 20, 1969). The supplemental NADA provides for use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for several production and therapeutic indications in broiler and replacement chickens, growing turkeys, growing pheasants, growing quail, and beef steers and heifers fed in confinement for slaughter. The supplemental NADA is approved as of October 6, 2015, and the regulations are amended in 21 CFR 558.76 to reflect the approval. Pharmgate, as successor to Pennfield, has since withdrawn the hearing request for NADA 141-137. Approval of this supplemental NADA did not require review of any new safety or effectiveness data. Therefore, a freedom of information summary was not prepared. The DESI evaluation was concerned only with the effectiveness of the drug products and use combinations. Nothing in this document constitutes a bar to further proceedings with respect to questions of safety of the subject drugs in treated animals or of the drugs or their metabolites in food products derived from treated animals. Products that comply with FDA's findings of effectiveness are eligible for copying, as described in the ``Generic Animal Drug and Patent Term Restoration Act; Eighth Policy Letter,'' August 21, 1991 (56 FR 41561). Accordingly, sponsors may now obtain approval of abbreviated NADAs for this Type A medicated article. The Agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 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 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 2. Amend Sec. 558.76 as follows: 0 a. Revise the section heading and paragraph (a); 0 b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); 0 c. Add new paragraph (b); and 0 d. Revise newly redesignated paragraph (e)(1). The revisions and addition read as follows: Sec. 558.76 Bacitracin methylenedisalicylate. (a) Specifications. (1) Type A medicated articles containing 10, 25, 30, 40, 50, 60, or 75 grams bacitracin methylenedisalicylate per pound. (2) Type A medicated article containing 50 grams bacitracin methylenedisalicylate per pound. (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) through (xiii), and (e)(1)(xv) of this section. (2) No. 069254 for use of products in paragraph (a)(2) of this section as in paragraphs (e)(1)(ii), (e)(1)(iv), (e)(1)(xiv), and (e)(1)(xvi) of this section. * * * * * (e) * * * (1) It is used as follows: [[Page 79475]] ---------------------------------------------------------------------------------------------------------------- Combination in Bacitracin grams per ton (g/ Indications for use Limitations Sponsor methylenedisalicylate amount ton) ---------------------------------------------------------------------------------------------------------------- (i) 4 to 50 g/ton............. ................. Chickens, turkeys, and ..................... 054771 pheasants: For increased rate of weight gain and improved feed efficiency. (ii) 4 to 50 g/ton............ ................. Broiler and ..................... 069254 replacement chickens, growing turkeys, and growing pheasants: For increased rate of weight gain and improved feed efficiency. (iii) 5 to 20 g/ton........... ................. Quail not over 5 weeks ..................... 054771 of age: For increased rate of weight gain and improved feed efficiency. (iv) 5 to 20 g/ton............ ................. Growing quail: For For use in quail not 069254 increased rate of over 5 weeks of age. weight gain and improved feed efficiency. (v) 10 to 25 g/ton............ ................. Chickens: For For first 7 months of 054771 increased egg production. production and improved feed efficiency for egg production. (vi) 10 to 30 g/ton........... ................. Swine: For increased For growing and 054771 rate of weight gain finishing swine. and improved feed efficiency. (vii) 10 to 30 g/ton.......... Chlortetracycline Swine: For increased Feed for not more 054771 approximately rate of weight gain than 14 days; 069254 400, varying and improved feed bacitracin with body weight efficiency; for methylenedisalicylat and food treatment of e provided by No. consumption to bacterial enteritis 054771; provide 10 caused by Escherichia chlortetracycline milligrams (mg) coli and Salmonella provided by Nos. per pound of choleraesuis and 054771 and 069254 in body weight per bacterial pneumonia Sec. 510.600(c) of day. caused by Pasteurella this chapter. multocida susceptible to chlortetracycline. (viii) 10 to 30 g/ton......... ................. Swine: For control of Feed for not more 054771 porcine proliferative than 14 days; enteropathies chlortetracycline (ileitis) caused by and bacitracin Lawsonia methylenedisalicylat intracellularis e as provided by No. susceptible to 054771 in Sec. chlortetracycline. 510.600(c) of this chapter. (ix) 50 g/ton................. ................. Broiler chickens: As Feed continuously as 054771 an aid in the sole ration. prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (x) 100 to 200 g/ton.......... ................. Broiler chickens: As Feed continuously as 054771 an aid in the control sole ration. Start of necrotic enteritis at first clinical caused or complicated signs of disease, by Clostridium spp. vary dosage based on or other organisms severity of susceptible to infection, bacitracin. administer Replacement chickens: continuously for 5 As an aid in the to 7 days or as long control of necrotic as clinical signs enteritis caused or persist, then reduce complicated by medication to Clostridium spp. or prevention level (50 other organisms g/ton). susceptible to bacitracin. (xi) 200 g/ton................ ................. Turkeys: As an aid in Feed continuously as 054771 the control of the sole ration. transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate . Quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate. (xii) 250 g/ton............... ................. 1. Growing/finishing As the sole ration. 054771 swine: For control of Not for use in swine swine dysentery weighing more than Treponema 250 pounds. hyodysenteriae on Diagnosis should be premises with history confirmed by a of swine dysentery veterinarian a when but where signs of results are not the disease have not satisfactory. yet occurred; or following an approved treatment of the disease condition. [[Page 79476]] 2. Pregnant sows: For As the sole ration. control of Feed to sows from 14 clostridial enteritis days before through caused by C. 21 days after perfringens in farrowing on suckling piglets. premises with a history of clostridial scours. Diagnosis should be confirmed by veterinarian when results are not satisfactory. (xiii) To provide 70 mg per ................. Feedlot beef cattle: Administer 054771 head per day. For reduction in the continuously number of liver throughout the condemnations due to feeding period. abscesses. (xiv) To provide 70 mg per ................. Beef steers and Administer 069254 head per day. heifers fed in continuously confinement for throughout the slaughter: For feeding period. reduction in the number of liver condemnations due to abscesses. (xv) To provide 250 mg per ................. Feedlot beef cattle: Administer 054771 head per day. For reduction in the continuously for 5 number of liver days then condemnations due to discontinue for abscesses. subsequent 25 days, repeat the pattern during the feeding period. (xvi) To provide 250 mg per ................. Beef steers and Administer 069254 head per day. heifers fed in continuously for 5 confinement for days then slaughter: For discontinue for reduction in the subsequent 25 days, number of liver repeat the pattern condemnations due to during the feeding abscesses. period. ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: December 16, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2015-32000 Filed 12-21-15; 8:45 am] BILLING CODE 4164-01-P
![79474 Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Rules and Regulations
DEPARTMENT OF HEALTH AND Industrial Rd., Omaha, NE 68144, filed type that does not individually or
HUMAN SERVICES a hearing request for its approved, non- cumulatively have a significant effect on
DESI finalized NADA 141–137 for a the human environment. Therefore,
Food and Drug Administration bacitracin methylenedisalicylate Type A neither an environmental assessment
medicated article. nor an environmental impact statement
21 CFR Part 558 In March 2015, Pennfield transferred is required.
sponsorship of NADA 141–137 to This rule does not meet the definition
[Docket No. FDA–2015–N–0002] Pharmgate LLC, 1015 Ashes Dr., Suite of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
New Animal Drugs for Use in Animal 102, Wilmington, NC 28405 (Pharmgate) it is a rule of ‘‘particular applicability.’’
Feeds; Bacitracin (80 FR 13226, March 13, 2015). Therefore, it is not subject to the
Subsequently, Pharmgate filed a congressional review requirements in 5
Methylenedisalicylate
supplement to NADA 141–137 for U.S.C. 801–808.
AGENCY: Food and Drug Administration, PENNITRACIN MD 50G (bacitracin
HHS. Type A medicated article) with labeling List of Subjects in 21 CFR Part 558
ACTION: Final rule. conforming to the findings of Animal drugs, Animal feeds.
effectiveness in the 2003 NOOH. In Therefore, under the Federal Food,
SUMMARY: The Food and Drug addition, the submitted labeling Drug, and Cosmetic Act and under
Administration (FDA) is amending the included indications for use approved authority delegated to the Commissioner
animal drug regulations to reflect by FDA that were not subject to DESI of Food and Drugs and redelegated to
approval of a supplemental new animal findings of effectiveness (34 FR 7906, the Center for Veterinary Medicine, 21
drug application (NADA) filed by May 20, 1969). CFR part 558 is amended as follows:
Pharmgate LLC for the use of a Type A The supplemental NADA provides for
medicated article containing bacitracin use of a Type A medicated article PART 558—NEW ANIMAL DRUGS FOR
methylenedisalicylate to manufacture containing bacitracin USE IN ANIMAL FEEDS
Type B and Type C medicated feeds for methylenedisalicylate to manufacture
chickens, turkeys, pheasants, quail, and Type B and Type C medicated feeds for ■ 1. The authority citation for 21 CFR
feedlot cattle. This supplemental several production and therapeutic part 558 continues to read as follows:
approval reflects FDA’s effectiveness indications in broiler and replacement Authority: 21 U.S.C. 354, 360b, 360ccc,
conclusions that relied on the National chickens, growing turkeys, growing 360ccc–1, 371.
Academy of Sciences/National Research pheasants, growing quail, and beef
steers and heifers fed in confinement for ■ 2. Amend § 558.76 as follows:
Council Drug Efficacy Study Group’s
evaluation of the effectiveness of this slaughter. The supplemental NADA is ■ a. Revise the section heading and
drug as well indications for use not approved as of October 6, 2015, and the paragraph (a);
■ b. Redesignate paragraphs (b), (c), and
subject to this review. regulations are amended in 21 CFR
558.76 to reflect the approval. (d) as paragraphs (c), (d), and (e);
DATES: This rule is effective December ■ c. Add new paragraph (b); and
22, 2015. Pharmgate, as successor to Pennfield,
has since withdrawn the hearing request ■ d. Revise newly redesignated
FOR FURTHER INFORMATION CONTACT: paragraph (e)(1).
for NADA 141–137.
Matthew Lucia, Center for Veterinary Approval of this supplemental NADA The revisions and addition read as
Medicine (HFV–128), Food and Drug did not require review of any new safety follows:
Administration, 7500 Standish Pl., or effectiveness data. Therefore, a
Rockville, MD 20855, 240–402–0589, § 558.76 Bacitracin methylenedisalicylate.
freedom of information summary was
email: matthew.lucia@fda.hhs.gov. not prepared. (a) Specifications. (1) Type A
SUPPLEMENTARY INFORMATION: In the The DESI evaluation was concerned medicated articles containing 10, 25, 30,
Federal Register of August 8, 2003 (68 only with the effectiveness of the drug 40, 50, 60, or 75 grams bacitracin
FR 47332), as corrected October 7, 2003 products and use combinations. Nothing methylenedisalicylate per pound.
(68 FR 57911), as part of the Drug in this document constitutes a bar to (2) Type A medicated article
Efficacy Study Implementation (DESI) further proceedings with respect to containing 50 grams bacitracin
program, the Center for Veterinary questions of safety of the subject drugs methylenedisalicylate per pound.
Medicine (CVM) announced the in treated animals or of the drugs or (b) Sponsors. See sponsors in
effective conditions of use for several their metabolites in food products § 510.600(c) of this chapter:
drug products and use combinations derived from treated animals. (1) No. 054771 for use of products in
that were listed in 21 CFR 558.15. CVM Products that comply with FDA’s paragraph (a)(1) of this section as in
proposed to withdraw the NADAs for findings of effectiveness are eligible for paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v)
those products or use combinations copying, as described in the ‘‘Generic through (xiii), and (e)(1)(xv) of this
lacking substantial evidence of Animal Drug and Patent Term section.
effectiveness following a 90-day Restoration Act; Eighth Policy Letter,’’ (2) No. 069254 for use of products in
opportunity to supplement the NADAs August 21, 1991 (56 FR 41561). paragraph (a)(2) of this section as in
with labeling conforming to the relevant Accordingly, sponsors may now obtain paragraphs (e)(1)(ii), (e)(1)(iv),
findings of effectiveness. approval of abbreviated NADAs for this (e)(1)(xiv), and (e)(1)(xvi) of this section.
In response to that notice of Type A medicated article. * * * * *
opportunity for a hearing (NOOH), The Agency has determined under 21 (e) * * *
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Pennfield Oil Co. (Pennfield), 14040 CFR 25.33(a)(1) that this action is of a (1) It is used as follows:
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![79476 Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Rules and Regulations
Bacitracin Combination in
methylenedisalicylate grams per ton Indications for use Limitations Sponsor
amount (g/ton)
2. Pregnant sows: For control of As the sole ration. Feed to sows
clostridial enteritis caused by C. from 14 days before through 21
perfringens in suckling piglets. days after farrowing on premises
with a history of clostridial scours.
Diagnosis should be confirmed by
veterinarian when results are not
satisfactory.
(xiii) To provide 70 mg per .............................. Feedlot beef cattle: For reduction in Administer continuously throughout 054771
head per day. the number of liver condemnations the feeding period.
due to abscesses.
(xiv) To provide 70 mg per .............................. Beef steers and heifers fed in con- Administer continuously throughout 069254
head per day. finement for slaughter: For reduc- the feeding period.
tion in the number of liver con-
demnations due to abscesses.
(xv) To provide 250 mg .............................. Feedlot beef cattle: For reduction in Administer continuously for 5 days 054771
per head per day. the number of liver condemnations then discontinue for subsequent 25
due to abscesses. days, repeat the pattern during the
feeding period.
(xvi) To provide 250 mg .............................. Beef steers and heifers fed in con- Administer continuously for 5 days 069254
per head per day. finement for slaughter: For reduc- then discontinue for subsequent 25
tion in the number of liver con- days, repeat the pattern during the
demnations due to abscesses. feeding period.
* * * * * for Regulatory Affairs, Office of the an increase of 0.36 percent in the select
Dated: December 16, 2015. General Counsel, Pension Benefit rate, and a decrease of 0.03 percent in
Bernadette Dunham,
Guaranty Corporation, 1200 K Street the ultimate rate (the final rate).
NW., Washington, DC 20005, 202–326– PBGC has determined that notice and
Director, Center for Veterinary Medicine.
4024. (TTY/TDD users may call the public comment on this amendment are
[FR Doc. 2015–32000 Filed 12–21–15; 8:45 am]
Federal relay service toll free at 1–800– impracticable and contrary to the public
BILLING CODE 4164–01–P 877–8339 and ask to be connected to interest. This finding is based on the
202–326–4024.) need to determine and issue new
SUPPLEMENTARY INFORMATION: PBGC’s interest assumptions promptly so that
PENSION BENEFIT GUARANTY regulation on Allocation of Assets in the assumptions can reflect current
CORPORATION Single-Employer Plans (29 CFR part market conditions as accurately as
4044) prescribes actuarial possible.
29 CFR Part 4044
assumptions—including interest Because of the need to provide
Allocation of Assets in Single- assumptions—for valuing plan benefits immediate guidance for the valuation of
Employer Plans; Interest Assumptions under terminating single-employer benefits under plans with valuation
for Valuing Benefits plans covered by title IV of the dates during the first quarter of 2016,
Employee Retirement Income Security PBGC finds that good cause exists for
AGENCY: Pension Benefit Guaranty Act of 1974. The interest assumptions in making the assumptions set forth in this
Corporation. the regulation are also published on amendment effective less than 30 days
ACTION: Final rule. PBGC’s Web site (http://www.pbgc.gov). after publication.
The interest assumptions in Appendix PBGC has determined that this action
SUMMARY: This final rule amends the B to Part 4044 are used to value benefits is not a ‘‘significant regulatory action’’
Pension Benefit Guaranty Corporation’s for allocation purposes under ERISA under the criteria set forth in Executive
regulation on Allocation of Assets in section 4044. Assumptions under the Order 12866.
Single-Employer Plans to prescribe asset allocation regulation are updated Because no general notice of proposed
interest assumptions under the asset quarterly and are intended to reflect rulemaking is required for this
allocation regulation for valuation dates current conditions in the financial and amendment, the Regulatory Flexibility
in the first quarter of 2016. The interest annuity markets. This final rule updates Act of 1980 does not apply. See 5 U.S.C.
assumptions are used for valuing the asset allocation interest assumptions 601(2).
benefits under terminating single- for the first quarter (January through
employer plans covered by the pension March) of 2016. List of Subjects in 29 CFR Part 4044
insurance system administered by The first quarter 2016 interest Employee benefit plans, Pension
PBGC. As discussed below, PBGC has assumptions under the allocation insurance, Pensions.
published a separate final rule regulation will be 2.82 percent for the
document dealing with interest In consideration of the foregoing, 29
first 20 years following the valuation CFR part 4044 is amended as follows:
assumptions under its regulation on date and 2.95 percent thereafter. In
rmajette on DSK2TPTVN1PROD with RULES
Benefits Payable in Terminated Single- comparison with the interest PART 4044—ALLOCATION OF
Employer Plans for January 2016. assumptions in effect for the fourth ASSETS IN SINGLE-EMPLOYER
DATES: Effective January 1, 2016. quarter of 2015, these interest PLANS
FOR FURTHER INFORMATION CONTACT: assumptions represent no change in the
Catherine B. Klion (Klion.Catherine@ select period (the period during which ■ 1. The authority citation for part 4044
PBGC.gov), Assistant General Counsel the select rate (the initial rate) applies), continues to read as follows:
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Document Created: 2015-12-22 02:31:25
Document Modified: 2015-12-22 02:31:25
| 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. | |
| Dates | This rule is effective December 22, 2015. | |
| Contact | Matthew Lucia, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0589, email: [email protected] | |
| FR Citation | 80 FR 79474 | |
| CFR Associated | Animal Drugs and Animal Feeds |
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