81 FR 63191 - Vaccines and Related Biological Products Advisory Committee; Cancellation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 178 (September 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 178 (September 14, 2016)
| Page Range | 63191-63191 | |
| FR Document | 2016-22051 |
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)] [Notices] [Page 63191] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22051] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Vaccines and Related Biological Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The meeting of the Vaccines and Related Biological Products Advisory Committee scheduled for November 16, 2016, is cancelled. This meeting was announced in the Federal Register of August 30, 2016 (81 FR 59634). FOR FURTHER INFORMATION CONTACT: Sujata Vijh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240- 402-7107, [email protected]; or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. Dated: September 8, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016-22051 Filed 9-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices 63191
TABLE 5—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
UNDEFINED DURATIONS OF USE IN SHEEP
Indication/disease Ingredient(s)
Vibrionic Abortion ..................................................................................... Chlortetracycline.
Enterotoxemia ........................................................................................... Chlortetracycline.
TABLE 6—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
UNDEFINED DURATIONS OF USE IN HONEY BEES
Indication/disease Ingredient(s)
Foulbrood .................................................................................................. Oxytetracycline.
Dated: September 7, 2016. procaine penicillin, and sulfamethazine) DEPARTMENT OF HEALTH AND
Leslie Kux, Type A medicated article that pertain to HUMAN SERVICES
Associate Commissioner for Policy. use of the procaine penicillin
[FR Doc. 2016–21972 Filed 9–12–16; 11:15 am] component for the production Food and Drug Administration
BILLING CODE 4164–01–P indications of growth promotion and
increased feed efficiency in swine. [Docket No. FDA–2016–N–0001]
Pharmgate requested voluntary
DEPARTMENT OF HEALTH AND withdrawal of approval of these Vaccines and Related Biological
HUMAN SERVICES indications for use because Products Advisory Committee;
PENNCHLOR SP 500 Type A medicated Cancellation
Food and Drug Administration article is no longer manufactured.
[Docket No. FDA–2016–N–0002] Therefore, under authority delegated AGENCY: Food and Drug Administration,
to the Commissioner of Food and Drugs HHS.
Withdrawal of Approval of Part of a and redelegated to the Director of the ACTION: Notice.
New Animal Drug Application; Center for Veterinary Medicine, and in
Chlortetracycline, Procaine Penicillin, accordance with § 514.116 Notice of
and Sulfamethazine SUMMARY: The meeting of the Vaccines
withdrawal of approval of application and Related Biological Products
AGENCY: Food and Drug Administration, (21 CFR 514.116), notice is given that Advisory Committee scheduled for
HHS. approval of those parts of NADA 138– November 16, 2016, is cancelled. This
ACTION:Notification of withdrawal of 934 that pertain to use of procaine meeting was announced in the Federal
approval. penicillin for the production indications Register of August 30, 2016 (81 FR
of growth promotion and increased feed
59634).
SUMMARY: The Food and Drug efficiency in swine are hereby
Administration (FDA) is withdrawing withdrawn, effective September 14, FOR FURTHER INFORMATION CONTACT:
approval of those parts of a new animal 2016. Sujata Vijh, Center for Biologics
drug application (NADA) for a 3-way, NADA 138–934 was identified as Evaluation and Research, Food and
fixed-ratio, combination drug Type A being affected by guidance for industry Drug Administration, 10903 New
medicated article that pertain to use of (GFI) #213 ‘‘New Animal Drugs and Hampshire Ave., Bldg. 71, Rm. 6128,
the procaine penicillin component for New Animal Drug Combination Silver Spring, MD 20993–0002, 240–
production indications in swine. This Products Administered in or on 402–7107, sujata.vijh@fda.hhs.gov; or
action is being taken at the sponsor’s Medicated Feed or Drinking Water of FDA Advisory Committee Information
request because the 3-way Type A Food-Producing Animals: Line, 1–800–741–8138 (301–443–0572
medicated article is no longer Recommendations for Drug Sponsors for in the Washington, DC area), and follow
manufactured. Voluntarily Aligning Product Use the prompts to the desired center or
DATES: Withdrawal of approval is Conditions with GFI #209,’’ December product area. Please call the Information
effective September 14, 2016. 2013. Line for up-to-date information on this
FOR FURTHER INFORMATION CONTACT: Elsewhere in this issue of the Federal meeting.
Cindy L. Burnsteel, Center for Register, FDA is amending the animal Dated: September 8, 2016.
Veterinary Medicine (HFV–130), Food drug regulations to reflect the
and Drug Administration, 7500 Standish Janice M. Soreth,
withdrawal of approval of these parts of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Pl., Rockville, MD 20855, 240–402– NADA 138–934. Acting Associate Commissioner, Special
0817, cindy.burnsteel@fda.hhs.gov. Medical Programs.
Dated: September 6, 2016. [FR Doc. 2016–22051 Filed 9–13–16; 8:45 am]
SUPPLEMENTARY INFORMATION: Pharmgate
LLC (Pharmgate), 1015 Ashes Dr., Suite William T. Flynn, BILLING CODE 4164–01–P
102, Wilmington, NC 28405 has Acting Director, Center for Veterinary
requested that FDA withdraw approval Medicine.
of those parts of NADA 138–934 for [FR Doc. 2016–21984 Filed 9–13–16; 8:45 am]
PENNCHLOR SP 500 (chlortetracycline, BILLING CODE 4164–01–P
VerDate Sep<11>2014 20:55 Sep 13, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 9990 E:\FR\FM\14SEN1.SGM 14SEN1](https://thefederalregister.org/doc/81_FR_63369/page/1.svg)
Document Created: 2016-09-14 02:27:30
Document Modified: 2016-09-14 02:27:30
| 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 | Notices | |
| Action | Notice. | |
| Contact | Sujata Vijh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240- 402-7107, [email protected]; or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. | |
| FR Citation | 81 FR 63191 |
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