Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability, 2874-2875 [2016-00822]

Download as PDF 2874 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–4563] Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #238 entitled ‘‘Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.’’ This draft guidance provides recommendations on the submission of chemistry, manufacturing, and controls (CMC) and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This draft guidance is applicable to both new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs) products. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 21, 2016. SUMMARY: ADDRESSES: You may submit comments as follows: asabaliauskas on DSK5VPTVN1PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact VerDate Sep<11>2014 17:50 Jan 15, 2016 Jkt 238001 information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. [FDA– 2015–N–4563] for Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Gregory Hunter, Center for Veterinary Medicine (HFV–142), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0675, email: Gregory.Hunter@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of draft GFI #238 entitled ‘‘Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.’’ This draft guidance provides recommendations on the submission of chemistry, manufacturing, and controls (CMC) and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This draft guidance is applicable to both new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs) products. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Modified Release Veterinary Parenteral Dosage Forms: E:\FR\FM\19JAN1.SGM 19JAN1 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices Development, Evaluation, and Establishment of Specifications.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032; the collections of information in section 512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB control number 0910–0669. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: January 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–00822 Filed 1–15–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK5VPTVN1PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Auditory Neuroscience. Date: February 2–3, 2016. Time: 8:00 a.m. to 6:00 p.m. VerDate Sep<11>2014 17:50 Jan 15, 2016 Jkt 238001 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John Bishop, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7844, Bethesda, MD 20892, (301) 408– 9664, bishopj@csr.nih.gov. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Biomedical Computing and Health Informatics Study Section. Date: February 5, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101. Contact Person: Peter J. Kozel, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, Bethesda, MD 20892, 301–435–1116, kozelp@ mail.nih.gov. Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Instrumentation and Systems Development Study Section. Date: February 10–11, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Best Western Tuscan Inn, 425 North Point Street, San Francisco, CA 94133. Contact Person: Kathryn Kalasinsky, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158 MSC 7806, Bethesda, MD 20892, 301–402– 1074, kalasinskyks@mail.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Surgery, Anesthesiology and Trauma Study Section. Date: February 10–11, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton San Diego Mission Valley, 901 Camino Del Rio South, San Diego, CA 92108. Contact Person: Weihua Luo, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5114, MSC 7854, Bethesda, MD 20892, (301) 435– 1170, luow@csr.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section. Date: February 11–12, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Pier 2620 Hotel, 2620 Jones Street, San Francisco, CA 94133. Contact Person: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7848, Bethesda, MD 20892, 301–402–4411, tianbi@csr.nih.gov. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 2875 Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR13–213: Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities. Date: February 11, 2016. Time: 8:00 a.m. to 11:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Jane A. DoussardRoosevelt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435–4445, doussarj@csr.nih.gov. Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Social Psychology, Personality and Interpersonal Processes Study Section. Date: February 11–12, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Westgate Hotel, 1055 Second Avenue, San Diego, CA 92101. Contact Person: Marc Boulay, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 300– 6541, boulaymg@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Nursing and Related Clinical Sciences Overflow. Date: February 11–12, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The St. Regis Washington DC, 923 16th Street N.W., Washington, DC 20006. Contact Person: Martha L. Hare, Ph.D., RN, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3154, Bethesda, MD 20892, (301) 451–8504, harem@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR13–137: Bioengineering Research. Date: February 11, 2016. Time: 8:00 a.m. to 9:00 a.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue N.W., Washington, DC 20037. Contact Person: Yvonne Bennett, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5199, MSC 7846, Bethesda, MD 20892, 301–379– 3793, bennetty@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Interventions to Prevent and Treat Addictions. Date: February 11, 2016. Time: 11:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Mayflower Hotel, 1127 Connecticut Avenue N.W., Washington, DC 20036. E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2874-2875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00822]



[[Page 2874]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4563]


Modified Release Veterinary Parenteral Dosage Forms: Development, 
Evaluation, and Establishment of Specifications; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (GFI) #238 entitled 
``Modified Release Veterinary Parenteral Dosage Forms: Development, 
Evaluation, and Establishment of Specifications.'' This draft guidance 
provides recommendations on the submission of chemistry, manufacturing, 
and controls (CMC) and pharmacokinetic information, as well as 
procedures to follow, to support the approval of modified release 
parenteral drug products intended for use in veterinary species. This 
draft guidance is applicable to both new animal drug applications 
(NADAs) and abbreviated new animal drug application (ANADAs) products.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
[FDA-2015-N-4563] for Modified Release Veterinary Parenteral Dosage 
Forms: Development, Evaluation, and Establishment of Specifications. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gregory Hunter, Center for Veterinary 
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0675, email: Gregory.Hunter@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of draft GFI #238 entitled 
``Modified Release Veterinary Parenteral Dosage Forms: Development, 
Evaluation, and Establishment of Specifications.'' This draft guidance 
provides recommendations on the submission of chemistry, manufacturing, 
and controls (CMC) and pharmacokinetic information, as well as 
procedures to follow, to support the approval of modified release 
parenteral drug products intended for use in veterinary species. This 
draft guidance is applicable to both new animal drug applications 
(NADAs) and abbreviated new animal drug application (ANADAs) products.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Modified Release Veterinary Parenteral Dosage Forms:

[[Page 2875]]

Development, Evaluation, and Establishment of Specifications.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 514 have been approved under 
OMB control number 0910-0032; the collections of information in section 
512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB 
control number 0910-0669.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

    Dated: January 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00822 Filed 1-15-16; 8:45 am]
 BILLING CODE 4164-01-P
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