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- Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability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Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #238 entitled ``Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.'' This draft guidance provides recommendations on the submission of chemistry, manufacturing, and controls (CMC) and pharmacokinetic information, as well as procedures to follow,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 This draft guidance is applicable to both new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs) products.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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 21, 2016.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