81 FR 39651 - Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 117 (June 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 117 (June 17, 2016)
| Page Range | 39651-39652 | |
| FR Document | 2016-14355 |
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)] [Notices] [Pages 39651-39652] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14355] ----------------------------------------------------------------------- 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; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #238 entitled ``Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.'' This guidance provides recommendations on the submission of chemistry, manufacturing, and controls 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 guidance is applicable to both new animal drug applications and abbreviated new animal drug application products. DATES: Submit either electronic or written comments on Agency guidances at any time. 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 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 protected]. SUPPLEMENTARY INFORMATION: [[Page 39652]] I. Background In the Federal Register of January 19, 2016 (81 FR 2874), FDA published the notice of availability for a draft guidance for industry entitled ``Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications,'' giving interested persons until March 21, 2016, to comment on the draft, and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated January 2016. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Modified Release Veterinary Parenteral Dosage Forms: 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 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 guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: June 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14355 Filed 6-16-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39651
III. Petitions DATES: Submit either electronic or • Confidential Submissions—To
written comments on Agency guidances submit a comment with confidential
Anyone with knowledge that any of at any time. information that you do not wish to be
the dates as published are incorrect may made publicly available, submit your
submit either electronic or written ADDRESSES: You may submit comments
as follows: comments only as a written/paper
comments and ask for a redetermination
submission. You should submit two
(see DATES). Furthermore, any interested Electronic Submissions copies total. One copy will include the
person may petition FDA for a
Submit electronic comments in the information you claim to be confidential
determination regarding whether the
following way: with a heading or cover note that states
applicant for extension acted with due
diligence during the regulatory review • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
period. To meet its burden, the petition
instructions for submitting comments. Agency will review this copy, including
must be timely (see DATES) and contain
Comments submitted electronically, the claimed confidential information, in
sufficient facts to merit an FDA
including attachments, to http:// its consideration of comments. The
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov will be posted to second copy, which will have the
Petitions should be in the format the docket unchanged. Because your claimed confidential information
specified in 21 CFR 10.30. comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on http://
Submit petitions electronically to comment does not include any www.regulations.gov. Submit both
http://www.regulations.gov at Docket confidential information that you or a copies to the Division of Dockets
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, Management. If you do not wish your
petitions (two copies are required) to the such as medical information, your or name and contact information to be
Division of Dockets Management (HFA– anyone else’s Social Security number, or made publicly available, you can
305), Food and Drug Administration, confidential business information, such provide this information on the cover
5630 Fishers Lane, Rm. 1061, Rockville, as a manufacturing process. Please note sheet and not in the body of your
MD 20852. that if you include your name, contact comments and you must identify this
Dated: June 13, 2016. information, or other information that information as ‘‘confidential.’’ Any
Leslie Kux, identifies you in the body of your information marked as ‘‘confidential’’
Associate Commissioner for Policy. comments, that information will be will not be disclosed except in
[FR Doc. 2016–14353 Filed 6–16–16; 8:45 am] posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
DEPARTMENT OF HEALTH AND public, submit the comment as a 56469, September 18, 2015, or access
HUMAN SERVICES written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). default.htm.
Written/Paper Submissions Docket: For access to the docket to
[Docket No. FDA–2015–N–4563] read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
Modified Release Veterinary Parenteral follows:
received, go to http://
Dosage Forms: Development, • Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
Evaluation, and Establishment of written/paper submissions): Division of
docket number, found in brackets in the
Specifications; Guidance for Industry; Dockets Management (HFA–305), Food
heading of this document, into the
Availability and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, and/or go to the Division of Dockets
• For written/paper comments Management, 5630 Fishers Lane, Rm.
HHS. submitted to the Division of Dockets 1061, Rockville, MD 20852.
ACTION: Notice. Management, FDA will post your
comment, as well as any attachments, Submit written requests for single
SUMMARY: The Food and Drug except for information submitted, copies of the guidance to the Policy and
Administration (FDA) is announcing the marked and identified, as confidential, Regulations Staff (HFV–6), Center for
availability of guidance for industry if submitted as detailed in Veterinary Medicine, Food and Drug
#238 entitled ‘‘Modified Release ‘‘Instructions.’’ Administration, 7519 Standish Pl.,
Veterinary Parenteral Dosage Forms: Instructions: All submissions received Rockville, MD 20855. Send one self-
Development, Evaluation, and must include the Docket No. FDA– addressed adhesive label to assist that
Establishment of Specifications.’’ This 2015–N–4563 for ‘‘Modified Release office in processing your requests. See
guidance provides recommendations on Veterinary Parenteral Dosage Forms: the SUPPLEMENTARY INFORMATION section
the submission of chemistry, Development, Evaluation, and for electronic access to the guidance
manufacturing, and controls and Establishment of Specifications.’’ document.
pharmacokinetic information, as well as Received comments will be placed in
sradovich on DSK3TPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
procedures to follow, to support the the docket and, except for those
Gregory Hunter, Center for Veterinary
approval of modified release parenteral submitted as ‘‘Confidential
Medicine (HFV–142), Food and Drug
drug products intended for use in Submissions,’’ publicly viewable at
Administration, 7500 Standish Pl.,
veterinary species. This guidance is http://www.regulations.gov or at the
Rockville, MD 20855, 240–402–0675,
applicable to both new animal drug Division of Dockets Management
Gregory.Hunter@fda.hhs.gov.
applications and abbreviated new between 9 a.m. and 4 p.m., Monday
animal drug application products. through Friday. SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1](https://thefederalregister.org/doc/81_FR_39768/page/1.svg)
![39652 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
I. Background DEPARTMENT OF HEALTH AND comments, that information will be
HUMAN SERVICES posted on http://www.regulations.gov.
In the Federal Register of January 19, • If you want to submit a comment
2016 (81 FR 2874), FDA published the Food and Drug Administration with confidential information that you
notice of availability for a draft guidance do not wish to be made available to the
for industry entitled ‘‘Modified Release [Docket No. FDA–2013–E–0677] public, submit the comment as a
Veterinary Parenteral Dosage Forms: written/paper submission and in the
Determination of Regulatory Review
Development, Evaluation, and manner detailed (see ‘‘Written/Paper
Period for Purposes of Patent
Establishment of Specifications,’’ giving Submissions’’ and ‘‘Instructions’’).
Extension; ZILVER PTX DRUG
interested persons until March 21, 2016, ELUTING PERIPHERAL STENT Written/Paper Submissions
to comment on the draft, and those
comments were considered as the AGENCY: Food and Drug Administration, Submit written/paper submissions as
HHS. follows:
guidance was finalized. The guidance • Mail/Hand delivery/Courier (for
announced in this notice finalizes the ACTION: Notice. written/paper submissions): Division of
draft guidance dated January 2016. Dockets Management (HFA–305), Food
SUMMARY: The Food and Drug
II. Significance of Guidance Administration (FDA) has determined and Drug Administration, 5630 Fishers
the regulatory review period for ZILVER Lane, Rm. 1061, Rockville, MD 20852.
This level 1 guidance is being issued • For written/paper comments
PTX DRUG ELUTING PERIPHERAL
consistent with FDA’s good guidance submitted to the Division of Dockets
STENT and is publishing this notice of
practices regulation (21 CFR 10.115). Management, FDA will post your
that determination as required by law.
The guidance represents the current comment, as well as any attachments,
FDA has made the determination
thinking of FDA on ‘‘Modified Release except for information submitted,
because of the submission of an
Veterinary Parenteral Dosage Forms: marked and identified, as confidential,
application by Cook Medical
Development, Evaluation, and if submitted as detailed in
Technologies, LLC, to the Director of the
Establishment of Specifications.’’ It does ‘‘Instructions.’’
U.S. Patent and Trademark Office Instructions: All submissions received
not establish any rights for any person (USPTO), Department of Commerce, for must include the Docket No. FDA–
and is not binding on FDA or the public. the extension of a patent which claims 2013–E–0677 for ‘‘Determination of
You can use an alternative approach if that medical device. Regulatory Review Period for Purposes
it satisfies the requirements of the DATES: Anyone with knowledge that any of Patent Extension; ZILVER PTX DRUG
applicable statutes and regulations. of the dates as published (see the ELUTING PERIPHERAL STENT.’’
SUPPLEMENTARY INFORMATION section) are Received comments will be placed in
III. Paperwork Reduction Act of 1995
incorrect may submit either electronic the docket and, except for those
This guidance refers to previously or written comments and ask for a submitted as ‘‘Confidential
approved collections of information redetermination by August 16, 2016. Submissions,’’ publicly viewable at
found in FDA regulations. These Furthermore, any interested person may http://www.regulations.gov or at the
collections of information are subject to petition FDA for a determination Division of Dockets Management
review by the Office of Management and regarding whether the applicant for between 9 a.m. and 4 p.m., Monday
Budget (OMB) under the Paperwork extension acted with due diligence through Friday.
Reduction Act of 1995 (44 U.S.C. 3501– during the regulatory review period by • Confidential Submissions—To
December 14, 2016. See ‘‘Petitions’’ in submit a comment with confidential
3520). The collections of information in
the SUPPLEMENTARY INFORMATION section information that you do not wish to be
21 CFR part 514 have been approved
for more information. made publicly available, submit your
under OMB control number 0910–0032;
ADDRESSES: You may submit comments comments only as a written/paper
the collections of information in section
as follows: submission. You should submit two
512(n)(1) of the FD&C Act (21 U.S.C.
copies total. One copy will include the
360k) have been approved under OMB Electronic Submissions information you claim to be confidential
control number 0910–0669. Submit electronic comments in the with a heading or cover note that states
IV. Electronic Access following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
Persons with access to the Internet www.regulations.gov. Follow the Agency will review this copy, including
may obtain the guidance at either http:// instructions for submitting comments. the claimed confidential information, in
www.fda.gov/AnimalVeterinary/ Comments submitted electronically, its consideration of comments. The
GuidanceComplianceEnforcement/ including attachments, to http:// second copy, which will have the
GuidanceforIndustry/default.htm or www.regulations.gov will be posted to claimed confidential information
http://www.regulations.gov. the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on http://
Dated: June 13, 2016.
solely responsible for ensuring that your www.regulations.gov. Submit both
Leslie Kux, comment does not include any copies to the Division of Dockets
Associate Commissioner for Policy. confidential information that you or a Management. If you do not wish your
[FR Doc. 2016–14355 Filed 6–16–16; 8:45 am] third party may not wish to be posted, name and contact information to be
sradovich on DSK3TPTVN1PROD with NOTICES
BILLING CODE 4164–01–P such as medical information, your or made publicly available, you can
anyone else’s Social Security number, or provide this information on the cover
confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
that if you include your name, contact information as ‘‘confidential.’’ Any
information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1](https://thefederalregister.org/doc/81_FR_39768/page/2.svg)
Document Created: 2016-06-17 01:04:58
Document Modified: 2016-06-17 01:04:58
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Gregory Hunter, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0675, [email protected] | |
| FR Citation | 81 FR 39651 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR