82 FR 851 - In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 2 (January 4, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 2 (January 4, 2017)
| Page Range | 851-852 | |
| FR Document | 2016-31855 |
[Federal Register Volume 82, Number 2 (Wednesday, January 4, 2017)] [Notices] [Pages 851-852] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31855] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-4437] In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This draft guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether or not the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017. 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-2016-D-4437 for ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' 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 [[Page 852]] 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: 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 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: Kevin Rice, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0680, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft GIF #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This draft guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether or not the pioneer RLNAD currently has an in-use statement on the labeling. 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 ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' 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 21 CFR part 511 have been approved under OMB control number 0910-0117. The collections of information in sections 512(b) and (n) of the Federal Food, Drug, and Cosmetic Act 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 https://www.regulations.gov. Dated: December 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31855 Filed 1-3-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices 851
committee is a non-discretionary please visit us at http://www.fda.gov/ • Federal eRulemaking Portal:
Federal advisory committee established AdvisoryCommittees/default.htm. https://www.regulations.gov. Follow the
to provide advice and consultation to Dated: December 28, 2016. instructions for submitting comments.
the Commissioner. The Commissioner Leslie Kux,
Comments submitted electronically,
of Food and Drugs is charged with the including attachments, to https://
Associate Commissioner for Policy.
administration of the Radiation Control www.regulations.gov will be posted to
[FR Doc. 2016–31847 Filed 1–3–17; 8:45 am] the docket unchanged. Because your
for Health and Safety Act of 1968. This
Act creates the Technical Electronic BILLING CODE 4164–01–P comment will be made public, you are
Product Radiation Safety Standards solely responsible for ensuring that your
Committee and requires the comment does not include any
DEPARTMENT OF HEALTH AND confidential information that you or a
Commissioner to consult with the
HUMAN SERVICES third party may not wish to be posted,
Committee before prescribing standards
for radiation emissions from electronic Food and Drug Administration such as medical information, your or
products. This Committee provides anyone else’s Social Security number, or
advice and consultation to the confidential business information, such
[Docket No. FDA–2016–D–4437] as a manufacturing process. Please note
Commissioner of Food and Drugs on the
technical feasibility, reasonableness, that if you include your name, contact
In-Use Stability Studies and
and practicability of performance information, or other information that
Associated Labeling Statements for
standards for electronic products to identifies you in the body of your
Multiple-Dose Injectable Animal Drug comments, that information will be
control the emission of radiation from Products; Draft Guidance for Industry;
such products, and may recommend posted on https://www.regulations.gov.
Availability • If you want to submit a comment
electronic product radiation safety
standards to the Commissioner for AGENCY: Food and Drug Administration, with confidential information that you
consideration. HHS. do not wish to be made available to the
The Committee shall consist of a core public, submit the comment as a
ACTION: Notice of availability.
of 15 voting members including the written/paper submission and in the
Chair. Members and the Chair are SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
selected by the Commissioner or Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’).
designee from among authorities announcing the availability of a draft Written/Paper Submissions
knowledgeable in the fields of science guidance for industry (GIF) #242
entitled ‘‘In-Use Stability Studies and Submit written/paper submissions as
or engineering applicable to electronic
Associated Labeling Statements for follows:
product radiation safety. Members will • Mail/Hand delivery/Courier (for
be invited to serve for overlapping terms Multiple-Dose Injectable Animal Drug
written/paper submissions): Division of
of up to 4 years. Terms of more than two Products.’’ The purpose of in-use
Dockets Management (HFA–305), Food
years are contingent upon the renewal stability testing is to establish a period
and Drug Administration, 5630 Fishers
of the Committee by appropriate action of time during which a multiple-dose
Lane, Rm. 1061, Rockville, MD 20852.
prior to its expiration. The core of drug product may be used while
• For written/paper comments
voting members will include five retaining acceptable quality
submitted to the Division of Dockets
members selected from governmental specifications once the container is
Management, FDA will post your
agencies, including State and Federal opened (e.g., after a container has been
comment, as well as any attachments,
Governments, five members from the needle-punctured). This draft guidance
except for information submitted,
affected industries, and five members reflects the Agency’s current thinking
marked and identified, as confidential,
from the general public, of which at on how to formulate in-use statements,
if submitted as detailed in
least one shall be a representative of as well as how to design and carry out
‘‘Instructions.’’
organized labor. A quorum shall consist in-use stability studies to support these Instructions: All submissions received
of 10 members, of which at least 3 shall in-use statements, for multiple-dose must include the Docket No. FDA–
be from the general public, 3 from the injectable drug products intended for 2016–D–4437 for ‘‘In-Use Stability
government agencies, and 3 from the use in animals. This current thinking Studies and Associated Labeling
affected industries. pertains to both generic drug products Statements for Multiple-Dose Injectable
Further information regarding the and pioneer drug products regardless of Animal Drug Products.’’ Received
most recent charter and other whether or not the pioneer reference comments will be placed in the docket
information can be found at http:// listed new animal drug (RLNAD) and, except for those submitted as
www.fda.gov/AdvisoryCommittees/ currently has an in-use statement on the ‘‘Confidential Submissions,’’ publicly
CommitteesMeetingMaterials/Radiation- labeling. viewable at https://www.regulations.gov
EmittingProducts/ DATES: Although you can comment on or at the Division of Dockets
TechnicalElectronicProductRadiation any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
SafetyStandardsCommittee/default.htm. 10.115(g)(5)), to ensure that the Agency Monday through Friday.
or by contacting the Designated Federal considers your comment on this draft • Confidential Submissions—To
Officer (see FOR FURTHER INFORMATION guidance before it begins work on the submit a comment with confidential
CONTACT). In light of the fact that no final version of the guidance, submit information that you do not wish to be
change has been made to the committee either electronic or written comments made publicly available, submit your
mstockstill on DSK3G9T082PROD with NOTICES
name or description of duties, no on the draft guidance by March 6, 2017. comments only as a written/paper
amendment will be made to 21 CFR ADDRESSES: You may submit comments submission. You should submit two
14.100. as follows: copies total. One copy will include the
This document is issued under the information you claim to be confidential
Federal Advisory Committee Act (5 Electronic Submissions with a heading or cover note that states
U.S.C. app.). For general information Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
related to FDA advisory committees, following way: CONFIDENTIAL INFORMATION.’’ The
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![852 Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
Agency will review this copy, including needle-punctured). This draft guidance DEPARTMENT OF HEALTH AND
the claimed confidential information, in reflects the Agency’s current thinking HUMAN SERVICES
its consideration of comments. The on how to formulate in-use statements,
second copy, which will have the as well as how to design and carry out Food and Drug Administration
claimed confidential information in-use stability studies to support these [Docket No. FDA–2016–N–4232]
redacted/blacked out, will be available in-use statements, for multiple-dose
for public viewing and posted on injectable drug products intended for Battery Safety Concerns in Electronic
https://www.regulations.gov. Submit use in animals. This current thinking Nicotine Delivery Systems; Public
both copies to the Division of Dockets pertains to both generic drug products Workshop; Establishment of a Public
Management. If you do not wish your and pioneer drug products regardless of Docket; Request for Comments
name and contact information to be whether or not the pioneer RLNAD
made publicly available, you can AGENCY: Food and Drug Administration,
currently has an in-use statement on the HHS.
provide this information on the cover
labeling. ACTION: Public workshop; establishment
sheet and not in the body of your
comments and you must identify this II. Significance of Guidance of public docket; request for data,
information as ‘‘confidential.’’ Any information, and comments.
information marked as ‘‘confidential’’ This level 1 draft guidance is being
will not be disclosed except in issued consistent with FDA’s good SUMMARY: The Food and Drug
accordance with 21 CFR 10.20 and other guidance practices regulation (21 CFR Administration (FDA) Center for
applicable disclosure law. For more 10.115). The draft guidance, when Tobacco Products (CTP) is announcing
information about FDA’s posting of finalized, will represent the current several actions concerning issues related
comments to public dockets, see 80 FR thinking of FDA on ‘‘In-Use Stability to batteries used in electronic nicotine
56469, September 18, 2015, or access Studies and Associated Labeling delivery systems (ENDS), including
the information at: http://www.fda.gov/ Statements for Multiple-Dose Injectable electronic cigarettes (e-cigarettes). These
regulatoryinformation/dockets/ actions are intended to give CTP staff an
Animal Drug Products.’’ It does not
default.htm. opportunity to hear from the public,
establish any rights for any person and
Docket: For access to the docket to including tobacco product
is not binding on FDA or the public. manufacturers, importers, researchers,
read background documents or the You can use an alternative approach if
electronic and written/paper comments and academic investigators, about ENDS
it satisfies the requirements of the battery safety concerns (e.g.,
received, go to https:// applicable statutes and regulations.
www.regulations.gov and insert the overheating, fire, explosion), risk
docket number, found in brackets in the III. Paperwork Reduction Act of 1995 mitigation, and design parameters.
heading of this document, into the Additionally, FDA is interested in
‘‘Search’’ box and follow the prompts This draft guidance refers to information related to communication
and/or go to the Division of Dockets previously approved collections of to consumers and the general public
Management, 5630 Fishers Lane, Rm. information found in FDA regulations. related to ENDS battery safety concerns.
1061, Rockville, MD 20852. These collections of information are FDA is announcing a public workshop
Submit written requests for single subject to review by the Office of on ENDS batteries and safety hazards.
copies of the guidance to the Policy and Management and Budget (OMB) under The 2-day public workshop will include
Regulations Staff (HFV–6), Center for the Paperwork Reduction Act of 1995 presentations and panel discussions
Veterinary Medicine, Food and Drug (44 U.S.C. 3501–3520). The collections about ENDS battery safety concerns as
Administration, 7519 Standish Pl., of information in 21 CFR part 514 have well as how potential safety hazards and
Rockville, MD 20855. Send one self- been approved under OMB control risks are communicated to consumers
addressed adhesive label to assist that number 0910–0032. The collections of and the general public. In conjunction
office in processing your requests. See information in 21 CFR part 511 have with the public workshop, FDA is
the SUPPLEMENTARY INFORMATION section establishing a public docket to gather
been approved under OMB control
for electronic access to the draft data and information on hazards and
number 0910–0117. The collections of
guidance document. risks associated with the use of batteries
information in sections 512(b) and (n) of in ENDS. Regardless of attendance at the
FOR FURTHER INFORMATION CONTACT: the Federal Food, Drug, and Cosmetic public workshop, interested parties are
Kevin Rice, Center for Veterinary Act have been approved under OMB invited to submit comments, including
Medicine (HFV–140), Food and Drug control number 0910–0669. data and research.
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0680, IV. Electronic Access DATES: The public workshop will be
kevin.rice@fda.hhs.gov. held on April 19 and 20, 2017, from
Persons with access to the Internet 8:30 a.m. to 4:30 p.m. Individuals who
SUPPLEMENTARY INFORMATION: may obtain the draft guidance at either wish to attend the public workshop
I. Background http://www.fda.gov/AnimalVeterinary/ must register by March 17, 2017.
GuidanceComplianceEnforcement/ Electronic or written comments to the
FDA is announcing the availability of
a draft GIF #242 entitled ‘‘In-Use GuidanceforIndustry/default.htm or docket will be accepted until May 22,
Stability Studies and Associated https://www.regulations.gov. 2017.
Labeling Statements for Multiple-Dose Dated: December 28, 2016. ADDRESSES: The public workshop will
mstockstill on DSK3G9T082PROD with NOTICES
Injectable Animal Drug Products.’’ The Leslie Kux, be held at the FDA White Oak Campus,
purpose of in-use stability testing is to Associate Commissioner for Policy. 10903 New Hampshire Ave., Bldg. 31
establish a period of time during which [FR Doc. 2016–31855 Filed 1–3–17; 8:45 am]
Conference Center, the Great Room (Rm.
a multiple-dose drug product may be 1503), Silver Spring, MD 20993–0002.
BILLING CODE 4164–01–P
used while retaining acceptable quality Entrance for the public meeting
specifications once the container is participants (non-FDA employees) is
opened (e.g., after a container has been through Building 1 where routine
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Document Created: 2017-01-04 00:29:34
Document Modified: 2017-01-04 00:29:34
| 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 of availability. | |
| 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 6, 2017. | |
| Contact | Kevin Rice, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0680, [email protected] | |
| FR Citation | 82 FR 851 |
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