82 FR 18913 - Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 77 (April 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 77 (April 24, 2017)
| Page Range | 18913-18914 | |
| FR Document | 2017-08199 |
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)] [Notices] [Pages 18913-18914] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08199] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on Naloxone Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final versions of the guidance, submit either electronic or written comments on the draft guidances by June 23, 2017.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 [[Page 18914]] 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-2007-D-0369 for ``Draft Guidance on Naloxone Hydrochloride.'' 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific guidances available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of a new draft guidance for generic naloxone hydrochloride nasal spray. FDA initially approved new drug application 208411 for NARCAN (naloxone hydrochloride) nasal spray in November 2015. We are now issuing a new draft guidance for industry on generic naloxone hydrochloride nasal spray (``Draft Guidance on Naloxone Hydrochloride''). In November 2016, Adapt Pharma Operations Limited (APOL), manufacturer of the reference listed drug NARCAN nasal spray, submitted a citizen petition requesting that FDA refrain from approving any ANDA referencing NARCAN nasal spray unless certain conditions are satisfied, including conditions related to demonstrating BE. FDA has reviewed the issues raised in the citizen petition and is responding to it separately in the docket for that citizen petition (Docket No. FDA- 2016-P-4094, available at https://www.regulations.gov).\1\ --------------------------------------------------------------------------- \1\ On January 31, 2017, Mucodel Pharma LLC (Mucodel) submitted a citizen petition requesting that FDA ``refrain from approving any [intranasal] naloxone drug application (whether an NDA or ANDA) for the emergency treatment of a known or suspected opioid overdose until the FDA considers whether such application adequately addresses the reliability of [intranasal] naloxone in actual field use.'' (Docket No. FDA-2017-P-0663). This petition remains under review and FDA's issuance of the naloxone hydrochloride nasal spray product-specific guidance and its response to the citizen petition from APOL are not intended in any way to address the merits of the Mucodel citizen petition. --------------------------------------------------------------------------- The new draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The new draft guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for naloxone hydrochloride nasal spray. 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. II. Electronic Access Persons with access to the Internet may obtain the draft guidances at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: April 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-08199 Filed 4-21-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices 18913
onsite registration on the day of the the drug review process. To support this Office of Regulatory Affairs District
public workshop will be provided primary goal, CDER has initiated Offices in the firms’ respective regions.
beginning at 7:30 a.m. various training and development Firms that want to learn more about this
For those without Internet access, programs to promote high performance training opportunity or that are
please contact Scott Winiecki, (see FOR in its regulatory project management interested in offering a site tour should
FURTHER INFORMATION CONTACT) to staff. CDER seeks to significantly respond by sending a proposed agenda
register. If you need special enhance review efficiency and review by email directly to Dan Brum (see
accommodations due to a disability, quality by providing the staff with a DATES and FOR FURTHER INFORMATION
please contact Scott Winiecki no later better understanding of the CONTACT).
than September 1, 2017. pharmaceutical industry and its Dated: April 17, 2017.
Transcripts: A transcript of the public operations. To this end, CDER is
Anna K. Abram,
workshop will be accessible at https:// continuing its training program to give
regulatory project managers the Deputy Commissioner for Policy, Planning,
www.regulations.gov approximately 30
Legislation, and Analysis.
days after the workshop. It may also be opportunity to tour pharmaceutical
[FR Doc. 2017–08183 Filed 4–21–17; 8:45 am]
viewed at the Division of Dockets facilities. The goals are to provide the
following: (1) Firsthand exposure to BILLING CODE 4164–01–P
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm. industry’s drug development processes
1061, Rockville, MD 20852. and (2) a venue for sharing information
about project management procedures DEPARTMENT OF HEALTH AND
Dated: April 18, 2017. HUMAN SERVICES
(but not drug-specific information) with
Anna K. Abram,
industry representatives. Food and Drug Administration
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. II. The Site Tours Program [Docket No. FDA–2007–D–0369]
[FR Doc. 2017–08178 Filed 4–21–17; 8:45 am] In this program, over a 2- to 3-day
BILLING CODE 4164–01–P period, small groups (five or less) of Product-Specific Guidance for
regulatory project managers, including a Naloxone Hydrochloride; New Draft
senior level regulatory project manager, Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND can observe operations of
HUMAN SERVICES AGENCY: Food and Drug Administration,
pharmaceutical manufacturing and/or
HHS.
packaging facilities, pathology/
Food and Drug Administration toxicology laboratories, and regulatory ACTION: Notice of availability.
[Docket No. FDA–2014–N–0179] affairs operations. Neither this tour nor SUMMARY: The Food and Drug
any part of the program is intended as Administration (FDA, the Agency, or
Training Program for Regulatory a mechanism to inspect, assess, judge, we) is announcing the availability of a
Project Managers; Information or perform a regulatory function, but is
new draft guidance for industry on
Available to Industry meant rather to improve mutual
generic naloxone hydrochloride nasal
understanding and to provide an avenue
AGENCY: Food and Drug Administration, spray entitled ‘‘Draft Guidance on
for open dialogue. During the Site Tours
HHS. Naloxone Hydrochloride.’’ The new
Program, regulatory project managers
ACTION: Notice. draft guidance, when finalized, will
will also participate in daily workshops
provide product-specific
SUMMARY: The Food and Drug with their industry counterparts,
recommendations on, among other
Administration’s (FDA’s) Center for focusing on selective regulatory issues
things, the design of bioequivalence
Drug Evaluation and Research (CDER) is important to both CDER staff and
(BE) studies to support abbreviated new
announcing the continuation of the industry. The primary objective of the
drug applications (ANDAs) for naloxone
Regulatory Project Management Site daily workshops is to learn about the
hydrochloride nasal spray.
Tours and Regulatory Interaction team approach to drug development,
including drug discovery, preclinical DATES: Although you can comment on
Program (the Site Tours Program). The any guidance at any time (see 21 CFR
purpose of this document is to invite evaluation, tracking mechanisms, and
regulatory submission operations. The 10.115(g)(5)), to ensure that the Agency
pharmaceutical companies interested in considers your comment on this draft
participating in this program to contact overall benefit to regulatory project
managers will be exposure to project guidance before it begins work on the
CDER. final versions of the guidance, submit
management, team techniques, and
DATES: Pharmaceutical companies may either electronic or written comments
processes employed by the
send proposed agendas to the Agency by pharmaceutical industry. By on the draft guidances by June 23, 2017.
June 23, 2017. participating in this program, the ADDRESSES: You may submit comments
FOR FURTHER INFORMATION CONTACT: Dan regulatory project manager will grow as follows:
Brum, Center for Drug Evaluation and professionally by gaining a better
Research, Food and Drug Electronic Submissions
understanding of industry processes and
Administration, 10903 New Hampshire procedures. Submit electronic comments in the
Ave., Bldg. 22, Rm. 5480, Silver Spring, following way:
MD 20993–0002, 301–796–0578, III. Site Selection • Federal eRulemaking Portal:
dan.brum@fda.hhs.gov. All travel expenses associated with https://www.regulations.gov. Follow the
jstallworth on DSK7TPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: the Site Tours Program will be the instructions for submitting comments.
responsibility of CDER; therefore, Comments submitted electronically,
I. Background selection will be based on the including attachments, to https://
An important part of CDER’s availability of funds and resources for www.regulations.gov will be posted to
commitment to make safe and effective each fiscal year. Selection will also be the docket unchanged. Because your
drugs available to all Americans is based on firms having a favorable comment will be made public, you are
optimizing the efficiency and quality of facility status as determined by FDA’s solely responsible for ensuring that your
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![18914 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
comment does not include any made publicly available, you can FDA initially approved new drug
confidential information that you or a provide this information on the cover application 208411 for NARCAN
third party may not wish to be posted, sheet and not in the body of your (naloxone hydrochloride) nasal spray in
such as medical information, your or comments and you must identify this November 2015. We are now issuing a
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any new draft guidance for industry on
confidential business information, such information marked as ‘‘confidential’’ generic naloxone hydrochloride nasal
as a manufacturing process. Please note will not be disclosed except in spray (‘‘Draft Guidance on Naloxone
that if you include your name, contact accordance with 21 CFR 10.20 and other Hydrochloride’’).
information, or other information that applicable disclosure law. For more
identifies you in the body of your information about FDA’s posting of In November 2016, Adapt Pharma
comments, that information will be comments to public dockets, see 80 FR Operations Limited (APOL),
posted on https://www.regulations.gov. 56469, September 18, 2015, or access manufacturer of the reference listed
• If you want to submit a comment the information at: https://www.gpo.gov/ drug NARCAN nasal spray, submitted a
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- citizen petition requesting that FDA
do not wish to be made available to the 23389.pdf. refrain from approving any ANDA
public, submit the comment as a Docket: For access to the docket to referencing NARCAN nasal spray unless
written/paper submission and in the read background documents or the certain conditions are satisfied,
manner detailed (see ‘‘Written/Paper electronic and written/paper comments including conditions related to
Submissions’’ and ‘‘Instructions’’). received, go to https:// demonstrating BE. FDA has reviewed
www.regulations.gov and insert the the issues raised in the citizen petition
Written/Paper Submissions
docket number, found in brackets in the and is responding to it separately in the
Submit written/paper submissions as heading of this document, into the docket for that citizen petition (Docket
follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for No. FDA–2016–P–4094, available at
and/or go to the Division of Dockets
written/paper submissions): Division of https://www.regulations.gov).1
Management, 5630 Fishers Lane, Rm.
Dockets Management (HFA–305), Food 1061, Rockville, MD 20852. The new draft guidance is being
and Drug Administration, 5630 Fishers Submit written requests for single issued consistent with FDA’s good
Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to the guidance practices regulation (21 CFR
• For written/paper comments Division of Drug Information, Center for 10.115). The new draft guidance, when
submitted to the Division of Dockets Drug Evaluation and Research, Food finalized, will represent the current
Management, FDA will post your and Drug Administration, 10001 New thinking of FDA on the design of BE
comment, as well as any attachments, Hampshire Ave., Hillandale Building, studies to support ANDAs for naloxone
except for information submitted, 4th Floor, Silver Spring, MD 20993– hydrochloride nasal spray. It does not
marked and identified, as confidential, 0002. Send one self-addressed adhesive establish any rights for any person and
if submitted as detailed in label to assist that office in processing is not binding on FDA or the public.
‘‘Instructions.’’ your requests. See the SUPPLEMENTARY
Instructions: All submissions received You can use an alternative approach if
INFORMATION section for electronic
must include the Docket No. FDA– it satisfies the requirements of the
access to the draft guidance document.
2007–D–0369 for ‘‘Draft Guidance on applicable statutes and regulations.
FOR FURTHER INFORMATION CONTACT:
Naloxone Hydrochloride.’’ Received Xiaoqiu Tang, Center for Drug II. Electronic Access
comments will be placed in the docket Evaluation and Research, Food and
and, except for those submitted as Drug Administration, 10903 New Persons with access to the Internet
‘‘Confidential Submissions,’’ publicly Hampshire Ave., Bldg. 75, Rm. 4730, may obtain the draft guidances at either
viewable at https://www.regulations.gov Silver Spring, MD 20993–0002, 301– http://www.fda.gov/Drugs/Guidance
or at the Division of Dockets 796–5850. ComplianceRegulatoryInformation/
Management between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: Guidances/default.htm or https://
Monday through Friday. www.regulations.gov.
• Confidential Submissions—To I. Background
submit a comment with confidential Dated: April 18, 2017.
In the Federal Register of June 11,
information that you do not wish to be Anna K. Abram,
2010 (75 FR 33311), FDA announced the
made publicly available, submit your availability of a guidance for industry Deputy Commissioner for Policy, Planning,
comments only as a written/paper entitled ‘‘Bioequivalence Legislation, and Analysis.
submission. You should submit two Recommendations for Specific [FR Doc. 2017–08199 Filed 4–21–17; 8:45 am]
copies total. One copy will include the Products,’’ which explained the process BILLING CODE 4164–01–P
information you claim to be confidential that would be used to make product-
with a heading or cover note that states specific guidances available to the 1 On January 31, 2017, Mucodel Pharma LLC
‘‘THIS DOCUMENT CONTAINS public on FDA’s Web site at http://www. (Mucodel) submitted a citizen petition requesting
CONFIDENTIAL INFORMATION.’’ The fda.gov/Drugs/GuidanceCompliance that FDA ‘‘refrain from approving any [intranasal]
Agency will review this copy, including RegulatoryInformation/Guidances/ naloxone drug application (whether an NDA or
the claimed confidential information, in default.htm. ANDA) for the emergency treatment of a known or
its consideration of comments. The As described in that guidance, FDA suspected opioid overdose until the FDA considers
second copy, which will have the
jstallworth on DSK7TPTVN1PROD with NOTICES
adopted this process to develop and whether such application adequately addresses the
claimed confidential information disseminate product-specific guidances reliability of [intranasal] naloxone in actual field
redacted/blacked out, will be available and to provide a meaningful use.’’ (Docket No. FDA–2017–P–0663). This petition
remains under review and FDA’s issuance of the
for public viewing and posted on opportunity for the public to consider naloxone hydrochloride nasal spray product-
https://www.regulations.gov. Submit and comment on the guidances. This specific guidance and its response to the citizen
both copies to the Division of Dockets notice announces the availability of a petition from APOL are not intended in any way
Management. If you do not wish your new draft guidance for generic naloxone to address the merits of the Mucodel citizen
name and contact information to be hydrochloride nasal spray. petition.
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Document Created: 2017-04-22 00:11:22
Document Modified: 2017-04-22 00:11:22
| 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 versions of the guidance, submit either electronic or written comments on the draft guidances by June 23, 2017. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. | |
| FR Citation | 82 FR 18913 |
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