Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability, 54295-54296 [2015-22683]
Download as PDF
Lhorne on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, is the
subject of NDA 12–122 held by Eli Lilly,
and initially approved onNovember 14,
1960. GLUCAGON is indicated for
treatment of severe hypoglycemia and as
a diagnostic aid in the radiologic
examination of the stomach, duodenum,
small bowel, and colon.
Under NDA 12–122, GLUCAGON
(glucagon hydrochloride) for injection,
EQ 1 mg base/vial and EQ 10 mg base/
vial, was produced from animal sources.
On September 11, 1998, FDA approved
Eli Lilly’s NDA 20–928 for GLUCAGON
(glucagon rDNA origin), 1mg/vial.
Subsequently, Eli Lilly discontinued
sales of animal-sourced GLUCAGON in
2002. In 2005, FDA moved animalsourced GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Walter G. Jump, on behalf of
Cornerstone Regulatory, submitted a
citizen petition dated August 7, 2007
(Docket No. FDA–2007–P–0248), under
21 CFR 10.30, requesting that the
Agency determine whether animalsourced GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition,
reviewing Agency records, and based on
the information we have at this time,
FDA has determined under § 314.161
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
that GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal from sale of
GLUCAGON (glucagon hydrochloride)
for injection, EQ 1 mg base/vial and EQ
10 mg base/vial. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that the product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, may
be approved by the Agency as long as
they meet all other legal and regulatory
requirements for the approval of
ANDAs. However, it is the Agency’s
view that it would be challenging for a
prospective applicant to provide
adequate data to meet the statutory
requirements for an ANDA that relies on
NDA 12–122 for GLUCAGON (glucagon
hydrochloride) for injection in the
absence of comparative data with the
animal-sourced glucagon approved in
NDA 12–122.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22673 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
54295
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1039]
Nonclinical Evaluation of EndocrineRelated Drug Toxicity; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Nonclinical Evaluation of EndocrineRelated Drug Toxicity.’’ The purpose of
this guidance is to clarify when
additional studies are warranted after
the standard toxicology tests have been
conducted and there is a signal for
potential adverse endocrine-related
toxicity. This guidance finalizes the
draft guidance entitled ‘‘Endocrine
Disruption Potential of Drugs:
Nonclinical Evaluation’’ issued on
September 20, 2013.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this 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 guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Abby Jacobs, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 22, Rm. 6474, Silver Spring,
MD 20993–0002, 301–796–0174.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Nonclinical Evaluation of EndocrineRelated Drug Toxicity.’’ This guidance
focuses on nonclinical testing designed
to assess the potential for a drug to
cause endocrine effects that are
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\09SEN1.SGM
09SEN1
54296
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
unintentional and adverse. The standard
comprehensive test battery is generally
sufficient to identify endocrine-related
toxicity. Depending on the outcome of
a standard battery of nonclinical tests,
additional nonclinical studies may be
warranted to more fully characterize the
endocrine-related toxicity potential of a
drug.
This guidance finalizes the draft
guidance entitled ‘‘Endocrine
Disruption Potential of Drugs:
Nonclinical Evaluation’’ issued on
September 20, 2013 (78 FR 57859).
Revisions to the draft guidance address
public comments and try to give more
clarity regarding when additional
studies could be appropriate.
This 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 nonclinical
evaluation of endocrine-related drug
toxicity. 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. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
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 parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Lhorne on DSK5TPTVN1PROD with NOTICES
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22683 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0221]
Formal Dispute Resolution: Appeals
Above the Division Level; Revised
Draft Guidance for Industry and
Review Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry and review
staff entitled ‘‘Formal Dispute
Resolution: Appeals Above the Division
Level.’’ This guidance is intended to
provide recommendations for industry
and review staff on the procedures in
the Center for Drug Evaluation and
Research (CDER) and Center for
Biologics Evaluation and Research
(CBER) for resolving scientific and/or
medical disputes that cannot be
resolved at the division level. This
guidance describes procedures for
formally appealing such disputes to the
office or center level and providing
information to assist FDA officials in
resolving the issue(s) presented. This
draft guidance revises the draft guidance
of the same name issued March 13,
2013.
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 revised
draft guidance before it begins work on
the final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 8,
2015.
ADDRESSES: 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, or Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
revised draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Khushboo Sharma, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6468,
Silver Spring, MD 20993–0002, 301–
796–0700; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
and review staff entitled ‘‘Formal
Dispute Resolution: Appeals Above the
Division Level.’’ In the course of the
review of applications for user fee
products, a wide variety of scientific
and/or medical issues are discussed that
are critical to a sponsor’s drug product
development program. Sometimes, a
sponsor may disagree with the Agency
on a matter, and a dispute arises.
Because these disputes often involve
complex scientific and/or medical
matters, it is critical that there be
procedures in place to help ensure
open, prompt discussion of such
disputes. The procedures and policies
described in this guidance are intended
to promote rapid resolution of scientific
and/or medical disputes between
sponsors and CDER or CBER.
This draft guidance revises the draft
guidance of the same name issued
March 13, 2013 (78 FR 15955). Based on
the docket comments for the draft
guidance as well as on its own
initiative, FDA made the following
changes. The scope of the guidance was
expanded to include formal dispute
resolution requests for human drug
applications covered under the
Biosimilar User Fee Act of 2012.
Additionally, certain areas were revised
to provide more clarity, such as when a
matter is and is not appropriate for a
formal dispute resolution request, and
information to include in the supporting
background information. Also, this
guidance clarifies that CDER and CBER
intend to manage formal requests for
appeals of scientific and/or medical
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54295-54296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1039]
Nonclinical Evaluation of Endocrine-Related Drug Toxicity;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Nonclinical
Evaluation of Endocrine-Related Drug Toxicity.'' The purpose of this
guidance is to clarify when additional studies are warranted after the
standard toxicology tests have been conducted and there is a signal for
potential adverse endocrine-related toxicity. This guidance finalizes
the draft guidance entitled ``Endocrine Disruption Potential of Drugs:
Nonclinical Evaluation'' issued on September 20, 2013.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this 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 guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Abby Jacobs, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg., 22, Rm. 6474, Silver Spring, MD 20993-0002, 301-
796-0174.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Nonclinical Evaluation of Endocrine-Related Drug Toxicity.''
This guidance focuses on nonclinical testing designed to assess the
potential for a drug to cause endocrine effects that are
[[Page 54296]]
unintentional and adverse. The standard comprehensive test battery is
generally sufficient to identify endocrine-related toxicity. Depending
on the outcome of a standard battery of nonclinical tests, additional
nonclinical studies may be warranted to more fully characterize the
endocrine-related toxicity potential of a drug.
This guidance finalizes the draft guidance entitled ``Endocrine
Disruption Potential of Drugs: Nonclinical Evaluation'' issued on
September 20, 2013 (78 FR 57859). Revisions to the draft guidance
address public comments and try to give more clarity regarding when
additional studies could be appropriate.
This 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 nonclinical evaluation of endocrine-related
drug toxicity. 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. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that 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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22683 Filed 9-8-15; 8:45 am]
BILLING CODE 4164-01-P