Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability, 37231-37232 [2013-14674]
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Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
Mirabegron
S
Sodium ferric gluconate
T
Timolol maleate
Trientine
III. Drug Products for Which Revised
Draft Product-Specific BE
Recommendations Are Available
FDA is announcing revised draft
product-specific BE recommendations
for drug products containing the
following active ingredients:
A
Albuterol sulfate (multiple reference listed
drugs)
Ambrisentan
C
Carbidopa; Entacapone; Levodopa
Colesevelam
number found in brackets in the
heading of this document. The
guidances, notices, and 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.
V. 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.
Dated: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–14675 Filed 6–19–13; 8:45 am]
D
Dexamethasone; Tobramycin (multiple
reference listed drugs and dosage forms)
Didanosine
Drospirenone; Estradiol
E
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Entacapone
F
Food and Drug Administration
Fentanyl citrate
I
Isotretinoin
[Docket No. FDA–2012–D–0938]
Minocycline hydrochloride
Guidance for Industry; Guidance on
Abbreviated New Drug Applications:
Stability Testing of Drug Substances
and Products; Availability
M
P
Phentermine hydrochloride; Topiramate
T
Tenofovir disoproxil fumarate
Topiramate (multiple reference listed drugs
and dosage forms)
TKELLEY on DSK3SPTVN1PROD with NOTICES
For a complete history of previously
published Federal Register notices
related to product-specific BE
recommendations, please go to https://
www.regulations.gov and enter docket
number FDA–2007–D–0369.
These draft and revised draft
guidances are being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). These
guidances represent the Agency’s
current thinking on product-specific
design of BE studies to support ANDAs.
They do not create or confer any rights
for or on any person and do not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
IV. Comments
Interested persons may submit either
electronic comments on any of the
specific BE recommendations posted on
FDA’s Web site 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
VerDate Mar<15>2010
17:01 Jun 19, 2013
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance entitled ‘‘ANDAs: Stability
Testing of Drug Substances and
Products.’’ FDA is recommending
generic drug manufacturers follow the
stability testing recommendations in the
International Conference on
Harmonisation (ICH) guidances Q1A
(R2) through Q1E. The use of these ICH
recommendations will standardize
FDA’s stability testing policies, which
will help make the abbreviated new
drug application (ANDA) review
process more efficient.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. See the SUPPLEMENTARY
SUMMARY:
PO 00000
Frm 00033
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37231
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:
Radhika Rajagopalan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 7500 Standish Pl.,
MPN2, rm. 243, HFD–640, Rockville,
MD 20855, 240–276–8546.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘ANDAs: Stability Testing of Drug
Substances and Products.’’ Because of
increases in the number and complexity
of ANDAs and FDA’s desire to
standardize generic drug review, FDA is
recommending that the generic drug
industry follow the approach in the
following stability related ICH
guidances: (1) ‘‘Q1A (R2) Stability
Testing of New Drug Substances and
Products,’’ November 2003; (2) ‘‘Q1B
Photostability Testing of New Drug
Substances and Products,’’ November
1996; (3) ‘‘Q1C Stability Testing for New
Dosage Forms,’’ November 1996; (4)
‘‘Q1D Bracketing and Matrixing Designs
for Stability Testing of New Drug
Substances and Products,’’ January
2003; and (5) ‘‘Q1E Evaluation of
Stability Data,’’ June 2004. These
guidances can be found on the FDA
Guidances (Drugs) Web site under
International Conference on
Harmonisation—Quality at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/ucm065005.htm. FDA also
recommends that industry follow the
ICH outlined definitions, glossaries,
references, and attachments.
Although the ICH stability guidances
were developed for new drug
applications to ensure the stability of
new drug substances and products, FDA
believes the recommendations provided
in the ICH guidances on stability testing
also are appropriate for ANDAs. FDA is
recommending that applicants follow
the ICH stability guidances for all
ANDA submissions under section 505(j)
of the Federal Food Drug, and Cosmetic
Act (21 U.S.C. 355(j)) and relying on
drug master files.
This guidance also replaces stability
study storage condition
recommendations made by the Office of
Generic Drugs (OGD) in an August 18,
1995, letter to all ANDA applicants.
E:\FR\FM\20JNN1.SGM
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37232
Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
That letter stated that OGD would
accept ANDAs with the ICH
recommended long-term room
temperature conditions for stability
studies, 25 ± 2° C, 60 ± 5 percent RH.
On September 25, 2012 (77 FR 58999),
FDA announced the availability of draft
guidance for industry on ‘‘ANDAs:
Stability Testing of Drug Substances and
Products.’’ The public comment period
closed on December 24, 2012. We are
finalizing the guidance with minor
changes and intend to publish a draft
guidance to address the public
comments in a question-and-answer
format in the near future.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this stability testing
for generic drug substances and
products. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.regulations.gov or https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Dated: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–14674 Filed 6–19–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the contact person listed below in
advance of the meeting.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Cardio-metabolic
risk and epigenetic differences among
children conceives by infertility.
Date: July 1, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To provide concept review.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Officer, Division of
Scientific Review, National Institute of Child
Health and Human Development, 6100
Executive Boulevard, Rockville, MD 20892–
9304, (301) 435–6680,
skandasa@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 14, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–14649 Filed 6–19–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
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provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; NIA DBSR
DATASETS.
Date: July 11–12, 2013.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Alfonso Latoni, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7702, Alfonso.Latoni@nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel;
Osteoimmunology.
Date: July 11, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20814,
(Telephone Conference Call).
Contact Person: Elaine Lewis, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7707, elainelewis@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Treatment of
Obesity in Older Adults.
Date: July 18, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20814,
(Telephone Conference Call).
Contact Person: Elaine Lewis, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7707, elainelewis@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: June 14, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–14647 Filed 6–19–13; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\20JNN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37231-37232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0938]
Guidance for Industry; Guidance on Abbreviated New Drug
Applications: Stability Testing of Drug Substances and Products;
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 entitled ``ANDAs: Stability Testing of
Drug Substances and Products.'' FDA is recommending generic drug
manufacturers follow the stability testing recommendations in the
International Conference on Harmonisation (ICH) guidances Q1A (R2)
through Q1E. The use of these ICH recommendations will standardize
FDA's stability testing policies, which will help make the abbreviated
new drug application (ANDA) review process more efficient.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist the 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: Radhika Rajagopalan, Center for Drug
Evaluation and Research, Food and Drug Administration, 7500 Standish
Pl., MPN2, rm. 243, HFD-640, Rockville, MD 20855, 240-276-8546.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``ANDAs: Stability Testing of Drug Substances and Products.''
Because of increases in the number and complexity of ANDAs and FDA's
desire to standardize generic drug review, FDA is recommending that the
generic drug industry follow the approach in the following stability
related ICH guidances: (1) ``Q1A (R2) Stability Testing of New Drug
Substances and Products,'' November 2003; (2) ``Q1B Photostability
Testing of New Drug Substances and Products,'' November 1996; (3) ``Q1C
Stability Testing for New Dosage Forms,'' November 1996; (4) ``Q1D
Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances and Products,'' January 2003; and (5) ``Q1E Evaluation of
Stability Data,'' June 2004. These guidances can be found on the FDA
Guidances (Drugs) Web site under International Conference on
Harmonisation--Quality at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm. FDA
also recommends that industry follow the ICH outlined definitions,
glossaries, references, and attachments.
Although the ICH stability guidances were developed for new drug
applications to ensure the stability of new drug substances and
products, FDA believes the recommendations provided in the ICH
guidances on stability testing also are appropriate for ANDAs. FDA is
recommending that applicants follow the ICH stability guidances for all
ANDA submissions under section 505(j) of the Federal Food Drug, and
Cosmetic Act (21 U.S.C. 355(j)) and relying on drug master files.
This guidance also replaces stability study storage condition
recommendations made by the Office of Generic Drugs (OGD) in an August
18, 1995, letter to all ANDA applicants.
[[Page 37232]]
That letter stated that OGD would accept ANDAs with the ICH recommended
long-term room temperature conditions for stability studies, 25 2[deg] C, 60 5 percent RH.
On September 25, 2012 (77 FR 58999), FDA announced the availability
of draft guidance for industry on ``ANDAs: Stability Testing of Drug
Substances and Products.'' The public comment period closed on December
24, 2012. We are finalizing the guidance with minor changes and intend
to publish a draft guidance to address the public comments in a
question-and-answer format in the near future.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this stability testing for generic drug
substances and products. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.regulations.gov or https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14674 Filed 6-19-13; 8:45 am]
BILLING CODE 4160-01-P
