82 FR 32556 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 134 (July 14, 2017)

Page Range		32556-32557
FR Document		2017-14781

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances, when finalized, provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.

Federal Register, Volume 82 Issue 134 (Friday, July 14, 2017)

[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32556-32557]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-14781]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances 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 additional draft and revised draft product-specific
guidances. The guidances, when finalized, provide product-specific
recommendations on, among other things, the design of bioequivalence
(BE) studies to support abbreviated new drug applications (ANDAs). In
the Federal Register of June 11, 2010, FDA announced the availability
of a guidance for industry entitled ``Bioequivalence Recommendations
for Specific Products'' that explained the process that would be used
to make product-specific guidances available to the public on FDA's Web
site. The guidances identified in this notice were developed using the
process described in that guidance.

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 a
draft guidance announced in this notice before it begins work on the
final version of the guidance, submit either electronic or written
comments on the draft guidance by September 12, 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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 ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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 Dockets
Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 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'' that 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 as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's Web
site

[[Page 32557]]

and announced periodically in the Federal Register. The public is
encouraged to submit comments on those recommendations within 60 days
of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on May 17, 2017 (82 FR 22668). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's Web site.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

FDA is announcing the availability of a new draft product-specific
guidance for industry for drug products containing the following active
ingredients:

Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Aspirin.
Aspirin; omeprazole.
Brexpiprazole.
Brivaracetam.
Cefdinir.
Clocortolone pivalate.
Cyanocobalamin.
Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir.
Dextroamphetamine sulfate.
Diclofenac sodium.
Fluphenazine hydrochloride.
Gentamicin sulfate.
Glycopyrrolate.
Obeticholic acid.
Silver sulfadiazine.
Tenofovir alafenamide fumarate.
Tiopronin.
Tipiracil hydrochloride; Trifluridine.
Triamcinolone acetonide (multiple reference listed drugs).
Uridine triacetate.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

FDA is announcing the availability of a revised draft product-
specific guidance for industry for drug products containing the
following active ingredients:

Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Brimonidine tartrate.
Dabigatran etexilate mesylate.
Dorzolamide hydrochloride.
Gefitinib.
Latanoprost.
Methoxsalen.
Metoprolol tartrate.
Minocycline HCl (multiple reference listed drugs).
Minoxidil.
Pimozide.
Propafenone hydrochloride.
Tetrabenazine.
------------------------------------------------------------------------

For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. 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: July 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14781 Filed 7-13-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices 32557

and announced periodically in the TABLE 2—REVISED DRAFT PRODUCT- applications, the disclosure of which
Federal Register. The public is SPECIFIC GUIDANCES FOR DRUG would constitute a clearly unwarranted
encouraged to submit comments on PRODUCTS—Continued invasion of personal privacy.
those recommendations within 60 days Name of Committee: Center for Scientific
of their announcement in the Federal Metoprolol tartrate. Review Special Emphasis Panel; Spinal Cord
Register. FDA considers any comments Minocycline HCl (multiple reference listed Injury, Epilepsy, and Other Neurological
received and either publishes final drugs). Disorders.
Minoxidil. Date: August 3–4, 2017.
guidances or publishes revised draft Pimozide.
guidances for comment. Guidances were Time: 9:00 a.m. to 1:00 p.m.
Propafenone hydrochloride. Agenda: To review and evaluate grant
last announced in the Federal Register Tetrabenazine.
on May 17, 2017 (82 FR 22668). This applications.
Place: National Institutes of Health, 6701
notice announces draft product-specific For a complete history of previously Rockledge Drive, Bethesda, MD 20892
guidances, either new or revised, that published Federal Register notices (Virtual Meeting).
are posted on FDA’s Web site. related to product-specific guidances, go Contact Person: Samuel C. Edwards, Ph.D.,
II. Drug Products for Which New Draft to https://www.regulations.gov and Chief, Brain Disorders and Clinical
enter Docket No. FDA–2007–D–0369. Neuroscience, Center for Scientific Review,
Product-Specific Guidances Are National Institutes of Health, 6701 Rockledge
These draft guidances are being
Available Drive, Room 5210, MSC 7846, Bethesda, MD
issued consistent with FDA’s good
FDA is announcing the availability of guidance practices regulation (21 CFR 20892, (301) 435–1246, edwardss@
a new draft product-specific guidance 10.115). These draft guidances, when csr.nih.gov.
for industry for drug products finalized, will represent the current Name of Committee: Center for Scientific
containing the following active thinking of FDA on, among other things, Review Special Emphasis Panel; Member
ingredients: Conflict: Glioblastoma, Multiple Sclerosis.
the product-specific design of BE Date: August 4, 2017.
studies to support ANDAs. They do not Time: 11:00 a.m. to 2:00 p.m.
TABLE 1—NEW DRAFT PRODUCT-SPE- establish any rights for any person and Agenda: To review and evaluate grant
CIFIC GUIDANCES FOR DRUG PROD- are not binding on FDA or the public. applications.
UCTS You can use an alternative approach if Place: National Institutes of Health, 6701
it satisfies the requirements of the Rockledge Drive, Bethesda, MD 20892
Aspirin. applicable statutes and regulations. This (Telephone Conference Call).
Aspirin; omeprazole. guidance is not subject to Executive Contact Person: Samuel C. Edwards, Ph.D.,
Brexpiprazole. Order 12866. Chief, Brain Disorders and Clinical
Brivaracetam. Neuroscience, Center for Scientific Review,
Cefdinir. IV. Electronic Access National Institutes of Health, 6701 Rockledge
Clocortolone pivalate. Drive, Room 5210, MSC 7846, Bethesda, MD
Persons with access to the Internet 20892, (301) 435–1246, edwardss@
Cyanocobalamin. may obtain the draft guidances at either
Dasabuvir sodium; Ombitasvir; Paritaprevir; csr.nih.gov.
http://www.fda.gov/Drugs/Guidance (Catalogue of Federal Domestic Assistance
Ritonavir.
Dextroamphetamine sulfate. ComplianceRegulatoryInformation/ Program Nos. 93.306, Comparative Medicine;
Diclofenac sodium. Guidances/default.htm or https:// 93.333, Clinical Research, 93.306, 93.333,
Fluphenazine hydrochloride. www.regulations.gov. 93.337, 93.393–93.396, 93.837–93.844,
Gentamicin sulfate. Dated: July 10, 2017. 93.846–93.878, 93.892, 93.893, National
Glycopyrrolate. Institutes of Health, HHS)
Anna K. Abram,
Obeticholic acid. Dated: July 10, 2017.
Silver sulfadiazine. Deputy Commissioner for Policy, Planning,
Tenofovir alafenamide fumarate. Legislation, and Analysis. Sylvia L. Neal,
Tiopronin. [FR Doc. 2017–14781 Filed 7–13–17; 8:45 am] Program Analyst, Office of Federal Advisory
Tipiracil hydrochloride; Trifluridine. BILLING CODE 4164–01–P Committee Policy.
Triamcinolone acetonide (multiple reference [FR Doc. 2017–14751 Filed 7–13–17; 8:45 am]
listed drugs). BILLING CODE 4140–01–P
Uridine triacetate. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Drug Products for Which Revised DEPARTMENT OF HEALTH AND
Draft Product-Specific Guidances Are National Institutes of Health HUMAN SERVICES
Available
Center for Scientific Review; Notice of National Institutes of Health
FDA is announcing the availability of Closed Meetings
a revised draft product-specific National Institute of Mental Health;
guidance for industry for drug products Pursuant to section 10(d) of the
Notice of Closed Meeting
containing the following active Federal Advisory Committee Act, as
ingredients: amended (5 U.S.C. App.), notice is Pursuant to section 10(d) of the
hereby given of the following meetings. Federal Advisory Committee Act, as
TABLE 2—REVISED DRAFT PRODUCT- The meetings will be closed to the amended (5 U.S.C. App.), notice is
SPECIFIC GUIDANCES FOR DRUG public in accordance with the hereby given of a meeting of the
provisions set forth in sections National Advisory Mental Health
mstockstill on DSK30JT082PROD with NOTICES

PRODUCTS
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Council.
as amended. The grant applications and The meeting will be closed to the
Brimonidine tartrate.
Dabigatran etexilate mesylate. the discussions could disclose public in accordance with the
Dorzolamide hydrochloride. confidential trade secrets or commercial provisions set forth in sections
Gefitinib. property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Latanoprost. and personal information concerning as amended. The grant applications
Methoxsalen. individuals associated with the grant and/or contract proposals and the

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Document Created: 2018-10-24 11:16:45
Document Modified: 2018-10-24 11:16:45

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 a draft guidance announced in this notice before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 12, 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 32556

82 FR 32556 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 134 (July 14, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration