82 FR 22668 - 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 94 (May 17, 2017)

Page Range		22668-22669
FR Document		2017-09961

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances 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 94 (Wednesday, May 17, 2017)

[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22668-22669]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-09961]

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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances 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(s) on
these draft guidances before it begins work on the final version of
such guidances, submit either electronic or written comments on the
draft guidance by July 17, 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-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 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 guidances 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 documents.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug

[[Page 22669]]

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 https://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 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 December 23, 2016 (81 FR 94394). 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
guidances for industry for drug products containing the following
active ingredients:

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

-------------------------------------------------------------------------
Acetylcysteine
Amphetamine
Aprepitant
Azelastine hydrochloride
Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium
bicarbonate; sodium chloride
Carbidopa; levodopa
Chlordiazepoxide hydrochloride; Clidinium bromide
Clonazepam
Edoxaban tosylate
Gentamicin sulfate
Hydrocortisone
Hydrocortisone butyrate
Linagliptin; Metformin hydrochloride
Lorcaserin hydrochloride
Methylnaltrexone bromide
Nitroglycerin
Nystatin; Triamcinolone acetonide (multiple reference listed drugs)
Oxymetazoline hydrochloride; Tetracaine hydrochloride
Sofosbuvir; Velpatasvir
Venetoclax
------------------------------------------------------------------------

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

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

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

-------------------------------------------------------------------------
Acamprosate calcium
Apixaban
Bexarotene
Calcium acetate (multiple reference listed drugs)
Deferiprone
Dolutegravir sodium
Emtricitabine; Tenofovir disoproxil fumarate
Fingolimod
Lanthanum carbonate
Nevirapine
Phenytoin (multiple reference listed drugs)
Propafenone hydrochloride
Trospium chloride (multiple reference listed drugs)
------------------------------------------------------------------------

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.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

Dated: May 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09961 Filed 5-16-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices 22669

Evaluation and Research, Food and TABLE 1—NEW DRAFT PRODUCT-SPE- Guidances/default.htm or https://
Drug Administration, 10903 New CIFIC GUIDANCES FOR DRUG PROD- www.regulations.gov.
Hampshire Ave., Bldg. 75, Rm. 4730, UCTS—Continued Dated: May 11, 2017.
Silver Spring, MD 20993–0002, 301– Anna K. Abram,
796–5850. Hydrocortisone
Hydrocortisone butyrate Deputy Commissioner for Policy, Planning,
SUPPLEMENTARY INFORMATION: Legislation, and Analysis.
Linagliptin; Metformin hydrochloride
I. Background Lorcaserin hydrochloride [FR Doc. 2017–09961 Filed 5–16–17; 8:45 am]
In the Federal Register of June 11, Methylnaltrexone bromide BILLING CODE 4164–01–P
Nitroglycerin
2010 (75 FR 33311), FDA announced the Nystatin; Triamcinolone acetonide (multiple
availability of a guidance for industry reference listed drugs)
entitled ‘‘Bioequivalence DEPARTMENT OF HEALTH AND
Oxymetazoline hydrochloride; Tetracaine hy- HUMAN SERVICES
Recommendations for Specific drochloride
Products’’ that explained the process Sofosbuvir; Velpatasvir Food and Drug Administration
that would be used to make product- Venetoclax
specific guidances available to the [Docket No. FDA–2017–N–2364]
public on FDA’s Web site at https:// III. Drug Products for Which Revised
www.fda.gov/Drugs/ Draft Product-Specific Guidances are Determination That CALCIJEX
GuidanceComplianceRegulatory Available (Calcitriol) Injectable, 1 Microgram/
Information/Guidances/default.htm. Milliliter and 2 Micrograms/Milliliter,
As described in that guidance, FDA FDA is announcing the availability of Was Not Withdrawn From Sale for
adopted this process as a means to revised draft product-specific guidances Reasons of Safety or Effectiveness
develop and disseminate product- for industry for drug products
containing the following active AGENCY: Food and Drug Administration,
specific guidances and provide a HHS.
meaningful opportunity for the public to ingredients:
ACTION: Notice.
consider and comment on those
guidances. Under that process, draft TABLE 2—REVISED DRAFT PRODUCT- SUMMARY: The Food and Drug
guidances are posted on FDA’s Web site SPECIFIC GUIDANCES FOR DRUG Administration (FDA or Agency) has
and announced periodically in the PRODUCTS determined that the drug product listed
Federal Register. The public is in this document was not withdrawn
encouraged to submit comments on Acamprosate calcium from sale for reasons of safety or
those recommendations within 60 days Apixaban effectiveness. This determination means
of their announcement in the Federal Bexarotene
Calcium acetate (multiple reference listed
that FDA will not begin procedures to
Register. FDA considers any comments withdraw approval of abbreviated new
drugs)
received and either publishes final Deferiprone drug applications (ANDAs) that refer to
guidances or publishes revised draft Dolutegravir sodium this drug product, and it will allow FDA
guidances for comment. Guidances were Emtricitabine; Tenofovir disoproxil fumarate to continue to approve ANDAs that refer
last announced in the Federal Register Fingolimod to the product as long as they meet
on December 23, 2016 (81 FR 94394). Lanthanum carbonate relevant legal and regulatory
This notice announces draft product- Nevirapine requirements.
specific guidances, either new or Phenytoin (multiple reference listed drugs)
Propafenone hydrochloride FOR FURTHER INFORMATION CONTACT:
revised, that are posted on FDA’s Web
Trospium chloride (multiple reference listed Stacy Kane, Center for Drug Evaluation
site.
drugs) and Research, Food and Drug
II. Drug Products for Which New Draft Administration, 10903 New Hampshire
Product-Specific Guidances are For a complete history of previously Ave., Bldg. 51, Rm. 6236, Silver Spring,
Available published Federal Register notices MD 20993–0002, 301–796–8363.
FDA is announcing the availability of related to product-specific guidances, go SUPPLEMENTARY INFORMATION: In 1984,
a new draft product-specific guidances to https://www.regulations.gov and Congress enacted the Drug Price
for industry for drug products enter Docket No. FDA–2007–D–0369. Competition and Patent Term
containing the following active These draft guidances are being Restoration Act of 1984 (Pub. L. 98–417)
ingredients: issued consistent with FDA’s good (the 1984 amendments), which
guidance practices regulation (21 CFR authorized the approval of duplicate
TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when versions of drug products approved
CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current under an ANDA procedure. ANDA
UCTS
thinking of FDA on, among other things, applicants must, with certain
the product-specific design of BE exceptions, show that the drug for
Acetylcysteine studies to support ANDAs. They do not which they are seeking approval
Amphetamine establish any rights for any person and contains the same active ingredient in
Aprepitant are not binding on FDA or the public. the same strength and dosage form as
Azelastine hydrochloride You can use an alternative approach if the ‘‘listed drug,’’ which is a version of
Bisacodyl; polyethylene glycol 3350; potas- it satisfies the requirements of the the drug that was previously approved.
nlaroche on DSK30NT082PROD with NOTICES

sium chloride; sodium bicarbonate; sodium applicable statutes and regulations. ANDA applicants do not have to repeat
chloride the extensive clinical testing otherwise
Carbidopa; levodopa IV. Electronic Access
Chlordiazepoxide hydrochloride; Clidinium necessary to gain approval of a new
bromide
Persons with access to the Internet drug application (NDA).
Clonazepam may obtain the draft guidances at either The 1984 amendments include what
Edoxaban tosylate https://www.fda.gov/Drugs/Guidance is now section 505(j)(7) of the Federal
Gentamicin sulfate ComplianceRegulatoryInformation/ Food, Drug, and Cosmetic Act (21 U.S.C.

VerDate Sep<11>2014 15:18 May 16, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\17MYN1.SGM 17MYN1

Document Created: 2017-05-17 01:42:18
Document Modified: 2017-05-17 01:42:18

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(s) on these draft guidances before it begins work on the final version of such guidances, submit either electronic or written comments on the draft guidance by July 17, 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 22668

82 FR 22668 - 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 94 (May 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration