82 FR 36792 - Product-Specific Guidances; Final Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of final 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 BE recommendations available to the public on FDA's Web site. The product- specific guidances identified in this notice were developed using the process described in that guidance.

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36792-36794]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product-Specific Guidances; Final 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 final 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 BE 
recommendations available to the public on FDA's Web site. The product-
specific guidances identified in this notice were developed using the 
process described in that guidance.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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

[[Page 36793]]

Guidances; Final 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 a final 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 a final 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 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. Final product-specific guidances 
were last announced in the Federal Register on September 21, 2015 (80 
FR 57000). This notice announces final product-specific guidances that 
are posted on FDA's Web site.

II. Drug Products For Which Final Product-Specific Guidances Are 
Available

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

       Table 1--Final Product-Specific Guidances for Drug Products
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Acarbose.
Acetaminophen; Aspirin, Caffeine.
Acetaminophen; Butalbital; Caffeine; Codeine phosphate.
Acitretin.
Amoxicillin (multiple reference listed drugs).
Amoxicillin; Clavulanate potassium.
Aspirin; Butalbital; Caffeine (multiple reference listed drugs).
Aspirin; Butalbital; Caffeine; Codeine Phosphate.
Atenolol.
Atenolol and Chlorthalidone.
Cetirizine HCl.
Chlorthalidone.
Citalopram HBr.
Citalopram hydrobromide.
Clarithromycin.
Clindamycin HCl.
Clomiphene Citrate.
Clonazepam.
Clozapine.
Cyclobenzaprine HCL.
Cycloserine.
Dapsone.
Desipramine HCl.
Desmopressin Acetate.
Diflunisal.
Diphenhydramine HCl.
Dipyridamole.
Disulfiram.
Donepezil HCl.
Doxazosin mesylate.
Doxepin HCl.
Doxercalciferol.
Eprosartan Mesylate.
Ethambutol HCl.
Hydrochlorothiazide; Losartan Potassium.
Hydrochlorothiazide; Triamterene.
Hydrochlorothiazide; Valsartan.
Hydrocodone bitartrate; Ibuprofen.
Hydrocortisone.
Hydromorphone HCl.
Selegiline hydrochloride.
Sotalol HCl.
Tenofovir Disoproxil Fumarate.
Tiagabine HCl.
Valproic acid.
Verapamil HCl.
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    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 final guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These guidances 
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.

III. Electronic Access

    Persons with access to the internet may obtain the final guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.


[[Page 36794]]


    Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16581 Filed 8-4-17; 8:45 am]
 BILLING CODE 4164-01-P