Product-Specific Guidances; Final Guidances for Industry; Availability, 36792-36794 [2017-16581]

Download as PDF 36792 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–16516 Filed 8–4–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0041] Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case; Withdrawal of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of March 15, 2017. DATES: August 7, 2017. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of March 15, 2017 (82 FR 13817), ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case,’’ FDA requested comment on the information collection associated with safety assurance cases (SACs). Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. In the March 15, 2017, Federal Register notice, FDA proposed to extend the information collection related to SACs (OMB control number 0910– 0766). However, we are withdrawing the notice because, upon further review of the information collection request (ICR) associated with the notice and comments received on the information collection, we have determined that the estimated burden expressed in the SAC ICR is included as part of the estimated burden for the information collections in the premarket notification (510(k)) ICR (OMB control number 0910–0120). Because the information collected for safety assurance cases is already included under another information collection approval, we have discontinued the ICR and we are withdrawing the March 15, 2017, notice requesting comment on the information collection. The guidance entitled ‘‘Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff’’ (https://www.fda.gov/ucm/groups/ fdagov-public/@fdagov-meddev-gen/ documents/document/ucm209337.pdf), which provides recommendations on the inclusion of safety assurance cases as part of the premarket submissions for new, changed, or modified infusion pumps submitted by device manufacturers, continues to provide the Agency’s current thinking on this topic. Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–16561 Filed 8–4–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 productspecific 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 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. 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 SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 E:\FR\FM\07AUN1.SGM 07AUN1 mstockstill on DSK30JT082PROD with NOTICES Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 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 productspecific guidances available to the public on FDA’s Web site at http:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific 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 productspecific 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 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. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 36793 TABLE 1—FINAL PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS— Continued 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. 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/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. E:\FR\FM\07AUN1.SGM 07AUN1 36794 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–E–2171, FDA– 2016–E–2169, and FDA–2016–E–2170] Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VONVENDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by October 6, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 5, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 6, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. mstockstill on DSK30JT082PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 • 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 Nos. FDA– 2016–E–2171, FDA–2016–E–2169, and FDA–2016–E–2170 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36792-36794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16581]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.gpo.gov/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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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