Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 53826-53828 [2020-19164]

Download as PDF 53826 Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices application became effective was on October 22, 2003. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): June 21, 2018. FDA has verified the applicant’s claims that the biologics license application (BLA) for ELZONRIS (BLA 761116) was initially submitted on June 21, 2018. 3. The date the application was approved: December 21, 2018. FDA has verified the applicant’s claims that BLA 761116 was approved on December 21, 2018. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 660 days or 394 days of patent term extension. III. Petitions khammond on DSKJM1Z7X2PROD with NOTICES Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket Nos. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 VerDate Sep<11>2014 19:30 Aug 28, 2020 Jkt 250001 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: August 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–19085 Filed 8–28–20; 8:45 am] BILLING CODE 4164–01–P 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. 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 productspecific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance. SUMMARY: Submit either electronic or written comments on the draft guidance by October 30, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: DATES: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 • 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, 240–402–7500. E:\FR\FM\31AUN1.SGM 31AUN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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: Mara Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993–0002, 301–796–0683. VerDate Sep<11>2014 19:30 Aug 28, 2020 Jkt 250001 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 website at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ 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 website 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 June 4, 2020. This notice announces draft product-specific guidances, either new or revised, that are posted on FDA’s website. II. Drug Products for Which New Draft Product-Specific Guidances are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: 53827 TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued Active Ingredient(s) Tafenoquine succinate Talc 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 PRODUCTSPECIFIC GUIDANCES FOR DRUG PRODUCTS Active Ingredient(s) Abacavir sulfate; Dolutegravir sodium; Lamivudine Amphotericin B Budesonide Dolutegravir sodium Dolutegravir sodium; Rilpivirine hydrochloride Esomeprazole magnesium Ketorolac tromethamine Loteprednol etabonate; Tobramycin Maraviroc Metoprolol succinate Mycophenolate mofetil (multiple referenced listed drugs) Omega-3-acid ethyl esters Rivaroxaban Sodium polystyrene sulfonate Theophylline (multiple referenced listed drugs) For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and TABLE 1—NEW DRAFT PRODUCT-SPE- enter Docket No. FDA–2007–D–0369. CIFIC GUIDANCES FOR DRUG PRODThese draft guidances are being UCTS issued consistent with FDA’s good guidance practices regulation (21 CFR Active Ingredient(s) 10.115). These draft guidances, when finalized, will represent the current Alpelisib thinking of FDA on, among other things, Amlodipine benzoate the product-specific design of BE Amoxicillin; Clarithromycin; Omeprazole Amoxicillin; Omeprazole magnesium; studies to support ANDAs. They do not Rifabutin establish any rights for any person and Bortezomib are not binding on FDA or the public. Darolutamide You can use an alternative approach if Diroximel fumarate it satisfies the requirements of the Drospirenone applicable statutes and regulations. Empagliflozin; Linagliptin; Metformin hydrochloride IV. Electronic Access Erdafitinib Esketamine hydrochloride Gallium DOTATOC Ga–68 Glasdegib maleate Lamivudine; Tenofovir disoproxil fumarate Larotrectinib sulfate Lefamulin acetate Sumatriptan PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. E:\FR\FM\31AUN1.SGM 31AUN1 53828 Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices Dated: August 26, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–19164 Filed 8–28–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Communication Disorders Review Committee, October 15, 2020, 08:00 a.m. to October 16, 2020, 05:00 p.m., Embassy Suites—Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC, 20015 which was published in the Federal Register on January 13, 2020, 85 FR 1816. This notice is being amended to change the meeting location from in person to a virtual meeting. The meeting is closed to the public. Dated: August 25, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–19072 Filed 8–28–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the 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: Healthcare Delivery and Methodologies Integrated Review Group; Community Influences on Health Behavior Study Section. Date: September 23–25, 2020. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. VerDate Sep<11>2014 19:30 Aug 28, 2020 Jkt 250001 Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Tasmeen Weik, DRPH, MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3141, Bethesda, MD 20892, (301) 827–6480, weikts@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Cardiovascular and Respiratory Sciences AREA/REAP Review. Date: September 25, 2020. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Xiang-Ning Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, (301) 435– 1744, lixiang@csr.nih.gov. Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Lung Cellular, Molecular, and Immunobiology Study Section. Date: September 29–30, 2020. Time: 9:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: George M Barnas, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD 20892, (301) 435– 0696, barnasg@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel PAR Panel; Technology Development and Research for Coronavirus Disease 2019 (COVID–19). Date: September 29–30, 2020. Time: 9:30 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Kee Forbes, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7806, Bethesda, MD 20892, (301) 272– 4865, kee.forbes@nih.gov. Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group Pathophysiological Basis of Mental Disorders and Addictions Study Section Date: September 30-October 1, 2020. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Boris P Sokolov, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217A, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 MSC 7846, Bethesda, MD 20892, (301) 408– 9115, bsokolov@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: August 25, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–19071 Filed 8–28–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the 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 of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity Prevention. Date: September 16, 2020. Time: 3:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@ extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Pages 53826-53828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19164]


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

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 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 website. 
The guidances identified in this notice were developed using the 
process described in that guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by October 30, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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, 240-
402-7500.

[[Page 53827]]

     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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: Mara Miller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002, 301-
796-0683.

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 website 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 
website 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 June 4, 2020. This notice announces draft 
product-specific guidances, either new or revised, that are posted on 
FDA's website.

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

    FDA is announcing the availability of 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
------------------------------------------------------------------------
                          Active Ingredient(s)
-------------------------------------------------------------------------
Alpelisib
Amlodipine benzoate
Amoxicillin; Clarithromycin; Omeprazole
Amoxicillin; Omeprazole magnesium; Rifabutin
Bortezomib
Darolutamide
Diroximel fumarate
Drospirenone
Empagliflozin; Linagliptin; Metformin hydrochloride
Erdafitinib
Esketamine hydrochloride
Gallium DOTATOC Ga-68
Glasdegib maleate
Lamivudine; Tenofovir disoproxil fumarate
Larotrectinib sulfate
Lefamulin acetate
Sumatriptan
Tafenoquine succinate
Talc
------------------------------------------------------------------------

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
------------------------------------------------------------------------
                          Active Ingredient(s)
-------------------------------------------------------------------------
Abacavir sulfate; Dolutegravir sodium; Lamivudine
Amphotericin B
Budesonide
Dolutegravir sodium
Dolutegravir sodium; Rilpivirine hydrochloride
Esomeprazole magnesium
Ketorolac tromethamine
Loteprednol etabonate; Tobramycin
Maraviroc
Metoprolol succinate
Mycophenolate mofetil (multiple referenced listed drugs)
Omega-3-acid ethyl esters
Rivaroxaban
Sodium polystyrene sulfonate
Theophylline (multiple referenced 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/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.


[[Page 53828]]


    Dated: August 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19164 Filed 8-28-20; 8:45 am]
BILLING CODE 4164-01-P
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