Product-Specific Guidances; Guidance for Industry; Availability, 20694-20696 [2020-07751]

Download as PDF 20694 Federal Register / Vol. 85, No. 72 / Tuesday, April 14, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based, harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency, International Federation for Animal Health—Europe; FDA; the U.S. Department of Agriculture; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry, and Fisheries; and the Japanese Veterinary Products Association. Six observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, one representative from the industry in Canada, one representative from the government of South Africa, and one representative from the industry in South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals. II. Guidance for Industry on Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV In the Federal Register of December 28, 2018 (83 FR 67289), FDA published the notice of availability for a draft guidance entitled ‘‘Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV’’ (VICH GL58), giving VerDate Sep<11>2014 18:26 Apr 13, 2020 Jkt 250001 interested persons until February 26, 2019, to comment on the draft guidance. FDA did not receive comments on the draft guidance. Comments received by other VICH member regulatory agencies were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated December 2018. The VICH Steering Committee held a meeting in September 2019 and agreed that the final guidance document entitled ‘‘Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV’’ (VICH GL58) should be made available for implementation. This guidance document is an annex to the VICH parent stability guidance, GFI #73 (VICH GL3(R)), ‘‘Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),’’ 1 and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV. This guidance provides additional guidance on the storage conditions for stability testing in countries located in Climatic Zones III (hot and dry) and IVB (hot and very humid), which are not covered by GFI #73 (VICH GL3(R)). This guidance document seeks to exemplify the core stability data package for new veterinary drug substances and medicinal products, but leaves flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. III. Significance of Guidance This guidance, developed under the VICH process, is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). For example, the document has been designated ‘‘guidance’’ rather than ‘‘guideline.’’ In addition, guidance documents do not include mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘require,’’ or ‘‘requirement,’’ unless FDA is using these words to describe a statutory or regulatory requirement. The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 1 https://www.fda.gov/media/70241/download. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. V. Electronic Access Persons with access to the internet may obtain the final guidance at either https://www.fda.gov/animal-veterinary/ guidance-regulations/guidance-industry or https://www.regulations.gov. Dated: April 7, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–07752 Filed 4–13–20; 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; Guidance 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 guidances for industry entitled ‘‘Guidance on Chloroquine Phosphate’’ and ‘‘Guidance on Hydroxychloroquine Sulfate.’’ These 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 guidance entitled ‘‘Guidance on Hydroxychloroquine Sulfate’’ was developed using the process described in that guidance and finalizes the draft guidance of the same title issued in April 2011. The guidance entitled ‘‘Guidance on Chloroquine Phosphate’’ is being implemented without prior public comment because FDA has determined that prior participation for SUMMARY: E:\FR\FM\14APN1.SGM 14APN1 Federal Register / Vol. 85, No. 72 / Tuesday, April 14, 2020 / Notices this guidance is not feasible or appropriate in light of the Coronavirus Disease 2019 (COVID–19) public health emergency but remains subject to comment in accordance with the Agency’s good guidance practices. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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’’). jbell on DSKJLSW7X2PROD with NOTICES 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; Guidance for Industry; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential VerDate Sep<11>2014 18:26 Apr 13, 2020 Jkt 250001 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.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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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 guidance documents. FOR FURTHER INFORMATION CONTACT: Mara Miller, Center for Drug Evaluation PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 20695 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 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 March 3, 2020. This notice announces final product-specific guidances that are posted on FDA’s website. The guidance entitled ‘‘Guidance on Hydroxychloroquine Sulfate’’ was developed using the process described in that guidance and finalizes the draft guidance of the same title issued in April 2011. The guidance entitled ‘‘Guidance on Chloroquine Phosphate’’ is being implemented without prior public comment because FDA has determined that prior participation for this guidance is not feasible or appropriate (see 21 CFR 10.115(g)(2)). This document is being implemented immediately but remains subject to comment in accordance with the Agency’s good guidance practices, and FDA intends to revise the guidance as warranted and appropriate after reviewing any public comment we receive. There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named ‘‘SARS–CoV–2’’ and the disease it causes has been named ‘‘Coronavirus Disease 2019’’ (COVID–19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a E:\FR\FM\14APN1.SGM 14APN1 20696 Federal Register / Vol. 85, No. 72 / Tuesday, April 14, 2020 / Notices declaration of a public health emergency related to COVID–19 and mobilized the Operating Divisions of HHS.1 In addition, on March 13, 2020, the President declared a national emergency in response to COVID–19.2 Due to the need to act quickly and efficiently to respond to the COVID–19 public health emergency, the guidance entitled ‘‘Guidance on Chloroquine Phosphate’’ is being issued as a final guidance and not as a draft guidance as is usual under the guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products.’’ II. Drug Products for Which New Final Product-Specific Guidances are Available FDA is announcing the availability of new final product-specific guidances for industry for drug products containing the following active ingredients: TABLE 1—FINAL PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS Chloroquine phosphate Hydroxychloroquine sulfate 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 final 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. jbell on DSKJLSW7X2PROD with NOTICES III. Electronic Access Persons with access to the internet may obtain the guidances at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. 1 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. (Jan. 31, 2020), available at https://www.phe.gov/emergency/news/ healthactions/phe/Pages/2019-nCoV.aspx). 2 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID–19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/ presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. 18:26 Apr 13, 2020 Jkt 250001 Dated: April 8, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–07751 Filed 4–13–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3380] Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products; Guidance for Industry; Availability Active ingredient(s) VerDate Sep<11>2014 The guidances also are available at FDA’s web page titled ‘‘COVID–19Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders’’ (https://www.fda.gov/ emergency-preparedness-and-response/ mcm-issues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders) and through FDA’s web page titled ‘‘Search for FDA Guidance Documents’’ available at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products’’ and encourages the submission of premarket approval application (PMA) supplements containing the needed information to modify the intended use of specific companion diagnostics as described in this notice (i.e., companion diagnostics that identify patients with nonsmall cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication). This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The guidance includes SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader indications will optimally facilitate clinical use. The guidance announced in this notice finalizes the draft guidance entitled ‘‘Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products’’ dated December 2018. DATES: The announcement of the guidance is published in the Federal Register on April 14, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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.’’ E:\FR\FM\14APN1.SGM 14APN1

Agencies

[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Notices]
[Pages 20694-20696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product-Specific Guidances; Guidance 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 guidances for industry entitled ``Guidance on 
Chloroquine Phosphate'' and ``Guidance on Hydroxychloroquine Sulfate.'' 
These 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 guidance entitled ``Guidance on Hydroxychloroquine Sulfate'' was 
developed using the process described in that guidance and finalizes 
the draft guidance of the same title issued in April 2011. The guidance 
entitled ``Guidance on Chloroquine Phosphate'' is being implemented 
without prior public comment because FDA has determined that prior 
participation for

[[Page 20695]]

this guidance is not feasible or appropriate in light of the 
Coronavirus Disease 2019 (COVID-19) public health emergency but remains 
subject to comment in accordance with the Agency's good guidance 
practices.

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

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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; Guidance for 
Industry; Availability.'' 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.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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 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 March 3, 2020. This notice announces final 
product-specific guidances that are posted on FDA's website.
    The guidance entitled ``Guidance on Hydroxychloroquine Sulfate'' 
was developed using the process described in that guidance and 
finalizes the draft guidance of the same title issued in April 2011.
    The guidance entitled ``Guidance on Chloroquine Phosphate'' is 
being implemented without prior public comment because FDA has 
determined that prior participation for this guidance is not feasible 
or appropriate (see 21 CFR 10.115(g)(2)). This document is being 
implemented immediately but remains subject to comment in accordance 
with the Agency's good guidance practices, and FDA intends to revise 
the guidance as warranted and appropriate after reviewing any public 
comment we receive.
    There is currently an outbreak of respiratory disease caused by a 
novel coronavirus. The virus has been named ``SARS-CoV-2'' and the 
disease it causes has been named ``Coronavirus Disease 2019'' (COVID-
19). On January 31, 2020, the Department of Health and Human Services 
(HHS) issued a

[[Page 20696]]

declaration of a public health emergency related to COVID-19 and 
mobilized the Operating Divisions of HHS.\1\ In addition, on March 13, 
2020, the President declared a national emergency in response to COVID-
19.\2\ Due to the need to act quickly and efficiently to respond to the 
COVID-19 public health emergency, the guidance entitled ``Guidance on 
Chloroquine Phosphate'' is being issued as a final guidance and not as 
a draft guidance as is usual under the guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products.''
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services Alex M. Azar II, 
Determination that a Public Health Emergency Exists. (Jan. 31, 
2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).
    \2\ Proclamation on Declaring a National Emergency Concerning 
the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), 
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

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

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

       Table 1--Final Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Chloroquine phosphate
Hydroxychloroquine sulfate
------------------------------------------------------------------------

    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 final 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 guidances at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
    The guidances also are available at FDA's web page titled ``COVID-
19-Related Guidance Documents for Industry, FDA Staff, and Other 
Stakeholders'' (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page titled 
``Search for FDA Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: April 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07751 Filed 4-13-20; 8:45 am]
 BILLING CODE 4164-01-P
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