[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.

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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the draft guidance of the same title issued in April 2011.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

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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.''
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    \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/.
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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
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                          Active ingredient(s)
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Chloroquine phosphate
Hydroxychloroquine sulfate
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    For a complete history of previously published Federal Register 
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These final guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These 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


