[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51898-51900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product-Specific Guidances for Ferric Oxyhydroxide; Revised Draft 
Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of revised draft guidances for industry entitled 
``Draft Guidance for Ferric Oxyhydroxide.'' The revised draft 
guidances, when finalized, will provide product-specific 
recommendations on, among other things, the design of bioequivalence 
(BE) studies to support abbreviated new drug applications (ANDAs) for 
ferric oxyhydroxide oral tablets (previously sucroferric oxyhydroxide) 
and ferric oxyhydroxide intravenous injectable (previously iron 
sucrose).

DATES: Submit either electronic or written comments on the draft 
guidances by November 16, 2021 to ensure that the Agency considers your 
comment on these draft guidances before it begins work on the final 
versions of the guidances.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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,

[[Page 51899]]

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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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 ``Draft Guidance for Ferric Oxyhydroxide.'' 
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.
    <bullet> 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 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398 and/or <a href="/cdn-cgi/l/email-protection#8adad9cda7dbffeff9fee3e5e4f9caeceeeba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="114142563c4064746265787e7f62517775703f7979623f767e67">[email protected]</span></a>.

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,'' which 
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/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process to develop 
and disseminate product-specific guidances and to provide a meaningful 
opportunity for the public to consider and comment on the guidances. 
This notice announces the availability of revised draft guidances on 
ferric oxyhydroxide oral tablets and ferric oxyhydroxide intravenous 
injectable.
    FDA initially approved new drug application (NDA) 205109 VELPHORO 
in November 2013 and NDA 021135 VENOFER in November 2000.\1\ In March 
2015, FDA issued a draft product specific guidance for industry on 
generic ferric oxyhydroxide oral tablets (previously entitled ``Draft 
Guidance for Sucroferric Oxyhydroxide'') and in November 2013, FDA 
issued a draft product specific guidance for industry on generic ferric 
oxyhydroxide intravenous injectable (previously entitled ``Draft 
Guidance for Iron Sucrose''). We are now issuing revised draft 
guidances for industry on generic ferric oxyhydroxide oral tablets and 
ferric oxyhydroxide intravenous injectable.
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    \1\ The active ingredients were previously identified as 
sucroferric oxyhydroxide and iron sucrose, respectively, at the time 
of approval of these NDAs. FDA later concluded that the active 
ingredient in both of these products is ferric oxyhydroxide. See 
Letter to Areta Kupchyk, Foley Hoag LLP, from Patrizia Cavazzoni, 
M.D., Acting Director, Center for Drug Evaluation and Research, 
Docket No. 2016-P-1163 (May 26, 2021).
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    In August 2021, Sidley Austin LLP submitted a citizen petition 
requesting that FDA take several actions, including refraining from 
changing the product label or labeling for VENOFER, any action to 
modify the existing product-specific guidance for VENOFER, and any 
action to change the established name of VENOFER to ferric oxyhydroxide 
(Docket No. FDA-2021-P-0893). FDA is reviewing the issues raised in the 
petition and will consider any comments on the draft guidances entitled 
``Draft Guidance for Ferric Oxyhydroxide'' before responding to the 
petition. FDA's issuance of the draft guidances on generic ferric 
oxyhydroxide oral tablets and ferric oxyhydroxide intravenous 
injectable does not represent a final decision on the issues raised in 
the petition.
    The revised draft guidances are being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidances, when finalized, will represent the current thinking of FDA 
on the design of BE studies to support ANDAs for ferric oxyhydroxide. 
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.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

[[Page 51900]]

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 13, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20064 Filed 9-16-21; 8:45 am]
BILLING CODE 4164-01-P


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