Product-Specific Guidances for Ferric Oxyhydroxide; Revised Draft Guidances for Industry; Availability, 51898-51900 [2021-20064]

Download as PDF 51898 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices comprehension, reactions, and perceptions; and (3) adding to the regulatory science knowledge base. Quantitative studies play an important role in exploring areas of research and gathering information because they can be used to summarize a population of interest on key variables or reveal systematic relationships between variables. Foundational research to inform message development and the formative pretesting of messages are a staple of best practices in communications research. Obtaining voluntary feedback from intended audiences during the development of messages and materials is crucial for the success of every communication program. The purpose of obtaining information from formative pretesting is that it allows FDA to improve materials and strategies while revisions are still affordable and possible. Formative pretesting can also avoid potentially expensive and dangerous unintended outcomes caused by audiences interpreting messages in a way that was not intended by the drafters. By maximizing the effectiveness of messages and strategies for reaching targeted audiences, the frequency with which tobacco communication messages need to be modified should be greatly reduced. The voluntary information collected will serve the primary purpose of providing FDA information about various measures of ad performance including message comprehension, perceived effectiveness, emotional responses and knowledge, attitudes, and behavior change to assess the ability of messages, advertisements, and materials to reach and successfully communicate with their intended audiences. Quantitative testing messages and other materials with a sample of the target audience will allow FDA to refine messages, advertisements, and materials directed at consumers while the materials are still in the developmental stage. In addition, quantitative information is needed by FDA to track changes in response to policy and regulatory actions and to expand the tobacco regulatory science base by providing information on changing behaviors, knowledge, and attitudes about tobacco products, including postmarketing surveillance of tobacco products. In the Federal Register of March 5, 2021 (86 FR 12952), FDA published a 60-day notice requesting public comment on the proposed collection of information. One PRA related comment was received. (Comment) The comment suggested specific types of messages that FDA should test and then implement in public health campaigns. (Response) FDA appreciates the comment. The content and focus on studies submitted through this generic clearance will depend on Agency priorities and needs, which are not yet determined at this time. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Screener ............................................................... Self-Administered Surveys ................................... 485,580 133,728 1 1 485,580 133,728 0.083 (5 minutes) ......... 0.33 (20 minutes) ......... 40,465 44,576 Total ............................................................... ........................ ........................ ........................ ....................................... 85,041 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Number of respondents to be included in each new survey will vary, depending on the nature of the material or message being tested and the target audience. Table 1 provides examples of the types of activities that may be administered and estimated burden levels during the 3-year period. Time to read, review, or complete the activity is built into the ‘‘Average Burden per Response’’ figures. Our estimated burden for the information collection reflects an overall increase of 60,000 hours and a corresponding increase of 461,808 responses. We attribute the adjustment to an increase in the number of new quantitative studies that are anticipated underneath this information collection during the next 3 years (proposed extension). Dated: September 10, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–20057 Filed 9–16–21; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:19 Sep 16, 2021 Jkt 253001 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. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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: DATES: Electronic Submissions 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 SUMMARY: intravenous injectable (previously iron sucrose). 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, E:\FR\FM\17SEN1.SGM 17SEN1 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 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 ‘‘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. • 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 VerDate Sep<11>2014 16:19 Sep 16, 2021 Jkt 253001 ‘‘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 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 PSG-Questions@fda.hhs.gov. 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 productspecific guidances available to the public on FDA’s website at https:// www.fda.gov/drugs/guidancecompliance-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. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 51899 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. 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 productspecific 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. 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). E:\FR\FM\17SEN1.SGM 17SEN1 51900 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices III. Electronic Access Electronic Submissions Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. 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’’). 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–1967] Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Agency’s Biosimilars User Fee Program. DATES: Submit either electronic or written comments on the collection of information by November 16, 2021. 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 November 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 16, 2021. 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. SUMMARY: VerDate Sep<11>2014 16:19 Sep 16, 2021 Jkt 253001 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– 2018–N–1967 for ‘‘Biosimilars User Fee Program.’’ 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, 240–402–7500. • 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 ‘‘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. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. Under the PRA (44 U.S.C. 3501–3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice SUPPLEMENTARY INFORMATION: E:\FR\FM\17SEN1.SGM 17SEN1

Agencies

[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]


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

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.

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

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:
     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.
     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 ``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.
     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 [email protected].

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.