Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 9366-9368 [2022-03248]

Download as PDF 9366 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 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. SUPPLEMENTARY INFORMATION: 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 of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Center for Devices and Radiological Health Appeals Processes OMB Control Number 0910–0738— Extension This information collection supports implementation of recommendations found in FDA guidance. As discussed in the document entitled ‘‘Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health (CDRH) Appeals Processes’’ (July 2019), there are various processes by which appeals requests regarding review of decisions or actions by CDRH may be submitted to the Agency. The guidance is available for download from our website at https://www.fda.gov/regulatory- information/search-fda-guidancedocuments/center-devices-andradiological-health-cdrh-appealsprocesses. The guidance document provides general format and content recommendations in this regard, discusses applicable regulations with regard to the timing of such submissions, and describes the collection of information not expressly specified under existing regulations such as the submission of the request for review, minor clarifications as part of the request, and supporting information. While CDRH already possesses in the administrative file the information that would form the basis of a decision on a matter under appeal, the submission of information as recommended in the guidance regarding the appeal request itself, as well as data and information relied on by the requestor in the appeal, will help facilitate timely resolution of the decision under review. We are accounting for burden respondents may incur as a result of these Agency recommendations in this collection request. Additional information about the CDRH appeals process is described in the companion guidance entitled ‘‘Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A— Guidance for Industry and Food and Drug Administration Staff’’ (March 2020), also available for download from our website at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents/center-devicesand-radiological-health-cdrh-appealsprocesses-questions-and-answers-about517a. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 CDRH Appeals Processes: Guidance for Industry and FDA Staff Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Recommended format and content elements ..................... 35 1 35 8 280 jspears on DSK121TN23PROD with NOTICES1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We estimate 35 requests will be submitted annually to review decisions and actions by CDRH employees, we attribute one respondent per submission, and we assume each request will take 8 hours to prepare. Based on our evaluation of the information collection since last OMB approval, we have made no adjustments to the currently approved burden estimate. Dated: February 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–03546 Filed 2–17–22; 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. VerDate Sep<11>2014 18:54 Feb 17, 2022 Jkt 256001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 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. DATES: Submit either electronic or written comments on the draft guidance by April 19, 2022 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: jspears on DSK121TN23PROD with NOTICES1 SUMMARY: 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 VerDate Sep<11>2014 18:54 Feb 17, 2022 Jkt 256001 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. • 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. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 9367 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, PSGQuestions@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’’ 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/guidancecompliance-regulatory-information/ guidances-drugs. 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 November 9, 2021 (86 FR 62182). This notice announces draft productspecific 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: E:\FR\FM\18FEN1.SGM 18FEN1 9368 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices TABLE 1—NEW DRAFT PRODUCT-SPE- thinking of FDA on, among other things, CIFIC GUIDANCES FOR DRUG PROD- the product-specific design of BE UCTS Active ingredient(s) Aclidinium bromide; Formoterol fumarate. Apomorphine hydrochloride. Atropine sulfate. Brilliant blue G. Capmatinib hydrochloride. Cladribine. Dicyclomine hydrochloride. Dolutegravir sodium. Enzalutamide. Estradiol (multiple referenced listed drugs). Etelcalcetide. Flortaucipir F-8. Fluoroestradiol F-18. Heparin sodium. Irinotecan hydrochloride. Leuprolide acetate (multiple referenced listed drugs). Mirabegron. Nusinersen sodium. Posaconazole. Progesterone. Remdesivir (multiple referenced listed drugs). Ripretinib. Selpercatinib. Selumetinib sulfate. Sodium chloride. Vasopressin. Viloxazine hydrochloride. 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) jspears on DSK121TN23PROD with NOTICES1 Apixaban. Clozapine (multiple referenced listed drugs). Enzalutamide. Estradiol. Gefitinib. Liothyronine sodium. Methylprednisolone acetate. Mycophenolate mofetil. Osimertinib mesylate. Ruxolitinib phosphate. Valbenazine tosylate. 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 VerDate Sep<11>2014 18:54 Feb 17, 2022 Jkt 256001 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. Paperwork Reduction Act of 1995 FDA tentatively concludes that these draft guidances contain no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V. Electronic Access Persons with access to the internet may obtain the draft guidances 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. Dated: February 10, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–03248 Filed 2–17–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Proposed Collection: Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No. 0906–0044—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30-day comment period for this Notice has closed. DATES: Comments on this ICR should be received no later than March 21, 2022. SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Samantha Miller, the acting HRSA Information Collection Clearance Officer, at (301) 443–9094. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Rural Communities Opioid Response Program (RCORP) Performance Measures, OMB No. 0906–0044— Revision. Abstract: RCORP is authorized by Section 711(b)(5) of the Social Security Act (42 U.S.C. 912(b)(5)) and is a multiinitiative program that aims to: (1) Support treatment for and prevention of substance use disorder (SUD), including opioid use disorder (OUD); and (2) reduce morbidity and mortality associated with SUD, to include OUD, by improving access to and delivering prevention, treatment, and recovery support services to high-risk rural communities. To support this purpose, RCORP grant initiatives include: • RCORP-Implementation grants to fund established networks and consortia to deliver SUD/OUD prevention, treatment, and recovery activities in high-risk rural communities; • RCORP-Medication Assisted Treatment Expansion grants to enhance access to medication-assisted treatment within eligible hospitals, health clinics, or tribal organizations in high-risk rural communities; • RCORP-Neonatal Abstinence Syndrome grants to reduce the incidence and impact of Neonatal Abstinence Syndrome in rural communities by improving systems of care, family supports, and social determinants of health; • RCORP-Psychostimulant Support grants to strengthen and expand prevention, treatment, and recovery services for individuals in rural areas who misuse psychostimulants; to enhance their ability to access treatment and move towards recovery; and ADDRESSES: E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9366-9368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03248]


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

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.

[[Page 9367]]


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 April 19, 2022 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.
     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, [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'' 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/guidance-compliance-regulatory-information/guidances-drugs.
    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 November 9, 2021 (86 FR 62182). 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:

[[Page 9368]]



     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Aclidinium bromide; Formoterol fumarate.
Apomorphine hydrochloride.
Atropine sulfate.
Brilliant blue G.
Capmatinib hydrochloride.
Cladribine.
Dicyclomine hydrochloride.
Dolutegravir sodium.
Enzalutamide.
Estradiol (multiple referenced listed drugs).
Etelcalcetide.
Flortaucipir F-8.
Fluoroestradiol F-18.
Heparin sodium.
Irinotecan hydrochloride.
Leuprolide acetate (multiple referenced listed drugs).
Mirabegron.
Nusinersen sodium.
Posaconazole.
Progesterone.
Remdesivir (multiple referenced listed drugs).
Ripretinib.
Selpercatinib.
Selumetinib sulfate.
Sodium chloride.
Vasopressin.
Viloxazine hydrochloride.
------------------------------------------------------------------------

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)
-------------------------------------------------------------------------
Apixaban.
Clozapine (multiple referenced listed drugs).
Enzalutamide.
Estradiol.
Gefitinib.
Liothyronine sodium.
Methylprednisolone acetate.
Mycophenolate mofetil.
Osimertinib mesylate.
Ruxolitinib phosphate.
Valbenazine tosylate.
------------------------------------------------------------------------

    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. Paperwork Reduction Act of 1995

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

V. Electronic Access

    Persons with access to the internet may obtain the draft guidances 
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: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03248 Filed 2-17-22; 8:45 am]
BILLING CODE 4164-01-P
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