Federal Register / Vol. 87, No.

139 / Thursday, July 21, 2022 / Notices 43531

In the Federal Register of June 1, 2020 ACTION: Notice; establishment of a instructions for submitting comments.
(85 FR 33165), FDA announced the public docket; request for comments. Comments submitted electronically,
establishment of a public docket to including attachments, to https://
solicit comments on the Orange Book, SUMMARY: The Food and Drug www.regulations.gov will be posted to
including questions related to the Administration (FDA) announces a the docket unchanged. Because your
presentation of information on forthcoming public advisory committee comment will be made public, you are
therapeutic equivalence (e.g., ‘‘How meeting of the Oncologic Drugs solely responsible for ensuring that your
useful is the second letter of a Advisory Committee. The general comment does not include any
therapeutic equivalence evaluation function of the committee is to provide confidential information that you or a
code?’’), which also relate to the content advice and recommendations to FDA on third party may not wish to be posted,
of this guidance. FDA is continuing to regulatory issues. The meeting will be such as medical information, your or
consider the comments to this docket. open to the public. FDA is establishing anyone else’s Social Security number, or
This draft guidance is being issued a docket for public comment on this confidential business information, such
consistent with FDA’s good guidance document. as a manufacturing process. Please note
practices regulation (21 CFR 10.115). DATES: The meeting will be held on that if you include your name, contact
The draft guidance, when finalized, will September 22, 2022, from 9 a.m. to 6 information, or other information that
represent the current thinking of FDA p.m. Eastern Time and September 23, identifies you in the body of your
on ‘‘Evaluation of Therapeutic 2022, from 9 a.m. to 1:15 p.m. Eastern comments, that information will be
Equivalence.’’ It does not establish any Time. posted on https://www.regulations.gov.
rights for any person and is not binding ADDRESSES: Please note that due to the • If you want to submit a comment
on FDA or the public. You can use an impact of this COVID–19 pandemic, all with confidential information that you
alternative approach if it satisfies the meeting participants will be joining this do not wish to be made available to the
requirements of the applicable statutes advisory committee meeting via an public, submit the comment as a
and regulations. online teleconferencing platform. written/paper submission and in the
Answers to commonly asked questions manner detailed (see ‘‘Written/Paper
II. Paperwork Reduction Act of 1995
about FDA advisory committee meetings Submissions’’ and ‘‘Instructions’’).
While this draft guidance contains no may be accessed at: https://
collection of information, it does refer to Written/Paper Submissions
www.fda.gov/AdvisoryCommittees/
previously approved FDA collections of AboutAdvisoryCommittees/ Submit written/paper submissions as
information. Therefore, clearance by the ucm408555.htm. follows:
Office of Management and Budget FDA is establishing a docket for • Mail/Hand Delivery/Courier (for
(OMB) under the Paperwork Reduction public comment on this meeting. The written/paper submissions): Dockets
Act of 1995 (PRA) (44 U.S.C. 3501– docket number is FDA–2022–N–0634. Management Staff (HFA–305), Food and
3521) is not required for this draft The docket will close on September 21, Drug Administration, 5630 Fishers
guidance. The previously approved 2022. Submit either electronic or Lane, Rm. 1061, Rockville, MD 20852.
collections of information are subject to written comments on this public • For written/paper comments
review by OMB under the PRA. The meeting by September 21, 2022. Please submitted to the Dockets Management
collections of information in 21 CFR note that late, untimely filed comments Staff, FDA will post your comment, as
10.30 have been approved under OMB will not be considered. Electronic well as any attachments, except for
control number 0910–0191. comments must be submitted on or information submitted, marked and
before September 21, 2022. The https:// identified, as confidential, if submitted
III. Electronic Access as detailed in ‘‘Instructions.’’
www.regulations.gov electronic filing
Persons with access to the internet system will accept comments until Instructions: All submissions received
may obtain the draft guidance at either 11:59 p.m. Eastern Time at the end of must include the Docket No. FDA–
https://www.fda.gov/drugs/guidance- September 21, 2022. Comments received 2022–N–0634 for ‘‘Oncologic Drugs
compliance-regulatory-information/ by mail/hand delivery/courier (for Advisory Committee; Notice of Meeting;
guidances-drugs, https://www.fda.gov/ written/paper submissions) will be Establishment of a Public Docket;
regulatory-information/search-fda- considered timely if they are Request for Comments.’’ Received
guidance-documents, or https:// postmarked or the delivery service comments, those filed in a timely
www.regulations.gov. acceptance receipt is on or before that manner (see ADDRESSES), will be placed
Dated: July 18, 2022. date. in the docket and, except for those
Lauren K. Roth, Comments received on or before submitted as ‘‘Confidential
Associate Commissioner for Policy. September 8, 2022, will be provided to Submissions,’’ publicly viewable at
the committee. Comments received after https://www.regulations.gov or at the
[FR Doc. 2022–15612 Filed 7–20–22; 8:45 am]
that date will be taken into Dockets Management Staff between 9
BILLING CODE 4164–01–P
consideration by FDA. In the event that a.m. and 4 p.m., Monday through
the meeting is canceled, FDA will Friday, 240–402–7500.
continue to evaluate any relevant • Confidential Submissions—To
DEPARTMENT OF HEALTH AND
applications or information, and submit a comment with confidential
HUMAN SERVICES
consider any comments submitted to the information that you do not wish to be
Food and Drug Administration docket, as appropriate. made publicly available, submit your
You may submit comments as comments only as a written/paper
[Docket No. FDA–2022–N–0634]
lotter on DSK11XQN23PROD with NOTICES1

follows: submission. You should submit two

copies total. One copy will include the
Oncologic Drugs Advisory Committee; Electronic Submissions information you claim to be confidential
Notice of Meeting; Establishment of a
Submit electronic comments in the with a heading or cover note that states
Public Docket; Request for Comments
following way: ‘‘THIS DOCUMENT CONTAINS
AGENCY: Food and Drug Administration, • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ FDA
HHS. https://www.regulations.gov. Follow the will review this copy, including the

VerDate Sep<11>2014 19:16 Jul 20, 2022 Jkt 256001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1
 43532 Federal Register / Vol. 87, No. 139 / Thursday, July 21, 2022 / Notices

claimed confidential information, in its proposed indication (use) for this committee meeting. Background
consideration of comments. The second product is for the treatment of patients material and the link to the online
copy, which will have the claimed with previously treated, locally teleconference meeting room will be
confidential information redacted/ advanced or metastatic non-small cell available at https://www.fda.gov/
blacked out, will be available for public lung cancer (NSCLC) harboring HER2 AdvisoryCommittees/Calendar/
viewing and posted on https:// exon 20 insertion mutations. Select default.htm. Scroll down to the
www.regulations.gov. Submit both patients with NSCLC for treatment with appropriate advisory committee meeting
copies to the Dockets Management Staff. poziotinib based on the presence of link. The meeting will include slide
If you do not wish your name and HER2 exon 20 insertion mutations using presentations with audio components to
contact information be made publicly an FDA-approved test. During the allow the presentation of materials in a
available, you can provide this second session of September 22, 2022, manner that most closely resembles an
information on the cover sheet and not the committee will hear an update on in-person advisory committee meeting.
in the body of your comments and you new drug application (NDA) 214383, for Procedure: Interested persons may
must identify the information as PEPAXTO (melphalan flufenamide) for present data, information, or views,
‘‘confidential.’’ Any information marked injection, submitted by Oncopeptides orally or in writing, on issues pending
as ‘‘confidential’’ will not be disclosed A.B. This product was approved under before the committee. All electronic and
except in accordance with 21 CFR 10.20 21 CFR 314.500 (subpart H, accelerated
written submissions submitted to the
and other applicable disclosure law. For approval regulations) for use in
Docket (see ADDRESSES) on or before
more information about FDA’s posting combination with dexamethasone for
September 8, 2022, will be provided to
of comments to public dockets, see 80 the treatment of adult patients with
the committee. Oral presentations from
FR 56469, September 18, 2015, or access relapsed or refractory multiple myeloma
the public will be scheduled between
the information at: https:// who have received at least four prior
approximately 11:40 a.m. to 12:10 p.m.
www.govinfo.gov/content/pkg/FR-2015- lines of therapy and whose disease is
and 4:30 p.m. to 5 p.m. Eastern Time on
09-18/pdf/2015-23389.pdf. refractory to at least one proteasome
September 22, 2022. Oral presentations
Docket: For access to the docket to inhibitor, one immunomodulatory
agent, and one CD38-directed from the public will be scheduled
read background documents or the between approximately 11:45 a.m. to
electronic and written/paper comments monoclonal antibody. The confirmatory
trial demonstrated a worse overall 12:15 p.m. Eastern Time on September
received, go to https:// 23, 2022. Those individuals interested
www.regulations.gov and insert the survival and failed to verify clinical
benefit. Confirmatory studies are post- in making formal oral presentations
docket number, found in brackets in the should notify the contact person and
heading of this document, into the marketing studies to verify and describe
the clinical benefit of a drug after it submit a brief statement of the general
‘‘Search’’ box and follow the prompts nature of the evidence or arguments
and/or go to the Dockets Management receives accelerated approval. Based on
the updates provided, the committee they wish to present, the names and
Staff, 5630 Fishers Lane, Rm. 1061, addresses of proposed participants, and
Rockville, MD 20852, 240–402–7500. will have a general discussion focused
on next steps for the product. an indication of the approximate time
FOR FURTHER INFORMATION CONTACT: She- requested to make their presentation on
On September 23, 2022, the
Chia Chen, Center for Drug Evaluation or before August 30, 2022. Time allotted
committee will hear an update on new
and Research, Food and Drug drug application (NDA) 211155, for for each presentation may be limited. If
Administration, 10903 New Hampshire COPIKTRA (duvelisib) capsule, the number of registrants requesting to
Ave., Bldg. 31, Rm. 2417, Silver Spring, submitted by Secura Bio, Inc. This speak is greater than can be reasonably
MD 20993–0002, 240–402–5343, Fax: product was approved under section accommodated during the scheduled
301–847–8533, ODAC@fda.hhs.gov, or 505(b) of the Federal Food, Drug, and open public hearing session, FDA may
FDA Advisory Committee Information Cosmetic Act (FD&C Act) for use in the conduct a lottery to determine the
Line, 1–800–741–8138 (301–443–0572 treatment of adult patients with speakers for the scheduled open public
in the Washington, DC area). A notice in relapsed or refractory chronic hearing session. The contact person will
the Federal Register about last minute lymphocytic leukemia or small notify interested persons regarding their
modifications that impact a previously lymphocytic lymphoma after at least request to speak by August 31, 2022.
announced advisory committee meeting two prior therapies. The update For press inquiries, please contact the
cannot always be published quickly includes the final overall survival data Office of Media Affairs at fdaoma@
enough to provide timely notice. from the DUO trial (IPI–145–07) fda.hhs.gov or 301–796–4540.
Therefore, you should always check the submitted in response to post-marketing
FDA’s website at https://www.fda.gov/ FDA welcomes the attendance of the
requirement 3494–3 detailed in the
AdvisoryCommittees/default.htm and public at its advisory committee
September 24, 2018 approval letter,
scroll down to the appropriate advisory meetings and will make every effort to
available at https://www.accessdata.
committee meeting link, or call the accommodate persons with disabilities.
fda.gov/drugsatfda_docs/appletter/
advisory committee information line to If you require accommodations due to a
2018/211155Orig2s000ltr.pdf. Based on
learn about possible modifications disability, please contact She-Chia Chen
the updated overall survival information
before coming to the meeting. (see FOR FURTHER INFORMATION CONTACT)
along with the safety data with
SUPPLEMENTARY INFORMATION: duvelisib, the committee will discuss a at least 7 days in advance of the
Agenda: The meeting presentations current assessment of benefit-risk. meeting.
will be heard, viewed, captioned, and FDA intends to make background FDA is committed to the orderly
lotter on DSK11XQN23PROD with NOTICES1

recorded through an online material available to the public no later conduct of its advisory committee
teleconferencing platform. During the than 2 business days before the meeting. meetings. Please visit our website at
first session of September 22, 2022, the If FDA is unable to post the background https://www.fda.gov/
committee will discuss new drug material on its website prior to the AdvisoryCommittees/AboutAdvisory
application (NDA) 215643, for meeting, the background material will Committees/ucm111462.htm for
poziotinib tablets, submitted by be made publicly available on FDA’s procedures on public conduct during
Spectrum Pharmaceuticals, Inc. The website at the time of the advisory advisory committee meetings.

VerDate Sep<11>2014 19:16 Jul 20, 2022 Jkt 256001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1
 Federal Register / Vol. 87, No. 139 / Thursday, July 21, 2022 / Notices 43533

Notice of this meeting is given under Section 505(j)(7) of the FD&C Act reviewed our files for records
the Federal Advisory Committee Act (5 requires FDA to publish a list of all concerning the withdrawal of
U.S.C. app. 2). approved drugs. FDA publishes this list XYLOCAINE (lidocaine hydrochloride)
Dated: July 18, 2022. as part of the ‘‘Approved Drug Products Topical Solution 4 percent, from sale.
Lauren K. Roth,
With Therapeutic Equivalence We have also independently evaluated
Evaluations,’’ which is known generally relevant literature and data for possible
Associate Commissioner for Policy.
as the ‘‘Orange Book.’’ Under FDA postmarketing adverse events. We have
[FR Doc. 2022–15609 Filed 7–20–22; 8:45 am]
regulations, drugs are removed from the found no information that would
BILLING CODE 4164–01–P list if the Agency withdraws or indicate that this drug product was
suspends approval of the drug’s NDA or withdrawn from sale for reasons of
ANDA for reasons of safety or safety or effectiveness.
DEPARTMENT OF HEALTH AND effectiveness or if FDA determines that Accordingly, the Agency will
HUMAN SERVICES the listed drug was withdrawn from sale continue to list XYLOCAINE (lidocaine
Food and Drug Administration for reasons of safety or effectiveness (21 hydrochloride) Topical Solution 4%, in
CFR 314.162). the ‘‘Discontinued Drug Product List’’
[Docket No. FDA–2021–P–1248] A person may petition the Agency to section of the Orange Book. The
determine, or the Agency may ‘‘Discontinued Drug Product List’’
Determination That XYLOCAINE determine on its own initiative, whether delineates, among other items, drug
(Lidocaine Hydrochloride) Topical a listed drug was withdrawn from sale products that have been discontinued
Solution 4%, Was Not Withdrawn From for reasons of safety or effectiveness. from marketing for reasons other than
Sale for Reasons of Safety or This determination may be made at any safety or effectiveness. FDA will not
Effectiveness time after the drug has been withdrawn begin procedures to withdraw approval
AGENCY: Food and Drug Administration, from sale, but must be made prior to of approved ANDAs that refer to this
Health and Human Services (HHS). FDA’s approval of an ANDA that refers drug product. Additional ANDAs for
ACTION: Notice.
to the listed drug (§ 314.161 (21 CFR this drug product may also be approved
314.161)). FDA may not approve an by the Agency as long as they meet all
SUMMARY: The Food and Drug ANDA that does not refer to a listed other legal and regulatory requirements
Administration (FDA, Agency, or we) drug. for the approval of ANDAs. If FDA
has determined that XYLOCAINE XYLOCAINE (lidocaine determines that labeling for this drug
(lidocaine hydrochloride), Topical hydrochloride) Topical Solution 4%, is product should be revised to meet
Solution 4%, was not withdrawn from the subject of NDA 010417, held by current standards, the Agency will
sale for reasons of safety or Fresenius Kabi USA, LLC, and initially advise ANDA applicants to submit such
effectiveness. This determination means approved on May 7, 1959. XYLOCAINE
labeling.
that FDA will not begin procedures to is indicated for the production of topical
anesthesia of the mucous membranes of Dated: July 14, 2022.
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to the respiratory tract or the genito- Lauren K. Roth,
this drug product, and it will allow FDA urinary tract. Associate Commissioner for Policy.
to continue to approve ANDAs that refer In a letter dated January 29, 2018, [FR Doc. 2022–15594 Filed 7–20–22; 8:45 am]
to the product as long as they meet Fresenius Kabi USA, LLC, requested BILLING CODE 4164–01–P
relevant legal and regulatory that FDA withdraw approval of NDA
requirements. 010417 for XYLOCAINE (lidocaine
hydrochloride). In the Federal Register DEPARTMENT OF HEALTH AND
FOR FURTHER INFORMATION CONTACT: of October 29, 2018 (83 FR 54355 at HUMAN SERVICES
David Faranda, Center for Drug 54356), FDA announced that it was
Evaluation and Research, Food and withdrawing approval of NDA 010417 Food and Drug Administration
Drug Administration, 10903 New as of November 28, 2018. This product
Hampshire Ave., Bldg. 51, Rm. 6258, [Docket No. FDA–2022–D–0219]
is identified as discontinued in the
Silver Spring, MD 20993–0002, 301– Orange Book.
796–8767, David.Faranda@fda.hhs.gov. Human Prescription Drug and
Lyne Laboratories, Inc., submitted a Biological Products—Labeling for
SUPPLEMENTARY INFORMATION: Section citizen petition dated December 2, 2021 Dosing Based on Weight or Body
505(j) of the Federal Food, Drug, and (Docket No. FDA–2021–P–1248), under Surface Area for Ready-to-Use
Cosmetic Act (FD&C Act) (21 U.S.C. 21 CFR 10.30, requesting that the Containers—‘‘Dose Banding’’; Draft
355(j)) allows the submission of an Agency determine whether Guidance for Industry; Availability
ANDA to market a generic version of a XYLOCAINE (lidocaine hydrochloride)
previously approved drug product. To Topical Solution 4%, was withdrawn AGENCY: Food and Drug Administration,
obtain approval, the ANDA applicant from sale for reasons of safety or HHS.
must show, among other things, that the effectiveness. ACTION: Notice of availability.
generic drug product: (1) has the same After considering the citizen petition
active ingredient(s), dosage form, route and reviewing Agency records and SUMMARY: The Food and Drug
of administration, strength, conditions based on the information we have at this Administration (FDA or Agency) is
of use, and (with certain exceptions) time, FDA has determined under announcing the availability of a draft
labeling as the listed drug, which is a § 314.161 that XYLOCAINE (lidocaine guidance for industry entitled ‘‘Human
lotter on DSK11XQN23PROD with NOTICES1

version of the drug that was previously hydrochloride) Topical Solution 4%, Prescription Drug and Biological
approved and (2) is bioequivalent to the was not withdrawn for reasons of safety Products—Labeling for Dosing Based on
listed drug. ANDA applicants do not or effectiveness. The petitioner has Weight or Body Surface Area for Ready-
have to repeat the extensive clinical identified no data or other information to-Use Containers—‘Dose Banding’.’’
testing otherwise necessary to gain suggesting that this drug product was The guidance is intended to assist
approval of a new drug application withdrawn for reasons of safety or applicants in incorporating dose
(NDA). effectiveness. We have carefully banding information into the drug

VerDate Sep<11>2014 19:16 Jul 20, 2022 Jkt 256001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1