Drugs for Human Use; Drug Efficacy Study Implementation; Potassium Aminobenzoate Oral Preparations; Withdrawal of Hearing Request; Withdrawal of New Drug Application; Final Resolution of Drug Efficacy Study Implementation, 13294-13295 [2022-04971]
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13294
Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices
Estimated Total Annual Burden
Hours: 3,410.
Authority: Section 471(e)(4)(E) of the
Act (42 U.S.C. 671), as amended by
Public Law 115–123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–04939 Filed 3–8–22; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
I. Background
[Docket No. FDA–1977–N–0015 (Formerly
77N–0187); DESI 7663]
Drugs for Human Use; Drug Efficacy
Study Implementation; Potassium
Aminobenzoate Oral Preparations;
Withdrawal of Hearing Request;
Withdrawal of New Drug Application;
Final Resolution of Drug Efficacy
Study Implementation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that all outstanding hearing
requests regarding POTABA (potassium
aminobenzoate) Tablets, Capsules,
Powder, and Envules under Docket No.
FDA–1977–N–0015 (formerly 77N–
0187) (this Drug Efficacy Study
Implementation (DESI) 7663) have been
withdrawn. Therefore, as proposed in
the notice of opportunity for hearing
(NOOH), FDA finds that the products
subject to the application identified in
this docket, or any identical, related, or
similar (IRS) products, have not been
shown to be effective for use under the
conditions of use prescribed,
recommended, or suggested in the
labeling, and hereby withdraws
approval of the application under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: This notice is applicable April 8,
2022.
ADDRESSES: 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
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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17:44 Mar 08, 2022
Jkt 256001
The most relevant background
documents regarding this matter are
available in the docket. However,
additional background documents are
available upon request (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Astrid Lopez-Goldberg, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5185,
Silver Spring, MD 20993–0002, 301–
796–3485, email:
Astrid.LopezGoldberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In 1962, Congress amended the FD&C
Act to require that new drugs be proven
effective for their labeled indications, as
well as safe, in order to obtain FDA
approval (Drug Amendments of 1962
(Pub. L. 87–781)). These amendments
also required FDA to conduct a
retrospective evaluation of the
effectiveness of the drug products that
FDA had approved as safe between 1938
and 1962. FDA contracted with the
National Academy of Sciences/National
Research Council (NAS/NRC) to make
an initial evaluation of the effectiveness
of over 3,400 products that had been
approved only for safety between 1938
and 1962. The NAS/NRC reports for
these drug products were submitted to
FDA in the late 1960s and early 1970s.
The Agency reviewed and reevaluated
the reports and published its findings in
Federal Register notices. FDA’s
administrative implementation of the
NAS/NRC reports was called the DESI.
DESI covered the approximately 3,400
products specifically reviewed by the
NAS/NRC, as well as the even larger
number of IRS products that entered the
market without FDA approval. If FDA’s
final DESI determination classifies a
drug product as lacking substantial
evidence of effectiveness for one or
more indications, that drug product and
those IRS to it may no longer be
marketed for such indications and are
subject to enforcement action as
unapproved new drugs.
II. Final Resolution of Hearing Request
Regarding Potassium Aminobenzoate
Oral Preparations Under Docket No.
FDA–1977–N–0015 (Formerly 77N–
0187); DESI 7663
In a Federal Register notice published
on August 28, 1970 (35 FR 13755), FDA
announced its evaluation of a report
received from the NAS/NRC under DESI
7663 regarding POTABA (potassium
aminobenzoate) Tablets, Capsules,
Powder, and Envules, New Drug
Application (NDA) 007663, held by
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Glenwood LLC (formerly known as
Glenwood Laboratories, Inc.), 83
Summit St., Tenafly, NJ 07670 (herein
after ‘‘Glenwood’’). The notice stated
that the drug products were possibly
effective in the treatment of
scleroderma, dermatomyositis,
morphea, linear scleroderma,
pemphigus, and Peyronie’s Disease and
lacked substantial evidence of
effectiveness for the treatment of
rheumatoid arthritis, sarcoidosis, and
pulmonary fibrosis. Glenwood, and any
other person marketing such drug
products without approval, was given
60 days to revise its labeling to delete
those indications for which substantial
evidence of effectiveness was lacking
and 6 months to submit data to provide
substantial evidence of effectiveness for
the indications for which the drug was
regarded as possibly effective. The
notice stated that, at the end of the 6month period, FDA would evaluate the
data to determine whether substantial
evidence of effectiveness had been
provided, and, if it had not, FDA would
initiate the withdrawal of approval of
NDA 007663 under section 505(e) of the
FD&C Act (21 U.S.C. 355(e)).
Glenwood did not submit data to
provide substantial evidence of
effectiveness for the indications for
which the drug was regarded as possibly
effective within the period provided by
the 1970 Federal Register notice, and
the Agency issued a NOOH on the
proposed withdrawal of approval of
NDA 007663 in the Federal Register of
February 4, 1972 (37 FR 2688).
In response to a court order, FDA
published a notice in the Federal
Register on December 14, 1972 (37 FR
26623), which stated that POTABA,
among other drugs, could remain on the
market pending completion of further
scientific studies.
In a Federal Register notice published
on August 19, 1977 (42 FR 41922), the
Agency revoked the exemption granted
in the December 14, 1972, notice
pursuant to which POTABA had
remained on the market pending its
continued study. In a separate NOOH
for DESI 7663, also published in the
Federal Register of August 19, 1977 (42
FR 41921), FDA noted that Glenwood
did not submit data providing
substantial evidence of effectiveness
and that no other person had submitted
data or protocols or expressed an
intention to perform clinical studies on
potassium aminobenzoate. This notice
reclassified the possibly effective
indications to lacking substantial
evidence of effectiveness and proposed
to issue an order under section 505(e) of
the FD&C Act withdrawing approval of
Glenwood’s NDA and all amendments
E:\FR\FM\09MRN1.SGM
09MRN1
Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES1
and supplements thereto on the grounds
that new information, evaluated
together with the evidence available
when the application was approved,
showed there is a lack of substantial
evidence that the drug is effective under
the conditions of use prescribed,
recommended, or suggested in the
labeling. The Agency again invited
Glenwood, and any other interested
person(s) who would be adversely
affected by the withdrawal of approval
of NDA 007663, to submit: (1) On or
before September 19, 1977, a written
notice of appearance and request for
hearing and (2) on or before October 17,
1977, the data, information, and
analyses relied upon to justify a hearing.
On September 12, 1977, Glenwood
filed a written notice of appearance and
requested a hearing, and on October 17,
1977, Glenwood submitted data in
support of its hearing request. Along
with these submissions, Glenwood
requested that the Agency delay action
on the hearing request until the firm had
conducted another placebo-controlled
study. Subsequently, Glenwood
initiated a clinical trial at the Downstate
Medical Center of the State University
of New York and supplemented its
hearing request with additional data,
including a progress report on the
clinical trial of POTABA conducted at
the Downstate Medical Center.
Following a meeting between
Glenwood and FDA on November 18,
1985, Glenwood sponsored another
controlled clinical trial, and the final
study report was submitted on February
4, 1993.
By letter dated October 21, 2010, FDA
asked Glenwood whether it wanted to
pursue its pending hearing request
regarding POTABA. By letter dated
November 11, 2010, Glenwood affirmed
its hearing request.
By letter dated June 8, 2020, FDA
again asked Glenwood whether it
wanted to pursue its pending hearing
request regarding POTABA. By letter
dated July 2, 2020, Cheplapharm
Arzneimittel GmbH, successor-ininterest to Glenwood LLC, stated that it
did not wish to pursue the hearing
request for POTABA.
III. Conclusions and Order
There are no outstanding hearing
requests regarding potassium
aminobenzoate oral preparations under
Docket No. FDA–1977–N–0015, DESI
7663. Therefore, as proposed in the
NOOH, FDA withdraws approval of
NDA 007663 under section 505(e) of the
FD&C Act.
Shipment in interstate commerce of
any drug product identified in this
docket under DESI 7663, or any IRS
VerDate Sep<11>2014
17:44 Mar 08, 2022
Jkt 256001
product, that is not the subject of an
approved NDA or abbreviated new drug
application is unlawful as of the
effective date of this notice (see DATES).
Any person who wishes to determine
whether this notice covers a specific
product should write to Astrid LopezGoldberg at the Center for Drug
Evaluation and Research (see FOR
FURTHER INFORMATION CONTACT). Firms
should be aware that, after the
applicable date of this notice (see
DATES), FDA intends to take
enforcement action without further
notice against any firm that
manufactures or ships in interstate
commerce any unapproved product
covered by this notice.
IV. Discontinued Products
Firms must notify the Agency of
certain product discontinuations in
writing under section 506C(a) of the
FD&C Act (21 U.S.C. 356c). See https://
www.fda.gov/Drugs/DrugSafety/
DrugShortages/ucm142398.htm. Some
firms may have previously discontinued
manufacturing or distributing products
covered by this notice without
discontinuing the listing as required
under section 510(j) of the FD&C Act (21
U.S.C. 360(j)). Other firms may
discontinue manufacturing or
distributing listed products in response
to this notice. All firms are required to
electronically update the listing of their
products under 510(j) of the FD&C Act
to reflect discontinuation of unapproved
products covered by this notice (21 CFR
207.57(b)). Questions on electronic drug
listing updates should be sent to
eDRLS@fda.hhs.gov. In addition to the
required update, firms can also notify
the Agency of product discontinuation
by sending a letter, signed by the firm’s
chief executive officer and fully
identifying the discontinued product(s),
including the product National Drug
Code number(s), and stating that the
manufacturing and/or distribution of the
product(s) have been discontinued. The
letter should be sent electronically to
Astrid Lopez-Goldberg (see FOR FURTHER
INFORMATION CONTACT). FDA plans to
rely on its existing records, including its
drug listing records, the results of any
future inspections, or other available
information, when it identifies violative
products for enforcement action.
Dated: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04971 Filed 3–8–22; 8:45 am]
BILLING CODE 4164–01–P
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13295
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0075]
Food and Drug Administration Quality
Metrics Reporting Program;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the establishment of a
docket to solicit comments on changes
to FDA’s previously proposed quality
metrics reporting program (QM
Reporting Program). This notice
describes considerations for refining the
QM Reporting Program based on lessons
learned from two pilot programs with
industry that were announced in the
Federal Register in June 2018, a Site
Visit Program and a Quality Metrics
Feedback Program, as well as
stakeholder feedback on FDA’s 2016
revised draft guidance for industry
entitled ‘‘Submission of Quality Metrics
Data.’’ FDA is interested in responses to
the questions listed in section III of this
document, in addition to any general
comments on the proposed direction for
the program. This notice is not intended
to communicate our regulatory
expectations for reporting quality
metrics data to FDA but is instead
intended to seek input from industry to
inform the future regulatory approach.
DATES: Submit either electronic or
written comments by June 7, 2022.
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 June 7, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 7, 2022. 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:
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://
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13294-13295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1977-N-0015 (Formerly 77N-0187); DESI 7663]
Drugs for Human Use; Drug Efficacy Study Implementation;
Potassium Aminobenzoate Oral Preparations; Withdrawal of Hearing
Request; Withdrawal of New Drug Application; Final Resolution of Drug
Efficacy Study Implementation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that all outstanding hearing requests regarding POTABA (potassium
aminobenzoate) Tablets, Capsules, Powder, and Envules under Docket No.
FDA-1977-N-0015 (formerly 77N-0187) (this Drug Efficacy Study
Implementation (DESI) 7663) have been withdrawn. Therefore, as proposed
in the notice of opportunity for hearing (NOOH), FDA finds that the
products subject to the application identified in this docket, or any
identical, related, or similar (IRS) products, have not been shown to
be effective for use under the conditions of use prescribed,
recommended, or suggested in the labeling, and hereby withdraws
approval of the application under the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
DATES: This notice is applicable April 8, 2022.
ADDRESSES: 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 between 9 a.m. and 4 p.m.,
Monday through Friday. Publicly available submissions may be seen in
the docket.
The most relevant background documents regarding this matter are
available in the docket. However, additional background documents are
available upon request (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5185, Silver Spring, MD 20993-0002, 301-
796-3485, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe, in
order to obtain FDA approval (Drug Amendments of 1962 (Pub. L. 87-
781)). These amendments also required FDA to conduct a retrospective
evaluation of the effectiveness of the drug products that FDA had
approved as safe between 1938 and 1962. FDA contracted with the
National Academy of Sciences/National Research Council (NAS/NRC) to
make an initial evaluation of the effectiveness of over 3,400 products
that had been approved only for safety between 1938 and 1962. The NAS/
NRC reports for these drug products were submitted to FDA in the late
1960s and early 1970s. The Agency reviewed and reevaluated the reports
and published its findings in Federal Register notices. FDA's
administrative implementation of the NAS/NRC reports was called the
DESI. DESI covered the approximately 3,400 products specifically
reviewed by the NAS/NRC, as well as the even larger number of IRS
products that entered the market without FDA approval. If FDA's final
DESI determination classifies a drug product as lacking substantial
evidence of effectiveness for one or more indications, that drug
product and those IRS to it may no longer be marketed for such
indications and are subject to enforcement action as unapproved new
drugs.
II. Final Resolution of Hearing Request Regarding Potassium
Aminobenzoate Oral Preparations Under Docket No. FDA-1977-N-0015
(Formerly 77N-0187); DESI 7663
In a Federal Register notice published on August 28, 1970 (35 FR
13755), FDA announced its evaluation of a report received from the NAS/
NRC under DESI 7663 regarding POTABA (potassium aminobenzoate) Tablets,
Capsules, Powder, and Envules, New Drug Application (NDA) 007663, held
by Glenwood LLC (formerly known as Glenwood Laboratories, Inc.), 83
Summit St., Tenafly, NJ 07670 (herein after ``Glenwood''). The notice
stated that the drug products were possibly effective in the treatment
of scleroderma, dermatomyositis, morphea, linear scleroderma,
pemphigus, and Peyronie's Disease and lacked substantial evidence of
effectiveness for the treatment of rheumatoid arthritis, sarcoidosis,
and pulmonary fibrosis. Glenwood, and any other person marketing such
drug products without approval, was given 60 days to revise its
labeling to delete those indications for which substantial evidence of
effectiveness was lacking and 6 months to submit data to provide
substantial evidence of effectiveness for the indications for which the
drug was regarded as possibly effective. The notice stated that, at the
end of the 6-month period, FDA would evaluate the data to determine
whether substantial evidence of effectiveness had been provided, and,
if it had not, FDA would initiate the withdrawal of approval of NDA
007663 under section 505(e) of the FD&C Act (21 U.S.C. 355(e)).
Glenwood did not submit data to provide substantial evidence of
effectiveness for the indications for which the drug was regarded as
possibly effective within the period provided by the 1970 Federal
Register notice, and the Agency issued a NOOH on the proposed
withdrawal of approval of NDA 007663 in the Federal Register of
February 4, 1972 (37 FR 2688).
In response to a court order, FDA published a notice in the Federal
Register on December 14, 1972 (37 FR 26623), which stated that POTABA,
among other drugs, could remain on the market pending completion of
further scientific studies.
In a Federal Register notice published on August 19, 1977 (42 FR
41922), the Agency revoked the exemption granted in the December 14,
1972, notice pursuant to which POTABA had remained on the market
pending its continued study. In a separate NOOH for DESI 7663, also
published in the Federal Register of August 19, 1977 (42 FR 41921), FDA
noted that Glenwood did not submit data providing substantial evidence
of effectiveness and that no other person had submitted data or
protocols or expressed an intention to perform clinical studies on
potassium aminobenzoate. This notice reclassified the possibly
effective indications to lacking substantial evidence of effectiveness
and proposed to issue an order under section 505(e) of the FD&C Act
withdrawing approval of Glenwood's NDA and all amendments
[[Page 13295]]
and supplements thereto on the grounds that new information, evaluated
together with the evidence available when the application was approved,
showed there is a lack of substantial evidence that the drug is
effective under the conditions of use prescribed, recommended, or
suggested in the labeling. The Agency again invited Glenwood, and any
other interested person(s) who would be adversely affected by the
withdrawal of approval of NDA 007663, to submit: (1) On or before
September 19, 1977, a written notice of appearance and request for
hearing and (2) on or before October 17, 1977, the data, information,
and analyses relied upon to justify a hearing.
On September 12, 1977, Glenwood filed a written notice of
appearance and requested a hearing, and on October 17, 1977, Glenwood
submitted data in support of its hearing request. Along with these
submissions, Glenwood requested that the Agency delay action on the
hearing request until the firm had conducted another placebo-controlled
study. Subsequently, Glenwood initiated a clinical trial at the
Downstate Medical Center of the State University of New York and
supplemented its hearing request with additional data, including a
progress report on the clinical trial of POTABA conducted at the
Downstate Medical Center.
Following a meeting between Glenwood and FDA on November 18, 1985,
Glenwood sponsored another controlled clinical trial, and the final
study report was submitted on February 4, 1993.
By letter dated October 21, 2010, FDA asked Glenwood whether it
wanted to pursue its pending hearing request regarding POTABA. By
letter dated November 11, 2010, Glenwood affirmed its hearing request.
By letter dated June 8, 2020, FDA again asked Glenwood whether it
wanted to pursue its pending hearing request regarding POTABA. By
letter dated July 2, 2020, Cheplapharm Arzneimittel GmbH, successor-in-
interest to Glenwood LLC, stated that it did not wish to pursue the
hearing request for POTABA.
III. Conclusions and Order
There are no outstanding hearing requests regarding potassium
aminobenzoate oral preparations under Docket No. FDA-1977-N-0015, DESI
7663. Therefore, as proposed in the NOOH, FDA withdraws approval of NDA
007663 under section 505(e) of the FD&C Act.
Shipment in interstate commerce of any drug product identified in
this docket under DESI 7663, or any IRS product, that is not the
subject of an approved NDA or abbreviated new drug application is
unlawful as of the effective date of this notice (see DATES). Any
person who wishes to determine whether this notice covers a specific
product should write to Astrid Lopez-Goldberg at the Center for Drug
Evaluation and Research (see FOR FURTHER INFORMATION CONTACT). Firms
should be aware that, after the applicable date of this notice (see
DATES), FDA intends to take enforcement action without further notice
against any firm that manufactures or ships in interstate commerce any
unapproved product covered by this notice.
IV. Discontinued Products
Firms must notify the Agency of certain product discontinuations in
writing under section 506C(a) of the FD&C Act (21 U.S.C. 356c). See
https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm. Some
firms may have previously discontinued manufacturing or distributing
products covered by this notice without discontinuing the listing as
required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)). Other
firms may discontinue manufacturing or distributing listed products in
response to this notice. All firms are required to electronically
update the listing of their products under 510(j) of the FD&C Act to
reflect discontinuation of unapproved products covered by this notice
(21 CFR 207.57(b)). Questions on electronic drug listing updates should
be sent to [email protected]. In addition to the required update, firms
can also notify the Agency of product discontinuation by sending a
letter, signed by the firm's chief executive officer and fully
identifying the discontinued product(s), including the product National
Drug Code number(s), and stating that the manufacturing and/or
distribution of the product(s) have been discontinued. The letter
should be sent electronically to Astrid Lopez-Goldberg (see FOR FURTHER
INFORMATION CONTACT). FDA plans to rely on its existing records,
including its drug listing records, the results of any future
inspections, or other available information, when it identifies
violative products for enforcement action.
Dated: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04971 Filed 3-8-22; 8:45 am]
BILLING CODE 4164-01-P
