Determination That SANDOSTATIN (Octreotide Acetate) Injection, Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 29585-29586 [2021-11575]
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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10637 Marketplace Operations
CMS–10501 Healthcare Fraud
Prevention Partnership (HFPP) Data
Sharing and Information Exchange
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
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17:49 Jun 01, 2021
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Information Collection: Marketplace
Operations; Use: The data collections
and third-party disclosure requirements
will assist HHS in determining
Exchange compliance with Federal
standards and monitoring QHP issuers
in FFEs for compliance with Federal
QHP issuer standards. The data
collection will also assist HHS in
monitoring Web-brokers for compliance
with Federal Web-broker standards. The
data collected by health insurance
issuers and Exchanges will help to
inform HHS, Exchanges, and health
insurance issuers as to the participation
of individuals, employers, and
employees in the individual Exchange,
the SHOP, and the premium
stabilization programs. Form Number:
CMS–10637 (OMB control number
0938–1353); Frequency: Annually;
Affected Public: Private sector (Business
or other for-profits); Number of
Respondents: 3,902; Total Annual
Responses: 3,902; Total Annual Hours:
2,336,190. (For policy questions
regarding this collection contact:
Nikolas Berkobien at 301–492–4400.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Healthcare
Fraud Prevention Partnership (HFPP)
Data Sharing and Information Exchange;
Use: Section 1128C(a)(2) of the Social
Security Act (42 U.S.C. 1320a–7c(a)(2))
authorizes the Secretary and the
Attorney General to consult, and arrange
for the sharing of data with,
representatives of health plans for
purposes of establishing a Fraud and
Abuse Control Program as specified in
Section 1128(C)(a)(1) of the Social
Security Act. The result of this authority
has been the establishment of the HFPP.
The HFPP was officially established by
a Charter in the fall of 2012 and signed
by HHS Secretary Sibelius and US
Attorney General Holder. In December
2020, President Trump signed into law
H.R.133—Consolidated Appropriations
Act, 2021, which amended Section
1128C(a) of the Social Security Act (42
U.S.C. 1320a–7c(a)) providing explicit
statutory authority for the Healthcare
Fraud Prevention Partnership including
the potential expansion of the publicprivate partnership analyses.
Data sharing within the HFPP
primarily focuses on conducting studies
for the purpose of combatting fraud,
waste, and abuse. These studies are
intended to target specific
vulnerabilities within the payment
systems in both the public and private
healthcare sectors. The HFPP and its
committees design and develop studies
in coordination with the TTP. The core
function of the TTP is to manage and
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29585
execute the HFPP studies within the
HFPP. Form Number: CMS–10501
(OMB control number: 0938–1251);
Frequency: Occasionally; Affected
Public: Private sector (Business or other
for-profits); Number of Respondents: 28;
Number of Responses: 28; Total Annual
Hours: 120. (For questions regarding
this collection, contact Marnie Dorsey at
(410–786–5942).
Dated: May 27, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–11591 Filed 6–1–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0163]
Determination That SANDOSTATIN
(Octreotide Acetate) Injection, Equal to
0.2 Milligrams Base/Milliliter and Equal
to 1 Milligrams Base/Milliliter, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that SANDOSTATIN
(octreotide acetate) injection, equal to
(EQ) 0.2 milligrams (mg) base/milliliter
(mL) and 1 mg base/mL, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
SUMMARY:
E:\FR\FM\02JNN1.SGM
02JNN1
jbell on DSKJLSW7X2PROD with NOTICES
29586
Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, is the subject of NDA
19667, held by Novartis
Pharmaceuticals Corporation. NDA
19667 was initially approved on
October 21, 1988, and the EQ 0.2 mg
base/mL and EQ 1 mg base/mL strengths
were approved on June 12, 1991.
SANDOSTATIN is indicated to reduce
blood levels of growth hormone and
IGF–I (somatomedin C) in acromegaly
patients who have had inadequate
response to or cannot be treated with
surgical resection, pituitary irradiation,
and bromocriptine mesylate at
maximally tolerated doses.
SANDOSTATIN is also indicated for the
symptomatic treatment of patients with
metastatic carcinoid tumors where it
suppresses or inhibits the severe
diarrhea and flushing episodes
associated with the disease.
SANDOSTATIN is also indicated for the
treatment of profuse watery diarrhea
associated with vasoactive intestinal
peptide-secreting tumors.
In a letter received by the Agency on
May 11, 2020, Novartis Pharmaceuticals
Corporation notified FDA that
VerDate Sep<11>2014
17:49 Jun 01, 2021
Jkt 253001
SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, was being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Caplin
Steriles Limited submitted a citizen
petition dated February 5, 2021 (Docket
No. FDA–2021–P–0163), under 21 CFR
10.30, requesting that the Agency
determine whether SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–11575 Filed 6–1–21; 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; Rural Health Care
Coordination Program Performance
Improvement and Measurement
System Database, OMB No. 0906–
0024—Reinstate With Changes
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with 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.
DATES: Comments on this ICR should be
received no later than July 2, 2021.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Health Care Coordination Program
Performance Improvement and
Measurement System Database, OMB
No. 0906–0024—Reinstate with
Changes.
Abstract: The Rural Health Care
Coordination (Care Coordination)
program is authorized under Section
330A(e) of the Public Health Service
(PHS) Act (42 U.S.C. 254(e)), as
amended, to ‘‘improve access and
SUMMARY:
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Pages 29585-29586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11575]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0163]
Determination That SANDOSTATIN (Octreotide Acetate) Injection,
Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that SANDOSTATIN (octreotide acetate) injection, equal to
(EQ) 0.2 milligrams (mg) base/milliliter (mL) and 1 mg base/mL, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that
[[Page 29586]]
the drug for which they are seeking approval contains the same active
ingredient in the same strength and dosage form as the ``listed drug,''
which is a version of the drug that was previously approved. ANDA
applicants do not have to repeat the extensive clinical testing
otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
SANDOSTATIN (octreotide acetate) injection, EQ 0.2 mg base/mL and
EQ 1 mg base/mL, is the subject of NDA 19667, held by Novartis
Pharmaceuticals Corporation. NDA 19667 was initially approved on
October 21, 1988, and the EQ 0.2 mg base/mL and EQ 1 mg base/mL
strengths were approved on June 12, 1991. SANDOSTATIN is indicated to
reduce blood levels of growth hormone and IGF-I (somatomedin C) in
acromegaly patients who have had inadequate response to or cannot be
treated with surgical resection, pituitary irradiation, and
bromocriptine mesylate at maximally tolerated doses. SANDOSTATIN is
also indicated for the symptomatic treatment of patients with
metastatic carcinoid tumors where it suppresses or inhibits the severe
diarrhea and flushing episodes associated with the disease. SANDOSTATIN
is also indicated for the treatment of profuse watery diarrhea
associated with vasoactive intestinal peptide-secreting tumors.
In a letter received by the Agency on May 11, 2020, Novartis
Pharmaceuticals Corporation notified FDA that SANDOSTATIN (octreotide
acetate) injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book. Caplin Steriles Limited
submitted a citizen petition dated February 5, 2021 (Docket No. FDA-
2021-P-0163), under 21 CFR 10.30, requesting that the Agency determine
whether SANDOSTATIN (octreotide acetate) injection, EQ 0.2 mg base/mL
and EQ 1 mg base/mL, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that SANDOSTATIN (octreotide acetate) injection, EQ
0.2 mg base/mL and EQ 1 mg base/mL, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that SANDOSTATIN (octreotide acetate) injection,
EQ 0.2 mg base/mL and EQ 1 mg base/mL, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL,
in the ``Discontinued Drug Product List'' section of the Orange Book.
The ``Discontinued Drug Product List'' delineates, among other items,
drug products that have been discontinued from marketing for reasons
other than safety or effectiveness. FDA will not begin procedures to
withdraw approval of approved ANDAs that refer to this drug product.
Additional ANDAs for this drug product may also be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11575 Filed 6-1-21; 8:45 am]
BILLING CODE 4164-01-P
