Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 27092 [2021-10535]
Download as PDF
<![CDATA[
27092
Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices
Food and Drug Administration
[Docket Nos. FDA–2019–N–5666, FDA–
2011–N–0231, FDA–2010–N–0161, FDA–
2011–N–0275, and FDA–2013–D–0575]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Empirical Study of Promotional Implications of Proprietary Prescription Drug Names ..........................................
Adverse Experience Reporting for Licensed Biological Products; and General Records ......................................
Export Certificates for FDA Regulated Products .....................................................................................................
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions ...........................
Expedited Program for Serious Conditions-Drugs and Biologics ...........................................................................
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10535 Filed 5–18–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–P–2244 and FDA–
2020–P–2245]
Determination That ISOPTIN
(Verapamil Hydrochloride) Tablets 40
Milligrams, 80 Milligrams, and 120
Milligrams, and CALAN (Verapamil
Hydrochloride) Tablets, 40 Milligrams,
80 Milligrams, 120 Milligrams, and 160
Milligrams, Were 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 ISOPTIN
(verapamil hydrochloride) tablets, 40
milligrams (mg), 80 mg, and 120 mg,
and CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160
mg, were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for ISOPTIN
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:43 May 18, 2021
Jkt 253001
(verapamil hydrochloride) tablets, 40
mg, 80 mg, and 120 mg, and CALAN
(verapamil hydrochloride) tablets, 40
mg, 80 mg, 120 mg, and 160 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3601, Nicole.Mueller@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
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,’’
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
0910–0896
0910–0308
0910–0498
0910–0616
0910–0765
Date approval
expires
4/30/2023
4/30/2024
4/30/2024
4/30/2024
4/30/2024
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.
ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, are
the subject of NDA 018593, held by Mt.
Adams Technologies, LLC, and initially
approved on March 8, 1982. CALAN
(verapamil hydrochloride) tablets, 40
mg, 80 mg, 120 mg, and 160 mg, are the
subject of NDA 018817, held by Pfizer
Inc., and initially approved on
September 10, 1984. ISOPTIN and
CALAN are indicated for the treatment
of angina, arrythmias, and essential
hypertension.
Center Laboratories, Inc., submitted
two citizen petitions dated November
30, 2020 (Docket Nos. FDA–2020–P–
2244 and FDA–2020–P–2245), under 21
CFR 10.30, requesting that the Agency
determine whether ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Page 27092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10535]
[[Page 27092]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2019-N-5666, FDA-2011-N-0231, FDA-2010-N-0161, FDA-
2011-N-0275, and FDA-2013-D-0575]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Empirical Study of Promotional 0910-0896 4/30/2023
Implications of Proprietary
Prescription Drug Names................
Adverse Experience Reporting for 0910-0308 4/30/2024
Licensed Biological Products; and
General Records........................
Export Certificates for FDA Regulated 0910-0498 4/30/2024
Products...............................
Certification to Accompany Drug, 0910-0616 4/30/2024
Biological Product, and Device
Applications or Submissions............
Expedited Program for Serious Conditions- 0910-0765 4/30/2024
Drugs and Biologics....................
------------------------------------------------------------------------
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10535 Filed 5-18-21; 8:45 am]
BILLING CODE 4164-01-P
