Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP, 61065-61066 [2019-24527]
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61065
Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices
OMB control number 0910–0340. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Format and Content Requirements for
Over-the-Counter Drug Product
Labeling—21 CFR Part 201
OMB Control Number 0910–0340—
Extension
This information collection supports
FDA regulations at § 201.66 (21 CFR
201.66), which establish standardized
content and format requirements for the
labeling of all marketed over-thecounter (OTC) drug products. The
regulations set forth the content and
format requirements for the Drug Facts
portion of labels on OTC drug products.
These regulations require OTC drug
product labeling to include uniform
headings and subheadings, presented in
a standardized order, with minimum
standards for type size and other
graphical features.
Currently marketed OTC drug
products are already required to comply
with these labeling requirements and
will incur no further burden to comply
with Drug Facts labeling requirements
in § 201.66. Labeling modifications
already required to be in Drug Facts
format are ‘‘usual and customary’’ as
part of routine redesign practice, thus
they do not create additional burden
within the meaning of the PRA.
Therefore, burden for this information
collection is that which is necessary to
comply with the labeling requirements
in § 201.66, applicable to new OTC drug
products and OTC sunscreen drug
products introduced to the marketplace
under new drug applications,
abbreviated new drug applications, or
an OTC drug monograph. New OTC
drug products must comply with the
labeling requirements in § 201.66 as
they are introduced to the marketplace.
Based on our electronic drug
registration and listing database, we
estimate that approximately 10,463 new
OTC drug product stock keeping units
(SKUs) are introduced to the
marketplace each year. We estimate that
these SKUs are marketed by 1,416
manufacturers. We estimate that the
preparation of labeling for new OTC
drug products requires 12 hours to
prepare, complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is 94,296
hours.
All currently marketed sunscreen
products are required to comply with
the Drug Facts labeling requirements in
§ 201.66, so they will incur no further
burden under the information collection
provisions in the regulation. However, a
new OTC sunscreen drug product, like
any new OTC drug product, will be
subject to a one-time burden to comply
with Drug Facts labeling requirements
in § 201.66. We estimate, based on our
electronic drug registration and listing
database, that 5,253 new SKUs of OTC
sunscreen drug products will be
marketed each year. We estimate that
these 5,253 SKUs will be marketed by
294 manufacturers. We estimate that 12
hours will be spent on each label. This
is reflected in table 1, row 1.
When determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e). We
receive very few requests for
exemptions or deferrals. We also
estimate that a request for deferral or
exemption requires 24 hours to
complete. This is reflected in table 1,
row 2.
In the Federal Register of June 19,
2019 (84 FR 28555), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
from a trade organization representing
nurse practitioners. The comment
advocated revising FDA regulations to
provide for provider-neutral language in
Agency regulations but acknowledged
its use in current Agency guidance. We
appreciate this comment, but we decline
to adopt the suggestion at this time.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
§ 201.66(c) and (d) for new OTC drug products .................
§ 201.66(e) ...........................................................................
855
1
9.19
1
7,858
1
12
24
94,296
24
Total ..............................................................................
........................
........................
........................
........................
94,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 82,797 hours and a
corresponding increase of 6,898
disclosures. This increase corresponds
with data obtained from our database.
Dated: October 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24509 Filed 11–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4777]
Haemonetics Manufacturing, Inc.;
Withdrawal of Approval of Abbreviated
New Drug Application of Anticoagulant
Citrate Dextrose Solution A, USP
AGENCY:
ACTION:
VerDate Sep<11>2014
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Food and Drug Administration,
HHS.
Jkt 250001
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Notice.
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The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of abbreviated
new drug application (ANDA) BA
710497/0 for Anticoagulant Citrate
Dextrose Solution A, USP (ACD–A), In
Plastic Bags, held by Haemonetics
Manufacturing, Inc. Haemonetics
Manufacturing, Inc., requested in
writing that the Agency’s approval of
the application be withdrawn because
the drug is no longer being marketed
and has waived its opportunity for a
hearing.
SUMMARY:
E:\FR\FM\12NON1.SGM
12NON1
61066
Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices
Approval is withdrawn as of
December 12, 2019.
FOR FURTHER INFORMATION CONTACT:
Sana F. Hussain, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
Haemonetics Manufacturing, Inc., 400
Wood Rd., Braintree, MA 02184, has
requested that FDA withdraw approval
of ANDA BA 710497/0, pursuant to
§ 314.150(c) (21 CFR 314.150(c)),
because the drug is no longer being
marketed. By its request, Haemonetics
Manufacturing, Inc., has also waived its
opportunity for a hearing. Withdrawal
of approval of an application under
§ 314.150(c) is without prejudice to
refiling.
DATES:
Application No.
Proprietary name
ANDA BA 710497/0 ...
Anticoagulant Citrate Dextrose Solution A, USP
(ACD–A) In Plastic Bags.
Therefore, approval of the application
listed in the table, and all amendments
and supplements thereto, is hereby
withdrawn as of December 12, 2019.
Introduction or delivery for introduction
into interstate commerce for products
without an approved new drug
application or ANDA violates section
301(a) and (d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(a) and
(d)). The drug product that is listed in
the table above that is in inventory on
December 12, 2019 may continue to be
dispensed until the inventory has been
depleted or the drug product has
reached its expiration date or otherwise
becomes violative, whichever occurs
first.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24527 Filed 11–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health Center for
Scientific Review; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
VerDate Sep<11>2014
17:47 Nov 08, 2019
Jkt 250001
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Interventions and Mechanisms for
Addiction.
Date: December 2, 2019.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Marc Boulay, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
MSC 7808, Bethesda, MD 20892, (301) 300–
6541, boulaymg@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Interactive Digital Media STEM Resources for
Pre-College and Informal Science Education
Audiences (SBIR/STTR).
Date: December 3, 2019.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Marie-Jose Belanger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 6188,
MSC 7804, Bethesda, MD 20892, 301–435–
1267, belangerm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Lasker
Clinical Research Scholars Program (Si2/R00
Clinical Trial Optional).
Date: December 3, 2019.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Abdelouahab Aitouche,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4222,
MSC 7814, Bethesda, MD 20892, 301–435–
2365, aitouchea@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neurodevelopmental and Neurodegenerative
Disorders.
Date: December 3, 2019.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
PO 00000
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Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 4, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–24466 Filed 11–8–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[Docket No. USCBP–2019–0042]
Commercial Customs Operations
Advisory Committee (COAC)
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security (DHS).
ACTION: Committee Management; Notice
of Federal Advisory Committee Meeting.
AGENCY:
The Commercial Customs
Operations Advisory Committee (COAC)
will hold its quarterly meeting on
Wednesday, December 4, 2019, in
Washington, DC. The meeting will be
open to the public to attend either in
person or via webinar.
DATES: The COAC will meet on
Wednesday, December 4, 2019, from
1:00 p.m. to 5:00 p.m. EST. Please note
that the meeting may close early if the
committee has completed its business.
Comments must be submitted in writing
no later than December 3, 2019.
ADDRESSES: The meeting will be held at
the Ronald Reagan Building,
International Trade Center-Horizon
Ballroom, 1300 Pennsylvania Ave. NW,
Washington, DC 20229. For information
on facilities or services for individuals
with disabilities or to request special
assistance at the meeting, contact Ms.
Florence Constant-Gibson, Office of
Trade Relations, U.S. Customs and
Border Protection (CBP), at (202) 344–
1440 as soon as possible.
FOR FURTHER INFORMATION CONTACT: Ms.
Florence Constant-Gibson, Office of
Trade Relations, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue NW, Room 3.5A, Washington,
DC 20229; telephone (202) 344–1440;
facsimile (202) 325–4290; or Ms. Valarie
M. Neuhart, Acting Executive Director
SUMMARY:
E:\FR\FM\12NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61065-61066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4777]
Haemonetics Manufacturing, Inc.; Withdrawal of Approval of
Abbreviated New Drug Application of Anticoagulant Citrate Dextrose
Solution A, USP
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of abbreviated new drug application (ANDA) BA
710497/0 for Anticoagulant Citrate Dextrose Solution A, USP (ACD-A), In
Plastic Bags, held by Haemonetics Manufacturing, Inc. Haemonetics
Manufacturing, Inc., requested in writing that the Agency's approval of
the application be withdrawn because the drug is no longer being
marketed and has waived its opportunity for a hearing.
[[Page 61066]]
DATES: Approval is withdrawn as of December 12, 2019.
FOR FURTHER INFORMATION CONTACT: Sana F. Hussain, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION: Haemonetics Manufacturing, Inc., 400 Wood
Rd., Braintree, MA 02184, has requested that FDA withdraw approval of
ANDA BA 710497/0, pursuant to Sec. 314.150(c) (21 CFR 314.150(c)),
because the drug is no longer being marketed. By its request,
Haemonetics Manufacturing, Inc., has also waived its opportunity for a
hearing. Withdrawal of approval of an application under Sec.
314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Proprietary name
------------------------------------------------------------------------
ANDA BA 710497/0.......................... Anticoagulant Citrate
Dextrose Solution A, USP
(ACD-A) In Plastic Bags.
------------------------------------------------------------------------
Therefore, approval of the application listed in the table, and all
amendments and supplements thereto, is hereby withdrawn as of December
12, 2019. Introduction or delivery for introduction into interstate
commerce for products without an approved new drug application or ANDA
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331(a) and (d)). The drug product that is listed in the
table above that is in inventory on December 12, 2019 may continue to
be dispensed until the inventory has been depleted or the drug product
has reached its expiration date or otherwise becomes violative,
whichever occurs first.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24527 Filed 11-8-19; 8:45 am]
BILLING CODE 4164-01-P
