Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches, 106521-106522 [2024-31266]
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
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Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31275 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5702]
Transfer of Regulatory Responsibility
From the Center for Devices and
Radiological Health to the Center for
Biologics Evaluation and Research;
Medical Maggots and Medicinal
Leeches
AGENCY:
Food and Drug Administration,
HHS.
Notice; announcement of
transfer.
ACTION:
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106521
The Food and Drug
Administration (FDA) is announcing the
transfer of regulatory responsibility for
medical maggots and medicinal leeches
to the Center for Biologics Evaluation
and Research (CBER). These products
are currently regulated by the Center for
Devices and Radiological Health
(CDRH). FDA is transferring regulatory
responsibility of these products to CBER
because these products are living
organisms that more closely align with
products regulated by CBER. This action
affects only Center assignment and does
not change requirements applicable to
these products.
DATES: FDA is transferring regulatory
responsibility to CBER on December 30,
2024.
FOR FURTHER INFORMATION CONTACT:
Annette Marthaler, Office of
Combination Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Silver Spring, MD 20993,
301–796–8930, annette.marthaler@
fda.hhs.gov or combination@fda.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the transfer of regulatory
responsibility for medical maggots
(Phaenicia sericacta (blow fly) larvae)
and medicinal leeches (Hirudo
medicinalis) from CDRH to CBER.
Medical maggots (including maggots
and larvae) (product code NQK) (also
referred to as maggot therapy) are
harvested and provided disinfected for
use in debriding non-healing necrotic
skin and soft tissue wounds, including
pressure ulcers, venous stasis ulcers,
neuropathic foot ulcers, and nonhealing traumatic or post-surgical
wounds. Medicinal leeches (product
code NRN) belong to the Annelida
worm classification. The animal is a
bloodsucking aquatic animal living in
fresh water indicated as an adjunct to
graft tissue healing when problems of
venous congestion may delay healing, or
to overcome the problem of venous
congestion by creating prolonged
localized bleeding.
FDA is transferring the regulatory
responsibility for medical maggots and
medicinal leeches to CBER so that these
products are regulated by the same
Center that regulates other living
organisms for human use. The transfer
will help ensure the consistent and
effective regulation of products that are
living organisms for human use. This
transfer affects only Center assignment
and does not change requirements
applicable to these products.
For the transferred products,
submissions, communications, and
required reports should be directed to
CBER after December 30, 2024. CDRH
will continue to handle submissions
SUMMARY:
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
received (including those under review
or on hold) until the publication date of
this Federal Register document for
transferred products and, if applicable,
until a final decision on the submission
is reached. For questions on any
submissions with CDRH, please contact
CDRH Product Jurisdiction at
CDRHProductJurisdiction@fda.hhs.gov.
For questions on submissions to CBER,
please contact
CBERProductJurisdiction@fda.hhs.gov.
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31266 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3248]
Fosun Pharma USA Inc., et al.;
Withdrawal of Approval of 23
Abbreviated New Drug Applications;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on July 29, 2024. The
document announced the withdrawal of
approval of 23 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of August 28,
2024. The document indicated that FDA
was withdrawing approval of the
ANDAs 073462 for tolmetin sodium
capsules, equivalent to (EQ) 400
milligrams (mg) base; 073588 for
tolmetin sodium tablets, EQ 200 mg
base; 074002 for tolmetin sodium
tablets, EQ 600 mg base; 077040 for
citalopram hydrobromide tablets, EQ 10
mg base, EQ 20 mg base; EQ 40 mg base;
085787 for trifluoperazine
hydrochloride (HCl) concentrate, EQ 10
mg base/milliliters (mL); 086808 for
cyproheptadine HCl tablets, 4 mg;
087774 for phenylbutazone capsules,
100 mg; and 088602 for
pseudoephedrine HCl; triprolidine HCl
tablets, 60 mg/2.5.mg, held by Fosun
Pharma USA Inc., 104 Carnegie Center,
Suite 204, Princeton, NJ 08540.
Additionally, ANDAS 075631 for
ketorolac tromethamine injectable, 15
mg/mL and 30 mg/mL; 076427 for
milrinone lactate injectable, EQ 1 mg
base/mL; 076791 for haloperidol lactate
injectable, EQ 5 mg base/mL; 076828
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SUMMARY:
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haloperidol lactate injectable, EQ 5 mg
base/mL; 077947 for fluconazole
injectable, 200 mg/100 mL (2 mg/mL)
and 400 mg/200 mL (2 mg/mL); 078197
for granisetron HCl injectable, EQ 0.1
mg base/mL (EQ 0.1 mg base/mL);
091436 for levofloxacin injectable, EQ
500 mg/20 mL (EQ 25 mg/mL); 207101
for sumatriptan succinate injectable, EQ
6 mg base/0.5 mL (EQ12 mg base/mL);
and 215065 for methocarbamol solution,
1gram/10 mL (100 mg/mL), held by
Baxter Healthcare Corp., One Baxter
Parkway, Deerfield, IL 60015; and the
ANDAs 090367 for levofloxacin tablets,
250 mg, 500 mg, 750 mg; and 211959 for
clobazam tablets, 10 mg and 20 mg, held
by Celltrion USA, Inc., U.S. Agent for
Celltrion, Inc., One Evertrust Plaza,
Suite 1207, Jersey City, NJ 07302; and
the ANDA 212053 for chlorzoxazone
tablet, 375 mg and 750 mg, held by i3
Pharmaceuticals LLC, 200 Park Ave.,
Warminster, PA 18974. Before FDA
withdrew the approval of these ANDAs,
Fosun Pharma USA Inc.; Baxter
Healthcare Corp.; Celltrion USA, Inc.,
U.S. Agent for Celltrion, Inc.; and i3
Pharmaceuticals LLC, 200 Park Ave.,
Warminster, PA 18974, informed FDA
that they did not want the approval of
the ANDAs withdrawn. Because Fosun
Pharma USA Inc.; Baxter Healthcare
Corp.; Celltrion USA, Inc., U.S. Agent
for Celltrion, Inc.; and i3
Pharmaceuticals, LLC, timely requested
that approval of their respective ANDAs
not be withdrawn, the approvals are still
in effect. This notice corrects these
errors.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Monday, July 29,
2024 (89 FR 60902), appearing on page
60902 in FR Doc. 2024–16627, the
following correction is made:
On page 60902, in the table, the
entries for ANDA 073462, ANDA
073588, ANDA 074002, ANDA 075631,
ANDA 076427, ANDA 076791, ANDA
076828, ANDA 077040, ANDA 077947,
ANDA 078197, ANDA 085787, ANDA
086808, ANDA 087774, ANDA 088602,
ANDA 090367, ANDA 091436 ANDA
207101, ANDA 211959, ANDA 212053,
and ANDA 215065 are removed.
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31307 Filed 12–27–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Update to the Health Resources and
Services Administration-Supported
Women’s Preventive Services
Guidelines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
The Health Resources and
Services Administration (HRSA)
published a Federal Register Notice on
October 22, 2024, with proposed
updates to the HRSA-supported
Women’s Preventive Services
Guidelines (Guidelines). The proposed
updates specifically relate to
recommendations for Screening and
Counseling for Intimate Partner and
Domestic Violence, Breast Cancer
Screening for Women at Average Risk,
and Patient Navigation Services for
Breast and Cervical Cancer Screening.
Recommendations to update the
Guidelines are developed by the
Women’s Preventive Services Initiative
(WPSI) for consideration by HRSA.
WPSI convenes expert health
professionals to conduct rigorous
reviews of the evidence following the
National Academy of Medicine
standards for establishing foundations
for and rating strengths of
recommendations, articulation of
recommendations, and external reviews
and it develops draft recommendations
for HRSA’s consideration. After
consideration of public comment, HRSA
has accepted the recommendations as
revised and detailed in this notice.
Under applicable law, nongrandfathered group health plans and
health insurance issuers offering nongrandfathered group and individual
health insurance coverage must include
coverage, without cost sharing, for
certain preventive services, including
those provided for in the HRSAsupported Guidelines. The Departments
of Labor, Health and Human Services,
and the Treasury have previously issued
regulations describing how group health
plans and health insurance issuers
apply the coverage requirements. Please
see https://www.hrsa.gov/womensguidelines for additional information.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone:
(301) 443–2170, email: wellwomancare@
hrsa.gov.
E:\FR\FM\30DEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106521-106522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5702]
Transfer of Regulatory Responsibility From the Center for Devices
and Radiological Health to the Center for Biologics Evaluation and
Research; Medical Maggots and Medicinal Leeches
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; announcement of transfer.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
transfer of regulatory responsibility for medical maggots and medicinal
leeches to the Center for Biologics Evaluation and Research (CBER).
These products are currently regulated by the Center for Devices and
Radiological Health (CDRH). FDA is transferring regulatory
responsibility of these products to CBER because these products are
living organisms that more closely align with products regulated by
CBER. This action affects only Center assignment and does not change
requirements applicable to these products.
DATES: FDA is transferring regulatory responsibility to CBER on
December 30, 2024.
FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Silver Spring, MD 20993, 301-796-8930,
[email protected] or [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the transfer of regulatory
responsibility for medical maggots (Phaenicia sericacta (blow fly)
larvae) and medicinal leeches (Hirudo medicinalis) from CDRH to CBER.
Medical maggots (including maggots and larvae) (product code NQK) (also
referred to as maggot therapy) are harvested and provided disinfected
for use in debriding non-healing necrotic skin and soft tissue wounds,
including pressure ulcers, venous stasis ulcers, neuropathic foot
ulcers, and non-healing traumatic or post-surgical wounds. Medicinal
leeches (product code NRN) belong to the Annelida worm classification.
The animal is a bloodsucking aquatic animal living in fresh water
indicated as an adjunct to graft tissue healing when problems of venous
congestion may delay healing, or to overcome the problem of venous
congestion by creating prolonged localized bleeding.
FDA is transferring the regulatory responsibility for medical
maggots and medicinal leeches to CBER so that these products are
regulated by the same Center that regulates other living organisms for
human use. The transfer will help ensure the consistent and effective
regulation of products that are living organisms for human use. This
transfer affects only Center assignment and does not change
requirements applicable to these products.
For the transferred products, submissions, communications, and
required reports should be directed to CBER after December 30, 2024.
CDRH will continue to handle submissions
[[Page 106522]]
received (including those under review or on hold) until the
publication date of this Federal Register document for transferred
products and, if applicable, until a final decision on the submission
is reached. For questions on any submissions with CDRH, please contact
CDRH Product Jurisdiction at [email protected]. For
questions on submissions to CBER, please contact
[email protected].
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31266 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
