Meeting of the Advisory Committee on Infant and Maternal Mortality; Correction, 75004 [2023-24080]
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Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, Omegaven (fish
oil triglycerides) indicated as a source of
calories and fatty acids in pediatric
patients with parenteral nutritionassociated cholestasis. Subsequent to
this approval, the USPTO received a
patent term restoration application for
Omegaven (U.S. Patent No. 9,566,260)
from Children’s Medical Center
Corporation and the USPTO requested
FDA’s assistance in determining the
patent’s eligibility for patent term
restoration. In a letter dated November
29, 2019, FDA advised the USPTO that
this human drug product had undergone
a regulatory review period and that the
approval of Omegaven represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Omegaven is 4,246 days. Of this time,
4,007 days occurred during the testing
phase of the regulatory review period,
while 239 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: December 13,
VerDate Sep<11>2014
19:48 Oct 31, 2023
Jkt 262001
2006. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on December 13, 2006.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: December 1, 2017.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Omegaven (NDA 210589) was initially
submitted on December 1, 2017.
3. The date the application was
approved: July 27, 2018. FDA has
verified the applicant’s claim that NDA
210589 was approved on July 27, 2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 383 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Infant and Maternal Mortality;
Correction
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice; correction.
AGENCY:
HRSA published a notice in
the Federal Register of October 12,
2023, concerning a meeting of the
Advisory Committee on Infant and
Maternal Mortality. The document
contained incorrect location
information. The notice originally stated
that the meeting would be held in
person at HRSA Headquarters (5600
Fishers Lane, Room 5W07, Rockville,
Maryland, 20857) and virtually via
webinar. The meeting will now be fully
virtual via webinar and not held in
person. The webinar link and log-in
information will be available at the
Committee’s website before the meeting:
https://www.hrsa.gov/advisorycommittees/infant-mortality/.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal
Official, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room 18N84, Rockville, Maryland,
20857; 301–443–0543; or SACIM@
hrsa.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of October 12,
2023, FR Doc. 2023–22509, page 70682,
column 1, ADDRESSES section, paragraph
1, correct ‘‘This meeting will be held in
person at HRSA Headquarters (5600
Fishers Lane, Room 5W07, Rockville,
Maryland, 20857) and virtually via
webinar’’ to read: ‘‘This meeting will be
held by webinar.’’
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–24080 Filed 10–31–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
[FR Doc. 2023–24124 Filed 10–31–23; 8:45 am]
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
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[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Page 75004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Committee on Infant and Maternal
Mortality; Correction
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: HRSA published a notice in the Federal Register of October 12,
2023, concerning a meeting of the Advisory Committee on Infant and
Maternal Mortality. The document contained incorrect location
information. The notice originally stated that the meeting would be
held in person at HRSA Headquarters (5600 Fishers Lane, Room 5W07,
Rockville, Maryland, 20857) and virtually via webinar. The meeting will
now be fully virtual via webinar and not held in person. The webinar
link and log-in information will be available at the Committee's
website before the meeting: https://www.hrsa.gov/advisory-committees/infant-mortality/.
FOR FURTHER INFORMATION CONTACT: Vanessa Lee, MPH, Designated Federal
Official, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane,
Room 18N84, Rockville, Maryland, 20857; 301-443-0543; or
[email protected].
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of October 12, 2023, FR Doc. 2023-22509,
page 70682, column 1, Addresses section, paragraph 1, correct ``This
meeting will be held in person at HRSA Headquarters (5600 Fishers Lane,
Room 5W07, Rockville, Maryland, 20857) and virtually via webinar'' to
read: ``This meeting will be held by webinar.''
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-24080 Filed 10-31-23; 8:45 am]
BILLING CODE 4165-15-P
