Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications, 83551-83552 [2023-26300]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug or biologic 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, Nuzyra Injection
(NDA 209817) (omadacycline). Nuzyra
Injection (NDA 209817) is indicated for
the treatment of adult patients with the
following infections caused by
susceptible microorganisms:
• Community-acquired bacterial
pneumonia, and
• Acute bacterial skin and skin
structure infections.
Subsequent to this approval, the
USPTO received a patent term
restoration application for Nuzyra
Injection (NDA 209817) (U.S. Patent No.
7,553,828) from Paratek
Pharmaceuticals, Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
December 23, 2019, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of Nuzyra
Injection (NDA 209817) and Nuzyra
Tablets (NDA 209816) represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the products’ regulatory review period.
VerDate Sep<11>2014
17:22 Nov 29, 2023
Jkt 262001
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Nuzyra Injection (NDA 209817) is 4,361
days. Of this time, 4,118 days occurred
during the testing phase of the
regulatory review period, while 243
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: October 26,
2006. The applicant claims September
26, 2006, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
October 26, 2006, which was 30 days
after FDA receipt of the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: February 2, 2018. FDA
has verified the applicant’s claim that
the NDA for Nuzyra Injection (NDA
209817) was initially submitted on
February 2, 2018.
3. The date the application was
approved: October 2, 2018. FDA has
verified the applicant’s claim that NDA
209817 was approved on October 2,
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 1,812 days of patent
term extension.
Note: We have determined that the
regulatory review period for the human drug
product, NUZYRA, approved under NDA
209817 is the same as the regulatory review
period determined for the human drug
product, NUZYRA, approved under NDA
209816.
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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
83551
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.
Dated: November 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26363 Filed 11–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2562]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Temporary
Marketing Permit Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 2,
2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0133. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
SUMMARY:
E:\FR\FM\30NON1.SGM
30NON1
83552
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
OMB Control Number 0910–0133—
Extension
This information collection request
supports FDA regulations found in 21
CFR 130.17 (section 130.17). Section
401 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
341) directs FDA to issue regulations
establishing definitions and standards of
identity (SOIs) for food. Under section
403(g) of the FD&C Act (21 U.S.C.
343(g)), a food that is subject to a
definition and SOI prescribed by
regulation is misbranded if it does not
conform to such definition and SOI.
Section 130.17 provides for the issuance
by FDA of temporary marketing permits
(TMPs) that enable the food industry to
test consumer acceptance and measure
the technological and commercial
feasibility in interstate commerce of
experimental packs of food that deviate
from applicable definitions and SOIs.
Section 130.17(c) enables the Agency to
monitor the manufacture, labeling, and
distribution of experimental packs of
food that deviate from applicable
definitions and SOIs. The information
so obtained can be used in support of
a petition to establish or amend the
applicable definition or SOI to provide
for the variations. Section 130.17(i)
specifies the information that a firm
must submit to FDA to obtain an
extension of a TMP. To assist
respondents with the TMP process, we
have developed guidance entitled
‘‘Temporary Permits for Interstate
Shipment of Experimental Packs of
Food Varying from the Requirements of
Definitions and Standards of Identity:
Guidance for Industry’’ (November
2021). This resource can be found on
our website https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-temporary-permits-interstateshipment-experimental-packs-foodvarying-requirements.
Description of Respondents:
Respondents to this collection of
information include private sector
businesses including institutional and/
or industrial customers and food
industry members such as
manufacturers, packers, or distributors
desiring to apply for a TMP or TMP
extension.
In the Federal Register of July 17,
2023 (88 FR 45431), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total hours
130.17(c); Request for TMP ................................................
130.17(i); Request for TMP extension .................................
13
1
2
2
26
2
25
2
650
4
Total ..............................................................................
........................
........................
........................
........................
654
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26300 Filed 11–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4095]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Using Relative Supersaturation To
Support ‘‘Urinary Tract Health’’ Claims
for Adult Maintenance Cat Food; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
17:22 Nov 29, 2023
Jkt 262001
guidance for industry #284 entitled
‘‘Using Relative Supersaturation to
Support ‘‘Urinary Tract Health’’ Claims
for Adult Maintenance Cat Food.’’
FDA’s Center for Veterinary Medicine
(CVM) has evaluated the use of relative
supersaturation (RSS) methodology to
support urinary tract health claims for
certain adult maintenance cat food. RSS
is a measurement that estimates the
potential for crystal formation and
bladder stone growth, which is a
common affliction in cats. This draft
guidance provides recommendations for
how pet food manufacturers can use
RSS methodology to substantiate
general structure or function claims that
an adult maintenance cat food supports
urinary tract health by promoting a
healthy mineral content in the urinary
tract.
Submit either electronic or
written comments on the draft guidance
by February 28, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83551-83552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2562]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Temporary Marketing
Permit Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 2, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0133. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three
[[Page 83552]]
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-8867, [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)
OMB Control Number 0910-0133--Extension
This information collection request supports FDA regulations found
in 21 CFR 130.17 (section 130.17). Section 401 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341) directs FDA to issue
regulations establishing definitions and standards of identity (SOIs)
for food. Under section 403(g) of the FD&C Act (21 U.S.C. 343(g)), a
food that is subject to a definition and SOI prescribed by regulation
is misbranded if it does not conform to such definition and SOI.
Section 130.17 provides for the issuance by FDA of temporary marketing
permits (TMPs) that enable the food industry to test consumer
acceptance and measure the technological and commercial feasibility in
interstate commerce of experimental packs of food that deviate from
applicable definitions and SOIs. Section 130.17(c) enables the Agency
to monitor the manufacture, labeling, and distribution of experimental
packs of food that deviate from applicable definitions and SOIs. The
information so obtained can be used in support of a petition to
establish or amend the applicable definition or SOI to provide for the
variations. Section 130.17(i) specifies the information that a firm
must submit to FDA to obtain an extension of a TMP. To assist
respondents with the TMP process, we have developed guidance entitled
``Temporary Permits for Interstate Shipment of Experimental Packs of
Food Varying from the Requirements of Definitions and Standards of
Identity: Guidance for Industry'' (November 2021). This resource can be
found on our website https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements.
Description of Respondents: Respondents to this collection of
information include private sector businesses including institutional
and/or industrial customers and food industry members such as
manufacturers, packers, or distributors desiring to apply for a TMP or
TMP extension.
In the Federal Register of July 17, 2023 (88 FR 45431), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
130.17(c); Request for TMP...... 13 2 26 25 650
130.17(i); Request for TMP 1 2 2 2 4
extension......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 654
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26300 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P
