Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority, 78313-78315 [2024-21904]
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Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6200, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
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 biological 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, DAYBUE
(trofinetide). DAYBUE is indicated for
the treatment of Rett syndrome in adults
and pediatric patients 2 years of age and
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17:28 Sep 24, 2024
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older. Subsequent to this approval, the
USPTO received a patent term
restoration application for DAYBUE
(U.S. Patent No. 9,212,204) from Acadia
Pharmaceuticals Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
January 24, 2024, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
DAYBUE 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
DAYBUE is 5,106 days. Of this time,
4,864 days occurred during the testing
phase of the regulatory review period,
while 242 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: March 19,
2009. The applicant claims December
20, 2012, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
March 19, 2009, which was 30 days
after FDA receipt of an earlier IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: July 12, 2022. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
DAYBUE (NDA 217026) was initially
submitted on July 12, 2022.
3. The date the application was
approved: March 10, 2023. FDA has
verified the applicant’s claim that NDA
217026 was approved on March 10,
2023.
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 1,443 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
PO 00000
Frm 00035
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78313
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.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21941 Filed 9–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2381]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Recall Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 October 25,
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
SUMMARY:
E:\FR\FM\25SEN1.SGM
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78314
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices
by using the search function. The OMB
control number for this information
collection is 0910–0432. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
Medical Device Recall Authority
OMB Control Number 0910–0432—
Extension
This collection of information helps
to implement section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360h(e)) and
regulations in part 810 (21 CFR part
810) which set forth mandatory medical
device recall authority provisions.
Section 518(e) of the FD&C Act provides
FDA with the authority to issue an order
requiring an appropriate person,
including manufacturers, importers,
distributors, and retailers of a device, if
FDA finds that there is reasonable
probability that the device intended for
human use would cause serious,
adverse health consequences or death,
to: (1) Immediately cease distribution of
such device and (2) immediately notify
health professionals and device-user
facilities of the order and to instruct
such professionals and facilities to cease
use of such device.
The person named in the order will
have an opportunity for a regulatory
hearing or to provide a written request
to FDA asking that the order be
modified, vacated, or amended. FDA
may later amend the order to require a
mandatory recall of the device. FDA
currently allows for these requests,
along with other reports and records
concerning mandatory recalls, to be
submitted to the Agency using
electronic methods including email and
FDA’s eSubmitter program (https://
www.fda.gov/industry/fda-esubmitter).
FDA issued part 810 to implement the
provisions of section 518 of the FD&C
Act. The information collected under
the mandatory recall authority
provisions is used by FDA to implement
mandatory recalls.
Description of Respondents:
Respondents for this collection of
information are firms, including
medical device manufacturers,
importers, distributors, and retailers,
that have been issued a cease
distribution and notification order or
mandatory recall order in accordance
with the provisions under part 810,
during the timeframe(s) specified in the
order.
In the Federal Register of June 5, 2024
(89 FR 48174), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Collection activity—21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
2
1
1
1
2
1
8
8
16
8
1
1
1
8
8
2
1
2
16
32
2
12
24
40
960
2
1
2
8
16
....................
........................
..................
....................
1,040
Submission of information to FDA about device distribution and remedial
actions to be taken, as specified in the order—810.10(d) .......................
Submission of a written request for regulatory hearing—810.11(a) ...........
Submission of a written request to FDA asking that the order be modified
or vacated—810.12(a–b) ..........................................................................
Submission of a strategy for compliance with cease distribution and notification or mandatory recall order—810.14 ..............................................
Submission of periodic status reports to FDA to enable the Agency to assess progress in compliance with the order—810.16(a–b) .....................
Submission of a written request to FDA to certify compliance with and
terminate the order—810.17(a) ................................................................
Total Hours ...........................................................................................
1 There
Average
burden per
response
Total
hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Collection activity—21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Documentation of communications to appropriate person(s)—810.15(b)
2
1
1 There
Total
annual
records
I
2
I
Average
burden per
recordkeeping
Total
hours
8
16
are no capital costs or operating and maintenance costs associated with this collection of information.
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Collection activity—21 CFR section
Communications to appropriate person(s) concerning a cease distribution
and notification or mandatory recall order—810.15(a)–(c) ..........................
Follow up communications to appropriate person(s) who fail to respond to
the initial communication—810.15(d) ...........................................................
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Number of
disclosures
per
respondent
Total
annual
responses
Average
burden per
disclosure
Total
hours
2
1
2
12
24
2
1
2
4
8
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Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Collection activity—21 CFR section
Total
annual
responses
Average
burden per
disclosure
Total
hours
Notifications provided by recipients of communications to appropriate consignees—810.15(e) ......................................................................................
10
1
10
1
10
Total ..........................................................................................................
....................
....................
..................
....................
42
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden per response, burden per
recordkeeping, and burden per
disclosure estimates are based on FDA’s
recent experience with voluntary recalls
under 21 CFR part 7. Based on an
analysis of cease distribution and
notification and mandatory recall order
activity over the last 3 years, FDA
expects no more than two of such
actions per year as a conservative
estimate.
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: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21904 Filed 9–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–E–2829]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ELUCIREM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ELUCIREM and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
disclosures
per
respondent
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by November 25, 2024.
DATES:
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17:28 Sep 24, 2024
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Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
March 24, 2025. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 25, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
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Fmt 4703
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• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–E–2829 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; ELUCIREM.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
E:\FR\FM\25SEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78313-78315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21904]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2381]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device Recall
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 October 25, 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
[[Page 78314]]
by using the search function. The OMB control number for this
information collection is 0910-0432. Also include the FDA docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Medical Device Recall Authority
OMB Control Number 0910-0432--Extension
This collection of information helps to implement section 518(e) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e))
and regulations in part 810 (21 CFR part 810) which set forth mandatory
medical device recall authority provisions. Section 518(e) of the FD&C
Act provides FDA with the authority to issue an order requiring an
appropriate person, including manufacturers, importers, distributors,
and retailers of a device, if FDA finds that there is reasonable
probability that the device intended for human use would cause serious,
adverse health consequences or death, to: (1) Immediately cease
distribution of such device and (2) immediately notify health
professionals and device-user facilities of the order and to instruct
such professionals and facilities to cease use of such device.
The person named in the order will have an opportunity for a
regulatory hearing or to provide a written request to FDA asking that
the order be modified, vacated, or amended. FDA may later amend the
order to require a mandatory recall of the device. FDA currently allows
for these requests, along with other reports and records concerning
mandatory recalls, to be submitted to the Agency using electronic
methods including email and FDA's eSubmitter program (https://www.fda.gov/industry/fda-esubmitter).
FDA issued part 810 to implement the provisions of section 518 of
the FD&C Act. The information collected under the mandatory recall
authority provisions is used by FDA to implement mandatory recalls.
Description of Respondents: Respondents for this collection of
information are firms, including medical device manufacturers,
importers, distributors, and retailers, that have been issued a cease
distribution and notification order or mandatory recall order in
accordance with the provisions under part 810, during the timeframe(s)
specified in the order.
In the Federal Register of June 5, 2024 (89 FR 48174), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
Collection activity--21 CFR section Number of responses per annual burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Submission of information to FDA about device 2 1 2 8 16
distribution and remedial actions to be taken,
as specified in the order--810.10(d)...........
Submission of a written request for regulatory 1 1 1 8 8
hearing--810.11(a).............................
Submission of a written request to FDA asking 1 1 1 8 8
that the order be modified or vacated--810.12(a-
b).............................................
Submission of a strategy for compliance with 2 1 2 16 32
cease distribution and notification or
mandatory recall order--810.14.................
Submission of periodic status reports to FDA to 2 12 24 40 960
enable the Agency to assess progress in
compliance with the order--810.16(a-b).........
Submission of a written request to FDA to 2 1 2 8 16
certify compliance with and terminate the
order--810.17(a)...............................
---------------------------------------------------------------
Total Hours................................. ........... .............. .......... ........... 1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average burden
Collection activity--21 CFR section Number of records per annual per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
Documentation of communications to 2 1 2 8 16
appropriate person(s)--810.15(b)......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total Average Total
Collection activity--21 CFR section respondents per annual burden per hours
respondent responses disclosure
----------------------------------------------------------------------------------------------------------------
Communications to appropriate person(s) concerning 2 1 2 12 24
a cease distribution and notification or mandatory
recall order--810.15(a)-(c).......................
Follow up communications to appropriate person(s) 2 1 2 4 8
who fail to respond to the initial communication--
810.15(d).........................................
[[Page 78315]]
Notifications provided by recipients of 10 1 10 1 10
communications to appropriate consignees--
810.15(e).........................................
------------------------------------------------------------
Total.......................................... ........... ........... .......... ........... 42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden per response, burden per recordkeeping, and burden per
disclosure estimates are based on FDA's recent experience with
voluntary recalls under 21 CFR part 7. Based on an analysis of cease
distribution and notification and mandatory recall order activity over
the last 3 years, FDA expects no more than two of such actions per year
as a conservative estimate.
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: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21904 Filed 9-24-24; 8:45 am]
BILLING CODE 4164-01-P
