Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Summary Reporting Requirements Under the Right to Try Act, 64226-64227 [2022-23035]
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64226
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
TANF Financial Report, Form ACF–196T .......................................................
Estimated Total Annual Burden
Hours: 306.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Social Security Act,
Section 409; 45 CFR 286,245–286.285.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–23013 Filed 10–21–22; 8:45 am]
BILLING CODE 4184–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5553]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Annual Summary
Reporting Requirements Under the
Right to Try Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
51
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by November
23, 2022.
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 0910–0893. 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.
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.
Annual Summary Reporting
Requirements Under the Right to Try
Act
OMB Control Number 0910–0893
This information collection helps to
implement provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), added by the Right to Try Act,
which requires sponsors and
manufacturers who provide an ‘‘eligible
investigational drug’’ under the Right to
Try Act to submit to FDA an annual
summary of such use. Regulations under
§ 300.200 (21 CFR 300.200) will require
that sponsors and manufacturers submit
to FDA an annual summary no later
than March 31 of each year, including
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Annual
number of
responses per
respondent
4
Average
burden hours
per response
1.5
Annual
burden
hours
306
data for the preceding calendar year,
that includes the following data
elements:
• The name of the eligible
investigational drug and applicable
investigational new drug application
number.
• The number of doses supplied to
the eligible patient.
• The number of eligible patients
treated.
• The use for which the eligible
investigational drug was made available
to the eligible patient.
• Any known serious adverse events
and outcomes that the eligible patient
treated with an eligible investigational
drug experienced.
Description of Respondents:
Respondents to the information
collection are sponsors and
manufacturers who provide an eligible
investigational drug to eligible patients
in accordance with the Right to Try Act
and will submit to FDA annual
summaries.
In the Federal Register of September
14, 2022 (87 FR 56269), we published a
final rule (RIN 0910–AI36), including an
analysis of the information collection,
and discussed the development of an
associated form to facilitate submission
of the requisite information.
Accordingly, we have developed Form
FDA 5023 entitled ‘‘Right To Try
Reporting Requirement: Annual
Summary,’’ which is currently available
in the docket for comment purposes
only, and we are inviting public
comment. As required by the applicable
statute, section 561B of the FD&C Act
(21 U.S.C. 360bbb–0a), the information
is submitted to an FDA-designated point
of contact, and in accordance with
instructions to be posted at: https://
www.fda.gov/patients/learn-aboutexpanded-access-and-other-treatmentoptions/right-try.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\24OCN1.SGM
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
64227
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity; 21 CFR citation
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Sponsors and manufacturers submit annual summaries in
accordance with the Right to Try Act (§ 300.200) using
Form FDA 5023 ................................................................
6
1
6
2.5
15
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with estimates in our Final
Regulatory Impact Analysis for the
associated final rule, we estimate that
six sponsors and manufacturers will
prepare and submit Form FDA 5023 and
assume it takes 2.5 hours to prepare and
submit each summary, which results in
a total of 15 hours annually.
2022. Submit all data, information, and
analyses upon which the request for a
hearing relies by December 23, 2022.
Submit electronic or written comments
by December 23, 2022.
ADDRESSES: The request for a hearing
may be submitted by the ANDA holder
by either of the following methods:
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for a
hearing, will be posted to the docket
unchanged.
[FR Doc. 2022–23035 Filed 10–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2391]
Miles Laboratories Inc.; Proposal To
Withdraw Approval of an Abbreviated
New Drug Application for Alcohol and
Dextrose Injection; 5 Milliliters/100
Milliliters, 5 Grams/100 Milliliters;
Opportunity for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of an abbreviated new drug
application (ANDA) for Alcohol and
Dextrose Injection, 5 milliliters (mL)/
100 mL, 5 grams (g)/100 mL, and is
announcing an opportunity for the
ANDA holder to request a hearing on
this proposal: Miles Laboratories Inc.,
P.O. Box 1986, 4th and Parker St.,
Berkeley, CA 94701, is the last holder of
record. The bases for the proposal are
that the ANDA holder has repeatedly
failed to file required annual reports for
this ANDA and that the Agency has
scientific data and experience to show
that the drug product under this ANDA
is unsafe for use under the conditions of
use for which the product was
approved.
DATES: The ANDA holder may submit a
request for a hearing by November 23,
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SUMMARY:
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• 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.
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request 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. The request
for a hearing must include the Docket
No. FDA–2022–N–2391 for ‘‘Miles
Laboratories Inc.; Proposal To Withdraw
Approval of an Abbreviated New Drug
Application for Alcohol and Dextrose
Injection, 5 Milliliters/100 Milliliters, 5
Grams/100 Milliliters; Opportunity for a
Hearing.’’ The request for a hearing will
be placed in the docket and 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.
The ANDA holder may submit all
data and analyses upon which the
request for a hearing relies in the same
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Frm 00029
Fmt 4703
Sfmt 4703
manner as the request for a hearing
except as follows:
• Confidential Submissions—To
submit any data analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analyses. 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 any decisions on
this matter. 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
or available at the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Submit both copies to the Dockets
Management Staff. Any information
marked as ‘‘confidential’’ will not be
disclosed except in accordance with
§ 10.20 (21 CFR 10.20) and other
applicable disclosure law.
Comments Submitted by Other
Interested Parties: For all comments
submitted by other interested parties,
submit comments as follows:
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
E:\FR\FM\24OCN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64226-64227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23035]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5553]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Annual Summary
Reporting Requirements Under the Right to Try Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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 November 23, 2022.
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 0910-0893. 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,
[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.
Annual Summary Reporting Requirements Under the Right to Try Act
OMB Control Number 0910-0893
This information collection helps to implement provisions of the
Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Right to
Try Act, which requires sponsors and manufacturers who provide an
``eligible investigational drug'' under the Right to Try Act to submit
to FDA an annual summary of such use. Regulations under Sec. 300.200
(21 CFR 300.200) will require that sponsors and manufacturers submit to
FDA an annual summary no later than March 31 of each year, including
data for the preceding calendar year, that includes the following data
elements:
The name of the eligible investigational drug and
applicable investigational new drug application number.
The number of doses supplied to the eligible patient.
The number of eligible patients treated.
The use for which the eligible investigational drug was
made available to the eligible patient.
Any known serious adverse events and outcomes that the
eligible patient treated with an eligible investigational drug
experienced.
Description of Respondents: Respondents to the information
collection are sponsors and manufacturers who provide an eligible
investigational drug to eligible patients in accordance with the Right
to Try Act and will submit to FDA annual summaries.
In the Federal Register of September 14, 2022 (87 FR 56269), we
published a final rule (RIN 0910-AI36), including an analysis of the
information collection, and discussed the development of an associated
form to facilitate submission of the requisite information.
Accordingly, we have developed Form FDA 5023 entitled ``Right To Try
Reporting Requirement: Annual Summary,'' which is currently available
in the docket for comment purposes only, and we are inviting public
comment. As required by the applicable statute, section 561B of the
FD&C Act (21 U.S.C. 360bbb-0a), the information is submitted to an FDA-
designated point of contact, and in accordance with instructions to be
posted at: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.
We estimate the burden of this collection of information as
follows:
[[Page 64227]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR citation Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sponsors and manufacturers submit annual summaries in accordance 6 1 6 2.5 15
with the Right to Try Act (Sec. 300.200) using Form FDA 5023....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with estimates in our Final Regulatory Impact Analysis
for the associated final rule, we estimate that six sponsors and
manufacturers will prepare and submit Form FDA 5023 and assume it takes
2.5 hours to prepare and submit each summary, which results in a total
of 15 hours annually.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23035 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P
