Notice2022-23035
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Summary Reporting Requirements Under the Right to Try Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 204 (Monday, October 24, 2022)</title>
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[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64226-64227]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23035]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#6e3e3c2f3d1a0f08082e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="e5b5b7a4b691848383a5838184cb8d8d96cb828a93">[email protected]</span></a>.
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:
<bullet> The name of the eligible investigational drug and
applicable investigational new drug application number.
<bullet> The number of doses supplied to the eligible patient.
<bullet> The number of eligible patients treated.
<bullet> The use for which the eligible investigational drug was
made available to the eligible patient.
<bullet> 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: <a href="https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try">https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try</a>.
We estimate the burden of this collection of information as
follows:
[[Page 64227]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
Activity; 21 CFR citation Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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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....
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\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
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