Notice2022-21841
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic 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 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61052-61054]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21841]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0030]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Drug
Compounding Under Sections 503A and 503B of the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
[[Page 61053]]
DATES: Submit written comments (including recommendations) on the
collection of information by November 7, 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 0910-0800. 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#c797958694b3a6a1a187a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="326260736146535454725456531c5a5a411c555d44">[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.
Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act
OMB Control Number 0910-0800--Revision
This information collection helps support implementation of
sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the Federal
Food Drug and Cosmetic Act (FD&C Act), which govern requirements for
pharmacy compounding and outsourcing facilities, respectively. For
efficiency of Agency operations, we are revising the information
collection to include related reporting activities currently approved
under OMB control number 0910-0827. Specifically, upon electing and in
order to become an outsourcing facility, respondents must register
under section 503B of the FD&C Act and submit certain reports and
updates to FDA. The information is required to be submitted by
electronic means unless otherwise exempt, and prepared in such form and
manner as the Secretary of the Department of Health and Human Services
may prescribe through regulation or guidance.
In the guidance for industry entitled ``Electronic Drug Product
Reporting for Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act'' (December
2016), available on our website at <a href="https://www.fda.gov/media/90173/download">https://www.fda.gov/media/90173/download</a>, we explain how facilities that elect to register with FDA as
outsourcing facilities are to submit drug product reports, consistent
with section 503B of the FD&C Act. The guidance document describes who
must report and what information must be provided to FDA. The guidance
document also explains that drug compounding reports must be submitted
in structured product labeling (SPL) format using FDA's electronic
submissions system and discusses the consequences of outsourcing
facilities' failure to submit reports.
In the Federal Register of June 17, 2022 (87 FR 36507) we 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\
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Number of
Section 503B of the FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Initial product reports....... 3 53 159 0.0833 (5 13.25
minutes).
Waiver request from electronic 1 1 1 1............... 1
submission of initial product
reports.
June product reports.......... 75 53 3,975 0.025 (1.5 99.375
minutes).
December product reports...... 75 53 3,975 0.025 (1.5 99.375
minutes).
Waiver request from electronic 1 1 1 1............... 1
submission of product reports.
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Total..................... .............. .............. .............. ................ 214
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Respondents to this collection of information are outsourcing
facilities. Based upon our evaluation of the information collection, we
have adjusted our estimate downward by 16 hours (from 230 to 214)
annually to reflect more recent Agency data. We estimate that each year
three outsourcing facilities will submit a product report upon initial
registration under section 503B of the FD&C Act. We estimate that twice
each year 75 outsourcing facilities will submit a report identifying
all human drugs compounded in the facility in the previous 6 months.
For the purposes of this estimate, each product's SPL submission is
considered a separate product response, and therefore each facility's
product report will include multiple product responses. We estimate
that each facility will average 53 product responses. We expect each
product report will consist of multiple product responses per facility
and estimate that preparing and submitting this information
electronically may take up to 5 minutes for each initial product
response.
Assuming an average of 53 product responses per facility, we
estimate that, for semiannual reports, preparing and submitting this
information electronically will take 1.5 minutes per product response.
Our burden estimate for semiannual product report submissions is lower
than for initial product reports because outsourcing facilities can
save each product response once initially created and submitted. For
subsequent reports, an outsourcing facility may resubmit the same
file(s) after changing the RootID and version number (both SPL
metadata), effective date (to identify the reporting period), and the
number of units produced, along with other data as appropriate, to
appropriate values for the reporting period. Furthermore, if a product
was not compounded during a particular reporting period, no product
response would be sent for that product during that reporting period.
We expect to receive no more than one waiver request from the
electronic submission process for initial product reports and
semiannual reports, and that each waiver request will take 60 minutes
to prepare and submit.
[[Page 61054]]
Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21841 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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