Document ID: FDA-2015-N-0030-8511
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2022-10-07T04:00Z

[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61052-61054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0800. 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, 
[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.

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 https://www.fda.gov/media/90173/download, 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
----------------------------------------------------------------------------------------------------------------
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.
                               ---------------------------------------------------------------------------------
    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