Notice2022-13068
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
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Published
June 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on electronic reporting for outsourcing facilities.
Full Text
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<title>Federal Register, Volume 87 Issue 117 (Friday, June 17, 2022)</title>
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[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36507-36509]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13068]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0030]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on electronic reporting for
outsourcing facilities.
DATES: Submit either electronic or written comments on the collection
of information by August 16, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 16, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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.''
[[Page 36508]]
Instructions: All submissions received must include the Docket No.
FDA-2015-N-0030 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Drug Compounding Under
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.''
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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#66363427351207000026000207480e0e1548010910"><span class="__cf_email__" data-cfemail="550507140621343333153331347b3d3d267b323a23">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 ``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.
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 per response Total hours
respondents respondent responses
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Initial product reports...................... 3 53 159 0.0833 (5 minutes)....................... 13.25
Waiver request from electronic submission of 1 1 1 1........................................ 1
initial product reports.
June product reports......................... 75 53 3,975 0.025 (1.5 minutes)...................... 99.375
December product reports..................... 75 53 3,975 0.025 (1.5 minutes)...................... 99.375
[[Page 36509]]
Waiver request from electronic submission of 1 1 1 1........................................ 1
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 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.
Dated: June 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13068 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P
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