Document ID: FDA-2015-N-0030-8509
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2022-06-17T04:00Z

[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36507-36509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 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.
    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