Document ID: FDA-2013-N-1428-0022
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Electronic Drug
Product Reporting for Human Drug Compounding Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2019-10-10T04:00Z

[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54612-54613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22189]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1428]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Electronic Drug 
Product Reporting for Human Drug Compounding Outsourcing Facilities 
Under Section 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.

DATES: Fax written comments on the collection of information by 
November 12, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0827. 
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, 
PRAStaff@fda.hhs.gov.

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.

Electronic Drug Product Reporting for Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act

OMB Control Number 0910-0827--Extension

    The Drug Quality and Security Act added section 503B to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) creating a 
category of entities called ``outsourcing facilities.'' Outsourcing 
facilities, as defined in section 503B(d)(4) of the FD&C Act, are 
facilities that must meet all the requirements described in section 
503B, including registering with FDA as an outsourcing facility and 
submitting regular reports identifying the drugs compounded by the 
outsourcing facility during the previous 6-month period. The first of 
these reports must be submitted upon initial registration as an 
outsourcing facility. Thereafter, semiannual product reports must be 
submitted, once during the month of June and once during the month of 
December, for as long as an establishment remains registered as an 
outsourcing facility.
    In addition, drug products compounded in an outsourcing facility 
can qualify for exemptions from the FDA approval requirements in 
section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to 
label products with adequate directions for use under section 502(f)(1) 
of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section 
503B are met.
    To help respondents understand the statutory requirements, how we 
interpret them, and the associated information collection, we developed 
the guidance document entitled ``Electronic Drug Product Reporting for 
Human Drug Compounding Outsourcing Facilities Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act.'' The guidance is available from 
our website at: https://www.fda.gov/media/90173/download. The guidance 
explains that, once an entity has elected to register as an outsourcing 
facility, it must submit reports identifying the drugs compounded by 
the outsourcing facility. The guidance also communicates who must 
report, the format of the report, the content to include in each 
report, when to report, how reports are submitted to FDA, and the 
consequences of outsourcing facilities' failure to submit reports.
    In the Federal Register of July 17, 2019 (84 FR 34184), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We therefore estimate the burden of the information collection as 
follows:

[[Page 54613]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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      Product reporting for                          Number of
     compounding outsourcing         Number of     responses per   Total annual   Average burden    Total hours
           facilities               respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Initial product reports.........              75            1.01              76               2             152
Waiver request from electronic                 1               1               1               1               1
 submission of initial product
 reports........................
June product reports............              75            1.01              76             0.5              38
December product reports........              75            1.01              76             0.5              38
Waiver request from electronic                 1               1               1               1               1
 submission of product reports..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             230
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on current data for outsourcing facilities, we estimate that 
75 outsourcing facilities will submit an initial report identifying all 
drugs compounded in the facility in the previous 6 months. For the 
purposes of this estimate, each product's structured product labeling 
(SPL) submission is considered a separate response, and therefore each 
facility's product report will include multiple responses. Taking into 
account that a particular product that is compounded into different 
strengths from different sources of active ingredient can be reported 
in a single SPL response, we estimate that each facility will average 
76 products. Our estimate is based on current product reporting data.
    We expect each product report will consist of multiple SPL 
responses per facility and estimate that preparing and submitting this 
information electronically may take up to 2 hours for each initial SPL 
response. We also estimate that the 75 registered outsourcing 
facilities will submit a report twice each year identifying all drugs 
compounded at the facility in the previous 6 months.
    As stated above, we estimate on average 76 SPL responses per 
facility and that preparing and submitting this information 
electronically will take approximately 30 minutes per response. We have 
reduced our burden estimate for semiannual product submissions because 
outsourcing facilities can save each SPL 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 SPL response needs be sent for that product during 
that reporting period.
    We expect to receive no more than one waiver request, each, from 
the electronic submission process for initial product reports and 
semiannual reports, and that each waiver request will take 1 hour to 
prepare and submit.
    Based on submissions we have received, we have reduced the number 
of responses significantly since our original estimate establishing the 
collection. This results in an overall reduction to the information 
collection by 36,072 hours.

    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22189 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P