[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34184-34186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) 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 drug product reporting for human 
drug compounding outsourcing facilities under section 503B of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by September 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 16, 2019. 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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-1428 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on 
Electronic Drug Product Reporting for Human Drug Compounding 
Outsourcing Facilities Under Section 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.
     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

[[Page 34185]]

FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/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.

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. 3501-3520), 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.

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 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 six-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, ``Guidance for Industry; Electronic 
Drug Product Reporting for Human Drug Compounding Outsourcing 
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' 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.
    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 six 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 six 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 since 
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.
    We therefore estimate the burden of the information collection as 
follows:

[[Page 34186]]



                                 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
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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              .5              38
December product reports........              75            1.01              76              .5              38
Waiver request from electronic                 1               1               1               1               1
 submission of product reports..
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    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 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: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15124 Filed 7-16-19; 8:45 am]
BILLING CODE 4164-01-P