[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